The company built Biederman a research lab, the Johnson & Johnson Center for Pediatric Psychopathology, pledging annual funding of $500,000. According to the Rothman report, a J&J employee explained internally that the purpose of the Center was "to generate and disseminate data supporting the use of risperidone in this patient population." All Biederman had to do was churn out a bunch of our-drug-is-better-than-yours studies under his imprimatur, which would hopefully act like kryptonite on many a skeptical shrink.
It was a bean counter in Pennsylvania's Office of Inspector General, whose job was apparently to rubber-stamp portions of that state's TMAP clone, who blew the whistle.
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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In an essay, the investigator, Allen Jones, described TMAP thusly: "a Trojan horse embedded with the pharmaceutical industry's newest and most expensive mental health drugs. Through TMAP, the drug industry methodically compromised the decision making of elected and appointed public officials to gain access to captive populations of mentally ill individuals in prisons and state mental health hospitals."
Jones's allegations triggered an investigation into TMAP's reach into the foster care system by the Texas Health and Human Services Commission's Office of Inspector General and the Texas Comptroller's Office.
The latter turned up some weird stuff, like the case of a six-year-old who'd received 60 prescriptions (including antipsychotics and mood stabilizers) in the course of a year. The child was eventually admitted to a hospital emergency room and treated for psychotropic poisoning.
The comptroller's investigators were alarmed by the numbers they crunched for fiscal 2004: 6,913 foster children accounting for 65,469 prescriptions of antipsychotics. The average number of prescriptions for all psychotropic drugs (not just antipsychotics) for the 686 kids aged zero to four was 6.7. The number of Risperdal prescriptions alone was 23,812, which cost the state roughly $4.5 million.
Clearly, there was a problem. And clearly, something as important as vulnerable children treated with medication whose safety and efficacy were in question demanded a serious, thoughtful response.
What the children got were a set of guidelines, the Psychotropic Medication Utilization Parameters for Foster Children, developed in 2005 by some of the same people already outed as industry shills.
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The parameters were overseen by some of the most important acronyms in state government: the Department of Family and Protective Services, the Department of State Health Services, and the Health and Human Services Commission.
They've been updated periodically, most recently in December 2010.
The acronyms involved have touted the parameters as being responsible for lowering the percentage of antipsychotics used in foster care. But among the more astounding things is that the parameters cite some of the same journal articles that the Rothman report exposed as ghostwritten and that two respected psychiatrists the Texas AG hired as expert witnesses in the Janssen lawsuit are critical of the parameters.
Dr. Robert Rosenheck, a professor of psychiatry at the Yale School of Medicine, wrote that "the review seems further unduly biased in favor of risperidone in particular."
The other expert witness, Dr. Bruce Perry, senior fellow of Houston's ChildTrauma Academy, and adjunct professor of psychiatry at Northwestern University, wrote that the group behind the parameters "should provide full disclosure regarding their current and past relationships with industry, including direct funds for consultation, speaking, and indirect funds to support 'education' or 'research.' This should also include the professional groups who are claiming to endorse this."
Besides that lack of financial disclosure, the parameters suffer from the inclusion of ghostwritten journal articles, something that a rash of lawsuits against drugmakers have shown is more common than originally thought.
In 2009, the Journal of the American Medical Association conducted a survey on the rates of ghostwriting in 630 articles published in six medical journals in 2008. The Journal published ghostwritten articles at a rate of 7.9 percent; the New England Journal of Medicine's rate was 10.9 percent.
As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles.
In 2003, according to Rothman, Excerpta Medica issued "Risperidone Publication Program Status Reports," indicating that 30 of the 145 articles to be published had authors listed as "to be determined."
Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters.
Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, "It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.'"
The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.
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