Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs

Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs

Thu, 18 Nov 2004

The Associated Press reports that at a Congressional hearing today, Dr. David Graham a drug safety expert at the FDA told the Senate Finance Committee that the public is “virtually defenseless” if another medication such as Vioxx proves unsafe after it has won Food and Drug Administration approval.

“I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx.” Dr. Graham warned that the arthritis drug had been linked to an increased risk of heart attack and stroke. He also testified that there were at least five other drugs on the market that warrant scrutiny: the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.

Dr. Sandra Kweder of FDA’s office of new drugs, did not agree with Graham’s assessment of the risk posed by the five drugs. She said “there is no magic formula” to determine which drugs most raise the most serious safety concerns.

If the FDA would at least monitor MedWatch–its own database of adverse drug event reports – we would not have to wait for a “magic formula.”

Dikinson’s FDA Webview reports (below) that Daniel Troy hand-picked Gerald F. Masoudi as his successor as Chief Counsel. Thus, Troy’s legacy may not be over. Dickinson and Newsday (excerpt below) provide insight into how the FDA became the permissive lap dog of the food, drug, and cosmetics industry when Troy, a political appointee with long standing ties to industry, ran the agency and methodically downgraded public safety issues.

There are many speculations about what prompted Daniel Troy to resign: perhaps the prospect of having to testify under oath before congressional committees may have influenced his resignation which was announced on Nov 16, effective Nov 28.

There has been growing public criticism of FDA’s failure to protect the public from hazardous drugs and the agency’s continued failure to monitor drug safety, coupled with the inordinate influence of industry in setting policy. Troy’s active intervention on behalf of drug manufacturers in lawsuits filed by individuals who had been harmed by drugs or devices–whose adverse effects were concealed–was a radical departure from FDA policy. Troy’s legal argument rested on the infallibility of “FDA’s scientific judgment” about safety.

One of the legal briefs submitted by Daniel Troy denied the need for a suicide warning on the drug label. However, FDA’s judgments have been shown to be unscientific–inasmuch as crucial safety evidence from clinical trials had been concealed. Industry selectively reported clinical trial results, hiding the adverse findings. When challenged publicly with evidence from antidepressant pediatric trials, the FDA was forced to re-analyze the complete data. Only then did the FDA reach a scientifically valid judgment: Black Box warnings were issued (Oct 15, 2004), acknowledging a causal relation between antidepressants and increased suicide risk.

The basis for Troy’s claims rested on scientifically faulty FDA-judgments that had relied on partial – therefore unscientific – information. This demonstrates that entrusting health / safety issues to a single agency is bad public policy. It invites manipulation by powerful stakeholders, undermining rational, science-based health / safety determinations. Neither the FDA nor any of us mortals is infallible; we all prone to errors in judgment.

Contact: Vera Hassner Sharav
212-595-8974

FDA Webview Reports /Review/Update/DTC Marketer)
FDAers Think Troy Weakened Them, Worry About Masoudi
11/17/2004

As chief counsel Daniel E. Troy’s impending departure from FDA is being noisily applauded by external critics, it is also being welcomed, quietly, by many program managers inside the agency who say that he has weakened them in meeting new regulatory and scientific public health challenges. And they worry about his apparent successor, raw newcomer Gerald F. Masoudi, who is an unknown factor but who they see as having been hand-picked by Troy.

For example, a high official told us 11/17, in sharply narrowing FDA’s traditional broad interpretations of statutory authority, Troy removed many previously effective tools for dealing with complex new issues not addressed in the Food, Drug and Cosmetic Act, such as biotechnology, gene transplants, dietary supplements, health claims for foods and others.

“Of course, Dan would say ‘Well, you have tried to interpret the statute in a broad way in the past, and now you’ve started losing in court,'” this official said. Such court losses – e.g., on the agency’s tobacco rule, and a string of First Amendment cases – were seen by Troy as being likely to continue so long as the agency persisted in exercising its traditional broad statutory interpretations, so he set about trimming the agency’s sails.

Instead of helping his “client” (FDA management) attain its goals, Troy routinely advised that it lacked statutory authority to reach those goals, this official said. “In writing regulations, we have attempted to put in requirements that might not have been explicitly in the statute, but that we would traditionally have used, be it records authority, or requirements for certain sorts of reporting by a firm. He would say, ‘Well, no, you don’t have that authority, I’m going to scale that back.'”

One example of this was Troy’s rejection of a CVM plan to regulate genetic transfers in food-producing animals under the new animal drug regulations. CVM protested that the 1938 FD&C Act could not have anticipated gene transfer technology, and that Congress has not been able to deal effectively with this issue, so creative regulation is the only way. “You’re putting a compound in a fish or a cow to cause it to grow differently – the scientists think that’s essentially the same as putting a drug in the animal,” a senior CVM official said. Troy refused to budge.

In a lengthening stream of such narrowing decisions, Troy managed to restrict FDA’s ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking – and feeling – weak. There is a philosophical basis for this result that many see in Bush Administration policies: reduce the power of government to “interfere” in the free working of the marketplace.

