by Art Levine
• • •
IN 2007, LOCAL AUTHORITIES LOOKED MORE CLOSELY AND CHARGED THE girl’s parents with poisoning Rebecca because they couldn’t get disability payments for her. They were convicted in 2010. After Kifuji was cleared by a grand jury of allegedly abetting their crimes, she was welcomed back by Tufts as “an outstanding physician.” She settled a related civil malpractice lawsuit for $2.5 million in 2013 without admitting culpability in the case.
Just as disturbing is the way Kifuji justified her actions by citing research from such academics as Dr. Joseph Biederman, a world-famous, industry-subsidized child psychiatrist from Harvard. He has been denounced by The New York Times as a “shill” after court documents revealed that he had solicited money from Janssen to do a study that “will support the safety and effectiveness” on Risperdal with preschoolers. Biederman’s work helped fuel in nearly a decade by 2003 a forty-fold increase in the diagnosis of pediatric bipolar disorder, paving the way for Kifuji’s heedless, fatal prescriptions.
The legitimacy given to such off-label prescribing of antipsychotics for children casts a shadow over the lives of many youths, particularly foster children, in Massachusetts and other states. Indeed, that’s especially true for all children on Medicaid, who, according to federally-funded researchers, are four times more likely to be prescribed antipsychotic drugs. Just as troubling is that Massachusetts’s Department of Children and Families (DCF) still has no capacity to monitor psychotropic drugs for kids.
Advocacy groups such as Children’s Rights have forced or challenged more than thirty states, including Massachusetts, to change their child welfare policies in ways that should also improve psychiatric care. (Massachusetts won its case, so it has felt free to ignore cries for genuine child-prescribing reforms.) Yet very few states have made significant progress in reining in the overmedication of kids in the federal-state Medicaid program. Antipsychotic prescriptions for foster care children have leveled off since 2008 to approximately 9 percent of all the nation’s 415,000 foster care kids, Rutgers University researcher Stephen Crystal reported in a 2016 Health Affairs study—600 percent higher than other Medicaid children. Relatively few states, he found, stirred themselves to provide psychotherapy services to these kids before doling out meds, or even measured their potentially deadly metabolic side-effects. “No state is doing a very good job,” says Crystal, the director of the Center for Health Services Research. Some states, such as California, drug nearly 25 percent of their foster care adolescents into submission with the full range of psychiatric medications, although that could change with tough new state legislation passed in August 2016, spurred by a disturbing San Jose Mercury News series.
• • •
IN THE YEARS AFTER REBECCA RILEY DIED, ANTIPSYCHOTIC DRUG MARKETING to kids continued unabated and even won new approval from the FDA. Somehow, more high-profile deaths in Texas and Florida, and the growing alarm over the legions of kids left in a stupefied state by these drugs, didn’t prompt major reforms.
In 2009, seven-year-old Gabriel Myers, woozy from two antipsychotics and an antidepressant, stumbled into the bathroom of his Florida foster home, wrapped a shower hose around his neck and hanged himself. Three years earlier, Dr. Sohail Punjwani, the physician who prescribed the off-label medications to Myers, ran experiments for Pfizer’s antipsychotic Geodon on kids between ten and sixteen. Florida children became guinea pigs for Pfizer even though the use of Geodon for children has never been approved. Six kids overdosed but survived. Three years before that, in 2003, a Florida teen under Punjwani’s care, Emilio Villamar, died of a heart attack after receiving cardiac-adverse Seroquel and other antipsychotics that also posed heart risks, according to a 2009 lawsuit filed by his mother. Although he received a belated warning letter from the FDA, Punjwani was never sanctioned by any state or federal agency for the deaths or overdoses, although he was arrested for cocaine possession in 2010 and entered a pretrial diversion program without being prosecuted. He defended his medical work to The Palm Beach Post in 2011, resenting his portrayal as a “child killer;” he also claimed he followed correct prescribing protocols in his depositions in the Villamar and Meyers malpractice lawsuits he settled for undisclosed sums.
