Posts Tagged ‘Risperdal’

Internal documents show drug company marketed their antipsychotic Risperdal for unapproved usage on elderly & kids

Wednesday, March 10th, 2010

Bloomberg.com
By Margaret Cronin Fisk, Jef Feeley and David Voreacos
March 10, 2010

Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.

The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.

“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”

Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.

“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601109&sid=ag4Ya8UOIob0&pos=13

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Kickbackers’ motto: ‘Do no harm’ (to profits)—How drug company used kickbacks to get patients on psych drugs

Tuesday, January 26th, 2010

Boston Globe
By Donald A. MacGillis
January 26, 2010

TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.

Risperdal is used principally for the treatment of schizophrenia and bipolar disorder. Doping the elderly into placidity is an off-label use of the drug, one that the Food and Drug Administration finally cautioned against in 2005. The reason for the black box warning the FDA required? Too many of the elderly who got the drug were dying.

There is one other reason to thank the federal government for going after the suspect payments Johnson & Johnson made to the middleman to juice up sales of its drugs: Since Medicaid covers most of the nursing home patients, the taxpayer ends up paying much of the bill.

The middleman between Johnson & Johnson and the nursing homes is Omnicare, the country’s largest pharmacy for nursing homes. Last November, it agreed, without “any finding of wrongdoing’’ or “any admission of liability,’’ to a $98 million settlement with the government for its role in helping Johnson & Johnson boost sales to nursing homes. The government says that between 1999 and 2004 Omnicare received tens of millions of dollars in the form of escalating rebates based on greater market share for Johnson & Johnson drugs and in payments ostensibly made by Johnson & Johnson for “data’’ from Omnicare, much of which Omnicare never provided. Other kickbacks, the government says, came in the form of “grants’’ and “educational funding.’’

Read entire article:  http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/01/26/kickbackers_motto_do_no_harm_to_profits/

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Drugmaker that got kickbacks for giving antipsychotics to nursing home patients deserves “a special place in hell”

Tuesday, January 19th, 2010

Baltimore Chronicle & Sentinel
By James Ridgeway
January 17, 2010

There really should be a special place in hell for pharmaceutical manufacturers who make money by exploiting the weakest and most vulnerable of patients: old people with dementia. I wrote about one such case back in April of last year:

Pharmaceutical giant Eli Lilly recently agreed to pay a record $1.4 billion dollars to settle charges that it illegally marketed the anti-psychotic drug Zyprexa as a treatment for Alzheimer’s and other forms of dementia in elderly patients. This despite the fact that the drug was not only unapproved for this “off-label” use, but had also been shown to cause obesity and diabetes.

Now, $1.4 billion might sound like a tough punishment, until you find out that Lilly’s total sales of Zyprexa have topped $37 billion. And at least some of those sales were thanks to doctors who, with guidance from Lilly drug reps, wrote thousands of prescriptions for patients with virtually no ability to defend themselves.

The steep fine against Lilly apparently didn’t discourage another drugmaker, Johnson & Johnson, from using even sleazier tactics to promote its own lucrative antipsychotic for use on nursing home residents. As the New York Times reported on Friday:

Johnson & Johnson paid kickbacks to the nation’s largest nursing home pharmacy to increase the number of elderly patients taking the antipsychotic Risperdal and several other medications, according to a complaint filed Friday by the office of the United States attorney in Boston.

Read entire article:  http://baltimorechronicle.com/2010/011810Ridgeway.shtml

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Feds say Johnson & Johnson paid millions in kickbacks to increase drug sales including the antipsychotic Risperdal

Friday, January 15th, 2010

Wall Street Journal
By Jonathan D. Rockoff
January 15, 2010

Federal prosecutors alleged that Johnson & Johnson paid one of the nation’s largest pharmacies serving nursing homes “tens of millions of dollars in kickbacks” to increase sales of drugs including blockbuster antipsychotic Risperdal.

Prosecutors charged in a complaint filed in federal court in Boston Friday that J&J illegally paid Omnicare Inc. to get the pharmacy company to buy J&J medicines and recommend their use to nursing homes. Omnicare’s yearly purchases of J&J products nearly tripled to $280 million, prosecutors alleged.

The alleged payments took place from 1999 to 2004 and took various forms, including payments for the pharmacy’s data and for education programs for customers, prosecutors said. Omnicare charged Medicaid for a “substantial portion,” they said.

Read entire article:  http://online.wsj.com/article/SB10001424052748703657604575004902853166786.html?mod=WSJ_hpp_sections_business

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Risperdal (an antipsychotic) Lawsuits Filed Over Breast Growth Among Boys

Monday, January 11th, 2010

AboutLawsuits.com
January 11, 2010

At least 10 families have filed lawsuits against the makers of Risperdal and Invega, alleging that the antipsychotic medications, often used to treat attention deficit disorder and autism, caused teen boys to grow breasts measuring as large as a 38D cup size in some cases.

The lawsuits were filed recently in the Philadelphia Court of Common Pleas by the families of boys who took the medications and experienced the noticeable breast growth side effects. The Invega and Risperdal lawsuits accuse the manufacturers of negligence and fraud, and say they failed to adequately warn users about the potential male breast growth effects of the drugs when given to teen boys. Most of the lawsuits involve the use of Risperdal alone.

Risperdal (risperidone) and Invega (paliperidone) are manufactured by Janssen, a division of Ortho-McNeil-Janssen, a subsidiary of Johnson and Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism. Invega is approved for the treatment of schizophrenia.

