The Drug That Gave Boys Breasts: How Johnson & Johnson Invented Pediatric Bipolar Disorder to Sell Risperdal
An Essay
Preface
This essay draws primarily on Gardiner Harris’s No More Tears: The Dark Secrets of Johnson & Johnson (Penguin Random House, 2025), a comprehensive investigation into the pharmaceutical company’s marketing practices based on internal documents, grand jury files, depositions, and trial transcripts. Harris, a former New York Times reporter who covered the pharmaceutical industry for over a decade, gained access to materials that remained sealed for years during federal investigations.
From 1994 to 2003, the number of American children and adolescents treated for bipolar disorder increased fortyfold. By 2003, approximately 800,000 children—about 1 percent of the population under age twenty—were being treated for the condition. Dr. Mark Olfson of the New York State Psychiatric Institute called it unprecedented: “I have been studying trends in mental health services for some time, and this finding really stands out as one of the most striking increases in this short a time.”
The increase made bipolar disorder more common among children than clinical depression. Psychiatrists made almost 90 percent of the diagnoses, and two-thirds of the young patients were boys.
The most rigorous investigation of child mental health, the Great Smoky Mountain Study, found virtually no evidence of mania before the teen years. No evidence has since emerged that the children diagnosed as having bipolar illness carried the disease into adulthood. The epidemic was treating a condition that, in the form being diagnosed, did not exist.
The Pied Piper of this vast increase was Dr. Joseph Biederman of Harvard University. Johnson & Johnson was his vital partner. Together, they manufactured a diagnosis that would justify the prescription of powerful tranquilizers to children as young as two years old—tranquilizers that would cause tens of thousands of boys to grow permanent breasts and contribute to the deaths of elderly patients who were also targeted by the same marketing machine.
Support Independent Research
This work remains free because paid subscribers make it possible. If you find value here, consider joining them.
What paid subscribers get: Access to the Deep Dive Audio Library — 170+ in-depth discussions (30-50 min each) exploring the books behind these essays. New discussions added weekly. That’s 100+ hours of content for less than the price of a single audiobook.
[Upgrade to Paid – $5/month or $50/year]
Get in touch Essay ideas, stories, or expertise to share: unbekoming@outlook.com
I. The Architect
Joseph Biederman was born in communist Czechoslovakia in 1949. His parents took him to Argentina when he was six months old. He graduated from the Faculty of Medical Sciences in Buenos Aires, trained at Hadassah University Hospital in Jerusalem, and rose through the ranks at Harvard-affiliated Boston Children’s Hospital.
Like almost every other prominent psychiatrist of his generation, Biederman’s success depended largely on his close relationships with drugmakers, which funded much of his research and paid him to deliver talks about his findings. But he was also beloved by patients and their parents. While many prominent psychiatrists pass off their most difficult patients to junior faculty, Biederman insisted on treating them himself. He often gave parents his home phone number in case of emergencies. His concern for them was heartwarming and real—and it provided moral cover for everything that followed. A doctor who genuinely cared could not possibly be harming children. The parents trusted him. The field trusted him. The companies paid him.
Charismatic and persuasive, he did more than any other person to convince the field of psychiatry that bipolar disorder—which, like schizophrenia, had long been thought to appear only in adulthood—afflicted children as young as one and two years old. And that the condition could be effectively treated with cocktails of powerful medicines that often included Risperdal and other antipsychotics.
Biederman could be demanding and tempestuous—especially when he didn’t get paid the money Johnson & Johnson had promised him. “Dr. Biederman is not someone to jerk around,” John Bruins, a company liaison to top academic figures in New England, wrote after Biederman said he’d been shorted $3,000. “He is a very powerful national figure in child psych and has a very short fuse.”
Johnson & Johnson quickly paid Biederman the missing $3,000.
Biederman soon pitched the company on a multimillion-dollar investment in a center that he promised would increase Risperdal’s sales. As an email from a top J&J executive explained, Biederman had “approached Janssen multiple times” to ask that the company fund a center named for it to study bipolar disorder in children. Biederman promised that if Johnson & Johnson invested in his research, the study results would increase the company’s sales.
When asked about this explicit promise in a deposition, Biederman was unapologetic: “We were talking to an interlocutor that was a commercial entity, so there has to be something for them.”