The Palm Beach Post also found in 2011 that doctors in the Department of Juvenile Justice–run jails and homes—including, for a while, Punjwani—were prescribing enormous amounts of expensive antipsychotics, mostly to keep kids under control. Over 325,000 anti-psychotic pills, including Seroquel and Risperdal, were doled out over a two-year period in jails that held no more than 2,300 boys and girls on any one day. At the same time, the four top prescribing doctors in the system were lavished with close to $200,000 in drug industry booty.
In response to the furor, the department denied that there was abusive prescribing. Six years after the scandal, however, psychotropic prescribing remains roughly the same—about 30 percent—and the juvenile agency refuses to disclose antipsychotic use or whether its doctors are receiving drug money. Florida has still largely refused to take meaningful measures to rein in such dangerous prescribing. Despite the efforts of such advocacy groups as Florida’s Children First, dangers persist throughout the state. Courts are supposed to review prescribing, but it’s not at all clear that such measures actually protect kids from needless medication. Yet experts see progress now that total prescribing of psychotropic medication to Florida foster care kids is down to a claimed 11 percent overall. (That assertion is derided as “bullshit” by Michael Freedland, the lawyer who successfully won settlements for the families of Meyers and Villamar.) While that low figure, if accurate, may seem promising, psych prescribing for foster care teens in Florida is still officially reported at more than 25 percent, mostly for stimulants and antipsychotics.
• • •
FORTUNATELY FOR BIG PHARMA, THE DANGEROUS OFF-LABEL PRESCRIBING for children that marked Florida and other states got an added boost in June 2009 when the FDA expanded official approval for children’s drugging with antipsychotics. In 2009 and in subsequent years, their manufacturers—AstraZeneca, Eli Lilly and Pfizer—were all targeted by the federal government for illegal marketing of their drugs while they were seeking to win FDA approval to market antipsychotics to children for the same uses that the Justice Department considered fraudulent. In January 2009, Eli Lilly agreed to pay $1.3 billion to resolve criminal and civil allegations that they were promoting Zyprexa for uses not approved by the FDA, including for children and adolescents. A few months after the 2009 FDA hearing, Pfizer spent $2.3 billion in criminal and civil payments to settle allegations of fraudulent marketing of four drugs, including Geodon, while denying any civil liability; and in 2010, AstraZeneca paid $520 million for allegedly fraudulently selling Seroquel. Drug companies are legally barred from promoting drugs for off-label uses, but all doctors are free to prescribe any non-opiate drug to anyone.
But in June 2009, the companies wanted FDA approval for their drugs for teens and children as young as ten for bipolar disorder and schizophrenia, leading to their off-label use today for sleepless toddlers and distracted ADHD teens. Experts for all three companies reassured the advisory committee that their drugs “were fine for kids,” despite side effects such as weight gain, prolactin increases (which causes breast growth in boys), heart arrhythmia, diabetes risk and skyrocketing pulses.
While the hearing focused on evidence supplied by the drug companies, there wasn’t much interest in the testimony of Liza Ortiz, a mother from Austin, Texas, grieving over the death of her thirteen-year-old son Philip earlier that year. Suffering from some psychotic symptoms, Philip was prescribed Seroquel after other drugs failed. Four days after it was added to a cocktail of other antipsychotics, he died in the hospital. As she and her family stood in the ICU, “I saw Philip’s body so stiff and rigid with seizures that his hands twisted in ways that I never thought possible,” she told the panelists.
Fortunately for the drug companies, they had a champion in Dr. Thomas Laughren, the Dire
ctor of the FDA’s Division of Psychiatry Products. He had previously been dubbed a “double agent” for the drug industry by the Alliance for Human Research Protection (AHRP), an anti-industry group, for hiding from another advisory panel in 2004 a staff report on the suicidal side effects of antidepressants on kids, as first reported by The San Francisco Chronicle. (Agency officials told a congressional committee that he didn’t pass along the staff findings on suicide risks because the study was “imperfect.”)
