Conflict of interest

FDA advisors face conflict cap

Tracy Staton — Tue, 05 Aug 2008 10:04:08 -0400

The FDA is tightening up its conflict-of-interest rules for those expert advisory panels that often get involved in the most contentious drug safety decisions (and approvals, too). For years, consumer advocates and others have argued that panel members shouldn't have any financial conflicts. Arguing back, the agency would say that limiting committees to experts without conflicts would exclude many if not most top docs and researchers.

But now FDA has given in--at least a little. If an expert or anyone else in his immediate family has financial conflicts of more than $50,000, he can't participate in that meeting. Also, four specific kinds of conflicts won't be allowed, period. And any conflict waivers--required for people with less than $50,000 at stake and without those four disqualifiers--would have to be absolutely necessary for the committee to have "essential expertise."

Already some are saying that $50,000 is too high a threshold--but FDA types said they're pushing to find advisers with "minimal or no conflicts." We'll see how that effort plays out.

- see the FDA release
- read the post at Pharmalot
- check out the Wall Street Journal Health Blog's item

Pfizer to stop funding for-profit CME

Tracy Staton — Thu, 03 Jul 2008 09:20:16 -0400

Drug companies have been catching flak lately not only for their direct payments and gifts to doctors--such as speaking fees and travel--but for funding the kind of continuing medical education that physicians need to keep their licenses current. Well, Pfizer is backing away from some of that CME sponsorhip. The drugmaker will no longer back CME courses provided by for-profit, third-party companies. It will keep paying for courses offered by med schools, teaching hospitals and medical societies, though.

Why the new policy? Pfizer wants to stave off "the perception of a conflict of interest," Pfizer told Dow Jones. The company spent $80 million on CME classes last year, with less than half going to the sorts of groups that now will be barred from support.

Now the question is whether other drugmakers will follow suit. The industry as a whole spent more than $1 billion funding CME, the WSJ Health Blog notes; drugmakers leapt into CME sponsorship in a big way after the industry agreed it should educate docs rather than just entertaining them. As the funding has grown, so have worries about undue influence. Some academic hospitals have even pledged to stop offering classes paid for with industry money.

- check out the release from Pfizer
- read the Health Blog post
- see the Pharmafocus story

AAMC: Ban pharma gifts at med schools

Mon, 28 Apr 2008 06:59:57 -0400

Will all medical schools bar the door to pharma giveaways? The Association of American Medical Colleges hopes so. After two years of study, the influential group drafted a policy that would ban drug and device companies from handing over free food, gifts, travel, and ghostwriting services to docs, staff, and students in all 129 U.S. med schools. "Most medical schools do not have strong conflict-of-interest policies, and this report will change that," one anti-conflicts of interest activist told the New York Times.

Schools can ignore the association's advice, but most don't. And though the rules would apply only to med schools, they could in turn influence providers of all stripes.

Drug companies spend more to soft-soap doctors than they do on research or consumer ads--and med schools are big targets, because they harbor not only influential profs but green students. "Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception... that practitioners are being 'bought' or 'bribed' by industry," the association's report said.

Interestingly, the task force that drafted this report wasn't expected to be so strident: Members included CEOs of Pfizer, Eli Lilly, Amgen, and Medtronic, and it was chaired by former Merck chief Dr. Roy Vagelos.

- get the AAMC report
- read the NYT story

JAMA: Merck paid docs for bylines

Wed, 16 Apr 2008 06:59:58 -0400

Merck wrote its own articles on Vioxx research and then paid prestigious doctors to append their bylines, according to a new story in the Journal of the American Medical Association. Of course, Merck isn't alone: the JAMA article notes that ghostwriting appears to be widespread in the pharma industry. "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician," said the study's lead author, Dr. Joseph S. Ross of the Mount Sinai School of Medicine.

But the ghostwritten Vioxx research is noteworthy because the drug went on to become a best-seller--and then a fiasco, as Merck withdrew it because of links to heart attacks and, most recently, agreed to pay $4.85 billion to settle related lawsuits. It's also interesting because those very lawsuits unearthed documents that shine a bright light on the way Merck promoted Vioxx data. Usually, those documents are kept in drug company filing cabinets and never meet the public eye. Also, the JAMA reports allege that Merck dragged its feet when reporting data on safety risks that arose during two studies of Vioxx in dementia patients.

Now, these JAMA articles relied only on the legal documents and published studies; none of the authors were contacted. Since the reports were published, some expert authors have defended their roles in the Vioxx articles, saying that they didn't simply come in after the fact and add their names, but participated in the research itself. "It's simply false that we didn't contribute to the final publication," one said. But that same professor told USA Today that he never had all the statistical analyses for that study; his role in it was to judge the accuracy of participants' Alzheimer's diagnosis, not the effect of the drug, he said.