The company gave the Harvard team $2 million for the center and spent beyond that to hire Biederman to give talks about his results. The investment paid huge dividends. The Harvard group published findings from a string of drug trials from 2001 to 2006 that seemed tailor-made to make Risperdal appear as beneficial as possible.
The trials were as primitive as the office experiments from the Victorian era. Medical journals like The Journal of the American Academy of Child and Adolescent Psychiatry dutifully published them as “studies,” claiming “significant reduction” in symptoms. The studies found that giving young children tranquilizers makes them seem more tranquil.
In one planned study presented to the company, Biederman proposed testing Risperdal in preschool children—those under six—and promised before the trial was conducted that its results “will support the safety and effectiveness of risperidone in this age group.”
Johnson & Johnson paid a ghostwriting firm to draft write-ups for some of Biederman’s studies. A June 2002 email from Dr. Gahan Pandina, a top member of Johnson & Johnson’s Risperdal clinical trial program, included a brief abstract of a study of Risperdal in children with disruptive behavior disorder. Pandina asked Biederman to sign a form listing himself as the author so the company could present the study to a conference. Biederman responded that he would “be happy to sign the forms if you could kindly send them to me.”
Some child psychiatrists watched with alarm as huge numbers of children were given powerful tranquilizers. David Shaffer, former head of child psychiatry at Columbia Medical School and the author of a classic textbook on child development psychology, assessed Biederman bluntly: “Biederman was a crook. He borrowed a disease and applied it in a chaotic fashion. He came up with ridiculous data that none of us believed. It brought child psychiatry into disrepute and was a terrible burden on the families of the children who got that label.”
In 2008, Senator Charles Grassley’s office explored how rich the consulting arrangements between drugmakers and academics could be. When Grassley’s staff asked Biederman how much J&J was paying him, his response was less than straightforward. Biederman and two colleagues initially reported receiving about $150,000 from multiple drugmakers over many years—a seemingly modest amount. But Grassley’s office had already heard directly from the companies that they had paid Biederman and his colleagues $1.6 million over several years—more than ten times what Harvard reported.
The corrected reports the university provided had numbers vastly higher than the earlier ones but still not close to the actual amounts. In just one example, Biederman originally reported no income from Johnson & Johnson for 2001. His corrected form showed $3,500. Johnson & Johnson reported paying him $58,169 that year.
At the time, Harvard policy forbade researchers from conducting clinical trials if they received payments of over $10,000 from the maker of the drug being studied. Biederman had clearly broken that rule, and he had done so with children—a population for whom such protections are considered nearly sacred.
In an emailed statement, Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said that he took conflict-of-interest policies “very seriously.”
After a yearlong investigation into Biederman’s faulty income disclosures, Harvard did little to punish him.
II. The Product
Risperdal was part of a wave of drugs called “atypical antipsychotics,” distinguishing them from older antipsychotics like Haldol, which are referred to as “typicals.” Atypicals were sold as safer than typicals because they were supposed to cause fewer tics and tremors—the involuntary movements that made patients on older drugs into social pariahs.
This supposed benefit was enough to make atypicals one of the most profitable drug classes in history. Since people with schizophrenia are often homeless or incapable of regular employment, state Medicaid programs were the largest purchasers. For about fifteen years, atypicals were Medicaid’s single largest expense. The prices were so high that many state Medicaid programs ran out of money buying them and ended up kicking thousands of poor people off their rolls as a result.
Neither claim about Risperdal—that it was more effective or safer than Haldol—turned out to be true.
The best comparisons of older and newer antipsychotics were done by government-funded researchers in the United States and Britain. In the CATIE trial, whose initial results were published in September 2005, researchers randomly assigned 1,493 people with schizophrenia to receive one of five drugs and followed them for eighteen months. Three-quarters of those given Risperdal stopped taking the drug or switched to another, either because it was ineffective or because the side effects were too severe. Those taking an older Haldol-like drug tolerated the medicine a bit longer, which meant it was still the better drug despite costing a fraction as much.
Most remarkable was that the tics and tremors happened just as often in those taking Risperdal. The main selling point of atypicals—a reduction in extrapyramidal side effects—was false hype.
“Probably the biggest surprise of all was that the older medication produced about as good an effect as the newer medications, three of them anyway, and did not produce neurological side effects at greater rates than any of the other drugs,” said Dr. Jeffrey Lieberman of Columbia University, who led the study.
