ngin - Norfolk Genetic Information Network

28 March 2002


thanks to nlpwessex for these 2 items

'Well-regarded by his peers, Wood has said he's particularly interested in the way our increased understanding of the human genome will lead to new drug discoveries, which in turn will necessitate "paradigm shifts in the way we think about evaluation of safety and efficacy." '


Favor of the Month

by Christiane Culhane
Only at TNR Online | Post date 03.18.02    E-mail this article

Perhaps because there's been so much coverage of campaign finance reform to distract reporters, some important--and disturbing--stories of apparent special influence have managed to escape the media's normally harsh glare. One such story is the tale of Alastair Wood, who was the leading candidate to take over the Food and Drug Administration (FDA) until the White House pulled his name from contention last month.

Few agencies have a mandate to regulate such a broad swath of American life as the FDA, which oversees products that amount to one quarter of the nation's consumer economy and 80 percent of the nation's food supply. And few agencies find themselves routinely mired in such high-profile controversies. In the last few years, the FDA and its officials have been major players in the debates over tobacco, food safety, and the rules governing the pharmaceutical industry.

It was Wood's expertise on the topic of drugs that made him a promising candidate to run the FDA. A pharmacologist and assistant vice chancellor at the Vanderbilt University School of Medicine, Wood has spent his "entire professional life studying and writing about drugs," as he said in recent congressional testimony. He is the Drug Therapy editor for perhaps the most prestigious medical publication in the country, the New England Journal of Medicine, and he has served on several FDA advisory committees.

Well-regarded by his peers, Wood has said he's particularly interested in the way our increased understanding of the human genome will lead to new drug discoveries, which in turn will necessitate "paradigm shifts in the way we think about evaluation of safety and efficacy." When the Bush administration let it be known that they were considering Wood as their top candidate to head up the FDA, the choice was hailed even by some of the administration's harshest critics. As one such person, Public Citizen's Sidney Wolfe, told me recently, Wood "should be the ideal candidate."

Unfortunately, when it comes to health care issues, anybody who makes folks like Sid Wolfe happy is bound to make certain entrenched interests unhappy. That was certainly true in Wood's case. And, unfortunately for him, the special interest he antagonized was the pharmaceutical industry.

For example, Wood has advocated for switching several prescription drugs to over-the-counter status--a move that would cost drug companies millions.

(Pharmaceutical companies can charge more for prescription drugs since insurance companies are paying for them, shielding consumers from the direct costs.) Wood says he is in favor of extensive post-market surveillance of pharmaceuticals in order to reassess safety and efficacy on an ongoing basis. Wood notes (rightly) that monitoring drugs even after initial approval can only help the pharmaceutical industry in the long run, by preventing would-be disasters (which might hurt the industry far more than a few recalls) and giving the FDA more data on which to base its initial assessments. "The greater our confidence in the ability to generate quality post-marketing data," Wood says, "the greater our ability to approve drugs earlier."

The idea that an FDA commissioner might from time to time take positions at odds with the pharmaceutical industry shouldn't be a liability; it ought to be an asset, given the agency's role. But this particular administration has reasons to think differently. In the 2000 election, the pharmaceutical industry gave George W. Bush $472,333, more than four times the amount they gave to Al Gore, according to the Center for Responsive Politics. During the same election cycle, 96 percent of the soft money donations from PhRMA (the Pharmaceutical Researchers and Manufacturers of America) went to the Republicans. (Don't forget, too, that Mitch Daniels was an executive at Eli Lilly, the pharmaceutical manufacturer, before he became Bush's budget director.)

When I called PhRMA, they insisted they had no position on Wood's nomination. But the industry has made no secret about their opposition to his ideas. And even if PhRMA never said a word to anybody in the administration, those donations alone would have been enough to make the

White House think twice before nominating somebody whom the industry seemed to find so objectionable. Indeed, when the White House called Wood in late February to inform him that he was no longer under consideration for the post, FDA watchers in the public interest community and on Capitol Hill took it for granted that Bush pulled back on the Wood nomination because drug makers had a problem with it. As Jim Manley, spokesperson for Senator Kennedy's office, said, "the reality is that this is a pro-business Republican administration that is very favorable to industry." The White House, naturally, insists it is merely looking for the most qualified candidate. But given Wood's sterling credentials, it's hard to imagine drug industry sentiments didn't have something to do with it.

The problem for the White House is that this still leaves them short one FDA commissioner nominee. And if the administration now turns around and appoints somebody more friendly to the pharmaceutical industry, it's bound to raise the ire of Senate Democrats, who control the nomination process and are already steamed about what happened to Wood. So far, the administration has decided to deal with this problem by not dealing with it at all. Bush has simply appointed a deputy director--who doesn't need Senate confirmation--and asked him to serve as acting commissioner if, er, when the White House gets around to appointing somebody permanently.

That appointee is Lester Crawford. A former inspections administrator in the Department of Agriculture who's now director of the Georgetown University Center for Food and Nutrition, his expertise is food safety--a topic of much greater relevance these days thanks to concerns about bioterrorism. But Crawford is a veterinarian by training, marking the first time in 20 years that the person running the FDA does not have an "M.D." after his name. Does that make him less qualified to run the agency? A few liberal critics think so. Then again, when pleasing the pharmaceutical industry is a criteria for choosing FDA officials, it's hard to be choosy.

Christiane Culhane is an assistant editor at TNR Online.


Bush to replace career USDA executive with lobbyist From CongressDaily

[NCGA are strong GMO people and get industry funding]
March 26, 2002

The Bush administration has decided to replace Pearlie Reed, chief of the Agriculture Department's Natural Resources Conservation Service, with National Corn Growers Association Washington lobbyist Bruce Knight, sources inside and outside USDA told CongressDaily Tuesday. The sources also said administration officials planned to inform high-ranking NRCS officials of the appointment Tuesday and that it will not take effect until May 4. Reed, a career civil servant, was appointed by Clinton administration Agriculture Secretary Dan Glickman and is the first African-American to hold the post, which administers conservation programs affecting privately owned farm land. Reed was traveling and could not be reached for comment. Knight said, "I can talk to you about that tomorrow."

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