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What You Need to know About Depression Medication

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Anonymous:

--- Quote from: "Inculcated" ---Previous poster, not everyone shares your opinion. Of course it’s perfectly understandable that you might feel that way considering it probably exceeds your reading comprehension skills to discern much out of the provided information.
--- End quote ---

Yep, that must be it.

Ursus:
This from the Alliance for Human Research Protection regarding suicide risk associated with Neurontin and Zoloft:

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Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy

Mon, 26 Jul 2004

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/Neur ... ea0504.pdf (780K 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

-----------------------------------------------------------------

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
Web: http://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 info@baumhedlundlaw.com

Ursus:
Bloomberg.com
Pfizer Faces First Trial on Neurontin Suicide Claim (Update1)

By Margaret Cronin Fisk, Jef Feeley and Cary O'Reilly



 July 24 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, goes to trial next week on claims its epilepsy medication Neurontin increases the risk of suicide, in a case the judge called "very tough" for the plaintiffs to win.

The July 27 trial will be the first of what plaintiffs' lawyers say are about 1,200 cases. It will show each side the other's strategy and may help point the way to settlements. The lead attorney for the family of Susan Bulger, 39, who took the drug before hanging herself in 2004, is Mark Lanier, winner of the biggest verdict over Merck & Co.'s painkiller Vioxx.

Pfizer says Bulger's suicide was unrelated to its medicine and points to what it calls a history of mental disorders and abusing drugs including cocaine. Her past might make it hard for the family to win, said Robert Rabin, a law professor at Stanford University in Palo Alto, California.

"If she was taking other drugs, there's a question if this particular drug contributed to the suicide," Rabin said in a phone interview.

U.S. District Judge Patti B. Saris in Boston made a similar point at a July 20 pretrial hearing. It's "a very tough case because of her personal history," she said.

Pfizer hasn't taken a reserve to deal with litigation expenses tied to the suits, said Christopher Loder, a company spokesman. Neurontin's 2008 sales of $387 million represented 0.8 percent of its total revenue, which included $12 billion for the cholesterol pill Lipitor, the world's biggest-selling drug.

Pfizer rose 19 cents, or 1.2 percent, to $16.34 in New York Stock Exchange composite trading at 11:39 a.m. The drugmaker's shares have fallen 7.7 percent this year.

Bulger's Life

The company says Bulger's life was "fraught with psycho-social stressors, including physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin."

"Mrs. Bulger attempted suicide multiple times before ever ingesting Neurontin," Pfizer said in court papers. "Six months before her suicide, Mrs. Bulger was caught buying cocaine on the street," it said.

Saris told lawyers she hadn't decided how much of the information will be admissible in the trial.

Lanier, a Houston lawyer representing the family and about 600 other Neurontin plaintiffs, counters that the drug helped push a "fragile lady" over the edge. He is asking for $250,000 in compensation plus punitive damages.

Lanier was among attorneys who negotiated a $4.85 billion settlement with Merck & Co. in 2007 to resolve the majority of cases over its painkiller Vioxx. He won a $253 million jury award in 2005 in the first Vioxx trial. The verdict was cut to about $26 million, then thrown out on appeal. The case is still on appeal in the Texas courts.

Lanier on Pfizer

The lawyer vowed in an interview to expose Pfizer's "seedy" handling of Neurontin during the three-week trial. Pfizer hid the drug's health risks to pump up profits, he said.

Lanier also will rely on a December decision by the U.S. Food and Drug Administration to order all makers of epilepsy drugs to add a suicide-risk warning to their labels.

The agency's reviewers found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of 11 drugs. Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently.

The government-required suicide warning may tip the scales against Pfizer in subsequent trials, said Rabin, the law professor. "Plaintiffs would have a better chance in other cases," he said.

"If this person wins, it opens the door for more litigation," said Les Funtleyder, an analyst with Miller Tabak & Co. in New York. "It could become an issue for Wall Street if the verdicts and settlements are large enough."

Testimony on Cause

The judge refused to dismiss the Bulger case and others on alleged failure to warn of Neurontin's side effects. She rejected Pfizer's bid to block expert testimony the drug increases the risk of suicide.

