Grassley's Winding Road to Biederman et al

Mainstream media outlets

and blogs are chattering about the news that Harvard psychiatrists Joseph Biederman, Timothy Wilens, and Thomas Spencer did not fully disclose their pharma consulting fees to the university, possibly in violation of academic and federal conflict-of-interest rules. According to the online Congressional record, Senator Chuck Grassley (Iowa-R) began an investigation last fall, which sought to determine the full extent of industry fees paid to the psychiatrists. The doctors also received NIH grants for clinical studies of commercial pharmaceuticals.

Persistent investigation by Grassley revealed that, from 2000 to 2007, Biederman and Wilens each earned more than $1.6 million from commercial sources, and that Spencer earned more than $1 million, according to the record. The majority of these fees (for services that are not specified) had not been reported to the university. The propriety, or even legality, of the physicians' reporting behavior is the subject of much online speculation. However, it remains unclear what led Grassley to investigate these physicians in the first place—among any number of possible targets.

Grassley may have been alerted to Biederman (and thereby, his Harvard colleagues) through the death of 4-year-old Rebecca Riley. As reported by "60 Minutes" in September of last year, Rebecca Riley died on December 13, 2006, at her home in Hull, Massachusetts, due to an overdose of psychiatric drugs. The drugs—Depakote (divalproex; Abbott), Seroquel (quetiapine; AstraZeneca), and clonazepam—were prescribed by Tufts psychiatrist Kayoko Kifuji for the child's bipolar disorder, which was diagnosed at the age of 2 years. Before her death, Rebecca had also been given an over-the-counter cold medication and at least one additional, unprescribed dose of clonazapam by her mother (and possibly more for a period of time before the child's death).

According to "60 Minutes," Dr. Kifuji's prescribing practices were heavily influenced by the research and views of Biederman, who was interviewed for the news show. Biederman has evidently been instrumental in the trend to apply the diagnosis of bipolar disorder, in broader terms, to very young children. And with the diagnosis goes pharmaceutical treatment in the form of some drugs that have not been systematically tested in children.

In a Boston Globe story, Kifuji's lawyer stated that the Harvard psychiatrists were "by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar." The paper also wrote of the extensive financial ties between pharma and Biederman, who had "received research funding from 15 drug companies and serves as a paid speaker or adviser to seven of them," including Eli Lilly (Zyprexa [olanzapine]) and Janssen (Risperdal [risperidone]). The Congressional record also reports financial ties between Biederman and BMS (Abilify [aripiprazole]), Cephalon (Vivitrol [naltraxone]), GSK, JNJ, and Pfizer.

Right or wrong, Biederman and his colleagues Wilens and Spencer have evidently influenced the diagnosis and treatment of bipolar disorder, as well as those of ADHD, through the medical literature (for example: Frazier JA et al. J Child Adolesc Psychopharmacol. 2001;11:239-250; Wilens TA et al. J Child Adolesc Psychopharmacol. 2003;13:495-505) and through pharma-supported CME programs (for example: "The Evolving Face of ADHD" and "Focus on ADHD"). The question is whether commercial funding influenced Biederman et al to promote the relatively aggressive, unapproved use of pharmaceuticals in children with psychiatric problems. The chief of psychiatry at MGH, Jerrold Rosenbaum, wrote in an e-mail to the Boston Globe, "I think a pharma person would not dare to tell Joe [Biederman] what to say...For Joe, it is his ideas and mission that drive him, not the fees."

As far as the aftermath of Rebecca Riley's death is concerned, the child's parents, Carolyn and Michael, were charged with first-degree murder and await trial. Dr. Kifuji agreed to suspend her medical practice pending an investigation by the Massachusetts medical board.

Photo: iStockPhoto.