The complaints allege that the boys experienced dramatic breast growth that was in addition to significant weight gain side effects of Risperdal and Invega. The boys’ doctors initially missed or dismissed signs of breast growth, assuming it was connected to the increases in weight. In some cases, the boys grew breasts as large as 38D, and the complaints indicate that some of the youths will require surgery for breast removal.

Read entire article: http://www.aboutlawsuits.com/risperdal-lawsuits-over-breast-growth-boys-7598/

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Rate of 2 to 5-year-old’s being given psychiatry’s most powerful/brain damaging drugs – antipsychotics – doubles.

Tuesday, January 5th, 2010

Jennifer Thomas
BusinessWeek
January 4, 2010

The rate of children aged 2 to 5 who are given antipsychotic medications has doubled in recent years, a new study has found.

Yet little is known about either the effectiveness or the safety of these powerful psychiatric medications in children this age, said researchers from Columbia University and Rutgers University, who looked at data on more than 1 million children with private health insurance.

“It is a worrisome trend, partly because very little is known about the short-term, let alone the long-term, safety of these drugs in this age group,” said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University in New York City.

Prescribing antipsychotics to children in the upper range of that age span — ages 4 and 5 — is justifiable only in rare, intractable situations in which all other treatments, including family and psychological therapy, have been tried and are not working, Olfson said.

And it’s questionable whether 2- and 3-year-olds should ever be prescribed antipsychotics, Olfson said.

Read entire article: http://www.businessweek.com/lifestyle/content/healthday/634536.html

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US Kids Represent Psychiatric Drug Goldmine

Monday, December 14th, 2009

Truthout
Evelyn Pringle
December 12, 2009

Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.

On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.

In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.

Read entire article: http://www.truthout.org/1213091

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With 2 million kids on antipsychotics (extremely powerful/dangerous drugs) FDA finally urges review of use in kids

Friday, December 4th, 2009

AttorneyAtLaw.com
December 4, 2009

The use of powerful antipsychotic drugs like Seroquel and Zyprexa in children should be further studied to determine the risks of metabolic disorders and other serious health complications, Food and Drug Administration staffers say in a new report.

FDA drug reviewers said medical researchers have found a direct link between the use of so-called atypical antipsychotics in younger children and weight gain, high cholesterol, and increased blood pressure, according to a Reuters news report.

Seroquel, Zyprexa and similar antipsychotic drugs are not approved for use in children, but an estimated two million American children are given the drugs by doctors each year to treat a variety of psychiatric disorders. An FDA advisory panel recently recommended approving their use in kids.

The research findings should prompt further FDA evaluation to determine the extent of the risks and possibly take action to limit the use of Zyprexa, Seroquel, and similar drugs in younger age groups, staff in the FDA’s division of pharmacovigilance wrote in an October 14 memo, according to Reuters.

Read entire article: http://www.attorneyatlaw.com/2009/12/fda-staff-urges-more-review-of-seroquel-and-zyprexa-use-in-kids/

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Antipsychotics Like Seroquel Blamed for Deaths and Strokes

Monday, November 16th, 2009

AboutLawsuits.com
November 16, 2009

According to a new report, side effects of antipsychotics, such as Seroquel, Zyprexa, Risperdal and Abilify, could be responsible for as many as 1,800 deaths and 1,620 strokes each year among the elderly with dementia in the United Kingdom.

The report, which was commissioned by the British government, found that the use of antipsychotics for dementia has been largely ineffective, resulting in improvement in only 20% of patients. As a result of the findings, the U.K. Department of Health has initiated plans to reduce the use of atypical antipsychotic drugs like Zyprexa, Risperdal, Abilify and Serquel for dementia in its own health system, and hopes that the reduction will be picked up by other nations as well.

There are an estimated 180,000 elderly people with dementia in the United Kingdom currently being treated with the antipsychotic drugs, according to the report’s author, Professor Sube Banerjee. However, only 36,000 were found to derive any benefit from the drugs.

“The findings of my review confirm that there are indeed significant issues in terms of quality of care and patient safety,” said Banerjee, professor of mental health at King’s College London Institute of Psychiatry, in a letter to the Minister of State that accompanied the report. “These drugs appear to be used too often in dementia and, at their likely level of use, potential benefits are most probably outweighed by their risks overall.”

Read entire article: http://www.aboutlawsuits.com/antipsychotics-for-dementia-blamed-for-deaths-6965/

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$112 million settlement: charged with kickbacks from drug company & recommending docs prescribe antipsychotic drug Risperdal

Wednesday, November 4th, 2009

Reuters
November 3, 2009

Omnicare Inc, the largest U.S. provider of pharmacy services to nursing homes, will pay $98 million and Teva subsidiary IVAX Pharmaceuticals will pay $14 million to settle allegations of kickbacks, the U.S. Department of Justice said on Tuesday.

The department said Omnicare both solicited and paid kickbacks.

Omnicare allegedly asked IVAX to pay $8 million in exchange for agreeing to purchase $50 million in IVAX drugs, the DOJ said.

It also accused Omnicare of soliciting kickbacks from Johnson & Johnson in exchange for recommending that physicians prescribe the antipsychotic drug Risperdal to nursing home patients.

“J&J’s kickbacks to Omnicare took multiple forms, including rebates that were conditioned on Omnicare engaging in an ‘Active Intervention Program’ for Risperdal and payments disguised as data purchase fees, educational grants, and fees to attend Omnicare meetings,” the Justice Department said.

Read entire article: http://www.reuters.com/article/healthcareSector/idUSN0350746820091103

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