A father who has lost two sons to war told The Daily Caller that the U.S. Central Command’s policy of allowing troops to deploy with a 180-day supply of the antipsychotic Seroquel has contributed to the deaths of troops and veterans. Seroquel, he said, has tragic side effects that military leaders have ignored in their quest to combat insomnia and post-traumatic stress disorder (PTSD) among fighting men and women.
The father, West Virginia school principal Stan White, said there are better ways to treat troops and veterans who suffer from PTSD. But because the maker of Seroquel, London-based AstraZeneca, has so much influence over Congress and the military, he insisted, that peer counseling and other treatment options are being shoved aside in favor of low doses of the drug.
White’s suspicions are slowly being validated by a series of studies, legal settlements, and military rulings — including a recommendation from the Department of Defense’s own advisory body on pharmaceuticals.
“I think AstraZeneca is so strong and has so much power that no one can speak out,” said White, who has remained stoic despite his losses. “Money talks. I truly believe AstraZeneca and other big pharma companies have control over Congress.”
His first son, Army Sgt. Robert White, died in combat in Iraq. When Robert’s younger brother Andrew returned from his own tour in the Middle Eastern country, a Veterans Administration doctor prescribed a combination of Seroquel and antidepressants for his PTSD.
Andrew died at home, and the state of West Virginia ruled that an accidental medication overdose was to blame.
But his father believes the “dangerous” pill cocktail killed him. And he told TheDC that he has identified 300 other soldiers and veterans who died from sudden cardiac arrest while taking Seroquel and antidepressants in combination.
Evidence supporting his theory has continued to accumulate, including a September 2011 study from the European Society of Cardiology which linked the “combined use of antipsychotic and antidepressant drugs” with an increased risk of sudden heart attacks.
Seroquel has been on the market since 1997, and in that time doctors have widely experimented with prescribing it for “off-label” purposes that the FDA has not approved. The drug, a mood stabilizer, is approved to treat schizophrenia and bipolar disorder, but it has also been used to treat insomnia in Parkinson’s disease patients, dementia in adults of all ages, and a variety of disorders in children.
Doctors have free rein to prescribe medications for off-label uses, and the FDA’s ever-growing avalanche of advisories sometimes makes it difficult for physicians to know what has been approved and what has not.
A 2009 University of Chicago national survey of physicians, for instance, found that one in eight doctors thought Seroquel was approved for treating dementia, even though the FDA had issued a specific warning against it.
Drug marketers, however, are forbidden to promote their products for any purpose not approved by the FDA.
In April 2010 AstraZeneca conceded that it had crossed that line, agreeing to pay the U.S. government $520 million to settle claims related to its illegal promotion of Seroquel for off-label uses.
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.
White remains convinced that AstraZeneca’s lobbying clout has overwhelmed whatever common sense might otherwise prevail in Washington, D.C. The Center for Responsive Politics reports that from 1999 to 2011, AstraZeneca spent $32.6 million lobbying federal government agencies with assistance from 14 different lobbying firms.
Dr. Peter Breggin, an upstate New York psychiatrist who has been critical of what he considers a general overuse of psychiatric medications, told TheDC that antipsychotics are the wrong prescription for patients who are facing stress, especially those who face acute stress during combat.
“Antipsychotic drugs simply [work by] suppressing your frontal lobe,” Breggin said. “You have less wherewithal from which to deal with life. You don’t want to give Seroquel to people dealing with stress, period.”
“The stress of war should not be treated as a medical problem. It’s a human problem, and it requires interventions that are psychological, social and educational.”
White continues to believe the VA and the military don’t embrace those non-pharmaceutical interventions for a simple reason: Drug therapy is cheaper. And it has the beneficial side effect of enriching the pharmaceutical industry, one of Congress’s biggest financial supporters.
But he and a small group of advocates continue to push for an end to the medical practice that he believes took the life of his younger son.
“We are calling upon the military for an immediate embargo of all antipsychotics and antidepressants,” White said, “until there has been a complete study.”