ASHINGTON - Dr. Alastair J. J. Wood had every reason to believe
he was about to be nominated by President Bush to one of the nation's most
important health jobs: commissioner of the Food and Drug Administration.
His medical credentials were unchallenged. Equally important, the
Vanderbilt University pharmacologist was being pushed strongly by Senator
William Frist, the Tennessee Republican who is perhaps Bush's most
important medical adviser.
Then, just as word leaked that Wood had won the job to head the 8,000
scientists and other employees who regulate one-fourth of US consumer
spending, the pharmaceutical industry and its allies struck back. If Wood
became commissioner, one influential industry ally wrote in a conservative
online magazine, the FDA's message to patients wanting life-saving drugs
would be: ''Drop dead.''
The article said Wood was obsessed with drug-safety review and,
applying the coup de grace, announced that he was ''a buddy of Senator Ted
Kennedy'' - even though Wood had never met or spoken to the Massachusetts
Democrat.
Within days, the White House dumped Wood. ''There was a great deal of
concern that he put too much emphasis on the safety,'' Frist said in an
interview, bluntly explaining why his friend was jettisoned.
The story of Wood's near-nomination - his embrace and subsequent
rejection by the Bush White House, and the attacks on him - vividly
illustrates one of the most important political and economic battles in
Washington. At its heart is a basic question: Should the government become
more lenient or more aggressive in screening new drugs for safety? At
stake are the fortunes of patients as well as of many biotech companies,
some of which are in their own life-or-death struggles over key medicines
awaiting FDA approval.
Wood, in his first public comments about the way his nomination was
dropped earlier this year, is more bemused than bitter, marveling at the
way his stock soared and plummeted based on what he calls ''made up''
allegations first aired in the online publication. The FDA job, he is
convinced, has become the medical industry's equivalent of a Supreme Court
justice nomination, in which any candidate with a long written record
becomes easier to attack.
Just as Robert Bork lost his bid to be a Supreme Court justice in 1987
under the burden of his voluminous writings and rulings, Wood, the drug
therapy editor of the New England Journal of Medicine, was sunk partly
because he had a paper trail, and once called for an independent board to
investigate potentially deadly drugs. That is an idea opposed by some in
the industry who prefer collecting their own reports of adverse drug
reactions and passing them on to the FDA, which then reviews whether its
approval of the drug was appropriate.
Wood remains puzzled at the opposition, saying the FDA may have an
inherent conflict of interest in reviewing the safety of drugs on which it
already has staked its prestige through approval. ''I think we should have
a better understanding [of why] a drug causes a series of deaths,'' Wood
said. ''I think it is unfortunate the way this ended.''
The fight over Wood comes at a time when the FDA is in turmoil.
Leaderless in the 16 months since Bush took office, the agency is under
extraordinary pressures: The drug industry and some patient groups want
faster approval and fewer safety reviews, while some public interest
groups have charged that the agency is already too closely tied to
industry and too quick to approve dangerous drugs that cause deaths.
The Bush administration is torn between these political and financial
pressures. Of the $10 million given by pharmaceutical companies to
politicians in the 2002 cycle, 72 percent went to members of the GOP,
according to the Center for Responsive Politics, which tracks
contributions.
The administration does not want to be painted as being too cozy with
the industry, so for more than a year, it considered and rejected one
potential nominee after another.
One of the rejects was Michael Astrue, the counsel of Cambridge's
Transkaryotic Therapies Inc. He was dropped after Kennedy, who chairs the
Senate Committee on Health, Education, Labor, and Pensions, said Astrue
was too closely tied to industry. Another candidate was Dr. Raymond
Woosley, who bowed out when he was offered the job as dean of the
University of Arizona College of Medicine.
It was Woosley who recommended his friend, Wood, even though he
anticipated problems. ''It is pretty clear that anyone who has said
anything that industry doesn't like isn't going to make it,'' Woosley said
in an interview.
Still, primarily because of Frist's recommendation, the White House
liked Wood. Frist, a heart surgeon at Vanderbilt before becoming a
senator, has helped Bush formulate his policy on issues such as stem cell
research. After the biotech industry complained in a letter to the White
House about the ''political vacuum'' caused by a leaderless FDA, the
administration responded by saying a commissioner would be nominated
within weeks, leaking word that Wood was the top choice.
