Mental Health Inc

by Art Levine

  The analysis shouldn’t have taken years to complete. Even the more complex of the two twelve-week studies only had twenty-five patients started on Seroquel, had a drop-out rate nearly twice that for the placebo and the outcomes were known by 2006. That study measured Seroquel’s impact against a placebo as an adjunct treatment for patients with severe PTSD who weren’t helped by Paxil alone. Those who were still taking Seroquel showed significant PTSD symptoms. (The results weren’t published at clinicaltrials.gov until 2014, years after the VA officially stopped recommending using antipsychotics for PTSD, although its use continues essentially unabated.) Dr. Stephen Xenakis, who has done his own PTSD research, pointed out the Hamner studies’ most glaring flaws: “AstraZeneca clearly delayed publishing because the data in general is weak. There are an insufficient number of subjects to show that the medication is an effective way to treat the condition.” Hamner, long after antipsychotics’ use for PTSD had been discredited, finally co-authored with AstraZeneca’s funding a December 2016 placebo-controlled study in The American Journal of Psychiatry that claimed that Seroquel was “efficacious” in treating PTSD, based on research he began in 2004.

  Even if Hamner’s original studies were never, in fact, published when it counted, their never-ending status as forthcoming journal articles added credibility to the unfounded notion that there was some scientific justification for using Seroquel beyond just knocking out PTSD patients at night. Despite the absence of any independent (i.e., without drug money), controlled journal studies showing Seroquel’s value for PTSD, Dr. Matthew Friedman pointed to Hamner’s still-unpublished research to justify Seroquel’s promise: “He presented some very interesting data that indicated that Seroquel might be better for PTSD.”

  Friedman and other VA researchers’ casual acceptance of Seroquel and, until recently, Risperdal for use with PTSD patients might have been shaped by the funding they’ve received in the past from AstraZeneca and other drug companies. They strongly dispute such imputations. As AlterNet’s Martha Rosenberg first reported in 2010, Friedman had received an AstraZeneca honorarium and, later, served as a “Pfizer visiting professor” in 2011 at the South Carolina College of Medicine, the academic home of Hamner. When I spoke to Friedman, his ties to Pfizer weren’t yet publicly known, but he dismissed the notion that any drug company funding could affect his views or research. As for that honorarium from AstraZeneca, he laughed it off: “That was just a luncheon symposium I hosted.”

  The influential Friedman continued to champion some antipsychotics, including Seroquel, as potentially useful adjunct treatments for PTSD even after the Journal of the American Medical Association published a damning 2011 study by the VA’s own researchers which showed that antipsychotics were essentially useless for those suffering primarily from PTSD. The study was quite unlike Hamner’s sketchy, unpublished early research on Seroquel or the seemingly more promising published research—largely funded by Janssen—on Risperdal’s value as an adjunct PTSD treatment. This rigorous, government-funded, large-scale study on Risperdal found it caused serious side effects and was no better than a placebo for patients with PTSD or anxiety and depression symptoms. By the time this six-month randomized study of over 250 patients was published, the VA had already spent $717 million on Risperdal alone in the previous decade and $846 million for Seroquel. Roughly 20 percent of all PTSD patients at the VA were receiving these off-label, dangerous antipsychotics. As a JAMA editorial on this important study concluded, “The results seriously call into question the use of atypical antipsychotics in PTSD treatment. Studies are needed to identify more effective treatments.”

  When the study was released in 2011, Risperdal and Seroquel risks were already exposed in government liability and fraud lawsuits.

  Yet none of these developments seemed to have any impact on the policies or practices of the VA regarding the overuse of antipsychotics. The percentage—roughly 20 percent—of PTSD patients receiving antipsychotics has declined only slightly since 2011, and nearly 800,000 prescriptions for Seroquel and 430,000 for Risperdal are written annually for VA patients. In short, over $1.5 billion was spent over the previous decade by the VA for two antipsychotics never proven effective for PTSD. As noted earlier, spending for Seroquel didn’t really start declining from a peak of $150 million in 2011 until the original version’s generic replacements were released after it lost its patent protection in 2012, while the number of prescriptions for the widely used medication—in any version—barely slowed by 3 percent.

