FDA Counsel's Rise Embodies US Shift

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FDA Counsel's Rise Embodies US Shift

Michael Kranish, Globe Staff
22 December 2002
The Boston Globe
(Copyright 2002)

WASHINGTON - The pharmaceutical giant Pfizer Inc. was facing last July the kind of lawsuit that sends shudders through the drug industry. The suit alleged that Zoloft, the company's top-selling antidepressant, had backfired and caused a patient to commit suicide.

So Pfizer turned for help to one of the most powerful lawyers in the Bush administration: Daniel E. Troy, chief legal counsel of the US Food and Drug Administration. Troy was quite familiar with the company, having served as a Pfizer attorney in legal combat with the FDA until just months before he joined the agency last year. Shortly after the one-year federal restriction on action involving his former clients expired, Troy filed a government brief that backed up Pfizer's case.

Troy's journey from relentless litigant against the FDA to its guiding legal star encapsulates the transformation of medical regulation under the Bush administration. It illustrates, as well, how a White House can use its administrative and legal powers to change the regulatory terrain without taking the often arduous course of asking Congress to change the law.

During the Clinton years, Troy was best known for suing the FDA. It was Troy who worked for the tobacco industry on the landmark Supreme Court case that prevented the agency from regulating tobacco. And he fought for years to allow pharmaceutical companies to promote drugs for unapproved uses. Now he deals in these, and similar issues, from a powerful position in the FDA.

The story of Dan Troy - protege of former judge Robert Bork and a hero to many in the tobacco and drug industries - has largely played out behind the scenes. While the White House and Senator Edward M. Kennedy, a Massachusetts Democrat, publicly argued during the last two years over who should lead the FDA, the agency was being quietly transformed by appointees such as Troy, who needed no congressional confirmation.

The impact will eventually be felt by anyone who buys food or a prescription drug or dietary supplement, all of which fall under the FDA's purview.

The FDA is an enormous agency - 10,000 employees regulating one- fifth of the nation's economy. Troy's ascendancy gives sweet satisfaction to those in the drug and tobacco industries who bristled under what they considered an overly zealous regulatory swing at the agency during the Clinton administration.

The tobacco industry, having employed Troy to keep from being regulated by the FDA, now appears unlikely to come under strict review by the agency.

The drug industry, having worked with Troy to overturn a Clinton- era effort to restrict the promotion of drugs for unapproved uses, is hoping the agency will unveil regulations allowing such "off- label" use.

The makers of antidepressants are happy to have him on their side on cases such as the Pfizer's.

Troy's office, which dispatches warning letters to drug companies about potentially false advertising, has cut the rate by which the FDA issues those warnings by two-thirds in the past year. Previously, such letters were sent out by a branch within FDA. But Troy, after arriving at the FDA in August 2001, arranged for all warnings to go through his office.

Through it all, Troy insists he is representing his client of the moment, not pushing a particular agenda. "I never took a science class," he said. "I'm just a lawyer."

To Troy's defenders, he is a welcome change at the FDA. "I like to see voices pop up that take a more aggressive stance, and Dan Troy is surfacing issues that needed to be surfaced for years," said Richard Frank, a lawyer who has worked with Troy. "We had eight years of Clinton."

To his critics, Troy is the ultimate industry insider. While public and congressional attention is often focused on the FDA commissioner, said Professor Richard Daynard, chairman of the Tobacco Products Liability Project at Northeastern University, a very real power is wielded from positions like Troy's. Said Daynard: "It certainly does raise the question of the fox in charge of the chicken coop."

Role with the FDA seen as `hypocritical'

Since he arrived at the FDA in the summer of last year, some of Troy's most aggressive efforts have come on behalf of the pharmaceutical industry, whose cause he once championed in court.

While in private practice, Troy took on one of the most important issues of concern to the industry: the effort to legalize promotion of "off-label" drug use. Under the law, doctors are allowed to prescribe a drug for any use once it is approved for a particular disease, but companies are not supposed to promote drugs for unapproved uses in most cases.

The issue of off-label use has made headlines this year because of a federal investigation in Massachusetts into whether Parke- Davis improperly promoted its anticonvulsant drug, Neurontin, for off-label use.

Troy was part of a team that sued the FDA over its off-label policy. Troy and his colleagues argued that pharmaceutical companies should at least be allowed to conduct classes and send scholarly articles to doctors that included suggestions about unapproved uses for their drugs.

Though the legal outcome of the case was somewhat ambiguous, Troy said he and his colleagues successfully obtained attorney's fees in the "hundreds of thousands of dollars" from the government.

Now, with Troy's input, the FDA is preparing to release its long- awaited policy on promoting unapproved drug use that many expect will relax federal restrictions.

