Posts Tagged ‘Zyprexa’

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After $1.4 billion criminal fine for illegal marketing, Eli Lilly tries something new—promoting “ethical behavior”

Monday, March 8th, 2010

IndyStar.com
John Russell
March 8, 2010

Eli Lilly and Co. has agreed to add four new senior positions to “promote highly ethical and compliant behaviors” as part of a settlement of two lawsuits arising from the company’s illegal marketing and promotion of several drugs.

The Indianapolis drugmaker also has agreed to upgrade its policies and procedures to ensure that patient safety “shall be of paramount importance,” according to a government filing the company made today.

Last year, Lilly paid $1.4 billion, the largest criminal fine ever imposed on a U.S. corporation, over the illegal marketing of Zyprexa. The company also pleaded guilty to a misdemeanor and agreed to additional oversight to resolve a 5-year-old federal investigation.

Federal prosecutors had said Lilly unlawfully promoted Zyprexa for agitation, aggression, hostility, dementia, depression and generalized sleep disorder, although the drug was approved only for schizophrenia and bipolar disorder.

The company had also improperly marketed Evista, its osteoporosis drug, and Prozac, its antidepressant.

In response, several shareholders sued the company, claiming it breached fiduciary duty in connection with the illegal marketing, exposing Lilly to substantial risk of damage. The suits are known as “derivative claims” as they were brought by shareholders on behalf of the company, rather than on behalf of shareholders, seeking to force the company to take corrective steps.

Read entire article:  http://www.indystar.com/article/20100308/BUSINESS/3080383/Eli-Lilly-adding-four-ethics-watchdogs

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Lawyer who took on drug giant Eli Lilly & won has a new target—the psychiatric industry & drugging of foster kids

Friday, February 12th, 2010

KTUU.com
By Rhonda McBride
February 11, 2010

ANCHORAGE, Alaska — An Alaska attorney who has gone up against a drug giant and won has a new target.

Jim Gottstein is taking on psychiatry in Alaska for over-prescribing medicine to children.

Gottstein was the attorney who forced Eli Lilly to pay more than $1 billion in settlements over the anti-psychotic drug Zyprexa.

He also heads up a group called the Law Project for Psychiatric Rights, which filed the lawsuit. The group claims over-prescribing is disabling children for life.

A growing number of children are prescribed psychiatric drugs, and a growing number of mental health advocates say we should be alarmed, because those drugs are often unnecessary

“They’re really a chemical lobotomy, because that’s what they do to the brain,” Gottstein said.

The list of those named in Gottstein’s lawsuit is long: More than a dozen child psychiatrists, health agencies, state officials, and pharmacies that include Walmart, Fred Meyer and Safeway.

“Eighteen-year-olds are having heart attacks from these drugs,” Gottstein said.

He says he’s tried to get the state and Alaska psychiatrists to use more restraint.

He says they are using powerful drugs on children that are intended for adults.

“People put on these drugs have a life expectancy of 25 years shorter than the general population. These drugs are so harmful, that they literally kill people,” Gottstein said.

Read entire article:  http://www.ktuu.com/Global/story.asp?S=11974882

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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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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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Pharma Funded FDA’s Christmas Present to Drug Companies: Approving use of deadly antipsychotic drugs for kids

Thursday, December 31st, 2009

Martha Rosenberg
OpEdNews.com
December 30, 2009

You couldn’t get much naughtier than Eli Lilly in 2009 who agreed to pay $1.42 billion for mismarketing Zyprexa and Pfizer who agreed to pay $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud.

Pharma will continue to dole out such payouts and consider them a slap on the wrist says a Bloomberg article until prosecutors and judges “use the ultimate sanction, a felony conviction that would render a company’s drugs ineligible for reimbursement by state health programs and federal Medicare.”

Nor did the mismarketing and fraud only enrich drug companies and loot Medicaid and Medicare tax dollars.

Doctor have also cleaned up like Chicago psychiatrist Michael Reinstein who received $500,000 to promote a drug that Medicaid records say he prescribed 41,000 times according to Chicago Tribune and Propublico, figures Reinstein disputes.

And Miami psychiatrist Fernando Mendez-Villamil who wrote 97,000 psychoactive prescriptions for Medicaid patients over 18 months says the Miami Herald –153 prescriptions a day. His prescribathon even drew a letter from Sen. Charles Grassley, ranking member of the Senate Finance Committee.

Read entire article: http://www.opednews.com/articles/-Naughty-Pharma-Still-Got-by-Martha-Rosenberg-091230-724.html

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Op Ed: New Year’s Resolutions for the Drug Industry for 2010

Wednesday, December 23rd, 2009

Martha Rosenberg
OpEdNews.com
December 23, 2009

There was only one thing worse than being unemployed in 2009: working for the drug sector.

