June 2, 2009

Consumer Reports to generic skeptics: show us the evidence!

To those who continue to sing the tired old tune that generic drugs are not as effective as brand name drugs, Consumer Reports wants to see the evidence. A post on the CR Health blog states:

Consumer Reports has long advocated the use of generic drugs because they are not only as effective and safe as their branded counterparts but cost less too. So when a segment aired last week on the Today Show that warned about the use of generic drugs to treat epilepsy and other disorders, based on a feature story from the June issue of SELF magazine, we took note.

There have been many anecdotal reports of epilepsy patients who noted an increased numbers of seizures after switching to a generic drug from a branded drug (or even from one generic to another). That is not a new story. But anecdotes don’t prove cause and effect. However, this issue has been observed by neurologists for many years, despite the available scientific evidence that finds generic drugs have the same effect in the body as the brand-name drugs. But reports—from both patients and physicians—of problems occurring when switching supposedly identical drugs continue to crop up. Clinical trials could help resolve this issue, but as far as we are aware, no trials have been done or are in the works. ...

What we find interesting is that the subject of generic efficacy and safety rears its head every few years, and especially now as several popular branded drugs to treat epilepsy have been recently scheduled to go off-patent: Lamictal (lamotrigine), Keppra (levetiracetam) and Depakote (divalproex sodium). Once that happens, generic drug makers can copy the brands and sell them for substantially less. Last year, consumers and their insurance companies spent about $3 billion on these three drugs alone in retail sales, placing them among the 100 top-selling drugs.

Clearly, drug makers have a huge financial interest in keeping their branded drugs to treat epilepsy on the market and free from competition from low-cost generics.

Besides the issue of drugs to treat epilepsy, the Today Show host also warned viewers that most generic drugs are manufactured overseas. What was not mentioned is that the majority of bulk pharmaceutical ingredients used by manufacturers to produce drugs in the U.S. are also manufactured overseas, according to the FDA.

Along those same lines, our recent analysis of drug manufacturers found that from 2004 to 2008 generic drug companies actually received fewer FDA warnings about manufacturing problems than did branded manufacturers. That's particularly notable, since there are far more generic than brand-name drugs on the market. Overall, generic drugs appear no more likely than brand-name drugs to pose risks, according to our review of available data and interviews with experts.

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May 18, 2009

Anti-Abilify Ad

Andy Behrman's story was in the WSJ last week (""A Celebrity Patient's Backing Turns Sour for Drug Company.") He's the former spokesman for Bristol-Myers Squibb and its psychiatric drug Abilify. Emphasis on "former" spokesman because now he's turned against the company and its product.

Here's his video with the message, "Ask Your Doctor If Abilify Is Wrong For You."


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May 14, 2009

The seamy, seedy side of celebrity drug promotions

A must read in the Wall Street Journal: "A Celebrity Patient's Backing Turns Sour for Drug Company."

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April 30, 2009

The Flying Nun Is a Grandmother Now But Drugs Allow Her To Play Twister

Sally Fields’ Boniva ads are the latest target of Consumer Reports’ terrific AdWatch series – this the sixth in a series that could go on forever if drug ad practices continue as we’ve seen.

This one has a special message about the costs of expensive drugs (Boniva is ten times the cost of a generic) – and the hidden costs of all of those “free trials” that drug companies offer so often.



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April 27, 2009

Poison Pills

Poison Pills.png Finished Tom Nesi’s book, “Poison Pills: The Untold Story of the Vioxx Drug Scandal.”

Chilling.

Sickening.

Everyone should read this story.

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April 23, 2009

Readers respond with their most disturbing drug side effects

My favorite: "gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them"

Readers of TheConsumerist.com sent in their picks for drugs with the worst side effects.

disturbingsideeffects.jpg

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April 21, 2009

How will the FDA regulate drug promotion via blog, podcast, social network, etc.?

John Mack tackles the question on his Pharma Marketing blog.

DDMAC-HeadinSand2.jpg


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April 20, 2009

Bipolar children a purely American phenomenon

Christopher Lane interviews journalist Philip Dawdy, who has written about the "astonishing" rise in the number of diagnoses of ADHD and bipolar disorder in teens and preschoolers.


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April 14, 2009

Did CBS cave in to Big Pharma bucks?

The Hollywood Reporter says Tim Robbin’s highly-regarded pilot “Possible Side Effects" has been dumped by Showtime. THR reports that the program...

“...takes a scathing look at the pharmaceutical drug industry, focusing on a dysfunctional family behind a major drug concern.

As a premium cable network, Showtime does not rely on advertisers, but its parent company CBS Corp. does, and pharmaceutical companies are among the top TV advertisers.”


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March 19, 2009

More UMN psychiatry ethics questions surface

I'm on the road, but I see that the Twin Cities papers and blogs are buzzing over new questions of conflict of interest in the University of Minnesota Medical School and specifically in the department of psychiatry.

The Star Tribune reports:

"In the spring of 2000, Dr. S. Charles Schulz attended a national medical conference to present favorable research on a new psychiatric drug called Seroquel. Schulz, chief of psychiatry at the University of Minnesota, reported that the drug was 'significantly superior' to the old gold-standard treatment for schizophrenia. In a press release by the manufacturer, AstraZeneca, he touted the 'dramatic benefits' of Seroquel's class of drugs. But newly released documents show that AstraZeneca knew the research didn't support the claim -- and knew two months before Schulz went public with it.

The disclosures have raised questions about Schulz's ties to the company as a paid consultant at a time when Congress and the university itself are intensifying their scrutiny of potential conflicts of interest in medical research."

The Pioneer Press story is here.

Dr. Frank B. Cerra, Sr. Vice President for Health Sciences at the UMN has an online statement:

"We are clearly operating in a new and different era of accountability, as is apparent from banking issues in New York and appointment issues in Washington in recent days.

For us, in the Academic Health Center this intense concern for accountability is somewhat familiar – with a new and different lens. We’re accustomed to the NIH environment where research grants have clear expectations for performance. And, as a public institution, we regularly report to the Minnesota legislature about our activities and outcomes. And it appears that the federal stimulus funding coming to Minnesota will add another layer of reporting, or accountability to ensure the University spends those dollars wisely.

In the midst of this heightened scrutiny, the media continues to focus on issues of conflict of interest as we publicly wrestle with developing new policies or procedures to manage the industry relationships necessary to bring new discoveries to the public and the marketplace

I’d like to make a couple of points loud and clear, as I have publicly on several occasions. Yes, the faculty within the Academic Health Center – and indeed in other parts of the University – have relationships with industry. Our new ideas, our discoveries would never go anywhere if there weren’t a company willing to develop or manufacture the results of our work. And then those discoveries would never make it into the marketplace to both improve and enhance care and health. Yes, pharmaceutical and device manufacturers pay for clinical trial work taking place at the University. There is no other source of funds. And, yes, our faculty – physicians, pharmacists, dentists and others – are compensated for their time and work.

Our job, as University administrators, is to ensure that those relationships are appropriately disclosed and appropriately managed, so that the public retains its confidence in our institution and its work. That’s accountability that’s critical for today and tomorrow."

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March 8, 2009

The Onion announces approval of drug for the annoyingly, insufferably cheerful

This story has all the elements of excellent health journalism.

• A breakthrough drug called Despondex -a new depressant.

• Profile of a woman who now knows her extreme happiness was abnormal - “Now I realize I was sick and needed treatment.”

• Interview of an expert talking about removing the stigma from those who have this ailment, calling it "a huge step forward in the battle against exuberance."

•The story also had good balance, citing another researcher's claims of a non-drug, natural remedy - such as a diet of corn syrup, white bread and a total lack of exercise.


FDA Approves Depressant Drug For The Annoyingly Cheerful

Prime parody, anchored by Bobbie Batista, former CNN anchor with whom I once worked.

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March 2, 2009

Viva Viagra in Virtual Reality

Shout out to John Mack and his Pharma Marketing blog for finding and writing about this ad he saw in a magazine.

Viagra magazine ad.png

Mack writes:

"I've circled two areas of this ad's imagery, which takes up more than 50% of the ad space, to illustrate what I mean. The circled areas show outdoor Viagra ads WITHIN the print ad!

If such outdoor ads existed in the "real" world, they would violate FDA regulations regarding fair balance because they do not mention any side effects or risks, just the benefits.

The tag line of the ad, "Guys are getting the message," obviously refers to these messages that dominate the world within the ad to which the "guy" in the ad is exposed.

If Viagra were an over-the-counter (OTC) medication, outdoor ads like the billboard and taxi ads shown in this print ad would be perfectly legal. Which leads me to believe that Pfizer is preparing the Viagra brand for OTC status. As you may know, Viagra will lose its patent protection as early as June, 2011, so it's not too early for Pfizer to subtly plant these OTC ad images in our mind."

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February 27, 2009

Call for more facts on magazine drug ads

What if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbs and calories of an Oreo cookie?

That's the way Natasha Singer started her piece in the New York Times yesterday about a new proposal for improved benefits-and-harms disclosure on drug ads.

Dartmouth's Steve Woloshin and Lisa Schwartz propose that the F.D.A. require new facts boxes on ads - somewhat akin to nutrition fact panels — "numerical tables that quantify the benefits of taking a drug compared with a placebo, and that list the odds of having side effects."

Woloshin told the Times: “We thought, if you could do it for Cocoa Krispies or Diet Coke, why couldn’t you do it for Lunesta or other drugs?”

Lunesta ad.png

Other excerpt:

The Dartmouth researchers, in one example, used data from a published study of the insomnia drug Lunesta to create a benefit box showing that volunteers who took the sleeping pill nightly for six months typically fell asleep 15 minutes faster than people on a placebo. The table, e-mailed to a reporter, also indicates that volunteers taking Lunesta typically slept for six hours and 22 minutes — or only 37 minutes longer than the placebo group. There was no difference in life-threatening side effects among the groups.

In 2007, Sepracor, the maker of Lunesta, spent about $293 million on advertisements for the sleeping pill, the highest ad spending that year among drug brands, according to Nielsen.

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February 24, 2009

CR takes on Chantix "stealth" ads

Kudos to Jamie Hirsh and the Consumer Reports team on another terrific "reality check/ad watch" - this time on "stealth" ads for the stop-smoking drug Chantix.

chantix.png

CR has done several of these now, but they can't do them fast enough in my view.

The truthtelling that should be done on direct-to-consumer drug ads is a huge task.

Remember: we're one of only two countries on the globe that allows direct-to-consumer drug ads.
And New Zealand - the other - has been making noise about adopting a ban.

Which would leave us where we often are in health care: #1 atop the world!!!!

Just not in ways we should be proud of.

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February 22, 2009

PR Diarrhea

If there's any doubt about the impact of public relations efforts on news coverage of health products, look at what the PR company Fleishman-Hillard brags about on its website. They describe a campaign for a diarrhea vaccine. From their website:

Don't Leave Home Without It

Fleishman-Hillard launches Dukoral. A three-pronged media relations campaign resulted in 19 million impressions (triple the project goal), physician acceptance and consumer demand for Dukoral.

Dukoral, the first and only oral vaccine for protection against most common causes of Traveller's Diarrhea. For the project spokespeople were identified in key Canadian Markets (Vancouver, Toronto, Montreal-bilingual) willing to speak to the media about Dukoral. The spokespeople represented Dukoral to travel, healthcare and consumer media. All media coverage has had a direct impact on the target audiences. Media coverage incorporated key messages about Travellers' Diarrhea and Dukoral's role in the prevention of this potentially serious illness. Attributed to the extensive media coverage physician have reported to sales team that many patients have asked for Dukoral bringing in articles consumers themselves have read.

Journalists love toilet jokes in their stories. Melody Petersen, in her book, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, wrote that too many journalists too easily fall into drug company plans to create a market for a drug, such as, in one case, a drug for “overactive bladders.” “Dozens of journalists at newspapers and television stations across the country wrote stories about the disorder said to be destroying the lives of millions of Americans,” she wrote. “Editors and television news directors loved these reports. Silly stories of people running to the toilet brightened the day’s news.”

Dukoral is not yet approved by the FDA.

Thanks for the tip to Alan Cassels, who also points out questions about the vaccine's effectiveness and its cost.

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February 9, 2009

Ghostwriting debate

The journal PLoS Medicine offers an online debate on the practice of ghostwriting in medical journals. Their background to the debate:

"Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer."

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February 2, 2009

Will Boston lose business due to medical conflict-of-interest laws?

Or is just fear-mongering on the part of industry and special interests?

The Boston Globe and blogger Alison Bass have written about the new Massachusetts "state's regulations, which establish a code of conduct for pharmaceutical company employees, will limit participation by drug company scientists in meetings and continuing medical education courses in Massachusetts." As a result, some medical groups are threatening to move their medical conferences out of Boston.

Blogger Bass writes:

"All three of the medical societies named in the (Globe) article -- The American Academy of Allergy, Asthma and Immunology, the American Society of Gene Therapy and the Heart Rhythm Society -- have received major funding from the pharmaceutical and medical device industry over the years.

Hmmm...could it be that the pharmaceutical and medical device industry had something to do with these rather unsubtle threats?

Spokespeople for two of the groups quoted in The Globe article said they were concerned that the proposed guidelines won't allow presentations by drug company employees at meetings in Massachusetts. According to local public health officials, that's simply not true. The regulations do allow company scientists to present at meetings but the presentations must be objective and cannot be used to flagrantly promote company's products. What a marvelous concept -- and a major departure from business as usual.

One need only visit the medical groups' websites to see the extent of industry funding behind these groups. In the March 2008 annual meeting program of the American Academy of Asthma, Allergy and Immunology, for example, the list of commercial supporters filled a full page, ranging from pharm companies such as GlaxoSmithKline, Merck, Schering Plough and AstroZenica to biotechs like Sepracor, Genentech and Teva Specialty.

Likewise, the Heart Rhythm Society's list of supporters for its May 2008 meeting in San Francisco includes all the major makers of cardiac medical devices: Medtronic, Boston Scientific and sanofi aventis (labeled Diamond Level sponsors), Boehringer Ingelheim (an Emerald Level Sponsor) and Biosense Webster, a subsidiary of Johnson and Johnson (alas only Ruby Level).

Similarly, the American Society of Gene Therapy listed Genzyme as its "partner" for its annual meeting last May in Boston and 15 biotech and medical device companies as major contributors and patrons.

So if The Boston Globe really wanted to do its homework, it could ask these three medical groups just how much money all this corporate sponsorship translates into every year and what kind of pressure the industry put on them to howl about regulations that were, by the way, designed to protect consumers."

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January 30, 2009

Only 50 Ways To Leave Big Pharma?

On the Pharmagossip site, Dr. Adriane Fugh-Berman posts new lyrics to go with Paul Simon's "50 Ways To Leave Your Lover." Excerpt of the refrain:

There must be fifty ways to leave Big Pharma Fifty ways to leave Big Pharma

Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just get yourself free
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free

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January 21, 2009

Lunch with pharma at breast cancer conference

Breast Cancer Action staffer Allison Young posted her thoughts about drug companies making their pitches at the annual San Antonio Breast Cancer Symposium held in December. She wrote about the pharma-sponsored advocacy luncheons she attended there. Excerpts:

"Genentech started off with a feel-good video about their relationship with patient advocates, some of whom were in the room. But all this high-priced PR seemed to fall by the wayside during the presentation when the scientist said, “We use progression-free survival as a marker because we find it meaningful? and the advocates, one by one, responded, “Well, we think our overall survival is what’s really meaningful.?

I anticipated a similar scenario at the Novartis luncheon, but I got the impression that Novartis had misjudged the audience and its realities. These are women living with breast cancer attending a scientific conference, and while there were varying degrees of pink ribbon fashion in the room, everyone was hungry for good information. They quickly bristled at the celebrity actress talking about how convenient it was to have 28-day infusions while traveling freely around North America, or the suggestion they brush their teeth more often to prevent dental side effects caused by Zometa (zoledronic acid). The advocates represent patients across the country who might have HMOs or no insurance at all, who were not given full and accurate information about potential side effects before taking Zometa, and who have a really hard time getting their team of doctors to work together: “I can’t get my surgeon to talk to my oncologist, and you want me to get my oncologist to talk to my dentist?? Ms. Gelb asked.

The day before I left for San Antonio, I received a call from a BCA member who had osteonecrosis of the jaw from taking zoledronic acid. And I know that as soon as I’m back in San Francisco, I’ll still be talking to women who are living the reality of breast cancer, minus the free lunch."

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January 18, 2009

Surprise! PhRMA chief doesn't want Medicare negotiating drug prices

I'll slip this in on the weekend because it's not really news and it's not at all surprising. PhRMA CEO Billy Tauzin is opposed to having the feds negotiate Medicare drug prices. The Medicare drug legislation he fought so hard to get passed while a Çongressman- even being singled out for praise by President Bush - bans such price negotiations. It closes the door on Medicare being able to wield its massive purchasing power in a way that could help health care consumers.

But that's not the way good old boy Billy sees it.

From the Kaiser Daily Health Policy Report last week:

Allowing Medicare to negotiate prescription drug prices on behalf of beneficiaries could reduce the number of drugs the program offers and result in higher costs for beneficiaries, Pharmaceutical Research and Manufacturers of America President and CEO Billy Tauzin said Wednesday, CQ HealthBeat reports. According to Tauzin, Medicare now offers access to thousands of drugs because the program relies on private-sector competition. Tauzin, speaking at a media roundtable, said, "When you put the government in the process you freeze out the private sector."

HHS Secretary-designate and former Senate Majority Leader Tom Daschle (D-S.D.) last week in testimony before the Senate Health, Education, Labor and Pensions Committee said the idea of allowing the secretary to negotiate drug prices "ought to be evaluated and looked at." Supporters of the idea have said it could save taxpayers billions of dollars and lower drug prices for all U.S. residents

It'll be fun to watch Billy function without his buddy in the White House.

By the way, if you never saw the 60 Minutes profile of Tauzin's role in the passage of the Medicare drug legislation, give it a look someday.

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January 15, 2009

"How in the hell can a guy walk out in 20-below zero and not wake up?"

Ambien?

The Star Tribune reports:

After Hayward, Wis., electrician Timothy Brueggeman froze to death while sleepwalking barefoot in his underwear Monday night, authorities were initially baffled. ...Going through Brueggeman's bedroom, investigators found a possible answer -- a bottle of Ambien. The most-prescribed sleep aid in the United States has helped millions, but it has also has been linked to hundreds of cases of sleepwalking, sleep-driving and even sleep-shoplifting. Such cases led to a class-action suit against Sanofi-Aventis. The drugmaker, which maintains that Ambien is safe when taken correctly and not mixed with alcohol or other drugs, didn't respond to requests for comment Wednesday.

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January 14, 2009

One more thing I hate about airplane tray tables

Sneak attacks by drug ads.

You know when you pull down that damn tray that it won’t be big enough, that it’ll push back into you if the huge person in front of you reclines his/her seat, and that it may be broken and not level – so putting a cup down becomes a liquid-balancing act at 36,000 feet with your new white shirt on (the only one you have for this trip).

But this week I pulled down my tray table on a flight and – SURPRISE!!! – a huge ugly orange drug ad jumped out at me. People sitting around me gasped.

Airline Zircam ad.JPG

As you can see from the photo I took with my trusty 2 megapixel iPhone camera, the rhino was horning into my onboard tranquility (yeah, right!) by hawking Zicam Gel Swabs. I don’t even want to think about where those swabs are supposed to go.

Ah, but the label reads “homeopathic.? What a relief. That makes the whole experience worthwhile.

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January 13, 2009

Are doctors loyalties divided?

The Milwaukee Journal - a paper facing all the struggles (and maybe some more) that any news organization faces - continues to shine through it all with its health news coverage.

Reporter John Fauber has a two-part series this week on "doctors moonlighting for drug companies." Excerpt:

It's a practice that increasingly is drawing criticism because of concerns that it can influence patient care and raise the cost of treatment, in addition to blurring the line between research and marketing.

The deans of the state's two medical schools say they would like to ban the practice or severely limit it.

"I am very bothered by our faculty using our school's name in giving non-academic promotional, marketing talks," said Robert Golden, dean of the UW medical school. "It's a major issue we are talking about now."

In October, the Wisconsin Medical Society, as part of its recommendations for ethical behavior, said doctors should not serve as speakers. The group has no authority to regulate or stop the practice.

See part one.

And part two.

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December 23, 2008

Ghostwriting & pharma's publication planning

A commentary by Adriane Fugh-Berman and Susanna J Dodgson in Open Medicine today is about ghostwriting of drug-related journal articles and publication planning - "the finely calibrated process by which clinical trials, commentaries and other articles supporting the efficacy of particular products are written and released into the biomedical literature. This article describes how industry uses publication planning to sway medical and public opinion through the medium of medical journals."

From the conclusion:

Publication planning, as it is currently practised by pharmaceutical companies, can undermine the medical literature. Industry control over the timing, content and authorship of studies and opinion pieces including reviews and commentaries distorts medical discourse. That academic health professionals (physicians, nurses, pharmacists) lend their names to articles to which they may have contributed nothing is ironic, considering that such behaviour by students in the same academic institutions would be considered plagiarism.

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December 12, 2008

Drug becomes "top PR blunder"

Ed Silverman blogs about "Vytorin: A Top Ten Public Relations Blunder."

How did Vytorin rate such a distinction? The authors of the list write:

“Market Vytorin and its Zetia sidekick with a memorable $100 million plus advertising campaign. Withhold study results showing that the combo doesn’t work as claimed…for 21 months.

Watch the drugs pull $5.2 billion in revenue in 2007 alone. Side effects, though, may include widespread consumer backlash, around 140 civil class-action lawsuits, and the unwelcome attentions of Congress, the US Department of Justice and a coalition of 35 state attorneys general…Merck and Schering-Plough allegedly didn’t release the results due to internal scientific concerns (reportedly because) there were reasons to doubt the study.'

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December 11, 2008

Pharma fails to get serious with drug ad reform

It's a joke to see the changes that drug makers say they will make to certain drug ads. Details are reported in the Wall Street Journal.

• They won't promote drugs for uses the FDA hasn't approved.
• They won't use actors posing as physicians without saying so.
• They won't let celebrity endorsers say they use a drug unless they really do.

Pardon my sarcasm, but, "Oh, thank you, Big Pharma, for making these drastic changes that only abide by the law and the code of honesty."

Congressman Bart Stupak said, "It's an opportunity to pull the wool over the eyes of consumers while they sell more drugs."

Peter Lurie of Public Citizen said, "I think the changes are pretty trivial."

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December 1, 2008

Conflict of interest on NPR's "On the Media"

NPR's "On the Media" program this weekend looked at drug industry influence on media messages, including an interview with Senator Charles Grassley about his investigations of the industry.

The program also featured an interview with me about our HealthNewsReview.org project and about other issues involving health care news sources' conflicts of interest.


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November 20, 2008

Entanglement of medical journalists & Big Pharma

In the BMJ this week, Steve Woloshin, Lisa Schwartz and Ray Moynihan raise new questions about "who's watching the watchdogs?" Excerpts:

"Industry sponsorship of training and further education of journalists now occurs in a variety of contexts—universities, conferences, and professional associations—raising similar concerns to those that apply to education of doctors.

The University of North Carolina’s master’s degree in medical journalism, one of the first in the United States, has at least two important forms of financial relations with drug companies. ...

Like some university programmes, the American Medical Writers Association, whose members include reporters and public relations specialists, receives sponsorship from the drug industry. Eli Lilly was a key sponsor of the association’s 2008 annual conference, and the company also sponsors its student scholarships.
...
One of the more astonishing forms of financial ties between journalists and drug companies is the sponsored award, which often involves lucrative cash prizes or opportunities for international travel. For example, Eli Lilly and Boehringer Ingelheim have co-sponsored an award for "reporting on urinary incontinence," carrying a prize of international travel. Boehringer has an award for reporting on "chronic obstructive pulmonary disease," offering prizes worth $5000 each, Eli Lilly one for reporting on oncology, and Roche one for "obesity journalism," with a prize of $7500. Sometimes awards are sponsored by organisations that are themselves heavily funded by industry, such as the non-profit Mental Health America. Its 2007 annual report shows that almost half of its funds came from drug companies, including more than $1m each from Bristol Myers Squibb, Lilly, and Wyeth.
...
A powerful contemporary example of entanglement involves a television network called Accent Health (whose logo includes the words "Your target is waiting"), said to be watched monthly by more than 10 million viewers in US medical waiting rooms. The network, which is produced by CNN, overtly offers sponsors, including drug companies, the chance to boost sales of their products, by, for example, putting "your brand in front of the valuable Baby Boomer population just before they discuss their health conditions with their doctor." One of the hosts is Sanjay Gupta, CNN’s chief medical correspondent and host of at least one other CNN health programme that is funded partly through drug company advertising. ...

As researchers and writers acting to improve medical journalism, we encourage journalists, educators, and professional associations to scrutinise their own relations with the industry as intensely as they do those between doctors and drug companies and to develop workable solutions. And, if they are to be good watchdogs, journalists need to mark their territory and clearly establish boundaries between themselves and the industry to avoid unhealthy entanglements.

"

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November 18, 2008

Drug company pricing shenanigans

The Wall Street Journal shows how a drug company uses classic tactics to:

A. raise its prices in advance of losing its patent and facing generic competition
B. meantime launching a new "longer-acting" form of the same drug
C setting the new drug's price much lower than the suddenly-inflated old drug's price.
D. setting the hook before generic competition kicks in.
Case in point: Cephalon Inc.'s Provigil narcolepsy drug is now 28% more expensive than in March and 74% more expensive than four years ago.

Meantime, the WSJ reminds us that "In September, Cephalon agreed to plead guilty to one misdemeanor count of violating the U.S. Food, Drug and Cosmetic Act and to pay $444 million to settle federal and state allegations that it promoted Provigil and two other drugs for off-label uses."

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November 10, 2008

More statin scrutiny & skepticism

On the ABC site, Norton Hadler writes:

Are you convinced this small effect is real, that it will reproduce if one were to repeat the JUPITER trial?

I am not. I am reflexively skeptical of effects of this magnitude. My main reason relates to the nature of the randomized controlled trials we rely on for evidence. There are many factors vying to seal a well person's cardiovascular fate.

For example, there are the so-called cardiovascular risk factors such obesity and tobacco abuse. By assigning volunteers randomly to Crestor or placebo, one hopes that the number of smokers and obese folks are equal in the two groups.

When the JUPITER investigators checked, indeed such measurable risk factors were distributed 50-50. One has to have faith that the factors that cannot be safely measured (such as the degree to which the blood vessels are diseased) also distribute 50-50. And one has to have faith that the factors that JUPITER was designed to ignore distribute 50-50.

Socioeconomic status, job security, education level are even more important risk factors that are independent of those measured and likely to vary widely across the research sites in these 26 countries. Slight imbalances between the Crestor and placebo groups could result in effects of the magnitude touted by JUPITER.

I never leap to act on the basis of such small effects. It's why this year if you feed your family margarine, you're not a caring person and last year it was butter that was bad for you.

If you're convinced these small effects are real, are they meaningful to you?

Are you willing to swallow Crestor every day for two years in the hopes you're the one in hundreds who just might be spared a non-fatal heart attack? Does it bother you that more of the volunteers on Crestor were diagnosed with diabetes?

This possible association aside, there is nothing to suggest that the volunteers for JUPITER were harmed in the two years. But that does not mean the drug is risk-free. Does it bother you that the occasional person on Crestor develops a muscle disease, or that some have liver or kidney irritation?

I am not tormented by such uncertainties as I doubt the small effects are real and therefore have no interest in taking Crestor. You and your prescribing physician should take pause, at the very least.

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Some words of caution about cholesterol study

I awake to all kinds of breathless news coverage about breakthroughs and paradigm shifts regarding the statin study called Jupiter.

But Merrill Goozner offers a terrific analysis on his site, reminding us about costs, about number needed to treat, and about what ISN'T emphasized in the study and in the news coverage. Excerpts:

Its lead investigator, Paul Ridker of Brigham and Women's Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more "apparently healthy men and women" on rosuvastatin, it's an additional $2 billion-plus in sales for AstraZeneca. If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it's $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.

and

We can look at the benefits another way -- in terms of the number of people who need to be treated to avoid a serious event. In this trial, 120 patients had to be treated for 1.9 years to prevent one serious cardiac event. Remember what rosuvastatin costs? $1,250 a year. That's $285,000 per event prevented just for the statin pills. The physician visits, CRP tests and lab work add additional thousands more.

and


So there you have it. A possibly unethical trial with marginal results gets trumpeted in the media as showing "wide benefit" (New York Times). Based on the laudatory quotes coming from the leaders of the American College of Cardiology, this off-label use of statins will quickly find its way into clinical practice guidelines and drug compendia. Within a few years, health care payers will be forking over billions more dollars to the statin drug makers in the name of preventing heart disease.