Troy argued as a private lawyer that relaxing the rules could save lives, but critics such as the Public Citizen Health Research Group, a consumer activist organization, told the FDA in October that further loosening of the off-label rules would "deal a body blow" to the government's ability to defend the public from unproven and unsafe treatments.

Troy has also played a strong hand, as in the Pfizer case, in the contentious debate over antidepressants.

Several drug companies have faced a string of lawsuits over allegations that antidepressants have caused increased suicidal thoughts in some people. FDA scientists have long rejected those assertions. Troy cited the FDA analysis and said, in an interview, "You want people who are depressed to take antidepressants. You don't want to warn people away from taking antidepressants" because of what he called an "over-warning."

But the Pfizer case brought to light the death of Victor Motus of California, who had taken the Zoloft for six days.

On Nov. 12, 1998, Motus was to fly to Washington to receive an award from President Clinton for his work at a local school district, the lawsuit says. Instead, he was found dead from a self- inflicted gunshot. His wife, Flora, alleged in the lawsuit that her husband complained that the use of Zoloft was making him "crazy."

Flora Motus's lawsuit says that Pfizer should have warned physicians that Zoloft could cause some people to have suicidal thoughts.

Pfizer had won similar cases, and a judge had initially sided with Pfizer on this case in December 2001. But with the case under appeal, the company was aware that trial lawyers had prevailed in another case against the maker of another anti-depressant Paxil.

In that case, a jury had found that the maker, GlaxoSmithKline, was 80 percent responsible for causing Donald Schell to kill his wife, daughter, granddaughter, and then himself. While Glaxo SmithKline vice president Dr. Alan Metz strongly denied any link between Paxil and increased suicidal thoughts, the company settled the case earlier this year with Schell's relatives.

In fighting the appeal, the Pfizer legal team sought help from Troy, asking him to file a brief saying that the US government agreed with Pfizer's contention that antidepressants did not increase suicidal thoughts.

"I called Dan Troy and informed him of the case," Pfizer attorney Malcolm Wheeler said. "This is a classic case in which the government's interests ought to be the same" as those of a private company. Wheeler's spokesman said that Wheeler contacted Troy in July, but could not provide a date.

Troy said that as long as his mandated one-year recusal period was over on May 31 - a year after he said he performed his last legal work for Pfizer - he didn't see any problem in filing a brief that helped the firm. Troy declined to describe the work for Pfizer, or reveal how much he was paid.

"My view of the case is not to help Pfizer but to help the FDA," Troy said. "When the recusal period was over, there was nothing wrong with getting involved."

So Troy and his legal staff filed a brief on Sept. 3, 2002, stating that the FDA had dismissed the notion that antidepressants increase some people's risk of suicide. And then the brief went further: saying that if Pfizer had tried to include a warning about such a link, it would have amounted to a violation of the law.

"Any warning that suggested a causal relationship between Zoloft and suicide would have been false or misleading and would have misbranded the drug in violation of federal law," the FDA brief argued.

In an interview, Troy said he filed the brief because he believes strongly in the FDA scientists who found no link to suicide. If the court concluded there should be a warning about suicide, Troy said, then that would undermine the FDA.

"You can't put anything on the label without coming to us first or getting our blessing," Troy said, adding that no state or court could require a tougher warning than the FDA. "We have absolute control over the label."

The opposing attorneys in the case disagreed. Not only has Troy turned the Bush administration's usual embrace of state's rights on its head, they argued, but the federal law allows a state to impose a tougher label. The attorneys cited a regulation that authorizes a drug manufacturer to "add or strengthen a contraindication, warning, precaution, or adverse reaction" without prior FDA approval, although the agency must eventually give its assent.

"Dan Troy basically built his career representing pharmaceutical companies suing the FDA, arguing that the FDA's determinations are arbitrary and capricious," said one of the plaintiff attorneys in the Pfizer case, Jessica Dart. "What is so obscene about Dan Troy's position in this litigation is that he has been issuing this mantra that the court cannot review the FDA's factual determination. His statements in this case are not only false but hypocritical."

Championed causes for drug companies

Troy presented the brief despite the jury's decision in the Schell case that Paxil caused an increase in suicidal thoughts. Troy said he had never heard of that decision. "I'm not familiar with the case," he said.

Troy is familiar with another lawsuit regarding Paxil, however. Dozens of Paxil patients have joined a lawsuit against Glaxo SmithKline, arguing that the company has engaged in false advertising by promoting its product as "not habit-forming."

Troy filed a brief in that case, saying that the FDA agrees with the allegation that Paxil is not habit-forming. The drug does not cause withdrawal symptoms, but causes a "discontinuation syndrome," Troy argued.

