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HEALTH CARE
Troy's Drug Industry Ploy

A sworn affidavit filed in a Texas court case against Pfizer Inc. reveals President Bush's top appointee at the Food and Drug Administration (FDA) counseled pharmaceutical industry insiders on how to escape oversight from his own agency. FDA Chief Counsel Daniel Troy, a former drug lobbyist best known for preventing the FDA from regulating big tobacco, headed a "roundtable discussion" in December 2003 with pharmaceutical firms and their defense lawyers. According to the affidavit, at the meetings he "made it abundantly clear that the FDA would exercise its intervention powers to protect [drug industry] defendants from liability in state and federal courts throughout the nation." Troy advised conference attendees, remarkably, to invest in research that would prove liability issues were keeping "good products off the shelf," even while admitting the FDA currently had "no good evidence" to support such a claim. "You guys really shoot yourself in the foot by not funding research to this effect," he said. "I'll even take anecdotal evidence and stories if you have them." Rep. Maurice Hinchey (D-NY) today will hold a Capitol Hill press conference with families who have been affected by Troy and the Bush administration's intervention on behalf of the drug industry.

TROY TOUTS LIMITED INFORMATION: According to the sworn affidavit, Troy told the drug industry conference it was the FDA's goal to "control the flow of risk info regarding these [drug and medical device] products" to the public. This directly contradicts the FDA's mission: to help "the public get the accurate, science-based information they need to use medicines and foods to improve their health." The affidavit states Troy made "no mention…of the FDA's real mandate, which is to regulate manufacturers on behalf of consumers." Instead, despite heading an agency meant to protect consumers, Troy promoted the Bush administration's tort reform agenda to the industry's representatives, making "numerous derogatory remarks about plaintiffs, 'runaway juries,' and even" calling some attorneys representing plaintiffs against drug companies "bounty hunters."

A TROY IN THE HENHOUSE: Like many other Bush appointees, Troy is now overseeing an industry which he used to represent. The Boston Globe reports, "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, as FDA counsel, Troy has made "unprecedented offer[s] to drug companies…likely to protect their profits and potentially hurt consumers." Since arriving at the FDA in 2001, "Troy's most aggressive efforts have come on behalf of the pharmaceutical industry," including the unprecedented intervention in select court cases on behalf of defendants, and the loosening of off-label rules which health advocates say could "'deal a body blow' to the government's ability to defend the public from unproven and unsafe treatments."

TROY TAKES STAND FOR PHARMACEUTICAL GIANTS: Troy's pro-industry stance goes way beyond words: the former industry representative has engaged in an "open-door policy" with industry. Early in his tenure, he "held at least 50 meetings with representatives from the industries FDA regulates." Journalists have requested records of those meetings, but were "informed by Troy's office that there are 'no minutes, no memos, no nothing.'" In addition, "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." Such letters used to be sent out by a branch within FDA, but Troy, has "arranged for all warnings to go through his office."

TROY'S PFIZER CONNECTION: When the pharmaceutical giant Pfizer faced a lawsuit in 2002 alleging the company's top selling antidepressant, Zoloft, had caused a patient to commit suicide, the drug company turned to its old friend Daniel Troy for help: The Boston Globe reported, "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." When FDA was asked by the House Appropriations Committee about Troy's connection to Pfizer, the administration claimed he worked less than 80 hours per year for the drug company. They did not say that, according to Troy's financial disclosure form, Pfizer had paid Troy's firm nearly $360,000 for services "provided directly by" Troy in less than six months.

TROY'S FDA - A NEW FRIEND FOR THE DRUG INDUSTRY: Under Troy's leadership, the FDA's oversight role in the drug industry has changed dramatically. Since President Bush took office, the FDA or Department of Justice has intervened in at least four major cases on behalf of pharmaceutical company defendants, each time claiming the FDA's own judgment would "implicitly preempt" any ruling against the industry. Each time, FDA statements submitted to the courts have sought to limit information available to consumers about potentially dangerous drugs. One DOJ "Statement of Interest" argued against requiring the manufacturer of Paxil to remove from its advertisements the statement the drug was "non-habit forming," even though testimony indicated users experienced traumatic withdrawal symptoms.

Center for American Progress

My daughter was on Paxil, and she had a horrible time getting off of it. And I've heard other horror stories.

[bassetman]

[Paquadez]

As with so much, today, "Safety" trials are synthesised, using computers.

Not too many years ago, drugs were trialled, for a considerable time, to ensure, as much as was possible, that there were no harmful side-effects.

Now, with the huge money made by drugs companies, the pressure is to get the latest wonder drug to market and to rely on product liability insurance and smart lawyers to head off any catastrophy.

Whilst Class Action Torts have helped bring some errring companies to book, there are many recent examples where such class actions have been settled (benefiting the lawyers!) and leaving the litigants poorly served.

Using "What If?" synthesis is all very clever, it all too often fails to develop the widest spectrum of probability. And therein lies the danger.

Paq