  “After the drug companies spent fifteen years marketing this stuff, doctors are trained to use it,” observes Yale researcher Dr. Robert Rosenheck, a co-author of the 2011 JAMA article and an investigator with the New England VA’s mental health research center in New Haven. More recently, he has questioned the impact so far of the VA’s new Psychotropic Drug Safety Initiative promoted by VA leaders after the Tomah scandals: “I haven’t seen any data showing that these efforts are having much effect.”

  Rosenheck has good grounds for such skepticism. One indicator of how little the program has accomplished was the testimony of Dr. Carolyn Clancy, then the VA’s interim Secretary for Health, who actually boasted to a congressional hearing in April 2015 about the success of the program launched nearly two years earlier: “We have noted a 1 percent decrease in the proportion of Veterans with PTSD and no psychosis diagnosis who received an antipsychotic medication.” That’s not much of a change if nearly 20 percent or more of PTSD patients are still getting the medications for unapproved uses—and a third of all veterans get psychotropic medications without having any known mental illness of any kind.

  One reason risky prescribing remains nearly as high as it was before the 2011 JAMA study, even in the face of the increasing numbers of veterans deaths, is likely due to the lack of any high-profile alerts and enforcement by the VA over the cardiac risk of the antipsychotics. A month before the JAMA study was published, The New York Times published an article in July 2011 about a new FDA-required warning that Seroquel and Seroquel XR should be avoided with at least twelve other medicines in seven different categories—including some antibiotics and opiates—because they could cause sudden cardiac arrest. Yet busy VA clinicians have never been clearly warned about these changes by the VA, although the VA periodically sends out warnings and advisories on other drugs. Since all of the atypical antipsychotics pose cardiac risks, it’s disturbing that with over 2.1 million such antipsychotic prescriptions written yearly by the agency it still hasn’t bothered to unmistakably warn anyone of the potentially fatal dangers posed by the most popular one, Seroquel, when combined with other commonly prescribed medications.

  The VA’s medical leadership has shown little interest or concern over this striking omission. I recently asked another Yale psychiatry researcher affiliated with the VA, Dr. Ilse Wiechers, who leads the agency’s psychotropic drug safety initiative, about whether the program warned about these FDA-flagged cardiac dangers. She responded: “I can’t say that’s the VA’s position. I provide warning information to my patients and I assume it would be brought up [by other doctors] during consultations with their patients.”

  This failure of a program billed as a “drug safety initiative” to warn its doctors about these cardiac risks comes as a shocking surprise to experts outside the VA. “I don’t understand it,” says Dr. Stephen Xenakis. “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.”

  But these flaws in prescribing at the VA go beyond even the corrupting effect of the drug industry or the world of turf-protection and failed accountability within the agency. Rosenheck, while not criticizing the VA, points to broader factors in the culture of the pharmaceutical-subsidized mental health system at large that insulate doctors from oversight: “This is an influential industry that affects everyone’s mind: ‘Don’t touch doctor’s rights’”—a vie
w shared by doctors, NAMI and other mental health groups and, of course, the drug industry that benefits from that messaging. “The idea is: To sell as many drugs as possible for as many illnesses as possible to increase the stockholders’ value, and use our patsies in the psychiatric profession to promote our drugs,” he notes.

  With so many forces working against limiting irresponsible prescribing, it’s not so surprising that even after the JAMA study was published, there was strong resistance to change within the VA and the wider field of psychiatry. Friedman, for instance, still held out hope for the value of Seroquel, and possibly other antipsychotics, with PTSD patients: “Not all atypical antipsychotics are created equal,” he insisted.

  In a grudging concession, he declared after the JAMA study that the VA would no longer recommend the use of Risperdal for PTSD patients as an adjunct treatment. Yet although the JAMA report was widely seen as condemning antipsychotics as a class for PTSD, Friedman said the agency wouldn’t change its longstanding PTSD guidelines for Seroquel: “There is insufficient evidence to recommend for or against its use.” As a result of that stance, heavy Seroquel prescribing remained essentially unimpeded. As Friedman blithely noted, “Doctors are free to prescribe medications they see as in the patient’s best interest.”

