We Need to Talk About Frankie

Of her three young boys, Lori Perry’s eldest son, Frankie, was by far the most rambunctious. He seemed to get into everything — even coating baby gates in Vaseline wasn’t enough to prevent him from climbing over them. Once, Lori woke up in the middle of the night to find Frankie covered in Ovaltine. He had climbed out of his crib, made his way down to the kitchen and onto a high granite countertop, and reached into the cabinet to peel open the tight plastic lid of a Costco-size can of powder. Lori had heard water running and tiptoed downstairs, fearing a burglar. Instead, she found Frankie in the bathroom, trying to wash off his chocolate-covered cheeks.

At 3, Frankie’s escapades became less adorable. He began throwing intense tantrums, often taking his anger out on his younger brother Michael. Sometimes, when Michael whined, Frankie would sit on him to make him stop. More worrying, Frankie hadn’t started talking — Lori didn’t know whether he understood when she reprimanded him.

In 2004, with a new infant at home and Frankie wandering the house after bedtime and butting heads with his brother, Lori felt overwhelmed. She started taking Frankie to specialists — first to a speech therapist, who eventually helped him say a few words. “It was very limited, like fire truck,” Lori says. Later, she took him to a pediatric neurologist, Peter Heydemann, who confirmed Lori’s concern that her son used “no expressive language” and diagnosed him with “mild to moderate global developmental delay, most prominent in language delays.”

Heydemann ordered further testing, including a hearing exam, but he also tried to reassure the worried mom. “In the end, he said we would have to wait,” she remembers. “He said sometimes boys develop later.” For Lori, though, Frankie’s speech delay had become a safety issue, especially since he was so impulsive. “He would run out in front of a car,” she says. “He would take off if you lost your grip, right out into the street … If I would tell him ‘no,’ I didn’t know if he understood. Frankie just didn’t respond sometimes when you spoke to him.” She was worried he wouldn’t be able to sit through school. He had difficulty sleeping and wasn’t fully potty-trained. “Try potty-training a nonverbal 3-year-old,” she says.

The family lived in Chicago, and so she called Children’s Memorial Hospital in Lincoln Park and met with a child psychologist there, who recommended the hospital’s Partial Hospitalization Program (PHP), which is designed to treat patients who need more intensive observation than would be possible in an outpatient setting. It was a ten-day program, during which psychologists and other experts would observe Frankie for several hours each day. Under the supervision of the program’s director, a psychiatrist named Karen Pierce, pediatric developmental therapists played with Frankie, testing his speech and fine motor skills as he played with puzzles and toys. They even tried to provoke the kinds of tantrums Lori had described, cutting his playtime short or taking his toys away. To everyone’s surprise, Frankie was unfazed — even when, at a therapist’s suggestion, his brother Michael was brought into the room to better simulate his home environment. “I think it was just that he was in a new place, so he was calmer,” says Lori, who stayed with Frankie the entire time. “As soon as he was back in the car he was the same, pulling his brother’s hair in the backseat.”

Lori hoped that the ten-day program would be the final stop in a tiresome procession of appointments and referrals, that she would leave with a course of treatment that would finally work, for “proper therapy,” as she says. Instead, she left with a prescription for a powerful anti-psychotic that would change the course of her and Frankie’s lives forever.

Frankie was given a diagnosis of attention deficit hyperactivity disorder (ADHD) and, for his speech delay, pervasive developmental disorder not otherwise specified (PDDNOS). The American Academy of Pediatrics recommends behavioral therapy or stimulants such as Ritalin and Concerta as first-line treatments for ADHD, but Pierce was concerned about Lori’s reports of Frankie’s aggression. So instead she prescribed Risperdal, a powerful neuroleptic, or anti-psychotic, used most often to prevent psychotic breaks in schizophrenic adults.

