The last time Janette Layne saw her husband alive, Sergeant Eric Layne was dozing on their couch with the TV on. That was in January 2008. Because of his mounting outbursts of rage and paranoia since returning from Iraq, psychiatrists at two VA hospitals had been prescribing him increasing doses of a drug cocktail for post-traumatic stress disorder that included the powerful antipsychotic Seroquel. Although not approved by the FDA for such "off-label" uses, Seroquel is among the most prescribed drugs in its class and at its peak brought in more than $5 billion a year for its manufacturer, AstraZeneca, despite side effects ranging from diabetes to sudden cardiac arrest.
Eric kept complaining of headaches and tremors—concerns that were discounted by the VA medical staff—while he gained too much weight, had trouble breathing and was so oversedated that, Janette says, he had become a "zombie."
Two weeks after he returned from a specialized inpatient PTSD program that increased his medication, he was dead. "All these doctors and medics and Ph.D.s kept telling us that he was fine," Janette says. "We trusted the doctors."
Critics of the VA estimate that more than 400 combat veterans and other military personnel have died suddenly after being overmedicated with PTSD "cocktails." As with opioid deaths, these fatalities aren't systematically monitored or studied. The few military and VA inquiries into this issue have largely blamed these mysterious deaths on suicides and natural causes—or, in a few cases, on some inexplicable "drug toxicity."
During the same post-9/11 years that antipsychotic prescribing increased at the VA, it was in the early stages of an initiative to cut down on prescribing for PTSD patients receiving potentially addictive benzodiazepines such as Klonopin, Xanax and Restoril. Meanwhile, the department allowed the use of Seroquel to jump more than 770 percent between 2001 and 2010, although, according to the Associated Press, the number of patients increased only 34 percent.
Over $1.8 billion was spent by the VA from 2001 through the first half of 2015 on the two most prescribed antipsychotics for PTSD, Risperdal and Seroquel, although they were never proved effective or even approved by the FDA for use with the disorder. Seroquel remains the most heavily prescribed antipsychotic in the VA system, with nearly 800,000 prescriptions annually—more than twice as many as for Abilify, the most prescribed antipsychotic for the rest of America. The agency still writes over 2.1 million prescriptions a year for all antipsychotics, the overwhelming majority for unapproved uses.
All of AstraZeneca's marketing of Seroquel for off-label uses, as the Justice Department found when it reached a $520 million settlement with the company in 2010, has continued to pay off. The drug remains off-label for PTSD, anxiety, insomnia and depression in youth, but virtually no one in the VA appears to be paying attention. As a psychiatrist at the Huntington VA hospital tells this reporter, "The drug companies pushed these new drugs for everything from alopecia to hemorrhoids to lumbago."
That push ignored the data. "The evidence for using antipsychotics with PTSD patients isn't very good, and the potential side effects can be deadly," says Dr. J. Douglas Bremner, the chief of Emory University Medical School's Clinical Neuroscience Research Unit.
Part of the VA's reluctance to rein in the high-risk, off-label prescribing of antipsychotics traces back to "the code," but also to the undue influence of the drug industry. Some of the earliest work that pushed Seroquel on veterans came from Dr. Mark Hamner, the director of psychopharmacology research and PTSD clinical care at the Ralph H. Johnson VA Medical Center in Charleston, South Carolina. With support from AstraZeneca, he researched a series of long-unpublished studies boosting Seroquel.
AstraZeneca was apparently so pleased with Hamner's work that it funded directly or served as a "collaborator" with the VA on two additional 12-week studies on Seroquel for PTSD symptoms. For nearly a decade or more, the studies' outcomes were known only to Hamner and, presumably, AstraZeneca. Retired Brigadier General Dr. Stephen Xenakis, a pioneering PTSD researcher who reviewed Hamner's studies for Newsweek, thinks he knows why the results weren't made public for years: "AstraZeneca clearly delayed publishing because the data in general is weak." Hamner denied that his ties to the company played any role in his publishing delays.
The drug industry and VA officials have kept veterans and their families ignorant about many of the dangers posed by these psychiatric medications. Seroquel and other antipsychotics can induce sudden cardiac arrest that, although a rare side-effect, often causes brain death in under five minutes. Atypical antipsychotics have been identified in over 100 studies since the 1990s as perhaps the single riskiest class of drugs for inducing a particularly dangerous form of arrhythmia. Dr. Fred Baughman, a retired California-based neurologist who launched a campaign raising alarms about Seroquel-related deaths in West Virginia, was blunt in his many press releases and letters to medical journals, starting in 2008: "There is an epidemic of sudden deaths occurring throughout the U.S. military."
His determination to discover what led to the medication-linked deaths didn't seem to be matched by the VA's Office of the Inspector General, which concluded there was no link between Seroquel and other leading antipsychotics with sudden cardiac death in its report on the deaths of Layne and another vet, 23-year-old Andrew White, who died a few weeks later. Formerly in a support group with Layne, he had died within a year of beginning treatment with psychiatric drugs. All of the inspector general's work ignored the most salient medical research and the VA's prescribing guidelines in place since 2004. (The Inspector General also missed that Andrew White's prescribing psychiatrist had his DEA authority to handle controlled medications lifted before he was he was hired by the VA—because a medical licensing board found that he'd stockpiled 19,000 narcotic and other pills at his home.)
"They turned a blind eye to the medical consensus," says Baughman of the inspector general's report. The most telling sign of a cover-up, he contends, is the failure to mention the most thorough review then available: an Expert Opinion on Drug Safety journal review, published several months before the inspector general's report. "It took an overt act of omission to miss this article," he says, noting how widely it was cited in the medical literature. Xenakis, the former Army psychiatrist, is just as blunt: "They cherry-picked the studies."
The VA's Office of the Inspector General declined to reveal what medical guidelines or scientific research was reviewed before releasing its report.
Dr. Grace Jackson, a former Navy psychiatrist and author of Rethinking Psychiatric Drugs, says after reviewing the inspector general's report and White's prescription history, "This is a whitewash that sanitizes [White's] medical records. It's a complete embarrassment. The way these drugs were used was overkill."
Nearly a decade after the inspector general ignored the drugs' cardiac dangers, the VA's new Psychotropic Drug Safety Initiative, modeled in part on its opiate campaign, still hasn't flagged the cardiac risk of Seroquel, the agency's most prescribed antipsychotic. Xenakis says of this omission: "It's outrageous. I'm stunned." He adds, "People are talking about reform in the VA, but with these kinds of things, it really exposes how far we have to go to change basic practices, culture and attitudes." —Art Levine
