Drug Advisory Committee Member Backs Out of Controversial Pharma Conference
MedPage Today reports that the FDA Drug Advisory Committee chair that was scheduled to speak at a pharmaceutical industry convention has removed herself from the event following criticism from a watchdog group, The Public Citizen.
Pharmaceutical Industry Convention Draws Attention from Watchdog Groups
The upcoming pharmaceutical conference “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations” planned for February has already resulted in controversy as a brochure made accessible to the public offers pharmaceutical companies an inside look to the mind of a FDA Drug Advisory Committee member for a registration cost exceeding $2,000 per chair.
Along with advertising guest speakers which include current Drug Advisory Committee members , the brochure, obtained by the Public Citizen, offers the chance to attend workshops which promise to show pharmaceutical companies “how to use clinical trial data to your advantage” and how to “make statistics work for you.”
Some allege that the promotion of these speeches and workshops further confirms that drug manufacturers are less concerned with using clinical data to determine the safety, efficacy and side effects of a drug, and are more committed to approaching trials in a way that is more likely to present favorable, marketable results.
The idea of conducting pre-clinical studies in a way that is guaranteed to provide a “competitive advantage” has been previous suggested by by companies like AstraZeneca in e-mails to potential researchers.
Advisory Committee Speaker Withdraws from the Event
“Either she is naive and signs up for things without knowing very much about them or she actually didn't know the title of the session she was going to be a speaker on, those things are not really very likely.” – Sidney M. Wolfe, MD senior adviser for the Public Citizen’s Health Research Group as published by MedPage Today
Lynn Drake, MD, chair of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee is now backing out of February’s convention claiming she misunderstood the nature of the event.
The Public Citizen has met Drake’s explanation with speculation pointing out that the convention is called “FDA Advisory Committee Prep: Real World Best Practices to Achieve Favorable Recommendations.” The founder of the group, Sidney M. Wolfe, MD, claims that the title leaves little room for misinterpretation.
In a letter addressed to the Food and Drug Administration’s Department of Health and Human Services, the watchdog group claims that any instruction by a current FDA advisory committee chair to the pharmaceutical industry on how best to present information in order to gain a favorable recommendation effectively undermines the committee’s role as a regulator and as a safe guard against dangerous drugs.
The group goes on to say to say that participation by any current member of an advisory committee could suggest that the committee member “is approaching the work of the committee from a pro-industry perspective” rather than the unbiased approach that is expected from committee members.
The FDA responded to the letter by stating that the agency had given Drake permission to attend the event, but did so without being provided all the information concerning what the event would cover.
The Public Citizen is currently calling for the FDA to revisit their policies and clarify regulations over conflicts of interest.
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