October 26

Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT

Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT

Mon, 26 Jul 2004

The New York Times reports that the Bush administration is actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers.

The administration argues that “if a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the FDA after years of rigorous testing and evaluation.”

The administration concedes in court documents that “the views stated here differ from the views that the government advanced in 1997,” in the United States Supreme Court.

At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide “additional protection to consumers.” Now the Bush administration argues that the agency’s approval of a device “sets a ceiling as well as a floor.”

Neither the FDA nor the Times addresses the issue of concealment of drug hazards from physicians and consumers.

The challenge for critics of the administration’s policy abrogating the right of citizens to seek legal redress for harm suffered from undisclosed hazards implicating medical products, is to refute the claim that FDA drug policies are governed by sound scientific evidence.

The FDA has, in fact, failed to ensure that only scientifically proven safe and effective drugs are approved, and failed to ensure that hazardous side-effects are fully disclosed.

Furthermore, the pre-emption argument has been refuted by the United States Department of Justice in a criminal case involving Pfizer (formerly Warner-Lambert). See: today’s Infomail citing the final US Attorney’s settlement: USA v. Warner-Lambert CRIMINAL No. 04-10150 RGS, June 4, 2004.

If the FDA fails to carry out its responsibility of protecting the public health and safety by enforcing requirements for full disclosure to physicians and the public of accurate, scientific information about adverse side-effects, then citizens have the right to seek legal redress. If public policymakers formulate policies to shield drug manufacturers from disclosing adverse drug effects by abrogating the legal rights and safety of ordinary citizens, those policymakers are outlaws.

The administration’s argument precluding individual citizens from suing drug companies for injury: “It is inappropriate for a jury to second-guess F.D.A.’s scientific judgment on a matter that is within F.D.A.’s particular expertise.”

But that argument is not supported by FDA’s record. FDA’s own medical experts have, on more than one occasion, recommended withholding approval of a drug for safety concerns, and / or recommended prominent warnings on drug labels. But agency officials overruled those medical experts and ignored the scientific evidence.

A Google search (or a search of AHRP’s website) will reveal case after case in which FDA officials overruled scientists’ recommendations and yielded to drug companies, with the predictable fatal consequences. [See below]

The case of SSRI Antidepressants: Dr. Andrew Mosholder is but the most recent example to come to light, of an FDA medical officer whose expert analysis and recommendations were suppressed by the agency because the recommendations might affect the financial interests of a drug manufacturer.

Dr. Mosholder was asked to analyze the Paxil data in Sept. 2003, after the British regulatory agency examined the clinical trial data and found a suicidal risk for children / adolescents prescribed Paxil / paroxetine. The British issued a prohibition on the use of Paxil for children (June 2003).

Dr. Mosholder then analyzed the suicidal behavior data submitted by drug manufacturers of 9 different antidepressants to the FDA from 22 randomized, placebo-controlled clinical trials. In these trials, 4,250 children / adolescents participated: 2,298 were given an active drug, and 1,952 were given a placebo.

Dr. Mosholder found that 108 child-patients suffered suicide-related events: 74 were on active drug, and 34 on placebo. Of these, 78 were serious adverse events–54 occurred in children taking an active drug, compared to 24 on placebo. Children on an antidepressant were at greater than twofold increased risk of drug-induced suicidal behavior.

Inasmuch as the drugs–with the possible exception of Prozac*–have failed to demonstrate a benefit in clinical trials, these serious risks are not offset by any scientifically proven benefit for children. Therefore, a minimal precautionary action would require prominent warnings to physicians and families.

Dr. Anne Trontell, Director, Div. Of Neuropharmacological Drug Products, and Dr. Mark Avigan, Director, Div. Drug Risk Evaluation, concurred with Dr. Mosholder’s analysis and conclusions, but disagreed that physicians and families should be warned about these risks.

