Pfizer issues prosecutors a manual to defend drug – Star Ledger

Pfizer issues prosecutors a manual to defend drug – Star Ledger

Thu, 5 Aug 2004

In the May 14, 2004, settlement of a lawsuit initiated by a whistleblower, Pfizer pleaded guilty to criminal fraud in the promotion of Neurontin, and agreed to pay $430 million. http://www.ahrp.org/infomail/04/05/16.php

A report in The NJ Star Ledger reveals that Pfizer, Eli Lilly, and GlaxoSmithKline have developed confidential company “play books” or “litigation manuals” to thwart any effort to sue them for drug induced harm. The Ledger reports that Pfizer provides prosecutors with copies of the manuals to thwart defendants accused of violent crimes from blaming Zoloft for their violent actions.

The Ledger notes, “The Pfizer manuals provide a rare look at the lengths to which drug makers sometimes go to defend products that are under attack. Although first created a decade ago, their existence is only now coming to light as part of the widening controversy over antidepressants.”

Until recently, the public had no idea that evidence exists showing a link between violent behavior and SSRIs such as Zoloft until recently when previously concealed evidence was brought to public attention. The evidence and the concealment of the evidence has sparked an intense public debate– and led to two congressional investigations as well as a major lawsuit by NYS Attorney General.

Corporations have a right to defend themselves, but shouldn’t defendants have a right to defend themselves? Especially as defendants accused of violent crimes are likely to go to prison–whereas corporations such as Pfizer merely pays a fine–even when admitting criminal fraud!

How is that due process?

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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http://www.nj.com/news/ledger/index.ssf?/base/news-16/1091683380116820.xml
Star-Ledger
Pfizer issues prosecutors a manual to defend drug
Zoloft is not culprit in violence, firm says
Thursday, August 05, 2004
BY ED SILVERMAN

As controversy mounts over the safety of antidepressant pills, one drug maker has been fighting back in an unusual way — distributing a “prosecutor’s manual” in criminal cases.

In cases around the country, Pfizer has offered a playbook to help prosecutors challenge claims that its Zoloft drug is the culprit behind violent crimes instead of the defendants on trial. The information given to prosecutors includes medical literature and legal arguments.

The Pfizer manuals provide a rare look at the lengths to which drug makers sometimes go to defend products that are under attack. Although first created a decade ago, their existence is only now coming to light as part of the widening controversy over antidepressants.

Some of the medicines are blamed by some medical experts for suicides and other violent acts. Moreover, the drugs have spawned accusations that drug makers have withheld crucial clinical-trial data about the rate of suicidal behavior among patients.

“The company may be within their rights to distribute this manual, but it’s certainly going to appear ill-advised to send information at a time when they’re accused of hiding data,” said Arthur Caplan of the Center for Bioethics at the University of Pennsylvania.

Next month, a Food and Drug Administration panel will meet to review clinical-trial data for antidepressants. And a congressional subcommittee will hold a hearing to review the FDA’s handling of antidepressants and to grill several drug-company executives.

A spokeswoman for Pfizer, which maintains Zoloft is safe and effective, told The Star-Ledger manuals are distributed to prosecutors only on “rare” occasions. The manual, she said, includes medical literature, package inserts or other information a prosecutor may find “useful.”

The manuals are not widely available. Pfizer has so far successfully argued in various courts the playbooks, also known as “Litigation Manuals,” are confidential. That has prevented the public from seeing the contents, but some details have been divulged in lawsuits filed in California over the safety of Zoloft.

The court documents, quoting the manual itself, said it is “designed to assist criminal prosecutors in cases in which a defendant alleges that his wrongful, violent conduct should be excused because when he committed the violent act, he was taking the antidepressant medicine that is marketed under the brand name Zoloft.”

Pfizer, the New York-based drug maker that employs about 5,500 people in New Jersey, has good reason to defend the drug. Last year, Zoloft generated $3.1 billion in sales.

Legal experts said Pfizer and other drug makers are not only within their rights to distribute manuals, but actually should do so in order to protect themselves. That is because a crime blamed on an antidepressant could lead to expensive civil lawsuits, they said.

“I’ve not heard of this before, but it’s definitely not unusual for a drug company, or any company, to anticipate potential liability and do some risk prevention,” said Robert Bloom, a professor at Boston College Law School and a former prosecutor.

“If I’m the corporate counsel at Pfizer, it’s really in my interest to make sure the prosecutor is successful,” he added. “And if they are presenting prosecutors with knowingly false information, the defense should present witnesses of their own. It’s the adversary system.”

The Pfizer manual is the subject of a tussle in a South Carolina murder case that is being closely watched because Zoloft is being blamed for the crime. In 2001, a 12-year-old boy named Christopher Pittman was charged with killing his grandparents while on Zoloft.

Defense attorneys are seeking a court order that would force the prosecutor to submit the manual. The prosecutor, who couldn’t be reached for comment due to an extended illness, has so far refused to disclose materials received from Pfizer.

Such manuals have turned up before. Eli Lilly has distributed one for its Prozac antidepressant, although a Lilly spokesman said the company referred to them as notebooks.

Two months ago, the same South Carolina prosecutor acknowledged receiving a manual about Paxil, which is made by GlaxoSmithkline, but wouldn’t reveal the contents. Defense attorneys have asked a judge to order the prosecutor to make it available.

A Glaxo spokeswoman denied that the company provided a manual. She described it as “a collection of primarily publicly available materials,” although she said she was unable to offer details about the information that was not publicly available.

Ed Silverman can be reached at (973) 392-1542 or esilverman@starledger.com.

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