Most everyone is aware of the Duke lacrosse team scandal, the debacle about alleged rape by Duke lacrosse team students that led to the resignation of prosecutor Nifong for prosecutorial misconduct, exoneration of the accused, an expose of the radical agendas of a subset of Duke's faculty, and a great deal of national publicity, or, I should say, notoriety.

Now, in Dec. 2007 several of the team members have filed a civil suit. The lawsuit filing documents are downloadable from these links (PDF files):

Part 1 (100 kb PDF)

Part 2 (1.3 Mb PDF)

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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, 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.)

So it is ironic that the latest Avandia controversy is about the premature release of a manuscript submitted for publication.

Recall how the story began, with the publication in the New England Journal of Medicine by Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here). The main achievement of the Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone completed to date. Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug, most of which have not been published to date. They did eventually appear on a web-site run by GSK. However, this web-site was relatively obscure, and it was not created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here). Nissen and Wolski found it, compiled the results of trials on Avandia, and combined their results with those of the few published trials in their meta-analysis.

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To many non-medical people, it really appears they believe the "fixes" to medicine are simple, deterministic (i.e., computerization as a panacea), and that many of the problems are generally a result of bad behavior by clinicians. The significant brouhaha about handwashing is such an issue:

Cleaner but not safer hands?

A study found that even when use of a gel rose at a hospital, infection rates were unchanged.

By Timberly Ross , Associated Press, Wed, Jan. 30, 2008

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We had posted often (see these posts here, here, and here from 2006 with links backward) about the hugely lavish compensation afforded to the Dr William McGuire, former CEO of UnitedHealth Group, one of the largest US insurers/ managed care organizations, and how this remuneration stood in stark contrast to the stated mission of UnitedHealth Group:

UnitedHealth Group is a diversified health and well-being company dedicated to making the health care system work better. The company directs its resources into designing products, providing services and applying technologies that:

- Improve access to health and well-being services;

- Simplify the health care experience;

- Promote quality; and,

- Make health care more affordable.

Most recently, controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here). More recently, McGuire agreed to pay back some of those options, although that would reportedly leave him with more than $800 million worth of options (see post here).

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Today's (20 January 2008) New York Times has a useful piece about the Conflict of Interest between device companies and surgeons.

Seems that, in the clinically still-murky field of spinal surgery, an awful lot of doctors are implanting devices made by companies in whom their financial interests, now disclosed, were there from the get-go.

What's most disturbing about this saga, though, is the notion that "in the case of the Prodisc clinical trial, as with any clinical research, the doctors were supposed to be acting not as advocates for the product but as objective scientists studying whether the disk was safe and effective."

How is it possible to do both? What are they thinking?

Oh, that's right. They're thinking, I can do well and do good.

But Richard Deyo, MD, of Oregon Health Sciences University, quoted in the Times piece, perhaps says it best:

"The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing...." More people are interested in getting on the gravy train than on stopping the gravy train."

Guess the Pogo Effect is now the norm.

A number of news items about managed care organizations/ health insurers published last week make for an interesting juxtaposition.

Innovative Physician Reimbursement?

First were articles about managed care proposals for innovative physician reimbursement. First, from the Boston Globe, an article about a proposal to resurrect capitation.

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On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody critiqued a newspaper op-ed that ostensibly decried excessive litigation in health care, but also seemed unduly concerned with defending Avandia and Zyprexa, two drugs that did turn out to have more adverse effects than expected.

On the Carlat Psychiatry Blog, Dr Daniel Carlat recounted the career of a "hired gun, MD" who earned an estimated $3 million total from honoraria giving pharma sponsored talks. Is this any way to provide continuing medical education? Would you trust a talk given by such a hired gun? Would you recognize a CME talk given by such a hired gun?

On Gooznews, Merrill Goozner posits the "lessons from Vytorin," principally, that clinical trials should not be run by pharmaceutical companies, but rather by an independent agency, a la the NIH.

A generation ago, the drug industry accounted for about a third of clinical trials, while academic medical centers, using largely government funds, accounted for two-thirds of the tests. Today, that ratio is reversed. One estimate I've seen suggested industry spends over $20 billion a year on clinical trials, well over half of its collective research and development budget.

The time has come to ask whether our privatized system of clinical trial research is serving the nation's health. The fact that a drug like Zetia can be approved and sold to millions of people for nearly a decade without any evidence that it actually saves lives is absurd.

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In today's news we find that Merck and Schering Plough are coming under lawsuits as a result of the ezetimibe/Vytorin controversy. This was perhaps to be expected:

Lawsuits target Vytorin's makers

Plaintiffs contend the firms knew the drug didn't work.

Sat, Jan. 26, 2008

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