Schwitzer health news blog

Undisclosed conflicts of interest in media interviews

Jeanne Lenzer and Shannon Brownlee have a piece in Slate today that asks, "Are doctors shilling for drug companies on NPR?"

The piece begins:

"A few weeks ago, devoted listeners of National Public Radio were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

We don't know just how much funding or when the show last received it, since neither Goodwin nor the show's producers responded to repeated requests for interviews. But the larger point is that undisclosed financial conflicts of interest among media sources seem to be popping up all over the place these days. Some experts who appear independent are, in fact, serving as stealth marketers for the drug and biotech industries, and reporters either don't know about their sources' conflicts of interests, or they fail to disclose them to the public."

Disclosure: I am interviewed in the story. But don't let that stop you. The piece is worth reading.

Conflicts of interest in psychiatry's bible group

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

"More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry. The conflicts of interests were posted online by the APA last week. They ranged from small to extensive. Leading the pack was William Carpenter, Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb. APA President Carolyn B. Robinowitz claimed that "we have made every effort to ensure that DSM-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development." The fifth DSM, produced in conjunction with the National Institute of Mental Health, will be published in 2012. It is used by mental health professionals to classify mental illnesses."

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.

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.

Tanning for dollars - researcher conflict of interest

The Wall Street Journal reports:

A Boston University researcher who authored an article in the New England Journal of Medicine last year recommending the moderate use of tanning beds as a way to treat or avoid vitamin-D deficiency has received research funding from an organization funded and controlled by the tanning-bed industry.

The link to researcher Michael Holick's work and the tanning industry wasn't made clear in the article. A note at the end of the article disclosed that Dr. Holick's research was funded, in part, by the UV Foundation. No information about the foundation was provided.

The nonprofit foundation, according to its Web site, is funded by the Indoor Tanning Association as well as the makers of tanning-bed equipment. The board of directors is composed entirely of tanning-bed-industry officials. Boston University was the top recipient of grants from the foundation from 2004 through 2006, the most recent three years of the group's Internal Revenue Service filings. In total, the university received $162,014 during that period.

On its Web site, the UV Foundation said it "has made a commitment of $150,000 over three years to Boston University, to continue the efforts of Dr. Michael Holick, a Vitamin D expert." The site said the foundation "is dedicated to exploring the positive effects of UV light and to increasing public awareness about those benefits."

Dr. Holick said in an interview that the money was an unrestricted grant that he used for vitamin-D research.

A report on the funding arrangement was to appear in Friday's edition of the Cancer Letter, a Washington-based trade publication. (See Cancer Letter story online.)

...

"I was surprised that the New England Journal, a very prestigious journal, would run the article this way," said Martin Weinstock, a Brown University dermatology professor. He said he was surprised the journal would run a piece by an industry-funded author.

Ghostwriting: a scary practice

A case study in this week's Journal of the American Medical Association tells us more about the practice of ghostwriting.

Ghostwriting is the practice whereby academic researchers allow their names to be listed as publishers of research articles even though some, most or all of the writing may have been done by industry-hired medical writers. If there's any acknowledgement of the outside help at all, it's often euphemistically phrased "editorial assistance."

The JAMA case study is particularly interesting because it involves the case of research involving Vioxx (rofecoxib). The authors say their analysis "demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support."

Another JAMA article contends that Merck, makers of Vioxx, tried to minimize deaths in two studies showing that the drug didn't work in treating or preventing Alzheimer's disease.

Merck calls the reports false and misleading.

Ghostwriting is misleading and deceptive, and the practice should be dragged into the light of day more often for more to see what impact it may have on the integrity of science.

Grassley Knocks Doc Taking Pharma Funds

The Wall Street Journal health blog reports:

"A University of Cincinnati psychiatrist who was the lead author of a 2002 study that concluded kids did well on AstraZeneca’s antipsychotic Seroquel has received hundreds of thousands of dollars from the company since then, according to Sen. Charles Grassley (R-Iowa).

Grassley raised the issue in a floor statement last week in support of a bill he’s co-sponsoring that would require drug and device makers with annual revenues of more than $100 million to disclose to the federal government on a quarterly basis anything of value given to physicians, such as payments, gifts, or travel expenses.

