by Art Levine
Andrew was no match for such bureaucratic forces. On his second visit to a nurse practitioner for a key medication review, he was clearly irritable, nervous, his legs shaking constantly. So he was given the powerful, sedating Seroquel as a substitute for the milder trazodone. What’s particularly striking is that no other, relatively safer drugs designed specifically for insomnia were ever tried on White—including a non-benzodiazepine drug approved in 2004 by the FDA, Lunesta. “The trazodone is ineffective and will switch to Seroquel because of the levels of suspicions he has and the agitation, irritability,” the nurse, no expert on psychiatric medications, noted nonetheless.
But at the time Andrew visited that professional in 2007—and, long after his death, through 2016—there were virtually no published controlled, independent studies that showed any “statistically significant” value in using Seroquel for PTSD or long-term insomnia. All remotely positive results about antipsychotics for trauma were found only in studies written by researchers who had been subsidized by AstraZeneca and other drug companies. Indeed, most of such AstraZeneca-funded sketchy research on PTSD didn’t even bother to compare Seroquel to anything else. But Andrew’s first VA prescriber heedlessly switched him to Seroquel to help his “mood” and sleep anyway.
All the drug company’s off-label marketing was paying off for AstraZeneca, as the Department of Justice found by tracking its sales tactics that it eventually cited in 2010 in the $520 million settlement. As Dr. Marvin Schauland, the osteopath and psychiatrist who became Andrew’s final prescriber at the Huntington VA hospital, points out, “The drug companies pushed these new drugs for everything from alopecia to hemorrhoids to lumbago.” Back in 2007 and 2008, Schauland notes, “The drug company salesmen could come into the VA to glad-hand us and give out samples.” The VA didn’t start limiting on-site visits by drug company reps until 2012, but there are still no meaningful limits placed on marketing to the VA’s doctors through such lures as fancy seminars with meals led by influential local physicians.
The 2010 Justice Department settlement with AstraZeneca outlined some of the various sleazy strategies the company used to influence everyone from family physicians in the community to VA psychiatrists to prescribe Seroquel for such unapproved uses as PTSD and anxiety. AstraZeneca paid the settlement without acknowledging wrongdoing.
Seroquel remains off-label for PTSD, anxiety, insomnia and depression in youth, but virtually no one in clinical practice at the VA appears to be paying attention. That’s in large part due to the effectiveness of the alleged illegal sales techniques that the company has deployed since 2001 and that the Department of Justice first highlighted in its April 2010 settlement agreement.
These shady gambits haven’t stopped, according to the new 2014 whistleblower fraud lawsuit filed by the Texas Attorney General against AstraZeneca concerning alleged misconduct since 2006, the last year covered in the 2010 anti-fraud agreement.
Despite all the salesmanship underway before and after Andrew’s death in February 2008, the VA’s own widely-flouted official guidelines didn’t support using antipsychotics for PTSD symptoms. But, in practice, the agency sanctioned the off-label use of antipsychotics with PTSD patients. “The evidence for using antipsychotics with PTSD patients isn’t very good, and the potential side effects can be deadly, really,” says Dr. J. Douglas Bremner, the chief of Emory University Medical School’s Clinical Neuroscience Research Unit and one of the world’s pioneering researchers on PTSD.
Andrew was started at a relatively low dose of Seroquel: 25 mg. That soon escalated, ultimately rising to 1,600 mg, twice the upper limit considered safe for use with people with severe schizophrenia. In fact, that dosage was more than five times the dosage used in the dubious schizophrenia studies first submitted by AstraZeneca to win FDA approval for that limited use of the drug in the late ’90s. “In those studies, they were using relatively low doses, but VA doctors are using Seroquel like a nerve pill, giving it out like Valium or Librium,” said Dr. John Nardo, the former director of the psychiatry residency at Emory University—who died in March 2017—and a retired psychiatrist who had published perhaps the most in-depth scrutiny of the shoddy Seroquel research with schizophrenics. “These doses being given to veterans are astronomical and since some of them have been killed, there’s nothing I know of in any research to indicate that those kinds of doses are rational. The VA has exerted no upper limit on this medication,” he observed.
