by Art Levine
Before the TMAP trial began in January 2012, the state attorney general outlined how what he portrayed as ethically dubious researchers—such as Jensen—helped spread the idea that Risperdal was the best of the new antipsychotics even though it was actually having horrifying effects on kids, including causing D-cup breast growth in teenage boys. The J&J marketing deceptions succeeded in large part because respected researchers put their names on studies that were actually churned out by J&J’s ghostwriting firms. Others just took the cash and cooked up studies with positive results pleasing to the Janssen division’s marketers. As the Texas Attorney General explained in a filing before the trial: “Defendants thus ‘seeded the literature’ and increased the ‘noise level’ in the Texas health care community,” peddling false tales of Risperdal’s superiority and “suitability for off-label use on vulnerable populations.”
Other antipsychotic manufacturers, such as AstraZeneca, supported the TMAP scheme with funding because, as Allen Jones says, “they could see which way the profit train was moving.” They welcomed the portrayal of new atypical antipsychotics in a positive light, even though Risperdal was touted as the best of the new wonder drugs.
J&J, looking to end the battering to its image it was taking in court, settled shortly after the TMAP fraud trial started. But they still faced more costly settlements. J&J ultimately paid out $2.2 billion in 2013 to settle government criminal and civil charges related to illegal marketing of the drug. Then in 2015, in the first of roughly 10,500 pending breast growth cases they faced by early 2017, a Philadelphia jury decided that the company owed $2.5 million to a twenty-year-old autistic man who had developed size 46 DD breasts as a teenager. In July 2016, another Philadelphia jury awarded a sixteen-year-old boy $70 million, a decision that J&J promptly appealed; he had been taking Risperdal since he was five—while his family was never told of the risks. The company faces lawsuits from more than 100,000 patients, although the company has won some Risperdal cases. The “warnings” section in its Risperdal label still doesn’t specifically mention breast growth—gynecomastia.
Even so, the lingering, horrible effects of TMAP are still felt in the lives of young people today.
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NONE OF IT HAS MATTERED TO POLICY-MAKERS. ALL THE HUGE RISPERDAL court judgments, the Texas Attorney General’s revelations about the 2010 foster care panelists, and the wave of Texas overdrugging haven’t changed federal officials’ hands-off approach to state Medicaid and foster care programs. Part of the problem, of course, is that federal Medicaid officials insist that they don’t have the legal authority to stop paying for worthless and dangerous drug uses; that’s in apparent opposition to a series of federal court rulings and Justice Department fraud lawsuits. Those legal findings concluded, as in a $2.3 billion DOJ settlement with Pfizer, that the federal government has been defrauded when it’s asked to pay for drug “uses that were not medically accepted indications and therefore not covered by those programs,” according to the DOJ announcement.
On top of that, federal Medicaid officials have said that they can’t even advise the states to stop paying for these groundless uses of antipsychotics, although states do have the option to refuse to make fraudulent drug payments. “To say ‘it’s not our responsibility’ while 92 percent of the [pediatric] Medicaid antipsychotic use is inappropriate and killing children, that’s not acceptable,” counters Toby Edelman, a senior policy analyst with the Center for Medicare Advocacy, which fights to get the federal CMS agency to regulate nursing home medications that kill thousands annually. At the same time, Department of Justice attorneys spend years building cases that have led to billions in fines and settlements from the drug industry for defrauding Medicaid and illegally marketing its products to doctors and agencies.
This struggle by DOJ to recover billions in waste will never catch up with Medicaid’s heedless spending on unaccepted uses of antipsychotics. “They’re just pretending to address the issue of overdrugging with a wink and a nod—the Justice Department gets billions from drug companies for causing off-label uses that aren’t supported by the law, while CMS is continuing to pay for these same prescriptions,” crusading mental health rights attorney Jim Gottstein observes.
California, for example, is one state whose controls over foster care antipsychotic prescribing are supposed to be monitored by HHS’s ACF branch under a 2011 law. But the agency has simply rubber-stamped California’s and other states’ slow-walked foster care medication plans—with disastrous consequences for many of its 60,000 foster care children, according to critics and youth advocates. “I was given all these medications, but I wasn’t functioning,” a former California foster youth, who asked to remain anonymous, told me.
