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."
The conflict of interest doesn't end with the committee members and the voting consultants. Even the public speakers that the committee members and voting consultants listen to in order to make their decisions are under the influence of Big Pharma. In fact, they're often supported by and sometimes provided travel by the very pharmaceutical company that makes the drug under review.
However, the question is whether this widespread conflict of interest affects the behavior of the committee members, voting consultants and public speakers. Ironically, the study found that the public speakers supported by the drug companies are more likely to disclose conflict than voting consultants and committee members. It also found that, in the words of Public Citizen, "For every voting member with a conflict of any type (index drug or competitor drug), there was a 10 percent greater likelihood that the meeting would favor the drug being considered."
A sway of even 10 percent is too much. Dr. Lurie believes that the external committee members and voting consultants who advise the CDER during new drug trials should be held to the same standards as the jurors in high-profile legal trials. "If a juror is found to have so much as read a newspaper, he or she can be dismissed in certain trials," he explains. "We should have zero tolerance for accepting levels of conflict that would have even a small impact upon voting outcome, but in our study we found such impacts. What we need is not simply disclosure of conflicts, but also greater efforts to identify members without conflicts."
On May 9 of 2006, less than two weeks after the Public Citizen study was published in the April 26 issue of JAMA, the House Appropriations Committee approved Rep. Hinchey's proposed amendment to the Agriculture, Rural Development, FDA and Related Agencies Appropriations bill for Fiscal Year 2007.
"Plain and simple, if a doctor or scientist has a personal, financial stake in a drug, they should not be allowed to sit on an FDA advisory panel and determine whether that drug is safe," Hinchey explains of the amendment that popularly bears his name. "This amendment puts an end to the FDA's rampant use of waivers for advisory panels that have for far too long endangered the safety of the American people. Now that this measure is in the House bill, it will take a lot of work to ensure that it stays in all the way until it becomes law, but I am confident that we can succeed."
The success of this amendment affects everyone who has ever used a prescription. Drugs should be approved on basis of science alone, not the financial interests of people in power.
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