While the article noted funding from J&J, as well as the fact that three of the authors were J&J employees, there was no conflict of interest statement and no disclosure of Excerpta Medica's involvement, Rothman wrote.
For another article, meant to tout Risperdal as a good treatment for acute mania, J&J and Excerpta Medica staffers met to hammer out the niggling details, like whose name would go on it. The "Publication kickoff meeting" notes state: "Lengthy discussion ensued around the importance of authorship from internal and external perspectives, and from clinical vs. commercial perspectives."
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.
Details
Related Content
More About
Perhaps a more malignant form of ghostwriting involved an article touting Risperdal's efficacy in children with below-average IQ: After reviewing Excerpta Medica's various drafts of the manuscript, Rothman wrote, "J&J conducted a separate review of the manuscript and made changes that would put Risperdal in a better light...In the abstract, for example, Pandina [a J&J employee] changed 'no negative effects' to 'positive effects.'"
Dr. Howard Brody, who heads the Institute for Medical Humanities at the University of Texas Medical Branch, has concerns about ghostwriting's contamination of medical literature. Brody studies conflicts of interest, which he explored in his 2007 book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry.
In looking at the rise of atypical antipsychotics, Brody says, two major questions come to light: Are they overprescribed, and "the question of the impact this has on what's in the medical literature and whether...we're distorting the scientific base of medicine by ghostwritten articles, and articles that are deliberately spun in order to sell drugs rather than to present the dispassionate, scientific information. And of course, you could do a lot more damage with the latter than you can with just one physician prescribing, you know, for one group of patients."
When asked about the inclusion of ghostwritten articles in the 2010 parameters for antipsychotics in foster care, DFPS spokesman Patrick Crimmons explained in an e-mail, "We don't agree with that characterization — that it is a 'ghostwriting company.' It is a publishing company."
_____________________
In 2009, State Rep. Sylvester Turner co-authored a bill calling for the prior authorization of any antipsychotic prescribed to children under age 11 who are enrolled in Medicaid.
The bill was DOA; a substitute measure calling for the Health and Human Services Commission to study the safety and appropriateness of antipsychotics for Medicaid children under 16 was passed in its place.
While it may be easy to criticize the acronym agencies for continuing to use potentially compromised doctors and data, it's another thing to be in the foster care trenches, treating children who can be in great physiological pain.
Just as the Texas Comptroller cherrypicked some truly outrageous instances of overmedication and departmental neglect in her report on antipsychotics in foster care, the commission found severe cases where nothing but antipsychotics seemed to work.
Take the case of a 20-month-old male whose mother reportedly used multiple drugs during pregnancy: He wouldn't stop banging his head and biting himself, had "an inability to soothe himself, and increased agitation with touch, making feeding, bathing, and diaper changes extremely difficult."
He couldn't be held, "as this will trigger crying episodes and repeated head banging and biting." Ultimately, a neurologist put him on a low dose of risperidone, which seemed to reduce the symptoms.
In perhaps a less compelling case, risperidone came to the rescue when a hyperactive and disruptive three-year-old girl didn't respond well to her daycare teacher sprinkling Dexedrine on her pudding. After risperidone, the girl "is now able to sit in groups," whereas before she would try to escape the classroom. "Several times she has managed to get out of the daycare, and was found outside near the street." (It is unclear whether the state commissioned another study to examine the mystery behind that particular daycare's apparently nonfunctioning doors or lack of a playground fence.)
Some physicians and mental health advocates saw Turner's bill as a medically risky governmental intrusion, another bureaucratic layer that might delay much-needed help.
Generally, the commission's study appears to have at least attempted a balanced, reasonable approach to examining the issue, with a goal of using the best science possible to determine if and when to use these kinds of drugs on such a young population.
That's why it's all the more frustrating that the study cites ghostwritten journal articles in its appendix, and holds up the conflict-of-interest-plagued parameters as an example of evidence-based policy. It's almost as if, six years after the Texas AG sued Janssen, the commission either wasn't aware of the evidence amassed in that lawsuit, or simply didn't care. (Unlike the parameters, the commission study at least attempted to identify the journal articles that were funded by drug companies.)
The commission found that, since 2005, "physicians have prescribed fewer psychoactive medications" to children in foster care. The study claimed that, from 2004 to 2009, "the percentage of youth in foster care receiving a psychoactive medication for 60 or more days decreased by more than a third, from 29.9 percent to 19.7 percent."
Recognizing a shortage of mental health experts in parts of the state, the commission called for the consideration of "consultation, including via telemedicine, for non-psychiatrists serving Medicaid youth with mental health disorders," as well as the consideration of wider integration of psychosocial services.
1 Like
