The outing of the RUC (RBRVS Update Committee), the secretive committee that has so much influence over how Medicare reimburses physicians, and hence bears much blame for the decline in US primary care, continues. (Our most recent post on this subject is here.)

First, on the Movin' Meat blog, Shadowfax, an emergency department physician, took up the issue. He emphasized how poorly the RUC represents the overall population of US physicians. Most seats on the RUC go to particular medical societies, regardless of their size. So there is a one seat for the 6,000 member American Society of Plastic Surgeons, and one seat for the 124,000 member American College of Physicians. Furthermore, Shadowfax charged that an informal alliance of sub-specialty surgeons and procedurally oriented medical sub-specialists dominates the agenda.

Also, DB's Medical Rants takes up the subject again, noting that the way the RUC works seems to reflect an American bias to reward doers more than thinkers.

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This is concerning regarding healthcare information security and integrity. Could software in health IT projects worked on by this student be compromised, e.g., by "back doors", trojans, etc.? (See last paragraph.)

With all the recent problems with healthcare and other confidential, potentially harmful information subject to misuse being leaked, I believe an audit of the companies and health IT projects/products he worked on would be an appropriate due diligence.

I've emailed Assistant U.S. Attorney Michael Levy on this issue and inquired if this angle is being or has been pursued.

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In the article "Design of Patient Tracking Tools May Have Unintended Consequences" excerpted below, researchers found that technology designed by technologists without adequate domain expertise, especially in complex domains such as hospital emergency departments (ED's), often does not work as expected. It can interfere with staff communications, for example - a potentially disastrous consequence in an ED environment where patients can be highly unstable.

A PI in the study observed that "the results provide an important case study of what can happen when new technologies are developed without sufficient understanding by designers of the nature of the work in which they will be used."

AHRQ has provided funding to develop simulations of proposed electronic patient tracking systems in order to better evaluate and match them to the needs of hospital emergency departments.

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Welcome to Health Care Renewal. Health Care Renewal was the product of brain-storming by some physicians and health care researchers who wondered why as health care costs inexorably rose, access decreased, and quality remained stagnant. With health care reform again looming, no one seemed to be able to explain this, much less have any solutions.

We found we all knew stories that suggested systemic problems with health care that provided some explanations, but seemed rarely to be discussed in polite conversation.

Basically, the problems arose from concentration and abuse of power. As health care organizations grew ever larger and more powerful, their governance became more unrepresentative of their constituencies, secretive and opaque, unaccountable, and unethical and amoral.

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On DB's Medical Rants, the nominally anonymous blogger took on the RUC (RBRVS Update Committee).

I am starting to believe that the distortions of physician reimbursement orchestrated behind the scenes by the shadowy RUC are one of the main reasons US health care is in such a mess. We had posted about the RUC, based on some important articles published this year that first brought its machinations to light (1,2,3) here and here.

A new article just appeared in JAMA on the topic(4) by the perspicacious Dr John Goodson, which provided a focus for what was really a Medical Rant:

The story of the RUC often reminds me of conspiracy theories. They (we never really know who they are) determine the fate of the world (or at least the economy). The RUC has disproportionate power and has apparently taken a reasonable idea (RBRVS) and corrupted it. If you want to know who to really blame, it is the RUC. I blame the AMA for developing a committee which does not represent the interest of overall health care, but rather the interests of subspecialties.

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"Dr Drug Rep," the New York Times Magazine article by Dr Daniel Carlat about his brief career giving pharmaceutical industry sponsored talks, apparently is creating quite a buzz. (See our previous post here.)

On the Hooked: Ethics, Medicine and Pharma Blog, Dr Howard Brody wonders about the reason Wyeth paid Dr Carlat so generously. Was it really because he was so good at persuading other doctors to prescribe Effexor? Or was it "to pay him $30K in bribes to get him to prescribe more Effexor in his own practice?"

