Amidst all the merrymaking of the past weeks, here’s what PostScript was reading…
FDA: a fixer-upper?
Obama and the FDA – will he fix it, and when? Those are the questions Tribune reporter Noam Levey asks about the troubled agency and where its reforms may fall on the growing list of the President-Elect’s priorities.
And Merrill Goozner at Gooznews talks about the consumer voice in discussions about the next FDA commissioner. Goozner says Obama’s FDA transition team has worked to bring all voices to the table, and is confident the consumer perspective has been heard. We liked his credo of sorts at the end:
“Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner,” Goozner writes. “That’s not faster cures. That’s smarter cures, even as the new commissioner insists that they still meet the agency’s statutory hurdles for safety and efficacy.”
And in the snowy Midwest this week, there were two very different stories swirling around conflicts of interest at two major academic medical centers.
The University of Wisconsin-Madison announced it will post signs at its health clinics indicating that doctors may take drug company money for research and consulting beginning in January. Earlier this year, the UW School of Medicine and Public Health revised its conflict of interest policies, tightening restrictions on industry-sponsored meals and establishing a strong samples program that would provide pharmacy vouchers to clinic patients, eliminating the freebies-bias toward newer and often more expensive drugs.
The Wisconsin State Journal reports that despite this move toward greater transparency with patients, who will be able to ask for details about their doctor’s industry relationships, the University will not be publishing physicians’ corporate receipts in a public way anytime soon.
“It would take a lot of time and effort to have an updated database,” the dean of the medical school, Dr. Robert Golden, told the Journal. “We believe it will be only a handful of patients requesting this.”
Meanwhile, the Minnesota Star-Tribune revealed that the head of the committee charged with developing a new set of conflict of interest policies for the University of Minnesota Medical School, Dr. Leon Furcht, was censured in 2004 by the Dean that appointed him for diverting $500,000 in industry research dollars to his own stem cell company. Furcht, who just emerged from a three-year sanction period that banned him from involvement with any commercially-backed research, is now co-chair of the committee convened to write the University’s policies regulating faculty and student interaction with industry.
This Star-Tribune editorial praises the COI policy process at the med school but says the choice of Furcht to head the committee undermines the credibility of any policies it will produce.
And the Los Angeles Times looks at the kerfuffle developing around the nondisclosure agreement the American Psychiatric Association had the writers of the DSM-V sign. The Diagnostic and Statistical Manual of Mental Disorders, which was last updated in 2000, has major influence on and implications for psychiatric diagnoses and treatment, insurance reimbursement, and social concepts of what it means to be well or disordered.
One of the new authors, Dr. Robert Spitzer of Columbia, has broken rank and has openly opposed the mandated secrecy as something neither his profession nor the field of medicine can afford. Reading about “chronic complaint disorder” from published working papers of an earlier DSM committee, we understand why they might not want to let the diagnostic dogs out just yet.
An excellent piece on the DSM in the New York Times, as well.
Angell Reviews Rx Books of 2008
Along literary lines, former New England Journal of Medicine editor Dr. Marcia Angell writes in the New York Review of Books about three books on Big Pharma’s influence on medicine: Our Daily Meds, Side Effects, and Shyness: How Normal Behavior Became a Sickness. Without the space limitations of other publications that tackle this complex web of problems around industry involvement with medical decision-making, Angell is free here to connect the dots: from the systemic bias of company-sponsored clinical trials, to the cultural secrecy and acceptance of corporate support by academic researchers who write treatment guidelines, prescribe, and advise the FDA, to the growth of off-label prescribing and industry’s subtle and multi-front campaign to promote it – Angell brings these texts together with her own experience as editor in what makes for an eloquent problem statement about the state of industry influence on academic medicine.
“The mission of medical schools and teaching hospitals—and what justifies their tax-exempt status—is to educate the next generation of physicians, carry out scientifically important research, and care for the sickest members of society,” Angell writes. “It is not to enter into lucrative commercial alliances with the pharmaceutical industry. As reprehensible as many industry practices are, I believe the behavior of much of the medical profession is even more culpable.”