Prescribing anti-psychotics to children is not uncommon. A 2015 Journal of the American Medical Association study found that in 2010, 418,000 kids under 12 were prescribed an anti-psychotic annually, which is not to say that that many children have psychotic disorders. According to a 2011 Pediatrics study of foster-care children given anti-psychotics, only a quarter were diagnosed with a psychotic disorder. More than half of them were diagnosed with ADHD. An increasing number of children receiving these drugs are toddlers. In 2014, nearly 20,000 prescriptions for atypical anti-psychotic drugs like Risperdal, Abilify, Zyprexa, and Seroquel were written for children 2 years old and younger, up from 13,000 the previous year, according to IMS Health, a company that tracks prescription data.

The FDA has never approved any atypical anti-psychotic medication for children under 5, but once a medication is on the market, there’s no rule preventing doctors from prescribing them off-label. And in fact, off-label use is often how the FDA and drug companies discover new and potentially life-saving applications for a drug. As one FDA director who helps oversee the approval of new psychiatric drugs told me, the FDA label reflects only the uses for the drug that have been clinically verified. “In other words, it wouldn’t be the FDA’s role to say because a drug works in 10-to-17-year-olds, that it doesn’t work in 9-year-olds, but I can tell you it’s not on-label for you to use this drug in a 9-year-old because I didn’t have data in 9-year-old kids.”

With anti-psychotic drugs, though, off-label use seems to have occurred at a particularly alarming rate. Those for whom the drugs were initially intended — adults with schizophrenia and bipolar disorder — make up, respectively, just 1 and 1.5 percent of the U.S. population, so drug companies have also promoted the use of anti-psychotics to treat sleeplessness, anxiety, and mild to moderate depression. A 2015 American Journal of Psychiatry study found that more than one of every five patients who visited a psychiatrist for anxiety in 2007 left with a prescription for an anti-psychotic drug. By that time, half of Johnson & Johnson’s Risperdal sales came from off-label prescriptions for children and the elderly. Asked whether the company promotes off-label use of Risperdal, a Johnson & Johnson representative said the company has “robust and current information about their products” and that it’s a public-health benefit to “respond to unsolicited requests for information about off-label uses.”

The diagnosis that leads to a Risperdal scrip for children is often “early onset bipolar disorder,” a disease essentially invented in the 1999 book The Bipolar Child by New York psychiatrist Demitri Papolos and his wife. The book invites parents struggling with difficult kids to consider the idea that their children may be bipolar with the help of a 65-item questionnaire. Alongside a handful of uncommon symptoms that parents are prompted to look for, like “makes clear threats of suicide” and “makes clear threats of violence to others or self,” nearly all are symptoms that seem to describe typical toddler and childhood behavior: “has difficulty arising in the AM,” “has difficulty settling at night,” “craves sweet-tasting foods,” “is easily distracted during repetitive chores and lessons,” “is very intuitive and/or creative,” and “complains of being bored.” Perhaps unsurprisingly, more parents began seeing signs of bipolar disorder in their young children. One Texas mom, Sheri Lee Norris, was initially told her 2-year old daughter Heather had ADHD, reported the Dallas Star-Telegram. After reading The Bipolar Child, Norris returned to Heather’s psychiatrist with a copy of the book in hand and left with a new diagnosis of bipolar disorder. Papolos also wrote that parents should “breathe a sigh of relief” if their clinicians are amenable to prescribing medications outside the parameters set by the Diagnostic and Statistical Manual of Mental Disorders (DSM) — the psychiatric bible.

If it seems surprising that a child psychiatrist would be so keen to suggest strong drugs, it shouldn’t be. Doctors may truly believe that these drugs are helpful to their young patients, but there is often financial incentive that accompanies such beliefs. In 2000, Papolos started the Child & Adolescent Bipolar Foundation, an influential advisory board now called the Balanced Mind Parent Network. Its website featured message boards, chat rooms, and a drug database, and advocated “screening school children for emerging bipolar disorders.” (The foundation has since scaled back its web presence.) According to the group’s own conflict-of-interest disclosures, the team of experts tasked with writing the foundation’s guidelines for pediatric bipolar disorder — guidelines that advocate treatment with medication — were paid speakers for nearly every major pharmaceutical company that manufactures an atypical anti-psychotic drug, including Johnson & Johnson, Otsuka, Bristol-Myers Squibb, and Eli Lilly.

