Posts Tagged ‘diabetes’

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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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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Drugmaker pays psychiatrist nearly $500,000 to promote antipsychotic drug Seroquel despite misgivings about his research

Friday, November 13th, 2009

Christina Jewett, ProPublica
SamRoe, Chicago Tribune
November 11, 2009

Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues.

“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.

Read entire article: http://www.chicagotribune.com/health/chi-drugs-seroquel-reinsteinnov11,0,6067737.story

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Children on antipsychotics 3 times more likely to develop diabetes (a known side effect of antipsychotics)

Thursday, November 12th, 2009

Kelly Sinoski
Vancouver Sun
November 11, 2009

Children and youth on certain antipsychotic medications are more prone to getting diabetes and becoming fat, according to a new study published in the Canadian Journal of Psychiatry.

But the British Columbia doctors involved in the two-year study say parents shouldn’t rush to take their children off the drugs and instead should consult their physicians on ways to monitor and beat the metabolic side-effects.

“On the one hand, the medication has significant and worrying side-effects,” said study co-author Dr. Jana Davidson, medical director of child and adolescent mental health and addiction programs at BC Children’s Hospital.

“On the other hand, in some of these cases the kids being on medication is what allows them to function in their lives and allows them to stay in their families.”

About 6,000 youth in B.C. are on antipsychotic medications and prescription rates have been soaring in the past five years, according to the study.

Between 2002 and 2006, prescriptions of atypical or second-generation antipsychotics for B.C. youth rose by about 22 per cent, from one in 200 youth to one in 154.

Read entire article: http://www.vancouversun.com/health/Children+antipsychotic+drugs+more+prone+diabetes+Canadian+study/2212393/story.html

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Forbes: New study shows “Hefty Side Effect For Kids On Antipsychotics”

Wednesday, October 28th, 2009

Robert Langreth
Forbes
October 27, 2009

A new study is likely to add to the furious debate over the rapid rise in the prescription of heavy-duty antipsychotic drugs to children. It found that kids’ weight balloons by 10 to 19 pounds in just the first three months on the drugs, often leading to worrisome elevations of cholesterol, triglycerides and other metabolic parameters.

Weight gain is a known side effect of the drugs, but the new study is notable because it found far greater increases than had been seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class of medications, called atypical antipsychotic drugs.

“Weight gain was pervasive even in medications usually considered to be weight neutral in adults,” says Albert Einstein College of Medicine psychiatrist Christoph Correll, who led the study, which was conducted at the Zucker Hillside Hospital in Queens, N.Y. “The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes.”

Read entire article: http://www.forbes.com/2009/10/27/antipsychotics-lilly-astrazeneca-business-healthcare-children.html

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