The challenge Johnson & Johnson’s executives faced was to take a medicine that was no better than its predecessor, price it at forty times higher, and find ways to persuade psychiatrists, insurers, patients, and everyone else involved in psychiatric care to prescribe and buy it.
The FDA approved Risperdal only for treating schizophrenia. The company’s Risperdal business plan for the year 2000, approved by Alex Gorsky—then the rising executive who oversaw the drug’s marketing—identified the drug’s two key growth areas as dementia in the elderly and use among children. Neither use was approved by the FDA. Promoting a drug for unapproved uses is a federal crime.
The company estimated that drug sales in 2000 for just the pediatric use would reach $821 million annually in the United States alone. More than a third of the nation’s psychiatrists were serving as part-time sales representatives for makers of antipsychotic medicines, and most of the rest were taking significant gifts of food, travel, and other valuable items.
FDA officials were deeply skeptical of J&J’s plans to make Risperdal the drug of choice in defiant children, characterizing the range of behaviors the company targeted as “aggressive behaviors that annoy others.” FDA officials were so worried that Risperdal’s hormonal effects would interfere with normal childhood development that they asked Johnson & Johnson to conduct animal studies first to assess how the drug might hinder maturation.
The company refused.
III. The Buried Data
In clinical trials, the benefits of Risperdal in children were measured by a reduction in behaviors such as “talks back to teacher, parents, or other adults,” “stubborn, has to do things own way,” and “disobedient.” More than half of children given Risperdal in clinical trials reported feeling tired and sleepy. Nearly a third experienced headaches, one fifth vomited, and one sixth suffered stomachaches. Kids who are sleepy, headachy, or queasy tend to stop lashing out.
But tranquilizing children over even modest periods of time has serious consequences: reduced life expectancy, obesity, diabetes, and permanent motor disorders. Children gain on average between four and six pounds every month while taking Risperdal. A few months of drug use leads many to become grossly obese, weight that many find impossible to lose.
From its earliest trials, Risperdal was shown to have a disturbing effect on patients’ endocrine systems. The drug led to elevated levels of prolactin, a hormone involved in the production of milk during pregnancy. No other antipsychotic, new or old, raised prolactin levels like Risperdal. Higher prolactin levels can lead boys to develop female breasts—a condition known as gynecomastia—and young girls and boys to start leaking milk.
For boys, the development of breasts is permanently disfiguring, since the tissue never goes away unless removed in a double mastectomy, a serious operation that can leave deep scars. Risperdal’s FDA-approved prescription label had a precaution that it caused excessive levels of prolactin, but reassured that gynecomastia was a rare occurrence, meaning it happened in fewer than one patient in a thousand.
In hopes of finally dismissing this problem, the company sponsored a yearlong study in mentally disabled children in which researchers were asked to check for gynecomastia by physically inspecting patients’ chests at the trial’s beginning and then at the three-, six-, and twelve-month marks. The study was named RIS-INT-41.
From the start, the ethics of this trial were problematic. Federal rules regarding human research mandate that unless researchers believe the purported benefits of a drug far outweigh any risks, a trial cannot be conducted on children. But helping these children was never the primary corporate purpose of the trial. The main goal was to see whether they would grow breasts.
Interim results arrived on November 2, 2000, and they were awful. Of the 319 patients enrolled at the time, eleven had gynecomastia, for a rate of 3.4 percent—more than thirty times the rate Risperdal’s label warned about. By the time the study was completed, the number of cases climbed to twenty-five—a rate of 8.3 percent.
Despite these dismal results, the company continued the study for another full year. Although most of the kids dropped out, the rate of gynecomastia among those who remained jumped to 13 percent.
Johnson & Johnson’s study showed that about one boy in ten suffered a permanently disfiguring side effect—one that few parents would knowingly risk, particularly when Risperdal was the only drug in its class that had this effect and was no more effective than competing antipsychotics.
Risperdal’s sales in 2000 totaled $1.08 billion, with Gorsky exceeding the company’s goal of $1.05 billion. Much of that success came from selling for use in children—a market that would be jeopardized if the true results of RIS-INT-41 ever got out.
So Gorsky’s team set about burying those numbers.
