Seroquel Diabetes Risks Hidden, Documents ShowFeb 27, 2009 | Parker Waichman LLP
Recently unsealed documents indicate that Seroquel maker AstraZeneca many have attempted to hide the antipsychotic drug's diabetes risks. The documents - which include company emails and voicemails - add weight to claims that AstraZeneca hid Seroquel's serious side effects for years.
According to The Wall Street Journal, Seroquel - which was introduced in 1997 - has long been linked to a risk of weight gain and diabetes. Information on this risk was originally included in the "Adverse Reactions" section of its label. In 2003, the Food & Drug Administration (FDA) required AstraZeneca to give the information added prominence by moving it to the label's "Warnings" section. Then last month, the label was updated to include data on children and adolescents, including blood-glucose levels, cholesterol, weight gain and increased appetite, the Journal said.
According to Bloomberg.com, AstaZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the drug's diabetes risk. Several states that have also sued AstraZenaca have charged that the company illegally promoted Seroquel for unapproved uses.
Documents unsealed in the course of litigation appear to back up these claims. According to Bloomberg.com, a February 1997 e-mail from an AstraZeneca official said that the company had engaged in a “great smoke-and-mirrors job” in dealing with U.S. and Canadian investigators regarding a trial that didn’t produce favorable results on the issue of weight gain and Seroquel.
In a December 1999 email, the company's publication manager wrote that AstraZeneca "buried" disappointing results from three clinical trials. The same email also faulted AstraZeneca for having "cherry picked" data from one of those studies for use in a presentation, Bloomberg said.
The Wall Street Journal report details a transcript from a 2005 voicemail to AstraZeneca sales reps in which a company employee says the reps should address doctors' fears about their patients' weight gains by telling them that data showed no causal link between diabetes and the drug. According to the Journal, that email may have contradicted a 2000 position paper about the safety of Seroquel sent to Dutch regulatory authorities. In that paper, an AstraZeneca doctor wrote that there was a relationship between the drug and diabetes.
A company spokesperson told the journal that the position paper did not "accurately reflect its position", that the paper was "an initial draft for discussion purposes", and that the doctor who wrote it ultimately "concluded the evidence did not establish that Seroquel causes diabetes."
The first Seroquel lawsuit is scheduled to go to trial in April. Other atypical antipsychotic have also been linked to diabetes. According to Bloomberg, Zyprexra-maker Eli Lilly as agreed to pay at least $1.2 billion to similar settle lawsuits filed by about 31,000 patients.