Meanwhile, our health care outcomes -- including cardiovascular disease -- will still rank somewhere between Romania and Poland. Health care costs will still be rising at twice the rate of overall inflation. And those truly at risk of heart disease still won't be getting the counseling that might save their lives.


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November 5, 2008

Vytorin saga gets messier

From the Wall Street Journal Health Blog:

The latest in the never-ending Vytorin saga: The Department of Justice and attorneys general from 35 states are investigating whether Merck and Schering-Plough improperly promoted the cholesterol drug.

Merck said the DOJ is investigating whether the companies’ Vytorin promotion caused false claims to be submitted to federal health care programs. What’s that mean?

The False Claims Act (and state versions of it) has become a popular legal tool that public officials use against drug makers, saying for instance that their alleged improper marketing of drugs causes government programs such as Medicare or Medicaid to pay for the drugs under false pretenses.


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October 30, 2008

Patients v. Pharma

See Niko Karvounis's blog entry, "The Case of Patients v. Big Pharma." It starts:

On November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the “business case of the century?—and with good reason. In essence, Monday’s ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks.

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September 30, 2008

Editors may not know what they're doing with health news stories

A study in JAMA this week concludes that "News articles reporting on medication studies often fail to report pharmaceutical company funding and frequently refer to medications by their brand names despite newspaper editors' contention that this is not the case." Excerpts:

"Even when this information is reported, it is seldom placed prominently in the text. As a result, those who learn about medical research from the news media may remain unaware of how the research has been funded. In addition, our analysis suggests that news articles usually refer to medications by their brand names rather than their generic names. As a result, those who read about medications in the US news media may frequently learn to refer to medications by their brand names."

In a survey, most newspaper editors said they always or often disclosed drug company funding as part of the story - but the researchers' analysis of news stories showed that NOT to be the case.

"Our study also showed that the majority of major newspapers lacked written policies on the reporting of pharmaceutical company funding and the use of generic medication names. Although most publications had unwritten policies specifying that company funding should be reported, only a few had unwritten policies concerning generic names. These findings may partially explain why journalists so frequently neglect to report when research has received company funding and so frequently refer to medications by their brand names. However, many articles in our analysis from publications with policies about the reporting of company funding and the use of generic names frequently did not follow these policies.

...Additionally, news releases—which many journalists rely on for summaries of technically difficult material—often fail to indicate when a study has been company funded. One study published in 2002, for example, found that only 22% of news releases issued by medical journals noted when a study had received company funding.

Our findings raise several concerns. For patients and physicians to evaluate new research findings, it is important that they know how the research was funded so they can assess whether commercial biases may have affected the results. Additionally, the use of generic medication names by the news media is preferable so that physicians and patients learn to refer to medications by their generic names, a practice that is likely to reduce medication errors and may decrease unnecessary health care costs."

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September 29, 2008

Fibromyalgia in the French Quarter

According to the Fierce Pharma website, Pfizer kept increasing ad spending (by almost 25%) in 2007 while many drug companies were cutting their ad spending. The site says that one of Pfizer's drugs, Lyrica, "saw its budget skyrocket 123 percent. In 2007, Pfizer won a new fibromyalgia indication for Lyrica--originally a nerve pain drug--and spent almost $74 million on promotion."

Pfizer's website says " Fibromyalgia is a real medical condition. It includes all-over muscle pain that can make it hard to do even day-to-day tasks. The pain may vary from mild to severe."
Picture 3.png
The woman in their ads must have the mild form. She's sauntering around the French Quarter with her guy. I guess we're supposed to believe that Lyrica allowed her to do that.

Back when the drug was approved, the New York Times asked if the disease was real. Excerpt:

"But other doctors — including the one who wrote the 1990 paper that defined fibromyalgia but who has since changed his mind — say that the disease does not exist and that Lyrica and the other drugs will be taken by millions of people who do not need them."

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September 24, 2008

We don't get all the bad news from drug trials

A new study published in PLoS Medicine suggests that more than half the clinical trials to support drug approval remain unpublished 5 years or more after FDA approval. The journal editors summarize:

"(These findings) also reveal selective reporting of results. For example, they show that a pivotal trial in which the new drug does no better than an old drug is less likely to be published than one where the new drug is more effective, a publication bias that could establish an inappropriately favorable record for the new drug in the medical literature. Importantly, these findings provide a baseline for monitoring the effects of the FDA Amendments Act 2007, which was introduced to improve the accuracy and completeness of drug trial reporting. Under this Act, all trials supporting FDA-approved drugs must be registered when they start, and the summary results of all the outcomes declared at trial registration as well as specific details about the trial protocol must be publicly posted within a year of drug approval on the US National Institutes of Health clinical trials site."

Maggie Mahar blogs about the news of this study, offering some additional perspectives.

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September 22, 2008

Merck continues to push Gardasil HPV vaccination for more women

Judith Siers-Poisson writes that the Gardasil HPV vaccine has not turned out to be the shot in the arm that Merck hoped it would be.


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September 16, 2008

Should Pharma PR Pros Write the Government’s Advice to Consumers?

The FDA has launched a new website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers." masthead.jpg

But Merrill Goozner and the Integrity In Science Watch project of the Center for Science in the Public Interest distributed a news release with their concerns. Excerpts::

Drug ads can be confusing and often deceptive, so it makes sense that the Food and Drug Administration would develop a web site aimed at helping consumers separate fact from fiction. But to develop such a site the FDA turned to a nonprofit front group erected by Shaw Science Partners, a public relations firm that specializes in launching new drugs such as Viagra, Celebrex, Zoloft, Cymbalta and the now-withdrawn Rezulin.

CSPI today called on the FDA to scuttle the web site, to terminate its relationship with the drug companies’ PR. firm, and to seek out advice from leading physicians, pharmacists, or consumer groups before publishing a new site aimed at educating consumers. The connection between the FDA site and the Big Pharma PR. firm was reported this morning in Integrity in Science Watch, published by the Center for Science in the Public Interest. ...

“It’s not that any of the information presented on this web site is wrong, per se,? said Goozner. “But if the goal were to educate consumers about drug ads, the site is a dismal failure. Nowhere are consumers encouraged to view drug ads with any kind of skepticism. Nowhere are consumers urged how to evaluate messages about side effects. The agency basically invited an industry-funded front group to write the advice. Not surprisingly, they delivered a turkey.?

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September 15, 2008

No Mas, No Gracias, No Pharma Gifts

A news story in the BMJ explained (excerpts):

Healthcare professionals in Spain are beginning to fight back against the pressure that the drug industry exerts on them to prescribe particular products. Professionals from a wide range of medical fields have created the No Gracias ("No thank you") group, part of the international No Free Lunch movement, a network of non-profit organisations that aim to "encourage health care providers to practise medicine on the basis of scientific evidence rather than on the basis of pharmaceutical promotion".pages_pharaphenelia.gif

The group’s main objective is to put an end to such practices. It warns: "The penetration of the drug industry into health care has resulted in a complex network of interests and collusion that affects the whole sector. The industry finances professional training, an area severely neglected by the public sector, by offering free courses, meetings, trips, meals, and presentations. Health centres open their doors to company sales representatives who, with their gifts of greater or lesser value (presented as "educational opportunities"), generate a sponsorship culture that damages the autonomy of the professional and the rationale behind the prescription."

Things are changing in the Spanish healthcare system. Medical professionals admit that they are part of the reason why some ethical issues were ignored previously, and now they want to change attitudes.

But the No Gracias group also recognises that it needs to take action outside the profession and has taken steps to bring the debate into the Spanish parliament, recognising that the influence of drug companies in the healthcare system requires action at the national level.

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September 3, 2008

Cross-border influence of US drug ads

There's been considerable news coverage of a study published online by the BMJ this week about the impact of direct-to-consumer drug advertising. Much of it appears under headlines suggesting such ads are a waste of time and money.

The study tried "to assess the impact of direct to consumer advertising of prescription drugs in the United States on Canadian prescribing rates for three heavily marketed drugs" - one of which was later withdrawn for safety reasons. Canada does not allow direct-to-consumer drug advertising, but its citizens clearly have access to, and may be influenced by, US advertising.

But many news stories are missing some of the concluding comments of the authors, which I pasted below:

The implications of our analysis are threefold. Firstly, it indicates that illicit cross border exposure to direct to consumer advertising has the potential to modify drug use, even where such advertising is technically prohibited. As advertising over global mediums such as the internet increases, this phenomenon may grow in importance. Secondly, to our knowledge, these results are the strongest evidence that direct to consumer advertising can increase use of a drug that was removed from the market as a result of concerns about safety. Finally, our findings suggest that the impact of direct to consumer advertising campaigns is mixed, as they seem to work for some drugs and not others. If the overall impact of direct to consumer advertising is limited or variable, then a substantial portion of expenditure on such advertising—borne by governments, insurers, and patients in the form of higher costs or by companies as reduced profits—may be better spent elsewhere. Previous commentary may have overemphasised the impact of direct to consumer advertising for many individual drugs for which evidence that it increases use is either weak or non-existent. Until we better understand how direct to consumer advertising modifies prescribing for particular drugs, debates about its positive and negative consequences will continue to be based on conjecture rather than strong evidence.
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August 25, 2008

Ads use fear to sell HIV drugs

The Wall Street Journal reports that patient support groups are criticizing GlaxoSmithKline over drug ads that they say attempt to scare patients away from trying other, newer drugs.

One ad's image is sharks in the water, with the message: "Don't take a chance -- stick with the HIV medicine that's working for you."

Another - for Glaxo's drug Lexiva - tells patients to ask their doctor, "Will the HIV medicine make my skin or eyes turn yellow?" That side effect has been reported with other HIV drugs.

Bristol-Myers Squibb has an ad showing a toilet - with the text, "Ask your doctor if there are HIV medications with a low risk of diarrhea." Of course BMS thinks it has such a drug.

The WSJ reports:

Such comparison ads are common elsewhere. But the pharmaceutical industry traditionally sold HIV drugs with images of hope and by explaining the benefits of their treatments. The tough new tack has some patient groups unsettled, saying it could scare off patients.

A development fueling the sharp-elbows advertising: The market for HIV medicines has grown crowded, and companies want to protect their market share.

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August 19, 2008

Who can afford the newest drugs?

The Seattle Times reports on expensive new biotech drugs overwhelming patients and their insurance. Excerpt:

For some patients, such new-generation drugs, often called "biologicals" or "bioengineered" when they are created by genetically modified living cells, have performed magic. In some cases, they work when other drugs have failed, or for diseases that previously had no drug treatments at all.

But they cost a lot — often $2,000 to $3,000 per month.

And in a double whammy, some insured patients who previously paid a fixed amount — likely $30 to $50 even for the most expensive, brand-name drugs — are suddenly finding the rules have changed.

For these new drugs, an increasing number of patients must pay a percentage of the tab, generally 25 to 30 percent. For many of those patients, that can mean a bill of $600 to $900 a month for a drug that they may need for many years.

The rising bill for such complex drugs threatens to financially overwhelm patients and employers, and — if current trends continue — to unravel the very philosophy of health insurance.

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August 9, 2008

And we ain't talkin' recreational drug use

A report in the BMJ claims:

People in England over the age of 60 years are using twice as many prescription drugs now as they were 10 years ago, new figures released by the NHS Information Centre show.

The statistics on prescriptions dispensed in the community show that people aged 60 or over are now given an average of 42.4 prescribed items a year, up from 22.3 in 1997. The overall number of prescriptions dispensed rose by nearly 60% over this period.

Overall 796 million prescribed items were dispensed in England in 2007, whereas the number was 752 million in 2006 and 500 million in 1997. On average, 15.6 items are prescribed per person each year; 10 years ago the average was 10.3 items. However, the average number of items prescribed to children under 16 years fell in the same period, from 4.9 to 3.9 a year.


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August 8, 2008

Why are so many drug prices going up 100% or higher?

USA Today reports:

Drug companies are quietly pushing through price hikes of 100% — or even more than 1,000% — for a very small but growing number of prescription drugs, helping to drive up costs for insurers, patients and government programs.

The number of brand-name drugs with increases of 100% or more could double this year from four years ago, researchers from the University of Minnesota say. Many of the drugs are older products that treat fairly rare, but often serious or even life-threatening, conditions.

"There's no simple explanation," says Stephen Schondelmeyer, director of the PRIME Institute at the University of Minnesota, which studies drug industry economics. "Some companies seem to figure no one is watching so they can get away with it."

The price increases are drawing legal and political scrutiny:

• In a decision awaiting approval by the 9th U.S. Circuit Court of Appeals, drugmaker Abbott agreed last week to pay up to $27.5 million to settle a lawsuit over a 400% price increase on its HIV/AIDS drug Norvir. The price did not change.

• Sen. Amy Klobuchar, D-Minn., and Sen. Charles Schumer, D-N.Y., asked the Government Accountability Office last week to investigate large price hikes. Klobuchar asked the Federal Trade Commission in April to investigate Ovation Pharmaceuticals, which raised prices on four drugs in 2006 by up to 3,437%.


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July 31, 2008

Big Pharma & Big Politics

The Wall Street Journal reports:

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. ...

FDA officials "are too cozy with the companies they regulate," Sen. Chuck Grassley (R., Iowa) said, adding that new leadership must "fix the culture." ...

"There's a total inability of the FDA to carry out" its mission," said Rep. John Dingell (D., Mich.)

Meantime, the folks at the Center for Media & Democracy on their PRWatch.org website caught a couple of things I had missed regarding Big Pharma and Big Politics.

Pushing Prescriptions

Source: Center for Public Integrity, June 24, 2008

"Washington's largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort," reports M. Asif Ismail. The spending, from companies and trade associations including Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, jumped 36 percent over the previous year. Much of the increase went to Democrats, after they became the majority party in Congress. "In the current election cycle so far, for the first time on record, the pharmaceutical and health products industry has given slightly more money to Democrats than Republicans," Ismail notes. Just two years earlier, "Democrats received only 31 percent of the contributions from the industry, while the Republicans received 67 percent." The industry's lobbying successes have included "thwarting congressional efforts to restrict media ads for prescription drugs," "blocking the importation of inexpensive drugs from other countries," and "ensuring greater market access for pharmaceutical companies in international free trade agreements."

If You Can't Beat 'em, Hire 'em

Source: Wall Street Journal (sub req'd) July 23, 2008

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices." He was also an active litigator who worked against consumer interests. "Representing the Washington Legal Foundation, an industry-supported business think tank, Mr. Troy argued for the protection of commercial speech. ... He was also part of the winning team representing Brown & Williamson in a suit against the FDA regarding tobacco advertising." At the FDA, he was known as a loyal friend of the very industries the regulatory agency is charged with monitoring. "Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical-device makers, saying that having met the FDA's approval and labeling standards, manufacturers should be protected from state-based suits for damages." His move to GSK is another example of the revolving door between government and industry. GSK said of Troy, "His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients."


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July 28, 2008

Here's why off-label drug marketing is off the charts

The AP reports on a Government Accountability Office analysis of FDA monitoring of off-label drug promotion - which means marketing of drugs for purposes for which they are not approved. Excerpt:

"The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA "isn't keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it's the FDA's job to enforce that law," Grassley said in a statement. "As a result, drug makers aren't being held accountable for promoting unapproved use of medicine and patient safety is diminished."

Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements."

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July 16, 2008

Olympians pushing Botox - an "outrageous caper"

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, released this statement yesterday:

"It is a sad day when two superb Olympic athletes - whose performances earned a total of 14 gold medals combined - prostitute themselves for undisclosed amounts of money to help Allergan sell Botox. Instead of tens of millions of people watching the athletes’ performances in the past as they strived for their personal best, people will now be able to watch videos of doctors’ performances as they inject former swimmer Mark Spitz and former gymnast Nadia Comaneci with Botox.

This sends a terrible message to athletes, young or old, and to others that they should not accept the way they look as they age but, rather, should try to look their "personal best" by the Botox-enhanced pretense that they are younger than they really are.

Another trouble with this slick marketing campaign is that botulinum toxin (available as Botox and Myobloc) can cause life-threatening adverse reactions. In January, Public Citizen petitioned the Food and Drug Administration (FDA) to immediately increase its warnings about Botox and Myobloc; adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. While the data in our petition mainly related to problems associated with the medical use of Botox, adverse reactions can occur with cosmetic use as well. Since when did "personal best" involve subjecting oneself to a risky procedure?

Two weeks after we filed our petition, the FDA issued a press release warning of the dangers of injecting botulinum toxin but stopped short of forcing drug makers to send out warning letters to doctors or putting a black box warning on the drug as we had requested.

By peddling a product that can seriously injure people, these athletes are tarnishing their past athletic achievements. Botox is nothing to play around with. The public should not be lulled into a false sense of security by Allergan’s outrageous caper."

Read the Allergan news release for a lesson in disease-mongering and marketing. They're coining a new condition called "The 11" - as explained by Comaneci: "About five years ago, I realized that while I exercised and ate right most of my life, there was nothing I could do on my own that would get rid of those two stubborn frown lines stamped on my forehead. They looked like an '11' and made me upset with the way I looked, and that's when I decided to talk to my physician about BOTOX(R) Cosmetic treatment. I attained a perfect '10' at age 14, and I'm working hard to stay close to that in all that I do." Then they go on to describe "How the '11' makes people feel." Including Spitz saying, "As a financial advisor and motivational speaker, my facial expression is a very important part of my message. When I am serious, my '11' makes me look angry and unapproachable rather than congenial. I knew I had to do something about it, but for a long time, I just didn't know what my options were. Then I heard about Botox."
Photo 14.jpg
I've always loved the Willie Nelson song lyrics:


This Face is all I have, worn and lived in
And lines below my eyes are like old friends...
This face of mine
And I kept believing the reflection on the wall
Who needs to be the fairest of them all
I never looked like you, cool and streamlined
I have this honesty that grows with time
And when cracks appear they suit me fine
Like a good old dog you won't hear me whine
And this face is all I have, worn and lived in.


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July 15, 2008

Green ($$$) Mountain State for drug marketing

The Mental Gymnastics blog last week posted a piece on drug company payments to Vermont doctors. vermontmap.jpg Excerpts:

"Vermont Attorney General William Sorrell released a report on pharmaceutical marketing efforts in Vermont on July 8, 2008. See the report here. Media has been reporting the aggregate amounts that psychiatrists earned the most money from these payments. Eleven psychiatrists received roughly 20 % of these funds. However, the second largest aggregate amount went to cardiologists. Two cardiologists shared payouts of $312,898, or an average of $156,440 each, no small potatoes.

An interesting finding is the medications that were promoted. The top ten medications promoted were the following:

1. Strattera (ADHD)
2. Metadate CD (ADHD)
3. Januvia (Type 2 Diabetes)
4. Lexapro (Depression)
5. Cymbalta (Depression)
6. Lantus (Diabetes)
7. Seroquel (Bi-Polar Disorder and Schizophrenia)
8. Namenda (Alzheimer’s)
9. Vytorin/Zetia (Cholesterol)
10. Benicar (Hypertension)"

According to the VT attorney general's report for FY 2007, "84 pharmaceutical manufacturers reported spending $3,138,794.00 in Vermont on fees, travel expenses, and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products. That represents a 33% increase over reported expenditures for similar expenses in FY 06, and a 42% increase over reported expenditures for similar expenses in FY 05."

Clearly, pharma doesn't think Vermont is too little to care about.


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July 12, 2008

List of drugs doctors wouldn't take

MSNBC.com recently posted an article from Men's Health about the "8 Drugs Doctors Wouldn't Take."

The article states:

"...plenty of M.D.'s do know which prescription and over-the-counter drugs are duds, dangers, or both. So we asked them, "Which medications would you skip?"

It looks like they only asked five doctors - but here's what they came up with:

• Advair for asthma

• Avandia for diabetes

• Celebrex for pain relief

• Ketek, antibiotic

• Prilosec & Nexium for heartburn

• Visine Original eyedrops, "to get the red out"

• Pseudoephedrine, decongestant

If they had talked with more doctors, that list could have been a lot longer than 8 drugs.

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July 11, 2008

Reax to PHRMA's toothless code of ethics

AP reports:

Dr. Brian Hurley, president of the American Medical Student Association, said the new rules are an improvement but they don't go far enough. He said gifts given to doctors as educational materials or occasional meals are still gifts. "Aggressive" marketing practices have made drug companies a lot of money, he said, and they have little incentive to stop those tactics.

"Educational gifts or educational programming that pharma's member companies put together are marketing in disguise," he said.

The Boston Globe reports:

The Prescription Project, a Boston-based national coalition of groups that monitors pharmaceutical marketing, released a statement noting that promotional spending by the pharmaceutical industry has increased since PhRMA adopted its first guidelines on gifts in 2002. It also said that a report released this week in Vermont, one of the few states that requires disclosure of marketing payments to doctors, showed an overall 33 percent increase in pharmaceutical payments in the last year.

The Baltimore Sun reports:

"This announcement is a P.R. ploy. It really is a meaningless gesture," said Dr. Jerome P. Kassirer, a Tufts University School of Medicine professor and author of On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Kassirer said even small gifts persuade doctors to prescribe new drugs that cost more than older treatments and may have harmful side effects because they aren't well understood yet.

The 31 pages of revised guidelines don't curtail several promotional efforts that have drawn the particular ire of critics. Left unaddressed, for example, are the fees drug companies pay to physicians for speaking to fellow doctors about diseases and treatments or for advising the companies about products and medical conditions.

Nor would the recommendations advise against the widespread practice of having company sales representatives bring breakfast or lunch to doctors' offices and then pitch new drugs during the free meals.

"It's best for consumers if there's competition around price and not competition around influence, reciprocity and advertisements, and I don't think we see that here," said Dr. John Santa, director of Consumer Reports' health ratings center.

The Wall Street Journal reports:

Sidney Wolfe, director of the health research group at Public Citizen, a consumer organization, said the new code of conduct, like other transparency initiatives, is a "thinly disguised PR effort." He added that such codes are toothless and that "there's not going to be a serious effort to detect violations."

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July 10, 2008

Drug industry move that doesn't go far enough

This just in on a move that, on the surface, doesn't go nearly far enough.

Bloomberg reports:

The U.S. pharmaceutical industry revised its code of conduct, banning gifts to doctors such as pens, mugs and restaurant meals. The drugmakers may still provide food to physicians in their offices, and pay them speaking and consulting fees.

Drugmakers' salespeople may provide ``occasional meals'' in offices of health-care professionals ``in conjunction with informational presentations,'' the Pharmaceutical Research and Manufacturers of America said today in a statement on PR Newswire. The Washington-based lobbyist group also issued more detailed standards on continuing education and disclosure of speaking or consulting fees.

Relations between drug companies and doctors, including medical researchers, have come under scrutiny in Congress. Senator Charles Grassley, Republican of Iowa, criticized payments from Johnson & Johnson and Eli Lilly & Co. to Harvard Medical School doctors who helped pioneer the use of psychiatric drugs in children.

The new code, scheduled to go into effect in January, 2009, ``is part of an ongoing effort to ensure that pharmaceutical marketing practices comply with the highest ethical standards,'' the pharmaceutical association's statement said.

More on this later.

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July 9, 2008

Aussies fine Lilly for Cialis promotion

The newspaper, The Australian, reports:

"THE makers of an anti-impotence treatment have been fined $60,000 for a publicity initiative that the industry's self-regulating complaints body found breached the ban on promoting drugs direct to the public.

Eli Lilly, the maker of the erectile dysfunction drug Cialis, was also found by Medicines Australia's Code of Conduct Committee to have issued a product-specific media statement in April this year.

The complaint was lodged over a press release issued by Eli Lilly in April, which was timed to coincide with the release of a new version of the drug called Cialis Once-a-Day.

The press release, headlined "New research reveals scheduled sex a turn-off", reported the results of a national Galaxy poll -- commissioned by Eli Lilly -- which purported to show that 74 per cent of Australian men said "spontaneity ... is an important part of sex". The poll also claimed that more than half of men aged 45 to 54 "admit ... that their ability to have sex on impulse has declined drastically or noticeably" since they turned 30.

The release linked the results to the launch of Cialis Once-a-Day, which it said would "(restore) their ability to respond to spontaneous opportunities for sex".

The press release and its claims, which were widely reported in the media, became the subject of a complaint to Medicines Australia's code of conduct committee by consumer group Choice and LaTrobe University academic Ken Harvey. It was also featured on ABC TV's Media Watch in May.

In his complaint, Harvey said the press release in his view was "not bona fide news but rather thinly disguised promotion of the prescription drug tadalafil (Cialis) to the general public. Eli Lilly have now provided the latest example of how a drug company can undermine quality use of medicines activities."


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July 3, 2008

"No Drug Reps" certificate for your door

PharmedOut.org, a project run by Dr. Adriane Fugh-Berman of Georgetown University Medical Center, now posts online a certificate which doctors can use to declare their independence from industry influence. Fugh-Berman says, “The certificate will help patients choose physicians who depend on evidence rather than marketing.? The certificate helps physicians as well, adds Fugh-Berman, because it explains to patients why drug samples are not available. “Patients love free samples,? notes Fugh-Berman, “but samples are the single most effective marketing tool pharmaceutical companies have. Once patients start a drug, they usually stay on it, and samples are usually for expensive drugs that are prescribed for chronic conditions.?
certificate.png

The PharmedOut.org site offers other related resources:

Help Your Doctor Break the Sample Habit

Fast Facts on Generic Drugs (pdf file)

Fugh-Berman A, Ahari S. Following the Script: How Drug Reps Make Friends and Influence Doctors. PLoS Medicine; April 2007;(4)4:e150.

The Physician-Pharma Relationship (slideshow)

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June 23, 2008

Key opinion leaders not in the public interest?

Journalist Ray Moynihan reports on the role of the influential experts paid by industry to help "educate" the profession and the public. Excerpt:

In the world of medicine, "key opinion leader" is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs. These influential doctors are engaged by industry to advise on marketing and help boost sales of new medicines. Across all specialties, in hospitals and universities everywhere, many leading specialists are being paid generous fees to peddle influence on behalf of the world’s biggest drug companies.

Read the article and listen to the video clips with former drug rep Kimberly Elliott.

Moynihan's concluding quote:

David Blumenthal, a Harvard University researcher who has studied the relationships between industry and the profession, says company payments to key opinion leaders, rather than being corrupt, are simply not in the public interest. "I think these are legal relationships between consenting adults who have overlapping interests that are not consistent with the interests of the larger society or necessarily with the patients served by these physicians." Blumenthal is part of a small but growing global chorus, which includes advocacy groups No Free Lunch and Healthy Skepticism, that is calling for a major winding back of industry influence over the medical profession and in particular its education.

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June 14, 2008

Were the data on Paxil suicide risk cooked?

The Wall Street Journal reports:

GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo "improperly" counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo.

However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.

The real risk for suicidality from Paxil, says the report's author, Joseph Glenmullen, was eight times its risk for patients on placebo. "Glaxo was aware of this risk, and hid it," Dr. Glenmullen's report states. The drug was approved for sale in the U.S. in 1992. Dr. Glenmullen said, in an interview Thursday, that if Glaxo had given the agency the "correct" data in 1991, the FDA would likely have added warnings about the risk for suicidality when it approved Paxil.

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June 9, 2008

UK & Canadian questions: who's guarding the henhouse?

Two news items of special interest in last week's BMJ.

One discussed product placement in doctors' waiting rooms in the UK.

The other reported on funding threats to the Canadian drug watchdog project, Therapeutics Initiative.

Bottom line: this brief international glimpse shows increasing drug company marketing successes at a time when watchdog groups are being challenged.

Happy Monday.

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June 7, 2008

FDA sending far fewer warning letters to pharma

This came out on a Friday afternoon, but should not be lost in the black hole of weekend news.

The Wall Street Journal reports:

The drug industry has been grumbling over how tough on safety the FDA is these days, but by one measure the agency has fallen off significantly a few years ago. The number of warning letters the FDA sends out has been cut in half in recent years. ...

David Kessler, who ran the FDA during the Clinton years, said the decline is something of a flag. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,? he said. “It’s not the only measure, but any significant drop raises significant questions of what’s going on.?

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May 12, 2008

Why didn't FDA act on Procrit ads?

The Cancer Letter reports:

Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Procrit (epoetin alfa) improved “fatigue? associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy.

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May 11, 2008

Getting "informed consent" for drug trials in poor countries

Merrill Goozner reports that the FDA decided that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

Why should you care? Gooz says this "increases the likelihood that more trials will go abroad and that more of them will not even be registered with the FDA, which makes them all but impossible to monitor."

Huge issue. And, as Gooz points out, one not reported by many news organizations.

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May 7, 2008

Did you want butter on your cigarette butt?

The Wall Street Journal reports on a World Health Organization announcement about problems with the new generation of sleeping pills - a market that grew by 10% last year.

