March 09, 2007

Half Of Seroquel Sales Are Off-Label

That's according to this Bloomberg Wire Service article.

"Almost half of Seroquel sales in 2006 were for disorders for which AstraZeneca has yet to gain regulatory approval, according to Datamonitor Plc, a London-based market research firm. The other half was for approved indications such as treating schizophrenia and for bi-polar disorder, also known as manic depression, according to Terence McManus, a Datamonitor analyst.

The amount of off-label use is 'across the class,' McManus said in an interview March 6.

Seroquel sales increased 24 percent in 2006 to $3.4 billion. Revenue may jump 30 percent more this year to $4.4 billion, according to David Seemungal, an analyst at Standard & Poor's Equity in London. He estimates that Seroquel sales of London- based AstraZeneca will peak in 2010 at $5.75 billion."

Apparently, the situation is roughly the same for the other atypicals. Gosh, I wonder if Waxman's committee will ask about this.

Posted by Philip Dawdy at March 9, 2007 10:34 AM
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Comments

I believe it.

Posted by: Lisa at March 9, 2007 12:16 PM

Did you see the Wall Street Journal op-ed by the former FDA chairmen (now working at the prestigious conservative think-tank the American Enterprise Institute) railing the current FDA administration for advancing the idea fo stronger restrictions on off-label uses of medications.

The one time the FDA take progressive measures, the inside lobbying pharma-complex fights back in the guise of restriction of doctors "liberties".

The absurdity and hypocrisy are mind-boggling. Off label scripts have a place, its called open-label trials and supplemental new drug approval status (sNDA). It can be done by the books, ethically and scientifically.

I'm also wondering about legality of sNDA's by scientists/drug companies on drugs patented by other companies. You have any insight on this?

I think more lax laws on sNDA's on existing patents could spark more scientific discoveries and be an economic benefit by breaking down monopolization of drugs before patent expiration.

The AEI fellows probably wouldn't like that though. Goodness forbid liberty of scientific progress.

Posted by: zipzip at March 10, 2007 07:05 AM

As long as doctors seek to maintain a superior relationship with their patient (don't question--just blindly trust my EXPERT advice), not only will off-label prescribing continue unabated, so will the cavalier dispensing of "freebies." (Guess since the doctor passes out a "freebie," he can't be held liable for inappropriate prescribing?

Recently, husband's first visit with a (hopefully) new endo ended with the Dr. handing him a couple of 6-packs of FREE Lexapro (this mood enhancer "might" work very well to achieve lower blood pressure readings? Needless to say, the doctor was not hired, the search continues, and this doctor will continue to mis-treat patients.

Posted by: Melody at March 10, 2007 04:46 PM

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