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Drug industry costs doctor top FDA post

By Michael Kranish, Globe Staff, 5/27/2002

WASHINGTON - 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

This story ran on page A1 of the Boston Globe on 5/27/2002.
Copyright 2002 Globe Newspaper Company.

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