The first thing executives did was water down the study’s numbers by combining them with results from two other studies. In neither of the other studies had investigators undertaken the kind of close chest examinations conducted in RIS-INT-41. Since children often become grossly obese on Risperdal, breasts can get lost in the folds, so chest inspections are crucial. Not looking for gynecomastia, the investigators in these other studies didn’t find it.
Having cherry-picked its studies, Johnson & Johnson hired a statistical analysis firm to run the numbers. The rate of gynecomastia dropped to 5.1 percent in boys—but that was still too high. Worse, an accompanying analysis made clear that there was a statistically significant relationship between the onset of gynecomastia and elevated prolactin levels after two months of therapy. That proved that instead of being a random event, the gynecomastia cases had been directly caused by Risperdal.
Ethical rules of science mandate that before a meta-analysis is conducted, scientists must create an analytical plan and then publish the results no matter what. Rejiggering the analytical plan after the results have been seen—particularly when those results are disappointing—is unethical.
The company rejiggered the analytical plan anyway.
Then someone got the idea of excluding all the children who were ten and older. The justification was that kids ten and older were approaching puberty, and breast growth in boys during that time could be a random occurrence. Most of the breast growth in the study had occurred in older boys.
Company scientists presented this analysis to its pediatric advisory board at a November 2002 meeting at the Palace Hotel in New York City. These advisors were prominent pediatricians, and since they were being paid by Johnson & Johnson, they could not be described as independent. But they said they could not agree to an analysis excluding all patients ten and older, and they told the company that a table including every patient had to be in the final publication. Failing to include such a table “would be hiding data.”
A fourth draft of the paper was written. The main addition was a statistical table—largely ignored in the study’s text—that listed the number of prolactin-related adverse events in all trial participants. But the table suffered from an almost juvenile sleight of hand in which the ratio of children suffering problems was divided by the wrong number. For the ratio of boys suffering prolactin-related problems, the top number was the number of boys suffering a problem, as it should have been. The bottom number should have been the total number of boys in the study. Instead, the researchers used the total number of all the children in the study, including the girls. This nearly halved the boys’ ratio.
Dr. Denis Daneman, a professor of pediatrics at the University of Toronto and one of the study’s two co-authors, who only worked part-time for J&J, would later say that he had been tricked. “They never showed me that table. There can be no debate about what they did. They crossed the line. What they did in withholding data was unconscionable.” He said he had since donated the money the company paid him.
In courtroom testimony, Ivo Caers, the head of the Risperdal clinical development program, acknowledged that the company not only suppressed the breast data from publication but refused to tell the FDA about that data despite laws requiring the company to do so. “We decided that is not an analysis that makes sense to send to the FDA,” he said.
The lawyer followed up: “You ultimately would want the FDA to see anything that they might interpret to be a red flag, correct?”
“No,” Caers responded.
“You’d rather make that decision yourself?”
“Yes.”
When it was finally published in The Journal of Clinical Psychiatry, nearly four years after the company got the results of RIS-INT-41, the meta-analysis study falsely concluded, “Although in some cases prolactin levels did remain above those seen prior to the initiation of risperidone therapy, there is no evidence that untoward effects related to prolactin are likely to be seen at those dosing levels.”
The pattern is worth naming. Cherry-pick which studies to include. Rejigger the analytical plan after seeing disappointing results. Exclude the patients who suffered most. Divide by the wrong denominator. Refuse to share the real numbers with regulators. Delay publication for years while sales continue. When it finally appears, bury the damaging table in an appendix that contradicts the triumphant abstract. This is how scientific misconduct operates in practice: not through crude fabrication but through a sequence of defensible-seeming decisions, each one a small betrayal, that collectively transform a dangerous finding into a reassuring one.
In 2000, 1,176,000 Risperdal prescriptions for children were written in the United States, with patients spending an average of three months on the drug. If half were boys—and that is almost certainly an undercount, since two-thirds of pediatric bipolar diagnoses were in boys—and if the gynecomastia rate was anywhere close to the 8 to 13 percent that RIS-INT-41 found, the scale of harm becomes clear. Extrapolated across a decade of aggressive pediatric marketing, the number of boys who grew permanent breasts likely reaches into the tens of thousands.
IV. The Victims
Austin Pledger was seven years old when his parents first gave him Risperdal in June 2002. He had been diagnosed with a pervasive development disorder, a form of autism. Austin couldn’t read social cues. His frustration often boiled over into outbursts.
