The federal case was opened because of what the government said were illegal Medicare and Medicaid claims, but AstraZeneca’s aggressive promotion of Seroquel for off-label uses started the ball rolling.
According to a Department of Justice press release, “by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.”
“AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder,” the statement continued, “such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.”
The Associated Press reported a few months later that the Department of Veterans Affairs spent $125.4 million on Seroquel in 2009, making it the agency’s second-largest prescription drug expenditure. The Department of Defense’s Seroquel spending increased nearly 700 percent between 2001 and 2009, when it peaked at $8.6 million.
The AP also noted that there has only been one published study on the use of Seroquel for insomnia related to PTSD. It followed just 20 patients and lasted only six weeks. It was funded by AstraZeneca.
Nevertheless, CENTCOM, the global command that has led the Afghan and Iraq conflicts during the past decade, confirmed to TheDC that it continues to allow military doctors to prescribe “low-dose (25mg) Seroquel, used only as a sleep aid,” a policy in place since March of 2010.
“Any use of Seroquel outside of this context or dose requires review by the CENTCOM Surgeon to assess safety in the setting of deployment,” said CENTCOM public affairs officer Sgt. T. G. Taylor.
AstraZeneca has not responded to Stan White’s accusations about its apparent success lobbying government agencies to green-light its marquee antipsychotic drug in the military.
In a statement to TheDC, AstraZeneca said Seroquel, now one of the top-selling medications in the world, has helped “millions of people suffering from a variety of debilitating mental illnesses and allowed them to lead meaningful lives.”
“[W]e believe Seroquel is safe and effective medication when used as recommended in the prescribing information,” said Anna Padula, senior manager of corporate affairs.
White said the military’s off-label use of Seroquel to treat deploying troops’ insomnia is dangerous since many soldiers also take antidepressants.
The Defense Pharmacy and Therapeutics Committee, an expert advisory group, seems to agree.
In a May 2011 meeting chaired by Dr. Jonathan Woodson, the Assistant Secretary of Defense for Health Affairs, the committee declared that CENTCOM should be discouraged from allowing troops to deploy with Seroquel because of the risk of cardiac arrest and other “adverse events.”
White told TheDC that he has sent the veteran affairs committees in both the House and Senate a package of research linking Seroquel to sudden cardiac arrest. He spoke directly with the chairpersons of each committee, he said, and then sent a copy of the research to first lady Michelle Obama.
Congress has barely lifted a finger, he said.
But a source close to the House Veterans Affairs Committee told TheDC that the committee has asked the Department of Veterans Affairs for a report about its use of Seroquel. The source would not offer offer a timeline for the release of that report.