Their "general causation testimony is reliable," and plaintiffs showed that a relationship between the medicine and increased suicide risk is "biologically plausible," she said.

"What you have here is a standard case of individual trials that are going to produce early readings from a host of jurisdictions," said Professor Anthony Sebok of Benjamin N. Cardozo School of Law in New York. "The manufacturers will have to litigate five to 10 cases as they did in Vioxx to get a clear picture of what juries will do."

After several verdicts, "each side begins to see what its expected returns will be," Sebok said. "That'll impact on the price of settlement."

Suit in 2007

Bulger's family, of Peabody, Massachusetts, sued New York-based Pfizer and its Warner Lambert unit in August 2007, more than three years after Bulger's husband and 4-year-old daughter found her body in their basement. Ronald Bulger said he gave his wife four Neurontin pills an hour before she killed herself.

She took the drug, approved to treat epilepsy, for mood swings and arthritis pain, her family's lawyers said. Pfizer's marketing of the drug for so-called off-label uses played a role in her decision to take it, the family says in the lawsuit.

Companies are forbidden to market medications for off-label use. Doctors may prescribe a medicine for any condition. Drugs developed and approved as safe and effective for one condition sometimes are found to help with others.

Warner-Lambert paid $430 million in 2004 to resolve off- label marketing allegations involving Neurontin by the U.S. Justice Department. The family's lawyers can introduce evidence about that settlement, Saris said July 20.

'Appropriate' Label

"Pfizer believes that the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," said Loder, the spokesman.

"The Neurontin label prior to Mrs. Bulger's death was adequate and appropriate based on the reliable scientific data concerning the medicine, and all pertinent safety information was provided to the FDA," Loder said.

The trial is to start as Pfizer pushes to complete its $64 billion purchase of rival drugmaker Wyeth. Investors in Madison, New Jersey-based Wyeth voted to approve the cash-and- stock buyout earlier this week.

The acquisition will give Pfizer the pneumonia vaccine Prevnar and the antidepressant Effexor to offset some of the $12 billion in sales it will begin losing in 2011 when Lipitor faces generic competition.

Saris is overseeing all federal-court litigation over Neurontin, which includes product-liability claims like the Bulger family's and suits by insurance companies and consumers seeking to recoup money spent on the drug.

No Whitey Bulger Ties

Pfizer hired William Ohlemeyer, a former associate general counsel for cigarette maker Altria Group Inc., to defend it in the case, Lanier said. Loder, the company spokesman, declined to comment on who will be the company's lead defense lawyer, or to say exactly how many Neurontin claims Pfizer faces.

Ohlemeyer, from the New York office of Boies, Schiller & Flexner LLP, along with Mark Cheffo, a mass-tort defense specialist from New York's Skadden, Arps, Slate, Meagher & Flom LLP, are listed as lawyers for the drugmaker on Pfizer's court filings.

Saris told lawyers for both sides she will instruct jurors there are no family ties between the plaintiffs and James "Whitey" Bulger, a Boston crime boss and FBI informant who has been a fugitive since 1994, Lanier said.

Whitey Bulger, one of the FBI's 10 most-wanted men, has been indicted on 18 counts of murder, conspiracy, extortion and narcotics trafficking over his actions as the head of Boston's Winter Hill Gang. The FBI is offering $2 million for information leading to the fugitive's arrest.

The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at jfeeley@bloomberg.net; Cary O'Reilly in Washington at caryoreilly@bloomberg.net.

Last Updated: July 24, 2009 11:45 EDT


©2009 BLOOMBERG.COM L.P. ALL RIGHTS RESERVED.

Joel:
Edited: Wednesday, October 06, 2010

Anonymous:
Thanks Ursus,

I am loving all of the info you are posting on this thread. Keep it up, I plan to use this thread as a reference after big pharma makes the media corps take down all of this info from the net.

Really, big pharma and the troubled teen industry... both so corrupt you know they are eventually going to be working together. They probably already are. I have heard of kids being heavily drugged in programs...who pays? Somebody pays.

Big pharma probably gets business from teen programs (parents and insurance companies) and the programs get a nice kick-back donation for their cause from big pharma.   F-R-A-U-D

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