Yet all this was done to Andrew without any sign that the doctors at the VA or others he eventually consulted ever took seriously the risks the drug posed: extreme weight gain, diabetes and even sudden cardiac arrest, among others. In fact, in over two hundred pages of VA medical records reluctantly released to the White family after his death, there is no indication that any VA staffer he dealt with knew about the findings of the agency’s own VA/DOD Guidelines for Management of Post-Traumatic Stress. Adopted in 2004, they said there was “insufficient evidence” to recommend using antipsychotics for PTSD. The latest version of the guidelines hasn’t changed that weak—and ignored—cautionary note for Seroquel.
As of 2016, the VA still had not created any high-profile alerts about the dangers posed by Seroquel, especially relating to the risk of drug toxicity it poses when mixed with other medications. At the grassroots level today (and back in 2007, when Schauland took charge of prescribing for Andrew), clinicians either didn’t pay attention to the unenforced VA treatment guidelines for mental illnesses, including PTSD—or didn’t even know they existed. “There’s no set drug regimen for PTSD,” Schauland claims, “so you to try to make a regimen to fill the needs of the patient.” Yet even in the VA guidelines in effect when Andrew sought treatment, there were some prescribing recommendations. For instance, only the serotonin-based antidepressants were viewed as having significant benefit then for PTSD. The latest version of the guidelines has been expanded to include, among other medications, the beta-blocker Prazosin as having some benefit, while the VA labels antipsychotics as having “unknown benefit” at best.
Whatever the treatment guidelines said on paper, for Andrew, the VA’s indifference to safe prescribing was only worsened by the lack of well-proven, personalized cognitive therapies for PTSD available to him at VA clinics, although they may fail half the time. For example, one of the most relatively effective, thoroughly researched treatments is Cognitive Processing Therapy, which trains the veteran to pay attention to and challenge the emotions generated by past traumas. In White’s medical records, except for one brief notation in the last week of his life, there’s virtually no hint that local VA personnel knew such therapies existed or that they should be used to help him. Schauland, who was in charge of his care, says, “I couldn’t do psychotherapy because I was just there for meds. That’s what the psychologists were for; I thought patients were going to groups or individual therapy.” It’s a telling sign of the VA’s continuing failures that no health-care provider took responsibility for ensuring that Andrew got appropriate care, including targeted psychotherapies for PTSD.
It didn’t matter that the agency’s mental health handbook had recommended evidence-based behavioral treatments since at least 2004. That’s because there have never been any full-scale efforts to implement them, despite various grand pronouncements by VA leaders to do so. White’s sporadic counseling sessions were little more than superficial check-ins on his current status, supplemented by occasional medication reviews by psychiatrists, including Schauland. “The therapists weren’t trained to deal with PTSD,” declares West Virginia veterans’ advocate Tom Vande Burgt. Vande Burgt’s therapist, for instance, often used the time to just chat about problems in her own marriage.
Meanwhile, even the VA’s lackluster Inspector General repeatedly confirmed the lack of widespread adherence to effective PTSD treatment strategies by the VA’s mental health providers. Shirley White recalls that, just a day before his death, Andrew visited a Ph.D.-level psychologist, the only one ever assigned to him: “He’s a
year into treatment and this is the first time they talked about strategies.”
In truth, smaller and rural clinics were especially prone to neglect the VA’s own therapy guidelines, the Inspector General’s office has found over and over again, in part because of the difficulty in recruiting mental health practitioners. Yet both in big cities and rural areas, the Inspector General reported in 2009, less than a year after Andrew’s death, “At present we are unaware of a system by which the Veterans Health Administration [the VA’s lead health-care division] reliably tracks provision and utilization of evidence-based PTSD therapies on a national level.” There has been little improvement since then, despite the hiring of more therapists.
