Posts Tagged ‘Geodon’

Pfizer Makes Bank from DrugsThat Can Kill You—To say Pfizers been accused of wrongdoing is like saying BP had an oil spill

Monday, July 12th, 2010

AlterNet
By Martha Rosenberg
July 10, 2010

The drug company Pfizer is best known for Lipitor, a drug that brings cholesterol down and Viagra, a drug that brings other things up.

But the “world’s largest research-based pharmaceutical company” which sits between Goldman Sachs and Marathon Oil on the Fortune 500, is also closely associated with a seemingly never-ending series of scandals.

To say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8 ) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

Nor does Pfizer back down when faced with legal troubles.

Even as it was under the probation of a 5-year Corporate Integrity Agreement (CIA) with Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002, it off-label marketed its seizure drug Neurontin and entered into another CIA in 2004.

Read entire article:  http://www.alternet.org/story/147467/

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Prescription Pill-Popping By Far a Leading Killer as Florida’s Drug Deaths Spike 20%

Thursday, July 1st, 2010

FlaglerLive.Com
July 1, 2010

Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined. Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today by the Florida Medical Examiners Commission.

That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state.

The number of people killed by prescription drugs is a significant 20 percent increase over last year’s 6,200 deaths attributed to overdoses. Much of the increase is due to a spike in oxycodone addiction. The increase in prescription-drug addiction continues a trend that began in Florida 10 years ago, when prescription drugs overtook illegal drugs as leading causes of drug-related deaths.

Alcohol is also included in the examiners’ analysis, and it leads the way of all drug-related deaths, with 4,046.

The annual report is a stark look at the effects of legalized drug addiction and over-prescription of drugs, both of which affect a far larger segment of the population than recreational or illegal narcotics.

For the first time in 2009, the commission tracked deaths by region. In Flagler County’s district, which includes St. Johns and Putnam counties, 22 deaths were attributed to oxycodone (the fourth lowest number in the state’s 23 districts), with 13 of those deaths directly attributed to the drug, and nine cited as being present among other drugs that contributed to death.

Hydrocodone claimed 16 lives in the district. Cocaine contributed to 19 deaths in the Flagler district, though only four cases were directly attributed to the drug. In 15 cases, cocaine was present in the body in conjunction with other drugs that proved lethal. Overall in Florida, cocaine-related deaths (including the majority of cases where cocaine wasn’t directly the factor but was present in the body at the time of death), have fallen from a peak of 2,179 in 2007 to 1,462 in 2009. (Again, cocaine was the direct result of death in 529 cases out of those).

Ken Kramer, a researcher with the Citizens Commission on Human Rights of Florida, says the numbers underestimate the extent of the problem, because medical examiners do not track deaths attributed to antipsychotic drugs or to antidepressants, both of which carry black-box or black-label warnings. The warnings on antidepressants, required by the Food and Drug Administration, state that the drugs increase the risk of suicidal thinking and behavior in children, adolescents and young adults up to age 24. (Antidepressants include Paxil, Prozac, Zoloft, Effexor, Lexapro and Celexa.)

Anti-psychotic drugs carry a variety of black label warnings of increased mortality in elderly patients (including a death rate almost twice as high for people taking Risperdal, for example). Those drugs, prescribed and often overprescribed in nursing homes and assisted living facilities, include Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa.

“Certainly, the actual number of prescription drug deaths is higher than the annual report states,” Kramer said. “It is unknown just how much higher because the Medical Examiners Commission does not track these classes of drugs.”

Two years ago Kramer got his concern heard by the commission following an email exchange with a commissioner in which he argued that antidepressants and anti-psychotic drugs’ contributions to mortality should be part of the annual report. He was rebuffed. One examiner vsaid he had not seen “more than the occasional death caused by these types of drugs,” according to the minutes of the Aug. 13, 2008 meeting of the commission.

Read entire article:  http://flaglerlive.com/7256/florida-prescription-drugs-deaths-oxycontin-oxycodone

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Behind the Psychopharmaceutical Industrial Complex; Pharma-funded front groups masquerading as “patient advocates”

Tuesday, June 22nd, 2010

Scoop Independent News
By Evelyn Pringle
June 22, 2010

Non-Profit Advocacy Groups

As a main component of the Psychopharmaceutical Industrial Complex, the so-called “patient advocacy” organizations have become the leading force behind the American epidemic of mental illness over the past two decades.

Drug makers, and their foundations, funnel millions of dollars to these non-profits every year. In return, the leaders recruit their members as foot soldiers to carry out the latest marketing campaigns and to provide a fire-wall so that no money trail can be tracked back to the drug companies.

Gigantic Pyramid

The psychiatric front groups form a gigantic pyramid and once pharmaceutical money enters the system through a major organization, it gets channeled into a huge spider-web that weaves through many groups, making it nearly impossible to keep track of where it came from or where it all went. Often, when the grant reports of the drug companies list a large donation to one organization, the annual reports of the other groups will show smaller gifts from that same organization.

The “charity” groups are exempt from income tax and the “contributions” funneled through them are tax deductible. The money is used for disease mongering campaigns to both market disorders and pressure public health care programs and private insurers to pay for expensive treatments.

“Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent,” according to Citizens Commission on Human Rights International, a mental health watchdog group.

In a June 2, 2010, commentary titled, “Psychiatric Fads and Overdiagnosis,” on the Psychology Today website, Dr Allen Frances points out that it “is too bad that there is no advocacy group for normality that could effectively push back against all the forces aligned to expand the reach of mental disorders.”