“Today, I am going to report on the actions of one physician to explain how industry payments to medical experts can affect medical practice,” Grassley said by way of introducing his remarks. Grassley then reviewed the funding for Melissa DelBello, who had reported to the University of Cincinnati that she had received $100,000 from AstraZeneca in 2003, the year after the study’s publication in the Journal of the American Academy of Child & Adolescent Psychiatry. She reported another $80,000 in 2004. The payments covered lectures, consulting fees, service on advisory boards and reimbursements for travel-related costs, Grassley said.

“The fact that a physician can promote a drug to other doctors and receive NIH funding, while hiding a very clear conflict of interest, is disturbing,” Grassley concluded."

NEJM tries to clear up dirty lung study controversy

See the New England Journal of Medicine's correction, clarification and editorial over the controversial lung cancer CT screening study.

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."

Tobacco conflict of interest behind lung cancer study

Gardiner Harris of the New York Times has just raised important new questions about the integrity of pro-screening work promoted by a leading researcher and published by the New England Journal of Medicine. Excerpt of his story:

In October 2006, Dr. Claudia Henschke of Weill Cornell Medical College jolted the cancer world with a study saying that 80 percent of lung cancer deaths could be prevented through widespread use of CT scans.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.

The foundation got four grants from the Vector Group, Liggett’s parent, from 2000 to 2003.

Dr. Jeffrey M. Drazen, editor in chief of the medical journal, said he was surprised. “In the seven years that I’ve been here, we have never knowingly published anything supported by” a cigarette maker, Dr. Drazen said.

Well, Dr. Drazen, knowingly or not, your journal did publish the work. Now what?

This should rock the world of medical science and medical journals.

Stay tuned. Kudos to reporter Harris for digging and shining light on this episode.

Newspaper lets hospital buy news coverage

I've blogged in the past about TV news operations accepting sponsored news deals with local medical centers. In these deals, oftentimes the news only includes perspectives from that sponsoring hospital.

Now, in the first instance I'm aware of, the trend has come to newspapers. The HometownAnnapolis.com website of The Capital newspaper yesterday announced:

Partnership should improve health coverage

Published March 16, 2008
By TOM MARQUARDT

In today's editions we are experimenting with a new concept that could alarm some readers: Anne Arundel Medical Center, or AAMC, has paid us to provide content for our Health & Fitness page once a month.

Newspapers don't normally sell access to news pages, and certainly we would not give away content privileges on any other news page. I'm sure County Executive John Leopold would love to have his staff write the stories for the front page, but that's not going to happen for any price.

But partnering with the hospital on the Health page seemed to make sense. We don't have a health reporter to write about medical issues and often use stories from syndicated services that quote doctors from other cities.

The local hospital is giving us stories about local physicians and programs it has to offer - in their words, without an effort to balance the copy with comments from other hospitals or from doctors who don't practice at AAMC.

The stories are written in newspaper style and the hospital staff is responsible for the page's design. To be open and transparent about the partnership, a disclaimer is clearly displayed at the top of the page.

I'm not entirely comfortable with the arrangement, purely for journalistic reasons. But in the end I think the reader benefits - and that's my goal.

Instead of generic stories originating from another city, the reader will have local news featuring people they recognize, doctors they use and services that are available to them. The hospital staff is getting to the stories we are not able to write because of other priorities.

Is the page more readable now? You tell me.

Wow. "Partnering" - or being paid by a hospital to provide their news? Actually, he calls it content, not news. Whew. Because we used to call that advertising.

Also a relief - "the stories are written in newspaper style and the hospital staff is responsible for the page's design." So they'll look professional! Just like, or maybe even better than, real news.

And who cares if we give readers only one side of a story? Maybe a side that is so incomplete it can hurt them? And so what if we don't disclose the financial conflicts of interest of the doctors who might appear in the stories written and designed by the hospital itself? And so what if there are other opinions or other approaches from other doctors on the other side of town that don't get covered?

The main thing is: "Is the page more readable now?"

Troubling questions about failure to disclose conflicts of interest

The Cancer Letter (subscription required), a terrific publication about federal cancer policy and funding, opens new questions about disclosure of conflicts of interest in this country.

