Martha Rosenberg: Are You Bipolar? A Drug Company Hopes So

A BUZZFLASH GUEST CONTRIBUTION
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 its 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 9,000 lawsuits -- 15,026 plaintiffs -- alleging the company failed to adequately warn patients about Seroquel side effects such as 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.

There was "reasonable evidence to suggest Seroquel therapy can cause" diabetes and related conditions documents show, Wayne Geller, AstraZeneca's Global Safety Officer, wrote after analyzing available studies and internal trials, says Bloomberg news.

Created in 1988 and approved for schizophrenia in 1997, Seroquel had an "efficient" journey from R&D to sales. But in 2005, an article in the New England Journal of Medicine found Seroquel and other atypical antipsychotics except one had no advantage over the older antipsychotics such as Haldol and Thorazine, including the reduction in rigidity and tremors, which was sold as their advantage over the old drugs!

The same year, an article in the British Medical Journal found Seroquel and a similar atypical antipsychotic were ineffective in reducing agitation among Alzheimer's patients and actually made cognitive functioning worse.

And in AstraZeneca's own clinical trials, 2.4 percent of people who began treatment with normal blood sugar became technically diabetic after 52 weeks on Seroquel, plaintiff lawyer Paul Pennock testified at the Tampa pretrial hearing -- almost a 70 percent increase over those not taking the drug.

Nor can AstraZeneca claim it has marketed Seroquel legally and for approved uses only. On Thursday, January 3, 2008, an AstraZeneca sales rep "made an unsolicited sales call to a physician at his office" and "stated that Seroquel was approved for treatment of Major Depressive Disorder (MDD)," charges a letter in December sent to James L. Gaskil, Pharm.D., Director of AstraZeneca's Promotional Regulatory Affairs from FDA Regulatory Review Officer Amy Toscano, Pharm.D.

When the physician asked for written information, the rep sent a mailing with "information about Seroquel and Seroquel XR's use for MDD, and included summaries of eight clinical trials with referenced citations. This mailing was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements," charges the FDA.

AstraZeneca reps were even coached to sell product using the Winnie the Pooh figures Tigger -- bipolar! -- and Eeyore -- depressed! -- reports the pharma site Pharmalot.

The characterizations could come in handy. In December the AstraZeneca sought approval from the FDA for its ulcer drug Nexium for the "overlooked GERD population" of "patients ages 0 to 1 year old." Yes, infants!

"While some reflux and regurgitation are normal in infants and may not require medical treatment," says Marta Illueca, MD, AstraZeneca's Nexium Brand Medical Director, "Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants."

They may have bipolar disorder too.

A BUZZFLASH GUEST CONTRIBUTION

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