Schwitzer health news blog

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."

More MRI & imaging centers - do we ever say "NO"?

A few days ago, the Star Tribune reported on plans for still another diagnostic imaging center in a Minneapolis suburb that has more MRI machines than in many entire countries. Excerpt:

Along a two-mile stretch of France Avenue in Edina, medical providers have installed so many powerful magnetic resonance imaging (MRI) scanners that radiologists joke that anyone driving through with a pacemaker should beware.

Come September, there'll be a new one. ...

Its opening is likely to reignite a debate on whether Minnesota has too many diagnostic imaging facilities, encouraging doctors to order unnecessary procedures and pushing up medical costs. It's also likely to raise the ethically thorny question of whether doctors should refer patients to a facility in which they have a financial stake.

"Imaging has been an area of concern for a long time," said Julie Sonier, director of the Minnesota Department of Health's health economics program, which does reviews of major medical investments. "Issues about the concentration in Edina have also been a concern for some time."

A 2007 Health Department report said there was anecdotal evidence in Minnesota that physician investments in facilities led to financial conflicts of interest and overuse.

Among the reader responses are these:

• As a patient, how do you know that you really need a test that may be uncomfortable, that might have some risk associated, that might have radiation exposure associated, and that you might have to pay for when you know that the person telling you you need it stands to make up to $1000 just for suggesting it? The answer is you can't. This practice is a pox on medicine.

• There are as many MRI scanners in the Twin Cities as in all of Canada. Is the health of Canadians compromised by fewer imaging studies? Obviously not. There is no relationship between the number of tests and procedures performed in medical care and the health outcomes of the patients. More medical care is not better care. The Health Department should carefully examine the merits of this expansion of imaging services.

Insurers say we're wasting $30B a year on scans

Bloomberg reports:

"Insurers, led by WellPoint Inc. and Magellan Health Services Inc., are increasingly rejecting imaging procedures recommended by U.S. doctors as the companies work to trim $30 billion a year they say is wasted on the tests.

CT and MRI scans that allow doctors to peer inside the body can cost as much as $2,000 each. Almost 50 percent of scans for some conditions fail to improve patients' diagnoses or treatment, according to a report issued today by America's Health Insurance Plans, a Washington-based trade group.

With U.S. health costs projected to grow to 25 percent of the economy in 2025 from 16 percent now, insurers are turning to so-called radiology benefit managers who can reject scans determined to be unneeded, said Shay Pratt of the Advisory Board Co., a Washington-based consultant to hospitals. Doctors ordered 115 million of the procedures last year. More than 80 million Americans already must get advance approval for the tests, and that may grow to 120 million in two years, Pratt said. ...

Almost $100 billion a year is spent on imaging in the U.S. and that may double by 2013 unless costs are reined in, according to the report today by America's Health Insurance Plans. ...

The Congressional Budget Office cited the ``widespread diffusion of new medical technologies and services'' as a leading cause of cost increases in its November report forecasting that health care will grow from 16 percent of the U.S. economy to 25 percent by 2025 unless changes are made. Health spending is currently $2.4 trillion, according to U.S. estimates.

Medicare, the U.S. health-care program for the elderly and disabled, has taken an initial step by reducing payments for scanning facilities when they perform more than one procedure on the same patient in the same day. ...

The Government Accountability Office, the investigative arm of Congress, said last month that Medicare should consider requiring pre-authorization for outpatient imaging of its 44 million beneficiaries."

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."

Mid-summer blog break

Will be back to this labor of love next week.

ABC proclaims a miracle

Journalistic hype of health news never stops.

The latest: ABC News last week called the drug Dimebon a "miracle drug" for Alzheimer's Disease on its website.

It was tested in about 100 people. It was only tested against placebo, not head-to-head with any other existing Alzheimer's treatment.

ABC News didn't interview the principal investigator in the story that aired last Thursday night. HealthDay did, and she told them: "This is not a cure for Alzheimer's disease, but the benefits could last for a long time. The drug appears to slow the clinical progression of the disease."

