April 6

UK Parliament Report Re: Pharma Influence / US Regulators Comatose as 258 Fatal Suicides Linked to Neurontin

UK Parliament Report Re: Pharma Influence / US RegulatorsComatose as 258 Fatal Suicides Linked to Neurontin

Wed, 6 Apr 2005

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: https://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: https://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: https://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

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