Political interference in the process of science and rampant conflicts of interest in scientific advisory panels are undermining the agency’s ability to protect the public from dangerous drugs.

FDA under fire from its own scientists

The FDA is already deeply mired in controversy over drugs trials in Third World countries [1] (FDA in Third World drug trial scandals , this issue) The Union of Concerned Scientists (UCS) has fanned the fires by releasing the results of a survey that demonstrates the pervasive political influence on science at the FDA [2].

The survey was sent to 5 918 FDA scientists and elicited 997 replies.  Almost one fifth of scientists (18.4 percent) said that they “have been asked for non-scientific reasons to inappropriately exclude, or alter technical information or their conclusions in FDA scientific documents.”

This response ech oes previous public complaints made by FDA scientists who said that their findings on the painkiller Vioxx produced by Merck & Co were dismissed [3]. Merck eventually had to pull Vioxx from the market because of a study that linked the doubling of heart risk to the use of the drug. This is a serious indictment of FDA’s lack of accountability, and one that compromises their ability to protect public health and safety.

Other responses to the UCS survey showed that:

• 17 percent had been asked by FDA officials to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials
• 40 percent fear retaliation from voicing safety concerns in public
• 47 percent, that’s less than half, think that the FDA routinely provides complete and accurate information to the public
• 61 percent knew of cases where Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations of actions
• 81 percent agreed that the public would be better served if the independence and authority of FDA post-market safety systems were strengthened.

Dr Francesca Grifo, Senior Scientist and Director of UCS’s Scientific Integrity Programs [2] said, “FDA leaders should act now to improve transparency and accountability and renew the respect for independent science at the agency.”

Conflicts of interest rampant at the FDA

But how do drugs like Vioxx get onto the market in the first place? A study published this year by Washington based consumer advocates The Public Citizens Health Group [4] found that conflicts of interests were rampant within the FDA’s 16 drug committees and 32 other advisory panels. In 73 percent of the 221 drugs reviews conducted during 2001-2004, there was a financial conflict of interest with the affected company or product competitors involving one or more panel members.

Only one percent of the 3 000 panellists were recused (disqualified) within the same period, despite substantial conflicts involving investments exceeding $25 000, and grants or contracts topping $100 000.  In the case of Vioxx (and other controversial painkillers such as Celebrex and Bextra) ten members with direct links to the drug manufacturers were on the panel that approved them.

The barrage of criticisms being heaped upon the FDA led the agency to announce a major internal review of drugs advisory committees in May this year. But critics feel that change is unlikely to come from within the FDA itself.  The fact that the review is internal cast doubts over its sincerity.

Merrill Goozner, Director of Integrity in Science, supports the internal review of the FDA’s advisory committees prompted by the criticisms.  He said [5]: “This should be turned into more of a deliberative body without a stake in the outcome, rather than a kind of good-old-boy network of people whose primary interest is to get their hands on a new therapy either to test or for [their own] patients.”

FDA scientists criticised for corporate links

The FDA has been rightly criticised by US Congressman Maurice Hinchey, an influential democrat. Hinchey blasted the FDA scientific advisory panels as being little more than partially owned subsidiaries of the pharmaceutical industry. He is so outraged that scientists with conflicts of interest are allowed onto drug advisory committees that it has spurred him on through the House of Representatives to attach a rider to the FDA budget that would prohibit the agency from using conflicted panellists [5].

But this strong move has been politically compromised; the rider was lifted providing that potential conflicts are disclosed and posted on the FDA’s website fifteen days before drug advisory committees convene [ 6 ]. This effectively maintains the FDA’s practice that permits a scientist with a conflict of interest to apply for a waiver on the grounds that the individual’s experience outweighs the seriousness of the conflict. It is a federal policy that critics are trying to change.

There is a common consensus that the voting of the panel that approved Vioxx would have been different had those members with links to the pharmaceutical industry been excluded. In the interest of Public Health there must be more transparency about the information presented to FDA drugs committees, and more stringent rules on conflicts of interest.