Troy’s past use of forums provided by the ultra-conservative/libertarian Federalist Society and his actions since as chief counsel present a sharp contradiction between FDA’s traditional modus operandi and that society’s dictum: “The courts must declare the sense of the law; and if they should be disposed to exercise WILL instead of JUDGMENT, the consequences would be the substitution of their pleasure for that of the legislative body.” In other words, if FDA did not get from Congress what it needs, it should not try litigation, or regulatory initiatives that might lead to litigation.

There are two ways FDAers look at this posture: (1) Troy was trying to protect the agency from losing any cases in court, and (2) Troy was trying to prevent it from winning any cases in courts that could, in Federalist parlance, legislate from the bench.

Troy’s resignation has thrust his apparent choice of successor onto center stage. As expected, HHS general counsel Alex Azar named Masoudi acting chief counsel “until a permanent replacement is appointed,” according to an 11/16 statement by acting commissioner Lester Crawford. Informed sources speculated that Masoudi could be that appointee. A 1993 graduate of the University of Chicago Law School, he joined FDA as deputy associate general counsel/deputy chief counsel earlier this month, and did not respond to requests for his biography and an interview.

However, an Internet search revealed that he authored in 1993, University of Chicago Law Review article, Kosher Food Regulation and the Religion Clause of the First Amendment, which has since become very widely referenced on various legal Web sites and by other scholars.

At Kirkland & Ellis, whose Web site no longer mentions him, he was one of four attorneys who in 1999 sued three cable Internet companies for client GTE in Western Pennsylvania federal court alleging Sherman Antitrust Act violations in the bundling of high-speed cable data transport services. In 2001, he represented the H.J. Heinz Co. in defending against a Federal Trade Commission suit that sought to block a proposed merger between Heinz and Beech-Nut Foods.

One of Masoudi’s most recent cases at Kirkland & Ellis involved a rate-regulation case this year before the Louisiana Public Service Commission in which he represented Arkansas Electric Energy Consumers, Inc.

Meanwhile, outside critics of Troy have raised their rhetoric against him. In a public e-mail to acting commissioner Lester Crawford 11/17, Alliance for Human Research Protection director Vera Hassner Sharav charged that Troy “was a symbol of what is rotten at the FDA: the pharmaceutical industry’s influence has ensured that business interests take precedence over public safety.

“Industry-influenced advisory committees,” she continued, “have led to the approval of lethal drugs that were widely marketed until the death toll became publicly known. Troy actively intervened on behalf of pharmaceutical companies in civil cases brought by individuals who sought justice in the court. Let us hope that other senior FDA officials who have similarly disregarded their role as public servants and have shielded drug manufacturers who concealed the hazardous effects of their products, resulting in preventable deaths, will resign as well.

“The FDA has been derailed from its mission, which is to ensure that the public is protected from unsafe and ineffective drugs, and that physicians and the public rare provided scientifically accurate information.

“Whereas Troy intervened on behalf of pharmaceutical companies claiming that the FDA’s authority pre-empted all others in matters of drug safety – even when they concealed lethal drug effects – New York State Attorney General, Eliot Spitzer, brought action against GlaxoSmithKline, charging the company with fraudulent marketing of Paxil (seroxat). That action undermined Troy’s pre-emption authority argument – and ultimately undermined his standing.

“In light of the skyrocketing expenditures for prescription drugs – U.S. consumers spent $216 billion on prescription drugs last year, up 11.5% in a year (according to IMS Health) – Dr. Lester Crawford’s claim that Daniel Troy’s ‘reforms’ saved consumers $35 billion, is not credible.” Meanwhile, Rep. Maurice Hinchey (D-NY), who has had several policy run-ins with Troy, said 11/16 the resignation announcement (see earlier story) “is a rare bright spot in what has been a dark period for FDA.” According to Hinchey, Troy worked tirelessly to weaken FDA’s ability to face challenges such as the withdrawal of Vioxx and the flu vaccine shortage. “Under Troy’s direction,” he said, “the agency has argued in court that manufacturers, some of whom he represented in private practice, should not be held responsible if their products injure customers. He wasted precious taxpayer dollars on other personal ideological pursuits as well. Instead of working to strengthen FDA’s mandated role as a guardian of public health, Troy has made it the agency’s mission to protect corporate profits.” Hinchey called on Crawford to “return FDA to its appropriate mission… by removing politics from the chief counsel’s office and appointing a career civil servant” as Troy’s replacement.

http://www.newsday.com/news/politics/ny-usfda114002814oct11,0,5464956,print.story
NEWSDAY
ERASING THE RULES Industry has some friends on the inside
Bush-appointed administrators at the FDA have consistently sided with the interests of business
BY THOMAS FRANK
October 11, 2004

Two years ago, California walnut growers conceived the perfect promotion: put labels on packages saying walnut consumption reduces the risk of heart disease.

There was one problem.