On the Carlat Psychiatry Blog, Dr Carlat himself went over some of the comments he has been getting since he published his article. Some were hostile, calling him a "hypocrite," etc. There were equally hostile comments on some of the other blog posts on this topic. This is not very surprising. Dr Carlat's article raised ethical questions about marketing practices frequently used by pharmaceutical companies (and probably also biotechnology companies and device manufacturers). A lot of people make a lot of money from these practices, not only the well-paid physician speakers, but the drug reps who recruit them, and the marketing executives who are responsible for the whole mess. I bet they are not all happy with their exposure in the NY Times Magazine. Recall a quote I posted from the Aspen Health Forum, " there are powerful economic forces invested in this current culture. It would be foolish and naive to think they won't resist change."

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Even though many other bloggers have commented on it, I must note an article just published in the New York Times Magazine by Dr Daniel Carlat, editor of the Carlat Psychiatry Report and blogger on the Carlat Psychiatry Blog.

Dr Carlat recounts what inspired him to produce a newsletter on psychiatry treatment that is supported by no pharmaceutical company money, and to blog acerbically about the influence of vested interests on medical education.

It seems that in 2001, he became, as the article is entitled, "Dr Drug Rep." One of the local drug reps enticed him into giving "educational" lectures, over drug company supplied lunches, to physicians and others in their offices. The lectures, of course, were mainly positive about the drug company's product (a serotonin and norepinephrine reuptake inhibitor used to treat depression, venlafaxine, Effexor by Wyeth).

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We previously discussed, most recently here, the unfortunate and unexplained death of young patient after an injection of an experimental gene-therapy agent. 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.

Whether the treatment had anything to do with her illness and death were initially unclear. A hearing by the US National Institutes of Health (NIH) Recombinant DNA Advisory Committee did not reach any conclusions about what caused the patient's death. (See post and here.) The NIH panel "said it was too early to conclude that the gene therapy had not been a factor, perhaps by suppressing ... [the patient's] immune system," (per the International Herald Tribune.) I should also note that even apparently innocuous viruses sometimes are not. The US Center for Disease Control (CDC) recently warned of cases in which people have died after infection with a type of virus, a type 14 adenovirus, that usually just produces a mild upper respiratory infection.

Nonetheless, now the US Food and Drug Administration (FDA) is allowing Targeted Genetics to restart the trial. The company's CEO, H. Stewart Parker, is claiming "this is a vindication for the product, the company and the field of gene therapy," (per Bloomberg News. There is a similar quote in a Seattle Times article.)

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The Hartford Courant reported last week how the state of Connecticut has stopped four managed care organizations/ health care insurers from running its HUSKY state insurance program for poor children.

Escalating a long-running battle over the state's Freedom of Information law,the state is yanking the primary management of the HUSKY health insurance program for poor children out of the hands of four insurance companies.

The announcement Monday by Gov. M. Jodi Rell marked the latest stage in a battle that has lasted more than two years over whether the private companies could be forced to comply with public FOI disclosure laws.

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The story of the delay in reporting results of the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck) was reported by Matthew Herper in Forbes, Alex Berenson in the New York Times, and theHeart.org and MedScape. Then several prominent skeptical bloggers, including Howard Brody on the Hooked: Ethics Medicine, and Pharma blog, Dr Aubrey Blumsohn on the Scientific Misconduct Blog, and Dr Scott Aberegg on the Medical Evidence Blog analyzed the situation. Therefore, I need not post a lot of detail.

Basically, although ezetimibe has been shown to reduce LDL ("bad") cholesterol, it has never been shown that using the drug to do so produces any clinical benefit, e.g., prevents heart attacks or strokes, prolongs life, etc. The ENHANCE trial was designed to determine whether the drug at least reduced arterial obstruction, thought to be a good predictor of bad clinical events. After reporting of the trial's results was delayed, it became evident that:

• The trial's Principal Investigator had no access to the trial's original data, and no control over how the data was analyzed.
• The data was owned and analyzed by the drug companies that nominally "sponsored" the trial.
• The same drug companies decided to change the trial's endpoint after the trial was implemented and the data was collected.
• The companies justified the decision as coming from an expert panel they convened (and presumably paid for.) However, they did not reveal who was on the panel.

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