Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Lack of Efficacy/ Undisc

[Guest guest]

> JustSayNo

> Wed, 28 Jul 2004 11:42:06 -0000

> [sSRI-Research] Pfizer Lawsuits: Zoloft /

> Neurontin Concealed Evidence: Lack of Efficacy/

> Undisc

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

>

> FYI

>

> On July 23, 2004, a citizen's consumer protection

> lawsuit was filed

> against Pfizer Pharmaceuticals for concealment of

> evidence and

> deceptive marketing of the antidepressant Zoloft.

> The California law

> firm of Baum Hedlund has filed a suit against Pfizer

> on behalf of a

> doctor of public health / nurse and on behalf of

> " all California

> residents who have been misled about Zoloft. " [press

> release below]

>

>

>

> On May 14, 2004, Pfizer, pleaded guilty in federal

> court to criminal

> fraud charges for the unlawful promotion and

> marketing of Neurontin

> by its predecessor, Warner-Lambert. Pfizer agreed to

> pay $430 million

> in settlement.

>

>

>

> The New York, the law firm of Finkelstein &

> Partners, petitioned the

> US Attorney and the Judge who presided over the

> Neurontin case to

> consider the thousands of individuals who have been

> harmed—many died

> because their " doctors were fraudulently enticed to

> prescribe

> Neurontin. " The letter noted that Pfizer " with full

> knowledge of the

> problem knowingly continued marketing the drug

> for unapproved,

> off-label conditions, thereby becoming criminally

> prosperous. "

>

>

>

> Andrew Finkelstein noted that the firm knew of 160

> " Americans who,

> having never attempted any form of suicide before

> taking Neurontin,

> committed suicide while on the drug. " Furthermore,

> he informed the

> court, he knew of " over two (2,000) Americans who,

> having never

> attempted suicide before taking Neurontin, were

> hospitalized

> following a suicide attempt while on the drug. "

>

>

>

> Finkelstein asked the court to hold Pfizer officials

> personally

> responsible:

>

> " A prison sentence must be considered when so many

> lives have been

> damaged through a clear corporate program of

> criminal activity. "

>

> See, Finkelstein's letter:

>

http://www.ahrp.org/SuitsDecisions/NeurontinPlea0504.pdf

>

>

>

> The United States Attorney states in the

> government's final Pfizer /

> Neurontin settlement:

>

>

>

> " The Government notes that in a May 18, 2004 letter

> to the Court, an

> attorney, who stated that he represents thousands of

> former Neurontin

> users, objected to the proposed criminal resolution

> on, apparently,

> the ground that it does not go far enough. The

> United States believes

> that evaluation of thousands of claims by individual

> Neurontin users,

> each of whose experience is unique, would unduly

> complicate and

> prolong sentencing. See U.S.S.G. § 5E1.1(b)(2).

> Moreover, the

> proposed global settlement does not foreclose the

> rights of

> nongovernmental victims to seek redress. " [p. 43]

>

> See: United States of America v. Warner-Lambert

> [Pfizer], US Dist.

> Mass, CRIMINAL NO. 04-10150 RGS, June 2, 2004.

>

>

>

> " Moreover, the proposed global settlement does not

> foreclose the

> rights of nongovernmental victims to seek redress. "

> That statement

> refutes and invalidates the FDA-Bush administration

> policy that

> prevents individual citizens from seeking redress

> for medical injury

> from products approved by the FDA. [see today's

> follow-up AHRP

> Infomail]

>

>

>

> The statement was signed by the Michael J. Sullivan,

> United States

> Attorney, District Of Massachusetts; Thomas E.

> Kanwit and Sara M.

> Bloom, Assistant U.S. Attorneys, U.S. Attorney's

> Office, Dist. of

> Massachusetts; and Jill Furman, Trial Attorney,

> Department of

> Justice.

>

>

>

> FDA's failure to take action to protect public

> safety from hazardous

> drugs borders on criminal negligence.

>

> The FDA has yet to require Pfizer to issue label

> warnings about the

> alarming suicide risk for patients prescribed

> Neurontin. Indeed,

> Finkelstein filed a Citizen Petition with the FDA

> (May 17, 2004)

> requesting the addition of postmarketing suicide

> report information

> to the Neurontin label.

>

>

>

> The petition notes that FDA's Adverse Event

> Reporting System (AERS)

> database shows " a substantial increase in

> fatalities during the

> first six months of 2003. There were reports of

> " eight completed

> suicides from 1998 through 2002. Seventeen

> additional suicides

> recorded for the period between January – June

> 2003. "

>

>

>

> The disparity in numbers between actual drug-related

> harm--such as,

> suicides and suicide attempts--and the incidents

> voluntarily reported

> to FDA's MedWatch demonstrates that voluntarism

> doesn't work. There

> is a pressing need for mandatory reporting and

> disclosure of all

> serious adverse drug effects.

