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“Study 15”: After Twelve Years of Silence, It’s Now Known as the Cursed Study

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Two physicians once leaned over to me during a break in a live radio interview and whispered, “It’s the joke in medicine: Newer is not necessarily better, especially when it comes to drugs.” I was dumbfounded. New drugs had to be better, right?

Indeed, the common wisdom in psychiatric circles has been that newer drugs are far better than their older counterparts. But a taxpayer-funded probe has revealed newly unearthed documents from Study 15—a long-term study of the drug Seroquel, an anti-psychotic medication which the FDA approved in 1997, declaring it to be safe and effective. The study was never published or shared with doctors, but it was shared with the US Food and Drug Administration.
While the FDA maintains it doesn’t have the authority to release such studies into the public domain, details of Study 15 have now emerged in lawsuits alleging that Seroquel caused weight gain, hyperglycemia (increased blood sugar), and diabetes in thousands of patients. A Washington Post analysis found that 4 out of 5 patients quit taking Seroquel in less than a year.
Study 15 also had a lot to say about the effectiveness of Seroquel. All anti-psychotic medications treat the symptoms of the disease—in this case, agitation, hallucinations, and delusions—but do not cure the disease. Comparing discontinuation rates (stopping the medication) as the best measure of drug effectiveness, Seroquel failed to outperform the older drug, Haldol, in preventing psychotic relapses.
Eight years after Study 15 was buried, a new study has found Seroquel to have few advantages over Haldol. It also found that 82% of patients stopped taking Seroquel because of its intolerable side effects. On top of that, Seroquel is ten times more expensive than older drugs to treat schizophrenia.
So whose interests does the FDA really safeguard? It is time to reform the FDA from the ground up. Please join us in our efforts.

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