FDA counsel's rise embodies US shift
By Michael Kranish, Globe Staff, 12/22/2002
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 s een 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 GlaxoSmithKline 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 GlaxoSmithKline, 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 a s 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.
This story ran on page A1 of the Boston Globe on 12/22/2002.
© Copyright 2002 Globe Newspaper Company.
Last Updated on
04/14/04
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