Not only did the two biggest drug settlements in US history occur in 2009–Eli Lilly’s $1.42 billion for mismarketing Zyprexa and Pfizer’s $2.3 billion for Bextra, Geodon, Lyrica and Zyvox fraud–the Supreme Court ruled people can sue if they’re harmed by a prescription drug even if it had FDA approval.

No wonder Wyeth and Pfizer and then Merck and Schering-Plough formed defensive mergers in 2009, the former timed to knock out headlines about the Bextra settlement.

High profile suicides also occurred in 2009 prompting the FDA to add black box warnings to the asthma drugs Singulair, Accolate and Zyflo, the antismoking drugs Chantix and Zyban and authorities to question the antidepressants given to 80 percent of Iraq war veterans with post traumatic stress disorder.

The open secret of industry subsidized journal articles and Continuing Marketing, sorry Medical Education courses (CMEs) also came under Congressional investigation in 2009–as did the drug industry ties of faux grassroots groups like the National Alliance on Mental Illness (NAMI) and high flying researchers like Harvard’s Joseph Biederman, MD.

Read entire article: http://www.opednews.com/articles/New-Year-s-Resolutions-for-by-Martha-Rosenberg-091223-751.html

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That British Drug Maker Glaxo’s $1 Billion Paxil Settlements Were Disclosed by Press – Not Drug Maker – Is Cause for Concern

Tuesday, December 15th, 2009

Jim Edwards
BNET
December 15, 2009

British drug company GlaxoSmithKline (GSK) has paid $1 billion to settle lawsuits related to Paxil. The fact that it was disclosed by Bloomberg and not the company itself illustrates how lousy financial disclosure rules are in Europe and why drug companies based there cannot be trusted to tell the truth about what is going on with their litigation liabilities and, by extension, the safety of their drugs.

Bloomberg got the $1 billion number by piecing together litigation records, analysts’ reports and GSK’s own partial statements on the issue. But compare the Paxil situation with those faced by Eli Lilly (LLY) and AstraZeneca (AZN). Both companies have been engaged in litigation that has cost them billions (over the antipsychotics Zyprexa and Seroquel, respectively). And both companies have disclosed the full legal bill attached to those suits. (It’s more than $3.3 billion for Lilly and $1.1 billion for AZ.

Those numbers were disclosed in both companies’ earnings reports. Interestingly, Lilly disclosed them because it was required to report anything “material” by the SEC — it’s an American company and that’s the law. Fines and prosecutions await American firms that fail to report bad news.

Read entire article: http://industry.bnet.com/pharma/10005807/gsks-1b-paxil-problem-highlights-murky-disclosures-from-euro-drug-companies/

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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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FDA ‘considers’ Antipsychotic drug labels warning of weight gain/diabetes. Considers? Do your job-issue the warnings.

Wednesday, December 9th, 2009

Jennifer Corbett Dooren
The Wall Street Journal
December 8, 2009

WASHINGTON (Dow Jones)–A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.

Thomas Laughren, the director of FDA’s division of psychiatric products, said the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose, which can cause diabetes and blood cholesterol levels which can lead to cardiovascular problems over time.

While the labels of the drugs already discuss weight gain and its associated problems, Laughren said the agency is considering putting all the information in the warnings section, which would amount to a strengthening of the warning.

Laughren made his comments Tuesday at a pediatric advisory committee meeting which was reviewing the safety of several drugs used in children, including antipsychotics.

Laughren said the labels for AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa were already changed last week when the agency approved the products for use in younger patients and, in Seroquel’s case, when it was approved as an add-on treatment for major depression. However, he said all of the drug labels in the class could change as the FDA continues its “comprehensive” review.

The drugs are used to treat a variety of mental illnesses, including bipolar disorder, schizophrenia and depression that doesn’t respond to other types of medication.

A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

In advance of the pediatric panel meeting, FDA staff recommended the agency should conduct an additional review of antipsychotic drugs to look at the impact of weight gain in children. Several studies have shown children and adolescents gain weight at a faster rate than adults.

Other drugs in the class include Risperdal, made by a unit of Johnson & Johnson (JNJ); Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co.; and Pfizer Inc.’s (PFE) Geodon. Antipsychotics were the top-selling drug class in the U.S. last year, with $14.6 billion in sales, ahead of the $14.5 billion in sales of cholesterol drugs, according to IMS Health.

See article: http://online.wsj.com/article/BT-CO-20091208-714877.html

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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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