Among the oddities reported by the Journal:

• people eat, walk, make phone calls or get behind the wheel while still asleep after taking the drugs;
• some people have cut themselves with knives, consumed inedibles like buttered cigarettes and woken up gasping for air with their mouths full of peanut butter, a particular sleep-eating favorite.

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April 28, 2008

Shearlings plowed - or Plough shares in blogosphere

In the hyper-specialization of the blogosphere, now we even have a blog tracking an individual drug company.

Shearlings Got Plowed is the name of a blog covering recent problems at drugmaker Schering-Plough

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April 25, 2008

Drug companies' 1,044 broken promises

Bloomberg News reports:

Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today.

The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.

To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President George W. Bush signed legislation in September that allows the FDA to require certain post-approval studies.

``Drugs often come on the market with an expectation that studies will be conducted,'' said Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization, in an interview. ``In fact, many of these studies begin late or do not begin at all.''

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use.

Some research has been pending for years. Of the 1,044 studies that hadn't begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them, according to the FDA.

So don't be surprised when you hear the next news about a "blockbuster" drug that is found to have "surprise" side effects months or years after it's been on the market.

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April 22, 2008

Off-label promotion equals 19th Century medicine

Drs. Adriane Fugh-Berman and Douglas Melnick have written to the FDA:

"Loosening restrictions on the distribution of materials on off-label uses is an abdication of the FDA’s responsibility to protect the public. Off-label uses of pharmaceuticals have not been subject to the testing and review required for marketing approval. The scientific review of evidence of effectiveness and safety that drugs undergo prior to an approved, labeled indication for a drug protects patients. With off-label use, this protection does not exist.

While off-label use is sometimes necessary, it should be undertaken with the care and caution due the uncontrolled experiment to which a patient is being subjected. While some off-label uses are supported by randomized controlled trials, 73% of 150 million off-label prescriptions written in 2001 were for conditions that had little to no scientific support for efficacy.

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Belief is an unreliable gauge of efficacy. In the 19th century, physicians believed that mercury, arsenic, and bloodletting were effective for common ailments. More recently, physicians believed that oxygen therapy benefited premature babies when instead it caused blindness , and that menopausal hormone therapy benefited women’s health when the opposite was true . In these and many other cases, randomized controlled trials trumped prevailing medical opinion with truth. While “medically-recognized standards of care? may exist outside of a product’s approved product labeling, it is inappropriate for the manufacturers to create or promote these off-label uses without conducting the studies and applying for the new indication with the agency.

Previously, although it was technically possible for pharmaceutical companies to distribute reprints regarding off-label uses, the FDA’s requirements were sufficiently stringent that companies generally avoided such distribution. FDA required an advance copy of any publications on off-label uses to be distributed, any information that the manufacturer had regarding effectiveness and safety of the new use, and a certification that the manufacturer was submitting a supplemental application for a new indication or reasons why a supplemental application was not being filed.

These safeguards have been jettisoned in the proposed guidance, part of which reads as if it were ghostwritten by industry. …

The 1962 Kefauver Amendment to the Food, Drug, and Cosmetic Act required efficacy of a drug before marketing. Allowing promotion for untested uses after marketing makes no sense. Let’s not turn back the clock to the 19th century, when physicians prescribed drugs with no evidence of efficacy.

Industry has much to gain, and the public health much to lose, by the implementation of this guidance. Restrictions on off-label promotion of drugs should be strengthened, not gutted. The FDA should not jettison its responsibilities to protect consumers."

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April 21, 2008

Drug-and-device-reps-free zone

Psychiatrist Daniel Carlat, whose blog is one of the smartest publications on the Web, recently
wrote:

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

Meantime, my local Star Tribune newspaper today published a story cheerleading for a local device manufacturer.

Strib device rep.png

With the story came the photo above, showing a device rep making his pitch to health care professionals. The story and the photo seem to come from a different planet - far away from any controversy or concerns about the coziness of such a reps-in-the-clinical-setting repertoire. Not a word about the kind of concerns that Dr. Carlat and so many others have raised. But as I've noted before, there appears to be an "anything goes" attitude with a different code of ethics for local business news on the business page.

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April 19, 2008

Protesting off-label drug promotion

In his blog yesterday, Merrill Goozner wrote how "Patients Protest Promiscuous Promotion of Off-Label Prescribing."
Excerpt:

A coalition of consumer groups later today will send a scathing letter to the Food and Drug Administration protesting a proposal to give manufacturers a blank check to promote the off-label use of drugs and devices. The letter, signed by Consumers Union, the Center for Science in the Public Interest, the Government Accountability Project and a half dozen other patient and consumer groups, charges the lenient guidelines will undermine the FDA's authority to regulate off-label marketing and lower incentives for firms to conduct rigorous clinical trials or seek agency approval for the uses to which the drugs are being put.

The guidelines mark a "180-degree reversal of prior practice (by) eliminating Food and Drug Administration review of articles that manufacturers plan to distribute to physicians. As a weak and dangerous alternative, the draft guidance proposes a de minimus self-regulating standard," the letter asserts.

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April 12, 2008

Drug ads should tell you the cost

A South Carolina physician states in a letter to the editor in this week's BMJ:
2003-10-13-lamisil.jpg
"Practising in the United States, I am well acquainted with direct to consumer advertising of prescription drugs. I suggest (and have suggested in the past to the Food and Drug Administration) that if such advertising is allowed, it should be mandatory for the manufacturer to state the typical cost of a course of treatment with the drug. My own experience of the $600 (£300; {euro}385) treatment for onychomycosis was that this information could save a great deal of time in explaining to the patient why the drug is not covered by their insurance. It could also prevent a whole unnecessary discussion in the first place as patients quite readily recognise that the cost is out of proportion to their problem."

Onychomycosis is toenail fungus. You know the ads.


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April 11, 2008

WSJ Health Blog Flogs Vytorin Again

Scott Hensley of the Wall Street Journal Health Blog just posted this:

Merck and Schering-Plough attempted to recreate information from a crucial meeting about a major study on cholesterol blockbuster Vytorin after a Congressional panel began an investigation, according to documents obtained by a Congressional subcommittee, the WSJ reports.

In a letter Friday, Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) asked why minutes of the companies’ ad hoc expert panel, which had met in mid-November, had been “created after the fact? in December. Spokesmen for Merck and Schering-Plough couldn’t be reached immediately by the WSJ for comment.

The minutes, circulated Dec. 19, a week after Dingell’s investigation began, suggest that the companies’ experts had agreed to move the goal post for the study, which would have made Vytorin and its sister drug Zetia look better. Internal company documents released by the House Commerce Committee, which Dingell chairs, include strong complaints from one of the study panel members. Click on image at right to see the documents.

“It was my understanding that there were no minutes or transcript of this meeting,? James Stein, a cardiac imaging expert at the University of Wisconsin, wrote in an email to Schering-Plough. (See his comment to the same effect in the margin of draft minutes that appears in the image above.) Some of the new minutes of the Nov. 16 meeting didn’t accurately represent his recollections or details of the debate during the meeting said Stein in an email to Schering-Plough.

“It was the decision of the company to change the endpoint,? Stein wrote in comments back to company about the minutes.

The companies had issued a press release on Nov. 19, shortly after the consultants’ meeting saying the outside experts recommended such a change, which is contrary to generally accepted scientific practice.

Earlier this month the Merck/Schering-Plough joint venture that sells Vytorin made public an email exchange with John Kastelein, the cardiologist who ran the study called Enhance, and who had objected to the proposed change in the endpoint for the study.

In March, Forbes’ Matt Herper laid out the challenge for Dingell’s panel posed by the creation of minutes from the meeting after the fact. The retrospective memo writing, he wrote, “could also make it more difficult for the companies to defend their own decision making with regard to the study.?

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April 10, 2008

Two views about drugs from other countries

Amidst all the stink over the drug Vytorin in this country - including the barrage of two-sided full-page ads in US newspapers - Canadians are chucklingbecause they never got hooked on Vytorin like Americans did. And the story suggests that direct-to-consumer drug ads in the US (not allowed in Canada) may have a lot to do with the higher use here.

Then, from the UK comes a story that claims that cancer drug trials are being stopped too soon. An Italian research team says that the usefulness of some cancer drugs is being exaggerated because manufacturers are stopping trials the moment they find a benefit - but before all the evidence is in hand.

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April 3, 2008

How drug companies wine & dine doctors

An Australian newspaper gives a glimpse of how much drug companies spend to wine and dine doctors at "educational events." Excerpt:

"A drug giant spent more than $514,000 on a weekend seminar that included just six hours of "education content".

The symposium by Australian-based AstraZeneca included gourmet meals, alcohol and two nights free accommodation.

A new report shows "Big Pharma" is prepared to spend millions showering doctors with hospitality in the hope they will prescribe their drugs.

It reveals drug companies spent $31 million on educational events in the second half of last year, including $16 million on meals, airfares and accommodation.

Drug companies funded 14,643 functions during the period, 52 of which are under investigation for possible breaches of new industry rules.

Critics attacked the spending as an "orgy of wining and dining designed to schmooze doctors and boost the sales of new medicines".

But doctors claimed the hospitality amounted to little more than "a glass of orange juice and a sandwich".

Industry body Medicines Australia said drug companies had to keep doctors informed about new medicines.

"No one knows more about pharmaceuticals than the people who make them," chief executive Ian Chalmers said.

Medicines Australia refused to disclose which companies hosted the suspect events until the cases are reviewed.

Companies that breach the rules face $200,000 fines.

More than 220 gastroenterologists attended the AstraZeneca event, which was one of the most expensive disclosed.

Another company, Roche Products, spent $511,791 on a weekend hepatitis symposium for 337 specialists at Melbourne's Grand Hyatt, including $415,000 on hospitality.

Pfizer spent $340,000 on a cardiovascular forum for 220 specialists in Sydney, and Wyeth spent $333,000 sending 178 psychiatrists to an $1800-a-head event on Sydney.

Australian Medical Association president Rosanna Capolingua said the events were necessary and spending was reasonable."

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April 1, 2008

More suggestions of drug company deceit on Vytorin

The New York Times adds more questions to the Vytorin drug data delay story. Excerpt:


"The lead outside investigator on a crucial trial of two widely used heart drugs said in an e-mail message last July that Merck and Schering-Plough, the companies that make the drugs, were deliberately delaying the release of the trial results “to hide something.?

The companies did not release the preliminary results of the trial, called Enhance, until January, almost two years after the trial was finished. When they were finally released, the trial’s results showed that the drugs, Vytorin and Zetia, did not work to reduce plaque in arteries. The results led a panel of cardiologists to recommend on Sunday that the drugs be used only as a last resort. ... The drugs are used to lower cholesterol and are among the most widely prescribed medicines in the United States, with sales of $5 billion last year. Shares of Merck and Schering plunged on Monday."

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March 31, 2008

WSJ Health Blog's March Madness drug company CEO brackets

At a conference yesterday, Scott Hensley of the Wall Street Journal Health blog showed off a story I had missed. Since it's the last day of March and basketball's Final Four is now set, the time is just right to look at it. See the Journal's “Our March Madness: The Drug Company CEO Bracket?.

They explain:

Restless shareholders, listless labs and a tidal wave of generic competition confront the top executives at drug makers around the globe. Big Biotech has plenty of problems of its own. Did we mention pushback on prices?

So we wonder who among the leaders of the current executive pack will win the test of endurance to remain the last CEO standing? Take a look at our second annual bracket by clicking on the image at the right. Feel free to start your own office pool.

The posting is fun. It's interactive. You can vote on the poll. And the user comments are worth reading. One wrote: "A more relevant question is - which CEO has the most integrity?"

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March 30, 2008

Top 5 reasons to question a new antidepressant

I just heard psychiatrist Dan Carlat give a talk that touched on Wyeth's new antidepressant Pristiq. Much of what he said is captured in a post on his terrific blog.

In short, here are his top 5 reasons to forget about Pristiq. You can read the details on his blog.

1. It’s a blatant patent extender.
2. It's not very effective.
3. It is not more easily dosed than Effexor XR (as the company claims).
4. It has no meaningful metabolic advantages.
5. Wyeth’s own lead investigator is unimpressed.

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March 29, 2008

25 Shocking Facts About Pharma

The Nursing Online Education Database has posted an article entitled, "25 Shocking Facts About the Pharmaceutical Industry."

Here's a part of their list. You can read the full entries by going to their site.

• The price of drugs is increasing faster than anything else a patient pays for.
• Your doctor may have an ulterior motive behind your prescription.
• Pharmaceutical companies spend more on marketing than research.
• Brand name meds often have a 1,000% mark-up price.
• Drug reps often have no medical or science education.
• Pharmaceutical companies are helping, hurting the AIDS epidemics.
• Doctors can choose to reveal or keep private their prescription records.
• Good PR trumps patient care.
• Abbott Laboratories charged Medi-Cal nearly $10 for saline solution.
• Guilty of Medicare fraud: Pharmaceutical companies are also being tried in federal courts as an answer to their exploitation of Medicare.
• Combined wealth of top 5 pharmaceutical companies outweighs GNP of sub-Saharan Africa.
• Pfizer is fifth-best wealth creator.
• Americans pay more for prescription meds than anyone else in the world.
• "New" Drugs aren't really new:
• Some drug companies are taking advantage of underdeveloped countries to perform clinical trials.

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March 21, 2008

Pfizer Enlists a Labor Union (SEIU) to Promote Lipitor

On her terrific Health Beat blog, Maggie Mahar reports:

A couple of weeks ago Dr. Alicia Fernandez, an associate professor of clinical medicine at UC San Francisco, received a very unusual letter from The International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU).

The letter began by noting that Fernandez is part of the union’s approved physician network, and then launched into what can only be described as a shameless sales pitch for Lipitor, Pfizer’s blockbuster cholesterol-lowering drug.

First, the alarming statistics presented in the letter:

* 1 in 3 adults has some form of CVD (cardio-vascular disease)
* About every 26 seconds, an American will suffer a coronary event
* Stroke is a leading cause of serious, long-term disability in the United States
* Every 45 seconds, someone will suffer a stroke.

Then, the endorsement: “Lipitor is available to our members through their prescription plan. IAEP leadership stands behind LIPITOR as the lipid-lowering agent of choice when it is prescribed by a physician. This confidence in LIPITOR is based on its proven efficacy and is supported by its vast clinical experience of more than 15 years…"

The letter went on, at length, to praise Lipitor’s benefits and to downplay the drug’s risks. In clinical trials, the letter states, “the most common adverse events were constipation, flatulence, dyspepsia and abdominal pain.? But while other risks may not be as “common? they are certainly worth mentioning. They include memory loss which can look like Alzheimer’s and severe muscle pain.

A few days ago, Fernandez received a second, identical letter. Never before in her professional experience had she received a drug ad from a union.

“I’ve never seen anything like this. I’ve never seen Labor endorse a drug product,? she told me. “This is incredible.? Unfortunately, Fernandez adds, this is not the first time that she has seen a drug company use a progressive organization to promote its product. ...

Why would Pfizer need the union’s help in peddling its drug? Lipitor, after all, is the best-selling drug in the world, with sales of almost $13 billion in 2006.

But recently, Lipitor has been attracting some decidedly negative publicity.

Read her blog for the rest of the entry. Drug promotion becomes curiouser and curiouser.

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March 19, 2008

Laws to overcome Pharma's influence

Two items in the news recently highlighted proposed legislation to limit the influence of drug companies on physicians - and therefore, on consumers as well.

The Boston Globe reports on a proposed state law that would ban all gifts to doctors from drug companies.

"Other states have passed laws attempting to limit the pharmaceutical industry's influence. In Minnesota, legislators enacted a ban on gifts in excess of $50 from pharmaceutical companies. In Vermont, legislators have passed laws requiring pharmaceutical company representatives to disclose the dollar value of gifts over $25 to doctors. Peggy Kerns, director of the ethics center at the National Conference of State Legislatures in Denver, said Murray's legislation is the first attempt at an outright ban on gifts to doctors that she had heard of."

Then, the Integrity in Science Watch project reports that:

Legislation that would send government-funded educators into doctors’ offices with independent information about prescription drugs received a boost last week at a Senate Committee on Aging hearing. “Pharmaceutical sales reps (known as detailers) are currently one of the only ways doctors can learn about the latest drugs on the market,? said Sen. Herb Kohl (D-WI). “These sales reps often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by the biased information often put forth by these sales representatives.? Experimental programs that send scientific professionals with clinical training into physicians’ office to provide them with objective, unbiased information – sometimes known as academic detailing – are now underway in five states and the District of Columbia. Kohl and Sen. Dick Durbin (D-IL) will introduce legislation that would create a federal academic detailing program later this spring.

The program is a potential moneysaver for the federal government, which added a senior citizen drug benefit to Medicare in 2003 and spent an estimated $47 billion on the program last year. Pennsylvania’s academic detailing program reduced the total cost of patient prescription by $60 per physician in the six months after an academic detailer’s visit, according to Nora Dowd Eisenhower, head of the state’s Department of Aging. Jerry Avorn of Harvard Medical School told the committee that an experimental academic detailing program that reached 400 doctors in four states saved $2 for every $1 in costs. “Research has shown that when doctors have full access to comprehensive and unbiased data on all the drugs available, they prescribe the best drug--not just the newest one--and healthcare spending is lowered,? said Kohl. The pharmaceutical industry spends an estimated $7 billion a year on direct-to-physician marketing, employing over 80,000 detailers to reach the nation’s 700,000 practicing physicians.

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March 13, 2008

Sleep may be not be the big problem special interests claim it is

I've blogged about the cloud of doubt that should hang over the annual proclamations made by the National Sleep Foundation during the highly-promoted National Sleep Awareness Week. The reason: special interests like sleeping pill makers fund the effort.

Now the Washington Post reports:

Americans are not as sleep-deprived as they think they are and, in fact, appear to be getting more Z's these days than they got a few years ago, according to an independent analysis of government statistics.

The new findings run counter to the widespread public perception that Americans are getting less and less sleep because of increasing workplace demands and the plethora of distractions available around the clock on the Internet and cable television.

"Many Americans work too much, but most do not seem to be cutting corners on their sleep to do so," said John P. Robinson, a sociologist at the University of Maryland, who led the analysis with faculty colleague Steven Martin.

Their report, "Not So Deprived: Sleep in America, 1965-2005," scheduled for release by the university today, finds that Americans on average got 59 hours of sleep per week in 2005, the latest year for which precise statistics are available. That is three hours more than in 2000.

The new numbers contrast significantly with the 2008 "Sleep in America" poll, the oft-quoted survey conducted annually by the Washington-based National Sleep Foundation, which advocates for better diagnosis and treatment of sleep problems.

Released last week, that survey concluded that Americans get an average of 48 hours of sleep per week.

The difference, experts said, reflects the two groups' methodologies. The Sleep Foundation survey asks Americans to estimate how much sleep they typically get. By contrast, the Maryland analysis draws upon detailed "time-use" data collected by the U.S. Census Bureau for the Department of Labor Statistics. In that approach, individuals must account for every minute of the previous day.

"This gives us a much better picture of where the time goes than when people just make an estimate," Robinson said.


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March 10, 2008

The butterfly in your bedroom

Just as the nation awakes from another National Sleep Awareness Week, funded in part by sleeping pill manufacturers (a fact often not reported by journalists who dutifully report from the news release), we are reminded of rising sleeping pill usage patterns.

The Wall Street Journal reported last week:

"The increased use of sleeping pills has “been particularly sharp for young adults,? William Marder, SVP and general manager of Thomson Healthcare, told the Health Blog. A lot of the uptick, he said, is driven by the availability of newer sleep aids, such as Sanofi-Aventis’ Ambien and Sepracor’s Lunesta."

That would be the same Ambien and Lunesta that have been so heavily advertised on TV and in print, perhaps making sleep pill use appear to young people like it's a harmless trip to butterfly land.


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March 8, 2008

How much will we spend for so modest a benefit?

A great letter to the editor appeared in the Wall Street Journal yesterday:

I am still trying to recover from the Food and Drug Administration's recent decision to go against its advisory panel's recommendation and approve Avastin to treat advanced breast cancer ("Genentech Clears Hurdle on Cancer Drug Avastin," Leading the News, Feb. 23).

Although Avastin is ushering in a new wave of "targeted" cancer therapies, which minimize the gut-wrenching side-effects that many of us previously endured with our cancer treatment, the cost to our health-care system is astronomical. What is the true cost of this drug? While the average charge a provider may pay for Avastin may be $7,700 a month, it certainly isn't what a patient is billed. My experience in reviewing hundreds of medical claims involving Avastin shows that the average monthly patient charge when given in an oncologist's office is closer to $18,000 a month, while many hospitals charge more than $35,000 a month. With 38,000 American women eligible for this drug and an average treatment of six months, we suddenly have several billion dollars added to our annual health-care tab.

If the FDA has been given the power to make decisions that have such huge ramifications, it must be accountable for the cost-benefit ratio of these decisions. In this case, a study showed there was no survival benefit yet the cost will be billions of dollars per year. Is there any wonder why our health-care expenditures are expected to double to over $4 trillion within 10 years?

Peter S. Dumich, M.D.
Augusta, Ga.


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March 7, 2008

We don't know jack

Journalists Jeanne Lenzer and Shannon Brownlee have a column in this week’s BMJ, “Do we really know the truth about antidepressants?? But the question could be applied to any drug on the market.

They explain that not all drug trials have to be registered and access to full data is constrained by trade secrecy laws that permit companies to withhold all information about drugs that do not win approval for a new indication, even when the drug is already on the market for other indications.

Trade secrecy protection?

Where does consumer protection enter in?

Why aren’t these failed trials made public?

It’s a very thoughtful piece by two of this country’s best health journalists.

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March 6, 2008

Four related stories in one day – impact of the drug ad assault

In an interesting piece of work, MIT’s Dan Ariely reports on research that suggests that people given identical pills receive greater pain relief from the one they think costs more. He says this might explain why people lack confidence in generic pills and believe that more expensive brand name equivalents work better.

Meantime, Reuters reports that generic drug use may have slowed the growth of U.S. prescription drug costs last year to its lowest level in more than a decade.

However, USA Today reports that drug ads are pushing more Americans to ask their doctors about drugs that are advertised. And, as a result, more docs are then recommending prescriptions.

And the Associated Press reports:

“In a David vs. Goliath battle, Pennsylvania is among a handful of states trying _ with modest results at best - to counter the pharmaceutical industry's multibillion-dollar marketing and cut costs for prescription-aid programs for senior citizens, who are bombarded with "ask your doctor" advertising.?
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February 27, 2008

Drug Trials Should Not Be Done for Marketing Purposes Only

I've blogged earlier about something being smelly about the ENHANCE trial, comparing the cholesterol drug Zetia plus Zocor versus Zocor alone.

This week, a commentary in the Journal of the American Medical Association addresses some of the stink. Excerpts:

The unusual release on January 14, 2008, in the news media and on a drug company Web site, of a portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peer-reviewed medical journal is not expected for months, and the first public presentation of the study's findings in a medical setting will not occur before late March 2008.

Lesson 1: Drug Trials Should Not Be Done for Marketing Purposes Only

Lesson 2: The News Media Must Be Sure to Get the Facts Straight. Errors in Reporting Can Cause Serious Damage, and Patients May Be Harmed or Become Distressed From the Resulting Confusion

Lesson 3: Leading Scientific, Patient-Oriented, and Disease-Oriented Organizations Must Scrupulously Avoid Conflict of Interest

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February 25, 2008

Pfizer pulls plug on Dr. J ads

This just in.

Pfizer's President of Worldwide Pharmaceutical Operations Ian Read said:

"...the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople."

Hail the power of public opinion.

Probably the best example yet of a direct-to-consumer drug ad blowing up in the drug company's face.

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February 16, 2008

FDA considers opening the door to more "off-label" promotion

In a move that leaves you wondering about health policy in this country, the Food and Drug Administration is considering loosening regulations on "off-label" promotion of drugs. The Wall Street Journal reports:

The FDA's move already is raising objections from industry critics. Democratic Rep. Henry Waxman of California wrote to the agency urging it to hold off on issuing the guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.

On his blog, Merrill Goozner writes:

As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA... has proposed opening the floodgates to wider promotion and use of unproven drugs.

There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.

This is a head-scratcher. It raises anew the old questions about whom the FDA is protecting: citizens or industry.

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February 13, 2008

Do statins like Lipitor "make women stupid"?

The Wall Street Journal published anecdotal reports that statins like Lipitor "make women stupid" - that the drug "dulls the minds of some patients."

The Journal reminds us that anecdotes don't equal data, but that:


Researchers at the University of California at San Diego are nearing completion of a randomized controlled trial examining the effects of statins on thinking, mood, behavior, and quality of life. Separately, the UCSD researchers are collecting anecdotal experiences of patients, good and bad, on statins; memory problems are the second most common side effect, after muscle aches, in about 5,000 reports to date.

"We have some compelling cases," says Beatrice Golomb, the study's lead researcher. In one of them, a San Diego woman, Jane Brunzie, was so forgetful that her daughter was investigating Alzheimer's care for her and refused to let her babysit for her 9-year-old granddaughter. Then the mother stopped taking a statin. "Literally, within eight days, I was back to normal -- it was that dramatic," says Mrs. Brunzie, 69 years old.

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February 8, 2008

Dr. J's drug ad stunt double; fighting the fog

The New York Times provides even more questions and answers about the Lipitor ads starring artificial heart inventor Dr. Robert Jarvik.

The Times reports:

"...it has helped rekindle a smoldering debate over whether it is appropriate to aim ads for prescription drugs directly at consumers.

A Congressional committee, concerned that the Lipitor ads could be misleading, has said it wants to interview Dr. Jarvik about his role as the drug’s pitchman.

Some of the questions may involve his credentials. Even though Dr. Jarvik holds a medical degree, for example, he is not a cardiologist and is not licensed to practice medicine. So what, critics ask, qualifies him to recommend Lipitor on television — even if, as he says in some of the ads, he takes the drug himself?

And, for that matter, what qualifies him to pose as a rowing enthusiast? As it turns out, Dr. Jarvik, 61, does not actually practice the sport. The ad agency hired a stunt double for the sculling scenes."

Meantime, the Los Angeles Times has a column on a new ad campaign for a sleep disorder pill:

You'd probably be interested in a drug that'll keep you peppy even when you're running on fumes.

How about a drug that can cause depression, anxiety, hallucinations, psychosis, mania and suicidal thoughts? How about chest pain, sores or serious rashes?

You had to sift through the fine print of full-page newspaper ads that ran coast to coast last week to learn that these drugs are one and the same. The ads were for Provigil, which its maker, Cephalon Inc., is pitching to consumers as the solution for something many people might not even realize is a disorder: excessive sleepiness.

Provigil, the ads said, can help "fight the fog."

Next time I find the urge to go rowing through the fog on an early morning after a sleepless night, I hope I can find a stunt double.

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February 6, 2008

Drug companies use ads to overcome what the data showed

An Advertising Age story appearing on PRWatch.org:

The pharmaceutical companies Merck and Schering-Plough, which co-market the cholesterol drug Vytorin, "have gone into damage-control mode, taking out newspaper ads." The PR campaign follows the companies' reluctant publication of a study showing that neither of the drugs present in Vytorin "reduced the buildup of fatty plaque in arteries." The study "was completed in 2006, but Merck and Schering said they didn't release it for nearly 21 months due to the complexity of the data and their own scientific concerns." The drug companies' ads, which ran in the New York Times and USA Today, refer to the damning study as "a single study that has generated a lot of confusion." The ads stress that the drugs "have been proven to lower LDL (bad) cholesterol," but what the study showed was that Vytorin is not "any better than generic Zocor in reducing the buildup of fatty plaque." Members of Congress have called for an investigation into why the "massive advertisement campaign for Vytorin was allowed to continue," after the study was belatedly made public. (The drug makers pulled their Vytorin TV -- but not print -- ads on January 22, reports Associated Press.) Class-action lawsuits are also being filed, alleging that the drug companies "misrepresented and withheld significant information" from the Food and Drug Administration and the public.
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February 4, 2008

When Drug Trials Go Wrong

Don't miss an important story from the Wall Street Journal last week about things going wrong in clinical trials, questions about informed consent forms, and about liability - especially as companies speed up the pace of trials.

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February 2, 2008

Possible Billion Dollar Fine For Off-Label Drug Promotion

The New York Times reports on what would be the largest fine ever paid by a drug company for violating laws on how drug makers can promote their medicines. It involves Eli Lilly's marketing of the antipsychotic drug Zyprexa.

Excerpts:

"Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Eli Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines for any uses not formally approved by the Food and Drug Administration. ...

Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States."

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January 30, 2008

More Pharma Tricks With Off-Label Claims About Their Drugs

I've been meaning to blog about this for some time.

