Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits_NYT

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> Wed, 28 Jul 2004 11:41:03 -0000

> Mosholder Suppressed Report

> Posted/ Bush Moves to Block Medical Suits_NYT

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> 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:

> http://www.ahrp.org/risks/SSRImosholder/index.html

>

>

> 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. http://www.ahrp.org/infomail/04/05/24.html

> See also: Jeanne Lenzer, FDA's counsel accused of

> being too close to

> drug industry BMJ, July 24, 2004

> http://bmj.bmjjournals.com/cgi/reprint/329/7459/189?

>

maxtoshow== & HITS= & hits=10 & RESULTFORMAT== & fulltext==Troy & searchid=90843404662_4\

568 & stored_sear

> ch== & FI

> RSTINDEX==0 & volume=29 & issue=t59

>

> 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

> ;

> webmd.com/content/article/22/1728_55973

> FEN-PHEN: http://www.redux-settlement.com/

> Phenylpropanolamine (PPA):

>

http://www.latimes.com/news/nationworld/nation/la-na-ppa28mar28-

> 1,1,2552623.

> htmlstory?coll==la-home-left1

> RISPERDAL (risperidone); ZYPREXA (olanzapine):

> http://www.ahrp.org/infomail/0702/12b.html

>

> *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:

> http://www.ahrp.org/risks/ProzacKids1203.html ;

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

http://www.nytimes.com/2004/07/25/politics/25DRUG.html?hp

>

> THE NEW YORK TIMES

> In a Shift, Bush Moves to Block Medical Suits

> July 25, 2004

> By ROBERT PEAR

>

> 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

>