California, until very recently, was typical of most states that haven’t bothered yet to even develop formal plans or have only recently crafted feeble “guidelines” that are rarely enforced; Illinois, Oregon and New York are among the few states that have sought to do more. But prompted in part by the San Jose Mercury News series, California passed laws in 2015 and 2016 that added nurses to monitor prescribing; required doctors to try to arrange psychotherapy for their patients before giving them drugs; and expanded the power of the licensing board to investigate overprescribing doctors.
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WHEN PATIENTS COME TO AN HONEST, CARING PSYCHIATRIST LIKE Kruszewski, it’s hard to undo all the damage wreaked by overmedication. “About 95 to 97 percent of the children that I treat that are getting antipsychotics are given them for reasons that aren’t approved by the FDA,” he says. Just as troubling, he says, are the wide range of devastating side effects they suffer that aren’t much emphasized in the recent federal HHS Inspector General’s report or by the medical community, among them cardiac and metabolic problems, and elevated prolactin levels which cause breast growth in boys. “Imagine trying to be a seventeen-year-old black male in inner-city Philadelphia with breasts so large you should be wearing a D-cup bra—and then trying to get along with your peers,” he points out. “My introduction to this was a sixteen-year-old African-American boy and when I asked him to take off his shirt, he had massive breasts. He had been prescribed Risperdal for sleep for three years by his family doctor.”
After all his years fighting pharmaceutical industry fraud, it’s especially disturbing to Kruszewski that neither the youth he sees, ages twelve to nineteen—about a quarter of his practice—nor their families have been warned about the side effects or even the potential benefits of the drugs they’re given. Most commonly, those antipsychotics have been Risperdal, Seroquel and Abilify, given for bipolar disorder, insomnia (primarily Seroquel) and ADHD.
One of the key challenges in slowing the epidemic of overmedication, Kruszewski observes, is this dilemma: “We have to overcome the expediency of giving a prescription to solve a problem that will actually make the problem worse. As long as doctors are being expedient in their prescription writing, we can’t win this battle.”
The same short-term philosophy, it turns out, is actually the governing principle at most of the nation’s nursing homes and other long-term care facilities housing the elderly—even if it puts patients’ lives at risk. Like children, the elderly are another vulnerable population that is very profitable for drug companies.
CHAPTER 2
Nursing Homes: Drugging Our Seniors to Death
IN JANUARY 2013, A HISTORIC EVENT IN MODERN MEDICAL CARE TOOK place in a small courthouse in Bakersfield, California. Grey-haired Gwen Hughes, a former director of a nursing home in rural Kern Valley, appeared as feeble as possible when she rolled into the courtroom in a wheelchair with an oxygen pump attached to face sentencing after being convicted of overdrugging patients. Three patients died under Hughes’s “care,” while as many as twenty others were injured. This wasn’t some serial-killing “Angel of Mercy” nurse plotting to kill patients, but a case of “convenience drugging,” as then-Attorney General Jerry Brown said when announcing the arrest in 2009, orchestrated by a
real-life Nurse Ratched who used psychotropic drugs to sedate patients who acted up or irritated her. It was arguably the first, and, so far, the only time in US history that a health professional was prosecuted for overmedication as part of the legitimate medical care provided.
Hughes was abetted in her crimes by Pamela Ott, the now disgraced top administrator of the hospital district; pharmacist Debbie Hayes, whom Hughes browbeat into writing prescriptions for antipsychotic drugs such as Risperdal without a doctor’s permission; and staff physician Hoshang Pormir, who signed off on the scrips without evaluating the patients or seeking their consent. Despite the gauzy sales claims by TMAP, Johnson & Johnson, and their academic shills, psychotropic medicines such as Risperdal were finally unmasked for what they were: a product as potentially fatal as a gun.
