Tuesday, March 3, 2009

AstraZeneca Warned Doctors in Japan About Seroquel Link to Diabetes

Bloomberg News reports: "AstraZeneca Plc pushed salespeople to tell U.S. doctors its antipsychotic drug Seroquel didn't cause diabetes more than two years after warning physicians in Japan of possible links to the disease, internal documents show." The company sent a letter in November 2002 to Japanese doctors warning them that "12 reports" showed "that Seroquel users were diagnosed with high blood-sugar levels over a 21-month period, according to company documents unsealed last week in connection with litigation over the drug." According to AstraZeneca spokesperson Tony Jewell, "Every country has a different regulatory administration with different regulatory standards and requirements." However, the failure to disclose the information to the FDA has been called "irresponsible" and Sidney Wolfe, the director of Public Citizen's health-research group, said, "If there's enough evidence to warn people in Japan, there's enough evidence to warn people here."

Meanwhile, the St. Petersburg (FL) Times editorializes, "Beyond arbitrating private disputes, the courts play a key role in protecting the public interest" and "a federal magistrate in Orlando is deciding whether to open records of the drug company AstraZeneca or allow the maker of the blockbuster drug Seroquel to hide potentially embarrassing information." The Times says "Thousands of personal injury lawsuits have been filed against AstraZeneca by patients who claim the drug led to weight gain and diabetes" and "some 6,000 cases have been consolidated in the U.S. District Court in Orlando for pretrial hearings." The paper concludes, "The public has the right to know if a drug company is putting sales before safety - and if the FDA is acting in the public interest."

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