  The failure of the VA to effectively warn its local doctors about the antipsychotics’ dangers amounted to a death sentence for some patients. It led the doctors in Virginia’s Tidewater area to heedlessly prescribe Seroquel and other drugs to Kelli Grese, a petite, dark-haired thirty-seven-year-old former Navy hospital corpsman who also developed psychosis—a relatively rare side effect—from Adderall given for her wrongly diagnosed ADHD, her prescription drug addiction to VA-provided Klonopin, and severe depression, all following a thirteen-year regimen of nearly thirty drugs often prescribed off-label for assorted makeshift diagnoses. She’d gone to the Hampton, Virginia, VA in the 1990s with what was originally a modest case of PTSD. But in the eight months before she died, she tried killing herself three times with the Seroquel she was repeatedly prescribed—and her final prescription was for a 120-day supply of the drug written twice in two days in late October 2010. A little more than two weeks later, on Veterans Day, she succeeded in her fourth attempt, swallowing most of the Seroquel pills given her. Shortly before a wrongful death trial was scheduled in April 2013, her twin sister Darla reluctantly settled the case for a modest $100,000 due to the financial and emotional strain. Yet the filings in the case remain one of the few public records of the agency’s mishandling of psychiatric prescribing, even though the agency didn’t acknowledge liability.

  Kelli Grese, in truth, was pushed downhill towards her death by several physicians at different VA facilities. They couldn’t be bothered to coordinate her treatments or pay attention to the side effects of the deluge of psychiatric drugs they were giving her over the years, and were abetted by nearly as inept civilian psychiatrists during her emergency hospital stays. Darla Grese points out, “She was passed on from physician to physician with no continuity. They kept writing new prescriptions, copying and pasting the old prescriptions without reading any of the complaints and concerns.” (The moving story is told in full in Darla’s book, Sister Surrendered.)

  With the agency now promising to offer new and improved “integrated” and coordinated care, its failure to acknowledge its past failures with such patients as Kelli Grese and Andrew White doesn’t bode well for any future reforms.

  • • •

  AS EVIDENCE AND LEGAL SETTLEMENTS MOUNTED ABOUT THE DANGERS OF Seroquel and its alledgedly fraudulent marketing to government health programs, the VA’s continuing inaction on overprescribing took its heaviest toll on veterans struggling with both mental illness and addictions. At the Huntington VA that played a role in killing Andrew White, for instance, the latest known antipsychotic prescribing rate for PTSD patients is 23 percent, slightly higher than the VA average when the 2011 JAMA study demonstrated that they shouldn’t be used at all for PTSD. Even more disturbing, nearly 18 percent of all Huntington VA patients were prescribed opiates, a rate about 300 percent higher than the national average for all adult male patients and far higher than the 7.7 percent of VA patients nationally who are using take-home opioids. (Carefully monitored opiate prescribing for patients with severe pain, of course, has a legitimate role.) Officials at the Huntington VA who provided their data said in a written statement that there are “positive trends” underway in reducing antipsychotic and opiate use, and they’re following VA safety guidelines.

  VA officials don’t acknowledge their role in contributing to alarming opiate addiction rates among veterans through their aggressive prescribing practices. A 2012 JAMA study showed that veterans with mental health disorders and PTSD were three times more likely to receive opioids for pain diagnoses than other veterans. “They are essentially prescribing heroin pills; the effects of these opiates are indistinguishable from heroin and the VA jumped on this campaign to encourage highly addictive prescribing,” says psychiatrist Dr. Andrew Kolodny, the co-director of Brandeis University’s Opioid Policy Research Collaborative. When told about the opiate usage figure—roughly 18 percent—from the Huntington VA, all he could say, after a shocked pause, was: “Wow! That’s very problematic.”

  “These are iatrogenic—medically-caused—addictions by the VA,” Kolodny adds. “The chickens are coming home to roost.”