Incredibly, the prescribing actions in Hughes’s case are standard medical practice. Although the federal government has since 1987 barred the use of chemical restraints on the elderly by federal law, it is virtually never enforced. In fact, nearly 300,000 elderly nursing home patients a day receive antipsychotics, close to a quarter of the patient population, largely to control their behavior. One-third of all dementia patients in long-term nursing care are dosed with antipsychotics, while, according to GAO estimates in 2015, nearly 200,000 other dementia patients in shoddy, unregulated “assisted living facilities” are also treated with these drugs. Despite a decade-old FDA “black box” warning label on every bottle clearly stating that using antipsychotics for “dementia-related psychosis” can increase the risk of death, roughly 90 percent of the drugs are doled out for unapproved, off-label uses, including Alzheimer’s and dementia behavioral symptoms.
“You have probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications for an indication that the FDA knows the drug doesn’t work,” Dr. David Graham, a leading FDA drug safety expert, told a congressional panel. “With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank,” he said. “We have got so many clinical trials that show these drugs don’t work that it is like malpractice to be using it.”
At the Kern Valley nursing facility, no one warned the families victimized by Hughes about the dangers posed by the drugs they administered so freely. The sudden decline in health of Fanny May Brinkley, a lively ninety-seven-year-old, came as a shock to those who loved her. To Hughes, however, Brinkley apparently talked too much. She was force-fed Depakote, an anti-seizure medication with powerful sedating and weakening effects, without the consent required by state law. Usually feisty, Brinkley suddenly became “lethargic,” according to her granddaughter, Tammy Peters: “I just thought it was old age.” Six days later, Fanny May was in the hospital emergency room, and there she died. According to the California Attorney General’s office, several others who didn’t die were left to suffer in their beds, unable to eat, emaciated and drooling.
It was heart-wrenching at the hearing to see Peters, a stolid blonde woman in a gray sweatshirt and dark pants, address the judge, her voice quaking with anger and tears. The paper shook in her hands as she read from her handwritten statement: “We thought putting our grandmother in a home was what was best. We were all impressed with these people, but they calculatedly and maliciously drugged and killed our grandmother,” she said. “I will never trust another nursing home to care for anyone I love again. On behalf of our family, we ask for the harshest sentence you can give.”
Hughes faced ten felony charges, but she pled no contest to one count of causing harm or death to an elderly or dependent adult; in return, the nine other charges were dismissed. She was sentenced to three years in prison, the harshest sentence possible. Her colleagues Ott, Hayes and Pormir, sentenced earlier, didn’t get prison sentences. After Hughes was sentenced, Deputy Attorney General Steven Muni told a local TV reporter, “I hope this sends a message to all nursing homes, and many are owned by for-profit chains, that you can’t put profits over people.”
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THE SENTENCING OF HUGHES IN 2013 GAVE HOPE THAT CALIFORNIA’S law enforcement agencies, and perhaps even the federal government, were finally ready to crack down on nursing homes that abused the elderly. After all, since research showed that 15,000 nursing home patients die needlessly every year, that’s a fatality rate equivalent to five 9/11 attacks per year. As of this writing, however, nothing has really changed. “The message providers took away was probably this: Don’t do this in an obviously mean-spirited way,” says Tony Chicotel, a staff attorney with California Advocates for Nursing Home Reform. Despite all the patients jammed with drug-filled needles or left to die in a stupefied state, Chicotel says that most nursing home caretakers have convinced themselves that this is somehow altruistic: “They believe they are motivated by wanting to do the right thing; the patient is exhibiting distress.”
Even so, it’s still not clear why the staff at Roseville Point Health and Wellness, a facility near Sacramento proud of its five-star Medicare rating, decided to give eighty-two-year-old Genine Zizzo debilitating shots of Haldol a few days into her week-long stay for physical therapy for a serious back sprain. Though Zizzo had a heart condition, she didn’t have dementia or any mental illness; instead, she was an active, independent woman who drove herself around town and did her own laundry, as The Sacramento Bee first reported. Zizzo only required nursing home care because she tripped over a tube connected to the oxygen machine she was using for her condition. Her doctors at Kaiser Permanente, after reviewing her X-rays, recommended a brief stay at the Roseville facility.