The Integrity in Science Watch project summarized it this way:

In the wake of allegations that a prominent lung cancer researcher failed to disclose a patent licensed to General Electric on interpreting CT scans in an article that claimed early CT scanning could substantially reduce lung cancer mortality, the New England Journal of Medicine last month ruled the patents “not relevant” to the subject of the article and refused to print a correction. Now, a follow-up investigation by the Cancer Letter, an industry newsletter, uncovered numerous instances when Weill Medical College researcher Claudia Henschke failed to disclose the patents in a series of continuing medical education (CME) seminars, including one held by the Radiological Society of North America (RSNA) a month after the article appeared in October 2006. The NEJM article could also be read for CME credit.

The Accreditation Council for Continuing Medical Education in 2005 adopted strict rules for disclosing granted and pending patents held by any presenter at a CME activity. “Royalties by themselves establish the financial relationship of the person with a commercial interest and create the potential for conflict of interest. Therefore, the relationship is relevant in CME,” Murray Kopelow, the chief executive of ACCME, told the Cancer Letter. The Center for Science in the Public Interest later this week will ask the ACCME to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities. And Sen. Charles Grassley (R-IA) said he plans to launch a Congressional inquiry in physician patenting activity. “It’s becoming clear that patents and royal payments to doctors deserve a lot more scrutiny from Congress, the FDA, professional journals and other watchdogs,” Grassley said.

This one is complex - involving researchers' disclosure, medical journals' policies, and the whole big, murky mess of continuing medical education.

And it's important - for the sake of honest, transparent, open disclosure of questions at the very heart of the integrity of scientific medical research.

Kudos to the bulldogs at the Cancer letter, who say that although their publication is subscription only, they'll send this particular article to any interested party if you e-mail them at: kirsten@cancerletter.com or paul@cancerletter.com.

Medicare to pick up tab for more heart scans

Earlier this week, Merrill Goozner may have given us the spot-on scary political reality when he put his touch on the story of Medicare approving new payments for expensive heart scans. Excerpt:

I suspect there will be a lot more of these decisions over the next nine months as Bush administration appointees hoping to line up their next jobs grant top-of-the-wish-list favors to special interests.

The New York Times website reported Wednesday that the Center for Medicare and Medicaid Services has reversed a proposed policy to cut off paying for heart scans, which can cost $600 or more. The preliminary decision announced last December found no clinical evidence that heart scans identify heart disease any better than other non-invasive procedures, like a stress test. According to the paper:

Medicare’s initial proposal, which would have ended payment for the scans unless the patients were enrolled in studies to determine the technology’s effectiveness, had met with fierce resistance from the doctors who perform these scans and the companies that make the equipment. They strongly defended the use of these scans as an important alternative to traditional angiography. ...

Lobbying by docs and equipment makers. Pay first, evidence later. It's the American way.

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.

Here we go again - another industry-funded Sleep Awareness Week

Don't let the special interest campaign catch you napping!

Dozens upon dozens of stories about Americans lacking sleep are popping up from news organizations all over the country this week, driven by another of the National Sleep Awareness Week campaigns of the National Sleep Foundation.

Few - if any - of these stories will tell you that it is industry special interests - sleeping pill makers, sleep labs, mattress makers - who are paying for this campaign. They do it every year. And news organizations fall into line like sheep and report the "new" findings every year.

Examples:

USA Today reports:

U.S. workers are silently suffering from a dramatic lack of sleep, costing companies billions of dollars in lost productivity, says a study out Monday.

Nearly three in 10 workers have become very sleepy, or even fallen asleep, at work in the past month, according to a first-ever study on sleep and the workplace by the non-profit National Sleep Foundation. The late-2007 survey was based on a random sample of 1,000 workers.

AP reports:

Hey you! Dozing at your desk! Wake up, go home and get more sleep! That could be the message from a survey released Monday by the National Sleep Foundation. The survey of 1,000 people found participants average six hours and 40 minutes of sleep a night on weeknights, even though they estimated they'd need roughly another 40 minutes of sleep to be at their best.

CNN, WebMD, UPI, the St. Louis Post-Dispatch and many, many more news organizations are reporting the same stuff - handed to them by the industry-funded campaign.

