Posts Tagged ‘Geodon’

Drugging Kids For Profit: Powerful & dangerous antipsychotic drugs being used on kids more and more often

Monday, January 4th, 2010

Ed Silverman
Portfolio.com
January 4, 2010

If elderly people with dementia are so vulnerable to the risks posed by antipsychotics, why are so many nursing-home residents regularly prescribed the medications?

The answer can be found in a controversy with its roots in aggressive marketing and lackadaisical supervision. Known in the medical community as atypical antipsychotics, this group of drugs was originally approved by the Food and Drug Administration to treat adults suffering from schizophrenia. They go by snazzy names such as Zyprexa, Geodon, Abilify, and Seroquel. Later, regulators allowed doctors to prescribe them for treating bipolar disorder. Over the past decade, the pills have become a veritable goldmine; in 2008 alone, sales in the U.S. reached $14.6 billion.

But critics say those big sales are actually due, in part, to an epidemic of off-label marketing, which is promoting a drug for unapproved uses, although doctors are free to write a prescription regardless. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.

Read entire article: http://www.portfolio.com/industry-news/health-care/2010/01/04/drugging-kids-for-profit/

« Return to news items


  • Share/Bookmark

Dr. Peter Breggin: Antipsychotic Drugs, Their Harmful Effects, and the Limits of Tort Reform

Monday, November 2nd, 2009

Dr. Peter Breggin
The Huffington Post
October 31, 2009

There are many problems within our legal system that could benefit from reform. But within the area in which I have great experience as a psychiatric expert, so-called tort reform has already gone too far. It is already too difficult for injured patients or their surviving families to bring malpractice suits against physicians and health facilities, and product liability suits against drug companies, even when their cases have great merit. I believe in private health care and I believe in the free market, but liberty requires checks and balances. The right to sue medical practitioners and pharmaceutical companies provides a necessary control in our free market system, as well as a means for individuals to seek compensation and justice.

Harm Caused by Antipsychotic Drugs

For illustrative purposes, I’ll focus on the newer antipsychotic drugs, the so-called atypicals, including Zyprexa, Risperdal, Geodon, Seroquel, and Abilify. These drugs produce horrendous adverse effects that often lead the victims or their surviving families to consider bringing lawsuits against doctors, health care facilities, or drug companies.

First, the antipsychotic drugs produce tardive dyskinesia. Tardive dyskinesia involves drug-induced abnormal movements that commonly disfigure patients and in some cases result in lifelong pain and total disability.

Read entire article: http://www.huffingtonpost.com/dr-peter-breggin/antipsychotic-drugs-their_b_341108.html

« Return to news items


  • Share/Bookmark

Lawsuit alleges Pfizer used bogus research to get approval for its blockbuster antipsychotic drug Geodon

Monday, October 5th, 2009

Lee Howard
TheDay.com
October 4, 2009

A lawsuit filed against Pfizer Inc. two years ago and just unsealed last month calls into question the safety of the company’s popular antipsychotic drug Geodon as well as the reputation of some of the researchers who worked on its clinical trials.

The lawsuit, filed by Dr. Stefan Kruszewski of Harrisburg, Pa., alleges that three of the researchers who helped conduct Geodon clinical trials – Dr. Richard Borison, Dr. Bruce Diamond and Dr. Louis Fabre – have been sanctioned by regulatory authorities. Borison and Diamond were debarred by the U.S. Food and Drug Administration and received prison time, according to the suit, and Fabre earned sanctions in Texas for research misconduct.

”Pfizer’s reliance on clinical researchers with a known history of professional misconduct” – which news reports indicate go back at least as far as a 1997 indictment of Borison and Diamond and included the FDA’s 2005 shutdown of Fabre’s clinical-testing facility – “demonstrates the lengths to which the company is willing to go to facilitate its ‘positive’ clinical trials’ reporting,” according to the suit.

Read entire article: http://www.theday.com/re.aspx?re=a47a14f8-cbcb-4e3b-b91c-2bebce6d6232

« Return to news items


  • Share/Bookmark

CounterPunch: What Integrity Means to Pfizer

Thursday, October 1st, 2009

Martha Rosenberg
CounterPunch
September 30, 2009

The satire was biting:

“Thanks for making time to see me today,” posted a rep on cafepharma about a fictitious sales meeting with a psychiatrist. “Now, I know that you used Neurontin in the past for every condition under the sun. Pfizer knows very well that you guys were and still continue to be the largest writers of off-label Lyrica and so, in the spirit of Bextra [withdrawn in 2004] will you please write Lyrica as much as possible? Remember Dr, this is Pfizer. The company that never met an off-label sale that it wouldn’t cover-up.”