  In West Virginia and most states, the VA worsened the nation’s addiction crisis—it didn’t even start reporting all VA patients getting opiates to state databases until the end of 2015, a delay that allowed for more doctor-shopping and drug-dealing to civilians. The VA’s Interim Undersecretary for Health, Dr. Carolyn Clancy, even admitted at a Senate hearing in March 2015 that she hadn’t known that the state VAs weren’t sharing data as requested. “It’s shocking but not surprising,” says Patrick Knue, director of the national Prescription Drug Monitoring Program (PDMP) Technical Assistance Center. The VA pharmacies were finally compelled to share prescribing records by a federal opioid abuse law passed in July 2016, but even near the end of 2016, eighteen state VA programs still weren’t reporting. Independent experts say that the department is still working out compatibility problems with its software, but in a written statement, the VA claimed that its pharmacy software was “updated” to improve sharing data with state PDMPs along with the monitoring of individual facility pharmacies to ensure they share this critical information.

  It seems likely that actively enforcing the mutual exchange of opiate prescribing data with state agencies simply hasn’t been a high priority for the VA. Outside of sending two bland directives asking its staff to report to—and receive information from—the state databases on individuals’ opiate prescriptions, with one issued as late as March 2017, it’s hard to tell from the VA’s actions on this front that it’s reacting to the nation’s deadliest healthy scourge. In May 2016, for instance, the alarmed board chairman of the American Academy of Family Physicians wrote a letter directly to Dr. David Shulkin, then the head of the VHA, pleading for the department to impose mandatory opiate reporting on all VA programs, pointing out that the voluntary approach has failed to result in the VA “reporting necessary information to prevent the misuse and diversion of prescription drugs.” More than a year later, the president of the AAFP, Dr. John Meigs, told me in a statement that the organization has still not heard back from Shulkin or anyone else at the VA. “Prescription drug monitoring programs are among the important vehicles for preventing patients from abusing opioid medications and, as such, are a cornerstone of the American Academy of Family Physicians’ advocacy on dealing with this epidemic,” he declared.

  For the VA, not so much.

  In October 2015, President Obama traveled to Charleston, West Virginia, to denounce the scourge of prescription opiate and heroin abuse, but didn’t offer much in the way of funding for his proposed initiative. West Virginia has the highest rate of drug overdose deaths in the country, accounting for a thir
d of all accidental deaths in the state. “This crisis is taking lives; it’s destroying families and shattering communities all across the country,” President Obama said. He didn’t cite the VA’s own role in spreading this wave of addiction or overmedication, or his administration’s failure for years to address the rising tide of 120,000 opiate deaths under his watch—likened by Kolodny to President Reagan’s inaction on AIDS.

  In fact, Obama had personally honored in 2010 the then-director of the Huntington VA, Edward Seiler, over two years after Andrew White had died from Seroquel and other drugs, as one of only five VA directors given the Presidential Rank Award for federal civil servants. Seiler declared, “This is a high honor, exceeded only by the honor I have in serving America’s veterans.”

  Stan and Shirley White were working in a different way to protect America’s veterans. By April 2012, the last time I met with them in person, they still retained some hope after meeting with lame-duck Senator Jim Webb (D-Va.) and two staff members, who had expressed concerns about antipsychotic overprescribing. Just a day earlier, the Whites learned that the Department of Defense would stop providing Seroquel in backpacks as a sleep aid for combat soldiers and removed the drug from its approved formulary list for Mideast soldiers, although authorization to prescribe it could still be obtained. The VA refused to follow the DOD’s Seroquel initiative, but the retiring senator promised them that he would speak directly to the VA’s chief medical officer about antipsychotic overuse. Yet years after Andrew White died and they’d begun their campaign for reform, Shirley White still needed to tell these aides: “Nothing has changed. We’re hearing back from the families with soldiers who are returning that they are getting the same treatment that Andrew received.” The staffers seemed sympathetic as they listened, took careful notes, and, as congressional aides always promised, they said they’d look into it.