Yawn.

Wake me when the next disease-mongering campaign comes around.

What is there to debate about medicine's conflicts of interest?

As proof that you can foster debate over just about anything, the BMJ hosts a journal debate over the question of "Has the hunt for conflicts of interest gone too far?"

Harvard professor Thomas Stossel says "Yes," arguing that restrictions on doctors’ and academics’ interaction with commercial companies are damaging research.

But UCSF professor Kirby Lee says "No," believing that scrutiny of potential conflicts of interest is a price worth paying to maintain public trust.

Industry influence on medicine

Australian journalist Ray Moynihan writes in the BMJ about “the invisible influence of drug company sponsorhip” of doctors’ educational seminars. He writes that:

“it is not uncommon for drug company sponsors to suggest speakers at sessions that are assumed by the thousands of general practitioners who attend them to be totally independent. Drug industry representatives have confirmed that similar practices take place in the United Kingdom, where roughly half of all education for doctors is sponsored by drug companies.

In the case of one popular Australian provider of medical education, HealthEd, leaked documents and emails from a range of sources show drug company sponsors having input into the selection of some speakers at seminars held in recent years, despite the fact that these have been aggressively sold to general practitioners in brochures claiming that "all content is independent of industry influence."

Meantime, today's Star Tribune reports on a U.S. Senate hearing called "Surgeons For Sale." Excerpt:

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to "adult entertainment" clubs. Fat checks for what some see as questionable work.

Such payments to doctors by medical device companies -- often disguised as "consulting agreements" meant to encourage use of their products -- were the subject of a packed, daylong hearing Wednesday before the U.S. Senate Special Committee on Aging.

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

Financial conflicts of interest in spine study

The New York Times reports on the testing and approval of an artificial spinal disc - the Prodisc. The Times says the case "provides a stark example of conflicts of interest among clinical researchers — conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug. Instead of serving as objective gatekeepers who can screen out potentially harmful or ineffective new devices or drugs, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients."

Who's Behind the Bible of Mental Illness?

I'm late in drawing attention to an article from several weeks ago in U.S. News & World Report.
It was headlined, "Who's Behind the Bible of Mental Illness: Critics say that touted efforts against conflicts fall short." Excerpt:

In what is arguably the most important mental-health development since the early 1990s, the American Psychiatric Association will spend the next five years producing a new edition of the psychiatrist's "bible," the official guidebook for diagnosing mental problems. The Diagnostic and Statistical Manual of Mental Disorders, as it is known, is hugely influential because it determines what is and is not a mental disorder. In turn, it is responsible for much of the sales growth in prescription drugs.

The most recent edition of the DSM, published in 1994, drew controversy because it turned what had once been a thin guidebook into an 886-page tome that significantly expanded the definition of mental illness. Traits once associated with shyness, for example, became symptoms of "social anxiety disorder." And drug companies went on to spend millions promoting medicines for those problems. Eyebrows were further raised in 2006 when a study showed that more than half of the researchers who worked on the manual had at least one financial tie to the drug industry.

This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests. It calls the effort the "most transparent" in the medical industry. Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: "Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved."

Conflict of interest in continuing medical education

John Mack, publisher of Pharma Marketing News, recently wrote an essay worrying about drug industry support of continuing medical education or CME. Excerpts:

"In 2006, commercial support of CME totaled about $1.19 billion ($1.44 billion if you include advertising and exhibits at CME events). That represents about 50% of the total support.

Why won’t physicians pay for CME?

Although $1.2 billion is only a small fraction of the total promotional spend of the industry, a billion here, a billion there, and pretty soon we’re talking about real money! Why should pharma contribute so much for CME in the first place? Doesn’t that naturally lead to biased content? Shouldn’t there be a ban on commercially-funded accredited CME? Why can’t physicians pay for their CME like many other professionals do?"

Reminders of how much money people make in medicine

Item 1 in today's news:

Former UnitedHealth CEO Bill McGuire finally settled with the Securities and Exchange Commission over his stock options scandal. In all, he pays back $618 million. But don't lose sight of the fact he still holds options that are valued at $1.8 billion.

