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AstraZeneca Hides Behind Court Secrecy to Leave Consumers in the Dark
Federal Legislation Will Give Public Access to Information on Product Dangers Sealed in Court Records
Washington, DC—The Food and Drug Administration (FDA) might be denied access to vital information regarding the safety of the drug Seroquel, manufactured by AstraZeneca, because of court documents the company refuses to make public. The FDA advisory panel meeting scheduled for April 8 is set to determine if AstraZeneca can market Seroquel XR to patients for major depression and anxiety disorders, extending the market share to approximately 20 million more patients. The drug is currently approved for schizophrenia and bipolar disorder.
The currently sealed documents are part of litigation in New Jersey state court, and include unpublished clinical trial information and internal conclusions by the company on the increased risk of weight gain and diabetes which were not previously shared with the FDA.
Ted Baker, 60, of Bastrop, La., a Vietnam veteran who suffers from post-traumatic stress disorder and major depressive disorder, was prescribed Seroquel in 2001 as an antidepressant and continued to take it until 2006. Due to his Seroquel use, he was diagnosed with Type II diabetes in March 2004. Attorneys for Mr. Baker have asked a New Jersey Superior Court judge to unseal the Seroquel trial data so the FDA can use the data before approving expanded use of the drug and its risks to millions more people
“The expanded use of Seroquel could expose millions more people to diabetes and those patients have the right to know that AstraZeneca is hiding data behind sealed court records which shows the company promoted the drug as being safe and effective while minimizing information about the risks to the FDA,” said Ted Baker’s attorney Ellen Relkin of Weitz & Luxenberg, P.C. “The drug manufacturer bears responsibility for ensuring the accuracy of its label at all times and AstraZeneca has repeatedly shirked its duty to provide a warning that adequately describes the risk to patients.”
The Sunshine in Litigation Act expected to be introduced today by U.S. Rep. Robert Wexler (D-FL) and U.S. Rep. Jerrold Nadler (D-NY) and introduced last week by Sen. Herb Kohl (D-WI) and Sen. Lindsay Graham (R-SC) would make secrecy agreements in federal court cases more difficult; ensuring that life saving information is not kept hidden from the public.
“Sealed court records are hiding the dangers of prescription drugs and Seroquel is the latest example of how companies use secrecy agreements to hide product risks and mislead consumers into thinking they are safe,” said American Association for Justice Senior Vice President of Public Affairs Linda Lipsen. “Companies that are unable to hide behind secrecy agreements would be motivated to fix or recall product dangers, preventing consumers from suffering unnecessary injury or death.”