NEWS - Public Citizen exposes frequent financial conflicts of interest at FDA advisory committee meetings

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April 25, 2006

Public Citizen Exposes Frequent Financial Conflicts of Interest at FDA

Advisory Committee Meetings

Study Published in JAMA Finds Conflicts Rarely Result in Recusal and Are

Related to Voting Behaviors

WASHINGTON, D.C. - Conflicts of interest at drug advisory committee meetings

for the U.S. Food and Drug Administration (FDA) are common and often of

considerable monetary value, but rarely result in recusal, finds a study

conducted by Public Citizen and published in The Journal of the American

Medical Association (JAMA). The study details financial conflicts of

interest between drug advisory committee members and the companies producing

the drugs they evaluated; it also examines conflicts with competing

companies. The study exposes a weak but statistically significant

relationship between certain conflicts and votes in favor of the drug under

consideration.

The study appears in the April 26 issue of JAMA, and was authored by Dr.

Lurie, Dr. Cristina Almeida, Stine and Dr. Sidney Wolfe, all

of Public Citizen's Health Research Group, and Stine of the

Department of Earth and Planetary Science at the University of California,

Berkeley.

The Center for Drug Evaluation and Research (CDER) at the FDA approves 25 to

30 new chemical entities each year, often relying in its decision-making on

the advice of outside advisory committee members and FDA-invited voting

consultants. In September 2001, Public Citizen threatened a lawsuit against

the FDA to force it to disclose detailed information about the financial

interests of committee members, as required by law. In response, the FDA

instituted new guidelines in January 2002, requiring more detailed financial

conflict of interest disclosure publicly at the beginning of advisory

committee meetings held to consider specific drugs.

The study examined those disclosed conflicts, using all posted agendas and

transcripts from FDA drug advisory committee meetings from 2001 to 2004,

approximately one year before and three years after the new guidelines.

During this period, 28 percent of advisory committee members and voting

consultants had a conflict, and at least one member or consultant had a

conflict in 73 percent of the meetings. Despite this, only one percent of

members were recused from attending the meeting. The data were limited to

self-reported conflicts disclosed at the beginnings of advisory meetings,

which could underreport actual conflict rates.

For advisory committee members and voting consultants present, the study

found that 19 percent of consulting arrangements involved more than $10,000,

30 percent of investments were worth more than $25,000 and 23 percent of

contracts or grants exceeded $100,000.

" Conflicts of these magnitudes should result in automatic recusal from

advisory committee meetings, " said Lurie, MD, MPH, 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 study also found that speakers in the public session were frequently

supported and/or flown to the meeting by the manufacturer of the drug under

review. In fact, public speakers were more likely to disclose a conflict

than advisory committee members or voting consultants.

The FDA guidelines appear to have improved conflict of interest disclosure

but should be expanded to require naming the competitor company, explaining

the reasons for a member's recusal and to cover meetings that do not address

specific products.

The study employed six analytic methods to determine whether a relationship

between conflicts and voting behavior exists. These considered the potential

impact of conflicts both on individual voting behaviors as well as on the

overall outcome of meetings. A weak but, in several cases, statistically

significant relationship between certain types of conflicts and voting

behaviors was detected in a variety of different analyses.

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. The exclusion of advisory committee

members and voting consultants with conflicts would have produced margins

less favorable to the drug being considered in a majority of meetings, but

would not have altered the overall outcome of any of the meetings in this

study.

In the study, the authors compared conflict standards for advisory

committees with those applied to juries, which make decisions with more

limited societal impacts than advisory committees. " If a juror is found to

have so much as read a newspaper, he or she can be dismissed in certain

trials, " Lurie said. " 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. "

http://www.citizen.org/pressroom/release.cfm?ID=2184

Not an MD

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Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

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