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.