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

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

by Martha Rosenberg

December 28, 2008 at 11:38:45

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.

There was " reasonable evidence to suggest Seroquel therapy can cause "

diabetes and related conditions wrote Wayne Geller, AstraZeneca's

Global Safety Officer 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 like 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 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 sent to L. Gaskil, Pharm.D., Director

of AstraZeneca's Promotional Regulatory Affairs from FDA Regulatory

Review Officer Amy Toscano, Pharm.D. in December.

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 A.A.

Milne figures Tigger--bipolar!--and Eeyore--depressed!-- reports the

pharma site Pharmalot.

The characterizations could come in handy.

In December AstraZeneca sought approval from the FDA for Nexium for

the " overlooked GERD population " of " patients ages 0 to 1 year old. "

" 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.

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