Lori didn’t think to question Frankie’s diagnosis or the powerful drugs Pierce had put him on. “The best hospital I had read and heard about was Children’s Memorial,” she explains. “If you wanted to see the best specialists in any area for a child, you went to Children’s.” Lori claims Pierce never once mentioned that Risperdal was an atypical anti-psychotic. In fact, the only explanation Pierce offered in the medical record for her decision to prescribe the powerful drug was the note “to help him sleep.”

“They told me it was like a magic pill that was going to slow him down enough to learn, that his speech would get better, he could be in school, he would sit still and eat,” Lori recalls. “And it did, because after that he ate. And ate. And ate.”

Other worrisome symptoms began to show up immediately. Frankie was “drooling, stumbling, moving like he was in slow motion,” Lori says. “Almost like a drunk person.” She called Sharon Hirsch, the psychiatrist at Children’s then charged with Frankie’s care, to report her son’s worsening condition. When Hirsch learned of Frankie’s new symptoms, she doubled his dose from .25 milligrams to .5 milligrams of Risperdal per day. A month later, Lori’s husband, Frank, took the boy to see Hirsch again. “I remember telling Dr. Hirsch, he just — he’s gaining weight quickly. His eating is nonstop, and it was all new that this was happening,” he would later testify. Hirsch told him to cut empty calories and doubled the dose again, to 1 milligram daily. In October, after Frankie had been on Risperdal for 11 weeks, Lori called Hirsch again, this time worried about her son’s excessive drooling, lack of coordination, and overall clumsiness. Hirsch increased his dose to 1.25 milligrams. By that time, Frankie’s weight had tripled.

In April 2005, after Frankie had been on Risperdal for nine months, Frank Sr. brought his son back to Children’s because Frankie had developed pronounced facial tics, a grimace Lori likens to an upside-down frown. By September 2005, Hirsch noted in Frankie’s chart that he “holds hand at odd angles” — a clear sign of tardive dyskinesia (TD), an involuntary movement disorder sometimes caused by dopamine antagonists like Risperdal, most often seen in schizophrenic adults who have had prolonged exposure to the drugs. But instead of taking Frankie off Risperdal or scaling back his dosage, Hirsch once again increased the dose, this time to 1.75 milligrams, more than triple the minimum recommended dose for children ages 5 to 17.

In November 2005, Hirsch left Children’s, and Poonam Jha took over Frankie’s care, noting in his chart poor coordination, left-sided weakness, and “no progress with physical skills/strength/balance.” By this time, the same boy who’d had the “superhuman ability” to scale gates, crib walls, cabinets, and countertops was receiving physical and occupational therapy for low muscle tone and motor coordination, and his tongue continually drooped out of his mouth. He’d also developed breasts.

At every visit, Hirsch, and then Jha, reassured Lori that despite the side effects, her son was improving. “They would say, ‘Look, he’s able to sit still, he’s much calmer now,'” Lori tells me. “They said, ‘If we take him off the drug, he’ll become more aggressive.” It wasn’t in her nature to distrust doctors, especially at a top Chicago hospital. “It confuses you when you’re hearing it from a doctor,” she says now, close to tears. “I second-guessed my own gut feeling.” When she suggested the symptoms could have something to do with the medication, Lori says both Hirsch and Jha would remind her of how rowdy and sometimes antagonistic Frankie had been before he started treatment. “It was very important to me that my son be able to function in school,” she says. “They’d say things like, ‘If you [stop the medication], he’s not ever going to be able to go to school.'”