Sounds like the PI is much more cautious than the "journalists" at ABC.

HealthDay also reported that the PI is on the Scientific and Clinical Advisory Board of the company that makes Dimebon and has stock options in the company. None of this was revealed in the ABC story.

And nothing that warranted calling it a miracle.

U.S. health system on the wrong track

In an announcement that got surprisingly little news attention, the Commonwealth Fund released its National Scorecard on U.S. Health System Performance, 2008. Excerpts:

"The U.S. health system is on the wrong track. Overall, performance has not improved since the first National Scorecard was issued in 2006. Of greatest concern, access to health care has significantly declined. As of 2007, more than 75 million adults—42 percent of all adults ages 19 to 64—were either uninsured during the year or underinsured, up from 35 percent in 2003. At the same time, the U.S. failed to keep pace with gains in health outcomes achieved by the leading countries. The U.S. now ranks last out of 19 countries on a measure of mortality amenable to medical care, falling from 15th as other countries raised the bar on performance. Up to 101,000 fewer people would die prematurely if the U.S. could achieve leading, benchmark country rates. ...

The U.S. spends twice per capita what other major industrialized countries spend on health care, and costs continue to rise faster than income. We are headed toward $1 of every $5 of national income going toward health care. We should expect a better return on this investment. ...

National leadership is urgently needed to yield greater value for the resources devoted to health care."

Another slam to retiree health benefits

In case you missed it, the Wall Street Journal yesterday reported:

GM's announcement Tuesday that it would cease medical coverage for its salaried retirees age 65 and above signals that a new era of ever-shrinking benefits has arrived. Beginning in January, even former employees who are already in retirement will lose their benefits, which most of the company's retirees use to supplement gaps in their traditional Medicare coverage. The auto maker will boost monthly pension payouts to help offset the cuts. The company's unionized workers aren't affected by the cut to retiree health benefits.

GM isn't the first company to do this, but its heft and influence could help usher in further cutbacks at other companies. ...

At this point, employees and retirees "have to feel lucky if they still have retiree [health-care] benefits, and have to start planning for when they won't," says Rick McGill, head of retiree medical consulting for employee-benefits firm Hewitt Associates. He says such benefits are "a dying breed."

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."

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.

Green ($$$) Mountain State for drug marketing

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

How a headline can ruin a health/science story

Recently a physician friend brought the following to my attention. The same story, written by the same person, but appearing under two very different headlines.

Here's the original New York Times headline:

The story stated at one point: "No one knows whether vaccinations had anything to do with the girls’ health problems, and the scientific significance of individual cases is always difficult to assess."

But the Seattle Times picked up the NYT story and used this headline:

The Seattle headline gives the misleading impression that there's a causal link between autism and vaccines. This is the kind of thing that gives headline writers a bad rep.

Local reax to USNWR hospital rankings

The annual "best hospitals" edition of US News & World Report always gets people talking.

This year's edition certainly riled fellow UMN blogger Bill Gleason, AKA Mr. Bonzo, AKA The Whining Dinosaur, who blogs about his concerns.

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.

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."

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.

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."

Wisdom of the crowd re: kids & cholesterol

Some user comments responding to the New York Times website story yesterday on the American Academy of Pediatrics recommending wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 show the ire and the wisdom of the crowd. Examples:

• "This is ridiculous."
• "Wow, this is just so wrong in so many ways. Shamefully!"
• "Yes, it was about time this as of yet unexplored market were tapped. We already have kids on Ritalin, so why not Lipitor, too?"
• "I think a good healthy breakfast for a child should consist of:
- Ritalin
- statins
- Prozac
- etc.
But isn’t age of 8 too late?"
•"This is scary."
• "Why not just treat the entire human population with prophylactic statins; we can start babies on the drug right from birth so that nobody will have plaque in their arteries."
• "Shocking. No evidence that statins at such a young age will benefit. As we know, children are not “little adults�.
• "Have we lost our minds?"
• "Pure Rubbish! Voodoo science brought to you by the pharmaceutical industry. I wonder how much money they paid the good doctors to spread this junk."