Dr. Mosholder’s medically responsible, science-based recommendation:

“Given the strength of the association shown by the present data, the clinical importance of the apparent effect…and the fact that the additional analyses are likely to take several more months to complete while considerable numbers of pediatric patients are being exposed to these drugs, I favor an interim risk management plan regarding the use of these drugs in the pediatric population. This might be of value to physicians, patients and families who are faced with the need to make a decision regarding pharmacotherapy at the present time. Specifically, I propose a risk management strategy directed at discouraging the off-label pediatric use of antidepressant drugs, particularly the use of drugs other than fluoxetine in the treatment of pediatric MDD [major depressive disorder]. Conceivably, this might include discouraging the initiation of treatment of drug-naïve pediatric MDD patients with off-label drugs, in the absence of some over-riding clinical consideration.”

Dr. Mosholder’s embargoed report and the accompanying Trontell and Avigan memos are posted on the AHRP website at: https://ahrp.org/risks/SSRImosholder/index.php

Of note: FDA’s chief counsel, Daniel Troy, is the architect of the administration’s aggressive intervention in court on the side of drug and medical device manufacturers. Troy is one of over 100 top government regulators appointed by the Bush administration, who were identified as advocates for the industries they are supposed to regulate.
See: Anne Mulkern, When Advocates Become Regulators. Denver Post, May 14, 2004. https://ahrp.org/infomail/04/05/24.php
See also: Jeanne Lenzer, FDA’s counsel accused of being too close to drug industry BMJ, July 24, 2004

Examples refuting the basis of FDA’s pre-emption argument: FDA’s decisions about drug safety are not always based on scientific evidence. All too often FDA decisions result in preventable deaths:
REZULIN: http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm
PROPULSID: http://www.latimes.com/news/nation/reports/fda/lat_propulsid001220.htm;
FEN-PHEN: http://www.redux-settlement.com/
Phenylpropanolamine (PPA): http://www.latimes.com/news/nationworld/nation/la-na-ppa28mar281,1,2552623.htmlstory?coll=la-home-left1
RISPERDAL (risperidone); ZYPREXA (olanzapine): https://ahrp.org/infomail/0702/12b.php

*It should be noted that in Dec. 2003, Eli Lilly, manufacturer of Prozac, issued a label change in the UK stating, Prozac is NOT recommended for children. See: https://ahrp.org/risks/ProzacKids1203.php ;

Contact: Vera Hassner Sharav
Tel: 212-595-8974

In a Shift, Bush Moves to Block Medical Suits
July 25, 2004

WASHINGTON, July 24 – The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.

The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a “change in governmental policy,” and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.

Allowing consumers to sue manufacturers would “undermine public health” and interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.

In 2002, at a legal symposium, the Bush administration outlined plans for “F.D.A. involvement in product liability lawsuits,” and it has been methodically pursuing that strategy.

The administration’s participation in the cases is consistent with President Bush’s position on “tort reform.”

Mr. Bush often attacks trial lawyers, saying their lawsuits impose a huge burden on the economy and drive up health costs. The Democrats’ vice-presidential candidate, Senator John Edwards, a longtime plaintiffs’ lawyer, says his proudest accomplishment in Washington was to help win Senate passage of a bill defining patients’ rights, including the right to sue. (The bill never became law.)

Jay P. Lefkowitz, former director of Mr. Bush’s Domestic Policy Council, said the F.D.A.’s litigation strategy embodied “good health policy and good tort reform.”

But Representative Maurice D. Hinchey, Democrat of New York, said the administration had “taken the F.D.A. in a radical new direction, seeking to protect drug companies instead of the public.” Mr. Hinchey recently persuaded the House to cut $500,000 from the budget of the agency’s chief counsel as a penalty for its aggressive opposition to consumer lawsuits.

In the Pennsylvania ruling, issued Tuesday, the appeals court threw out a lawsuit filed by Barbara E. Horn, who said her husband had died because of defects in the design and manufacture of his heart pump. The Bush administration argued that federal law barred such claims because the device had been produced according to federal specifications. In its briefs, the administration conceded that “the views stated here differ from the views that the government advanced in 1997,” in the United States Supreme Court.

At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide “additional protection to consumers.” Now the Bush administration argues that the agency’s approval of a device “sets a ceiling as well as a floor.”

The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers.

The threat of lawsuits, it said, “can harm the public health” by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to “underutilization of beneficial treatments.”

Allison M. Zieve, a lawyer at the Public Citizen Litigation Group who represented the plaintiff in the Pennsylvania case, said, “The government has done an about-face on this issue.” If courts accept the administration’s position, Ms. Zieve said, it would amount to a backdoor type of “tort reform” that would shield manufacturers from damage suits.