So, despite the recent scandals and public critiques, it still remains disturbing that so little has changed since White endured the VA’s inept care. After seeking treatment back in 2007, Andrew only got more Seroquel and increasing dosages of Klonopin, Paxil or other antidepressants—and little actual therapy. The medications just kept increasing even though he also told the clinic staff about continuing to drink heavily on most days, while declining to enter alcohol treatment. But the prescriptions he was given couldn’t quell his nightmares, increasing irritability, anxieties and pent-up rage. “I want to kill people,” he admitted at one thirty-minute session, while being quite concerned that he’d lose control if he returned to Iraq.
The only service offered by the VA that provided any comfort to Andrew was the weekly voluntary support group, led by the well-liked, dedicated social worker Deborah Linzmaier. (She declined to be interviewed.) It provided a safe space, understanding and some basic information on PTSD for those like-minded veterans struggling with the illness, but not personalized therapy.
But as the months wore on, Andrew faced more bad days. Although he dated a hard-partying girlfriend, a bartender, in the spring, he also ended up drinking as many as thirty beers in a night, moving in with her for several weeks and ultimately losing his job as a cook at Famous Dave’s. By that summer of 2007, he and his parents realized he was quickly going downhill, forgetting medical appointments, losing his short-term memory and becoming increasingly irritable. Yet the prescription drugs were doing little for him except causing noticeable side effects: tremors and a steep weight gain, eventually to 220 pounds, soon to be joined by the horrifying early growth of breasts and testicular shrinkage. “There wasn’t really any significant problems with side effects,” claims Schauland, who began treating him in late July. “He was not obese; he was a pretty good-sized man.”
In contrast, “Every side effect Seroquel has, Andrew had. Every one of them,” Shirley White observed. But the doctors at the VA reassured him—and later her—that there was nothing to worry about. The doctors who examined him sporadically noted the complaints in his medical records, but glossed over them and didn’t connect them to the Seroquel he was taking.
By now, Andrew’s nerves were all but shot. After a vet he knew from Iraq died in a car accident on the way to work, his depression only deepened, causing him to burst out into tears at odd times during the day and reminding him again of the death of his brother Bob. “The littlest thing makes me cry,” he told a counselor during a sudden walk-in clinic visit in July 2007. He also admitted that he was only sleeping two hours a night and was wracked with “horrible nightmares.” The drugs he was taking were still not working, he felt. Just as troubling, his days were sometimes disrupted by the waking nightmares of flashbacks triggered by unexpected noises, whether they were fireworks outside or mysterious sounds in his house that kept him as vigilant as the nights spent patrolling the perimeter at Al Qaim.
He was desperate enough for more or better pills that in July, on the same day as his local walk-in session, he drove to the mental health clinic sixty miles away at the VA Medical Center in Huntington. Once there, the social worker arranged for a quick medication review by a physician, who restarted him on Paxil, discontinued use of two other sedating meds but ramped up the dosages of Seroquel to 200 mg a day. Most critically for his future safety, though, they also gave him 25 mg tablets of added Seroquel and noted, in writing, “Take one-half tablet by mouth twice a day as needed.”
As needed—whenever he felt he needed some more. This was a risky approach for a PTSD patient who often couldn’t remember when or if he took his meds, who was desperate for relief and would soon get Seroquel refills mailed to him via the VA’s mail-order service like clockwork every thirty or ninety days, enough to eventually fill a large shoebox. Ultimately, “he had a drawer filled with Seroquel bottles,” Shirley White says bitterly. “He had an excess amount from the VA.”
Yet the added medication couldn’t erase the harsh memories of his tour of Iraq. All this was exacerbated by his increasing isolation in his room, playing the online multiplayer shooter war game Halo on his Xbox with an obsessed, furious intensity. His parents could hear him shouting at the futurist shooters he confronted on-screen, “Get the motherfucker!” His bedroom became his hiding place to retreat from the world, and as he told one VA counselor, “I’d like to crawl in a hole for a month and then come out and things would be better.” But he wasn’t, of course, able to shield himself from the world outside that was assaulting his nerves.