We may get some more public documents to pore over soon, however: Sen. Chuck Grassley has put one of the ghostwriting companies--Scientific Therapeutics Information--on the hot seat, asking the company about its dealings with Merck.

Plus, expect to see debate over JAMA's proposals for reform. They include a half-dozen bids for increased transparency in clinical trials and study publication.

- check out Merck's response to the JAMA articles
- find the JAMA abstract
- see Grassley's letters
- read the Boston Globe story
- see one researcher's conflicting accounts of a Vioxx study at Pharmalot
- check out JAMA's recommendations

Related Articles:
Could full data disclosure avert scandal? Report
Vioxx plaintiffs sign on, deal proceeds. Vioxx report
Positive data more likely to find its way to public. Report

Docs go cold turkey on industry pay

Tue, 15 Apr 2008 06:59:54 -0400

The shape of things to come, or a few anomalies that prove the prevailing trend? A few prominent research doctors are saying "No, thanks," to any payments from drug and device companies. They won't be paid for speaking at meetings or sitting on advisory boards, and any research they do with companies will be pro bono.

The scientists who made this choice--including Dr. Peter Libby, cardiovascular chief at Harvard's Brigham and Women's Hospital and Dr. Eric P. Winer, director of the Breast Oncology Center at Dana-Farber Cancer Institute--did so because they were tired of speaking out about disease and treatments only to have their positions questioned because of their relationships with companies. "It is not worth it to be under suspicion," Libby told The New York Times. "I just said enough is enough," Winer said. "And in truth, it has made my life simpler."

- read the article in the NYT

Related Articles:
Dr. Drug Rep tells all. Report
MN panel mulls conflict-of-interest policy. Policy report
Groups plan new fight to limit pharma-doctor ties. Report

Seroquel researcher got cash from AZ

Tue, 08 Apr 2008 06:59:56 -0400

Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee, who's been trying to rally support for a bill requiring drug and device makers to disclose anything of value given to doctors, raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.

Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.

Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH funding during the same period. University of Cincinnati said it applauds Grassley's "looking into this very important issue."

- read the WSJ Health Blog item
- see Grassley's Physician Payment Sunshine bill

Related Articles:
AZ takes steps to shore up Seroquel. Report
AZ's Seroquel receives additional approval. Report

ALSO NOTED: FDA: New Zyprexa sedates some;Vanderbilt outlaws rep freebies;

Mon, 04 Feb 2008 06:59:50 -0500

> Prepping for advisory panel review, FDA staff says long-lasting Zyprexa causes drowsiness. Report

> Vanderbilt Medical Center has become the latest hospital to ban gifts from drug reps as part of a new conflict-of-interest policy. Report

> European regulators gave the nod to Roche's chemotherapy drug Xeloda for use against metastatic colorectal cancer in combo with other chemo meds. Report

> U.K. doctors called on the National Health Service to share more information about its dealings with the pharmaceutical industry. Report

> Bayer CEO Werner Wenning says the company has plenty of cash to make acquisitions even after last year's buyout of German drug maker Schering. Report

> Schering-Plough got the FDA nod for its Asmanex Twisthaler asthma treatment for prevention of symptoms in children 4 to 11 years. Report

> Three more congressmen have joined the fray over Denderon's delayed prostate cancer vaccine Provenge. Report

> Following a label change, Novartis has won EU approval for its trouble diabetes drug Galvus. Report

> Biotech and emerging drug markets are big targets for venture capitalists. Report

And Finally... Could low-salt and high-veggie diets succeed where blood pressure meds fail? Report

MN panel mulls conflict-of-interest policy

Wed, 22 Aug 2007 06:59:55 -0400

What does Minnesota have that practically no other state does? A law that requires drug companies to report payments to doctors for lectures, consulting, research, and the like. What does Minnesota have that many other states might? A problem with drug makers paying members of state advisory panels that select the meds used by Medicaid patients. A doctor and a pharmacist on the state's eight-member committee each received thousands--more than $350,000 in the doctor's case--from pharmaceuticals firms for lecturing about their products.

Now, it's tough to prove a direct link between the money and the panel members' official decisions. But the state of Minnesota says it will begin screening these committee members for financial ties to the drug industry. Some other states, such as Nevada, bar panel members who have been paid by pharma companies. If the drive for disclosure of drug-doctor ties continues to grow, more states may decide to do the same.

- read the report from the Washington Post

Related Articles:
Congress debates pharma gift disclosure. Report
NY bill would require pharmas to report MD gifts. Report
States tighten screws on pharma marketers. Report
Review boards conflicts of interest are common. Report