Thursday, December 8, 2011

A Logical Fallacy Affecting Selection of Panelists on an FDA Advisory Committee

An old argument used to defend against criticisms of conflicts of interest was just employed in a disturbing context. 

Expert Removed from FDA Advisory Committee for Having an Opinion

As first reported on the PharmaLot blog, and later by the Newark Star-Ledger, a panelist was just disqualified from voting on a US Food and Drug Administration (FDA) panel for having previously expressed an opinion about the safety of the drug up for re-evaluation.  Per the Star-Ledger,

Federal drug regulators have notified Sidney Wolfe, one of the nation's leading advocates for drug safety, that he would not be permitted to join a committee of experts asked to review new dangers associated with a group of birth control pills, including Bayer Healthcare's top-selling Yaz.

The Food and Drug Administration scheduled a meeting Thursday of two advisory committees — one on drug safety and risk management and the other on reproductive health drugs — after new information emerged on the safety of oral contraceptives containing the synthetic hormone

Why Was Dr Wolf removed from the committee?
The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of 'Do Not Use Pills' in 2002.

'He did not volunteer this information,' said agency spokeswoman Erica Jefferson. 'It was brought to our attention.'

The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.

Logical Fallacy: False Dilemma

We frequently post about conflicts of interest affecting health care decision-makers.  It is now clear (e.g., look here) that leading health care academics often have significant financial relationships with drug and device companies and other health care corporations which could potentially influence their clinical research, clinical teaching, health policy recommendations, or direct patient care.  These relationships are frequently defended, often with logical fallacies used by those who themselves have conflicts. 

One common argument is based on the assertion that conflicts of interest are ubiquitous and everyone is conflicted.  Therefore, if one were to ban people with conflicts from responsible positions, there would be no one left to fill these positions, so such a ban would be untenable.  This seems to be an example of the false dilemma.  It is often employed by people who themselves have conflicts of interest.

One way to make it appear that everyone has conflicts of interest is to broaden the concept of conflicts of interest to "intellectual conflicts of interest."  Doing this facilitates the assertion that everyone who has an opinion on a subject has a conflict of interest, so this argument implies that all sentient beings have important conflicts.  This argument would make equivalent a doctor who would not use a particular drug because his or her reading of the clinical research literature about this drug suggests its benefits do not outweigh its harms, and a doctor who advocates using the drug, and is paid $100,000 a year by the marketing division of the company that makes this drug as a marketing consultant. 

The decision to prevent Dr Wolfe from voting on this committee seems to be based on this logical fallacy. As Dr Wolfe said,
In his statement, Wolfe said if intellectual conflict of interest means being informed and subsequently having opinions on a drug, then 'many more members of advisory committees would have to be excluded.'

'For members of a scientific and technical advisory committee, possessing information and expert views on matters within the purview of the committee is not a conflict of interest,' Wolfe wrote. 'To the contrary, qualified experts are likely to have developed views on a variety of subjects based on their professional experience.'

As Larry Husten wrote on the CardioBrief blog,
do we really want to choose advisory committee panelists who have never expressed opinions about the topics they are reviewing? Are we reaching the point where potential FDA panelists will be required, like Supreme Court nominees, to have avoided any discussion of all important issues at every point in the past?

Thus they point out the absurdity of banning people with "intellectual conflicts of interests," that is, with relevant opinions, as if they had real conflicts of interest. (But wait for someone to argue that if Wolfe were allowed to serve, it would be unfair to ban anyone with financial conflicts of interest from serving.)

What is most distressing about this case is that the sort of fallacious arguments usually employed by the conflicted to defend conflicts of interest are now being employed by leaders of government agencies, who are supposed to not have their own conflicts, and to serve the people, and in this case, to be dedicated to improving the health and safety of the population and of individual patients.

Every fallacious argument made in support of financial conflicts of interest affecting health care decision makers suggests we need to do more to combat such conflicts.  At an absolute minimum, all such conflicts should be fully disclosed in detail in any context in which they possibly could influence medical research, medical education, clinical care, or health policy.  Furthermore, we need to work towards ending as many such conflicts as possible.  A good starting point would be the recommendations made by the Institute of Medicine committee reports on conflicts of interest, and clinical practice guidelines.

See also comments by Merrill Goozner on the GoozNews blog.

ADDENDUM (9 December, 2011) - In response to comments below, see two posts by Dr Howard Brody in the Hooked: Ethics, Medicine, and Pharma blog on the problems with the concept of "intellectual conflict of interest" - here and here.

ADDENDUM (9 December, 2011) -  See further discussion by posted by Dr Brody today here.


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