Don’t forget, writes the next poster on the pharma site, the psychiatrist answers, “Great! and I also heard that it is about to be approved on state Medicaid and I can write it for anything. Is this true?” to which the rep assents in defiance of, “that nice little 2004 CIA agreement.”

Pfizer’s nice little 2004 “CIA” or Corporate Integrity Agreement in which a company promises to sin no more to which the poster refers was for fraudulent marketing of seizure drug Neurontin. It was preceded by a CIA for fraud related to Pfizer’s cholesterol drug, Lipitor, in 2002.

And this month it’s followed by a CIA for mis-marketing pain drug Bextra, antipsychotic Geodon, seizure drug Lyrica and antibiotic Zyvox.

Read entire article: http://www.counterpunch.org/rosenberg09302009.html

« Return to news items


  • Share/Bookmark

Lawsuit says NAMI (pharma front group that gets millions in Pharma $) was Trojan Horse used to push antipsychotics on kids

Thursday, September 17th, 2009

Jim Edwards
BNET
September 16, 2009

Pfizer funded the National Alliance for the Mentally Ill in order to turn the nonprofit into a “Trojan Horse” that would promote the antipsychotic drug Geodon for off-label use in children, according to a former pharmaceutical sales rep.

Mark R. Westlock of Fenton, Mo., was a rep for Pfizer from 1991 to 2007, when he claims he was forced to resign. His whistleblower suit against Pfizer was included in the a $2.3 billion Bextra settlement.

Following Pfizer’s funding, the NAMI web site suggested that Geodon be used in children even though the FDA had approved it only for adults, Westlock claims.

Read entire article: http://industry.bnet.com/pharma/10004316/pfizer-turned-nami-into-trojan-horse-to-push-geodon-off-label-to-kids-suit-claims/

« Return to news items


  • Share/Bookmark

Parents fight use of new psych meds for kids

Sunday, September 13th, 2009

Martha Rosenberg
San Francisco Chronicle
September 13, 2009

As newly approved drugs harm and even kill children, more parents are fighting back.

The most dramatic moment for the 70 doctors and 200 spectators attending June FDA hearings about approving new psychiatric drugs for children came when two bereaved mothers approached the open mike.

Liza Ortiz of Austin, Texas, told the advisory panel her 13-year-old son died of Seroquel toxicity in an ICU days after being put on the antipsychotic. “His hands twisted in ways I never thought possible,” she said.

Next was Mary Kitchens of Bandera, Texas, who described Seroquel’s lasting effects on her 13-year-old son Evan after being given the antipsychotic without her knowledge or permission by a residential treatment center.

But for Kitchens the most dramatic moment came after the hearings when she approached Dr. Robert Temple, the FDA’s director of the Office of Drug Evaluation, who had officiated on the panel.

“Can I show you the stamp on these Seroquel samples that proves my son was given an unapproved drug in 2003?” she asked him, displaying the original drug packaging, which she also showed at open mike. “The panel is considering whether these drugs should be approved for children – and I can show you they’ve been marketed to kids for years!”

“I’m sorry, ma’am – I can’t talk to you,” replied Temple, making a quick getaway.

« Return to news items


  • Share/Bookmark

Pfizer pays $300 million to resolve allegations of off-label marketing of its antipsychotic drug Geodon

Wednesday, September 2nd, 2009

PRNewswire
September 2, 2009

PHILADELPHIA — Pfizer, Inc. announced today it has agreed to plead guilty to criminal conduct and to pay more than $2 billion in criminal and civil fines, penalties and damages to settle allegations made in multiple whistleblower lawsuits that the pharmaceutical giant defrauded Medicare, Medicaid and other government-funded health care programs in connection with its market practices for four of its drugs. The settlement is the largest qui tam settlement in U.S. history.

Brian Kenney and Tavy Deming of Kenney Egan McCafferty & Young represented the Geodon whistleblowers and served as co-counsel to the Zyvox whistleblower.

As part of the record settlement, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing of its blockbuster atypical antipsychotic Geodon, which generated over $1 billion dollars in sales in 2008. The allegations were first made in a qui tam lawsuit filed by Kenney and Deming on behalf of Harrisburg psychiatrist, Dr. Stefan Kruszewski. Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic Zyvox. That case was filed by Ronald Rainero, a former Pfizer sales manager from New Jersey.

Read entire article: http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/09-02-2009/0005087128&EDATE

« Return to news items


  • Share/Bookmark