Her daughter, Marisa Conover, a former CBS Records marketing executive, lived nearby and was especially vigilant. She not only personally checked out the nursing home before admitting her mother, but, having learned about the dangers of antipsychotics, adamantly insisted to the admissions director: “Under no circumstances and not for any reason should my mother be given antipsychotic drugs.” She supplemented that request with an advanced medical directive and durable power of attorney that required her explicit approval before they could administer any treatments, with the authority to override any member of the staff, Conover says. In addition, she informed the staff before admission that her mother wasn’t incontinent and shouldn’t be placed in an adult diaper. That directive would also be violated.
Conover went to the facility every day, staying until visiting hours closed around midnight. As physical therapy began, her mother suffered from extreme pain. When Zizzo frequently called for help, overdrugging with painkillers began. According to Conover, Zizzo’s emergency call button was moved away from her reach. When Conover left her mother at about 1 a.m. on December 7, 2012, she pinned the call button on the sheet so her mom could get the help she needed. Later that night, four staffers allegedly grabbed Rizzo from her room, placed her in a wheelchair, tied her wrists with a cord and injected her with two shots of Haldol—an event buttressed by medical records and the coroner’s report.
When Conover came back later that morning, a nursing home staffer took her aside and told her, “There was an incident last night.” Conover was disturbed to hear the claim, expanded in the overnight nurse’s notes, that her mother was screaming and combative, and, improbably, that she had been moving up and down the hall, hitting and scratching and kicking the staff in a psychotic state. “They made her look like a Ninja turtle, and she couldn’t walk anywhere by herself,” she points out, as confirmed by Zizzo’s medical record at the home, which showed she needed two people to assist her.
Conover speculates that her mother was injected with the drug to stop her from pressing the call button to get the attention of the staff, but no one is really sure. The facility has declined repeated media requests to answer specific questions about Zizzo’s care; it’s worth noting that the array of allegations hasn’t been confirmed in a court of law, although the lackadaisical state health department finally confirmed in 2017 one finding: the nursing home didn’t obtain proper con
sent before injecting Zizzo with the antipsychotic. (That same agency faced a major lawsuit filed in 2013 for failing to properly—and promptly—investigate thousands of nursing home complaints, and the court ruled against the department on these issues in the fall of 2016.)
Zizzo’s decline after the injections was rapid, as she became increasingly comatose and an apparent victim of neglect. Seventeen days after entering the nursing home for routine physical therapy, she was dead.
“This was inappropriate drugging of the elderly, a bona fide malicious assault,” Conover charges. “It’s no different than using a knife, gun or bat, even if they did not intend to kill her.”
The death of Genine Zizzo is a window into not only the reality of deadly nursing home care, but the lengths that government officials take to keep nursing homes and other long-term care facilities protected from any genuine accountability.
To convey progress amid a wave of ongoing death and harm, the federal government instituted two programs: the dubious Five-Star Quality Rating System for nursing homes, which relies primarily on nursing homes’ self-reporting and weak state inspections; and a voluntary program in partnership with the nursing home industry that supposedly educates facilities’ caretakers about alternatives to antipsychotics. Both programs are overseen by CMS, the federal agency that compiles data on health-care quality as part of its role overseeing the Medicaid and Medicare programs.
The problem with both of the nursing home assessment programs, however, is that CMS assumes that nursing homes will report their practices accurately and that state health departments will monitor violations aggressively—neither of which has been the case so far. The Roseville facility, for example, was fined by state officials only three times for modest amounts between 2004 and 2016. This laissez-faire response came in the face of fifty citizen complaints against the facility just since 2012. In fact, CMS used the state’s upbeat inspection data to award Roseville a five-star rating early in 2017. All that should come as no surprise, considering that the California health department initially didn’t substantiate a single incident of wrongdoing in the death and alleged maltreatment of Genine Zizzo, while it delayed for years responding to the appeals of the Foundation Aiding the Elderly (FATE), the Sacramento-based advocacy group that filed a complaint on behalf of Conover in June 2013—and which did not receive a reply from state headquarters until April 2017.