On the PharmaLot blog, Ed Silverman posted about a new study that purported to show that research subjects don't care about conflicts of interest affecting study investigators. But Silverman also noted that the apparent conflicts of interest of one of the authors, a lawyer for a firm that represents many pharmaceutical companies, were not disclosed, at least in the press release about the article.

Furthermore, Silverman's post suggested that the college students who were the study subjects were only asked about studies in which "the investigator was an employee of the company, ... an employee and consultant, or ... an employee and a patent holder." They were not asked about investigators who had conflicts at all. Thus, at best, the article suggested that college students thinking about being subjects of clinical studies were indifferent about whether study investigators employed by a company thad made the product being tested on the subjects were also company consultants or stock-holders. Maybe the students reasonably assumed that an investigator employed by the company was already so conflicted that adding consulting fees or royalties would merely ice the cake. That's hardly the same as the author's assertion that "this study suggests that disclosure of conflicts may not play a large role in decision-making." One wonders if the study author's willingness to make assertions not supported by his own data had to do with his own conflicts of interest?

We, and many others have written about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how aspects of it seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. After considerable public discussion, and the threat of a US congressional investigation, things have changed, as Ron Winslow reported in the Wall Street Journal,

The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.

Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug.

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We have posted a few times about an ill-fated trial of a gene therapy treatment. To summarize the case thus far, a young woman received a dose of an adeno-associated virus carrying a gene that was meant to have a local immune suppression effect, tgAAC94, made by Targeted Genetics, directly into her joint as part of a phase I study meant to assess the safety of the treatment. Soon after the treatment, she became ill, then very ill, and ultimately died in an intensive care unit. Although many flaws in the trial were identified in retrospect, and although there was no proof one way or the other whether the treatment was related to the patient's death, the trial was just allowed to resume (see most recent post here). This post by Dr Chris Evans on the Bioethics Forum identifies yet more methodologic problems with the trial, further challenging the wisdom of resuming it without substantial modifications.

Multiple news reports over the weekend recounted the firing of the Dean of the University of California - San Francisco (UCSF) medical school, Dr David Kessler, after he claimed he tried to identify and rectify financial irregularities at the school. First, here are the main points from the San Francisco Chronicle:

Dr. David Kessler, the onetime commissioner of the Food and Drug Administration who became dean of the UCSF School of Medicine in 2003, was fired Thursday night after years of discord over finances at the prestigious medical school.

Kessler's boss, campus Chancellor Michael Bishop, announced the dean's departure Friday morning in an internal e-mail to faculty members but did not disclose the reason.

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We have posted a number of times, most recently 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. This imbalance has rippled through all of US health care, affecting how private insurers and managed care organizations reimburse physicians, and generally how the US systems favors procedures over talking, examining, thinking, diagnosing, prognosticating, deciding, and prescribing and super-specialization over generalism and primary care. The RUC ostensibly is just an advocacy group sponsored by the American Medical Association, yet it seems to be the only source of outside input about physicians' reimbursement used by the US Center for Medicare and Medicaid Services (CMS). Given this influence, it is dismaying that it is secretive, unrepresentative, and unaccountable. Neither its membership nor proceedings are public. It is dominated by proceduralists and sub-specialists. It is unaccountable to US physicians, much less the general public.

The importance of the RUC and the damage it does is being more widely recognized. Most recently, on the influential Health Care Blog, Brian Klepper spreads the word about the RUC, but suggests that only when the public and policy makers become aware of this problem will we be able to contemplate a solution.

As I mentioned earlier, a major impetus for setting up this blog was finding out that most physicians knew local examples of badly or corruptly run local health care organizations, and felt that their core values were threatened by the actions of these organizations. However, the doctors all felt they were peculiarly unlucky to practice in such a uniquely sleazy environment. They did not realize that things were likely just as bad in the next town, and thus, that the problems were systemic. When I have taken my Health Care Renewal talk on the road, only a few people in the audiences have ever heard of some of the most vivid examples of bad health care organizational governance, e.g., the collapse of the Allegheny Health Education and Research Foundation (see post here).

So it may be easy to dismiss the next story as just the sort of corruption that goes on in our little state of Rhode Island. But remember that the something similar is likely going on in your cities, states, and countries.

Starting with one of the first posts on this blog, we began to recount the follies of the management of Blue Cross and Blue Shield of Rhode Island (BCBSRI), a not-for-profit insurance company and managed care organization, the dominant health insurer in the state. In 2004, Blue Cross "fired its CEO this year after news reports of his huge salary, receipt of a $600,000 no-interest loan which he did not pay back, and, receipt of free acupuncture treatments from a practitioner who wanted to influence Blue Cross reimbursement policies. Meanwhile, Blue Cross was paying health care professionals poorly (often less than Medicare), while hiking premiums at double-digit rates." (See post here.) In 2005, the company settled a class action suit after it was accused of "bilking subscribers" by using a complex scheme to inflate their drug co-payments (see post here). In 2007, a former RI state senator pleaded guilty to literally being a Blue Cross "bag man," being paid for many more bags than he actually delivered to the company in return for promoting legislation favored by it (see post here).

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If this story is true, perhaps it is a good thing. I particularly like the idea of banning health IT advertising to doctors, and especially the idea of licensing requirements for those selling or promoting (I'd also add developing) HIT products.

My only request: can I help design the licensing exam?

It would be designed especially to root out the "usual suspects", e.g., shiny-haired, impressive-sounding, but otherwise incompetent "experts", "process jocks" and "process babes" with tunnel vision who believe the whole world operates like a Model T assembly line and create fiascos like this one, snake oil salespeople, and Medical Instamaticists, among others - although with a bit more finesse than used by Keyser S

On the Clinical Psychology and Psychiatry blog, this post discusses the remarkable article by the Task Force on External Funding of the American Psychological Association. The article provides a good summary of the problems entailed by "Corporate Funding and Conflicts of Interest," (its title) and gives some remarkably tough policy suggestions to the APA. The anonymous blogger speculated on the likelihood that advice will be taken.

The purpose of the Health Care Renewal blog is to address "threats to health care's core values," as noted in our side-bar.

The latest issue of JAMA contains an important article by Arnold Relman on this topic.(1) Much of its content will be very familiar to Health Care Renewal readers.

Relman's first point is that physicians' core values are threatened:

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We have posted frequently about the controversy about rosiglitazone (Avandia, by GlaxoSmithKline). Some of the distressing aspects of the case were various efforts made to keep information and opinions unfavorable to Avandia away from physicians, the patients, and the public, including efforts involving obfuscation, deception, and intimidation. (For example, see this post about the "spinning" of Avandia and the ridiculing of Avandia critics, and this post about attempts to silence an early Avandia critic.)

This month, the British Medical Journal printed a news article about the US Senate report that claimed that the critic, Dr John Buse, was intimidated by top GSK executives.

Perhaps with deliberate irony, on the same page was another news article, headlined, "One in 20 East German doctors spied on patients or colleagues." It was based on a study by the Hannah Arendt Institute for Research on Totalitarianism,

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