A month before Austin started the drug, a J&J salesman had made his first sales call on Austin’s doctor and spoke about the benefits of using Risperdal for children with behavior disorders. The salesman left behind 140 starter packages meant for children. A few weeks later, a different J&J salesman visited and left even more samples. Over the next two and a half years, this salesman visited the doctor twenty more times and dropped off thousands of child-sized doses.
The doctor warned Austin’s parents that Risperdal would likely cause some weight gain. “We were okay with that,” Benita Pledger said. “Austin was pretty thin, and I’m big on healthy foods, so we thought we could handle that.”
Before starting Austin on the drug, Benita and Phillip Pledger read through the drug’s physician prescribing label. They twice called a hotline number listed on the label to ask about side effects. They were told to talk to their doctor.
By then, nearly two years had passed since Johnson & Johnson had received the interim results from RIS-INT-41 showing that one boy in ten developed breasts. The company had buried those results, manipulated the statistics, and refused to tell the FDA. Austin’s parents had no way to know.
In the ensuing years, Austin seemed to have fewer tantrums, though they didn’t go away entirely. But he gained a significant amount of weight. The weight was distributed almost entirely in his chest. “He started to get really self-conscious about it,” Benita Pledger said, not even allowing his parents to see him without a shirt on.
After four years of treatment, the Pledgers switched to a different antipsychotic. Austin stopped gaining weight as quickly, but he still carried a lot of fat on his chest.
“When I was wearing my nightgown at night he looked at me and you could tell he thought he looked like me up there,” Benita Pledger said. “Not like the other boys he knew.”
In 2011, Benita Pledger was watching TV with Austin when she realized her son’s fat might not be just fat.
“Suddenly a commercial comes on, you know one of those 1-800 things, and the announcer says something like ‘Did your son take Risperdal and develop breasts?’” She grabbed a pen and wrote down the number. She hustled Austin to bed and then dialed. A woman on the line asked her a few questions and suggested she email a few photos of a shirtless Austin.
Benita went to her son’s bedroom and asked if she could take a few pictures of his muscles. “So he took off his shirt and flexed. He was so proud. Then I asked him to turn so I could take another picture from the side.”
The law firm called back almost immediately.
At a trial that began in January 2015, Benita Pledger was asked what she thought as Austin began growing breasts.
“I thought it was the weight gain, and I thought that as long as I kept trying to help him with his weight and exercise, that’s all I could do. I would just have to fight the weight as much as possible. I did not know that his breasts were for any other reason than that.”
Did she know at any time that there was a risk her son might develop gynecomastia?
“No. I knew nothing of that. I did not know boys could develop breasts or [if] it was a side effect from the medicine at all.”
Would she ever have allowed her son to be on the drug if she had known?
“Absolutely not. I—I can’t fight breast growth. I felt like with the weight gain, we could exercise... You can’t fight something like that. I didn’t even know that was a possibility.”
But J&J had.
The scale of harm to children remains difficult to calculate precisely, but the math laid out above suggests tens of thousands of boys grew permanent breasts during Risperdal’s decade of aggressive pediatric marketing. Young girls and boys also briefly expressed milk.
The elderly suffered a different harm. Four months after the disastrous results of RIS-INT-41, Gorsky and his team received data from RIS-AUS-05, a trial in 345 elderly nursing home patients in Australia and New Zealand suffering dementia. The patients given Risperdal had suffered too many strokes and heart attacks. “I am very reluctant to have these data in the public domain that soon,” Dr. Ivo Caers wrote in an email. “I propose to keep this discussion and concern in house.”
At a meeting on September 4, 2001, Gorsky and the company’s top leaders met to discuss how to resolve the dilemma. Dr. Harlan Weisman, who would within weeks be appointed Johnson & Johnson’s top scientist, told the gathering that he thought Risperdal was the most dangerous pill of its kind. Continuing to market Risperdal as a treatment for dementia would lead to a huge toll of injury and death.
Gorsky and his team decided to not only continue their sales efforts targeting the elderly but expand them. A month later, Gorsky was promoted to president of Janssen Pharmaceuticals.
