The AMA, the FDA and Ratings Agencies: Conflicts, Conflicts Everywhere

Money is a very powerful motivator. And this can inure to the benefit of the individual and to all of society. Unless it doesn’t. Like when there are clear conflicts of interest, where a financial payoff is received based upon performance that could be compromised due to self-interest, and where the conflicted party’s actions can hurt those whom they are purportedly supposed to be helping. Such as when a rating agency slaps premium ratings on instruments that it doesn’t really understand, garnering huge fees in the process while setting up those who bought the bonds for a sharp fall down the road. Or when a medical researcher has a financial interest in a certain product getting FDA approval, encouraging them to skew test data to get the approval but where the actual patients might get inappropriate treatment and suffer great harm. Here are two real-life situations where money, in the face of stark conflicts of interest, can and has been a dangerous tool that visited unnecessary suffering upon many, many innocent people.

Regulation should exist to protect those who cannot protect themselves, and who depend upon the truthfulness and ethics of parties in a position of authority to make informed, intelligent decisions. Like rating agencies and doctors sanctioned by the AMA. But we have seen two horrific breakdowns in recent months, breakdowns that must be addressed by the relevant governing bodies. The rating agency conflict problem has been extensively discussed on this blog and I won’t belabor the point. But the medical researcher conflict has not. Because while M.D.s supposedly learn the precept primum non nocere (first, do no harm) in medical school, some have clearly forgotten important message as they’ve evolved into high profile, highly compensated researchers and practitioners. And if only half of the information contained within today’s New York Times story is true, describing conflicts of interest around FDA approval of the Prodisc spinal implant, this may even exceed the gross self-dealings between rating agencies and their issuer brethren. Difficult to fathom.

Here are a few key excerpts from the story:

“As a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily,” Dr. Jack E. Zigler, a well-known spine specialist and one of the study’s lead researchers, said in a 2006 news release announcing the latest results of the Prodisc clinical trial.

As it turns out, Dr. Zigler had more than a medical interest in the outcome. So did doctors at about half of the 17 research centers involved in the study. They stood to profit financially if the Prodisc succeeded, according to confidential information from a patient’s lawsuit settled last year.

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The way the Prodisc was tested and approved 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, some medical experts say, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients.

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“The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing,” said Dr. Richard A. Deyo, a medical professor at Oregon Health and Science University. “More people are interested in getting on the gravy train than on stopping the gravy train.”

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“Industry’s goal is to make a profit for its shareholders, not to advance medicine,” said Dr. Rosen, who in 2006 saw a need to start a group called the Association for Ethics in Spine Surgery. It now includes 85 specialists who say one of their aims is to warn the public about industry influence on medical practice.

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Close relationships between surgeons and device companies can affect more than the potential quality of an individual clinical trial, said Dr. Drummond Rennie, a professor of medicine at the University of California, San Francisco who has studied conflicts of interest among physicians. Because the entanglements are so common, Dr. Rennie said, it is unlikely another surgeon will speak out about any potential misgivings they have about any device.

“The absolute ideal from a drug or device company is everyone is covered,” he said. “And what they have it covered with is money.”

This does not appear to be a situation where self-regulation can work. Doctors won’t rat each other out. And if a doctor with a big reputation and a big position sees a chance for a nice payoff to implicitly (or explicitly) endorse a device, who’s going to say “don’t do it?” FDA rules permit a researcher to receive payola, provided it is disclosed. This does not appear to have been what happened in the Prodisc case, however. But I’m not sure disclosure is even the issue here. When is it appropriate for a researcher to have a financial incentive for the outcome of a study to be one way or the other? I can’t think of when. Because without a financially disinterested party doing the study, where are the checks-and-balances in the system? Who is protecting the patient? Who is their advocate? This breach of ethics in a profession so seemingly bound by ethics is incomprehensible.

And while rating agency analysts don’t take anything remotely resembling the Hippocratic Oath or learning about primum non nocere, they are, without question, in a position of responsibility akin to that of a fiduciary as literally millions of people depend upon the quality of their work and the veracity of their ratings. With these two examples of conflicts run amok it appears that the ethics woven into the fabric of our society are becoming increasingly frayed. And this may well be more important that the financial market crisis itself.

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COMMENT:

AUTHOR: STS

EMAIL: seth_stafford@comcast.net

URL: 

DATE: 01/31/2008 11:47:21 AM

“Money is a very powerful motivator.”  

Indeed it is, and moral philosophers as otherwise inimical as Karl Marx and Milton Friedman have tended in modern times to agree that it is in some sense the *only* motivator.  This is a grave mistake.

Conservatism once had a moral significance that had less to do with our private behavior and rather more to do with our social contract.  A perfect example of this is the great pride John Adams took in his authorship of the Massachusetts Constitution.  

In Kant’s memorable phrase: “Out of the crooked timber of humanity, no straight thing was ever made.”  To compensate for this crookedness, we need to craft institutions capable of setting our selfish impulses in balance against each other.   Not central planning or micro-management, but a closely reasoned and elegantly stated set of rules which imposed a readily understood, transparent structure on an otherwise freewheeling political circus.  Our founding generation prided itself on it’s constitution-making more than its wealth-making.  

Who remembers *this* conservatism today?

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COMMENT:

AUTHOR: Dr. Larry

EMAIL: lrosen@integrativepeds.org

URL: http://integrativepeds.org

DATE: 01/31/2008 05:31:12 PM

Conflicts of interest in medicine?  You’ve touched the surface of a major iceberg.   It’s bad enough the main stream media reports of medical news are rife with COI and bias (when the CEO of Reuters sits on the Merck BOD, you know something strange is afoot), but actual medical journals select and report studies ALL THE TIME that are not free of COI.  And all that’s required is disclosure.  Is that really kosher?  Is it enough to say, “Yes, I can make a lot of money from publishing this, but hey, trust me, I’m telling the truth”?  All medical research is nuanced - I think our journals have a greater responsibility than assuming it’s OK as long as there’s a disclosure.

Case in point from recent history:

Pediatrics, the main academic journal for pediatricians, the signature journal of the AAP, published an article in Nov. 2007 titled, “Treating attention-deficit/hyperactivity disorder with a stimulant transdermal patch: the clinical art.”  

This article was practically a glowing ad for Daytrana, the first skin patch methylphenidate treatment for ADHD.  The authors’ disclosure (in fine print at article’s end):

“Dr Arnold has received research funding, consulting honoraria, and speaker fees from Shire, Lilly, Novartis, McNeil, Sigma Tau, and Noven; Dr LÛpez has received research funding, consulting honoraria, and/or speaker fees from Shire, Novartis, Noven, New River Pharmaceuticals, Celltech-Medeva, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, and Cephalon; Dr Jacob received speaker honoraria from Shire, Connetics, and Astellas; and Dr Findling receives or has received research support from, has acted as a consultant for, and/or has served on a speakers bureau for Abbott, AstraZeneca, Bristol-Myers Squibb, Celltech-Medeva, Forest, GlaxoSmithKline, Johnson & Johnson, Lilly, New River Pharmaceuticals, Novartis, Otsuka, Pfizer, Sanofi-Aventis, Shire, Solvay, and Wyeth. The other authors have indicated they have no financial relationships relevant to this article to disclose.”

Other authors?  I think that was everyone.

How am I supposed to take this seriously?

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