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FDA Would Limit Input of Doctors Paid by Drug Firms
By By Diedtra Henderson, Boston Globe
March
26, 2007
Amid disclosures that the pharmaceutical industry has funneled millions of dollars to leading physicians, the Food and Drug Administration yesterday moved to bar scientists from serving as advisers to the agency if they have financial ties to drug and medical-device companies exceeding $50,000.
Congressional critics and consumer advocates have long sought to eliminate or diminish the role of scientists who receive funding from drug companies and medical-device makers from decisions that directly affect those firms' products. The policy changes would take effect later this year, after the FDA sifts through public comments.
Randall Lutter , the agency's acting deputy commissioner for policy , said the proposal "strikes an appropriate balance" between the agency's need to tap the expertise of pre eminent researchers and of ensuring public confidence in its decision making.
Researchers with lesser financial interests could still attend meetings and participate in debates as advisers, but they would be prohibited from voting. Advisory panel votes are not binding, but the FDA usually follows the recommendations.
Up to one-quarter of current FDA advisers could be barred outright or prevented from voting on panels, said Peter Lurie , deputy director of Public Citizen's health research group . But because the FDA would have to seek more scientists without industry bias, the change would ultimately benefit patients, he said, by resulting in "panels that are less tainted and recommendations that are more respected."
FDA advisers are required to report to the agency their past and present financial ties to drug and device companies, as well as any financial arrangements they are negotiating.
The FDA publicly discloses panelists' financial interests in broad categories, such as less than $10,001 per year, and from $10,001 to $50,000 annually.
A study published by the Journal of the American Medical Association last April examined 221 FDA meetings held by 16 advisory committees from Jan. 1, 2001, to Dec. 31, 2004 . About 73 percent of the meetings included at least one adviser with financial ties to the drug industry. The 376 federal advisers who served on those panels reported just 11 direct financial conflicts of interest exceeding $50,000 in value, said Lurie, lead author of the study. Nineteen percent of the advisers who were drug company consultants were paid more than $10,000 during the previous year, according to the review. Under the change, they would still be eligible to serve as advisers, but could not vote.
The new regulations would cover doctors and researchers who received more than $50,000 in consulting fees or research grants in the previous 12 months from drug and device companies with a financial stake in the FDA's ultimate decision. The caps would also include the value of stock purchases over which the potential advisers have direct control. The FDA said it would individually review cases involving academic researchers whose potential conflicts of interest arise from industry funding or research grants paid to their educational institutions rather than for their own research.
The FDA has said in the past that public health would suffer if it barred the nation's top scientists from serving as advisers because of their financial conflicts. It routinely issues waivers allowing such scientists to serve on panels.
Members of Congress who have tried, without success, to eliminate such conflicts through legislation were guardedly optimistic about the FDA's proposal. Representative Maurice Hinchey , Democrat of New York , applauded it as a good first step.
"It's not perfect. The $50,000 is still too high," Hinchey said.
The planned changes follow a recent disclosure that the drug industry directed at least $33 million to physicians in Minnesota and Vermont from 2002 to 2004. Laws recently enacted by those states and a few others require such information to be made public.
Representative Rosa L. DeLauro , Democrat of Connecticut , was skeptical that the changes would make a difference.
"I am concerned that a closer inspection of the plan's details will reveal the loopholes that would render it toothless," DeLauro said in a statement. She said Congress would look for possible links between the FDA and doctors whose industry funding is revealed through the state disclosure laws.
"It would be very troubling if these doctors were also serving on an advisory committee and have the potential of reviewing data in a way that favors the industry over the patient," DeLauro said.
The FDA defended its current screening process to select federal advisers, and said the new restrictions would further bolster confidence. The agency has "done a very good job ensuring that the process already deserves the respect of the American public. We're not aware of any instances in which decision making processes have been unfairly or inappropriately adversely affected by conflicts that members may have," Lutter said.
The review led by Public Citizen's Lurie came to the same conclusion. It said panel members with financial ties to the drug industry did not dramatically sway the meeting outcomes.
But exactly how much impact drug-industry ties have on advisory recommendations is unclear. For instance, in 2006, a FDA panel unanimously agreed to allow renewed sales of Tysabri, a multiple sclerosis treatment comarketed by Biogen Idec Inc. of Cambridge.
The drug had been pulled from the market in February 2005 after being linked to rare but deadly brain disease.
In a move closely watched by Wall Street, the panel voted 7 to 5 to allow patients to use Tysabri before trying older therapies.
Under the proposed changes, five members of the panel, including its influential chair, had financial conflicts that would have disqualified them as advisers or that would have barred them from voting.
In interviews with the Globe, the advisers said the drug industry funding did not influence their votes.
Diedtra Henderson can be reached at dhenderson@globe.com.
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