Glaxo & NYS Attorney General agree to Court enforced Consent Order

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> SSRI-Research

> Fri, 27 Aug 2004 07:51:49 -0400

 

> [sSRI-Research] Glaxo & NYS Attorney

> General agree to Court enforced Consent Order

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

> New York State Attorney General has reached an

> agreement with

> GlaxoSmithKline. At issue in the case, was

> concealment of data about the

> safety of the antidepressant drug, Paxil, for

> children and adolescent. In

> the suit GSK was charged with fraud.

>

> While acknowledging that the settlement, requiring

> public disclosure of

> clinical study data summaries is not a panacea for

> drug safety, Eliot

> Spitzer announced: " This settlement holds GSK to a

> new standard of

> disclosure about studies concerning its drugs, a

> standard that helps to

> ensure that doctors and patients have access to

> all scientifically sound

> information so doctors can prescribe appropriate

> medication for their

> patients. By agreeing to release both positive and

> negative studies about

> the safety and efficacy of its drugs, GSK has set

> an example for the entire

> pharmaceutical industry. "

>

> The agreement calls for the establishment of an

> online " Clinical Trials

> Register " disclosing summaries of safety and

> efficacy information " for all

> GSK-sponsored clinical studies of drugs conducted

> after December 27, 2000

> (the date Glaxo Wellcome and SmithKlineBeecham

> merged) and any earlier

> studies that may be relevant. "

>

> The Consent Order establishes court enforced, drug

> safety disclosure

> standards beyond any required by the FDA. The case

> underscores FDA's

> neglence and failure to set disclosure standards

> to improve safe use of

> drugs. Effectively, Eliot Spitzer's lawsuit

> against GSK was a catalyst for

> challenging the pharmaceutical industry's

> secretive modus operandi. By

> challenging GSK's concealment of safety data, it

> became embarassingly clear

> that the FDA failed to establish and enforce drug

> safety disclosure

> requirements.

>

> See:

>

http://www.oag.state.ny.us/press/2004/aug/aug26a_04.html

>

> The New York Times reports that " Mr. Spitzer

> sharply criticized the Food and

> Drug Administration for failing to require such

> disclosures years ago. "

>

> Effectively, the case swept aside FDA's claims of

> pre-emption--which rested

> on the agency's claim of superior expertise.

>

> " Just like with the [securities and Exchange

> Commission ] S.E.C., we're

> asking where has the F.D.A. been all these years

> when clinical data has been

> hidden from public scrutiny? They have simply

> failed to confront the

> problem. "

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

>

http://www.nytimes.com/2004/08/26/business/26CND-DRUG.html?ex=1094539557 & ei=

> 1 & en=b5e0eacae077a2e7

>

> THE NEW YORK TIMES

>

> August 26, 2004

> Maker of Antidepressant Drug to Release All Trial

> Results

> By GARDINER HARRIS

>

> In a settlement that the New York State attorney

> general said would

> transform the drug industry, GlaxoSmithKline

> agreed today to post on its Web

> site the results of all clinical trials involving

> its drugs.

>

> " This settlement is transformational in that it

> will provide doctors and

> patients access to the clinical testing data

> necessary to make informed

> judgments, " the attorney general, Eliot Spitzer,

> said.

>

> While the case involves only GlaxoSmithKline, the

> British drug maker, Mr.

> Spitzer predicted other companies would soon

> follow its lead by posting the

> results of their own studies online. Eli Lilly,

> for example, has said it

> will create a Web site on which it will list the

> results of clinical tests

> of approved drugs, including trials of those drugs

> for new uses. Several

> other companies, including Johnson & Johnson and

> Merck, have said they

> support the concept of a publicly available

> database that would list trial

> results.

>

> If the drug makers do not take action, Mr. Spitzer

> threatened more lawsuits.

> " We have ongoing inquiries, " he said.

>

> And in comments reminiscent of his battles with

> the Securities and Exchange

> Commission and its former chairman, Harvey Pitt,

> Mr. Spitzer sharply

> criticized the Food and Drug Administration for

> failing to require such

> disclosures years ago.

>

> " Just like with the S.E.C., " Mr. Spitzer said,

> " we're asking where has the

> F.D.A. been all these years when clinical data has

> been hidden from public

> scrutiny? They have simply failed to confront the

> problem. "

>

> Mr. Spitzer filed suit in June against

> GlaxoSmithKline, contending that it

> committed fraud by publicizing the results of only

> one of five trials

> studying the effect of its huge-selling

> antidepressant, Paxil, in children.

> That single study showed mixed results. The others

> not only failed to show

> any benefit for the drug in children but

> demonstrated that children taking

> Paxil were more likely to become suicidal than

> those taking a placebo.

>

> Mr. Spitzer said that GlaxoSmithKline's selective

> disclosures, which have

> long been common in the drug industry, constituted

> a form of consumer fraud.

> But it is unclear whether posting clinical trial

> results on a Web site will

> entirely solve the problem.

>

> In the case of Paxil, for instance,

> GlaxoSmithKline's original analysis of

> its trials simply found an increased level of what

> the company termed

> " emotional lability " among children given the

> drug. Only after a reviewer at

> the F.D.A. asked the company to offer more

> information about this category

> did it become clear that the children and

> teen-agers given Paxil were more

> suicidal than those given placebos.

>

> Mr. Spitzer acknowledged that postings of clinical

> trial results online was

> not a cure-all.

>

> " Nobody should believe that we think this is a

> panacea and that there will

> be perfect understanding of testing and clinical

> variables, " Mr. Spitzer

> said. But he said such postings would allow

> academics and doctors to ask the

> right questions about drugs.

>

> Spokeswomen for GlaxoSmithKline and the F.D.A. did

> not immediately return

> phone messages.

>

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