Read the rest yourself.

More on the crushing costs of cancer drugs

A couple of items of note in today's Wall Street Journal.

First, the paper is the second in three days to highlight the dilemma raised by the cost of new cancer drugs. We noted the Sunday New York Times piece on Avastin in this blog yesterday. The WSJ reports:

American doctors rarely used to let costs factor into their treatment decisions. But rising prices -- some cancer drugs now cost more than $100,000 a year -- are dramatically changing that ethos in the field of oncology. Money issues are now disrupting relationships with patients, causing doctors to go into debt and threatening to interfere with treatment options.

Meantime, the WSJ also reports:

In a setback for GlaxoSmithKline PLC, experts advising Britain's health-care system say the company's Tyverb breast-cancer drug isn't effective enough to justify its cost.

If the preliminary judgment holds, Britain's National Health Service won't pay for Tyverb, one of Glaxo's most important new drugs. The treatment, sold as Tykerb in the U.S., costs about £21,000 ($42,000) a year in the U.K. European regulators approved Tyverb for sale in the European Union last month.

Medical experts advising Britain's National Institute for Health and Clinical Excellence, or NICE, found that although Tyverb has shown some benefit in delaying tumor progression compared with the current standard treatment, its benefits aren't sufficient when weighed against its costs, NICE said Monday.

We don't have an agency like NICE in the US.

More than 600 stories reviewed on HealthNewsReview.org

In case you don't visit the HealthNewsReview.org site often, I wanted to let you know about a new Publisher's Note just published there. It reads:

Our database of stories reviewed now numbers more than 600.

113 of the stories were by the Associated Press, which feeds most newsrooms. We've reviewed 38 stories by the Los Angeles Times, 37 by the New York Times, 33 by the Wall Street Journal, 21 by the Washington Post, and 19 by USA Today.

Of the television networks' morning programs and evening newscasts, we've reviewed 52 stories by ABC, and 45 each by CBS and NBC.

As you know, our highest rated stories get 5 stars, our lowest-rated get none. After 603 reviews, 12% got 5 stars, 24% got 4 stars, 29% got 3 stars, 27% got two stars, 6% got one star and 3% got zero stars.

But sometimes the star score doesn't tell the whole story. With a movie review, you wouldn't only be interested in the star score the reviewer came up with. You'd want to read WHY the reviewer loved or panned the flick. Similarly, you need to read the meat of our reviews - the criterion-by-criterion comments and the summary review - in order to get the full feeling for what we thought about a story.

For example, an ABC Good Morning America piece, "Breakthrough Cancer Study: Change Lifestyle, Change Risk", recently got a 4-star score. That's what it got when we applied our ten review criteria. But we didn't like the story all that much. Our review summary stated, in part:

There are times when our "star" scores are misleading. In this case the star score is deceptively high for how we really feel about the story. That is why these summary comments are important. This piece may have addressed many of our criteria, but was lacking in balance, independent perspectives, details about the actual study results and details about the types of patients who might be candidates for this lifestyle intervention. Viewers may have been given a far too optimistic picture of an early pilot study.

We've had other instances in the past where a story "felt" better than the low number of stars it got from a fair application of the ten criteria. So please read the whole review or you're not seeing the work and the thought that went into our analysis.

Finally, we want to praise a series that we have not reviewed. On Sunday June 29, the New York Times published a story, "Weighing the Costs of a CT Scan’s Look Inside the Heart". It was a terrific story and one that all of our readers should be sure to read. Then, on Sunday, July 6, the Times published "Costly Cancer Drug Offers Hope, but Also a Dilemma".

These stories were published under the series title of "The Evidence Gap" which the Times describes as a series that "will explore medical treatments used despite scant proof they work and will consider steps toward medicine based on evidence."