>

>

>

> FDA's failure to perform its regulatory function

> responsibly—as it is

> mandated to do, to prevent drug-related harm--has

> resulted in

> hundreds of thousands of human casualties--far more

> than the

> casualties that resulted from the failure of US

> intelligence agencies

> to prevent 9/11.

>

>

>

> Too many drugs are being prescribed without

> physicians' knowledge of

> the lethal risks.

>

> In hospitals alone, 106,000 Americans die each year

> due to non-error

> adverse drug reactions.

>

>

>

> In 1994, an estimated 2,216,000 (1,721,000 to

> 2,711,000) hospitalized

> patients had serious adverse drug reactions (ADRs)

> and 106,000

> (76,000 to 137,000) had fatal ADRs, making these

> reactions between

> the fourth and sixth leading cause of death.

>

> See: JAMA April 15, 1998; 279(15):1200-5

> BioMed Central Nephrology. December 22, 2003

>

>

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

>

>

----

> ----------

>

> July 23, 2004

> FOR IMMEDIATE RELEASE

>

> Baum Hedlund, A Professional Corporation

> 12100 Wilshire Blvd., Ste. 950

> Los Angeles, CA 90025

> Contact: Robin McCall, Media Relations

> Day: (800) 827-0087 or (310) 207-3233

> Evening and Weekend (818) 681-5697

> Email: RMcCall

> Web: www.baumhedlundlaw.com

>

>

>

> Pfizer Conceals Evidence and Misleads Doctors and

> Patients About

> Safety and Effectiveness of Zoloft

> - Private Attorney General Steps in Because FDA Has

> Failed

> California Consumers

>

> Los Angeles, California, July 23, 2004 --

> Antidepressant litigation

> attorney Karen Barth Menzies and her partner, Ronald

> Goldman, filed

> suit today alleging Zoloft-maker, Pfizer, misled

> physicians and the

> public regarding Zoloft's safety and efficacy,

> particularly with

> regard to suicidality and withdrawal symptoms caused

> by the drug's

> use.

>

> Today's consumer protection lawsuit was filed in

> Superior Court in

> downtown Los Angeles (case number BC318871). The

> suit details

> Pfizer's actions and omissions that downplayed

> Zoloft's risks and

> exaggerate Zoloft's alleged benefits. Pfizer did so,

> the complaint

> alleges, by suppressing evidence concerning: (1)

> Zoloft's lack of

> efficacy compared to placebos in treating conditions

> for which Zoloft

> is prescribed; (2) Zoloft's propensity to induce

> withdrawal and

> dependency; (3) the risk of increased suicidal and

> violent impulses

> in adult, child and adolescent Zoloft users; and (4)

> Zoloft's causing

> other side effects such as convulsions and

> psychosis.

>

> The Plaintiff, Roberta Madison, is a nurse and

> doctor of Public

> Health. She has brought the action as a Private

> Attorney General on

> behalf of all California residents who have been

> misled about Zoloft.

> Last month, New York Attorney General Eliot Spitzer

> filed a similar

> lawsuit on behalf of all " aggrieved consumers " in

> the state of New

> York related to the drug Paxil. California's Unfair

> Competition Law

> provides that a private citizen may act as Attorney

> General on behalf

> of consumers.

>

> Baum Hedlund is a national law firm representing

> thousands of

> antidepressant victims. Through its investigations

> on behalf of

> clients that suffered unwarned adverse side effects

> while using

> Zoloft, Baum Hedlund has obtained information

> supporting the

> complaint's allegations.

>

> Karen Barth Menzies of Los Angeles based Baum

> Hedlund, stated:

>

> " We are looking forward to working with Dr. Madison

> in this case to

> expose the fraud that has been perpetrated against

> the public by

> Pfizer. Pfizer has promoted the benefits as huge and

> the risks as

> minimal in an extremely deceptive way.

>

> " We have been trying for years to raise public

> awareness about these

> issues. We believe that the truth has been

> suppressed for too long

> and as a result there has been an enormous waste of

> money, thousands

> of people have been harmed by these drugs and many

> lives have been

> shattered. We hope this lawsuit will be a

> significant step toward

> exposing the fraud.

>

> " Once all the evidence comes out it will become

> clear that Pfizer was

> well aware of Zoloft's safety and efficacy issues

> for many years.

> Despite this knowledge, Pfizer has continued to

> market Zoloft

> as " highly effective, " when only one out of five or

> Pfizer's own

> clinical trials for Zoloft's license application

> indicated

> superiority over placebos. We believe that the

> evidence will prove

> that the risks of Zoloft far outweigh any alleged

> benefits. Because

> of Pfizer's marketing practices and concealment of

> the truth,

> California healthcare providers have not been able

> to conduct

> accurate risk/benefit analyses when prescribing

> Zoloft. Additionally,

> we have seen many doctors who were unaware of

> Zoloft's serious side

> effects and consequently mis-diagnosed them. Where

> the public health

> is at stake, there is no room for secrecy and

> deception. "

>

> Robin McCall

> Public Relations

> Baum Hedlund

> RMcCall

> 310-207-3233

> info

>