Paul Goldberg of The Cancer Letter allowed the PRWatch.org website to post one of his columns about how the Amgen drug company seemed to try to circumvent regulations on off-label claims about drugs by inviting patient testimonials on a website called ProtectCancerPatients.org.

Goldberg wrote:


Though the Internet designation ".org" suggests that the site is operated by an advocacy group, the "privacy policy" section notes that "this site is owned and operated by Amgen Inc." and can be used for communications with the company.

On the home page, the site is described as "online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them ... coverage for needed medicines."

"Amgen's mission is to serve patients, which is why we openly support the Protect Cancer Patients website," Kelley Davenport, an Amgen spokesman, said in an email. "The site educates cancer patients on Medicare and their caregivers about a Medicare policy that impacts cancer patients, so that their voices and concerns are heard by government policymakers.

"As evidenced by the personal testimonials on the site, the current Medicare policy will have a significant, direct impact to cancer patients on chemotherapy, and will limit the ability of physicians to make well-informed treatment decisions for their patients," Davenport said.

In testimonials, patients and their family members wrote that ESAs alleviated symptoms of anemia, improved quality of life, and were essential for survival. (Excerpts from the testimonials appear below.)

Considering that ESAs are approved only as a substitute for blood transfusions in solid tumors, many of these letters were discussing off-label uses, thereby potentially exposing the company to an FDA enforcement action, said several attorneys familiar with regulation of drug promotion.

"The question is Amgen's control over what went on there," said a former FDA attorney, who spoke on condition that his name wouldn't be used. "Unless Amgen gave a blind grant to somebody and had no idea that this was going to happen, they have potential liability."

When pharmaceutical companies are caught making claims beyond the label, punishment is usually limited to warning letters and the public embarrassment they create, lawyers say. "On a lobbying campaign like this, a company like Amgen views this as just one battle in the campaign," said Sheldon Rampton, research director of the Center for Media and Democracy and author of books on the public relations industry. "It's conceivable that they may end up suffering some minor consequence, but if the rest of the effort succeeds in overturning the CMS decision, they will have lost this battle but won the war."

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January 24, 2008

Drug company suppression of bad news

Journalist Jeanne Lenzer was interviewed on NPR's On The Media program last weekend, talking about drug compression suppression of negative data.

Her main points:

1.) Some patient deaths are considered "trade secrets" and are not reported

2.) New England Journal of Medicine reported last week that 97% of positive studies of antidepressants were published but only 8% of negative studies were reported as negative (the rest were either spun as positive or not reported at all).

3.) Data suppression is pervasive and affects far more than just antidepressant trials.

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January 23, 2008

Pharma profits

On his blog, Merrill Goozner (author of The $800 Million Pill) writes about drug company profits at 20% of sales.

Excerpt:

"The industry may be dogged by expiring patents, a collapsing new drug pipeline, and a steady drumbeat of bad news on its best-selling drugs like Vytorin, but none of it appears to have affected the bottom line. Only beverage and tobacco companies came close to the drug industry's profit margins. Even with $3-a-gallon gasoline, the oil and gas industry lagged far behind with profits at 8.7 percent of sales.

Perhaps the pummeling the drug companies are taking on the campaign trail from the leading Democrats signals the salad days are behind the industry. Each of the leading candidates is promising to give Medicare the right to negotiate drug pricing, which, given the larger role the government is playing in overall drug sales because of the senior drug benefit, should put a dent in those profit margins."

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January 10, 2008

Dr. J - all-star drug promoter

Pfizer, battling for its Lipitor drug which is now facing generic competition from simvastatin, has trotted out one-time artificial heart inventor Dr. Robert Jarvik for what have become ubiquitous TV ads. But the Wall Street Journal's health blog reports a new twist to the Dr. J story. Excerpt:

Now Congress has seen enough of Jarvik to ask Pfizer some questions about his qualifications to be recommending the cholesterol buster.

The House Committee on Energy and Commerce said today that it is investigating the use of celebrity endorsements in marketing prescription drugs directly to consumers. And Jarvik is Celebrity No. 1 on the list.

“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,? John Dingell (D-Mich.), chairman of the committee, said in a press release.

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January 7, 2008

The Cost of Pushing Pills

A new article in PLoS Medicine, "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," concludes that:


"...it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry's claim. ...(This) confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion."

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January 4, 2008

Pharma free samples - who gets 'em?

The drug industry often claims that the free samples of prescription drugs they give to doctors help the uninsured or those with low incomes. But - no big surprise - a study published in the American Journal of Public Health shows those people are the least likely to get the freebies.

A Reuters story quotes co-author Dr. Sara Cutrona: "Our findings suggest the free samples serve as a marketing tool, not a safety net." Other excerpts from that story:

"About $16.4 billion in drug samples were given out in the United States in 2004, up from $4.9 billion in 1996, the study said. Distributed by sales representatives, samples are nearly always the newest, most expensive drugs, the report said.

Critics have said that in addition to steering doctors and patients to pricey drugs, samples can lead to medications being used for conditions they were not intended to treat.

Drugmakers are forbidden from recommending drugs for uses for which they have not been approved by the U.S. Food and Drug Administration, but doctors can prescribe drugs for any use.

The now-recalled painkiller Vioxx, made by Merck & Co, was the most frequently distributed free drug sample in 2002, the study found.

Vioxx was often prescribed beyond its approved uses before it was withdrawn from the marketplace because of a link to an increased rate of heart attacks and death."


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December 20, 2007

Stocking Stuffers From Big Pharma

If you're hurting for last-minute stocking-stuffer ideas, you may want to ask a friendly physician for some of his/her leftover pharma fun trinkets. For inspiration, visit the website Drug Rep Toys: The toys and trinkets with which drug companies make themselves known to physicians.

More than a year ago, the publisher of the site started posting pictures of all the Pharma handouts he or his site visitors had received.

On a brief visit, I found:

• a pill counter (helpful reminder to take each and every "me too" drug)
• a calculator (helpful when tabulating one's health premium debt)
• a laser pointer (drives your dog crazy enough that he may need an anti-psychotic)
• a reflex hammer (always wanted one of those in the home toolkit)
• a six-pack tote (for self-medication)
• calipers (for wallet biopsies)
• stress balls (not a new DSM disease entity)

No one posted any pictures of airline tickets to resort settings for a "scientific meeting." I'm shopping for a different such website - perhaps one from a "key opinion leader" who has better stuff in his/her stocking this Christmas.

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December 19, 2007

Something smelly about statin trial: Congress investigates

The Integrity in Science Watch project of the Center for Science in the Public Interest reports:

The investigations subcommittee of the House Energy and Commerce Committee last week gave Schering-Plough and Merck until Christmas to turn over documents from a clinical trial involving the cholesterol-lowering drug Zetia. The New York Times reported last month that the companies had failed to meet last spring's release date for a trial that compared the efficacy of a combination of Zetia and Zocor to Zocor alone. The companies then missed a fall deadline and said they wouldn’t release the data from the 720-person Enhance trial until next spring. They also wanted to change the trial's clinical endpoint, which drew heavy criticism from cardiologists who prescribe the drug. The companies backed off that decision last week and reinstated the original protocols of the trial, according to the Wall Street Journal.

The letter, signed by chairman John Dingell (D-MI) and investigations subcommittee chairman Bart Stupak (D-MI), wanted to know why the clinical trial wasn’t registered in the government’s database until 18 months after its completion. Until the recently enacted Food and Drug Administration reform law required registration of most clinical trials prior to their start-up, registration was voluntary. Zetia, whose generic name is ezetimibe, was approved by the Food and Drug Administration in 2002 because it lowered bad (LDL) cholesterol. But, unlike statin drugs, it has never been tested in a clinical trial to show that it actually decreases mortality from heart attacks and strokes. Even the Enhance trial will only measure the drug’s impact on arterial plaque, not if it reduces deaths from heart disease. The drug is sold primarily as part of Vytorin, a pill combining Zetia and Zocor (simvastatin) that has captured 20 percent of the cholesterol-lowering drug market.

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December 4, 2007

Drug company ghostwriting

The Wall Street Journal's Health Blog recently had an item that suggests that drug companies' use of ghostwriters to promote positive findings and to not ask tough questions is alive and well.

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December 1, 2007

Off-label drug promotion guidelines off-target

Many health policy observers are concerned about the impact of drug company promotion of "off-label uses" - unapproved or new uses of drugs that were approved for another primary use.

The FDA is now drafting guidelines on promotion of off-label uses, but the draft concerns Senator Henry Waxman, as Ed Silverman explains on his Pharmalot blog. Excerpt:

Waxman is concerned the agency is opening what he calls an “ill-advised guidance? and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,? he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.?
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November 28, 2007

Dr. Drug Rep

The New York Times magazine on Sunday offered a fascinating insider view from a physician who agreed to work for a drug company as a speaker.

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November 17, 2007

"Troubling pattern of behavior by pharmaceutical executives"

The Wall Street Journal reports:

"Over a period of several years, drug maker GlaxoSmithKline PLC was so concerned about a prominent physician's negative views of its diabetes drug that it engaged in a concerted effort to intimidate him and stifle his opinion, a report by the U.S. Senate Finance Committee found.

The report offers a window into the rarely acknowledged practice among drug companies of monitoring and seeking to influence the opinions of leading physicians, who can make or break a drug's sales.

The Senate Finance Committee released the report Thursday, after researching Glaxo's relationship with John Buse, a diabetes expert and professor of medicine at the University of North Carolina in Chapel Hill. In 1999, Dr. Buse began expressing concerns about the cardiovascular risks of Avandia, one of Glaxo's top selling drugs.

The Senate Finance Committee investigated the matter because it has jurisdiction over Medicare and Medicaid and wants to ensure that they are paying for safe and effective medicines, the report says. The committee, led by Montana Democrat Max Baucus and Iowa Republican Chuck Grassley, didn't recommend any particular action. It said it feared the Avandia case was part of a "troubling pattern of behavior by pharmaceutical executives."

"The effect of silencing [Dr. Buse's] criticism is, in our opinion, extremely serious," the report concludes, noting that patients may have needlessly suffered heart attacks during the period. "Had GSK considered Avandia's increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr. Buse, instead of trying to smother an independent medical opinion, some of these heart attacks may have been avoided," the report says.

This week, the Food and Drug Administration forced Glaxo to add a strong new warning to Avandia's prescribing label about potential heart-attack risks for patients taking the drug.

A Glaxo spokeswoman, Nancy Pekarek, said the company strongly disputes the committee's conclusions. She said Glaxo had tried to correct Dr. Buse's "inaccuracies" about Avandia but had never tried to intimidate or silence him."

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November 12, 2007

Consumer Reports' terrific new drug ad watch

You must see Consumer Reports' terrific new "antidote to TV drug ads" - its new AdWatch feature.

In it, they dismantle the claims made in the ads for the drug Requip for restless leg syndrome.

I've spoken with some folks at CR and they're very pleased with the initial response to the new feature and plan many more like it.

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November 9, 2007

Drug company gifts to Third World doctors

The UK newspaper, The Independent, reports:

"Multinational drug companies are showering doctors in the developing world with gifts and inducements to persuade them to prescribe drugs of dubious value, an investigation has revealed.

Intense marketing of medicines has resulted in up to half of drugs being wrongly prescribed, the campaign group Consumers International says in its report Drugs, Doctors and Dinners. It calls for a ban on gifts to doctors.

A GP in Malaysia, Rafik Ibrahim, who practises near the capital, Kuala Lumpur, described how in a period of five weeks in August last year he spent 17 hours with drug-sales representatives who approached him on behalf of 25 drug companies. In Pakistan, doctors who wrote 200 prescriptions for one high-price drug were offered the down payment on a new car.

Multinational companies are turning to the developing world as profits stagnate in the West. But regulation in these countries is weak and drug sales representatives can influence prescribing by the inducements they offer.

India was one of the fastest-growing markets last year, with sales increasing 17.5 per cent to $7.3bn. But the health commission, in 2005, labelled 10 out of the 25 top-selling medicines as being "irrational or non-essential or hazardous".

Richard Lloyd, of Consumers International, said: "The pharma industry sees the developing world as a trillion-dollar opportunity... but consumer health expenditure in these countries can ill afford to be squandered." He added: "The best way to ensure patients in the developing world get rational impartial treatment is... to ban gifts for doctors." "

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November 8, 2007

More on Lipitor, Jarvik, and battling generics

Blogger Jay Parkinson gets hot about Pfizer's attempt to stave off generic competition for Lipitor. Excerpt:

"Many of you may have heard the ads recently playing all over the airwaves about the benefits of Lipitor, the best-selling drug in America. Here’s a little history behind these ads. Pfizer developed Lipitor years ago and aggressively marketed it touting it’s safety and effectiveness. It rose to the top and brings in over $12 billion dollars in annual sales. It’s had some competitors (such as Merck’s Zocor) but with all of the marketing to doctors and consumers, Lipitor secured over 40% of the market for cholesterol-lowering drugs. About 18 months ago, Merck lost Zocor’s patent and Zocor became available as generic simvastatin. Doctors have been switching their patients to simvastatin in droves. Some health insurance companies are even paying their doctors $100 for each switched patient! Not surprising. It’s very cost effective to switch patients because simvastatin can be had for about 10 cents a day, whereas Lipitor can be about $4 a day. Based on this cost difference, there are maybe 50 patients throughout the entire country who should still be on Lipitor…and that’s a big maybe.

In the past 18 months, Lipitor’s share of the market has decreased ten percent but currently still retains 30% of the market. Ten percent of $22 billion dollars is not pocket change. Pfizer’s not going down without a fight even when the patent on Lipitor will expire in March 2010. They’ve doubled their advertising for Lipitor (which was previously $140 million dollars in 2006) and gotten some jackasses like Dr. Robert Jarvik on board to sell their souls for Money…or…umm…Science. He invented the artificial heart. He is citing a joke of a study based on Science (or rather Money) and completely funded by Pfizer that says Lipitor decreases risk of heart attacks when compared to patients on Simvastatin. They also have Dr. Louis W. Sullivan (another jackass) on board with a sponsored propaganda tour of the United States promoting the benefits of Lipitor (well, not officially, the actual argument in this speaking tour is against insurers and their influence on medical decisions). I hope that fool’s propaganda tour rolls through NYC. I’d love to ask him one question:

“If Lipitor costs 400% percent more than generic simvastatin, shouldn’t there be a 400% added benefit to keeping patients on Lipitor??

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November 6, 2007

Lipitor ad/pr campaign to battle generic competition

This weekend, the New York Times had a terrific story on Pfizer's battle to pump life into Lipitor to stave off generic competition. Excerpt:

"It is shaping up to be the biggest shift yet to a generic drug, potentially saving the nation $2 billion a year or more in prescription costs.

And scientists and doctors say that for most of the 16 million people in America who take drugs to reduce cholesterol, the low-priced alternative will work as well as the name-brand medicine — Lipitor, which is made by Pfizer and is the nation’s most widely prescribed drug.

While Lipitor itself is not available as a generic, a very similar drug made by Merck, Zocor, lost its patent protection last year. The generic version of Zocor, simvastatin, is now much cheaper than Lipitor, leading insurers to press doctors and patients to switch.

But Pfizer is not letting its flagship drug go down without a fight.

The company has mounted a campaign that includes advertisements, lobbying efforts and a paid speaking tour by a former secretary of the federal Department of Health and Human Services. Pfizer is also promoting a study — whose findings many experts are questioning — that concluded that British patients who switched to simvastatin had more heart attacks and deaths than those who remained on Lipitor.

The Lipitor battle has become a test of the pharmaceutical industry’s ability to defend name brands, even as insurers, patients and doctors seek to whittle the nation’s $270 billion annual prescription drug bill by using generic alternatives whenever possible."

The Wall Street Journal's Health Blog quips that the ad campaign featuring artificial heart inventor Robert Jarvik makes him "nearly as ubiquitous as Verizon’s Test Man."

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October 25, 2007

Uncle Billy's Drug-Promoting Campfire Show

Former Congressman Billy Tauzin, a friend of the drug industry when he was in Congress. and now head of the Pharmaceutical Research and Manufacturers of America, has launched his own TV show to boost the industry's image.

The show is called "Healthcare Campfire with Billy Tauzin."

Doesn't that sound cozy?

Until an episode appears on a TV station in your market, you can read more about it.

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October 5, 2007

Pandora's box of DTC drug ads

Two New Zealand authors warn in this week's BMJ that Europe should avoid opening the Pandora's box of direct-to-consumer (DTC) drug advertising, and learn from what has happened in New Zealand.

The authors write that the European parliament is considering allowing the drug industry to have a much greater role in providing information to patients, with no restriction on the type of media. But they urge Europe to learn from the New Zealand experience. (New Zealand and the U.S. are the only two developed countries that allow DTC drug ads.)

Concerns about the impact of DTC ads on public health led the New Zealand Ministry of Health to reconsider the ad trend. But the advertising was allowed to continue with self regulation and a promised further review of compliance with the rules never took place.

So, the authors write, advertising became more widespread and proved extremely effective. For instance, intensive advertising of celcoxib and refecoxib on prime time television, aimed specifically at long term use in the elderly, resulted in widespread prescribing, despite early warnings of their cardiac risks. Similarly, just a few TV ads promoting oral terbinafine for toenail infections resulted in a doubling of national prescriptions within weeks.

Still, the New Zealand government has been unable to pass the necessary legislation to ban DTC ads, despite strong opposition from health professional groups and almost complete (90%) opposition from independent consumer and patient organizations.

The authors warn that allowing DTC ads in Europe will not help consumers make better decisions about medicines but will increase the pharmaceuticalization of health and will expose more of the population to new medicines (many of which offer little benefit over existing medicines) at a time when long term safety is unknown.

It will also rapidly drive up drug costs with major implications for already stretched health budgets - all of which will be of net harm to the overall public health, they warn.

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September 29, 2007

$500 million settlement doesn't wash away drug company sins

The Boston Globe reports:

"Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly, US Attorney Michael J. Sullivan said yesterday. ...

The agreement says Bristol-Myers Squibb gave kickbacks to physicians and healthcare providers from 2000 through mid-2003 to get them to prescribe the company's drugs. The kickbacks came in several forms, including consulting fees and trips to luxury resorts.

"Patients are entitled to unbiased decision-making from their physicians and should not have to worry that financial inducements or lavish entertainment have influenced their physicians' prescribing choices," Sullivan said. ...

Bristol-Myers Squibb participated in pricing schemes, including one involving its anti-depressant drug Serzone, that defrauded the Medicaid program, prosecutors said.

Bristol-Myers Squibb and Apothecon also inflated prices for a wide assortment of cancer-fighting and generic drugs, deceiving federal healthcare programs that established reimbursement rates based on those prices, prosecutors said. ...

Dr. Jerome Kassirer, a professor at Tufts University School of Medicine and outspoken critic of drug companies, is skeptical.

"A lot of these companies, when they get sued for a few million dollars, they just consider it loose change," he said. "I haven't seen any let-up in what they're doing. Most of the time, when they're caught, they'll often say, 'It was a renegade, someone who wasn't following the instructions. Our policy says we shouldn't do that.' "


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September 28, 2007

Avandia execs planned punishment for researcher's negative findings

A story in the September 29 issue of New Scientist magazine reports:

When the US Congress examined the controversy over the diabetes drug Avandia back in June, things got embarrassing for GlaxoSmithKline. A researcher who raised safety concerns in 1999, although he later withdrew them, was questioned about attempts by the company to silence him – a charge GSK denied. Now it has emerged that conversations about how to deal with the critic took place at the highest levels. Internal emails presented to the Senate this month show that several executives, including CEO Jean-Pierre Garnier, knew of plans to put pressure on John Buse, a diabetes researcher at the University of North Carolina at Chapel Hill (UNC). One email, entitled “Avandia Renegade?, was sent in June 1999 by William Claypool, a senior vice president at what was then called SmithKline Beecham, to Tachi Yamada, then chairman of research and development. It accuses Buse of misrepresenting safety data. Claypool suggests warning Buse not to repeat the claims, with the “punishment? being that “we would complain up his academic line? and to the bodies that gave Buse accreditation for teaching. Yamada’s reply, sent the same day, was copied to Garnier. In it, Yamada discusses the possibility of approaching the chairman of Buse’s department and of suing Buse for “knowingly defaming our product?.
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September 22, 2007

Drug and broadcast lobbies win again; no drug ad reform

As Ed Silverman reports on Pharmalot.com "intense lobbying by advertising agencies and broadcasters, as well as drugmakers" stifled tougher restrictions in the FDA reform bill.

Get ready for more (name the ads) couples in bathtubs, butterflies in bedrooms, and the famed green recliner. Drug ads, as one advocate gloated, look like they're here to stay.

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August 13, 2007

Under the influence of drug marketing

The Los Angeles Times last week published a series of articles on drug marketing.

Excerpts:

"In a nation that consumed $279-billion worth of prescription medications in 2006 - spending 80% of that on brand name drugs - their efforts appear to be paying off. Americans filling a prescription choose brand-name products 37% of the time, even though three quarters of all prescription drugs in the U.S. are available in cheaper generics."

"Each day in the United States, an army of roughly 100,000 pharmaceutical company sales reps storms the waiting rooms and offices of the nation's 311,000 office-based physicians."

"The drug industry, according to estimates by the Center for Public Integrity, has spent $758 million on lobbying - more than any other industry - since 1998."

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June 28, 2007

Vitamin D & Thee

My Canadian friend Alan Cassels co-authors a column in the Toronto Globe and Mail about how drug companies have countered news about what Vitamin D can do. Excerpt:

"...For decades, the data have been building, showing that larger amounts of vitamin D are good for you. Animal studies and large human studies have shown that taking a lot more vitamin D than 400 units is both safe and beneficial.

You don't have to dig too deeply to find evidence that the drug companies habitually wield science in a way that benefits, above all, their investors. Spinning the science has shaped the minds of regulators, members of the medical profession and, of course, the consumer against this simple, cheap and remarkably effective vitamin.

But how might the thinking unroll in the executive suite of a large company manufacturing patented drugs?

First: You know vitamin D is good, but you can't make any money out of it because you can't patent the damn stuff. No promise of sizable profits means unhappy shareholders. Can't have that.

Second: If vitamin D actually stops people from getting sick, it can take a serious chunk out of the market for the patented medicines we currently make. Can't have that, either.

Third: If people increase their production or intake of vitamin D (and a host of other key nutrients, through diet and lifestyle, or supplements), they might stop worrying so much about their health. So, the market for fear-based products —drugs that lower "nasty" cholesterol, alter blood pressure and improve blood sugar — could well shrink. This is definitely not good for shareholders.

Given this fact pattern, how have the leaders in corporate medicine responded to this potentially difficult competitor?

First: They've worked on promoting the message with regulators and doctors (and you, dear reader) saying too much vitamin D could be bad for you. Reinforcing the "recommended daily allowance" message (despite being based on outdated and unscientific assertions) prevents people from taking vitamins in doses large enough to compete with patented products. Despite scant evidence to this effect, they've suggested that a host of micro-nutrients will make people sick if taken in too large amounts.

Second: They've played down the dangers associated with patented products with the message that prescribed drugs must be "safe" because they are rigorously studied by our companies, approved by Health Canada, prescribed by competent physicians and dispensed by helpful pharmacists. You can't say the same about vitamin D, right?

Third: They've used their giant drug studies (which the regulator requires them to do, in order to license their patented medicine) and flooded medical journals, inserted themselves into physician education and made sure the media got the right spin on those products. The punchline: Drug good, vitamin bad."

Lots of interesting reader comments are linked at the end of the online column. One writes, "MUCH better use of valuable space in the (paper) than all that crap about Paris whats-her-name."

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June 27, 2007

Pharma's growing influence on continuing medical education

The Washington Post reports on a troubling trend:

Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.

The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.

Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.

"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials."

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June 8, 2007

Avandia critic says drugmaker tried to shut him up

The Washington Post reports on how North Carolina researcher John Buse, the incoming president of the American Diabetes Association, says he was intimidated by the maker of Avandia in 1999 when he began questioning the drug's safety. Excerpt:

"Buse said company officials considered his actions "scurrilous" and implied that he might be held accountable for a $4 billion drop in the drug firm's stock.

"I was characterized as a liar and I was characterized as being for sale," Buse told the House Oversight and Government Reform Committee, which released a letter that he wrote in response.

"Please call off the dogs. I cannot remain civilized much longer under this kind of heat," Buse wrote.

Moncef Slaoui of GlaxoSmithKline, the company's new name after a merger, expressed regret about the episode, attributing it to the "passion" of officials at the time."

Passionate, indeed. But nothing stirs pharma's passion like threats to the bottom line.

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June 6, 2007

How can we trust drug trials?

If we needed more evidence of questionable clinical trial ethics and publications resulting therefrom, we have it, in an article in PLoS Medicine. Cut to the conclusion:

"Randomized clinical trials of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug–drug comparison trials should be considered when making decisions regarding drug choice."

So, as the San Francisco Chronicle put it, "money talks -- and very loudly when a drug company is funding a clinical trial involving one of its products." The paper quotes study author Lisa Bero: "If I'm a clinician or funder of health care, I really want to know within a class of drug which one works better. What our study shows is that depends on who funds the study."

About a third of the statin trials did not disclose any funding source. Trials with no disclosed funding source were less likely to favor the so-called test drug than those with industry funding, researchers found.

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June 3, 2007

Disciplined Docs Still on Pharma Payroll

The New York Times has a terrific and troubling story on doctors who have been disciplined or criticized by a medical board but later paid by drugmakers. The Times reports:

"An analysis of state records by the New York Times found more than 100 such doctors in Minnesota, at least two with criminal fraud convictions. While Minnesota is the only state to make its records publicly available, the problem, experts say, is national."

One physician profiled, whose license was suspended for seven months and restricted for two years, has been paid by at least a dozen drugmakers after these disciplinary actions.

One expert interviewed in the story said:

"Clinical trial investigators must be culled from only the finest physicians in the country since they work on the frontiers of new knowledge. That drugmakers are scraping the bottom of the medical barrel is an outrage."
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May 31, 2007

Canadian "drug policy reform" effort driven by Pharma funds

A CanWest news report shows how a "drug policy reform" push from a self-described patient advocacy group is actually totally funded by drug companies.

The story begins:

"Louise Binder is HIV-positive and chairwoman of a coalition that fights for drug-policy reform in Canada. During a recent visit to the nation's capital she urged members of Parliament to rewrite the rules governing prescription drugs that would increase the access patients have to new, expensive medications and require the government to foot the bill.

One thing she didn't mention during that visit is the fact her association, the Best Medicines Coalition, receives 100 per cent of its funding from Canada's pharmaceutical companies - the very industry that stands to profit most from a governmental decision to approve new and expensive drugs for use and coverage in Canada."


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May 30, 2007

Pharma-funded nurses in UK - backdoor drug marketing?

The Wall Street Journal reports on a new drug company scheme in the UK.

Under the guise of "disease management programs," the paper says that drug companies are paying for nurses in doctors' offices to study patient charts to find people with chronic illnesses - which may often lead to a new prescription of a drug made by the company funding the nurses.

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May 29, 2007

Drug Industry Gifts Make Gastro-Conference Easier to Digest

From Caroline Rodriguez at the Integrity in Science Watch project of the Center for Science in the Public Interest:

"More than 15,000 doctors visited Washington, D.C. last week to attend the largest ever gathering of gastrointestinal physicians. Integrity in Science Watch paid a visit.

As soon as each doctor walked onto the convention floor, they were handed purple-pill backpacks advertising Nexium from AstraZeneca. The Shire Pharmaceuticals’ booth offered weary physicians a park-like atmosphere complete with gently rolling grassy hills, stone paths, park benches, and free hot dogs. The Abbott booth contained a mini-movie theater. On every aisle, companies provided free slushies, gourmet espressos, coffee, tea, sweets, hot dogs, and fresh pretzels. They also offered beach towels, blankets, movies, free internet access, and, the most popular gift of all, a comfortable place to sit and chat with colleagues or the model-like sales representatives who prowled the convention floor.

Most of the doctors surveyed did not express concerns about the potential influence of the gifts. Some said they expect free knick-knacks at conferences, but would oppose them at schools or hospitals. Others said it was important for companies to promote themselves. Almost no one favored cutting out free gifts at physician conventions and offices, but perhaps that was because this informal survey only included doctors clutching blankets, towels, key chains, or pens.

The quietest space on the convention floor was the corner reserved for the small booths of patient advocacy groups, text book sellers, and scientific journals. “We don’t get any sponsorship from corporations for our meeting booths,? said Crohn’s & Colitis Foundation of America representative Laura Hitchens, eyeing the towering Fuji stereo sound system blaring a description of a colonoscopy camera. Thelma King Thiel of the Hepatitis Foundation says they wouldn’t say no if a company was to offer to fund their booths, but not many companies are interested in prevention, she said."

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May 25, 2007

All-drugs-all-the-time-TV

A story out of the UK reports:

"Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines."

