FDA moves to quell claims over conflict of interest
disclosing the conflicts of interest of its advisory experts in a
bid to restore its reputation after a survey suggests its
scientists may be too closely tied with the drug industry and
scientific evidence is being "suppressed and manipulated."
The FDA currently has around 50 advisory panels that it uses to gain impartial technical advice on issues such as over-the-counter medications, cancer drugs and medical devices.
However, questions have been mounting over the conflicts of interest among many of these advisory panel scientists after a survey recently released by the Union of Concerned Scientists (UCS) found that 28 per cent of panel members disclosed financial conflicts, but only one per cent recused themselves from advising on matters of conflict.
The survey also found that that 61 per cent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
About one in six FDA scientists who participated in the UCS' anonymous survey also said they have experienced pressure to change the results of their work for nonscientific reasons.
The revelations have further damaged the FDA's reputation, already tarnished after its involvement in high-profile safety lapses such as with Vioxx, the inflammatory drug withdrawn in 2004 after risks of heart attack and stroke were identified, as well as Ketek, an antibiotic found to have links to liver failure that was allegedly approved on the back of fraudulent clinical evidence.
As the FDA moves into damage control, it announced last week a new pledge to stem these latest concerns by forcing its advisory scientists make more public disclosures about their links with industry when publishing their studies.
"This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency's advisory committees," the FDA stated last Monday.
"FDA is taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion."
However, FDA critics believe this new conflict-of-interest policy does not go far enough in stopping doctors and researchers with conflicts from serving on advisory panels.
New legislation that is currently pending in US Congress is seeking to ban the FDA altogether from employing outside advisors with any financial ties to any drug manufacturer with a stake in a panel's recommendation.
However, many in the industry, who are both for and against the FDA's current system, argue that this would be going too far.
Tightening the rules to this degree would force the FDA to rely on scientists who lacked expertise in a particular area, they claim.
Drug development has become so specialised that only a relatively small number of scientists have the detailed knowledge needed to evaluate a new medication and most have worked as consultants or advisors to drug companies some stage in their career.
When recommendations are being made that can determine the fate of drugs worth millions and may also have the potential to either save or endanger lives, it is natural that the FDA should have as much access as possible to those advisors who are top of their field.
While admitting that there were "clearly things we can improve on," FDA Deputy Commissioner Scott Gottlieb also insisted that imposing sweeping prohibitions is not the answer.
"The agency must retain the flexibility to grant waivers from conflict-of-interest rules to get the highest quality scientific advice," he said.
"We intend to codify this in a public guidance document so people will now have a reference to understand what the agency philosophy is."
