Psych Observer – Exposing Bad Psychiatry

By Miriam Hill |Inquirer Staff Writer

Shortly after new antipsychotic drugs came on the market in the late 1990s, the Food and Drug Administration started to worry that they might trigger diabetes in some patients.

So in 2000, the FDA asked AstraZeneca P.L.C. and other pharmaceutical companies to share data on cases of new-onset diabetes and related illnesses in patients taking the drugs. London-based AstraZeneca, which has U.S. headquarters in Wilmington, told the FDA that patients and doctors had reported 12 new cases of diabetes and five cases of related illnesses among the 623,000 who had taken its antipsychotic drug Seroquel.
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WASHINGTON, March 3 (Reuters) – U.S. regulators will ask outside advisers for input on safety concerns surrounding expanded use of AstraZeneca Plc’s (AZN.L: Quote, Profile, Research, Stock Buzz) schizophrenia drug Seroquel XR, the Food and Drug Administration said on Tuesday.

The issues for discussion at the April 8 advisory panel meeting include “concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia,” an FDA notice said.
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* Story Highlights
* Atypical antipsychotic drugs associated with higher risk of sudden cardiac death
* Atypicals were thought to be safer than older, so-called “typical” antipsychotics
* Three atypical antipsychotics are among the 10 top-selling drugs worldwide
* About 325,000 people in the U.S. die of sudden cardiac death each year

By Anne Harding

Susan Craig’s brother Roger died of a pulmonary embolism in 2007, at age 38. Diagnosed with bipolar disorder in high school, he had been on antipsychotic drugs for years. At the time of his death, he was carrying 280 pounds on his 6-foot-4-inch frame.

Craig, a public relations specialist who works at Columbia University in New York City, knew that Roger’s medications could cause weight gain. But she had never been told that the drugs he was taking might be harming his heart.

“We were never counseled by his psychiatrist or his primary care provider to watch for symptoms of heart disease or any risk of sudden death at all,” Craig says. There’s no evidence that Roger’s medications caused his death, but his family might have been able to get him help sooner if they had known about the risks, Craig explains.
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Nashville, TN, January 15: Atypical antipsychotics, a widely prescribed class of drugs that help combat psychiatric disorders like schizophrenia, autism and dementia, may actually double the patients’ risk of fatal heart attacks, just as the older drugs, a study has found.

The study conducted at the Vanderbilt University and the Nashville Veterans Affairs Medical Center analyzed Medicaid records (from 1990 to 2005) of nearly 277,000 people aged between 30 and 74 years. While one-third of the people were taking either a newer or an older version of the antipsychotics, two-thirds were nonusers.

For each antipsychotic drug user, two age and sex matched non-users were assessed. During follow-up period, 478 sudden cardiacdefine deaths occurred among those taking the drugs – twice the rate that occurred in the control group, researchers report.

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By Martha Rosenberg
If 100 million Americans have high cholesterol and only 8 million have schizophrenia or bipolar disorder, how can AstraZeneca’s Seroquel, not cholesterol pill Crestor, be its second best selling pill?

Right after its number one pill, the Purple Performer Nexium?

Can anyone say disease mongering?

For years, AstraZeneca has tried to convince depressed people they are really bipolar and need to take the atypical antipsychotic Seroquel (quetiapine fumarate) which is only approved for schizophrenia or bipolar disorder.

“Is It Really Depression or Could It Be Bipolar Disorder?”  trumpet the ads, urging unaware victims to take a Symptom Quiz and find out how sick they really are.

Full color spreads run in general interest magazines showing a rampaging woman her mouth contorted – think female Dark Knight – asking readers is this you?

“Are there periods of time when you have racing thoughts? Fly off the handle at little things? Spend out of control? Need less sleep? Feel irritable? You may need treatment for bipolar disorder.”

Now the FDA says AstraZeneca can not – repeat not – market Seroquel for depression.

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By Bruce E. Levine, AlterNet
Posted on July 23, 2008, Printed on July 24, 2008

American psychiatry has been rocked by Congress. Congressional investigators first exposed the financial relationships between high-profile psychiatrists and drug companies. “But now the profession itself is under attack in Congress,” reported the New York Times on July 12, 2008.

Specifically under attack is psychiatry’s premier professional organization, the American Psychiatric Association. The New York Times stated, “In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.”

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AstraZeneca’s CEO to be Deposed in London on Friday, June 20, 2008 NEW YORK, June 19

NEW YORK, June 19 /PRNewswire/ — Weitz & Luxenberg, PC, one of the
leading plaintiffs’ litigation law firms in America, filed a lawsuit today
against pharmaceutical giant AstraZeneca on behalf of a New York City Fire
Department Emergency Medical Technician whose diabetes was allegedly caused by
AstraZeneca’s drug Seroquel. The plaintiff, EMT Ernest Armstead, was one of
the many brave responders on the morning of September 11, 2001. He was
severely injured when the World Trade Center’s North Tower collapsed as he was
helping victims at the foot of the buildings.

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The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of “conventional” antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for “atypical” antipsychotic drugs. At that time, Boxed Warnings, the FDA’s strongest, were added. The Boxed Warning will now be added to an older class of drugs known as “conventional” antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

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New York psychiatrist Jeffrey Lieberman has heard Johnson & Johnson’s (JNJ) sales pitch for the new anti-schizophrenia drug Invega, but he’s not too impressed.

Problem is, Invega isn’t much different than one of J&J’s best-selling drugs, the antipsychotic Risperdal. In late June, Risperdal is scheduled to lose its U.S. patent protection, clearing the way for competing generic copies that are cheaper than Invega, which could further diminish Invega sales, already characterized as a disappointment by J&J.

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A Canadian study has found that prescribing antipsychotic drugs for elderly people may be dangerous.

Antipsychotic therapy is widely used to manage behavioural problems such as aggression which is sometimes associated with dementia; they are often prescribed prior to admission to a nursing home.

They are commonly used to treat psychosis with conditions such as schizophrenia, bipolar disorder, mania and delusional disorder.

The researchers from the Institute for Clinical Evaluative Sciences (ICES) in Ontario say elderly patients who are given antipsychotic drugs are at an increased risk of having an event that is serious enough to lead to hospitalization or death within a month of starting the therapy.

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