The Food and Drug Administration demanded substantial evidence to allow such claims, and it found that studies the growers touted were “of poor to moderate quality” or “not directly relevant.”

Even three outside experts the FDA hired said a link between walnuts and heart disease was “uncertain.”

But then the agency relaxed its standards. And on March 9, it reached an unprecedented decision: Labels could claim that walnuts “may” reduce heart-disease risk while noting that research was “not conclusive.”

The eased standards were long sought by the food industry, which found key allies in the Bush administration FDA. Top appointees who once advocated for FDA-regulated industries have heeded industry lobbying in ways that medical groups and consumer advocates say jeopardize public health.

After food-industry groups complained, a top appointee killed a measure to discourage consuming a cholesterol-raising fat. Plans to eliminate misleading sunscreen labels have been tabled following cosmetics-industry complaints. A post-Sept. 11 plan to help contain food contamination is nearly a year late as food-processing groups have objected.

Letters directing drug companies to stop false or misleading ads are reduced and delayed under new policy that some critics say increases the public’s exposure to misinformation.

In a dramatic legal novelty, the FDA has intervened for manufacturers in lawsuits, urging courts to dismiss damages claims against them. FDA briefs have helped the world’s two largest drug companies win product-liability cases.

The FDA says courts are not equipped to judge a product’s safety. On regulation, officials say their position reflects court rulings that warn about restricting commercial speech. Allowing inconclusive health claims on food labels such as walnuts gives consumers more information, the agency says.

“Naturally, our approach to enforcement may evolve as we adapt to new FDA legal authorities or evolving science and technology,” the FDA said in a recent statement. “But the goal of judicious enforcement of the law, to fulfill our mission of promoting and protecting the public health, remains constant.”

The walnut industry is already profiting from the new labels that will start next year. Walnut processing giant Diamond of California says publicity about them has helped lift sales 30 percent over last year.

But the American Medical Association said consumers may be duped. The walnut claims “have a reasonable chance of being erroneous,” it said. “An educated consumer will not know whether to believe or not to believe the claim.”

Rep. Henry Waxman (D-Calif.) wrote the 1991 law requiring “substantial scientific evidence” for health claims. “Congress didn’t want food manufacturers to make claims without substantiation,” he said. “The clear language of the statute is just being ignored.”

The influence behind many FDA decisions is chief counsel Daniel Troy, who was a sharp critic of the agency before President George W. Bush put him in charge of its legal affairs.

A Queens-born Columbia Law School standout, Troy, 44, came to the FDA primed for activism: Clerk for conservative icon Robert Bork; partner at blue-chip Wiley, Rein & Fielding; scholar at the pro-business American Enterprise Institute; litigant for the anti-regulatory Washington Legal Foundation.

Representing a tobacco company against the FDA in the late 1990s, Troy helped win a landmark Supreme Court ruling blocking the agency’s attempt to regulate tobacco products.

Litigating for the legal foundation, which drug-company foundations help fund, Troy challenged the FDA’s restrictions on promoting drugs for uses the FDA has not approved.

The policy, Troy wrote in 1999, reflects “an overzealous FDA.”

Appointed in August, 2001, Troy had vast authority. With no FDA commissioner until November 2002, Troy reigned for more than a year as top administrator in an agency that regulates 22 percent of the U.S. economy.

“He sent a signal to companies that if you want to deal with the FDA on a number of issues, he’s the man to see,” said a senior FDA official.

In three years, Troy has held 129 meetings with lobbyists and others with issues before the FDA.

Mark McClellan, commissioner from October 2002 to March 2004, held 30 such meetings, FDA records show.

From 1998 to 2001, Troy’s predecessor, Margaret Porter, held one meeting.

“She did not directly interact with industry,” said Jane Henney, FDA commissioner in 1999 and 2000. “She felt those interactions were done by the staff, and [lobbyists] should make their case to them.”

But the Bush administration made the chief counsel a political appointee for the first time since the 1980s, easing out civil-servant Porter and empowering Troy.

At the end of a meeting with cosmetics-industry officials two months into his job, Troy decided to delay indefinitely sunscreen regulations the industry opposed.

“We asked them to put it off. They’ve done what we asked,” said Tom Donegan, general counsel of the Cosmetic, Toiletry and Fragrance Association.

Donegan’s group opposed a proposed ban on sun-protection factors higher than 30, which the FDA found provided “extremely small” amounts of extra protection. Donegan told Troy the ban raised free-speech issues.

“He’s very receptive,” Donegan said.

The regulations, developed after 21 years of study and debate, also would have banned from sunscreen labels starting in 2003 terms such as “sunblock” and “waterproof,” which it determined were “misleading” and “unsupported.” Their use remains common.

Food-industry officials got Troy’s help after a National Academy of Sciences study requested by the FDA recommended “trans fat consumption be as low as possible” because it raised cholesterol. The FDA wanted that statement on food labels starting in 2006.

Industry officials who met Troy said the label may violate the First Amendment and could lead consumers and food processors to substitute similarly harmful saturated fat for trans fat.

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