On November 28, the Texas Attorney General is expected to begin a landmark trial against Johnson & Johnson on charges that the pharmaceutical giant “subverted scientific integrity” by paying off academic psychiatrists and state officials to boost the use of its atypical antipsychotic Risperdal among children and adults in that state. The case against J&J, for misleading doctors and consumers about the safety and effectiveness of its atypical antipsychotic Risperdal, has been reported before — by 1boringoldman, pharmalot and several Texas newspapers.
But a comprehensive report by an expert for the plaintiffs — Dr. David Rothman, a professor of social medicine and history at Columbia University — recently came to my attention, and what amazed me about Rothman’s findings, beyond the malfeasance of academic psychiatrists who sold their scientific integrity for thousands of dollars in speaking fees — was the sheer scope of the ghost-writing campaign that J&J (via its subsidiary, Janssen) embarked on to peddle Risperdal to doctors and patients throughout the country. Rothman cites 12 cases in which Janssen hired ghostwriting contractors to draft positive articles about Risperdal and then found academics willing to put their names on the articles, which were then published in supposedly respected medical journals, like the New England Journal of Medicine and the British Journal of Psychiatry.
Rothman reports that in most of these journal articles, which included clinical trials, there was no acknowledgment of the work of the ghostwriter (Excerpta Medica, a medical communications company). Nor were there any disclosures by the authors that they had financial conflicts (in other words, were receiving thousands of dollars in speaking or consulting fees from J&J). In one 2005 study published in the British Journal of Psychiatry that found Risperdal more effective than placebo in the treatment of acute mania, the role of the academic authors was so minimal that Excerpta Medica (whose role was not acknowledged) billed J&J $5,100 for composing a reply to a letter to the editor about the study.
In the 2002 NEJM study Rothman cites, the lead author was not even a member of the clinical research team that did the study but was recruited well after the manuscript had been drafted and revised by the ghostwriter and J&J employees. (The lead author, Dr. John Csernansky, was, however, a long-time member of J&J’s speakers bureau). The published article was used to market Risperdal with doctors as being more effective than other anti-psychotics over the long term.
In yet another egregious example of ghostwriting outlined by Rothman, Excepta Medica drafted a study purportedly showing that Risperdal was the established treatment in children and adolescents with severe behavioral disorders and then went looking for some key opinion leaders (KOLs) to attach their names to the article. They finally found Dr. Peter Jensen, a pediatric psychiatrist (who was paid more than $80,000 by J&J in consulting and speaking fees between 2002 and 2004) to attach his name to the study, which was published in The European Journal of Child and Adolescent Psychiatry in 2007, again with no acknowledgement of the ghostwriter’s role. Rothman cites example after example of overlap between the ghostwriter’s draft and the published piece and concludes that “the authors improperly put their name on it and failed to credit EM’s work.”
In yet another case, Rothman cites evidence that J&J made the authors of one study water down language about cardiovascular side effects from Risperdal. He also notes that the company decided not to publish a study showing an increased incidence of prolactin-induced side effects among patients on the drug. From what I understand, the plaintiffs in the upcoming trial in Texas plan to introduce evidence that J&J knew that Risperdal induced the development of breast tissue and milk production in some male patients taking the drug, but hid such negative side effects from doctors and patients for years.
Rothman’s report on J&J is painfully reminscent of what companies like GlaxoSmithKline, Eli Lilly, Pfizer and Forest Labs did to make their antidepressants blockbuster drugs (which I wrote about in Side Effects). I suspect Rothman’s detailed findings are part of what led a South Carolina Judge earlier this summer to call J&J’s actions in deceiving the public about Risperdal “detestable” in his $327 million ruling against the company — see Pharmalot.
Even so, Rothman’s 86-page report makes for disturbing reading. It is an indictment not only of J&J but of academic psychiatry and all the doctors and patient advocacy groups who were all too willing to sell their soul for money.