Remember: Europe doesn't allow direct-to-consumer drug advertising as we wise Americans do. And drug companies have been fighting that European ad ban. The story explains:

"The industry has been lobbying in Europe to be allowed direct access to patients. It argues that lifting restrictions would help its competitiveness and has hinted that companies may relocate to the US, where they can advertise to patients who then demand drugs from their doctors. Profits have soared there as a result."

I would look forward to such Pharma TV specials as "Adventures with Avandia," "The Virtues of Vioxx," and "Everybody Loves Statins."

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May 10, 2007

Drug whistleblower on Procrit promotions

The Wall Street Journal reports on a whistleblower lawsuit against Johnson & Johnson, with allegations about how the company tried to push sales of the anti-anemia drug Procrit "by offering contracts that fattened doctors' profits and urging its salespeople to push higher-than-approved doses." More:

"Dean McClellan, who worked for 12 years at J&J's Ortho Biotech unit selling Procrit, saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage. He says he was forced to retire in 2004 because the company told him his sales increases weren't high enough. He believes the company wanted him out because of his age, which was 55 at the time. Angry, he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Mr. Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Mr. Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition."

An FDA advisory committee meets today to reconsider the risks and benefits of Amgen’s Aranesp and Johnson & Johnson’s Procrit for cancer patients on chemotherapy.

The Wall Street Journal Health Blog reports: "The deliberations and recommendations of the panel could exert a powerful effect on use of the anemia drugs, whose side effects in some patients have raised questions about how broadly and aggressively they should be prescribed. A bunch of briefing documents appeared online today, and they show that the drugs could face a tough go of it."

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May 3, 2007

NH law protecting prescription data overturned

In a story that didn't get much attention this week - but should have - a federal judge overturned a New Hampshire law that made doctors' prescription-writing habits confidential.

The Associated Press reported: "The law made New Hampshire the first state to try to block pharmaceutical companies' hard-sell ptiches by restricting access to data that identifies doctors and other prescribers. Pharmaceutical company salespeople prize doctors' information because it profiles prescribing habits. They can learn which doctors favor brand names or generics, and who is more willing to prescribe new drugs."

The judge said the law violated the First Amendment. (Huh???)

The NH legislator who sponsored the law told the New York Times, "I feel that corporate interests took precedent over the needs of people in New Hampshire. I think it's like having a drug rep peering over a doctor's shoulder when he is writing a prescription."

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April 30, 2007

Drug company influence on patient advocacy groups

Here is more evidence of drug company influence on patient advocacy groups.

The need for disclosure is so clear - so that sick people are not misled into thinking that all of the information they get from some advocacy groups is unbiased and free from outside influence.

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April 23, 2007

Thailand does what U.S. can't: play hardball with Pharma

Thailand - little Thailand - has stood up to drug companies in ways the U.S. has not or will not. Read today's Wall Street Journal story.

But the U.S. - even with changes in Congress - can't muster the courage to even negotiate drug prices for Medicare. As Paul Krugman wrote in the New York Times:

"... The political news over the last few days has been grim. ...The Senate failed to end debate on a bill — in effect, killing it — that would have allowed Medicare to negotiate over drug prices. ...[I]n spite of overwhelming public support..., 42 senators, all Republicans, voted no."

Guess the drug lobby isn't as strong in Thailand.

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April 18, 2007

Medicare not getting best bang for taxpayer buck

The U.S. Senate today will consider a bill that would correct one of the most short-sighted clauses of any legislation ever passed in this country - the part of the Medicare Part D legislation that kept the government from negotiating the best prices for the drugs now being sold to seniors.

A Star Tribune editorial summarizes some of the folly of the current law:

"When the Department of Veterans Affairs buys prescription drugs for veterans, it negotiates discounts from drug manufacturers. When Medicaid buys drugs on behalf of poor families, it demands the lowest available price. Yet when Congress added a prescription drug benefit to Medicare in 2003, it specifically banned the government agency from negotiating discounts on behalf of senior citizens and taxpayers.

That was an egregious and bizarre decision, and Congress should reverse it as soon as possible. ....

It is the biggest new federal entitlement since the Great Society, and it is costing billions of dollars in borrowed money. The least Congress can do is let Medicare get the best bang for the taxpayer's buck."

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April 12, 2007

Expensive PR campaign for Gardasil

The Guardian of the UK reports:

"A campaign fronted by doctors and celebrities to persuade European governments, including the UK, to vaccinate all young girls against cervical cancer is being entirely funded by the drug company that markets the vaccine.

Sanofi Pasteur MSD, which markets Gardasil in Europe on behalf of the drug giant Merck, spent millions on what was billed as the "first global summit against cervical cancer", held in Paris on Thursday with doctors and patient organisations from across Europe.

The revelation comes as public health experts express disquiet about the promotion of a vaccine that is only effective in young girls - possibly at the expense of screening programmes that are essential to protect adults. They also worry that the long-term effects of the vaccine are not known. The vaccine protects against the most common strains of the sexually-transmitted human papilloma virus (HPV) which causes cervical cancer.

Diane Harper, a professor at Dartmouth medical school in New Hampshire, who led two vaccine trials, said the vaccine would not protect against all strains of the virus, and that nobody knows whether vaccinated 10-year-old girls would still be protected in 10 years' time, when they are sexually active and at risk. Mass vaccination programmes, she said, would be "a great big public health experiment".

Celebrities, doctors and journalists were shipped in from across Europe and the United States by PR agencies working for Sanofi. The summit, which resembled a political rally, called for country-wide vaccination programmes.

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April 11, 2007

New pains for painkillers

Arcoxia, Merck's new painkiller, comes up for review by an FDA advisory committee tomorrow. The Wall Street Journal Health Blog reports that a memo released yesterday "sets up the likely standard for Arcoxia’s review." Memo excerpt:

“…a new product that appears to have an increased overall risk profile for CV disease, particularly beyond that seen with other drugs, would not be appropriate for marketing unless the product fills an unmet medical need for a particular patient population that has no relatively safer approved products available to them, and provides a reasonable risk to benefit balance for that population.?

And the Public Citizen Health Research Group - a watchdog agency - asked the FDA " to order Pfizer to immediately stop its misleading 2 ½ minute television advertisement for Celebrex that began airing on April 2nd."

Public Citizen faults the Celebrex ad for:

* asserting, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are no greater than those of any of the other non-steroidal anti-inflammatory (NSAID) painkillers; and

* claiming that there are overall gastrointestinal benefits with Celebrex over two popular, over-the-counter painkillers, while trying to downplay the risk of serious stomach and intestinal problems such as bleeding and ulcers that applies to Celebrex and all other NSAIDS.

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April 7, 2007

60 Minutes on pharma influencing Congress - but why so late?

If you didn’t see 60 Minutes last Sunday (April 1), go to their website and read the story and watch the video link for the segment called “Under the Influence.? It’s the story of the incredible manipulation of Congress by the drug industry that took place to get the Medicare Part D legislation passed.

Excerpt:

The unorthodox roll call on one of the most expensive bills ever placed before the House of Representatives began in the middle of the night, long after most people in Washington had switched off C-SPAN and gone to sleep.

The only witnesses were congressional staffers, hundreds of lobbyists, and U.S. Representatives like Dan Burton, R-Ind., and Walter Jones, R-N.C.

"The pharmaceutical lobbyists wrote the bill," says Jones. "The bill was over 1,000 pages. And it got to the members of the House that morning, and we voted for it at about 3 a.m. in the morning."

Why did the vote finally take place at 3 a.m.?

"Well, I think a lot of the shenanigans that were going on that night, they didn't want on national television in primetime," according to Burton.

"I've been in politics for 22 years," says Jones, "and it was the ugliest night I have ever seen in 22 years."

Despite what a terrific piece this was, one wonders why it took 60 Minutes several years to catch up to this story. Some viewers wrote to CBS about how late this report came. Examples:

“Great story, AWESOME Story!!! Too bad CBS & 60 minutes waited over 3 YEARS after President Bush Jr. signed the bill into law to report on this. Perhaps if we the American people had heard this story back in early 2004, we would have made different choices when the 2004 presidential election came around.?

“CBS, where the hell were you in reporting this when it happened. Everyone else who was paying attention knew we were being screwed by this legislation, that it was just a give away to the drug companies. but like all (mainstream media), you were totally going to let it pass. Shame on you for taking so long wake up.?

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April 5, 2007

FDA Okays Conflicts on Committee Considering Merck’s New Pain Pill

The Center for Science in the Public Interest reports:

The Food and Drug Administration last week gave three scientists, including two with financial ties to Merck, permission to serve on an advisory committee and to vote on the fate of the company’s new Cox-2 inhibitor pain pill. The Arthritis Drugs Advisory Committee will consider Arcoxia (etoricoxib) when it meets later this month. Preliminary clinical trial data released by the company last year indicated Arcoxia raises blood pressure in some patients, but does not result in the same heart attack risk as Vioxx, the Cox-2 inhibitor Merck removed from the market in late 2004.

According to agency documents that were released last week, the committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine. The FDA also granted a waiver to Kenneth Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. Saag, the FDA said, is expert in analyzing large databases (Merck has tested the drug in over 35,000 patients) and the agency “was unable to find anyone as qualified.? However, the agency admitted that it only scrutinized its current roster of advisers and employees of the National Institutes of Health to identify candidates. Committee chair Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.

The Wall Street Journal reports:

Merck tested Arcoxia in a massive study, called Medal, that included 34,701 patients enrolled in three trials. The study showed a similar cardiovascular risk for Arcoxia and an older drug, diclofenac. But FDA committee members may question the use of diclofenac as the comparator, because while diclofenac is not categorized as a Cox-2 drug, experts including the American Heart Association view it as closer to the Cox-2s than other painkillers in its class. "What they did is say, our Cox-2 is similar to another Cox-2," says Bruce Psaty, a professor at the University of Washington who wrote about the issue in a recent New England Journal of Medicine commentary. "That's not terribly reassuring."

Steven Nissen, immediate past president of the American College of Cardiology, also pointed out that more patients on certain Arcoxia doses dropped out of the study due to high blood pressure. "I do not believe that [Arcoxia] should be approved," he said.

Wanna bet on the outcome?

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March 30, 2007

The Limitations of Drug Testing in Animals

A Wall Street Journal story today looks at an important question in science, in policy-making, and in journalism: "What do the results of animal studies really tell us about humans? That question still puzzles researchers even though guinea pigs, lab rats and their brethren have long been part of experiments."

Two examples from the story:

Many times, however, subtle results in animals are unclear and scientists just don't know what to make of them. In the case of the new Novartis drug Galvus, James Shannon, the company's global head of pharmaceutical development, told investors that Novartis researchers "do not understand -- do not know -- the mechanism of the skin findings" in monkeys. They do know that "humans appear to react to Galvus in a very different way."

Another example of the confusing disparities that can arise in testing is the case of the popular sleep drug Lunesta. It won FDA approval despite the fact that tumors appeared when rats and mice took huge doses of a closely related chemical cousin of the medication. Some FDA reviewers were concerned enough initially to recommend rejection of Lunesta. After further analyses, however, agency officials concluded the data from human testing didn't suggest a signal for cancer in people. But you won't see the issue highlighted in the company's ubiquitous green-moth commercials for the drug.

Journalists who report on preliminary findings from animal research without strongly emphasizing the inherent weaknesses in trying to interpret such findings are not serving the public.

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March 29, 2007

Whatever happened to the miracle obesity pill?

Earlier this week, I pointed out how - on one day - the Wall Street Journal appeared to favor positive drug news out of the American College of Cardiology meeting more than negative drug news. But day in and day out, the WSJ is one of the few news organizations to put negative drug news on page one. And today they should be praised for the spot they gave the story headlined, " 'Miracle' Obesity Pill Looks Less Miraculous." It begins:

"When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz.

Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia, as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid.

"That is amazing. People are going to want this drug today, I'm sure," effused an anchor on ABC's "Good Morning America."

Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia -- including depression and anxiety -- are likely giving the FDA particular cause for concern, analysts and doctors say."

This episode is repeated many times each year: journalists trumpeting preliminary unproven claims made by drug companies or pharma-funded researchers without exercising appropriate skepticism and caution.

Thanks to the WSJ for not only pointing this out, for doing so in its prominent page one position.

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March 28, 2007

High school students' science project finds Glaxo's false claims

The Associated Press reports that two 14-year old high school science students proved that drug company powerhouse GlaxoSmithKline was making unsubstantianted claims about one of its products. And the drug giant will be fined - although not much - for the misleading advertising.

This took place in New Zealand, where two science students found that Glaxo's black currant drink Ribena contained no detectable vitamin C. AP reports:

The multinational company admitted to 15 charges of misleading advertising between 2002 and 2006 in a suit filed by the Commerce Commission, a consumer watchdog, after a 2004 school science project exposed the false claims.

Ribena has long been sold as a healthy drink based on advertisements that black currant juice has more vitamin C than orange juice. Its New Zealand advertisements claimed Ready to Drink Ribena had 7 milligrams of vitamin C per 100 milliliters (0.25 ounce per 3.4 fluid ounces).

But high school students Anna Devathasan and Jenny Suo, then 14, found it contained almost no trace of vitamin C after testing the children's syrup-based drink as part of a science project in 2004. ...

The girls were in court to hear the verdict.

"We feel quite proud ... blown away," (one said.) "If we hadn't done that science test three years ago, Ribena could have been promoted as vitamin C full forever."

It was "remarkable nobody had even picked it up ... and we just stumbled on it by chance," she said, adding that she thought the fine should have been more because GlaxoSmithKline was a multibillion dollar company.

AP says the company was fined $156,000 in U.S. dollars.

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March 26, 2007

Negative drug news doesn't get the same play as positive

You're seeing lots of cardiovascular news this week because the annual meeting of the American College of Cardiology is going on in New Orleans.

I applaud the health news coverage of the Wall Street Journal, but even their coverage shows a bias toward the positive and against negative findings.

In today's WSJ, the front page of the "Marketplace" section, page B1, has a story on the "blockbuster drug plavix" and a pack of new rivals on the horizon.

But negative findings on two other drug studies are relegated to pages B6 and B7, deep in the paper and deeper in that section.

Stories headlined "Crestor Fails to Clear A Bar in Arterial Study" and "Two Heart-Failure Drugs Fail to Reduce Death, Admissions" were important, but got neither the quality nor quantity of space given to the generally positive Plavix (and rivals) story.

American consumers need to be reminded that not all drugs are blockbusters, and that hopes at the beginning of trials are often dashed at the end. Page 1 placement would drive that point home.
(But at least the WSJ reports on the negative findings somewhere - don't get me wrong.)

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March 23, 2007

Concern over doctors' ties to drug companies

The Star Tribune today has more details from the reports filed with the Minnesota Pharmacy Board about drug company payments to physicians. Minnesota and Vermont are the only two states that require drug companies to publicly disclose such payments.

The paper's lede:

Dr. Inder Anand went to Paris. Dr. David Lowe went to Mankato. And Dr. Rex Haberman traveled across the United States.

The three Minnesota doctors took the trips at the expense of pharmaceutical companies, which paid them tens of thousands of dollars in 2005 for their expertise and time.

The paper also reported:

Meanwhile, the reporting system that tracks payments in Minnesota was criticized in this week's journal article as flawed and incomplete.

State officials confirmed that one drug maker, Pfizer, did not file a 2005 report with the pharmacy board, even though it reported $2.8 million in payments in 2004.

"I'll be sending them a letter," said Cody Wiberg, the board's executive director. A Pfizer attorney did not return a call for comment Thursday.

Because of the increased public interest in the filings, Wiberg said the board will post copies of the documents on the board's website.

Eventually, he wants to put all of the information in a database so the public can search by doctors' names.

The paper lists some of the big givers and some of the big receivers.

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March 22, 2007

Lots of drug-related conflict of interest news this week

Gardiner Harris of the New York Times is all over issues about drug company influence on doctors and on the FDA this week. Today he writes:

Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.

Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A “significant number? of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many.

Yesterday, Harris' story on "Doctors' Ties to Drug Makers Are Put on Close View" simply blew away the competition - better by far than any other story I saw on the subject in many media across the country - including right here in Minneapolis. He and Janet Robert reported on records in Minnesota, where drug makers are required to disclose payments to doctors.

The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify.

The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.

The reporting on this latter story was complete and comprehensive, with many examples of Minnesota physicians receiving surprising amounts of money from drug companies; ten doctors and one dentist received more than $500,000. You should read the entire story. But be ready to take an anti-anxiety pill when you're done.

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March 12, 2007

Erythropoietin bad news hidden late on Friday?

Merrill Goozner suggests that the FDA announcement late last Friday afternoon, issuing an official warning against giving cancer patients erythropoietin drugs (Epogen, Procrit, Aranesp) for anemia, was timed to minimize bad news or embarrassment. Goozner writes:

"What struck me most about yesterday's announcement was its timing. It has long been a hallmark of White House public relations staff that the best time to release bad news was late on Friday afternoons. That way, the least number of people will hear about it through traditional news media sources. It's too late to make the Friday evening newscasts; and the print stories usually wind up inside the Saturday papers, which are the least read of the week. (The New York Times story, at least, got mentioned on the front page.)

Is this what the FDA wanted for this important warning? Is this the best way to counter the torrent of direct-to-consumer TV ads touting this drug by asking "if you're ready for chemotherapy"?

This late Friday afternoon release shows as much as anything how the culture of the agency has been transformed in recent years from industry watchdog to industry lapdog."

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February 28, 2007

New drug "Havidol" - when more is not enough

Have you heard about the blockbuster new drug, Havidol?

Its creators say that HAVIDOL is for the treatment of Dysphoric Social Attention Consumption Deficit Anxiety Disorder (DSACDAD). And they say it is the only known medication available for this newly recognized disorder.

Details at Havidol.com.

It's also a spoof.

The creator of the campaign, an Australian artist, tells Reuters that many people don't get the fact this is a parody or satire. This reminds me of the spoof a few years ago on Motivational Deficiency Disorder mentioned on this blog.

I am pumped. The Havidol website tells me: "No prescription drug can promise endless happiness. However given HAVIDOL's track record, and Future PHARMS (the manufacturer) commitment to perfecting life through chemistry, terminal happiness has become a real possibility."

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February 20, 2007

PBS ombudsman thinks Glaxo sponsorship isn't worth it

Broadcasting & Cable magazine reports:

"The sponsorship of a PBS program on obesity by diet drug maker GlaxoSmithKline has one veteran noncom TV watcher a bit exercised, but PBS says it is by the book.

Jeff Chester, executive director of the Center for Digital Democracy, and a frequent critic of what he sees as the increasingly commercialization of noncommercial broadcasting, has written to PBS ombudsman Michael Getler to complain about what he sees as too lax sponsorship policies.

Glaxo is underwriting the April broadcast of 'Fat: What No One is Telling You' ...

'We note that funding comes in part from GlaxoSmithKline,' Chester wrote Getler. 'The drug giant just happens to have a recently approved for over-the-counter drug on the market-under the brand name Alli, that is for 'use by overweight adults along with a reduced calorie, low-fat diet.' ...

PBS program executives need to 'cut the fat' out of their sloppy review of what's appropriate for underwriting,' said Chester."

Getler responded on his PBS ombudsman blog: "My view is that Chester’s eagle-eye provides a continuing, very useful challenge to PBS, a challenge that I agree with even though I sympathize with PBS’s constant search for funding, the difficulty of finding sponsorships to bolster more traditional funding, and that fact that some funders simply have an interest in seeing subjects aired and are willing to take their chances on how the program will come out. But in this case, there is little doubt how a program about obesity is going to turn out. Even though GlaxoSmithKline came in late and, under PBS policy, has no say in any of the content, this kind of possible conflict can undermine credibility and, without knowing the financial details, doesn’t seem worth it. "

(GS note: Thanks to one of my blog readers for tipping me off to this controversy.)

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February 19, 2007

Impotence drug ads during kids' TV shows

The Wall Street Journal reports: "Despite a pledge from the pharmaceutical industry to be more careful with prescription-drug advertising, impotence-drug makers are sliding back to tactics that drew widespread criticism from patients, doctors and regulators. A pediatricians' organization is calling for no impotence ads during hours when children are likely to be watching, and a major AIDS group has expressed concern that ads have become too suggestive again, encouraging people who aren't suffering from erectile dysfunction to use the drugs recreationally." ...

"The American Academy of Pediatrics has called for the erectile-dysfunction commercials to be restricted to after 10 p.m. so that children wouldn't view sex as 'a recreational sport.' ...

In December alone, an ad for impotence drug Viagra aired at around 9 p.m. during 'Prancer,' a G-rated movie about a young girl who nurses one of Santa's reindeers back to health; another spot for rival medicine Levitra appeared during an afternoon showing of the comedy 'Pee-wee's Big Adventure;' and another for Cialis graced an early-evening presentation of the holiday classic 'Miracle on 34th Street.' "

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February 14, 2007

Pharma promotion squashed in France

Ray Moynihan reports in the BMJ (subscription required) that a controversial proposal to have drug companies “patient compliance? programs declared legal in France has failed.

Excerpts:

“Critics described the proposal as a backdoor attempt to introduce into France direct to consumer drug advertising, which is currently banned throughout Europe.

Compliance support programmes organised by drug companies can include telephone reminders to consumers, personalised information for patients, and even home visits from nurses. The drug industry defends public health programmes as valuable for boosting adherence to treatment; others argue the programmes are Big Brother-style marketing strategies intended to boost profits.

A recently formed advocacy group called the Medicines in Europe Forum, which comprises patients, professionals, and others, successfully lobbied French politicians last month to reject the proposal. The group claims that compliance programmes are often little more than advertising stunts, designed to build brand loyalty and "increase the quantity of drugs consumed."

The controversy is part of the wider debate over whether aggressive United States-style drug advertising should be allowed on the other side of the Atlantic, an idea firmly rejected by the European parliament. Despite the ban, industry in Europe is continuing to push to liberalise restrictions on communications with the public, arguing that drug companies can provide patients with valuable health information.

Although the French plan to legalise company compliance programmes was defeated last month, it will be debated again in the French parliament later this year.?

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February 7, 2007

Concerns over push for mandated preteen cervical cancer vaccination

The Wall Street Journal (subscription required) reports on the growing opposition to state moves to mandate use of a new cervical cancer vaccine in preteen girls.

The paper reports: "Bills being drafted in some 20 U.S. states that would make a cervical-cancer vaccine mandatory for preteen girls are sparking a backlash among parents and consumer advocates.

The bills coincide with an aggressive lobbying campaign by Merck & Co., the maker of the only such vaccine on the market. Called Gardasil, the three-shot regimen provides protection against the human papillomavirus, a sexually transmitted virus that is responsible for the majority of cases of cervical cancer.

If the state bills become law, they would guarantee the Whitehouse Station, N.J., drug maker billions of dollars in annual revenue from the vaccine."

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February 6, 2007

Canadian paper bites on pharma-funded advocacy

A Vancouver Sun story is a good example of an imbalanced story that fails to address health policy issues with context and completeness. The story reports on an advocacy group report and, in so doing, takes a flawed advocacy stance itself.

The story begins: "Cancer patients are increasingly having to pay for important new drugs administered in public hospitals, the latest symptom of Canada's inconsistent and often inadequate funding of cancer treatment, an advocacy group reported Monday."

The story says, "One breakthrough leukemia drug is paid for by just a single province, (British Columbia)." The story didn't explain what qualifies as a breakthrough.

Then the story dipped into the language that is usually used when cost-effectiveness decisions are made by government officials - "rationing." The story says, " 'Essentially, we will continue to ration life-saving cancer treatment, and some Canadians will live and some will die simply because of where they live,' said the report."

Late in the story, it finally disclosed that the advocacy group was financed largely by pharmaceutical companies.

The report also looked at the availability of PET (positron emission tomography) scans and mammograms for cancer patients, raising questions about what the report said was underuse of the two technologies.

But overuse of PET and other scanning technologies is generally a bigger concern than underuse. And who's to say that women aren't choosing to forego mammography after weighing the evidence? The story certainly didn't look into that possibility.

Journalists will not contribute to a meaningful discussion on health care reform if they take the party line of a pharma-funded advocacy group as gospel.

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February 3, 2007

Molly Ivins would have loved this one

Molly Ivins used to call Texas governor Rick Perry, "Governor Good Hair," or Governor Rick "Good Hair" Perry.

But Molly would have had a field day with this news: Texas on Friday became the first state to require school-age girls to be vaccinated against a sexually transmitted virus that has been shown to cause cervical cancer.

The LA Times reports that Perry "signed an executive order mandating that most girls, starting in September 2008, receive the vaccination against the human papillomavirus before entering sixth grade. ... By sidestepping the Texas Legislature, Perry — a conservative Republican — avoided a showdown with GOP lawmakers and Christian organizations that oppose mandatory HPV vaccinations."

In so doing, Governor Good Hair was praised by some liberals and public health advocates. But, the Times reports, "the move drew criticism from conservative groups, which noted that the governor had accepted campaign contributions from the vaccine's manufacturer, Merck & Co.

'All Merck wanted was a mandate so the insurance companies would have to pay for this. Follow the money,' said Cathie Adams, president of the Texas Eagle Forum, an organization that promotes socially conservative government policies. ...

Merck has been pushing for laws mandating its Gardasil vaccine in numerous states. It has also launched a TV ad campaign featuring girls and the slogan 'One less,' to signify one fewer cancer patient for each person vaccinated.

The New Jersey-based drug company donated $6,000 to Perry's reelection campaign last year, Texas campaign finance records show. One of its top Texas lobbyists, Mike Toomey, is Perry's former chief of staff."

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February 1, 2007

Think of Baycol when you hear new drug hype

Whenever I think about premature enthusiasm for new drugs, when I hear doctors talking about putting statins in the water supply, when I hear news reports that a drug is safe -- I think of Baycol. The statin drug was approved about ten years ago, but pulled from the market about five years ago after being linked to 31 deaths.

The Houston Business Journal now reports:

"Bayer Corp. will pay $8 million to 30 states, including $200,000 to Texas, as part of a settlement requiring the company to fully disclose when drugs pose risks for patients with specific health conditions.

According to the settlement, Bayer failed to adequately warn physicians, pharmacies and patients of clinical studies revealing serious consequences of taking Baycol, a cholesterol-lowering drug. The company pulled the drug from the market in August 2001 due to its muscle-weakening side effects.

The terms also extend to the disclosure of clinical studies involving other Bayer drugs with possibly harmful side effects. ...

The terms of the judgment require that Bayer register its clinical studies and, upon the completion of each study, post the results on the Internet. The marketing, sale and promotion of Bayer's pharmaceutical and biological products must comply with the law and cannot include false or misleading claims."

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January 31, 2007

Kidney Foundation conflicts of interest?

The Integrity in Science Project of the Center for Science in the Public Interest reports:

"The non-profit National Kidney Foundation is refusing to release the final roster of the expert panel that meets in Dallas on Saturday to re-evaluate its anemia guidelines for people suffering from chronic kidney disease. Recent studies show that raising red blood cell counts to meet targets established in the 2006 NKF guidelines increases strokes and heart attacks for people on dialysis, and hastens the onset of dialysis for people with chronic kidney disease. Eleven of the 16 members of the committee behind those guidelines, which were underwritten by Amgen Inc., had ties to firms that sell drugs to alleviate anemia, which are Amgen, Roche and Johnson & Johnson. The government's Medicare program currently spends over $2 billion a year for these drugs.

The current roster on the NKF website lists 12 of 18 members with ties to those three firms. ...

In an article in the current issue of the Clinical Journal of the American Society of Nephrology, Daniel W. Coyne of Washington University School of Medicine in St. Louis blasted the committee's decision last year to ignore his own unpublished data showing excess mortality even though he offered the data from his industry-funded study to the committee. 'In whose interest was it not to delay release of the guidelines until the results of these studies were available,' he asked. In a written response, five physicians from the committee, four with ties to the drug makers, said reviewing only published studies 'served as a safeguard against bias.'

Coyne also attacked Medicare reimbursement policy, which rewards dialysis clinics for increased use of the drugs, and called on NKF to prohibit or 'greatly limit' physicians with conflicts of interest from serving on its guideline-writing panels. 'There are many physicians in academia with few or no ties to industry who are well trained to evaluate evidence from clinical trials and capable of writing guidelines,' he told Integrity in Science Watch. 'By not restricting corporate conflicts of interest among guideline panel members, the NKF has sometimes chosen physicians clearly favored by their sponsoring corporations, and effectively encourages those companies to attempt to influence all panel members.' In the written response to his article, the NKF committee members said prohibiting physicians with conflicts from sitting on the panel 'although attractive in theory, is unrealistic.' They called instead for greater transparency."

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January 30, 2007

More reason to avoid drug ads

USA Today reports on a study in the Annals of Family Medicine that shows - big surprise - that TV ads for prescription drugs rarely mention risk factors or non-drug treatments.