Wood, 55, appeared well-qualified for the job. Born and educated in
Scotland, he came to the United States in 1976 for a fellowship in
clinical pharmacology at Vanderbilt, where he is now associate vice
chancellor.
The pharmaceutical industry, meanwhile, was deeply concerned about who
would lead the FDA. In 2001, the FDA approved only 24 new drugs, compared
with 53 in 1996. Many industry officials have complained that the
underfunded and overburdened agency is agonizingly slow in approving any
new drug, hurting profits and denying potentially life-saving drugs to the
sickest patients.
Some in the industry, however, said they were reluctant to publicly
attack Wood, partly out of fear of earning the ire of someone who might
wield such enormous influence over the industry.
That problem was solved by Robert Goldberg.
Goldberg is not a lobbyist or a pharmaceutical company employee. But
for more than a decade, Goldberg has been writing research papers that are
mostly friendly to the industry. A former Newton resident who worked at
Brandeis University's Gordon Public Policy Center, Goldberg lives in New
Jersey and is senior fellow at New York's Manhattan Institute, a
free-market think tank. The institute's motto is telling: ''Turning
intellect into influence.''
''The people I know in clinical pharmacology, in the research trenches,
went berserk when they heard about Wood,'' Goldberg said. Goldberg, who
said he has ''received support from the pharmaceutical industry in the
past, as you might expect,'' decided to go after Wood in an article that
appeared in the online version of the conservative National Review
magazine.
If Wood became commissioner, Goldberg wrote, the FDA would be so tough
on drug manufacturers that the government's message to patients would be
''Drop dead.'' Goldberg wrote that Wood would be a ''clone'' of former FDA
commissioner David Kessler, who was appointed by Bush's father, and who
Goldberg and many in the drug industry believed was an overzealous
regulator. (Kessler did not return a call seeking comment.) Kessler had
been backed by Senator Orrin Hatch, a Utah Republican, just as Wood was
backed by Frist, Goldberg said, warning that the Tennessee senator's
blessing was no assurance for the industry.
''Like Kessler, he is a doctor sponsored by a Republican senator - and
a buddy of Senator Ted Kennedy, the guy who really nominates FDA
commissioners,'' Goldberg wrote. Six days later, the Wall Street Journal
echoed some of the same complaints in an editorial titled, ''It's Not
Ted's FDA.'' Wood said the articles became the talk of a White House
meeting; a White House official did not return a call seeking comment.
The pharmaceutical industry, meanwhile, was taking a more activist
approach, alerting member firms and spreading word about Wood in
Washington. Pfizer was ''the most aggressive,'' Goldberg said, in
circulating information about Wood.
Pfizer spokesman Andrew McCormick declined to confirm or deny
Goldberg's statement, saying, ''We are not going to comment on someone's
interpretation.'' But speaking generally, he said, ''I think along with
other companies in the industry we have noted that the approvals from our
perspective at the agency have slowed down significantly and we are
concerned about that.''
''I think we expressed the thought that whoever is chosen to head FDA
should look at risk-benefits in a balanced way,'' McCormick said.
Pfizer and some other pharmaceutical companies had a reason to be
concerned about Wood. In May 2001, Wood sat on an FDA advisory committee
that was considering whether to make three allergy prescription drugs into
over-the-counter products: Pfizer's Zyrtec, Schering-Plough's Claritin,
and Aventis's Allegra.
Wood favored the measure, but it was opposed by the drug makers. In
some cases, the repositioning of a drug into an over-the-counter product
can cost a manufacturer tens of millions of dollars because such products
sometimes are sold at a much lower price and are not covered under most
health plans.
''What we have today is an unseemly parade of people trying to protect
their own financial interests,'' Wood said at the hearing.
Nine months later, when Wood was on the verge of becoming the chief
drug regulator, the industry did not forget his comments. A White House
official called Wood and told him the nomination was off. ''He said, `It's
not going to happen,''' Wood recalled.
Three months afterward, the White House still hasn't announced a
nominee, although there is speculation that Dr. Lester Crawford, the
deputy FDA commissioner, might get the nod, even though he would be an
unusual pick given his background as a veterinarian.
As for Goldberg, he is proud of the role he played in the rejection of
Wood and is setting up a project he calls the Center for Medical
Progress.
''Pharmaceutical industries,'' Goldberg said, ''are more than welcome
to contribute.''
Michael Kranish can be reached at mailto:%20kranish@globe.com.
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