AstraZeneca Hid Bad Studies on Seroquel; Agrees to Increase Warnings

On Thursday, AstraZeneca, the manufacturer of Seroquel, a drug used to treat certain psychological conditions, agreed as part of court proceedings on the drug, to unseal and release certain documents to the public. Bloomberg News reports that these documents indicate AstraZeneca “buried” studies which were unfavorable about the drug. More than 15,000 people treated with Seroquel are suing the company claiming it withheld information regarding the relationship between Seroquel and diabetes from physicians and patients. There are also claims that Seroquel was promoted by AstraZeneca for uses that were not approved by the FDA. With regard to the suppression of these studies, one of AstraZeneca’s management is quoted as saying in an email that “The larger issue is how we face the outside world when they begin to criticize us for suppressing data.”
Bloomberg News further reports that one of the unsealed documents indicated that company officials felt one of the “buried” studies was a problem because it indicated weight gain while taking the drug. Gaining weight is known to be a factor in developing diabetes. The article goes on to discuss in detail several examples of AstraZeneca either hiding important study information from the FDA or working on how to “spin” information to avoid the negative implications. Where are the ethics? These are individuals bodies and health you are dealing with. Unfortunately, more indication that too many times its about the dollars and not about providing a safe and effective medication to the public.
At this same court proceeding, Bloomberg News also reports that lawyers for AstraZeneca indicated that it had agreed to strengthen the warning regarding Seroquel’s relationship to diabetes by moving it into the warnings and precautions section of the label, indicating there is a stronger link between the drug and diabetes. The litigation regarding this drug is continuing and I expect there will be further reports regarding some of the “confidential” documents which are now being made public. I will be sure to update if there is anything of significant interest.