Bush FDA Nominee Stirs Controversy

Published March 1, 2002

President George W. Bush is traveling a bumpy road as he tries to fill the position of FDA commissioner, which has been vacant since Commissioner Jane Henney resigned in January 2001.

According to media reports, legislators and drug industry executives have criticized Bush for not putting a higher priority on filling the vacancy.

Between a Rock and a Hard Place

Bush appears to be facing a no-win situation. If he names a candidate from the pharmaceutical industry, he raises the ire of Senate Democrats. A nominee from outside the industry could upset pharmaceutical companies who supported Bush’s election.

The controversy has already beached one possible candidate. In July 2001, the administration put forward the name of Michael Astrue, general counsel for the Cambridge, Massachusetts biotech company, Transkaryotic Therapies.

Seven Democratic Senators, including Edward Kennedy (D-Massachusetts), chairman of the Senate Health, Education, Labor and Pensions Committee, gave the nominee two thumbs down. Kennedy vowed he would not hold confirmation hearings if Astrue were nominated.

According to a report published by American Health Line in October last year, Kennedy’s opposition surprised White House officials, who expected the Massachusetts lawmaker to welcome the FDA from his home state. “It would be unprecedented for anyone to be appointed from an industry regulated by the FDA, and now is not the time to start,” Kennedy spokesperson James Manley told American Health Line.

More Controversy

Vanderbilt University drug safety expert Dr. Alistair Wood is the latest controversial candidate. Senator Bill Frist, M.D. (R-Tennessee) has put his political muscle behind Wood, a fellow Tennessean. But pharmaceutical industry executives are giving the nominee thumbs down.

Industry executives see Wood as a potentially overly aggressive regulator, using as evidence a series of articles written by Wood and published in the New England Journal of Medicine and Journal of the American Medical Association. Wood’s position on drug recalls and patient deaths led him to call for the FDA to be “more aggressive” in drug monitoring.

It’s not only the pharmaceutical industry that rejects Wood as the best choice to head the FDA. Robert Goldberg, senior fellow at the Manhattan Institute, also thinks Wood is a bad choice.

Writing in National Review Online, Goldberg notes, “What is remarkable is that while prescription drug use has increased in the past decade, the number of adverse events as a percentage of total prescriptions has hardly budged. Drug withdrawals [from the marketplace] as a percentage of new drugs remains at about 3 percent, essentially the same ratio from decades ago.

“Wood ignores this safety record,” continues Goldberg. “Instead, he calls for companies to adhere to an impossible safety standard.”

Asks Goldberg, “Like his cheering section in the Public Citizen, does he have contempt for private pharmaceutical profits that blinds and biases him against the right of companies to develop and market products based on their ability to make a clinical difference in people’s lives?”

A January 17 Wall Street Journal editorial points out, “Dr. Wood argues for the prohibition on direct-to-consumer advertising until extensive post-market studies have been done to prevent ‘the excessively rapid uptake of new drugs.’

“In other words,” the editorial continues, “a cancer patient shouldn’t be told of new treatments even after the hyper-cautious FDA has judged them safe and effective.”

“Against the Public Interest”

An executive for a leading pharmaceutical firm told Health Care News, “Dr. Wood is the original choice of former Vice President Al Gore and has won praise from Sen. Ted Kennedy, Ralph Nader, and Dr. Sydney M. Wolfe,” who is director of the health research group for Nader’s anti-business advocacy group, Public Citizen.

“Wood is on record saying the medical industry’s research-intensive discovery of new medicines is less pressing than better regulation of the old ones; that more regulation, instead of more competition, is the recipe America needs; and that U.S. consumers’ access to quality medicine is less important than lowering the price of medicines to the very poorest in society.”

Without mentioning Wood, Dr. Henry Miller, writing in his book To America’s Health: A Proposal to Reform the Food and Drug Administration, also warns against an FDA bent on over-regulation.

“It is in the public interest to spur innovation in the discovery, development, and marketing of new diagnostics and therapies, to stimulate vigorous competition among manufacturers, and to have an efficient system of oversight,” Miller writes. “The current system of drug regulation is, literally, overkill, and it works against the public interest.”

For reasons no one quite seems to understand, Republicans have failed to nominate a likely winner: Dr. David Sundwall, a former Reagan administration health official who has won praise from Kennedy and colleague Orrin Hatch because of his private medical work in Native American and Latino communities.

For more information …

Dr. Alistair Wood’s research and opinions have appeared in the May 12, 1999 issue of the Journal of the American Medical Association (page 1753) and the December 17, 1998 and October 12, 2000 issues of the New England Journal of Medicine, (pages 1951-1954 and 1191-1194, respectively).