In the wake of that publicity and congressional scrutiny, the FDA backed off expanding Paxil’s use for kids while continuing to allow such uses for Prozac, but a stronger pediatric warning label for all antidepressants was required by the end of 2004.
This time, in June 2009, Laughren was equally willing to advance the drug companies’ case for the use of antipsychotics with children. As he told the advisory panel, “We are in agreement with the sponsors that the data tend to support the effectiveness claims that they are seeking,” and that the drugs were just as safe for kids as they were for adults. In the end, though, the advisory committee ruled that all three drugs—Seroquel, Geodon and Zyprexa—were “acceptably safe” and effective for teenagers and children. (Laughren became a drug industry consultant after he left the agency in late 2012.)
After a further top-level review, the FDA decided in October 2009 to reject classifying Geodon as safe for children. According to a lawsuit ultimately rejected on appeal, that didn’t stop Pfizer executives from allegedly ramping up a new marketing drive in 2009 to promote the drug more aggressively to child psychiatrists—with added sales bonuses for winning higher prescribed doses—even after the FDA rejection and Pfizer’s agreement with DOJ to stop unlawful marketing. Those explosive charges are contained in a whistleblower fraud lawsuit filed in 2014 by former Pfizer sales reps Alex Booker and Edmund Hebron. Pfizer has denied the allegations. In May 2016, a federal judge rejected the lawsuit. That finding was finally upheld on appeal in January 2017, largely on the grounds that the whistleblowers couldn’t prove that the allegedly false marketing led to specific fraudulent billing incidents.
• • •
IN A TOXIC CLIMATE OF AGGRESSIVE, ILLEGAL SALESMANSHIP AND WEAK regulation in virtually all states, it isn’t surprising that even the feckless federal government occasionally expresses alarm at the overdrugging of kids. The findings of a 2015 federal inspector general’s report confirmed that poor children and foster care kids covered by Medicaid are being prescribed too many dangerous antipsychotic drugs at young ages for far too long—mostly without any medical justification at all.
Using a close-up study of nearly seven hundred claims in five of the biggest prescribing states—California, Florida, Illinois, Texas and New York—the investigation discovered that two-thirds of all prescriptions of these popular and costly atypical antipsychotics raised “quality of care” and safety concerns. One of the most troubling cases: a sixteen-year-old with bipolar disorder on three antipsychotics as part of his drug cocktail, who then went on to exhibit side effects including paranoia, hallucinations, darkly suicidal thoughts, insomnia and extreme weight gain.
Perhaps even more damning, the report found that 92 percent of all kids on Medicaid receiving antipsychotics didn’t have any of the relatively limited “medically accepted pediatric conditions” supposedly justifying their use for children as young as five. So given how much leeway the industry-influenced FDA has already given the drug manufacturers to legally deploy their wares on kids, just how far outside the bounds of sensible prescribing must a doctor go to merit FDA disapproval? But most of the few media accounts and the report itself ignored an even more fundamental example of failed oversight: the federal government’s lax monitoring of state Medicaid programs dispensing these potentially life-threatening medications to children.
Medicaid programs are generally all too glad to look the other way at such antipsychotic spending gone wild. This lack of rigorous enforcement is especially disturbing in light of the real-world experiences of children killed or damaged in states such as California and Texas that have been nearly as scandal-scarred as Florida. The federal government, in fact, has served as a handmaiden to deadly prescribing.
How bad is federal oversight? In 2012, both the Government Accountability Office (GAO) and ABC News reported that the federal government had touted arguably the worst prescription-monitoring program in the country, run by Texas. The state was so lax that Texas foster care children were fifty-two times more likely to be prescribed five or more psychiatric drugs at the same time than non-foster children. Yet HHS’s Administration for Children and Families (ACF) lauded the Texas drugging “parameters,” despite the fact that they helped turn too many kids into drooling, tremor-ridden “zombies,” as foster parents reported. The parameters were subsequently revamped by state experts and replaced in 2013 with tougher standards that only began to take effect in 2014, albeit on a limited scale.
