US Regulators Comatose as 258 Fatal Suicides Linked to Neurontin

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Mon, 11 Apr 2005 03:33:00 -0400

 

 

[sSRI-Research] US Regulators Comatose as 258 Fatal Suicides

Linked to Neurontin

 

 

 

UK Parliament Report Re: Phama Influence / US RegulatorsComatose as

258 Fatal Suicides Linked to Neurontin

 

Wed, 6 Apr 2005

 

http://www.ahrp.org/infomail/05/04/06.php

 

The Health Committee of the British House of Commons, has just

released its report, " The Influence of the Pharmaceutical Industry. "

 

This landmark document is not just of value to UK health care

officials, it provides American officials and analysts an intelligent

road map for examining the much larger scope of the factors that

undermine the health and safety of the American people who consume far

more prescription drugs than do the British. See:

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

 

Many of the parliamentary committee recommendations for fixing the

drug regulatory system in the UK (beginning on p. 99), apply equally

to the dysfunctional US regulatory system which cannot be relied upon

to protect the American public from drug-induced illness and death-as

manifested in the off-label, criminal marketing of a lethal drug.

 

The FDA adverse drug event database, MedWatch, has received 258

documented fatal suicide reports involving patients prescribed

Neurontin, for mostly unapproved, off-label uses.

 

Among the off-label uses: migraine headache, a multitude of pain uses,

and various psychiatric conditions, " such as bipolar disorder and

anxiety, social phobia and general mood stabilization. "

 

MedWatch reports represent only 1% to 10% of the actual adverse drug

effects. Thus, 258 completed suicides represent between 2,580 suicides

and 25,800 suicides attributed to Neurontin.

 

FDA's failure to take action to protect the American public from

severe--even fatal--prescription drug side-effects, borders on

criminal negligence.

 

The FDA approved Neurontin on December 30, 1993, but only for

adjunctive treatment of epilepsy and seizures. Recently uncovered FDA

documents, obtained during court procedures, reveal that in

December,1992, FDA's medical reviewer expressed serious concerns about

Neurontin's lethal hazards--which explains why the drug was only

approved for very limited use:

 

" Serious adverse events may limit the drug's widespread usefulness.

Depression, while it may not be an infrequent occurrence in the

epileptic population, may become worse and require intervention or

LEAD TO SUICIDE, as it has resulted in some suicidal attempts during

clinical trials. " (emphasis added)

 

FDA's current Director of Neuropharmacological Drug Products, Dr.

Russell Katz, was responsible for overseeing FDA's analysis of the

clinical trial data supplied by Parke-Davis Pharmaceuticals at the

time that Neurontin received FDA approval.

 

According to newly uncovered company documents obtained by the law

firm, Finkelstein & Partners, Parke-Davis (a division of

Warner-Lambert) reported that during clinical trials:

 

" Neurontin was attributable to four people actually attempting

suicide, two more having depression with suicidal ideations and twenty

two participants reporting depression so severe it required

pharmacologic intervention. Additionally, nineteen of the seventy

eight participants who reported depression during the clinical trials

had no prior history of depression. " See:

http://www.ahrp.org/risks/neurontinSuicide0305.pdf

 

Documents show that in 1996, the FDA knew about the promotion of

Neurontin for off-label uses--in complete disregard of the lethal

risks for unsuspecting patients-but the agency failed to exercise its

regulatory authority, or to meet its public responsibility to protect

consumers from drugs whose safety has not been scientifically

established. As a result of FDA's inaction, Neurontin's manufacturer

aggressively promoted the drug primarily for unapproved, off-label

uses in violation of Food, Drug and Cosmetics Act. In 2000,

Warner-Lambert was purchased by Pfizer.

 

In 2002, Nuerontin prescriptions for off-label uses reached 94%-among

these were patients who were especially vulnerable to depression that

could " lead to suicide. "

 

In March 2004, FDA's Director, Neuropharmacological Drug Products, Dr.

