Seroquel Maker Denied Diabetes Link to U.S. Doctors While Warning Them in Japan, Documents Show

AstraZeneca PLc, the drug company behind the popular antipsychotic drug Seroquel, insisted to U.S. doctors that the drug did not cause diabetes several years after the company had warned Japanese physicians of the apparent link between the two, newly released internal company documents show.

Internal company communications and documents being released as part of a pending lawsuit against the pharmaceutical giant by a patient who developed diabetes after taking the drug are offering an amazing and disturbing insight into how Seroquel, a blockbuster drug that generate $4.5 billion in sales in 2008, was marketed.

Warning Issued in Japan, Link Denied in U.S.

In November 2002, AstraZeneca sent a letter to Japanese physicians saying that over the course of less than two years, the company had received a dozen reports of Seroquel patients being diagnosed with high blood-sugar levels. One of the diagnosed patients died while others were left in a diabetic coma, the company warned.

However, three years later, company sales representatives were still telling doctors in the United Sates that there was no proof that Seroquel caused diabetes.

The company now faces about 15,000 personal-injury lawsuits from Seroquel patients who argue that the company failed to warn them or their doctors about the increased risk of diabetes from the drug while withholding vital information showing a link between the drug and the disease.

Some of those people suing the company say AstraZeneca also illegally promoted Seroquel for off-label, unapproved uses, including for the treatment of schizophrenia and bipolar disorder. It is illegal for drug companies to push for drugs to be used off-label to treat conditions that have not been approved by the Food and Drug Administration.

The documents detailing AstraZeneca’s marketing of Seroquel came to light after the company agreed to release more than 100 files concerning the drug in response to a Bloomberg News motion filed seeking to unseal the records in federal court in Orlando, Florida.

Delay in Warning U.S. Doctors

In the 2002 letter to Japanese physicians, AstraZeneca said the 12 diabetes-related cases had been reported from 130,000 patients who had taken Seroquel through the end of September 2002. The company advised Japanese doctors not to prescribe the drug for diabetic patients and to ensure that users monitor their blood-sugar levels closely to avoid devastating injuries.

By contrast, in the United States, Seroquel’s label was not changed to warn doctors and users about the need to monitor blood-glucose levels in patients until January 2004.

Shining a Light on Drug Company Dealings

Bloomberg News should be applauded for helping expose the evidence of bad-faith dealing and double-speak employed by AstraZeneca officials with regard to their drug, Seroquel. Using the company’s own documents to show contradictions in how the drug was sold to doctors in the United States for years after physicians in Japan had been sternly warned about the risk of developing diabetes is shocking and saddening. It raises serious questions about the risks of other popular drugs.

Tens of thousands of American consumers were unnecessarily put at risk of diabetes, all in the name of earning bigger profits for a huge drug company. If not for the diligent work of Bloomberg News to unseal the court documents and bring them out into the light of day, millions more might continue to take the drug.

We will be watching closely as the current lawsuit against AstraZeneca plays out in court and keeping an eye out for more bombshells from the newly released company documents.

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