FDA official recused in flu fight
His ties to drug firms spark questions over agency hiring policies
WASHINGTON -- Last week, President Bush, accompanied by Cabinet members, outlined the nation's defense plan should an avian flu that has killed 63 people in Southeast Asia reach the United States.
But a recent Food and Drug Administration hire whose job includes helping with pandemic planning was nowhere in sight. Dr. Scott Gottlieb, who joined the FDA as deputy commissioner for medical and scientific affairs, was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic. Gottlieb's former clients include Roche -- manufacturer of the highly sought antiviral Tamiflu -- and Sanofi-Aventis, parent company of the nation's sole flu vaccine manufacturer.
Manning Selvage & Lee paid Gottlieb a $12,500 monthly retainer for nine months for business development projects that included eight companies. Other firms regulated by the FDA he was involved with include Inamed Corp., one of two companies seeking to return silicone gel implants to the market. He also did private consulting work for VaxGen Inc., a California firm that won a $878 million federal contract to supply 75 million doses of anthrax vaccine for the nation's protective stockpile. The $9,000 he accepted from VaxGen for consulting work between May and July prevents him from doing FDA work related to that company until August 2006.
Gottlieb said a ''reasonable person would question my impartiality" in matters related to those firms, according to an Aug. 5 memo to then FDA commissioner Lester Crawford obtained by The Boston Globe through a Freedom of Information Act request.
His recusals, which last until January for Roche and until February for Sanofi, come as the Bush administration is making the fight to prevent bird flu its top health priority and as it promotes an FDA pandemic strike team charged with ensuring therapies to protect Americans get speedy regulatory review.
Gottlieb ''works on general process and management issues, and has not dealt with issues related to particular matters involving companies from which he is recused," Julie Zawisza, an FDA spokeswoman, said in a written response to questions. Gottlieb, who is paid $149,000 by the FDA, declined to comment.
An FDA critic said the transparency provided by such financial disclosures is good, but it would be better if Gottlieb -- who reports directly to the FDA commissioner -- did not have ties to drug companies.
''These conflicts need to be revealed; they need to be understood and eliminated as much as possible," said US Representative Maurice Hinchey, Democrat of New York. Hinchey was primary author of an amendment that passed the House which would reduce conflicts of interest among advisers whose votes guide FDA actions.
''Sure, he's a guy who comes to this with the right kind of background and credentials," Hinchey added. ''But there are a great many people in our country who are similarly qualified and capable who do not have such an intimate relationship with the principal drug company manufacturing the antiviral."
Robert Goldberg, director of the Manhattan Institute's Center for Medical Progress, said Gottlieb's past work for drug companies regulated by the FDA is a ''nonissue."
If Gottlieb had counseled Roche on winning FDA approval for expanded use of Tamiflu, ''that would be one thing. Then, I think a recusal might be in order," Goldberg said. ''If he was just consulting with Roche about what's going to be happening with FDA in terms of FDA reform . . . then everyone would be issuing recusals."
Shortly before stepping down in September, Crawford appointed a half dozen high-ranking staffers, a few of whom are restricted in their current duties because of work they did in the past. Like Gottlieb, they filed public financial disclosure forms with the Office of Government Ethics. The forms detailed assets, income, major debts, jobs held outside of the government, and any other work that paid them more than $5,000. In addition, Gottlieb sent a disqualification statement to Crawford that prevents him from being involved with former clients for specific periods to avoid the appearance of a conflict of interest.
Dr. Murray M. Lumpkin, former deputy director of the FDA center that evaluates new drugs, and promoted by Crawford to deputy commissioner for international and special programs, also has restrictions on his current duties. Lumpkin recused himself from issues involving the marketing and promotion of medical products for a long list of companies that come before the FDA. Lumpkin's most recent financial disclosure indicates his wife did consulting work on those topics last year for about three dozen firms regulated by the FDA, including Biogen Idec Inc. of Cambridge and Elan Corp., which are seeking to return the multiple sclerosis drug Tysabri to the market. Lumpkin earns $210,520 at the FDA.
Dr. Steven Galson, promoted by Crawford to become head of FDA's Center for Drug Evaluation and Research, since 2001 has been recused from all matters involving Human Genome Sciences. The company is seeking FDA approval for an experimental treatment for lupus. Galson's wife is employed by the company and earns income and stock options. The FDA pays Galson $176,087.
Zawisza referred to the men as ''highly regarded professionals who have responsibly submitted their required paperwork to our ethics office and whose professional integrity is beyond reproach."
Diedtra Henderson can be reached at email@example.com.