Item 2 in today's news:

A former department head fired from the Cleveland Clinic claims there are pervasive conflicts of interest at the world-renowned hospital. The Wall Street Journal reports the former head of the clnic's vascular intervention unit (a big bucks operation),

"said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients. ... His suit alleges the clinic has been "indifferent" to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos "Toby" Cosgrove, according to the complaint. The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring."

Some have called the issues of conflict of interest in patient care "a ticking time bomb" in health care.

You can find experts without conflicts of interest

The FDA has been criticized for how many scientists with conflicts of interest that the agency allows to serve on its advisory committees. The FDA says it can't find conflict-free experts. But a study by the Integrity in Science Watch project of the Center for Science in the Public Interest (CSPI) suggests the FDA isn't looking hard enough.

CSPI reports:

"For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. ... Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."

CSPI, along with other prominent science and consumer groups, urged the FDA "to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

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Meantime, read Maggie Mahar's blog for details on the FDA Science Board report, "FDA: Science and Mission At Risk." Some lowlights:

* “The Information Technology situation is problematic at best—and at worst it is dangerous.”
* “The FDA has substantial recruitment and retention issues”.
* “Critical data…including valuable clinical trial data...are sequestered in piles and piles of paper documents in large warehouses."
* “The FDA has an inadequate and ineffective program for scientist performance."
* "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."

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." "

Influence of industry on academic medicine

A new study published in the Journal of the American Medical Association gives perhaps the best picture yet of how extensive are industry-academic relationships are in medicine. The authors surveyed department chairs in the 125 accredited allopathic medical schools and the 15 largest independent teaching hospitals in the United States. 67 percent of the 688 eligible department chairs completed the survey.

It showed that "almost two-thirds (60%) of department chairs had some form of personal relationship with industry, including serving as a consultant (27%), a member of a scientific advisory board (27%), a paid speaker (14%), an officer (7%), a founder (9%), or a member of the board of directors (11%). ... More than two-thirds of chairs perceived that having a relationship with industry had no effect on their professional activities, 72% viewed a chair's engaging in more than 1 industry-related activity (substantial role in a start-up company, consulting, or serving on a company's board) as having a negative impact on a department's ability to conduct independent unbiased research."

The authors concluded:

"Failure to address the existence and influence of industry relationships with academic institutions could endanger the trust of the public in US medical schools and teaching hospitals."

The Associated Press reports:

Dr. Jerome Kassirer, a former New England Journal of Medicine editor and frequent critic of industry influence over doctors, called the study eye-opening.

"I was appalled by the results," Kassirer said. "No one knew that so many chairs of medicine and psychiatry were paid speakers. We've never had that data before."

British M.D.-journalist slams journalists for conflicts of interest

Ben Goldacre, in this week's BMJ writes:

I was surprised last week by an email circular I received from a science writers' mailing list. It was from the Aspirin Foundation, a group funded by the drug industry, and it was offering—on behalf of Bayer Healthcare—to pay expenses for journalists to attend the European Society of Cardiology's conference in Vienna.

Now aspirin is without doubt an excellent and cheap drug. But in my naivety I had no idea such things went on. I pinged off a few emails to friends and colleagues. Most poked fun at my innocence—quite rightly—but some were helpful. Not only is it extremely common for journalists to take money from drug companies, but there have been some astonishing cases in recent history, including one memorable case where a PR company invited journalists to "an exclusive preview" of new laser eye technology, with the offer to "discuss free treatment in return for editorial features."

"I organise the media programmes for a number of medical conferences run by scientific societies," said one person who, without wishing to be melodramatic, has asked to remain anonymous, "and I reckon at least 50% of the journalists present are paid for by drug companies. They get pretty well looked after too—first class travel, five star hotels, posh dinners, etc. Some of them indulge in double dipping, where they are paid by the day by the drug company and then by the publication that takes whatever they have written. Sometimes they don't even use the press room, spend all their time in company hospitality suites, and just go to company sponsored satellite sessions and press conferences."