In April 2006, Frankie fell down the stairs, telling his parents that his “legs wouldn’t work.” That was when Lori finally typed “Risperdal side effects” into a Google search box and “was shocked to see that he had these scary symptoms of this horrible, progressive disease that could be permanent.” She took Frankie back to Peter Heydemann, the pediatric neurologist who had initially evaluated him. By now, Frankie was 5 years old, taking 3 milligrams of Risperdal a day, 12 times his original dose. Heydemann attributed the constellation of symptoms to “Risperdal toxicity.” The large breasts, in particular, were a tell-tale sign. At Heydemann’s suggestion, Lori weaned down Frankie’s dose for the next seven days before stopping the medication completely.

Lori says that when Karen Pierce and Sharon Hirsch had talked to her about Risperdal, they sounded “like they were motivational speakers,” convinced that the exciting new medication would help her son. And in a way they were. According to disclosures from a medical-journal article, at the time she was treating Frankie, Hirsch was a paid speaker for the Johnson & Johnson subsidiary that makes Risperdal, as well as Eli Lilly, Novartis, and Shire. Pharmaceutical companies typically spend a quarter of their annual budgets paying these “key opinion leaders,” influential doctors and researchers, like Hirsch, Pierce (who was a paid speaker for Johnson & Johnson subsidiary Ortho-McNeil, Eli Lilly, and Novartis), and other doctors who promote their drugs to fellow physicians and medical students by speaking at conferences and spreading the word about promising off-label uses. Former KOLs say that they were rewarded with free flights, Broadway tickets, and money. (Hirsch, Piece, Jha, and Children’s Memorial Hospital declined to be interviewed for this story.) In 2013, the U.S. Department of Justice reached a $2.2 billion settlement — the largest ever for a single drug — with Johnson & Johnson, which plead guilty to marketing Risperdal for off-label uses and admitted to paying kickbacks to doctors.

Former opinion leaders and pharmaceutical reps say that these KOLs have been incredibly effective at marketing the need to diagnose children with mental illness early on. “The juvenile bipolar thing began with a few weird people … weird in the sense that they just didn’t have mainstream ideas at all,” explains David Healy, a former KOL for several major pharmaceutical companies. “Over a few years, you get industry building up these impressions that lots of people think this way, so that when doctors are faced with kids who are overactive with problem behaviors, they begin thinking, Oh, this could be juvenile bipolar disorder. And, of course, we’ve got Risperdal, and Zyprexa, and things like that to treat it.” As of 2015, Johnson & Johnson has netted nearly $30 billion in profits from Risperdal.

Frankie is now 16 years old. He is highly intelligent, a political-science enthusiast who can recount the military histories of Korea and the Balkans and the revolutions of Russia and China with a fluency that surpasses his years. He is an avid reader and writer and maintains a blog about human-rights issues, often trying to engage his mother in discussions about wealth inequality and child-labor laws. He also remains obese, and he moves slowly when he walks. His biggest challenges are his dramatically decreased muscle tone and fine motor coordination. “He can barely get out of the bathtub on his own,” Lori says. “He thinks he’s getting his license next year, but he can’t even tie his shoes.”

Frankie says he still experiences tremors in his hands, arms, and legs, which he tells me “most notably come out under times of stress,” or muscle rigidity, where his muscles feel stiff, weak, and painful. Because using a pencil is so difficult, Frankie has to bring a special keyboard to class for taking notes. He’s been bullied in school, suffered from depression, and faces “social challenges, like talking to people,” he says. “Sometimes I’m just socially awkward,” which is in part why he retreats so often to books. (Lori recently encouraged him to join the Boy Scouts as a way of connecting more with other teenagers and was delighted when he came home from a weekend at survival camp with merit badges for first aid and fire safety.)

By 2011, when Frankie was 10, it was apparent to Lori that he had reached a plateau in his improvement with physical therapy and was unlikely to ever again resemble the boy he was before Risperdal. In July of that year, she filed a lawsuit against Children’s Memorial Hospital and Sharon Hirsch and Poonam Jha, claiming they were medically negligent for administering Risperdal to a child Frankie’s age without informed consent, and for failing to monitor the child or stop the medication after clear signs of harmful side effects.

