In 1993, Johnson & Johnson owned schizophrenia.
Courtesy of David and Christina Harrison
A week before she went into foster care, Rachel Harrison looked healthy.
Courtesy of David and Christina Harrison
Rachel's parents say she appeared fatigued and ill during visitations while in CPS custody.
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That multimillion segment of the antipsychotic market had long been an untapped income source, populated by old-school generics that came with their fair share of side effects.
But now J&J, through its subsidiary Janssen Pharmaceuticals, blew the doors off the market with its risperidone tablet, available in a rainbow of colors and sold under the name Risperdal.
Quite simply, J&J's competitors could suck it. Astra Merck had expected to launch its counterpart nine to 12 months after Risperdal, but intelligence gathered by J&J spooks revealed that the company had voluntarily withdrawn its FDA application. And Eli Lily's competing pill was still years away from approval.
Of course, one of the biggest problems with schizophrenia, besides its soul-crushing dreadfulness and tendency to tear families apart, was that there was only so much of it to go around. Eventually, Janssen would have to expand Risperdal's usage and penetrate new markets. Bipolar. Dementia. Attention-deficit. And, just for the heck of it, stuttering.
Old people and kids were virgin territory; hopefully there were enough psychiatrists out there to find enough things wrong with them that could be treated by a little Risperdal. The problem was, the FDA had denied Janssen's application for pediatric use, which meant that — even though the drug could be prescribed off-label — it couldn't legally be marketed for anything other than schizophrenia in adults.
Janssen got around that prohibition by simply ignoring it and getting down to the business of figuring out how to infiltrate a state's Medicaid formulary and position Risperdal as the preferred drug for a variety of conditions. And the best way to do that was to get state mental health experts and influential doctors at universities to spread the gospel. These were the people Big Pharma calls KOLs — key opinion leaders, experts in their fields, whose casual approach to integrity and love of all-expense-paid junkets in Hawaii helped push product.
With its huge Medicaid population, encompassing prisons, psychiatric hospitals and foster care, Texas was the best state for this. Once a Risperdal-friendly system was installed in Texas, it could be exported to other states.
So Janssen reps went to Texas and trolled for whores. They came out in spades; from the state Department of Mental Health and Mental Retardation; from the University of Texas system; from state chapters of national mental health advocacy groups. They all helped Janssen market off-label Risperdal use in children by, in some cases, downplaying the side effects of severe weight gain, diabetes, tremors and the growth of (sometimes lactating) breasts in males.
In 2003, when the whistle was blown and the connection between the experts and the drug companies was revealed, state attorneys general licked their lips in anticipation of filing fraud suits to recover Medicaid costs.
The Texas Attorney General's Office filed its suit in 2004, alleging that Janssen's marketing suppressed information about Risperdal's side effects, manipulated or concealed clinical trial results and created "the false impression that valid and well-supported scientific evidence" supported the prescribing of the drug to children. In its goal to create "noise" in the market, the lawsuit states, Janssen seeded medical journals with ghostwritten studies that were essentially advertisements masquerading as legitimate studies.
But the Attorney General's lawsuit, set for January 9, is about money — about recovering millions the state had spent paying for Risperdal. It is not about the well-being of children in state care, who are still prescribed Risperdal and other antipsychotics. Those kids are other agencies' problems.
So that's how Rachel Harrison, a girl who was born three years after the state Attorney General filed suit, and who wound up in foster care in 2010, found herself swallowing four tablets of risperidone a day, with no clear diagnosis.
Her foster mother had initially complained of Rachel being hyperactive and uncooperative. One doctor thought she might have had a mood disorder. Whatever the case, the easiest thing to do to stabilize this kid in the care of one governmental department was to give her a heavy dosage of a powerful antipsychotic that another department was suing over, and to have taxpayers foot the bill.
Maybe it was the combination of all the other drugs Rachel was on while she was in foster care, but the risperidone didn't cause her to balloon out; she actually lost weight. Her hair became wispy and started falling out. Her eyes retreated into what now looked like a freakishly enormous head. One photo her mother was able to sneak during a visitation — before her cell phone was confiscated — looks like it should be the "before" picture, not the picture of a kid after she's in the state's care.
While there are certainly foster children, and others on Medicaid, who have severe enough conditions to warrant the use of antipsychotics, the remarkable thing is that some of the "key opinion leaders" exposed years ago are still crafting the guidelines for these meds in foster care, and some of the ghostwritten journal articles cited in the Attorney General's lawsuit are still being used to justify the drugs' continued usage.
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Before any major studies got off the ground, Janssen had already created Risperdal's advertising platform — "One Complete Antipsychotic" — and set its sights on corralling key opinion leaders who could deliver the message.
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