Senator expands investigation of Harvard psychiatrist

By Liz Kowalczyk, Globe Staff

Senator Charles E. Grassley has widened his investigation into well-known Harvard child psychiatrist Dr. Joseph Biederman, questioning whether Biederman promised pharmaceutical giant Johnson & Johnson that his research into the company's drugs would yield positive results before even beginning the studies.

The expanded probe is based in part on slide presentations that summarize projects at the Johnson & Johnson Center for Pediatric Psychopathology Research, a center at Massachusetts General Hospital that was funded by Johnson & Johnson and headed by Biederman from 2002 to 2005.

Under the heading "Key Projects for 2005," one slide promises to provide a J&J subsidiary, Janssen, "with critical competitive data on safety and efficacy of risperidone (an antipsychotic) in children" under age 10, while another talks about expanding use of the ADHD drug Concerta in teenagers.

Another slide indicates that a benefit of the center is to help J&J develop new uses for its drugs.

In a seven-page letter sent today to Harvard University President Drew Gilpin Faust and Mass. General President Dr. Peter Slavin, Grassley, an Iowa Republican, said he is concerned about the implications of the slides and asks why they "suggest an expectation of positive outcomes" prior to the beginning of the clinical trials.

Biederman, a Harvard Medical School professor and a psychiatrist at Mass. General, turned over the documents as part of his testimony in a huge multi-state lawsuit brought on behalf of patients who say they were harmed by antipsychotic drugs, including risperidone. It is unclear whether Biederman created the slide sets and whether he presented them publicly.

Biederman's lawyer, Peter Spivack, did not return a call from the Globe today. But Biederman said in a letter to the Globe in December that the Johnson & Johnson Center's goal was to advance science. "Any implication that J&J's interests interfered with the center's work is wrong. Indeed, I have published research critical of J&J compounds," he wrote. "I never owned J&J stock, and whether the company succeeded financially had no importance to me. What does matter to me is the treatment of children and families experiencing great suffering."

Spivack plans to ask a New Jersey state court judge next week to seal the testimony and documents, because they "could be immensely damaging to him, both personally and professionally," according to court documents.

Replying for Faust, Harvard Medical School Dean Dr. Jeffrey Flier wrote in a letter to Grassley late today that a medical school committee has been reviewing issues related to Biederman for several months, and that it will report its conclusions to the senator. "I want to assure you that this matter has our utmost attention and that the Medical School will take whatever action is warranted after all of the facts are known," Flier wrote.

Slavin sent a similar reply, saying a hospital investigation also would address the new issues raised by Grassley.

Court documents show that Johnson & Johnson gave at least $700,000 for the center.

Other slides tout additional benefits of the center, saying it "provides rationale to treat chronically and aggressively highly morbid child psychiatric disorders." Another set of slides called Key Projects for 2004, states that the center "will help clarify the competitive advantages of risperidone vs. other atypical neuroleptics" and "will support the effectiveness and safety of risperidone" in preschoolers.

Grassley asks in his letter how the studies could suggest they would support safety and effectiveness when they hadn't started yet. He went on to say that he asked an unnamed physician researcher to review the slides; the researcher said "it appeared the slides discussed in this letter were nothing more than marketing tools, as opposed to discussions of independent scientific research," Grassley wrote.

Johnson & Johnson apparently believed the Mass. General center was advantageous to the company. In a 2003 company business plan referred to by Grassley in his letter, the company notes it will leverage the Mass. General center to raise awareness of bipolar disorder in children because use of psychotropic drugs remains controversial.

Grassley notes that some of the center's projects turned into published papers, such as one Janssen-funded study published last year in which Biederman reported that he found a 30 percent reduction in ADHD symptoms in about one-third of children with bipolar disorder who took risperidone.

One of the country's most prominent advocates of diagnosing bipolar disorder in young children and treating them with antipsychotic drugs in some cases, Biederman has emerged as a key witness in the lawsuit brought on behalf of more than 2,000 patients, including children, who contend that they have been injured by psychiatric drugs known as atypical antipsychotics. Biederman is not a defendant in the case, but the plaintiffs' lawyers are aiming to present him as an example of how drug companies and researchers cooperated to boost "off label" prescribing of drugs for purposes that go beyond federally approved uses.

Last year, Grassley accused Biederman of failing to make timely disclosures to Harvard of more than $1.5 million that drug companies paid him in consulting and speaking fees. Biederman has said in statements and letters to the Globe that he complied with conflict-of-interest and disclosure rules at Mass. General and Harvard.

In his letter today, Grassley referred to a document called "Pharma Salary Summary," which apparently lists monthly payments to Biederman of up to several thousand dollars each from three drug companies, including Johnson & Johnson, during 2005, 2006 and 2007. Grassley asked whether Biederman reported these payments, which totaled more than $120,000, to Harvard and Mass. General, and what they were for.

He said he wanted a response to all his questions by April 17.

Dr. Marcia Angell, a former editor of the New England Journal of Medicine and an outspoken critic of physicians' ties to the drug industry, said it is generally difficult for doctors to remain objective when they work at drug-company funded centers. "Even if you have the best intentions, it's hard to remain objective about people who've been so good to you," she said.