By the time Frankie started taking the drug, doctors already knew that Risperdal could cause tardive dyskinesia, as well as weight gain, the growth of breasts, severe drooling, and respiratory issues. In 2005, a New England Journal of Medicine study found that newer atypical anti-psychotics, including Risperdal, actually caused more metabolic syndromes, including obesity and high cholesterol, than the older class of drugs like Haldol and Thorazine that they had replaced, and yet they were no more effective. Last July, Johnson & Johnson shelled out $70 million to a Tennessee teenager who grew breasts after taking Risperdal, which he had been prescribed at the age of 5. There are now 1,500 similar suits in the United States. (Hirsch would concede during the trial that she knew “common” side effects of Risperdal include weight gain, increased breast size, and drooling, but insist that none of these are “serious.”)

It would take more than four more years for Frankie’s case to finally go to trial. During that time, Frankie would become a teenager, more aware than ever of how he’s different from other kids. During a family vacation to Siesta Key in the summer a few years ago, Frankie caught a glimpse of his reflection in a car door and asked his mom if he should leave his shirt on. “I asked him, ‘Why, honey?'” Lori recounts. “But he refused to take it off. And lately, he keeps asking about his breasts.” He was too little when he was on the drug to remember what it was like, what he was like before. “It’s just kind of a chapter of my life to just put off to the side,” he says soberly. “It’s not something I want to embrace.”

During the trial, in February 2016, the jury saw videos of Frankie as a young boy. First, from when he was 2 and 3 years old, before he began taking Risperdal — ascending some rocks near a stream with his brothers at a state park, climbing the ladder of a tall metal slide at the playground, petting a giraffe at the zoo and jumping up and down with joy. Then there are several clips taken during the 20 months he was on the drug. One is from the boys’ first day of school, when Frankie is 4 and Michael is 3. In the car, Frankie sits staring into the camera, his eyes unfocused, glazed over. Drool is dripping from his lip. “I wanna see,” he says, referring to the image of himself. His speech is slurred, his reaction time visibly delayed. While Michael runs ahead to the school entrance, Frankie moves deliberately, holding his father’s hand. Another shot is taken at the same playground the jury had seen before. After nearly two years on Risperdal, Frankie struggles with the very slide he had easily ascended two years earlier.

The next series of videos were taken at the request of Heydemann, Frankie’s original pediatric neurologist and the one who diagnosed Frankie with Risperdal toxicity, in an attempt to monitor his therapeutic progress in the months after he stopped the medication. Frankie climbs the stairs, one hand on the railing, the other jerking up and down in an elliptical motion that resembles the flapping of a broken wing. Lori asks him questions: “What do you like to watch on TV?” His lips repeatedly part and come together as he struggles to form words. “Power Rangers,” he says slowly, his mouth an intermittent rictus. His hands are balled into fists he works to unfold in order to grasp the banister.

“You know, the sad thing is,” says Eileen O’Connor, Frankie’s attorney, after showing me the videos, “I look at him at that age and I think, This kid could have been an athlete.“

As angry as Lori is with Frankie’s childhood psychiatrists, she blames herself, too. “I know he wasn’t born like this,” she says. “I know that something that I put in his mouth caused this.” She still struggles to understand why she didn’t take him off Risperdal sooner. “I didn’t see the progression like you do in the videos,” she explains. “I saw him every day. I knew something was wrong, but … I just trusted the doctor.”

Even now, when he gets mad at me, he’ll say, “Why did you make me take that?” she says. “He doesn’t understand how hard it is to make decisions like that, especially when you’re misinformed.”

On the fifth day of the trial, the lawyers reached a settlement, the terms of which neither party is permitted to discuss. Frankie wants to use the money to advance research toward finding a cure for tardive dyskinesia. “My mom wants to do therapy [for me]. I just disagree with that,” he tells me. “I want to start a foundation to find a cure for the disease.”

This article was reported in partnership with The Investigative Fund at The Nation Institute, now known as Type Investigations, with support from the Puffin Foundation.