Please come to our Discussion Forum and offer your thoughts on our reviews, or on any aspect of health and medical news coverage.

Thanks for your continued interest in our project.

Gary Schwitzer
Publisher

Questions about costly cancer drug Avastin

For the second straight Sunday, the New York Times has published a terrific piece in its "Evidence Gap" series. This one, about the cancer drug Avastin, is headlined "Costly Cancer Drug Offers Hope, but Also a Dilemma." Excerpt:

"..like a half-dozen or so new biotechnology drugs with a similar combination — alluring promise, high price and only arguable benefits — Avastin raises troubling questions:

What does it mean to say an expensive drug works? Is slowing the growth of tumors enough if life is not significantly prolonged or improved? How much evidence must there be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation?"

Incidentally, readers of the Star Tribune may have thought they read the piece in Sunday's Star Tribune. They did not. They read a scant 754 words out of the original 4,500-word story published by the New York Times.

Why?

Not enough space? Not hardly.

Too much of importance going on over the July 4th weekend? Not hardly - and not by any reflection of what else was in the Strib today.

"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.�

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)

UnitedHealth faces the music

The Associated Press reports:

UnitedHealth Group Inc. will cut at least 4,000 jobs, or 5 percent of its workforce, in a restructuring and warned Wednesday that a weaker environment and higher costs will cut into profits this year. ... The company also said it will pay $895 million to settle lawsuits over stock options backdating, and will pay $17 million into a fund in an agreement to resolve a suit related to the Employee Retirement Income Security Act. ...

The options settlement stems from a 2006 complaint filed in U.S. District Court in Minnesota. The California Public Employees Retirement System (CalPERS) and Alaska Plumbing and Pipefitting Industry Pension Trust, the lead plaintiffs, argued that the backdating cost shareholders money.

The scandal ultimately forced out Bill McGuire, UnitedHealth's chief executive.

Hemsley said the settlement helps the company avoid more costly litigation.

Ramzi Abadou, an attorney representing CalPERS, called it "a significant, epic settlement" that far exceeded previous payouts in options backdating lawsuits. ...

McGuire is not part of the settlement. His attorney, David Brodsky, issued a statement saying McGuire will continue to fight "because he is not liable for any alleged shareholder losses."

Also see reader comments coming in to the Star Tribune website. Some examples:

• This was bound to happen due to their corporate greed. This company is imploding and as a former employee who knew well enough to get the hell out, I am happy to see it. Enough of these CEO's and the like making mulit-million dollar salaries at the expense of the little people, both employees and policy holders.

• How dumb do corporate PR departments think we are? They try to blame market conditions, but don't you think having to pay $895 million due to the backdating scandal has an impact on "rising costs". 4,000 jobs gone because of the illegal actions of a few people at the top. They pay out of their excess, and the rest pay with their jobs. Yeah, United Health!

• Mcguire "not responsible for alleged shareholder losses" - I love that quote! He certainly was willing to take credit (and MAJOR cash - 93m one year?) for shareholder gains! Seems to be a running theme - small groups of people making huge rewards but as soon as the money goes away they bail, leaving the taxpayers and shareholders to cover the loss. Some pundit on the radio said it well - our nation is one where we are capitalists when it comes to rewards but socialist about risk. one more way the average citizen gets shafted.

You wouldn't want to be a Republican Senator at a July 4th picnic

Bob Laszewski says "In the most amazing turn of events I have seen in 20 years of following health care policy in Washington, DC, the Democrats have the Republicans backed into an awful corner over the issue of the July 1st automatic 10.6% Medicare physician fee cut and corresponding private Medicare cuts to pay for nixing it. Also at stake is another 5% physician fee cut set for January 1, 2009."

Read his thoughtful blog piece.

Sometimes journalists are criticized for covering the "horse race" aspects of policy discussions. Sometimes, like this, it can't be avoided.