In the Pennsylvania case, the federal appeals court quoted extensively from the administration’s brief and said the views of the F.D.A. were entitled to great deference because the agency was “uniquely qualified” to determine when federal law should take precedence over state law.

Bush administration officials said their goal was not to shield drug companies, but to vindicate the federal government’s authority to regulate drug products.

Patients and their families said they felt betrayed.

Kimberley K. Witczakof Minneapolis said her husband, Timothy, 37, committed suicide last year after taking the antidepressant drug Zoloft for five weeks. “I do not believe in frivolous lawsuits,” Ms. Witczak said, “but it’s ridiculous that the government is filing legal briefs on the side of drug companies when it’s supposed to be protecting the public. My husband would be alive today if he had received adequate warnings about the risk of self-harm.” Ms. Witczak sued Pfizer, the maker of Zoloft, in May. The government has not intervened in her case.

Thomas W. Woodward of North Wales, Pa., whose 17-year-old daughter committed suicide last year after taking Zoloft for a week, said, “I’ve been sickened to see the government taking the side of pharmaceutical companies in court.” Mr. Woodward has not filed a suit.

Mr. Hinchey said that F.D.A. lawyers, led by the agency’s chief counsel, Daniel E. Troy, had “repeatedly interceded in civil suits on behalf of drug and medical device manufacturers.”

Ms. Witczak, Mr. Woodward and Mr. Hinchey said Mr. Troy had a potential conflict of interest because Pfizer was one of his clients when he was a lawyer in private practice.

Mr. Troy refused to discuss the agency’s legal arguments or the criticism of his role. Dr. Lester M. Crawford, the acting commissioner of food and drugs, said Mr. Troy had “complied with the ethical requirement to recuse himself from any matter involving a past client for a year” after he joined the government in August 2001.

In its court filings, the Bush administration argues that private lawsuits threaten to disrupt a comprehensive nationwide system of drug regulation, and that federal standards pre-empt requirements established by state judges and legislators. In effect, the administration says, if a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation.

Five of Mr. Troy’s predecessors sent a letter to Congress dated July 15 endorsing his position. The government occasionally filed such briefs in the last 25 years, they said, but “there is a greater need for F.D.A. intervention today because plaintiffs are intruding more heavily on F.D.A.’s primary jurisdiction than ever before.”

Some judges and legal experts disagree. Erwin Chemerinsky, a constitutional scholar at the University of Southern California Law School, said, “The Supreme Court has expressly ruled that F.D.A. regulation does not pre-empt state law and local regulation” in all cases.

In a Tennessee case involving a cardiac pacemaker, the Bush administration told a state trial court, “It is inappropriate for a jury to second-guess F.D.A.’s scientific judgment on a matter that is within F.D.A.’s particular expertise.”

If juries in different states reach different conclusions about the risks and benefits of a medical device, they will cause “chaos for the regulated industry and F.D.A.,” the administration said.

The administration has also joined Pfizer in opposing a lawsuit filed by Flora Motus, a California woman who said her husband had committed suicide after taking Zoloft. Mrs. Motus argued that Pfizer had not adequately warned doctors and patients that the drug could increase the risk of suicide.

But the Bush administration said that when federal officials approved Zoloft, they saw no need for such a warning, and that a false or unnecessary warning could “deprive patients of beneficial, possibly life-saving treatment.” Susan B. Bro, a spokeswoman for Pfizer, said this week, “There is no scientific evidence of a causal relationship between Zoloft and suicide.”

Likewise, the administration intervened in a California case to help GlaxoSmithKline fend off consumer demands for restrictions on the advertising of Paxil. The government said the restrictions “would overly deter use of a life-improving medication.”

Patients had persuaded a federal district judge to order a halt to television advertisements that declared, “Paxil is non-habit forming.” The administration joined the manufacturer in challenging that order. The judge, Mariana R. Pfaelzer, lifted the injunction in 2002 for other reasons, but said the administration’s arguments were unpersuasive and contrary to the public interest.

Copyright 2004 The New York Times Company

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available free for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided

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