Perhaps I'm naive, but I don't buy Ben's claim that it's "extremely common for journalists to take money from drug companies." But the points he makes about pharma's pervasive and troublesome influence on some journalists and news organizations is worth noting. He wrote:

"...There are real dangers in being too close to PR people: lovely though they may be, their trade is, by definition, manipulation. Drug companies are businesses, with responsibilities to their shareholders, and they wouldn't pay for journalists to attend their events if they didn't think it would affect media coverage of their product. After all, a journalist's article is far more credible than a paid advertisement, for anybody's money, and more likely to be read by potential consumers. ...

It's much easier to get someone to take your calls when they've taken your money. And I, for one, will in future read outraged media reports of academic conflicts of interest with a wry smile indeed."

Journal Watch tracks conflict of interest

It may become easier to discover journal article authors' potential conflicts of interest, through the web site, Journal Watch.

The Wall Street Journal reports the system adopted by Journal Watch "was the latest move to toughen disclosure after a series of cases in which authors' ties to the pharmaceuticals industry weren't disclosed. Journal Watch is owned by the Massachusetts Medical Society, publisher of the New England Journal of Medicine. Under Journal Watch's new system, to be adopted later this month, online readers will be able to click on an author's name and instantly see disclosures about his or her financial ties to drug makers and other sources of support. The site, aimed at doctors, summarizes significant articles on recent medical journals."

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.

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."

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.

Conflict of interest in advanced diagnostic imaging

The Health Affairs website today published a study that shows how physicians are often stretching or breaking the law when they refer patients to diagnostic imaging facilities with which they have a financial relationship. Excerpts:

"Laws enacted during the early 1990s to curb physician self-referral were a major step toward addressing the concerns about these arrangements; however, they contain exceptions that could enable self-referral to reappear but in a different form tailored to fit the exemption. This study is the first to document the prevalence and scope of self-referral arrangements in light of these exceptions. ...

Using data from a large insurer in California, we identified the self-referral status of providers who billed for advanced imaging in 2004. Nearly 33 percent of providers who submitted bills for magnetic resonance imaging (MRI) scans, 22 percent of those who submitted bills for computed tomography (CT) scans, and 17 percent of those who submitted bills for positron-emission tomography (PET) scans were classified as "self-referral." Among them, 61 percent of those who billed for MRI and 64 percent of those who billed for CT did not own the imaging equipment. Rather, they were involved in lease or payment-per-scan referral arrangements that might violate federal and state laws. ...

These findings should be of considerable concern to policymakers, employers, insurers, and consumers who recognize the need to control rapidly escalating health care spending. Efforts that address the exemptions in existing federal and state prohibitions on physician self-referral are likely to have major impacts on the increased use that characterizes these arrangements."

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.”

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?

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.

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.

Conflict of interest controversy with med school dean

The St. Paul Pioneer Press reports on a controversy surrounding University of Minnesota Medical School Dean Dr. Deborah Powell joining the board of PepsiAmericas, one of the world's largest sellers of Pepsi and Mountain Dew.

The paper reports:

“A recently completed internal review, standard for any U employee involved in outside work, found no conflict of interest in her service to PepsiAmericas, a publicly traded company that is the world's second-largest bottler of PepsiCo. brands.

In search of conflict-free experts

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

"The Food and Drug Administration's latest report on the make-up of its advisory panels reveals that little has changed in the 15 months since Congress required the agency to document its efforts to find scientists without ties to industry. In a report sent to Capitol Hill on Jan. 31, FDA Commissioner Andrew von Eschenbach reported that 24 percent of advisers to the agency’s seven centers and offices received conflict-of-interest waivers between November 2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had the worst performance, with 146 of 417 advisers, or 35 percent, requiring waivers because they owned stock in, consulted for, or served on the speakers' bureaus of firms with products up for approval or their competitors.

The agency's ability to identify advisers without conflicts of interest has not budged since Congress acted. ...
When questioned about the agency's failure to reduce its reliance on outside advisers with ties to industry, acting deputy commissioner Randall Lutter said that 'it is very difficult to get the quality of the expertise we want without going to people who have some sort of relationship with industry related to product development.' But as a Lancet editorial noted in 2005 shortly before Congress passed its law, 'it is hard to believe that in a country with 125 medical schools – not to mention the pool of international experts – the FDA cannot find experts who do not have financial ties with companies whose products are under review.' A New York Times editorial has pointed out that 'unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels.' "

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.)

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.

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 ha