According to the FDA News, an appropriations bill just passed denied funding to the new Reagan Udall Foundation. According to an FDA press release, "the private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."

Questions have been previously raised about the influence industry would have on this foundation. The FDA News previously reported

Rep. Rosa DeLauro (D-Conn.), chairwoman of the subcommittee that funds the FDA, has warned that there is no framework to minimize the industry's influence on the foundation.

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An op-ed in the New York Times by Dr Atul Gawande drew attention to an inexplicable government decision to shut down an apparently worthwhile research project.

IN Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

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The latest reminder of the pervasiveness of financial entanglements among physicians and medical researchers and health care corporations comes from a story in US News and World Report. The topic was how the American Psychiatric Association is attempting to make the development of the new edition of The Diagnostic and Statistical Manual of Mental Disorders the "most transparent" ever. The impetus behind the new transparency may have been criticism that the last edition was written by a group of authors heavily financially entangled with health care corporations (see post here, based on early reports of the results of this article: Cosgrove L, Krimsky S, Vijayaraghavan M et al. Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006; 75: 154-160, available here).

This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests.

Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare [see them here]; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: 'Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved.'

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Visit Women's Health News at its new home - http://womenshealthnews.wordpress.com

A roundup of recent posts:

Science vs. Spin: Reactions to New Research on Sex Ed and Abortion

CDC Releases Data on the Pre-Pregnant

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As reported by Liz Kowalczyk in the Boston Globe, the University of Massachusetts Medical Center has just adopted "some of the strictest conflict of interest rules in the country." In particular,

It prohibits doctors and other clinical staff from eating meals paid for by companies; bans all gifts, from candy to medical journals; stops drug companies from giving money directly to individual physicians and departments for educational programs; and places a complete ban on doctors joining company 'speakers bureaus' to give talks about products.

This policy seems more stringent than others recently adopted at other medical schools in the US.

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Here we go again. Last week, an article by Alex Berenson in the New York Times reported that Merck and Schering-Plough conducted trials of ezetimibe (Zetia, by Schering-Plough, and a component of Vytorin, by Merck) "that raise questions about its risks to the liver," but never publicly reported their results.

Partial results of the studies, alluded to in documents on the Food and Drug Administration's Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.

A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Dr. Robert J. Spiegel, said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.

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On the Health Care Blog, this post by Brian Klepper refers to some strong comments on the importance of transparency, originally made by Paul Levy on the Running a Hospital Blog.

With the run-up to the US presidential election starting in earnest, public discussion of health care policy issues is ramping up. As has occurred before, we hear a lot from people apparently on the right who advocate for a laissez faire approach to health care free of government involvement. Such people often tend to approve of much of what health care corporations do. We also hear a lot from those apparently on the left who favor government operation of particular segments of the health care system, particularly health insurance. They tend to be very critical of corporate health care, but to approve of much of what the government does.

These discussions often take place in the most prominent fora in the main stream media. For example, last week Dr Scott Gottlieb wrote "Stop the War on Drugs," a commentary for the Wall Street Journal. Gottlieb focused on how the US Food and Drug Administration and the Department of Justice challenge off-label marketing by pharmaceutical companies. He noted cases in which he contended that the government prosecuted companies for "educational" dissemination of information already widely available in the medical literature. Further, he implied that these attempts are part of efforts to make "off label" into "dirty words in the conventional lexicon." Gottlieb did not address cases in which companies promoted off-label use which was not supported by good evidence, e.g., the Neurontin case, and seemed to conflate marketing with education. His main point seemed to be that overly strict regulators were hindering physicians' education and hence keeping people from getting the drugs they need.

Also last week, Dr David Himmelstein and Dr Steffie Woolhandler wrote "I Am Not a Health Reform," a commentary for the New York Times. The thrust of this article was to discredit the employer mandate approaches now advocated by some presidential candidates to reform health care. They called the "mandate model" "economic nonsense." Instead, they asserted "only a single-payer system of national health care can save what we estimate is the $350 billion wasted annually on medical bureaucracy and redirect those funds to expanded coverage." Himmelstein and Woolhandler did not address any deficiencies in how our current national single-payer system, Medicare, allocates money, in particular how it follows reccommendations by the secretive, proceduralist-dominated RBRVS Update Committee (RUC) that have lead to a relentless squeeze on primary care. Their main point seemed to be that only government run health insurance will solve our current problems.

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We have posted frequently, most recently here and here, about the RBRVS Update Committee's (RUC) responsibility for Medicare's relatively poor reimbursement of primary care and other "cognitive" physicians' services compared to procedures. Although the AMA claims that the RUC is just an "expert panel," it appears de facto to be the only source of input to Medicare about how to revise physicians' reimbursement. However, rather than operating transparently so as to represent the views of at least the broad physician community, the committee's proceedings are secret, as are the names of its current members, who mainly represent surgical sub-specialties. Concern about the RUC has been more evident in the blogsphere, if not openly anywhere else. Most recently, the issue was noted on the Let's Talk Health Care blog, by none other than the CEO of Harvard Pilgrim managed care organization. Maybe now there is just a little momentum to take a closer look at how Medicare sets physician reimbursement, and maybe to develop a more transparent and accountable method of doing so that represents the interests of all physicians and all patients.

We have previously blogged about the apparently major conflicts of interest generated when a leader of an academic medical institution is also simultaneously on the board of directors of one or more for-profit health care corporations.

The Associated Press (here via the Houston Chronicle) just reported that Dr Harry Jacobson has been appointed to the board of directors of Merck and Co. The AP report also noted that Jacobson is on the board of Kinetic Concepts Inc. A cursory Google search revealed Dr Jacobson is a founder of Radiation Oncology Services of America (via the Nashville Business Journal) and was formerly on the board of the Renal Care Group (via PRNewsire).

Meanwhile, Dr Jacobson's day job is to be Vice-Chancellor of Health Affairs of Vanderbilt University. So here is yet another example of a top leader of an academic health care institution who is also on the board of directors of in this case three for-profit health care corporations, including one of the largest pharmaceutical companies in the world, plus two smaller local companies.

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