Unpublished 1997 Study Linked Drug to Weight Gain and Diabetes, Now Thousands Sue Claiming They Were Not Warned of Side Effects
Filed under: Drugs & Medical Devices, FDA, Prescription Drugs, Transparency
Photo by Bangin via Wikimedia Commons
The Washington Post reported today on the “silenced drug study” of AstraZeneca’s antipsychotic drug, Seroquel. The study, known as Study 15, was conducted in 1997 and showed an increase in weight gain and diabetes among Seroquel users. The results were never published and the information was not released to the public or physicians. The study was, however, provided to the FDA but they did not have the authority to publish the results. Seroquel was approved by the FDA in 1997 after they received the study’s findings.
AstraZeneca contends that they did disclose the drug’s health risks on the label, as required by the FDA. Spokesperson Tony Jewell wrote in an email to The Washington Post that the results of Study 15 “did not identify any safety concerns.” Study 15 compared Seroquel to another similar drug, Haldol. Jewell also wrote that “A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret.”
Over 9,000 lawsuits have been filed against the drug by patients who experienced weight gain, hyperglycemia and diabetes. It is through these lawsuits that internal documents and details regarding the buried study have emerged. Internal documents show that AstraZeneca was well aware of the results indicating significant weight gain and worked to spin the results favorably. The company presented information that Seroquel caused patients to lose weight at two meetings in 1999. This data was based on a much smaller company-sponsored study even though AstraZeneca had concerns with the study and the doctor who conducted it.
The Washington Post says:
The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.
An obvious concern with unpublished or silenced studies is that they may lead physicians to make medical decisions without all the information that should be available to them. As the Center for Health and Pharmaceutical Law & Policy recommends in its recently-released whitepaper:
All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature. Transparency in the relationship of industry and physicians would be critical tool in this effort.
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