After hours, with his drinking compounding his short temper, getting into arguments and fighting became almost inevitable. One Saturday night in mid-July, he went out on the town with a hard-drinking friend from work. In a parking lot outside a bar, they got into an argument over who was in good enough shape to drive. In the ensuing fistfight, Andrew was beaten up, with his ribs and back so badly bruised that he had to go to a local emergency room, getting a few days’ worth of Vicodin in the process. He came home later that day, recounting what happened without any contrition or shame. “That’s one of the things that this does to you,” Shirley says. “There’s no remorse. Things just happen.”
Still, in some ways, the incident seemed to be a wake-up call for Andrew that he hoped would lead to positive changes. He started cutting ties with his drinking buddies. Shirley says, “He’s thinking, ‘I need to disassociate myself from this. I want to try. I want to do better.’” Over the next few weeks, still experiencing the torment of PTSD flashbacks, sharp physical pains when he breathed and an inability to sleep, he switched his care from the local clinic and went to the Huntington hospital for medical and mental health evaluations. He hoped to get better quality treatment at the hospital.
That decision led to even more changes in his meds and the ultimate addition of more Seroquel. His initial evaluation at the Huntington hospital was conducted by Schauland, an osteopath-cum-psychiatrist with a past history of drug addiction and an apparent fondness for stockpiling 19,000 dosage units of narcotics and other prescription drugs at his home, according to Minnesota medical board records and a DEA investigation. At the time he saw Andrew White, he had faced state investigations instigated by the Minnesota medical licensing board—and already had his Drug Enforcement Administration (DEA) authority to prescribe controlled substances revoked in February 2007. Schauland, in his own view, had done nothing really wrong in failing to file the needed paperwork on his stockpile of medications.
Seroquel, despite its growing reputation as a street sedative with addictive potential—it was nicknamed Suzie Q—isn’t a “controlled” medication requiring a valid DEA registration. That category includes narcotics or, in Andrew’s case, the benzodiazepine Klonopin that Schauland prescribed. In need of psychiatrists, the local VA hired Schauland in June 2007, regardless of its purported policy of refusing to employ doctors who had faced DEA sanctions. West Virginia, though, permits its doctors to prescribe controlled medications without personal DEA registration as long as they have a facility’s DEA authority; all licensed doctors in the US can prescribe regular, non-controlled medicines that aren’t monitored by the DEA without needing a DEA permit. Schauland, in sum, wasn’t breaking any state or federal law despite his questionable background and untrammeled prescribing after be
ing hired by the Huntington VA.
But the Huntington VA, it turns out, has long exceeded the VA’s already excessive 20 percent national average rate of prescribing ineffective, off-label antipsychotics like Seroquel for PTSD patients. In practice, it did little to rein in doctors like Schauland, who prescribed as they saw fit for patients such as Andrew. Still, although Schauland temporarily discontinued Seroquel for Andrew in July 2007 and started him on Klonopin again, Andrew continued after this July visit using the earlier prescribed Seroquel pills the hospital staff had reassured him could be taken “as needed.” A few weeks later, Schauland then authorized higher doses of Seroquel to pacify Andrew’s complaints about sleep. Schauland also viewed the drug as having other useful benefits: “Andrew had a wild and wooly side and I was trying to calm him down,” he says.
Yet a few days after the July 2007 visit with Schauland, the sedating effects of Seroquel became dangerously obvious: he came home from his restaurant job on a Wednesday evening and slept thirty-six hours straight through to Friday. His parents frantically tried to rouse him, but Shirley recalls, “We could not wake him up.” They were so worried that Stan White checked in on him periodically to make sure he had a pulse and was still breathing. His parents, adept at discovering any alcohol abuse, knew their own son well enough to know that he hadn’t been drinking for a few days, so they grew far more concerned about his medications. Andrew managed to drive himself to the Vet Center, and with his mother on the phone, they were patched through to a clinical social worker at the hospital. At one point, defending why he was taking the sedative Klonopin during the day, he explained, “It mellows me out and keeps me from wanting to stick a knife in someone’s face at work.”