A 2022 modeling study by researchers at Memorial Sloan Kettering’s Drug Pricing Lab estimated that between 2000 and 2019, Risperdal and similar atypical antipsychotics caused as many as 1.2 million excess deaths among the elderly. The estimate is based on extrapolating clinical trial mortality data to the broader population of nursing home residents who received these drugs. If anything, the death count is an underestimate, since Risperdal was approved in 1993—seven years before the study period began.
To this day, atypical antipsychotics kill between twenty thousand and sixty-five thousand elderly patients every year, the Memorial researchers found. By comparison, overdoses involving prescription opioids caused about sixteen thousand deaths in 2020.
V. The System That Protected It
In 2003, Johnson & Johnson launched a “Back-to-School” marketing campaign for a new version of Risperdal that quickly dissolves in a child’s mouth. Sales reps held ice cream and popcorn parties in child psychiatrists’ offices and passed out lollipops and Risperdal-branded Lego toys and candy jars. One sales manager explained that “Risperdal popcorn” was intended to “butter up docs.”
Some sales reps testified that they visited child psychiatrists and child neurologists because those doctors might on rare occasions treat adults. Jason Gilbreath, a J&J sales rep, pitched Risperdal to Austin Pledger’s child neurologist twenty times over two years. He brought the doctor free drug samples in dosage sizes intended for children. But Gilbreath testified that he didn’t know the doctor exclusively treated children.
The plaintiff’s attorney asked, “You literally had to walk over toys and small people furniture to get in to see him, correct?”
“I don’t recall seeing toys,” Gilbreath testified. “It’s possible they were there. I don’t recall seeing them.”
Vicki Starr was a J&J sales rep who eventually became a whistleblower. The final straw for her was the issue of gynecomastia. Her psychiatrists were telling her they were seeing too many boys with breasts. She relayed the doctors’ concerns to her boss and other executives, hoping to get some explanation for the problem and offer her doctors a way to resolve or prevent it. “But they were like, ‘No, this doesn’t happen.’”
“That’s why I decided to leave,” she said. “They were like used car salesmen.”
On April 11, 2005, the FDA announced that Risperdal and its sister medicines would have to carry one of the starkest and most alarming warnings the agency has ever placed on widely prescribed drugs:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperdal is not approved for use in patients with dementia-related psychosis.
Johnson & Johnson kept going. The company gave sales reps two new messages. The first was to reassure doctors that they would never be sued for prescribing Risperdal to dementia patients who subsequently died, because no one would be able to distinguish between those the drug had killed and those who passed away naturally.
J&J sales rep Tim Humphries testified to a grand jury that his managers told him the brand team had met with doctors and discussed their concerns about getting sued. The managers said they told the doctors: “It’s so rare that—you know, how are they going to prove that? How’s an attorney going to prove that Risperdal itself caused that? Versus, you know, an eighty-five-year-old with the risk of stroke in the first place.”
The second message was to tell doctors that if they wanted to avoid scrutiny, they should diagnose their dementia patients with schizophrenia. Diagnoses of late-onset schizophrenia—a condition that is virtually nonexistent—soared from then on.
To this day, some 21 percent of nursing home residents are given Risperdal and other antipsychotics—mostly to keep them quiet. In more than half of these patients, doctors diagnose them with schizophrenia—mostly to hide what they’re doing from regulators.
On November 4, 2013, Attorney General Eric Holder announced that Johnson & Johnson and its subsidiaries had agreed to pay $2.2 billion and plead guilty to a misdemeanor. The government complaint noted that J&J lied about the risks of Risperdal to elderly patients with dementia, lied about its tendency to cause diabetes, and promoted its use in children despite knowing that the drug would cause many boys to grow breasts and both boys and girls to lactate.
Three days later, lawyers assembled at the federal court building in Philadelphia before U.S. District Judge Timothy J. Savage to formally enter J&J’s guilty plea. Joseph Braunreuther, a deputy general counsel for the company, said that the company “is responsible for the delivery of valuable therapy that changes people’s lives around the world, has been and remains committed to improving human life going forward with its therapies—”
Judge Savage cut him off. “Does it do that from altruistic motive or a profit motive?”
Braunreuther conceded that profit was a motive.
“The defendant marketed a drug approved for schizophrenia to elderly patients with dementia and mentally disabled children, which were not approved uses,” Savage said. “It did so despite its clear and unequivocal study showing the drug increased the risk of stroke and fatality among elderly patients suffering dementia. It did so in a calculated manner. It was not coincidental nor accidental. It was intended to maximize profit without regard to risk.”
