Study Rebuts Conflict Fears Around
FDA Financial Ties of Panels 

DIEDTRA HENDERSON / Boston Globe 26apr2006

[Abstract]

WASHINGTON — A consumer group's study of Food and Drug Administration advisory panel members with financial ties to the drug industry reached a surprising conclusion: They did not dramatically sway the meeting outcomes.

The analysis by Public Citizen, reported in today's Journal of the American Medical Association, looked at 221 meetings held by 16 advisory committees from Jan. 1, 2001, to Dec. 31, 2004. The FDA routinely follows its outside experts' advice when deciding such thorny issues as whether to return the multiple sclerosis treatment Tysabri to the market.

Some 73 percent of the FDA advisory meetings included at least one adviser with financial ties to the drug industry. Nineteen percent of the advisers who were drug company consultants were paid more than $10,000 during the previous year. Nearly one-quarter of drug industry contracts or grants reported by FDA advisers exceeded $100,000. Only 1 percent of the advisers with financial conflicts were excluded from panels by the FDA.

''These are large conflicts of interest. At least some of them ought to be grounds for recusal," said Peter Lurie, lead author of the JAMA article and deputy director of Public Citizen's health research group.

Susan Bro, an FDA spokeswoman, said the agency is committed to a ''strict code of ethics" and a ''transparent process."

As it assembles advisory panels, ''the FDA carefully weighs any potential financial interest with the essential need for world-class scientific expertise," Bro said. ''Only in this way can the agency protect and advance the highest standards of public health."

In January 2002, the FDA began releasing more details at meetings where votes were taken on specific products. The move came just months after Public Citizen threatened a lawsuit to prompt detailed disclosure of federal advisers' financial interests.

But the change in policy ''has had little impact on rates of recusal, restriction, or disclosed conflict," the five study authors concluded.

In fact, the agency now rarely discloses the name of rival drug companies when its advisers have financial ties to competitors, according to the JAMA article. Three years ago, it provided competitors' names 54 percent of the time.

Even some members of the public and patients who stepped to the microphone during the public hearing portions of the FDA meetings analyzed by Public Citizen voluntarily disclosed financial ties to drug companies — often the sponsor seeking approval of a new treatment. All told, 29 percent of federal advisers and consultants reported financial ties to drug companies, compared with 37 percent of patients and other public hearing speakers, the article said.

Consumer advocates said FDA advisers with financial conflicts erode public confidence in decision-making. Drug regulators should work harder to recruit outside experts who do not have industry ties, FDA critics say.

Indeed, the Center for Science in the Public Interest says the FDA should delay a meeting scheduled for this morning on rewording labels for high blood pressure drugs because nine of the expected 12 panel members have drug industry ties.

Merrill Goozner of the Center for Science in the Public Interest said FDA advisory panels are often ''unbalanced." With or without drug industry ties, the FDA's experts ''are biased toward approving new therapies," Goozner said.

Bro, the FDA spokeswoman, said the agency will not delay the meeting.

''No one participates in an advisory board capacity until they have been fully vetted by FDA staff and we are convinced they will make an unbiased, productive contribution to the scientific process," she said.

This spring, the FDA is expected to decide whether multiple sclerosis patients can again buy Tysabri, a drug voluntarily pulled from the market by its manufacturers — Biogen Idec of Cambridge and its Irish partner Elan Corp. — after it was linked to a potentially fatal brain infection. The FDA granted conflict waivers to five of 12 federal advisers who unanimously recommended the FDA return the drug to the market.

The JAMA paper comes, however, as members of Congress prod the agency to weed out advisers with drug industry connections.

''Allowing individuals with conflicts of interest to serve on advisory panels endangers the welfare of the American people," said Representative Maurice Hinchey, Democrat of New York.

Hinchey wants to eliminate such conflicts because they create ''an environment in which pure objectivity is lost and drugs that may not be safe wind up in homes across the country," he said.

Despite its finding that advisers with conflicts had a ''weak" impact on votes to approve or reject specific drugs, Public Citizen endorses the same zero-tolerance goal.

''The whole point of conflict of interest is that it's unconscious," Lurie said. ''Most of these people — if not all — are honorable enough people, they would not allow themselves to be influenced. It's the unconscious we need to be afraid of."

source: http://www.boston.com/business/healthcare/articles/2006/04/26/study_rebuts_conflict_fears_around_fda?mode=PF 26apr2006

Conflicts of Interest Influence Voting on FDA Advisory Panels, Study Finds

Washington Post 6apr2006

Nearly 30 percent of the experts on Food and Drug Administration advisory panels reported financial conflicts of interest, but excluding them would not have changed the recommendation for or against any particular drug, a consumer group said yesterday.

The study by Public Citizen's Health Research Group did find that conflicts of interest can slightly increase the likelihood that panelists will vote to recommend that the agency approve a drug. The group's analysis of voting data was culled from 221 drug advisory committee meetings from 2001 to 2004.

"For every additional conflict you have a 10 percent increased probability that the meeting will favor the company more," said co-author Peter Lurie, deputy director of health research.

The FDA often turns to panels of outside experts for advice on whether to approve a new drug and other matters. The agency is not required to follow the panels' recommendations but usually does.

Financial links between the panel members and drugmakers have come under scrutiny, with calls for the FDA to find advisers without industry connections.

Of nearly 3,000 panel members in the study, 28 percent disclosed a financial relationship within the previous year with the company that made a drug under discussion or a competitor, the study said. The most common ties were consulting arrangements, research contracts or grants, and stock holdings or other investments.

source: http://www.washingtonpost.com/wp-dyn/content/article/2006/04/25/AR2006042501877.html 26apr2006