The paper quotes the study's lead author: "All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."

USA Today summarized the main findings:

"•Only a quarter of the ads mentioned causes or risk factors for the condition treated by the drug.

•None of the commercials mentioned lifestyle changes as an alternative to medication (for example, diet and exercise to lower cholesterol), although about a fifth mentioned such changes as an adjunct to medication.

•Only a quarter of the commercials mentioned how common or uncommon the treated disease is.

•Most of the commercials were unrealistic in portraying medication's role in achieving health. The ads showed people who regained complete control of their lives after taking the advertised drug."

The paper also quotes Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. He said the study doesn't reflect changes brought about by his group's "Guiding Principles" for direct-to-consumer advertising. The voluntary guidelines came out about a year after the commercials in the study.

You be the judge: have you seen a big improvement in drug ads over the past year?

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January 29, 2007

Canadian Cancer Society & Pharma Funding

The Canadian Cancer Society proclaimed last week "National Non-Smoking Week," and CBC radio covered the topic on its program, "The Current."

The program's website stated: "The Canadian Cancer Society is one of the voices you'll be hearing from this week. The organization has just published an updated version of its "How-To" guide to quitting smoking ... a book called One Step At A Time.

Among other things, the new version contains information about smoking-cessation devices ... nicotine patches and chewing gum meant to help deal with nicotine withdrawal. Ordinarily, that wouldn't be cause for concern. But some health policy specialists are suspicious about the fact that some of the money behind the revised guide came from the pharmaceutical giant, Pfizer ... a company that has made many of the products the Canadian Cancer Society's guide promotes. ...

Nicotine replacement products are a booming business. For about fifteen years now, repentant smokers have been able to buy over-the-counter products like nicotine-laced gum and skin-patches. And the makers of those products have boldly promoted their virtues in commercials featuring a flight attendant on the edge.

Commercials such as these can give you the impression that it's just about impossible to quit smoking without medication."

Drug company funding of "disease awareness" or patient education campaigns can be problematic. On this radio program, University of Victoria drug policy researcher Alan Cassels (whose Media Doctor website operates much like our HealthNewsReview.org website) explained where the problems may lie.

You can download and listen to the entire program, using Real Player.

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January 23, 2007

$4.5 Billion Drug Ad Biz

The U.S. - one of only two countries in the world that allows direct-to-consumer advertising of prescription drugs (New Zealand is the other and it is reconsidering) - is poised for Congressional battles over those ads.

The New York Times reports: "Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate.

The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.

The pharmaceutical industry, which often gets what it asks for from Congress and the executive branch, seeks to renew the law and add a new set of user fees that would be pay salaries for additional F.D.A. employees to evaluate all consumer drug ads, before they are shown on television.

Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug. The companies want the delay to be left up to them, but critics say the F.D.A. should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

'From the beginning , everyone, including the company, agreed that not everybody ought to be getting Vioxx,' said Helen Darling, president of the National Business Group on Health, an organization of large employers. 'But the ads implied there was a widespread need for it.' "

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January 19, 2007

PharmedOut battles problematic drug promotion

PharmedOut.org is a new website and project run by doctors "to disseminate information about how pharmaceutical companies influence what we prescribe, to increase access to unbiased information about drugs, and to encourage physicians to choose pharma-free (CME) continuing medical education."

One thing the site offers is a list of more than 200 pharma-free web-based CME credits available without cost.

The site explains that "PharmedOut is funded through the Attorney General Consumer and Prescriber Education grant program, created as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, Inc., and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® (gabapentin) that violated state consumer protection laws."

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January 15, 2007

Influence of drug ads on M.D.-patient encounter

A Consumer Reports survey of 39-thousand patients and of 335 primary care doctors shows the influence of drug ads on the patient-physician encounter. The survey found that 78 percent of doctors said patients asked them at least occasionally to prescribe drugs they had seen advertised on television, and 67 percent said they sometimes did so.

On the flip side, patients said that almost one-third of the doctors failed to discuss side effects of prescribed drugs, and two-thirds never brought up costs of treatments and tests, patients said.

Consumer Reports advises readers: "Ignore drug ads. There’s another party in the examination room with you and your doctor: the pharmaceutical industry, which spends billions of dollars a year trying to get you to pester your doctor for expensive new brand-name drugs--and wining and dining doctors so that they’ll prescribe them.

Almost all the doctors we surveyed said they make at least some time to meet with pharmaceutical company representatives who arrive bearing free samples, gifts, and sales pitches for their drugs.

Twenty-two percent of physicians we surveyed said they field “I saw it on TV? requests quite often in a typical week. Patients most frequently ask about drugs for acid reflux, impotence, allergies, and insomnia--mainstays of the television ad lineups. Very few of the patients we surveyed--7 percent--admitted to asking for advertised drugs for their most bothersome health condition over the previous 12 months. Such requests were most likely from patients with insomnia or impotence. Forty-nine percent of patients who asked for a specific drug left the doctor’s office with the prescription they requested.

If you’re tempted to ask for a drug you saw advertised, don’t be offended if your doctor declines to prescribe it, as 54 percent of our surveyed physicians said they sometimes did. (Forty percent of doctors also said that advertising directly to consumers did not serve the public interest.)

Older drugs can be just as effective, have a longer safety record, and often cost less. The new drug might not be on your health plan’s list of approved medications; 60 percent of the doctors we surveyed complained about such restrictions.

Thirty-one percent of respondents who got prescriptions said their doctor didn’t adequately explain possible side effects, so be sure to ask about them. And 9 percent said their doctor didn’t review their other prescriptions to check for potentially harmful interactions with the new drug."

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January 3, 2007

Big Pharma Lecture Circuit discussion continues

Two days ago (January 1), I posted the contents of a letter to the editor of the Wall Street Journal from a physician criticizing the "Big Pharma Lecture Circuit." Today's WSJ has a response from another physician:

As a physician who occasionally lectures on behalf of industry, I must respond to Jon C. Bowersox's insulting comments ("Concerns About Big Pharma Lecture Circuit," Letters, Dec. 29), where he likens us to traveling snake oil purveyors of old.

Lectures done in the context of a pharmaceutical promotional event, such as a dinner, follow strict guidelines established by the FDA. They are anything but opinion-based -- data from pivotal trials is presented and recommendations cannot differ from those that have been FDA-approved and are contained in the package insert. Personal opinions may emerge during Q & A, but how is this a problem? Apparently, Dr. Bowersox thinks physicians who attend such meetings are dull clods and cannot make their own minds up about a specific recommendation.

And perhaps the good professor can explain how $2,500 for a lecture that often requires one or two days away from the office or hospital is an "outrageous fee?" It barely covers lost income.

Richard Amerling, M.D.
Editorial Board
Nephrology News and Issues
New York

Ah yes, the poor pharma-supported lecturer barely covering lost income. And where do patient interests fit into this discussion?

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January 1, 2007

Concerns About Big Pharma Lecture Circuit

The headline above is the subject line of a letter to the editor of the Wall Street Journal. It's an important message for the new year. It reads:

"Your article on how pharmaceutical companies use "medical education" to build new markets for existing products ("Drug Firm's Cash Sways Debate Over Test for Pregnant Women," page one, Dec. 13) proves that rhetoric still trumps science in influencing physician behavior. More than 100 years ago, traveling salesmen touted the miraculous benefits of patent medicines sold from the back of their wagons, even though there was no evidence to support their claims. Now, it is traveling professors collecting $2,500 for an hour's lecture, plus first-class tickets and accommodations, to deliver the same message. In an era where there is a national consensus that evidence-based medicine improves patient outcomes, it is appalling that physicians would take these outrageous fees to represent pharmaceutical companies based on beliefs and not data, sometimes pleading ignorance when required to sign financial-disclosure statements or claiming that it is on the behalf of patients.

It isn't the responsibility of the pharmaceutical industry to stop this behavior. Companies are obligated to maximize value for their shareholders. But physicians have a higher level of responsibility to their patients and families. The FDA has created a stringent review process for approving new drugs or new applications for an existing drug. To subvert this process not only puts patients at risk, but lowers the public trust in all physicians. Corporate executives now face criminal and civil penalties for misrepresentation. Physicians should be held to the same standards.

Jon C. Bowersox, M.D., Ph.D.

Professor and Vice Chairman
Department of Surgery
University of Cincinnati
Cincinnati

(Dr. Bowersox was previously global director of medical affairs for a major American pharmaceutical company.)

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December 29, 2006

Celebrity doctors become drug advertisers

Dr. Robert Jarvik had his moments of fame promoting his Jarvik-7 artificial heart. When it failed, he turned to promoting the heart drug Lipitor. (NBC's Robert Bazell opines.)

Dr. Howard Torman had a few moments of fame as a CBS News medical correspondent. When that dried up, he turned to doing TV ads for Viagra. Those ads are running currently, including a tight shot of Torman's name badge on his white coat, as if that means anything to millions who never heard of him or did but forgot.

Four years ago, ABC News medical correspondent Dr. Nancy Snyderman was suspended without pay for a week by the network after she recorded a radio commercial for Tylenol. She left ABC a few months later to become vice president of medical affairs at Johnson & Johnson—the company that makes Tylenol. Now she's back on the air, as NBC chief medical editor. When you read Snyderman's bio on a speaker's bureau website, you'll see that the NBC gig shares top billing with her former J&J drug company work.

Celebrity may be lucrative for these doctors-turned-salespeople. But there's also a price for celebrity. Is integrity part of the price?

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December 20, 2006

Push for herpes testing = push for herpes drug use?

It's another story of questionable promotion of a screening test, of "off-label" promotion of a drug, of risk-benefit decisions, and of behind-the-scenes drug company wrangling for broader use of one of its drugs.

The Wall Street Journal (subscription required) reports on a controversial push by some doctors for testing all pregnant women for genital herpes to reduce infections in newborns. Of course, it would also mean a boost for GlaxoSmithKline, which has a herpes drug, and which supports the "continuing medical education" lectures promoting the screening.

The WSJ reports: "Advocates of screening point to a stark reality: Babies born to a woman whose herpes infection is active can end up blind or with cerebral palsy, and some die. An estimated one-quarter of pregnant women in the U.S. carry the herpes virus in their bodies.

Yet only a small fraction of these women are at any risk of passing the virus to their babies. It's not clear whether treating infected women with herpes drugs would reduce this number. Meanwhile, most pregnant women who have the virus don't even know it. And they aren't routinely tested to find out.

Federal health agencies that have studied the possibility of universal screening of pregnant women for genital herpes have come down against it. So has the American College of Obstetricians and Gynecologists. Opponents see little benefit but potential risks if large numbers of women tested positive and began taking herpes drugs. Their side effects can range from allergic reactions to hypertension.

Glaxo says it doesn't market its herpes drug, called Valtrex, in any way for pregnant women. The company couldn't promote the drug to prevent neonatal herpes in any case, because the Food and Drug Administration hasn't approved it for that purpose.

Doctors, however, aren't restricted in how they use an approved drug, nor in what they can say about it in talks to other medical professionals. And currently, about 10 doctors are fanning out across the U.S. making the case for universal genital-herpes screening of pregnant women. Glaxo funds these talks by giving grants to hospitals and other institutions that host them."

One Ob-Gyn in the story said, "A screening program will be horribly inefficient and almost entirely ineffective and highly cost-ineffective. There are a few people who have made careers out of neonatal herpes and they are the ones pushing screening."

It's a messy story, well-reported by the WSJ.

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December 19, 2006

Dangerous "off-label" drug promotion campaign

The New York Times reports that drugmaker "Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials."

The Times reports the campaign was first called "Viva Zyprexa." "Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors 'do treat dementia' but 'do not treat bipolar; schizophrenia is handled by psychiatrists,' " according to the Times report.

The Times explains: "The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved. Lilly faces federal and state investigations over its marketing of Zyprexa."

The paper also reports that sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States.

A primer on off-label drug use and promotion is available on the HealthNewsReview.org website.

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December 13, 2006

Waiving conflict of interest on FDA panels

The Center for Science in the Public Interest (CSPI) reports on multiple waivers of conflicts of interest on three recent FDA advisory panels. Three experts with financial conflicts were allowed on this week's advisory panel on adult suicide risk from antidepressants. According to CSPI, one received between $10,000 and $50,000 per year from one of the companies affected by the panel hearing.

Last week, seven waivers were granted to members of a panel discussing safety concerns about Sanofi-Aventis' antibiotic Ketek.

And the FDA gave financial conflict-of-interest waivers to six physicians who sat on the advisory panel that evaluated the safety of drug-eluting stents made by Johnson & Johnson and Boston Scientific.

CSPI does a tremendous public service by disclosing what's going on at the FDA. The public - and many journalists - don't know the extent to which conflicts of interest may impact the integrity of science and of health care recommendations. We need to have a deep and ongoing public discussion about what these conflicts mean, how to judge them, and how to ensure unbiased review of new drugs and devices given the prevalence of conflicts of interest among America's physician-researchers.

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December 11, 2006

Fox guarding even more hen houses at FDA

Several news organizations - the Wall Street Journal and American Public Media's Marketplace - have reported that the Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require companies, for the first time, to pay fees to the FDA for the work of reviewing their TV drug ads, in exchange for speedier reviews. The Wall Street Journal story included this line: “The FDA is unusual among federal agencies because it negotiates with the companies it regulates, which are represented by their major trade organizations, over the amount and use of fees the industry pays to the agency.“

“Unusual? is mild. Controversial is more direct and appropriate. The current system of industry user fees has been criticized because of the potential pressure and conflict of interest it places on reviewers. In the Marketplace piece, Professor Steven Schondelmeyer of the University of Minnesota says, "It does create sort of a provider-client relationship where the agency begins to view that they're working for the industry that they're regulating, moreso than they're working for the public as a whole."

Don’t expect this move, if it happens, to put much more than a little speed-bump in the path of the runaway and troublesome TV drug ad business.

Advertising Age reports that such advertising budgets have boomed in the past ten years, from $12 million to $4.1 billion.

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November 30, 2006

U.S. pushing drugs on other countries

Yesterday we wrote again about the U.K. cost-effectiveness review agency named NICE. BMJ editor Fiona Godlee writes about NICE in her editor’s note, "Fear not the heat."

She writes: “The United Kingdom's main rationing body, the National Institute for Health and Clinical Excellence (NICE), is in the hot seat, and things look set to get hotter. NICE is facing its first ever legal challenge from the drug industry—about the decision making process behind its recommendation to restrict drug treatments for Alzheimer's disease. And it is under attack from US drug companies, apparently with White House backing, for stifling innovation in an overt attempt to gain unrestricted access to the National Health Service as part of a free market. (Editor's note: See story in The Guardian.)

What this shows is not that NICE is in trouble but that it is doing its job. It was set up to ensure that treatments available on the NHS provide value for money. Decisions to restrict drug treatments are hugely emotive to patients and clinicians. Controversy is inevitable. But the fact that there is insufficient evidence that the drugs are cost effective in the early stages of dementia is not NICE's fault and does not mean that the process is itself flawed, as Pfizer and others contend. Independent review of NICE's processes by the World Health Organization concluded that they are optimal for health technology assessment. Even if a judicial review recommended changes to the process in this case, the need for a body like NICE to make decisions on cost effectiveness will not go away.

Nor is the UK alone in this. Germany's Institute for Quality and Economic Efficiency in Health Care, which emulates NICE, is under attack from the drug industry for being insufficiently transparent. And … tensions with the industry have increased since the German government proposed extending the institute's role to include cost effectiveness of drugs as well as their clinical effectiveness. Australia's groundbreaking initiative to establish such a "fourth hurdle" crumbled under pressure from the US drug industry. An unholy deal was struck that allowed Australia access to US markets in exchange for unrestricted access to Australia's pharmaceutical market. Germany must hold its ground, and so too must the UK."

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November 12, 2006

PR firm pays journalists to attend drug hearing

The Center for Media and Democracy reports on a tidbit from across the pond:

“The U.K. drug industry's self regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA), has censured Janssen-Cilag after an employee from its PR firm, Burson-Marsteller (B-M), offered journalists cash if they attended a hearing of the government drug regulator. The offer related to a public hearing on Jannsen-Cilag's appeal against a decision against approving the drug Eprex before the National Institute for Clinical Excellence. "As it is possible that the hearing will take up most of the day, and we understand that your time is valuable, we are able to offer £200 (€293) if you wish to attend," the B-M employee wrote. The PMCPA found that Janssen-Cilag, a subsidiary of Johnson & Johnson, was responsible for B-M's actions. In June B-M told PR Week the offer was a "human error" but has declined to comment on whether the employee still works for the firm.?

If you care to read the entire PMCPA case report, go to the PMCPA website, search for "Janssen-Cilag," and then click on the “Media/Director v Janssen-Cilag Alleged payment to journalist? link. It takes you to a pdf file of the full, seven-page case report.

In this country, we don’t have a cost-effectiveness review agency such as the UK’s National Institute for Clinical Excellence (NICE – although drug companies probably view it as anything but nice.) But we still see many ethically-challenged efforts to promote more drugs to broader markets.

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November 11, 2006

Trust in medicine; docs can't be pharma lapdogs

A Georgetown professor warns in this week's BMJ that doctors can not be lapdogs to drug companies.

Her warning comes after she addressed a conference about the influence of the drug industry on continuing medical education. And after several companies withdrew or threatened to withdraw their support for future conferences because of what she said.

Professor Adriane Fugh-Berman’s talk covered the costs of drugs, the costs of promoting drugs to doctors, the salaries of drug representatives, and the funding of continuing medical education. She also covered psychological profiling and monitoring of physicians, including prescription tracking.

She writes, “Drug representatives are paid to be nice to us, as long as we cooperate, sustaining market share of targeted drugs, and limiting our continuing medical education lectures to messages that increase drug sales. ...If we remain dependent on pharmaceutical companies for sponsoring continuing medical education, then these courses will remain under the control of the drug industry. This control is not contractual, but it is enforced through psychological manipulation. ... As a last resort, we physicians could actually pay for our continuing education, as do lawyers, accountants, business people and aerobics teachers, to mention a few." ...Medicine must shed its docility and the corporate leash. Let us not be a lapdog to the pharmaceutical industry. Rather than sitting contentedly in our master’s lap, let us turn around and bite something tender. Freedom calls.?

In the same issue of BMJ, editor Fiona Godlee writes, "Trust is at stake in every decision doctors make, and unchecked clinical enthusiasm can threaten professional integrity. Above all, beware of optimism bias... Two papers in the BMJ suggest that this "unwarranted belief in the value of interventions" has been at work with statins."

Optimism bias is fed by pharma influence. Thanks, BMJ, for publishing these important observations.

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November 10, 2006

Dems win drops drug stocks

The Medicare prescription drug benefit legislation passed up a huge opportunity for the government to try to control drug costs. The legislation prohibits the feds from negotiating with drug companies for the best deal on all those drugs the government is now helping sell to seniors.

But the Washington Post reports: "Rep. John D. Dingell (D-Mich.), the presumptive chairman of the House Energy and Commerce Committee, said Democrats would try to close a gap in which Medicare beneficiaries must cover their drug expenses and push the government to negotiate with drugmakers for lower prices. He also vowed to remedy what he called the "large overpayment of insurance companies."

Dingell also said he would look into whether generic drugs were being kept off the market by deals among manufacturers and how drug companies were "creating new uses of questionable value" for old drugs nearing the end of patent protection. And he said Congress needed to scrutinize the Food and Drug Administration's licensing process. He took special aim at the dietary-supplement industry. "People are being killed" because of lax oversight, he said."

In response to this news, shares of big drug companies such as Pfizer fell the past two days. Drug benefits manager Medco Health Solutions Inc. has seen two days of Wall Street losses, as has Humana Inc., the second-largest provider of Medicare drug coverage.

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November 9, 2006

Cholesterol TV ads clog reality

How can you argue with ads for a drug attacking America's leading killer?

Easy - when you base the argument on facts and evidence rather than emotion and fear-mongering.

Canadian drug policy analyst Alan Cassels writes about disease-mongering in ads for cholesterol-lowering drugs such as Pfizer's Lipitor, the #1 selling prescription drug. He writes: "What most people won’t learn from such ads is that when scientists have done meta-analyses (a study of a collection of studies) of the largest statin drug trials, they inevitably find that the drugs show no difference in mortality, when compared against placebo. There may be some changes in heart attack rates, but no changes in overall deaths, which is what the ads are all implying. We don’ t call this disease avoidance, we call it disease substitution. The drug may prevent a heart attack death but in the process will cause other kinds of deaths, a sort of zero sum gain that is the equivalent of taking an expensive placebo."

Cassels writes about one Pfizer Lipitor ad that shows the tagged toe of a corpse. “What would you rather have, a cholesterol test or a final exam?? asks the headline. Cassels says "The key message is that getting a cholesterol check and then, probably taking drugs to alter your cholesterol, will prevent a premature death. Even, if you are otherwise healthy."

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November 8, 2006

Big Canadian media company fights to overturn drug ad ban

The U.S. midterm elections are over and health care reform didn't get the amount of attention it deserved. So let's take a peak over the border of our neighbor to the north and see what's going on up there.

As we often write about, the U.S. is one of only two countries that allows direct-to-consumer prescription drug advertising. The other, New Zealand, is considering a ban. But in Canada, the big CanWest MediaWorks media company wants to overturn the country's ban on drug ads.

Now a Canadian newswire reports that "A coalition of unions, women's and health groups have been granted intervenor status" in the case. "The groups argue that if CanWest is successful it would push up healthcare costs and undermine the sustainability of the Canadian healthcare system. CanWest is arguing that the ban on DTCA is a violation of their right to freedom of expression. In an analysis of the case, Colleen Flood and Michelle Zimmerman from the University of Toronto Faculty of Law, warn against assuming that the court won't decide in the media giant's favour. "In order for the current legislation to be upheld, courts will need to be persuaded that nothing short of the existing limits on DTCA would allow the federal government to achieve its other pressing societal concerns, such as protecting patient safety. This will be a difficult task," they wrote.

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November 1, 2006

Drug company astroturfing with patient advocacy groups

The New Scientist has an important article about the concerns “that some patient groups are perilously close to becoming extensions of pharmaceutical companies' marketing departments.?

The term “astroturfing? is used for fake grassroots campaigns created by PR professionals for special interests, spawning supposedly spontaneous upheaval of public opinion. In the case of drugs promoted by patient advocacy groups, there’s a lot of money and misinformation at stake.

The New Scientist says it “conducted the largest survey to date of industry donations to patient groups based in the US - the biggest single market for drugs and medical devices. … We selected 20 US patient groups operating on a national level with annual revenues of more than $100,000, plus five with revenues exceeding $10 million, pulling them at random from the GuideStar database, which provides information on US non-profit organisations.

In addition, we identified four further groups, again with annual revenues exceeding $100,000, associated with bipolar disorder, restless legs syndrome and attention deficit hyperactivity disorder. These conditions were highlighted in April by the journal PLoS Medicine as being susceptible to "disease-mongering" by the pharmaceutical industry.

Just two groups identified in New Scientist's survey - the National Women's Health Network (NWHN) and Breast Cancer Action - refuse to accept donations from pharmaceutical or medical device companies. "We want women to know that when they come to us, they are getting independent information," says Amy Allina, the network's programme director. "We think of ourselves as virtuous, but poor."

One researcher, a breast cancer survivor, concludes: "There is a tendency not to want to criticise the motives of the patient groups, because a lot of them are made up of people who are pretty seriously sick.? She and others say that patient advocacy groups must be more transparent so that patients can make informed judgements about whom they can really trust.

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October 26, 2006

Jane Pauley says she was duped on drug company ad supplement

The website, The Smoking Gun, reports that former NBC anchor Jane Pauley has sued the New York Times, claiming the paper duped her into granting an interview for what was really a drug-company advertising supplement.

The website reports: "In a lawsuit filed Tuesday in U.S. District Court, the 55-year-old broadcaster charges that she believed that the Times interview was for a news article on mental health issues, but that the story (accompanied by a full-page photo) ran in an October 2005 "special advertising supplement" promoting psychotherapeutic drugs sold by Eli Lilly and other pharmaceutical firms. Pauley, who in September 2004 disclosed her battle with bipolar disorder, alleges that the Times "duped" her into lending her name to its advertising gambit, according to the lawsuit. After going public about her bipolar disorder, the lawsuit notes, Pauley has worked with several mental health advocacy groups, including the National Mental Health Association. Pauley's lawsuit seeks unspecified damages from the newspaper and DeWitt Publishing, which helped arrange the advertorial."

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October 19, 2006

Eli Lilly not lily-white on Xigris promotion?

Three doctors at the National Institutes of Health, in an article in this week's New England Journal of Medicine, criticize the Eli Lilly drug company for its promotion of the expensive sepsis drug Xigris.

The doctors claim that Lilly manipulated treatment guidelines to give Xigris the upper hand over older, cheaper and equally effective treatments.

The authors wrote: "To improve sales of (Xigris) in 2002, Lilly hired Belsito and Company, a public relations firm, to develop and help implement a three-pronged marketing strategy. First, the product's sales were to be supported by marketing initiatives targeted to physicians and the medical trade media. Second, because (Xigris) was relatively expensive, word would be spread that the drug was being rationed and physicians were being "systematically forced" to decide who would live and who would die. As part of this effort, Lilly provided a group of physicians and bioethicists with a $1.8 million grant to form the Values, Ethics, and Rationing in Critical Care (VERICC) Task Force, purportedly to address ethical issues raised by rationing in the intensive care unit. Finally, the Surviving Sepsis Campaign was established, in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines."

Eventually the efforts of that ~$2 million task force led to treatment guidelines, as the New York Times reports, "that rated Xigris more highly than older treatments for which clinical trials treating sepsis had never been conducted."

The Times also reports that "Xigris, which costs about $8,000 for a four-day course of treatment, generated controversy even before federal regulators approved it in November 2001. To win approval, Lilly presented results from a clinical trial that showed that Xigris reduced the risk of death in sepsis patients to 25 percent, down from 31 percent with older treatments. But the details of the data from the trial left many scientists who reviewed it unconvinced of Xigris’s efficacy. Half of the 20 scientists who reviewed the drug for a Food and Drug Administration advisory committee hearing in October 2001 said the agency should not approve the drug without more data. A month later, the F.D.A. approved Xigris, but warned that its use should be limited to the sickest patients, where it appeared to have the greatest efficacy."

But then came the guidelines to boost use of Xigris.

The NEJM authors conclude: "The challenges involved in producing first-rate guidelines and performance standards are only exacerbated by the intrusion of marketing strategies masquerading as evidence-based medicine."

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October 18, 2006

Wolf in sheep's clothing? Beware pharma advocacy

From across the pond, The Guardian of the UK reports on a huge pharma-funded advocacy campaign, but one which the Brits may be smart enough to sniff out and control. Excerpts:

"Cancer United, which is due to be launched with a fanfare in Brussels tomorrow, is being presented as a pioneering effort by a coalition of doctors, nurses and patients to push for equal access to cancer care across the EU. However, the campaign is being entirely funded by Roche, the maker of Herceptin and Avastin. A senior company executive sits on the board. The company's PR firm Weber Shandwick is the secretariat and has been heavily promoting it to clinicians and journalists. And the principal study on which it is based has been hotly contested - and was also funded by Roche.

MEPs and the head of the European Cancer Patients Coalition have already withdrawn from Cancer United's executive board, amid concerns over the funding and lack of transparency.

Roche last night strongly denied the campaign was in effect a marketing exercise.

However, one of the UK's leading cancer experts, Michel Coleman from the London School of Hygiene and Tropical Medicine, told the Guardian he had grave concerns about Cancer United.

"Governments will no doubt be pressed to fund a big increase in expenditure on cancer drugs - on the entirely spurious grounds that such an increase has been proven to increase national survival rates. I wonder if all the dignitaries on the executive board of Cancer United are aware of this murky background.

"Cancer patient groups should think twice before accepting sponsorship from Cancer United."

He is highly critical of the study that is central to the campaign. The report, from the Karolinska Institute in Stockholm, links patient survival to the amount their government spends on drugs.

Prof Coleman said the report represents "woefully simplistic research... This is clearly nonsense. For most cancers, higher survival results from earlier diagnosis and a combination of expert surgery and/or radiotherapy, as well as from the use of cancer drugs. ... One can be highly critical of European inequalities in cancer survival - and I am critical - but attempting to manipulate public opinion or national cancer policies on the basis of poor science about the availability of cancer drugs is not the right strategy for addressing those inequalities," he said."

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October 10, 2006

$410 million a month on drug ads

A little item you may have missed from the AP last week:

"Pharmaceutical companies increased advertising spending by 9% in the first half of this year, suggesting they no longer feel constrained by complaints raised after the landmark withdrawal of the pain medicine Vioxx.