Russell Katz, was informed that there were thousands of cases of

attempted suicides by patients taking Neurontin, and more than 100

MedWatch reports of completed (fatal) suicides.

 

In May 2004, a Pfizer division (Warner-Lambert) pled guilty to

criminal marketing of Neurontin and agreed to pay a $240 million

criminal fine plus $190 million to settle civil liability suits by 50

State Attorneys General-totaling $430 million.

 

In addition to committing financial fraud, the company pled guilty to

criminal misbranding of the drug in promotional and advertising

material suggesting that " the drug is safe and effective for uses

which have not been approved by the FDA. "

 

In his Sentencing Memorandum [CRIMINAL NO. 04-10150 RGS] the US

Attorney noted: " Although approved only as an epilepsy drug for

specific indications, Parke-Davis nonetheless promoted Neurontin for a

multitude of pain uses, psychiatric conditions such as bipolar

disorder and anxiety, social phobia and general mood

stabilization, among other unapproved uses. " [p.10]

 

" One of the psychiatric uses for which Neurontin was promoted by

Parke-Davis, bipolar disorder, was particularly troubling because the

Company had very weak evidence of Neurontin's efficacy in treating

this condition. Indeed, in one study sponsored by Parke-Davis, the

placebo was as effective or more effective than was Neurontin. " [p. 22]

 

The US Attorney's settlement, however, focused entirely on the

company's financial fraud, but acknowledging " harm [from] the

unnecessary exposure of patients to adverse side effects of

Neurontin. " Fraudulent marketing of unsafe drugs that expose patients

to harmful adverse effects lies within the jurisdiction of the FDA.

 

But even after the guilty plea, the FDA has done nothing to protect

the public from the off-label marketing of a drug that endangers human

lives. There is no Black Box warning about hundreds of completed

(fatal) suicides and thousands of suicide attempts, no " Dear Doctor "

letter has been issued.

 

The FDA has done nothing to warn physicians or the public about the

mounting number of suicides linked to Neurontin.

 

On May 17, 2004, after documenting that FDA's MedWatch had received an

additional 60 fatal suicide reports-a total of 170 fatal suicides

linked to Neurontin-the lawfirm of Finkelstein & Partners filed a

Citizens' Petition requesting that the FDA issue a warning to the

public about the potential for suicide by patients prescribed Neurontin:

 

(i.) require the strongest warning on the label - a black box warning

- warning of an association between Neurontin and suicide; and (ii.)

require the manufacturer to disseminate " Dear Doctor " and " Dear

Healthcare Professional " letters cautioning them to watch for

increased depression in patients who were prescribed Neurontin. " See:

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

 

To date, the FDA has taken no action to protect the American public

from a lethal drug-even as its manufacturer pleaded guilty to a series

of criminal felonies in the marketing of this drug.

 

FDA's failure to take any action to protect unsuspecting patients from

drug-induced suicide, prompted a second letter from Finkelstein, dated

March 21, 2005, in which he informs Dr. Katz:

 

" Enclosed you will find two hundred fifty eight MedWatch forms, most

with redacted death certificates. Each represents a suicide of an

American who was on Neurontin when he or she took his or her own life.

To this day, completed suicide is not found anywhere on the warning

label for Neurontin. "

 

In the space of ten months-from May 2004 and March 2005-the number of

fatal suicides attributed to Neurontin in reports submitted to FDA's

MedWatch, jumped from 174 to 258: See:

http://www.ahrp.org/risks/neurontinSuicide0305.pdf

 

As was pointed out by the Department of Justice, Neurontin's sales

increased from $23 million in 1993--to $2.7 billion in 2003. That

increase--as the DOJ demonstrated--was accomplished through an

elaborate scheme of deceptive marketing and off label sales.

 

The UK government is taking steps to protect the British people from

widely marketed, hazardous drugs. Is it the US government agenda to

protect the pharmaceutical companies' blockbuster drugs at the expense

of the safety and security of the American people?

 

Contact: Vera Hassner Sharav

212-595-8974