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Sgt. Eric Layne's death was not pretty.
A few months after being prescribed a drug cocktail with the antidepressant Paxil, the mood stabilizer Klonopin and AstraZeneca's controversial antipsychotic drug Seroquel, the Iraq war veteran was "suffering from incontinence, severe depression [and] continuous headaches," according to his widow, Janette Layne, at FDA hearings for new Seroquel approvals last year.
Soon he had tremors. " " [H]is breathing was labored [and] he had developed sleep apnea," said Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention. He died while his family slept.
Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.
Sgt. Layne was not the first healthy veteran to die after being prescribed medical cocktails including Seroquel for PTSD.
In the last two years, Pfc. Derek Johnson, 22, of Hurricane, West Virginia; Cpl. Andrew White, 23, of Cross Lanes, West Virginia; Cpl. Chad Oligschlaeger, 21, of Roundrock, Texas; Cpl. Nicholas Endicott, 24, of Pecks Mill, West Virginia; and Spc. Ken Jacobs, 21, of Walworth, New York have all died suddenly while taking Seroquel cocktails.
Death certificates and other records collected by veteran family members suggest more than 100 similar deaths among Iraq and Afghanistan combat vets and other military personnel, many on PTSD cocktails with Seroquel and other antipsychotics, antidepressants, mood stabilizers, sleep inducers and pain and seizure medications.
Since the 2008 publication of "The Battle Within," the Denver Post's expose of a "pharmaco-battlefield" in Iraq, in which troops were found to be routinely propped up on antidepressants, the Department of Defense has sought to curb the deployment of troops with mental health problems to combat zones. The DOD has also stepped up monitoring of soldiers who have been medicated, according to the Hartford Courant. Thirty-four percent of the 935 active-duty soldiers who made suicide attempts in 2007 were on psychoactive drugs.
But the U.S. Army's Warrior Care and Transition Office reports that soldiers are dying after coming home, many in Warrior Transition Units that were established in 2007 to prepare wounded soldiers for a return to duty or civilian life. According to the Army Times, between June 2007 and October 2008, 68 such veteran deaths were recorded -- nine were ruled suicides, six are pending investigation and six were from "combined lethal drug toxicity." Thirty-five were termed "natural causes."
Although not been approved for PTSD, Pentagon purchases of Seroquel nearly doubled between 2003 and 2007. Elspeth Ritchie, medical director of the Army's Strategic Communications Office told the Denver Post the drug is "increasingly utilized as an adjunct for PTSD."
The Seroquel Scandals
It would be hard to find a drug with a wider fraud footprint than Seroquel -- at least one that's still on the market.
One of its first backers, Richard Borison, former chief of psychiatry at the Charlie Norwood VA Medical Center, lost his medical license, was fined $4.26 million and went to prison for a swindle involving Seroquel's original clinical studies.
AstraZeneca's U.S medical director for Seroquel, Dr. Wayne MacFadden, had sexual affairs with two different women doing research on Seroquel, a study investigator at London's Institute of Psychiatry and a Seroquel ghostwriter at the marketing firm, Parexel. According to court documents, MacFadden even joked about the conflicts of interest with one paramour.
Last year, the Chicago Tribune and ProPublica reported that Chicago psychiatrist Michael Reinstein, who wrote 41,000 prescriptions for Seroquel, received $500,000 from AstraZeneca. Meanwhile, a report in the Minneapolis Star Tribune discredited influential studies by AstraZeneca-funded Charles Schulz, MD, chief of psychiatry at the University of Minnesota.
Seroquel was even promoted by the disgraced former chief of psychiatry at Emory University School of Medicine, Charles Nemeroff, who was accused by congressional investigators of failing to report $1 million in pharmacological income -- in AstraZeneca-funded continuing medical education courses.