No company executives were charged. Although prosecutors listed four executives who could potentially be charged criminally in one secret memorandum, they gave up on the idea altogether. The problem, they wrote, was that they had no smoking-gun documents in which executives explicitly instructed subordinates to knowingly break the law. And having well-dressed and seemingly concerned executives at the defense table could blow up the entire case.
Though Johnson & Johnson pleaded guilty to bribing thousands of psychiatrists and doctors to prescribe Risperdal in unapproved ways, none of the doctors who accepted these bribes and then prescribed the drug—thereby endangering the lives of their patients—were ever charged.
Between 2010 and 2021, J&J spent $25 billion on litigation, a number likely higher than that of any other company in the Fortune 500.
The Biederman case demonstrates not only how thoroughly drugmakers can fool an entire medical specialty but how persistent the resulting mythology can be. Despite a cascade of revelations that emerged during litigation demonstrating his terrible medical ethics, Biederman’s studies remain among the most often cited and admired in child psychiatry.
When he died in January 2023, he still had his Harvard affiliation and was among the most respected leaders in psychiatry.
Alex Gorsky—who approved the business plan targeting children and the elderly, who oversaw the suppression of RIS-INT-41, who expanded the ElderCare sales force after learning Risperdal was killing nursing home patients—left J&J in 2004 as whistleblower lawsuits mounted. He returned four years later at an even higher executive level. In 2012, he was appointed CEO of Johnson & Johnson. He held that position for a decade, retiring in 2022.
References
Harris, Gardiner. No More Tears: The Dark Secrets of Johnson & Johnson. Penguin Random House, 2025.
Brill, Steven. “America’s Most Admired Lawbreaker.” The Huffington Post, Fall 2015.
Scull, Andrew. Desperate Remedies: Psychiatry’s Turbulent Quest to Cure Mental Illness. Harvard University Press, 2022.
Lieberman, Jeffrey A., et al. “Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia.” The New England Journal of Medicine 353, no. 12 (September 2005): 1209–23.
U.S. Attorney’s Office, Eastern District of Pennsylvania. “Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Fraud and Misbranding Allegations.” Justice.gov, November 4, 2013.
Memorial Sloan Kettering Cancer Center, Drug Pricing Lab. “Atypical Antipsychotics: Decades of Use, Unfathomable Harms.” May 31, 2022.
Support Independent Research
This work remains free because paid subscribers make it possible. If you find value here, consider joining them.
What paid subscribers get: Access to the Deep Dive Audio Library — 170+ in-depth discussions (30-50 min each) exploring the books behind these essays. New discussions added weekly. That’s 100+ hours of content for less than the price of a single audiobook.
[Upgrade to Paid – $5/month or $50/year]
Get in touch Essay ideas, stories, or expertise to share: unbekoming@outlook.com
New Biology Clinic
For those of you looking for practitioners who actually understand terrain medicine and the principles we explore here, I want to share something valuable. Dr. Tom Cowan—whose books and podcasts have shaped much of my own thinking about health—has created the New Biology Clinic, a virtual practice staffed by wellness specialists who operate from the same foundational understanding. This isn’t about symptom suppression or the conventional model. It’s about personalized guidance rooted in how living systems actually work. The clinic offers individual and family memberships that include not just private consults, but group sessions covering movement, nutrition, breathwork, biofield tuning, and more. Everything is virtual, making it accessible wherever you are. If you’ve been searching for practitioners who won’t look at you blankly when you mention structured water or the importance of the extracellular matrix, this is worth exploring. Use discount code “Unbekoming” to get $100 off the member activation fee. You can learn more and sign up at newbiologyclinic.com
"Between 2010 and 2021, J&J spent $25 billion on litigation."
I wonder how many people in the United States who took those nearly 19 million covid vaccines by Johnson & Johnson knew about the company's significant history of criminal fraud?
My elderly mom was in the hospital once. She was sitting up at a small table with me and we were playing cards. A nurse came in to give her some medication. Within 20 minutes she was in coherent. she could speak, but didn’t make sense. I was like WTF did you just give her??? Risperdal. Why??? For the rest of her hospital stay I never left her side. I slept on the floor. And got her out of there as soon as possible.