Amazingly, the guidelines panel that was originally praised by ACF was stacked with two drug company-subsidized academics who were cited in court records for helping defraud Medicaid as part of the TMAP scheme uncovered by Allen Jones. Even so, the state has made some progress in recent years reining in psychotropic use. State officials and even outside reform advocates proudly note that the use of such drugs by foster care kids for more than sixty days dropped to just under 20 percent. Still, the percentage of children two and under getting psychiatric drugs rose nearly 50 percent between 2005 and 2013, the years when the trumpeted reforms were put in place. Today, an alarming 62 percent of all Texas foster care teens are on psych meds, with nearly two-thirds of those medicated youth on antipsychotics, much higher than the national average.
“Kids’ bodies aren’t meant to take that many meds,” says Susan Rogers, a leading reformer who served on the board of the Texas Federation for Children’s Mental Health and was a foster care parent for nearly thirty years. She and her husband found that they were undermined by state-funded psychiatrists and social workers who were often indifferent to the disastrous side effects of the antipsychotics the Rogers were pressured to give youth who didn’t need them. “We had a foster daughter who blimped right up on Risperdal, gaining sixty pounds, and who was so miserable she became anorexic,” she recalls. “I had to buy her a totally new cheerleader’s uniform.”
Influential doctors throughout the state were awash in J&J money to promote the drug, the TMAP fraud lawsuit revealed. “The psychiatrist wouldn’t take her off this, and I said I’m going to do this anyway even if I lose my license [to provide foster care],” she says. She even worked extra hours to ensure that the school system provided the girl added therapy.
“We were screwed by the state,” she now says of the corrupted practices and rigged protocols that harmed her foster children.
Texas officials boast about the centralized monitoring role of STAR Health, a managed health care firm for foster kids that supposedly flags excessive prescribing as part of its electronic “health passports.” But all that wasn’t enough to protect Jo Angel Rodriguez, a troubled eleven-year-old girl who bounced around the foster care system until her death in 2009, which prompted a wrongful death lawsuit settled with Pfizer; Pfizer is the maker of the antipsychotic Geodon, linked to heart irregularities and allegedly pushed by company salesmen for use by children since 2001, according to the Justice Department. As reported by the San Antonio Current, Rodriguez was taken to the Laurel Ridge Treatment Center and was first given the antipsychotic Abilify, which caused vomiting and diarrhea, and then spurred the girl’s withdrawn and later aggressive behavior. The solution? More drugs.
A moonlighting medical school resident offered her Risperdal, and when she refused that, the novice doctor gave her a 20 mg shot of Geodon instead, helping trigger a heart attack resulting from a cardiac arrhythmia.
The continuing dangers facing Texas foster care children shouldn’t have been surprising to anyone paying attention to the dubious makeup of that fourteen-member “workin
g group” designing the 2010 guidelines that were hailed by the federal government; two of the experts, including Dr. Peter Jensen, the founder of Columbia University’s children’s mental health research center, were paid by J&J to promote ghostwritten or other questionable “research” on behalf of Risperdal that helped the TMAP psychotropic guidelines to loot sixteen other state programs, according to the Texas Attorney General. (They have declined to talk to me or other journalists over the years about the allegations in the lawsuit.)
A third panelist, Dr. Charles Fischer, a child psychiatrist at Austin State Hospital, was fired in November 2011 over allegations that he had molested teenage boys during “counseling” sessions over a twenty-year period, according to a Texas Medical Board order that temporarily suspended his license. He faced accusations from as many as six former patients and one former seven-year-old neighbor, now adults, at the trial that convicted him in mid-November 2016 of multiple counts of child abuse and sexual assault. He was sentenced to forty years in prison.
Texas court documents also showed that the groundwork for spreading TMAP was laid by J&J, which spent nearly $1 million on a trio of prestigious East Coast researchers, including Dr. Allen Frances of Duke University—now known as a critic of overmedication—to craft pro-Risperdal schizophrenia guidelines and promote a forerunner TMAP. The academics promised to help the company “increase its market share.” (Frances has defended those guidelines as “carefully and honestly done.”)