Friday, November 28, 2008

What Me Worry? - Academic Leaders Blissfully Unaware of the Commercial Purposes of their Research Center

A few weeks ago, the Boston Globe published an investigative report on differences in reimbursements insurers and managed care organizations provide to different hospitals and hospital systems. One major bullet point was that the Partners HealthCare system, whose flagship hospitals include the Massachusetts General Hospital and the Brigham and Womens Hospital, received higher reimbursement rates than other well-known hospital and health care systems. A second was by some measures of quality, the major Partners teaching hospitals did not do better than other Boston hospitals.

In the resulting debate in the blogsphere (for example, see these posts and accompanying comments, on the Running a Hospital blog, and on the Movin' Meat blog,) some argued perhaps Partners really did deserve the extra payment. After all, the Massachusetts General Hospital and the Brigham and Womens Hospital are two of the most prestigious hospitals in the US, and indeed, the world. It is not implausible that this prestige arose from some real quality advantages. Furthermore, as we and others have argued, the available measures of quality, including those proposed to govern so-called "pay for performance" (P4P) in health care, are deeply flawed. For example, because of the Massachusetts General Hospital's reputation, it may attract the most difficult and complex patients, and these patients' severity and complexity of illness may have caused the hospital to have high mortality rates, despite the best of care.

Thus, at the time, the extra reimbursement going to Partners hospitals did not seem an issue for Health Care Renewal. But this week another series of stories came out about "Man's Best Hospital," (as it was called in "Samuel Shem's" House of God).... And they suggested that the Partners system may have quality problems of another kind.

Revelations about a research center at the Massachusetts General Hospital, and the renowned psychiatrist who ran it resulted from discovery legal proceedings. Lawsuits against several drug companies claimed that children were injured by atypical anti-psychotic drugs produced by several companies. The plaintiffs asserted that Dr Joseph Biederman's research was "crucial to the widespread acceptance of pediatric uses of antipsychotic medicines," (per Gardiner Harris reporting in the New York Times). The Massachusetts General Hospital's web-site notes that Dr Biederman is "Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD at the Massachusetts General Hospital, and Professor of Psychiatry at the Harvard Medical School."

According to the NY Times article, Dr Biederman pressured Johnson & Johnson, the manufacturer of Risperdal (risperidone), an atypical antipsychotic drug, to finance a research center at Massachusetts General Hospital,
E-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to 'move forward the commercial goals of J.& J.'
A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.

A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and 'move forward the commercial goals of J.& J.,' court documents said.

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company 'multiple times to propose the creation' of the center. 'The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in' children and adolescents.

Furthermore, David Armstrong, writing for the Wall Street Journal, noted

Internal J&J records that are part of the plaintiffs' filing indicate that Janssen (Johnson & Johnson subsidiary) paid, or was requested to make payments, of $500,000 to help start up the center in 2002, another $200,000 for operating funds in 2003 and an additional $250,000 for 2004 activities. Janssen declined to comment on those figures.

Dr. Biederman was receiving direct compensation from J&J during those years, according to records obtained by Sen. Charles Grassley, who has been investigating drug-company payments to the Harvard researcher at others at academic medical centers. In 2001, Dr. Biederman was paid $58,169 by J&J although he reported to Harvard that he was only paid $3,5000, according to Sen. Grassley. In all, Dr. Biederman received more than $1.6 million between 2000 and 2007 from drug companies while reporting to Harvard receiving only several hundred thousand, Sen. Grassley's documents show.

Also, per the WSJ,

The emails also suggest that the company's marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates.

Officials from Massachusetts General Hospital denied that they knew what was really going on at the Center. Per an article in the Boston Globe,

Massachusetts General Hospital issued a statement yesterday saying that the center, the MGH-Johnson & Johnson Center for the Study of Pediatric Psychopathology, existed from 2002 to 2006 and gave many researchers 'the infrastructure necessary to complete projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner.'

The hospital controlled the center's programs, it said, and, 'The grant agreements stated that the center was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.'

The allegations in the Risperdal case 'have raised significant questions and concerns about the implementation of those agreements,' the statement said. 'The MGH takes these allegations very seriously and intends to investigate these issues thoroughly.'

Meanwhile, Harvard University denied any direct involvement. Per an article in Bloomberg News,

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn’t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.

'Harvard Medical School does not ‘own’ any of its teaching hospitals,' Cameron said in an e-mail. 'While we are affiliated with them through academic appointments, all teaching hospitals are individually governed.'

A major theme of this blog has been how the leadership of ever larger and more dominant health care organization have forsaken their missions, and instead acted to threaten physicians' and other health professionals' core values. For example, a leader of academic medicine asserted that faculty were judged more for their ability to bring in money, to be "taxpayers," in his words, but not to teach, do research, or take care of patients. This occurred while health care organizations were increasingly run by people from the business world who had little experience in or knowledge of the care of patients, or of biomedical or clinical science.

The sorry tale of Dr Joseph Biederman now adds to the evidence that at even the most elite academic medical institutions commercial purposes may outweigh the academic or clinical mission. The remarkable feature of this story is that the leaders of the particular institutions involved seemed blissfully unaware of what was going on.

At best, the leaders of Massachusetts General Hospital did not seem to know what the purposes of their own so-called research units were. Although Harvard Medical School has long been identified with its prestigious teaching hospitals, and vica versa, now the Medical School says it was "not involved" in the hospitals' and its own faculty's research activities. It all has the smell of "plausible deniability." Maybe the leadership of ostensibly academic institutions no longer want to know too much about their institutions' academic activities, presumably as long as those activities brought in enough money to be good "taxpayers."

But if academic leaders claim to know nothing about and have no involvement in their organizations' academic activities, what sort of leaders are they, and what really are their missions?

Meanwhile, all too many medical academics cloak themselves in the mantles of their academic respectability while helping to hawk drugs and devices, while claiming to be perfectly uninfluenced by the tens or hundreds of thousands or more dollars they are making on the side, and uninfluenced by how the huge grants their sponsors hand to their institutions promote their careers, making their academic cloaks all the more showy.

For additional comment on this case, see this post in the Clinical Psychology and Psychiatry Blog, this one on the Alison Bass blog, and this one on the University Diaries blog.

ADDENDUM (1 December, 2008) - Also see this post on the Carlat Psychiatry Blog.

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