The leaders of the supposedly “non-profits” earn outrageously high salaries, along with excellent benefit packages, while many of the patients they claim to represent are encouraged to seek federal disability payments of under $700 a month, and apply for public housing, food stamps, and Medicaid, to make ends meet. The top officials will often move from a leadership role in one organization to a higher position in another.

The drug makers rely on the front groups to do their bidding any time profits are threatened. For instance, if the FDA is considering adding a black box warning about a deadly side effect to a drug’s label, which may result in a drop in sales, representatives of front groups will show up at the FDA advisory panel hearings to testify against adding the warning.

They will also lobby FDA panels whenever there is a chance to increase profits, such as enlarging the drug customer base. In June 2009, the Psychopharmacologic Drugs Advisory Committee was set to meet to evaluate AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa for use with 13 to 17 year-olds diagnosed with schizophrenia, and 10 to 17 year-olds diagnosed with pediatric bipolar disorder.

On June 8, 2009, nine front groups issued a joint statement urging the panel to vote to approve all three drugs for kids. The groups signing the letter included the American Academy of Child and Adolescent Psychiatry, American Foundation for Suicide Prevention, American Psychiatric Association, Child and Adolescent Bipolar Foundation, Children and Adults with Attention-Deficit/Hyperactivity Disorder, Families for Depression Awareness, Mental Health America, National Alliance on Mental Illness, and the National Council for Community Behavioral Healthcare.

Read entire article:  http://www.scoop.co.nz/stories/HL1006/S00162.htm

Also see:  http://www.cchrint.org/psycho-pharmaceutical-front-groups/

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Huffington Post: Poor Kids far more likely to be prescribed psychiatric drugs

Thursday, May 20th, 2010

Huffington Post
By Bruce E. Levine
May 20, 2010

Children covered by Medicaid are far more likely to be prescribed antipsychotic drugs than children covered by private insurance, and Medicaid-covered kids have a higher likelihood of being prescribed antipsychotics even if they have no psychotic symptoms. This is reported in the May19, 2010 Journal of American Medical Association (JAMA) article, “Studies Shed Light on Risks and Trends in Pediatric Antipsychotic Prescribing.”

Researchers at Rutgers University and Columbia University found that children and adolescents covered by Medicaid were four times as likely as those with private insurance to receive an antipsychotic in 2004. Among those aged six to 17 years who were covered by Medicaid, 4.2 percent were prescribed at least one antipsychotic drug. In contrast, among those in this same age group who had private insurance, less than 1 percent were prescribed an antipsychotic. Nearly half of these Medicaid-covered pediatric patients receiving antipsychotic drugs had nonpsychotic diagnoses of attention deficit hyperactivity disorder (ADHD) or some other disruptive behavior disorder. In contrast, of the privately insured pediatric patients receiving antipsychotics, about one fourth were diagnosed with ADHD or some other disruptive behavior disorder.

The current issue of JAMA also reports another troubling study published earlier this year in the journal Pediatrics. This study, conducted by Robert Penfold of the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute, examined the use of the antipsychotic Geodon (ziprasidone) in pediatric patients covered by Medicaid in Michigan in 2001. Of the pediatric patients who had been diagnosed with a psychiatric disorder and had received Geodon, only 53.3 percent actually had a diagnosis of psychosis. The other children who received Geodon had one or more of the following diagnoses: 24.1 percent were diagnosed with explosive personality disorder, 17.6 percent were diagnosed with depressive disorder, and 13.1 percent of these kids who were prescribed Geodon had oppositional defiant disorder (ODD). What exactly does it take to get an ODD diagnosis?

Read entire article:  http://www.huffingtonpost.com/bruce-e-levine/psychiatric-drugs-and-poo_b_583568.html

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BNET – “Kid Overdoses in Antipsychotic Trial Caps a History of Screwups at Pfizer”

Thursday, April 22nd, 2010

BNET
By Jim Edwards
April 21, 2010

The FDA’s letter to Pfizer (PFE) describing overdoses of the antipsychotic Geodon  given to 13 children in clinical trials is merely the latest in a long history of controversies that have dogged the drug at virtually every stage of its existence. Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.

Taken together, the string of incidents suggests a lack of management accountability. Like many large companies, Pfizer operates as a series of silos or divisions, with different managers for sales, marketing, R&D, and regulatory compliance. The fact that screwups have occurred across all these divisions illustrates the value of having one manager, or management team, with accountability for the entire product, from soup to nuts.

The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:

… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.

…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…

Read entire article:  http://industry.bnet.com/pharma/10007813/kid-overdoses-in-antipsychotic-trial-caps-a-history-of-screwups-at-pfizer/

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FDA says Pfizer overdosed 13 children in antipsychotic drug trial

Tuesday, April 20th, 2010

Reuters
April 20, 2010

U.S. health regulators have warned Pfizer Inc. over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.

The FDA, in an April 9 warning letter to the world’s largest drugmaker, said Pfizer “failed to ensure proper monitoring of the investigation” for a product.

The agency did not name the drug in the public version of the letter, but Pfizer confirmed it related to the use of Geodon in children with bipolar disorder.

It said the company did not properly monitor the study and, “as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.”

Several children given overdoses experienced tremors, restless legs and other complications, the letter said.

Pfizer recognizes the issue’s seriousness and is committed to addressing the concerns, it said. Pfizer reported many items cited in the letter as many as four years ago, it said.

Since then it “has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators,” it said.

Read entire article:  http://www.reuters.com/article/idUSTRE63J4XQ20100420

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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/

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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

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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

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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

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