Are You Sure You're Not Psychotic Asks Shameless Drug Company?

December 28, 2008 at 11:38:45


Promoted to Headline (H3) on 12/28/08:
Are You Sure You're Not Psychotic Asks Shameless Drug Company?

by Martha Rosenberg Page 1 of 2 page(s)

www.opednews.com

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.

In December the FDA denied approval of Seroquel for major depressive disorder and asked the company instead for more information in a complete response letter (CRL).

Oops.

Of course to be AstraZeneca's number two pill, Seroquel must be used by more than the nation's schizophrenia and bipolar disorder patients who number only 8 million.

Almost half of Seroquel's 2006 sales were for off label uses says Bloomberg news including depression, autism and hyperactivity in adolescents and dementia, insomnia and Alzheimer's disease in the elderly.

Which wouldn't be so bad if Seroquel were safe.

But AstraZeneca faces nine thousand lawsuits--15,026 plaintiffs-- alleging the company failed to adequately warn patients about Seroquel side effects like severe weight gain, diabetes and pancreatitis.

Even as AstraZeneca vowed to defend the suits on their merits and not capitulate like Lilly with its $1.48 billion settlement with 32 states over similar drug Zyprexa this year, more bad ink spilled.

Documents surfaced in December that showed AstraZeneca knew as far back as 2000 about Seroquel's dangerous side effects at a pretrial hearing in a Tampa, Florida federal court for an upcoming Seroquel trial.