Conflicts of Interest at the FDA
Oh what a shock!
Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA’s drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.
The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug’s maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.
The CDER often relies on advice from external advisory committee members and voting consultants, who are invited by the FDA to make the decisions. According to Public Citizen, this is where the problem is. In September 2001, Public Citizen threatened to sue the FDA and force it to disclose detailed information about committee members’ financial interests. This is by no means an uncommon request. According to current conflict-of-interest law, politicians and high-ranking government officials are routinely required to disclose financial holdings.
In January 2002, the FDA responded to the problem by setting new guidelines for committee members. As of the beginning of 2002, all committee members and voting consultants are required to publicly disclose more detailed financial conflict-of-interest information at the beginning of advisory meetings. In theory, this should have solved the drug evaluation process’ conflict-of-interest problems, but it did not.
The Public Citizen study examined all of members’ disclosed conflicts from 2001 to 2004, a time range carefully set to include one year before the January 2002 guidelines took effect, and three years after the onset of the new guidelines. By looking at this period of time, Public Citizen could determine whether the January 2002 guidelines have effectively lessened conflicts of interest among the committee members who decided whether a new pharmaceutical drug “makes the grade.”
From 2001 to 2004, 28 percent of voting consultants and advisory committee members had conflict of interest, and at least one consultant or member had conflict of interest in 73 percent of all drug approval meetings. This means that, at least 73 percent of the time, new pharmaceutical drugs weren’t entirely objectively approved by the FDA because at least one person in power possibly had an external financial motive. Ethically speaking, someone with conflict of interest is expected to recuse himself or herself, or step down from, any and all decisions where that conflict of interest exists. Unfortunately, according to the Public Citizen study, only one percent of members with conflicts of interest actually abstained from attending the meeting in question. Such a low percentage is inexcusable.
Furthermore, this conflict doesn’t involve small change. The same study that discovered the epidemic nature of the conflict of interest found that 19 percent of consulting arrangements were over $10,000; 30 percent of investments were worth over $25,000; and 23 percent of contracts or grants equaled sums over $100,000.
These sums are too large to ignore. “Conflicts of these magnitudes should result in automatic recusal from advisory committee meetings,” says Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “With as many highly qualified professionals as we have in this country, there should be little difficulty identifying members with more limited or, ideally, no conflicts of interest.”
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