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 might 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 ideal 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 Ideal Hospital,” (as it was called in “Samuel Shem’s” Home 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 kids were hurt 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.’

Furthermore,

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 stated.

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, stated 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 begin 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 even though 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 recommend 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 finish projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner.’

The hospital controlled the center’s programs, it stated, and, ‘The allow 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 stated. ‘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 stated 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 more massive and more dominant health care organization have forsaken their missions, and instead acted to threaten doctors’ 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 might 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 ideal, the leaders of Massachusetts General Hospital didn’t seem to know what the purposes of their own so-called research units were. Even though 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 allows 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.

[Source : Health Care Renewal]

Earlier this year, an article by Shannon Brownlee and Jeanne Lenzer, “Stealth Marketers: Are Physicians Shilling for Drug Companies on Public Radio” in Slate discussed how the host and panelists on a segment of the acclaimed radio show, “The Infinite Mind,” broadcast on the US National Public Radio network, which minimized concerns about adverse effects of second-generation antidepressants had ties to companies that made such drugs. (See our post here.)

Last week, Gardiner Harris, writing in the New York Times, indicated that the show’s host, Dr Frederick Goodwin, had even more extensive financial ties to pharmaceutical companies than were previously known.

An influential psychiatrist who was the host of the popular public radio program ‘The Infinite Mind’ earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program.

The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by Senator Charles E. Grassley, Republican of Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first news media figure to be investigated.

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

‘But as we’ll be hearing this day,’ Dr. Goodwin told his audience, ‘modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.’

That same day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. In all, GlaxoSmithKline paid him more than $329,000 that year for promoting Lamictal, records given to Congressional investigators show.

Even though Dr Goodwin’s relationships to GSK were apparently substantial and prolonged, they were certainly not disclosed to listeners of “The Infinite Mind.”

In an interview, Dr. Goodwin stated that Bill Lichtenstein, the program’s producer, knew of his consulting but that neither thought ‘getting money from drug companies could be an issue.’

‘In retrospect, that should have been disclosed,’ he stated.

But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drugmakers and that, after an article in the on the internet magazine Slate this year pointed out that guests on his program had undisclosed affiliations with drugmakers, he called Dr. Goodwin ‘and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, ‘No.”

Here we go again. This is yet the latest case in which an influential physician spoke or wrote favorably about drugs or devices without disclosing he was a well-paid consultant for a company that had commercial interests in those very same treatments.

In this case, Dr Goodwin spoke directly to the public, rather than to fellow practitioners or academics. While it may be hard for even trained professionals to detect undisclosed commercial bias in the lectures they attend or the articles they read, it should be even harder for lay-people to detect such bias. Furthermore, Dr Goodwin was broadcasting on National Public Radio, an organization that does not carry advertising, and prides itself in its independence and commitment to education. That reputation might have lulled listeners into even more confidence that what they were hearing was educational, not advertising. Note that Mr Harris wrote,

‘The Infinite Mind’ has won more than 60 journalism awards over 10 years and bills itself as ‘public radio’s most honored and listened to health and science program.’ It has more than one million listeners in more than 300 radio markets.

Make that “had listeners,” since

Margaret Low Smith, vice president of National Public Radio, said NPR would remove ‘The Infinite Mind’ from its satellite radio service next week, the earliest date possible. Ms. Smith stated that had NPR been aware of Dr. Goodwin’s financial interests, it wouldn’t have broadcast the program.

Even though we wrote in Might that one segment of “The Infinite Mind” seemed to be more about stealth marketing than independent, educational broadcasting, now it appears that what was infinite about this mind was its dedication to marketing rather than education. Is there any space in health care that is not now permeated by the fog of deception and disinformation?

To begin to restore trust in health care, we must insist on total transparency, starting with full disclosure of all commercial and financial relationships that might influence clinical and health care policy decision making. Disclosing relationships, however, does not reduce their influence, or even make it possible to compensate for it. If physicians want to regain their leadership role in health care, they may have to declare that they will henceforth only serve patients, and, if they are academics, their students and science. As long as physicians work part-time for marketers, they risk being regarded as nothing better than fancy but not particularly honest carnival barkers.

ADDENDUM (24 November, 2008) - See also news coverage on the Pharmalot blog. Also, that blog and Postscript, the Prescription Project blog both discussed an ongoing investigation by Senator Charles Grassley (R - Iowa) into a consulting company called Ideal Practices LLC, which may have something to do with the “dissemination of ‘off-label’ information,” and of which Dr Goodwin was a “founding consultant.”

[Source : Health Care Renewal]

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