"Regarding Paxil, we looked at the precise ad, and we said the ad was fine," Troy said.

The question is whether patients, lacking medical or legal education, could be expected to know the scientific difference between those phrases. One plaintiff, Janelle Leonard, a third- grade teacher from Bradford, Mass., said she had severe withdrawal symptoms, including vertigo. "To me, `not habit-forming' means, you don't need to wean off a medication, you can just stop it. I truly feel I was addicted."

The fight over the meaning of "withdrawal" and "discontinuation" symptoms came to a head last August, when US District Judge Mariana R. Pfaelzer examined the GlaxoSmithKline ads and briefly ordered that the phrase "not habit-forming" be removed. "It is difficult to imagine that the FDA would object to the removal of the reference that `Paxil is not habit-forming,' " the judge wrote.

But Troy did object. He filed a brief arguing that the FDA has ultimate authority to decide the question, and the judge lifted her temporary order.

Still upset over the judge's action in the case, Troy said in the interview that he would fight for FDA's supremacy, ridiculing what he called the judge's suggestion that a state might find it necessary to write a tougher drug regulation than one issued by the FDA.

"She said it may be that something is false or misleading under state law but not under the Food, Drug and Cosmetic Act," Troy said, sounding incredulous that a judge would challenge his view. "That's nuts."

Some see Troy as a legal eagle

Troy's position on these issues comes as no surprise to those who know his background. In 1983 Troy was plucked out of Columbia Law School by Bork, one of Washington's best known and most controversial legal minds. Troy, a native of Queens, N.Y., and graduate of Cornell University, spent two years as a clerk for Bork, the outspoken federal judge who was rejected by the US Senate for a seat on the Supreme Court. Both men see themselves as strict followers of the Constitution.

Bork said Troy offers editing tips before Bork's books are submitted for publication. "He is an extremely good lawyer," he said.

Like Bork, Troy has shown a willingness to tackle issues on constitutional grounds even when there might be negative political fallout. In 1999, for example, he testified before Congress against extending hate-crimes protections to gay victims. Troy said he opposed "basing the degree of punishment on the status or characteristics of the victim. . . .Federal hate crimes legislation takes us back in the wrong direction, and hurts our national effort at cohesiveness and unity."

In an obscure book, "Retroactive Legislation," Troy lays out a defense for companies that dump toxic waste, arguing that companies shouldn't be subject to laws requiring the cleanup of such waste because the dumping wasn't illegal when it was done.

In The Politics and Law Book Review, a reviewer wrote that while Troy may have an argument "to go through all of this effort just to buttress an elaborate apology for gross toxic polluters is at best a questionable tactic."

Troy's signature issue is the First Amendment, and this is where he has been most helpful to the drug and tobacco companies. Troy argues that the First Amendment provides as much protection to commercial speech as it does to political speech, and that tobacco and drug companies should therefore be allowed to promote their products with few limitations.

"His clear purpose is to reduce FDA's involvement in advertising, and to permit the promotion of off-label uses of drugs," said Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, the consumer group affiliated with Ralph Nader. "There was a clear and predictable agenda when they brought him on."

Tobacco industry saw an advocate

In February 2001, Troy became involved in the effort by tobacco and advertising companies to overturn a Massachusetts statute that forbade tobacco advertising billboards within 1,000 feet of playgrounds and schools.

"Massachusetts argues that these regulations are constitutional because of the need to protect children from positive images of tobacco products," Troy wrote in a friend of the court brief for the American Advertising Federation. "The government cannot restrict a truthful message about a lawful product merely because some of those exposed to the message about that product may not lawfully purchase it."

The US Supreme Court overturned the Massachusetts law, partly on the grounds cited by Troy.

Troy's biggest tobacco victory came because of his work for the Brown & Williamson Tobacco Corp., a major cigarette maker. The case centered on the question of whether the FDA had the authority to regulate tobacco. Former FDA commissioner David Kessler argued that tobacco should be regulated as a drug that kills 400,000 people annually. Troy countered that the FDA had no such authority. Troy and his colleagues at his former Washington law firm of Wiley, Rein & Fielding won the case before the US Supreme Court.

"The most dangerous drug on the market is essentially totally unregulated, and that was the result of his and his colleagues' effective advocacy," said Daynard, the Northeastern University professor. "I would certainly want to give him a chance to show he was just zealously advocating his client's causes, but lawyers do tend to go beyond that and fall in love with their client's causes."

Michael Kranish can be reached at kranish@globe.com.

Caption: Pfizer Inc. turned to Daniel E. Troy for help after a lawsuit alleged that its drug Zoloft led a patient to commit suicide.