Spending rose to $2.46 billion in the six-month period as drug makers devoted larger portions of their budgets to magazine ads and poured more funds into campaigns to promote their images and disease awareness, according to TNS Media Intelligence. In the first six months of 2005, spending was essentially flat at $2.26 billion.

The Vioxx withdrawal in late 2004 cast a pall over pharmaceutical advertising as critics claimed drug makers' splashy campaigns minimized medicines' risks. Vioxx was a heavily advertised Merck & Co. pain reliever that was found to increase patients' risk of heart attacks and strokes.

Earlier this year, the pharmaceutical industry adopted voluntary guidelines to improve the accuracy and balance of ads so the severity of drugs' side effects aren't whitewashed. That is easier to accomplish in magazine ads so drug makers are using that medium more frequently, Jon Swallen, research director at TNS."

That last comment is a bit deceiving. Pharma may be using magazines more frequently, but they're still spending "only " a third of their money in that medium. TV - where the side effect whitewashing can still occur more easily - still gets the lion's share of the spending - 59%.

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October 9, 2006

Just say "NO" to drug reps

Last week the San Jose Mercury News reported, "The halls of Stanford University Hospital and Clinics will be just a little bit quieter today, the first day of a new ban on drug and device sales people bearing gifts, gratuities and unsolicited advice."

The story touches on this trend at Kaiser Medical Group, Yale, Penn and elsewhere.

One Kaiser exec says in the story, "The amount of waste created by the marketing activities of these companies is borne by patients.''

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October 6, 2006

WSJ "Health-Care Goldmines" series

The Wall Street Journal today published (subscription required) the fourth in a series of articles on middlemen striking it rich in the health care marketplace.

This one is a gem. Excerpt: "For years, a little-known unit of publishing giant Hearst Corp. called First DataBank has played a powerful role in determining what Americans pay for prescription drugs. First DataBank doesn't buy or sell drugs -- it publishes lists of drug prices. Health plans and state Medicaid programs use those prices as a benchmark in determining what they pay pharmacies.

If the benchmark goes up, so do costs for these payers. That's what happened in 2002, when First DataBank suddenly made broad revisions to its key published list. The new prices had the effect of fattening the profits of pharmacies, out of the view of patients and companies who pay for the soaring cost of health care."

What we don't know about U.S. health care is killing us - or our personal bottom lines.

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September 22, 2006

AARP - a prescription drug power broker

From former U.S. Senator David Durenberger’s Sept. 21 newsletter from the National Institute of Health Policy:

“AARP just launched a $500,000 advertising campaign to persuade Congress to allow Americans to buy prescription drugs in Canada. This is the same AARP that helped Republicans in 2003 pass Medicare reform legislation to provide a prescription drug benefit, but to prohibit Medicare from negotiating drug prices for Americans. This suggests it is AARP’s policy to require 26 million Canadians to do for Americans what they won’t allow 42 million Americans to do for themselves.

We do know now that one thing that drives AARP insurance policy is the Insurance Trust – separate from its policy board – which decides which insurance carrier will offer official AARP Medicare Supplemental and related products. UnitedHealth Group (UHG) owned that franchise before and after passage of the MMA, which gave the company a huge advantage over its rivals in the first year’s competition for Pt. D and Medicare Advantage plans. The same will hold true in the future unless someone in leadership at AARP insists on giving AARP member beneficiaries a choice of AARP- endorsed products. ….

No matter which way you look at it, the costs of prescription drugs are rising. AARP reported this week that the cost of the 200 most commonly-prescribed drugs for seniors has risen by an average of 6%. That’s twice the cost of living adjustment in Social Security. Plus the Medicare Pt. B and Pt. D drug co-pays are rising too. Considering the annual income of the aged and disabled with ongoing medication needs, these cost increases are painful."

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September 20, 2006

Biotech company loses patent argument; consumers benefit?

The Wall Street Journal (subscription required) reports that ImClone Systems was caught off guard by a judge's ruling this week about the patent for the cancer drug Erbitux. The Journal reports the judge "ruled Monday that three Israeli scientists were the true inventors of a patent covering a use of the monoclonal antibody Erbitux when given in combination with chemotherapy."

The paper further reports that the attorney for the three Israeli scientists "said his clients' win would be good for patients and good for competition. By seeking wider, nonexclusive licensing of the patent, (they) will encourage other manufacturers whose entry into the market will apply downward pressure on pricing for such cancer treatments."

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September 15, 2006

The impact and the cost of too many "Me Too" drugs

The Therapeutics Letter out of British Columbia reports that "Canada now spends 25% more on pharmaceuticals than on doctors." And "me too" drugs are responsible for 80% of the increase in spending. "Me too" drugs are new drugs that are basically old ideas in new wrapping - new competitors that don't represent a major advantage over existing alternatives but which allow drug makers to compete for a slice of a lucrative pie.

They report similar findings in France and Sweden.

The piece concludes that, "Since most new “me-too? drugs are much more expensive than equally effective older drugs, they represent a waste of health care resources. Physicians collectively have the power to prevent this waste and thus free up money for other sectors of the health care system. ... If the increased use of “me-too? drugs in Canada could be stopped for just one year, we could save more than $1 billion off of total drug costs. After this one-year break, even if everyone went back to usual prescribing patterns, the savings generated and carried forward would pay for the salaries of 4000 new primary care physicians."

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August 31, 2006

Americans ask "Why can't we get drugs from Canada?"

A Wall Street Journal online/Harris Interactive poll shows that two-thirds of Americans strongly believe a law prohibiting pharmaceutical imports from Canada and other countries is intended to protect drug-company profits. Only 9% feel strongly that it helps protect Americans from potentially harmful drugs.

Other poll results:

"80% of Americans favor allowing people to import prescription drugs from Canada and other countries if they are much less expensive there.

More than three-quarters of those polled said they believe confiscating drugs at the Canadian border jeopardizes the health of some Americans, compared with 15% who disagree. And 84% of those surveyed said they agree with making it legal to import drugs from Canada if they are approved and vetted by that country's drug regulatory agency, Health Canada, compared with 9% who disagree."

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August 24, 2006

Health care industry worried about Michael Moore's "Sicko"

AdAge.com is the latest publication to report that Michael Moore's pending documentary on the health care industry has industry execs rattled.

AdAge.com reports that drug company execs have told their employees not to talk with Moore. Quotes in the article:

"A review of America's health-care system should be balanced, thoughtful and well-researched to pin down what works and what needs to be improved," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America. "You won't get that from Michael Moore."

Added a spokesman for one of the top 10 pharma companies: "We expect it will be one-sided and
biased, just like his other documentaries."

Hmmm: one-sided and biased. Kinda like direct-to-consumer drug ads, in other words?

Moore has written, "I don't think the country needs a movie that tells you that HMOs and the pharmaceutical companies suck. Everybody knows that. I'd like to show you some things you don't know. So stay tuned for where this movie has led me. I think you might enjoy it."

The movie may not be released until early 2007.

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August 18, 2006

Baseball and impotence

The National Football League had its lucrative promotional deal with Levitra.

But America's national pasttime turns to the tried and true Viagra for its sponsorship.

Yes, little boys and girls, this is what you've been waiting for. It came in my e-mail inbox yesterday.

"Major League Baseball® and Viagra (sildenafil citrate) have teamed up to recognize the greatest comeback players in the sport... and you can help select the winners!"

And just think: "NO PURCHASE NECESSARY TO ENTER OR WIN." So 9-year old Billy can vote for Nomar Garciaparra, and he doesn't even have to buy Viagra to qualify!

What a great country!

viagra_ftr_logo.gif

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August 17, 2006

Restlessness over restless leg syndrome drug promotion

The Sunday Times of Great Britain reports:

"The pharmaceutical giant Glaxo Smith Kline (GSK) has been reprimanded by an industry watchdog for promoting an unlicensed drug to treat the disputed condition of restless legs syndrome. ... Some doctors claim the condition ... has been concocted or at least exaggerated to help sell drugs. While patients had previously complained to doctors of leg cramp at night, few had heard of restless legs syndrome before drugs became available to treat the illness."

It's interesting to see how another country deals with drug ads. Of course, the U.S. is only of only two industrialized countries in the world to allow direct-to-consumer prescription drug ads. And, of course, restless drug ads have filled American media for a long time.

Dartmouth and VA Outcomes Group researchers Woloshin and Schwartz recently published "Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick" in PLoS Medicine. Their analysis of news coverage of "restless legs" led to this conclusion: "The news coverage of restless legs syndrome is disturbing. It exaggerated the prevalence of disease and the need for treatment, and failed to consider the problems of overdiagnosis. In essence, the media seemed to have been co-opted into the disease-mongering process. ... The stories are full of drama: a huge but unrecognized public health crisis, compelling personal anecdotes, uncaring or ignorant doctors, and miracle cures.

The problem lies in presenting just one side of the story. There may be no public health crisis, the compelling stories may not represent the typical experience of people with the condition, the doctors may be wise not to invoke a new diagnosis for vague symptoms that may have a more plausible explanation, the cures are far from miraculous, and healthy people may be getting hurt.

We think the media could report medical news without reinforcing disease promotion efforts by approaching stories like 'restless legs' with a greater degree of skepticism. After all, their job is to inform readers, not to make them sick."

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August 16, 2006

Pfizer's "off-label" promotional shenanigans

An Annals of Internal Medicine article this week summarizes the authors' review of approximately 8000 pages of publicly available documents regarding the case of United States of America ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company. This is the lawsuit against Pfizer for illegal "off-label" promotion of the drug Neurontin - promoting it for a use for which it was not approved.

The authors write about Pfizer's recruitment of medical "thought leaders," "key influencers," and "movers and shakers. " "For example, in 2 documents Parke-Davis identified 40 potential thought leaders in the northeastern United States, including 26 current or future department chairs, vice chairs, and directors of academic clinical programs or divisions. Of these 40 leaders, 35 participated in at least 1 Parke-Davis–sponsored activity, including 14 who requested or were allocated $10 250 to $158 250 in honoraria, research grants, or educational grants between 1993 and 1997."

That is just one of many strategies outlined in this extensive review. Read it...and be ready to take an aspirin or your favorite upset stomach med.

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August 9, 2006

Drugmaker wants LESS risk information in drug ads

AdAge.com reported a while back that drugmaker AstraZeneca wants to limit the number of risks mentioned in a TV drug ad. They say consumers are overloaded and overwhelmed by multiple warnings. An AstraZeneca study supposedly found that listing three risks is optimal; more than five is too many.

Maybe AstraZeneca should do another study of how overloaded and overwhelmed American consumers are by the onslaught of drug ads. We see prime-time TV ads for three impotence drugs and for what seems like 18 new sleeping pills. What's optimal in that picture? What's overload?

Meantime, this proposal comes, according to AdAge.com, when "The Food and Drug Administration has repeatedly asked for more risk information, and in remarks earlier this year the director of its drug marketing, advertising and communications division, Thomas Abrams, noted that 82% of pharmaceutical company violations in the past year were related to inadequate presentations of risk information."

Of course AstraZeneca makes the cholesterol-lowering drug Crestor. And AstraZeneca is in an intense battle with other drugmakers for market share in this sector, fighting to get many more Americans taking their drug. Because of the potential benefits. And forget those nagging side effect warnings (e.g.: rhabdomyolysis, a rare but serious side effect of all statins, pharyngitis, headache, diarrhea, dyspepsia, nausea, myalgia, asthenia, back pain, flu syndrome, urinary tract infection, rhinitis, sinusitis.....oops, I violated the optimal 3-side effect limit!)

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August 3, 2006

Awesome Aussie Example of Pharma Largesse

Ray Moynihan gives us an inside look at one drug company's wining and dining of top doctors in The Australian. Excerpts:

"It was a glamorous Saturday night out in Sydney. The restaurant, the food, the wine and the calibre of guests were all first-class. The exclusive Guillaume at Bennelong restaurant sits atop the stairs at the Sydney Opera House, commanding one of the best views in the nation.

The restaurant's enticing degustation menu includes multiple courses, each served with a glass of one of the world's best wines, creating an unforgettable dining experience.

Among the 278 diners were some of the nation's top cancer specialists from our leading public hospitals. Some had brought partners, some were alone. All were there as guests of Swiss drug giant Roche Pharmaceuticals. At a cost of more than $65,000, Roche had booked out the restaurant and thrown a $200-a-head feast for the doctors.

"The gluttony of the whole thing was mind-blowing," says Karen McLeod, the former partner of one attending doctor. ...

Roche is officially arguing that the $200-a-head dinner was simple and modest. ...

Roche has quite an interest in blood disorders and cancer. Its top-selling drug in the world is MabThera, a cancer treatment for non-Hodgkins lymphoma, which costs almost $10,000 a treatment."

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August 2, 2006

Drug Makers Pay for Lunch As They Pitch

The headline above appeared in the New York Times last week, and the online version has photos and video of food being delivered to doctors' offices. Everyone knows drug companies throw gifts and lunches at doctors to influence prescribing, but the Times staked out one doctors' office building to see how often it happened. It happened almost every day, with great volumes of food.

An excerpt:

"Anyone who thinks there is no such thing as a free lunch has never visited 3003 New Hyde Park Road, a four-story medical building on Long Island, where they are delivered almost every day. On a recent Tuesday, they began arriving around noon. Steaming containers of Chinese food were destined for the 20 or so doctors and employees of Nassau Queens Pulmonary Associates. The drug maker Merck paid the $258 bill.

A deliveryman carrying trays of gourmet sandwiches sashayed past patients at Advanced Internal Medicine. The bill showed that Takeda Pharmaceuticals was picking up the bill. The doctors in the group must have liked the sandwiches. The next day, the exact same delivery came in, paid for by Cephalon.

Free lunches like those at the medical building in New Hyde Park, N.Y., occur regularly at doctors’ offices nationwide, where delivery people arrive with lunch for the whole office, ordered and paid for by drug makers to the tune of hundreds of millions of dollars a year.

Like the “free? vacation that comes with a time-share pitch attached, the lunches go down along with a pitch from pharmaceutical representatives hoping to bolster prescription sales. The cost of the lunches is ultimately factored in to drug company marketing expenses, working its way into the price of prescription drugs."

And, by the way, did you know that drug companies can deduct such marketing costs from their taxable income?

Some medical centers have now banned such free lunches, but they're in the minority.

One group fighting the practice is worthy of note for its goals and for its name: NoFreeLunch.org.

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July 26, 2006

Medical journals, drug ads and reform

The journal PLoS Medicine has re-opened the discussion of medical journal policies for dealing with industry in a new editorial. The journal reminds readers: "In PLoS Medicine's launch issue in 2004, we declared that we would not be part of 'the cycle of dependency that has formed between journals and the pharmaceutical industry'. We set out three policies aimed at breaking this cycle. First, we would not publish adverts for drugs and devices. Second, we would not benefit from exclusive reprint sales to drug companies, since our open access license would let readers make unlimited copies themselves. Third, we would decline to publish studies aimed purely at increasing a drug's market share."

When a recent policy paper in PLoS Medicine called for other medical journals to follow that example and ban ads for drugs and devices, a group of advertising agencies and public relations firms representing the pharmaceutical industry called this a “goofy idea.?

The discussion is healthy, not goofy. With so many recent instances of fraud on the part of scientists submitting papers to journals, and instances of failure to disclose conflicts of interest by authors, there is an erosion of trust at stake.

Read the PLoS Medicine editorial and educate yourself on some of the serious issues at play.

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July 11, 2006

Is this progress?

I'm catching up to a story that's now a couple of weeks old, but which is too good to miss.

Under a terrific headline, "Questions Over New Eyesight Drug That May Be as Good as Older, Cheaper One,"
Andrew Pollack of the New York Times reported on the new drug for wet-form macular degeneration, Lucentis. You may not have that condition, but the story still carries a powerful message about new drug development.

Pollack wrote: "...for patients, doctors, Medicare and other insurers, the drug's arrival will pose a conundrum. That is because the medicine, Lucentis, is expected to be 10 to 100 times as expensive as a similar drug that many ophthalmologists say is every bit as good. ... But the big question is whether insurers and patients will consider Lucentis worth prices that may be $10,000 a year or higher, compared with around $1,000 or less for the drug already on the market that many ophthalmologists say is just as good.

That drug, Avastin, is approved only to treat cancer. But used for the eye condition, which is legal and known as an off-label use, it works the same way as Lucentis. In fact, Lucentis is a derivative of Avastin tailored to be used in the eye. Like Lucentis, Avastin was developed by Genentech.

With Lucentis not yet available, off-label use of Avastin has become the treatment of choice for macular degeneration. Since last fall, thousands of eye patients have been treated with Avastin, with good results and minimal side effects, experts say.

But Genentech has no interest in getting Avastin approved for macular degeneration, because that would undermine the sales of Lucentis, which some analysts predict will have annual sales of several hundred million dollars."

One of the researchers who tested Avastin for macular degeneration is quoted: "The whole experience really opens your eyes to how our whole health care system is operating. We could be incentivized to use the most effective therapy at the most reasonable cost. But that's not how our system is set up."

Wow.

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July 7, 2006

Journal editor asks: Can we tame the monster?

And the monster is "an overpowerful, under-regulated drug industry and a research establishment and publishing industry in its thrall," according to BMJ editor Fiona Godlee. She reflects this week on last week's correction by the New England Journal of Medicine of a study it published on rofecoxib (Vioxx).

Excerpts of her editor's note: "The simple message is that increased cardiovascular risks were visible as early as four months into treatment, rather than the 18 months that Merck had claimed. But rofecoxib was withdrawn two years ago, so why all the fuss?

Well, reputations are at stake. The journal wants to show that it had made no mistakes in peer reviewing the study. And Merck, having already incurred financial loss, needs to protect its share price. ...

Between the interests of the public and the commercial interests of drug companies stand two potential safeguards—journal peer review and drug regulation. The pressures on journals to publish drug industry trials include the need for newsworthy content and revenues from reprint sales. These pressures are intensifying, and recent examples of selective reporting and data manipulation have made clear that peer review in its current form is unequal to the task. ...

Drug regulators too seem unequal to their task. Critics focus on their close relationship with industry; their lack of transparency; their lack of systematic post marketing surveillance; and an emphasis on efficacy over patient safety, which favours industry. ...

I suggest a more radical solution. ...Drug companies should not be allowed to evaluate their own products. To get their products licensed they would contribute to a central pot for independent, publicly funded clinical trials. Is this feasible? Is it the answer?"

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July 6, 2006

How drug companies squelch negative findings

Scott Hensley of the Wall Street Journal published an interesting piece last week headlined, "Quest for youth: how research on anti-aging pill lost momentum."

In it, he writes; "Four years after Pfizer Inc. ended a clinical test of an experimental anti-aging pill and stopped its development for that use, the results of the study still haven't been published in a scientific journal, where other researchers could take advantage of them.

The lag highlights an enduring issue in pharmaceutical research: the fate of data from trials of drugs that fail to live up to expectations. In recent years, drug makers have come under attack for failing to disclose negative research about medicines they have on the market. But there's another twist to the data dilemma that concerns drugs that don't get that far.

The research behind medicines that get nixed in the trial stage could be valuable to the scientific community. But that information may not immediately reach people, working in academia or at other companies, who might be able to solve the problems or otherwise build on the results."

But, oh, did Pfizer enjoy the publicity after small exploratory studies "showed promise." And journalists continue to cover non-peer-reviewed presentations on the drug at scientific meetings. See one review of one recent story. Journalists must realize they're not getting the whole story when they report on "revelations" at scientific meetings.

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June 22, 2006

Gannett stuffs newspapers with "HealthSmart" ad section

The Gannett Company has sold a 32-page issue of an insert entitled "USA Weekend HealthSmart" to drug company advertisers and to newspapers across the country. The New York Times reports that the insert appeared in 76 newspapers with an estimated circulation of 7.5 million.

I was one. I am no smarter for having scanned the section. I have, however, become familiar with many more drug ads thanks to this piece of fish-wrap. You can't call it news. There's lots of "advice." And then there are all the ads.

There is one four-page spread from Astra-Zeneca that could lead just about any reader to self-diagnose with bipolar disorder. The ads ask if there's ever been a period when you flew off the handle at little things...needed less sleep...felt irritable...were much more interested in sex than usual, etc. If so, the ad goes, you may need treatment for bipolar disorder. Gee, that's about 100% of us. What a nice market!

Sadly, this won't be the last of such bombardments. The Times reports: "Executives at USA Weekend initially considered the issue to be a test. But after seeing the results — more than 16 advertising pages, from marketers like AstraZeneca, Johnson & Johnson and Pfizer, bringing in more than $3 million in revenue... they are already looking at publishing HealthSmart again, perhaps as soon as the fourth quarter."

And the Times story suggests this is a sign of the health of U.S. newspapers. If this is healthy, I don't want to see sickness.

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May 23, 2006

Ambien Zombies

No one should miss a recent Washington Post story on Ambien, "the pill that drove us to sleep."

I'll only give you the lead, "Zolpidem tartrate, the sedative-hypnotic better known to wide-awake, stressed-out sheet kickers as Ambien, is an efficacious little helper if you ever thought you might go crazy from not sleeping. It's 'Goodnight Moon' for grown-ups. You should take it only with some Charlie Rose. Now it's also become the new explanation for that which goes bump in the night: I took an Ambien, Americans are saying, and then I don't know exactly what happened."

If you're not on Ambien right now, you should go read the rest yourself.

If you are on Ambien right now, you're probably falling asleep or raiding the fridge, so read it in the morning. And don't blame anyone but yourself.

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May 10, 2006

Wake up! More sleeping pill drug dirt!

Tufts med school prof Daniel Carlat, in an op-ed piece in the New York Times, says "makers of sleeping pills are now paying doctors to publish bad things about competing drugs."

Carlat claims that industry has colluded to slam the use of trazodone, an antidepressant that psychiatrists prescribe off label to treat insomnia because it works so well. He says trazodone has a long safety record and is cheap, costing as little as 10 cents a pill. He says new highly-advertised sleep drugs Ambien and Lunesta can cost $3 a pill or more.

Carlat continues: "Each time a psychiatrist prescribes trazodone, a potential sale of Lunesta or Ambien is lost. No doubt that is why, in the past few years, several articles have been published in professional journals that can only be described as trazodone-bashing. With titles like 'The Use of Trazodone as a Hypnotic: A Critical Review' (published in The Journal of Clinical Psychiatry), these articles purport to present balanced reviews of the scientific literature on sleeping pills. But the authors, psychiatrists with university affiliations, have been paid by Sepracor, Sanofi-Aventis or Takeda, the companies that stand to gain from trazodone's downfall."

In these articles, Carlat claims, "Trazodone is criticized as lacking high-quality research data on its ability to help people sleep. What is left unmentioned is that because trazodone is no longer patented, no pharmaceutical company stands to profit from doing such research."

Carlat calls for a mandate of "fuller disclosure of links between drug companies and authors. Several states now insist that drug makers report the gifts they give doctors. These same companies should be required to disclose the exact nature of a doctor's involvement in preparing a sponsored article, as well as the dollar amount of his or her fee. I suspect it would be the rare doctor who would want such information to come to light."

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May 9, 2006

Losers and winners in Medicare drug benefit

The Associated Press reports that the feds have "added 6,000 operators, quadrupled computer capacity for enrollment and will assist with more than 1,000 events in the week ahead as part of a final push for signing people up for the Medicare drug benefit" prior to the May 15 deadline.

Meantime, the Wall Street Journal has pointed out that "the massive effort has produced clear winners and losers among businesses and seniors. The early winners include some of the nation's largest health plans, which are peddling the drug coverage. After a rocky start in January, the plans have snagged roughly 15 million new customers and healthy government subsidies. Also buoyed: drug makers, which are reporting increased demand for some products used by seniors, such as drugs for chronic conditions. Many seniors are also giving the benefit good reviews, despite initial confusion about which plan to choose."

The WSJ also reports: "But not everyone is faring well. Many seniors have yet to sign up, which is leading to debate in Washington about extending the enrollment period. Medicare already has extended the deadline for people with low incomes. They stand to gain the most because of extra government subsidies, but their enrollment continues to lag. Dozens of smaller health insurers, meanwhile, are seeing only minimal enrollment gains, and independent pharmacists are criticizing the lower payments and suffering cash-flow problems. ... By far, the biggest winner in the race to sign up seniors is UnitedHealth Group Inc., which has used an alliance with AARP to help it grab more than 3.9 million new customers."

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May 8, 2006

Celebrex tries to bounce back with new ads

As the New York Times observed last week, ads for painkiller Celebrex are back. You've undoubtedly seen the one of the man walking up the steep stadium stairs while holding a little boy's hand. "52 steps won't keep you from taking him out to the ballgame," touts the ad copy.

"But a heart attack would," reminds the Times. And each new ad now includes the new warning: "Celebrex may increase the chance of a heart attack or stroke that can lead to death."

The Times says Pfizer, maker of Celebrex, "is offering consumers a decidedly mixed message. But 16 months after the company stopped advertising Celebrex over concerns about its heart risks, Pfizer has returned to the consumer ad market in hopes of reviving sales of the drug, which plunged last year during the ad moratorium."

Dr. Sidney Wolfe of the advocacy group Public Citizen told the Times, "There's no objective evidence of any unique benefit with this drug, and there is objective evidence of a unique risk."

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May 4, 2006

Bitter Pill Awards

A group called Prescription Access Litigation has announced this year's Bitter Pill Awards in four categories to drug companies engaging in over-zealous and questionable marketing practices. The drug industry’s national lobbying group, PhRMA, received two awards, and the remaining three awards were shared among makers of five of the nation’s most well-known drugs: Lunesta, Ambien/AmbienCR, Lipitor, Crestor and Strattera.

Disclosure: This effort is led by a bunch of class action law firms that say they're trying "to make prescription drugs more affordable for consumers by using class action litigation and public education to bring an end to illegal pharmaceutical price inflation."

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April 28, 2006

Generic drug's path to retail market often long and contentious

The headline above comes from a Knight Ridder newswire story. It depicts the two-year path it took for a cheaper generic version of the allergy drug Flonase to make it on the market.

An excerpt: "The delay was the result of a series of aggressive administrative and legal maneuvers by GlaxoSmithKline that thwarted the speedy entrance of the generic. After a federal judge in Baltimore rebuffed Glaxo's final legal challenge on March 6, the generic version by Roxane Laboratories hit store shelves. The generic sells for $61.99 at Walgreens.com, while Flonase costs $81.99. At CVS.com, the generic is $68.59 vs. $85.29 for Flonase.

For consumers, the case shows that good things eventually come to those who wait. But it also shows that a generic drug's path to the retail market is often long and contentious. The price and market share for a brand-name drug fall dramatically when a generic alternative becomes available, so former patent holders do all they can to stave off the competition.

According to Bain & Co., an international consulting firm, patents are set to expire on 75 brand-name drugs over the next two years and on an unprecedented 252 by 2014. A study by the Pharmaceutical Care Management Association released on April 18 found consumers and health plans could save more than $26.4 billion over the next five years by using cheaper generic versions of just 14 brand-name drugs scheduled to lose their patent protection between now and 2009."

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April 27, 2006

The Big Pharma Big Bucks Battle To Stifle Generic Drugs

The Washington Post reports that the Federal Trade Commission is frustrated with its inability to stop brand-name drug companies from cutting million dollar deals with generic drug makers to keep the cheaper generics off the market.

Two federal appeals court rulings last year rejected FTC actions that since the late 1990s had prevented brand-name companies from paying their rivals to drop patent challenges.

The Post reports: "An FTC analysis found at least seven such agreements so far in fiscal 2006, with three in 2005. Before that, no generic companies had been paid to drop their patent challenges for years.

Speaking (Monday) in Philadelphia, FTC Commissioner Jon Leibowitz said that if the appeals court decisions remain in force, rival drugmakers will have 'carte blanche to avoid competition and share resulting profits.' He said the commission had agreed to ask the Supreme Court to overturn one of the lower-court decisions.

'Until recently, payments by brand-name companies to generics were the exception, but now they're the rule,' he said in an interview after his speech. 'They appear to be a new way to do business, and that's very troubling. Hopefully the Supreme Court will take our case and reverse.'

Yeah, it's great to be alive in the era of consumer-driven health care in America!

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April 24, 2006

High times in the high blood pressure drug market

Journalist Merrill Goozner, on his blog, calls “attention to some of the complexities that underscore why the FDA’s draft 'Guidance for Industry for Labeling for Outcome Claims for Drugs to Treat Hypertension,' which will be discussed (this) week by the Cardiovascular and Renal Drugs Advisory Committee, is such a curious document. It isn’t so much that it is wrong. It’s what it leaves out and, more importantly, what it puts in that makes one wonder if the agency has sold its soul to the drug industry. …

The medical literature is filled with industry-funded studies that measure the antihypertensive effects of specific agents on patients that have other problems like kidney disease or peripheral arterial disease. These trials, which are sometimes referred to as ‘seeding trials,’ are a way to highlight one drug within this crowded field by getting articles about it published in specialty journals. If the FDA allows these trials to be included on labels, it allows drug detailers to mention that ‘benefit’ to physicians. In essence, it puts the FDA imprimatur on some of the most abusive sales tactics in today’s pharmaceutical marketplace.

