Should Drug Makers Be Given a Mulligan on Negative Clinical Studies? Disturbing Details Emerge From ‘Buried’ Seroquel Study

Results from a clinical study of the antipsychotic drug Seroquel, which were buried by the drug’s maker, AstraZeneca, show the drug caused patients to gain weight, exposing them to an increased risk of developing diabetes and other blood sugar disorders.

The research, dubbed Study 15, found that patients taking Seroquel study gained an average of 11 pounds in one year, findings which alarmed AstraZeneca scientists and officials. The study also showed that Seroquel did no better in controlling psychotic relapses than Haldol, an older drug competing with Seroquel for a share of the huge antipsychotic drug market.

Study 15 also determined that about 80 percent of Seroquel takers quit the drug in less than a year.

Earlier this month, it was reported that Study 15 was ‘buried’ by AstraZeneca officials due to the negative findings, but the details of the study’s findings were not released until now. The Food and Drug Administration reviewed Study 15’s results at the time they were reached, but the agency is not required to publicize detailed information on research data submitted by drug companies.

An AstraZeneca worker, in an internal company email later released, reportedly praised the company at the time for conducting a “great smoke and mirrors job” in concealing the negative results of Study 15.

Questions Surround Burying of Drug Studies

Anyone who has played golf and hooked a ball into the woods or sliced one into the lake knows what it means to take a mulligan, or a “do over.” While such freebies are only for fun in golf, when it comes to drug companies conducting clinical trials of new drugs, the lives and health of millions of Americans is at stake. AstraZeneca took a mulligan on Study 15 and only now, years later, are we finding out just how poorly Seroquel performed in the study.

Company officials knew then that their drug could result in weight gain, possibly leading to diabetes and other severe problems. But instead of stopping the research and revisiting Seroquel later, AstraZeneca just tucked Study 15 away in a filing cabinet and hoped no one would ever find out about the findings.

FDA Drug Study Disclosure Rules Should be Tightened

FDA rules should be changed to require the agency and drug companies to tell the public more details about the results of new drug clinical studies, even those which reach negative results. By stacking the deck and releasing the results of only those studies which come to favorable conclusions about the risks and efficiency of drugs like Seroquel, drug companies and the FDA paint a false, overly rosey image of the drugs.

The truth is, Seroquel was shown to cause patients to gain weight and develop diabetes and other blood sugar disorders long before the drug ever hit pharmacy shelves, but AstraZeneca and the FDA kept the results from ever being publicized. The result is, thousands of people died or suffered injuries that never had to happen.

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