Some might argue this is only guidance. Companies don’t have to follow it. Physicians and patients don’t read labels anyway. All true.

But the savvy marketing arms of the major drug companies know what’s at stake. Combine a failure to distinguish between drugs with the right to put the misleading claims of seeding trials on labels and what you’ve given them is a blank check to suggest their pricey patented drugs are superior to generic diuretics, even though the government guidelines say just the opposite. The net effect of this Guidance could be a huge setback for public health and the public purse.?

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April 5, 2006

Billion dollar battle over generic drugs

There's a billion dollar battle looming over generic versions of statin drugs.

Newhouse News Service reports that "Merck's Zocor, the No. 2 cholesterol-lowering medicine, loses its patent protection in June, opening the door for inexpensive generic copies that could ultimately save consumers billions of dollars."

"We are sitting on a monumental change that's about to occur," George Paz, chief executive of the pharmacy benefit management company Express Scripts, says in the Newhouse story. "That is going to be a significant opportunity for our members and our patients, our clients, to save money."

The story continues: "A 10-milligram tablet of the most popular brand-name cholesterol fighters, including Lipitor, Crestor and Vytorin, usually costs more than $2, while generic Zocor, or simvastatin, is expected to cost about 35 cents.

To stave off what could be mass defections to generic Zocor, most of the big players in the cholesterol market - Pfizer, Schering-Plough, AstraZeneca and even Merck - have mobilized armies of sales reps to visit cardiologists, attend medical conventions and flood doctors' offices with free samples."

That's one huge advantage the brand names have over the generics. What's the last time a physician opened his/her drawer to give you a sample and handed you a generic?

But Newhouse reports that the future will be even more interesting: "The drama surrounding Zocor may be just a preview of things to come. Nearly 70 branded drugs with annual U.S. sales of $46 billion - including 19 blockbusters with annual sales over $1 billion each - are set to go off patent by 2010. Once a generic version goes on the market, it typically cuts the brand-name's sales by 80 percent within the first year."

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March 30, 2006

Still another sleeping pill & ad war?

The Associated Press reports: "The maker of Ambien has begun a new ad campaign it hopes will reverse a sales slide triggered by reports that some patients couldn't recall driving or eating while sleepwalking when using the prescription sleep aid. The campaign Sanofi-Aventis SA launched Wednesday is likely the first salvo in what analysts predict will be a fierce advertising war in the market which has seen sales drop in the aftermath of the negative news. Sanofi's Ambien is expected to have a new competitor by this summer when Pfizer Inc. and partner Neurocrine Sciences Inc. are slated to debut a new pill."

"You are not going to be able to watch a television show without seeing a commercial for a sleeping pill," says one analyst.

Isn't it that way already?

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March 28, 2006

National Sleeping Pill Advertising Week

This week you can expect to read and see countless news stories about "how sleep problems affect performance in nearly every aspect of teenage life – academically, psychologically and physically."

It's because of a promotional campaign called the 9th annual Sleep in America poll of the National Sleep Awareness Foundation.

They call it "National Sleep Awareness Week." I call it "National Sleeping Pill Advertising Week." The Foundation is run by drug companies that make sleeping pills, and by sleep lab operators and mattress makers. Not quite an unbiased source.

While the promotion will cite all sorts of statistics about sleep-deprived teens, they are not likely to brag about this: I read one estimate that the use of sleeping pills in kids ages 10 to 19 has skyrocketed 85 percent in recent years, with spending up 223 percent.

As a nation, we're spending billions on sleeping pills and drug companies are spending hundreds of millions to get us to use more.

That's what National Sleep Awareness Week means to me.

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March 26, 2006

"No" to another ADHD drug

In case you were wondering, an FDA advisory panel rejected Cephalon's drug Sparlon for attention deficit hyperactivity disorder or ADHD. Sparlon contains modafinil, the same ingredient in Provigil, the company's sleep-disorders drug.

TheStreet.com reports "The advisory committee voted 12-to-1 against recommending Sparlon's approval, citing its concerns about Stevens-Johnson syndrome, a rare and vicious blistering of the skin that can be caused by certain drugs. The FDA isn't bound to follow its advisers' recommendations, but it usually does so."

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March 22, 2006

Does the world need another ADHD drug?

Merrill Goozner asks this question on his blog. An excerpt: “With nearly a half million kids on six different mind-bending drugs, you’d think the psychiatric profession already had enough options for attention deficit hyperactivity disorder. But that’s not the way our drug approval system works. It’s a free market out there, open to all comers. So this Thursday the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee will consider another drug for ADHD – Cephalon’s Sparlon, which is generically known as modafinil.

Late night truckers and shift workers are already familiar with this drug. In their sleep-disordered world, it is known as Provigil. It’s not an amphetamine. It’s mechanism of action, to use the mystifying argot of the drug scientists, is “poorly understood.? In layman’s language, that means they have no idea how or why it works.?

Read the rest of Goozner’s article, which discusses suicide risks, bribes, patent expiration and generic drug competition.

Goozner concludes: “I’m sure we’ll hear from plenty of testimony on Thursday from parents and physicians who swear by this new drug. But the jaded business reporter in me wonders if the kids are just pawns in the company’s patent game.?

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March 21, 2006

Plavix TV ads keep making claims that have been refuted

Bristol-Myers Squibb and Sanofi-Aventis, makers of the anti-clotting drug Plavix, continue to run TV commercials that include statements refuted by scientific research.

One such ad says, "Plavix, in combination with aspirin and other heart medicines, helps provide better protection against heart attack and stroke than aspirin and other heart medicines alone.?

Compare with that with the lead in a Wall Street Journal story just last week: “In a setback for Bristol-Myers Squibb Co. and Sanofi-Aventis SA, a large study found that adding the blood thinner Plavix to aspirin wasn't significantly more effective than aspirin alone in preventing heart attacks, strokes or death from cardiovascular disease in a broad group of high-risk patients.The findings put a dent in the hopes of the companies, which co-market the medicine and funded the study, to widen the market for Plavix, which already is a blockbuster.?

The ad is also guilty of “disease-mongering,? scaring viewers by trying to make them think they are all vulnerable, with lines such as: “Janet is a formidable woman. But she was no match for something smaller than the tip of a pen.? In other words, a clot. In other words, something so small it could be lurking inside all of us. Why aren't we all on Plavix?

And where is the FDA's oversight of such an ad? Oftentimes by the time the FDA catches up to an erroneous claim in a drug ad, the ad has run its course and the company is on to the next campaign.

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March 6, 2006

Pharma breaking promise on followup studies

As part of the deal when the FDA approves new drugs, sometimes it requires drug companies to promise to do followup studies of safety and effectiveness - post-marketing surveillance. Sometimes the promise is made in return for speedier FDA approval. But the New York Times reports that two-thirds of the studies had not even been started.

Dr. Alastair Wood, associate dean of Vanderbilt medical school, told the Times that the F.D.A. needed to get tougher on drug makers. "Who would turn in their homework if they didn't have to?" Dr. Wood asked.

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February 19, 2006

How drug lobbyists influence doctors

Last week, Dr. Jerome Kassirer of the Tufts University School of Medicine, and author of ''On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health,? had an op-ed piece under the headline above in the Boston Globe.

He wrote about what he called “corruptive influences in medicine.? For example: “The settlement of the $185 million class action lawsuit against Bristol-Myers Squibb announced at the end of January is a lesson in how physicians paid by the pharmaceutical companies as speakers and consultants can be hazardous to your health. While most of the attention of this suit focuses on how company officials defrauded investors by overly flamboyant predictions for the sales of the highly touted ''blockbuster" drug Vanlev, documents prepared for the suit show that behind the scenes, Bristol-Myers Squibb-paid physicians in major medical meetings were shamelessly exaggerating the benefits of the drug for patients with high blood pressure and heart failure and failing to report publicly on substantial numbers of life-threatening drug complications which they knew, from their close relationship to the company, to exist. Fortunately, the FDA saved hypertensive and cardiac patients from ever receiving Vanlev because it knew about the potentially fatal events, determined that they were excessive, and Bristol-Myers Squibb was eventually forced to withdraw its application to market the drug.?

Kassirer concluded: “It's about time that pharmaceutical companies cut back on their massive campaign to influence doctors and to use paid ''experts" to influence other doctors. It's about time physicians, academic medical centers, and professional medical organizations wean themselves away from the deep pockets of companies whose principal goal is not education but marketing.?

Meantime, USA Today last week reported that “at least nine states are considering bills that would require drugmakers to publicly report how much they and their sales representatives give to doctors, hospitals and pharmacists each year. A few proposals go further: A bill under debate in Massachusetts would ban all gifts to medical professionals from the drug industry. … Four states — Vermont, Minnesota, West Virginia and Maine — and the District of Columbia have laws requiring gift reporting by drugmakers. California requires that drugmakers declare they are compliant with federal and industry gift guidelines.?

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February 18, 2006

Cancer progress...but at what price?

The NY Times had a gut-wrenching story this week, "A Cancer Drug Shows Promise, at a Price That Many Can't Pay."

The drug is Avastin, which, as the Times reports, is "a drug already widely used for colon cancer, as a crucial new treatment for breast and lung cancer, too. But doctors are cringing at the price the maker, Genentech, plans to charge for it: about $100,000 a year. That price, about double the current level as a colon cancer treatment, would raise Avastin to an annual cost typically found only for medicines used to treat rare diseases that affect small numbers of patients. But Avastin, already a billion-dollar drug, has a potential patient pool of hundreds of thousands of people — which is why analysts predict its United States sales could grow nearly sevenfold to $7 billion by 2009. Doctors, though, warn that some cancer patients are already being priced out of the Avastin market."

The Times profiled how one man with cancer was forced to do his own cost-benefit analysis regarding a new cancer drug, and chose to decline a drug that he thought might only have marginal benefit for him. The drug would have cost him $1,000 a month even though he's covered by Medicare. He is quoted in the story: "If anybody came out and said, 'By God, this is the stuff. You want to get well, find a way to buy it,' that would be one thing. But that isn't the case. The forecast of how much it's going to do is not that wonderful."

How many other Americans are facing those decisions and making those choices?

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January 18, 2006

Pharma whistleblower lawsuit

On his always newsworthy blog, Merrill Goozner wrote this week about a drug company whistle-blower lawsuit that was unsealed in a Maine courtroom last week. Gooz wrote:

"The suit was filed by Paul McDermott, a former drug salesman for Genentech, Inc. While the focus of his complaint was Rituxan, an anti-cancer drug heavily promoted for use with rheumatoid arthritis patients by its co-sponsors, Genentech and Biogen-Idec, its explosive charges are an indictment of the drug industry’s entire system for reaching out to physicians to promote the off-label use of drugs. The suit called the system an illegal kickback scheme aimed at defrauding Medicare.

Here’s how it works. According to the complaint, Genentech and Biogen-Idec identified key opinion leaders among rheumatologists and signed them up as consultants. The drug reps then set up a series of “rheumatoid arthritis roundtable dinners? at fancy steak houses in many major cities (Morton’s and Ruth Chris got most of the business). The key opinion leaders were flown in and paid $2,000 to $2,500 to give presentations on the off-label use of the drug.

Don’t forget: It’s illegal for a drug company itself to promote the off-label use of a drug. But if a company outsider (the “consultant?) at a continuing medical education seminar or at a fancy dinner presents the information, then the company can pretend its hands are clean. In the words of the complaint, “materials promoting Rituxan for off-label treatment of rheumatoid arthritis are more fully accepted and integrated into physicians’ personal belief systems when they are presented as educational in nature in contrast to material that is clearly identified as promotional.?

The suit gave examples of physicians who refused to participate after learning they couldn’t change the slides or materials conveniently prepared by Genentech and Biogen sales reps.

The suit also alleged that Genentech marketers identified key journals where articles promoting the off-label use of Rituxan should appear, encouraged its consultants to write articles that would appear in those journals, and, in some cases, wrote the articles for the consultants. Not surprisingly, the off-label use of Rituxan for arthristis, which costs about $15,000 per treatment, has soared in recent years. Since most rheumatoid arthritis sufferers are seniors, Medicare picks up the tab.

McDermott was eventually fired after asking for a transfer. Genentech and Biogen are contesting the charges. Though the case was brought under the Civil War era False Claims Act, which returns two-thirds of any recovery to the government, the Bush administration’s Justice Department last week refused to intervene in the case."

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January 12, 2006

Pharma's so-called "educational" grants

A Senate Finance Committee investigation into educational grants awarded by pharmaceutical companies to physicians and groups that promote medications for unapproved uses has found the "payments are growing rapidly," the New York Times reports - now almost $1.5 billion a year.

"It's hard to see how you could call some of these grants 'educational,'" committee Chair Chuck Grassley (R-Iowa) said. Sen. Max Baucus (D-Mont.), ranking member of the committee, added, "If drug companies are crossing the line with these grants and influencing providers to make treatment decisions they might not otherwise make, that's a problem, and we're going to tackle that."

The Times reports that FDA regulations have "long allowed drug companies to give educational grants to individuals or groups that discuss or promote off-label uses." But feds "have been investigating whether these activities have strayed beyond educational purposes and violated antikickback statutes or resulted in the government's spending money in its Medicare and Medicaid health programs for prescriptions that were not warranted." The Times reports that more than half of all prescriptions written nationwide are for off-label uses.

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December 6, 2005

Sagging sales for impotence drugs

Marketing can only take a product so far, and then market realities set in.

Could that be happening with drugs for impotence, or erectile dysfunction, or ED (as marketing types prefer to call it)?

The New York Times reports: "Seven years after Pfizer made Viagra a cultural touchstone and commercial blockbuster, the market for impotence medicines appears to have fallen well short of what was once predicted.

Heavy advertising to consumers, totaling more than $400 million in 2004, has made Viagra and its newer competitors, Cialis and Levitra, among the best-known drug brands in the United States, and their combined global sales reached about $2.5 billion last year. But the number of new prescriptions for the drugs has fallen steadily this year. Doctors wrote about 10 percent fewer new prescriptions in October than they did in October of 2004. ... The drop in prescriptions comes as sales of other heavily marketed medicines, like antidepressants, are also stalling, and it may be another sign of the limits of consumer advertising to drive demand for drugs. In the late 1990's, drug makers used television advertising to introduce treatments for chronic conditions like arthritis and heartburn. But today, with many patients angry about drug prices and worried that companies are downplaying side effects, drug advertising seems to have lost some of its power. "


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December 5, 2005

More evidence against value of Cox-2 drugs

The safety questions about Vioxx and other Cox-2 drugs are now well known.

But one of the selling points that helped launch these drugs to begin with was that they were supposedly easier on the stomach than other anti-inflammatory drugs.

A study in last week's BMJ punches more holes in that argument as well.

A large British case-control study found "no strong evidence of enhanced gastrointestinal safety with any of the new cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs.... and that these drugs may not be as safe as originally thought. Given that enhanced gastrointestinal safety has been one of the main justifications for these drugs, this finding is important."

The authors cautioned: "This is an observational study and may be subject to residual confounding that cannot be fully corrected for."

But with more evidence accumulating, and with safety and efficacy and cost (they cost much more) in question, consumers have reason to question why they should be taking a Cox-2 drug.

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November 22, 2005

Glucosamine/chondroitin - the spin begins

With sales reaching more than $700 million a year, makers of supplements glucosamine and chrondroitin sulfate have not been hurting.

But do the supplements relieve arthritis pain?

Depends on how you view the data from a big NIH study, presented last week at the American College of Rheumatology meeting, and reported in the Washington Post.

The principal investigator said, "The first take-home message is that in the overall study population, none of the supplements were better than placebo."

The Post reports that supplement industry folks are taking solace in one aspect of the study. "When researchers looked at the 20 percent of participants with moderate to severe pain, they found that 79 percent of those taking a combination of the supplements experienced pain relief, compared with 69 percent of those who took Celebrex and 54 percent of those who took placebo. The combination was also better than either supplement alone."

The Post quoted one rheumatologist trying to put this in perspective: ""It is encouraging that glucosamine and chondroitin seem to help some people who have a significant knee disease -- it's something to consider -- but to think that it has replaced anything or works better across the board wouldn't be correct."

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November 9, 2005

Ads for SSRI antidepressants misleading?

Consumer ads for a class of antidepressants called SSRIs often claim that depression is due to a chemical imbalance in the brain, and that SSRIs correct this imbalance, but these claims are not supported by scientific evidence, according to a new article in PLoS Medicine.

The researchers studied U.S. consumer ads for SSRIs from print, television, and the Internet. They found widespread claims that SSRIs restore the serotonin balance of the brain. Yet there is no such thing as a scientifically established correct balance of serotonin, the authors say. They say that in the scientific literature it is openly admitted that the serotonin hypothesis remains unconfirmed and that there is a growing body of medical literature casting doubt on the serotonin hypothesis, which is not reflected in the consumer ads.

The authors point out that the widely televised animated Zoloft (setraline) commercials have dramatized a serotonin imbalance and stated, Prescription Zoloft works to correct this imbalance. Advertisements for other SSRIs, such as Prozac (fluoxetine), Paxil (paroxetine), and Lexapro (escitalopram), have made similar claims.

The authors say that while the Irish equivalent of the FDA, the Irish Medicines Board, recently banned GlaxoSmithKline from claiming in their patient information leaflets that paroxetine (Paxil) corrects a chemical imbalance, the FDA has never taken any similar action on this issue.

Commenting on the work, Australian researcher David Healy said: The serotonin theory of depression is comparable to the masturbatory theory of insanity. Both have been depletion theories, both have survived in spite of the evidence, both contain an implicit message as to what people ought to do. In the case of these myths, the key question is whose interests are being served by a widespread promulgation of such views rather than how do we test this theory.

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November 1, 2005

Drug industry PR fiasco over novel

The Philadelphia Inquirer reports on a bizarre drug industry fiasco.

Excerpt: "A pharmaceutical consultant secretly commissions a novel about terrorists poisoning Americans with medicine from Canada, then backs out and inadvertently spawns a thriller pillorying his own industry.

This is no pulp-fiction farce. Call it bookgate, an impossible-to-make-up public-relations disaster now dogging the pharmaceutical industry.

Its real-life cast includes a deputy vice president of the country's drug lobby, a celebrity divorce lawyer, a tell-all book publisher, and even former New York Times fabricator Jayson Blair in a cameo.

"It's a nightmare beyond nightmares," admitted Mark A. Barondess, the consultant who initiated the book deal and now calls it a mistake.

Ken Johnson, senior vice president of the Pharmaceutical Researchers and Manufacturers of America, or PhRMA, said the "idiotic" scheme had been concocted by an outsider with unauthorized help by one person in the trade group.

"We didn't know anything," Johnson said. "We have credible, safety-based arguments supporting our position against importation. We're not in the business of publishing pulp fiction and Looney Tunes." "

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October 26, 2005

No surprise: guideline authors have conflicts of interest

A study in the October 20 issue of Nature shows how many authors of published guidelines for prescribing medications often have financial interests in the companies whose treatments they recommend.

Almost half of the published guidelines examined in the study contained no information about potential conflicts, and more than one-third of the guidelines stated that the authors of the recommendations had no conflicts. Researchers found that in about half of the guidelines, at least one author had received research financing from a company that had a connection to the recommendation, and in 43% of the guidelines surveyed, at least one author had been a paid speaker for a relevant company.

Medical journals, journalists who cover health-medicine-science, and consumers must continue to strive for full disclosure.

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October 17, 2005

Onslaught of sleeping pill ads paying off?

All of those TV ads for Lunesta, Ambien and other sleeping pills --- and all that drug industry-sponsored promotion of the "National Sleep Awareness Week" may be paying off.

A new report by a prescription management company shows that among adults aged 20 to 44, use of sleep medications doubled between 2000 and 2004, while spending among the age group for sleeping pills jumped 190 percent.

But among children aged 10 to 19, use of sleep aids shot up 85 percent and spending was up 223 percent.

The report estimated that Americans filled more than 35 million prescriptions for sleeping pills in 2004, spending $2.1 billion.

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October 7, 2005

"Me Too" drugs make up much of drug costs

Drug expenditure in the Canadian province of British Columbia doubled between 1996 and 2003, and 80% of this increase was due to me-too drugs -- drugs that don't offer substantial improvements over less expensive alternatives already on the market. Details available in the BMJ.

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September 30, 2005

Free music downloads for drug purchases

The group Public Citizen told U.S. Senators this week that the adverse effects of direct-to-consumer (DTC) drug advertising outweigh the still-undemonstrated, theoretical benefits of the ads, and the federal government should do more to stop misleading ads from reaching consumers.

Public Citizen reports that "One of the more astounding DTC advertisements was produced by Galderma Laboratories, the makers of the prescription acne medication Differin. Broadcast both on the Internet and on MTV, the advertisements promise free music downloads to teens who coax their parents into taking them to the doctor and securing a Differin prescription. Teens who persuade their parents to secure a prescription get seven free downloads; a refill gets them 10 free downloads."

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September 27, 2005

Protecting deadly drug trade secrets?

Freelance journalist Jeanne Lenzer's piece in Slate, "Drug Secrets: What the FDA Isn't Telling," is important.

An excerpt: "The use of trade-secret laws to conceal deaths and serious side effects linked to drugs has the obvious flaw of putting profits before public health. It also subverts the covenant between researchers and study volunteers. Subjects... are told that even if they do not personally benefit from a new drug, the scientific knowledge gained from the study in which they've participated will benefit others. The volunteers should be told instead that scientists will learn about their experience only if it's good news for the drug they're helping to test."

Read the rest.

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September 15, 2005

Medical group shuts out No Free Lunch group

No Free Lunch is the name of an organization of health care providers that encourages doctors to refuse gifts from industry. Now the organization says that the American Academy of Family Physicians won't let them exhibit at the upcoming AAFP annual meeting in San Francisco.

No Free Lunch says that AAFP rejected them because their position was "not within the character and purpose of the Scientific Assembly" and therefore did not meet the AAFPs eligibility requirements. But No Free Lunch points out that AAFP did allow Coca-Cola, McDonald's and the Distilled Spirits Council to be present at the meeting.

No Free Lunch says that more than 5,000 physicians are expected to attend the meeting, and exhibitors are told on the AAFP website that seven dedicated exhibit hall hours provide you with the opportunity for one-on-one access to these high-prescribing, qualified buyers!

No Free Lunch claims that in April of this year, The American College of Physicians also denied them the opportunity to exhibit at its Annual Meeting in San Francisco. The group further claims that "ACP prevented No Free Lunch members and medical students from distributing literature --in some instances using armed San Francisco Police--even when this literature was the ACPs own guidelines on acceptance of gifts from industry."

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August 30, 2005

Disclosure of drug company gifts to doctors

A Vermont court should order the states attorney general to allow public access to all records disclosed by pharmaceutical companies under the Vermont Pharmaceutical Marketing Act, a law intended to allow the public to learn the amount of money doctors receive from drug manufacturers, Public Citizen said in a lawsuit filed Friday against the Vermont attorney general. The lawsuit, which calls for the release of records being withheld at the request of drug companies, was filed in Vermonts Washington County Superior Court.

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August 25, 2005

Drug companies try to polish their image

On the same day the Vioxx verdict was announced last week in Texas, Merck placed an ad on an evening network newscast, with the theme of putting patients first. The evidence presented in that trial would suggest that mission has not always been practiced.

And GlaxoSmithKline has been placing ads in the network newscasts featuring a GSK researcher using the old line about drug development costing $800 million. To see the holes in that flawed claim, read Merrill Goozners excellent book, The $800 Million Pill.

Where's the truth squad on such ads?

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August 24, 2005

Growing scrutiny of drug studies and drug co. claims

"When Eli Lilly & Co. wanted to get the big California health-maintenance organization Kaiser Permanente to use its new antidepressant, it ran straight into Debbie Kubota." That's how the Wall Street Journal begins its piece on how insurers are scrutinizing drug studies and drug company claims.

The story continues: "Two studies published in psychiatry journals described the new drug, called Cymbalta, as 'superior' to the older antidepressants Prozac and Paxil. But Dr. Kubota, a Kaiser pharmacist here, observed that in both studies the patients who did the best on Cymbalta received a higher dose of it than recommended on the label. Although each article mentioned the superiority of Cymbalta in its abstract, or summary, both acknowledged lower down that the studies weren't designed to show whether one drug was better than another.

Dr. Kubota's conclusion: The claim of superiority was 'speculative.' She issued a negative report to Kaiser's physician committees, which agreed and ruled that Kaiser would bar Cymbalta from its list of favored drugs for its biggest regions, Northern and Southern California.

As the cost of drugs in the U.S. approaches $250 billion a year, pharmaceutical companies are running up against a growing breed of detective trained to see through marketing spin. Working for insurers, state Medicaid programs and nonprofit bodies, these detectives cast a wary eye on published studies in medical journals, once considered an unimpeachable source. They search for subtle aspects of clinical-trial design that might show the drugs are not all they're cracked up to be."

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August 19, 2005

Docs criticize sleeping pill ads

What the FDA won't do, some physicians are doing. That is, to talk openly about the claims made by highly-advertised new sleeping pill Lunesta.

The Boston Globe reports on several physicians' criticisms of Lunesta ads. One says the ads don't mention how long the pills can safely be taken and he adds that more long-term studies of sleeping pill safety are needed. Another says "Patients who took this drug did not become normal sleepers." Another says behavioral therapy is preferable to pills for treating insomnia long-term.

The Globe says that a spokeswoman for the FDA said it would not discuss reviews of a particular company's advertising, such as why the manufacturer can claim Lunesta is ''approved for long-term use."

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August 18, 2005

What do we know (not know) about weight loss drug Meridia?

Dr. Sidney Wolfe, Director of Public Citizens Health Research Group, says that FDA denial of his group's petition to ban the weight loss drug Meridia is misguided.

In a statement on the Internet, Wolfe says: "For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive."

The statement concludes: "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to and makes the agency less vigilant over the companies that give it almost $200 million a year in funding?"

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August 9, 2005

Selling Sickness

I just finished reading an important new book, "Selling Sickness: How The World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients," by Ray Moynihan and Alan Cassels.

It documents disease-mongering, how drug companies foster the creation of medical conditions to create markets for their pills, the marketing of fear, the "medicalization" of normal states of health, the hidden agendas of "disease-awareness campaigns," problems with drug company relationships with celebrity spokespersons and patient advocacy groups, and other issues about which most consumers don't have a clue.

As one skeptic says in the book, "We're changing the experience of what it means to be human."

It also points to numerous instances of what the authors call "sycophantic media coverage" and an "indictment of the flaccid culture of much medical reporting."

I highly recommend the book.

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August 5, 2005

Drug debate: "Rx of choice" or "little better than nothing"?

A study in this week's New England Journal of Medicine claims that the drug modafinil, marketed as Provigil, can improve the wakefulness and performance of nighttime employees. But an editorial by another researcher in the same journal says the treatment is "little better than nothing."

The Wall Street Journal reports that last year, doctors wrote 1.9 million prescriptions for the drug, which generated $414 million in sales. The newspaper says, "The debate within the pages of the prestigious medical journal raises renewed questions over the reliability of research sponsored by drug companies. The study's lead author is Charles A. Czeisler, chief of the sleep medicine division at Harvard Medical School; his professorship is endowed by Cephalon for $2 million." Cephalon makes Provigil.

Posted by schwitz at 8:46 AM | Comments (0)
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August 2, 2005

Pharma's "softball" drug ad guidelines

The drug industry releases its voluntary code of conduct for direct-to-consumer drug ads today, an approach AdAge.com calls a "softball approach....falling well short of a mandate on the most serious issues."

AdAge reminds readers that this step may not stop Congress and/or the FDA from enforcing new rules. It quotes Senator Bill Frist: "Turn on your TV, and within 15 minutes you'll be bombarded by dreamy ads that suggestively over-promise and, even more likely, will make you and your children experts on erectile dysfunction. We must ask ourselves: 'Are these ads, which we know are costing billions, properly educating patients or just peddling expensive products?' "

Posted by schwitz at 9:35 AM | Comments (0)
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August 1, 2005

Drug company influence causes scientific split

A group of high blood pressure researchers is ending its 16-year relationship with a high blood pressure journal, and claims of improper drug company influence on doctors are at the root of the dispute.

The Wall Street Journal has details.

Dr. John Laragh, co-founder of the American Journal of Hypertension, complains that some doctors have become "heavily involved in pharma marketing for personal gain."

As the Journal appropriately frames the story, it is "a dispute reflecting heightened concerns about the control and credibility of medical information."

Posted by schwitz at 9:18 AM | Comments (0)
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