Friday, January 18, 2008

"Entrepreneurial Guidelines" SHAPE Up Poorly

Namby pamby. That's what Robert Lindeman, MD (aka the infamous former blogger, Flea) called us bloggers.

A bunch of wimps.

And you know what?

Many of us are. Perhaps for self-preservation. Perhaps to avoid having our words used against us in the court of law later.

But we're not the only ones. Our own professional societies including the AHA and ACC have been namby pamby, too, in my book - especially when it comes to refuting the "entrepreneurial" guidelines proposed by the "Association for the Eradication of Heart Attack (AEHA)." This group, with reportedly altrustic intent, has been so riddled with conflicts of interest, it makes one's head spin.

And now this group wants to MANDATE that insurers HAVE to pay for atherosclerosis screening tests, of which their organizer, Dr Morteza Naghavi, has a significant financial interests as founder and shareholder of Volcano Corporation and Endothelix, Inc.:
Later this year, Texas House Representative Rene Oliveira plans to introduce—for the second time—his bill into state legislature that would mandate insurers to cover screening of asymptomatic atherosclerosis using calcium scanning and carotid ultrasound, as set out in the SHAPE initiative.
Everyone was namby pamby except Peter D. Jacobson, JD, MPH, of the Center for Law, Ethics, and Health, University of Michigan School of Public Health.

He had balls. Big ones. In his editorial in JAMA, he called the practice of accepting unvetted self-initiated "entrepreneurial guidelines" into question, and wondered why the AHA, ACC, and National Institute of Health have been so namby pamby about refuting an initiative so ripe with conflicts of interest.
( As reported by heartwire, the controversial SHAPE task-force report was published as a Pfizer-sponsored supplement in the American Journal of Cardiology and initiated by the Houston-based Association for Eradication of Heart Attack (AEHA), founded by Dr Morteza Naghavi (American Heart Technologies, Houston, TX). While a number of prominent cardiologists were on the writing group and editorial committee for the SHAPE report, which explicitly billed itself as "a new practice guideline for cardiovascular screening in the asymptomatic at-risk population," neither the ACC nor the AHA—both of which have released their own cardiac imaging guidance documents in the past few years—were involved in the SHAPE recommendations.

In interviews with heartwire when the SHAPE publication first came out, representatives from the ACC, AHA, and the National Heart, Lung, and Blood Institute all distanced themselves from the SHAPE document. In an editorial published in August 2006, shortly after the SHAPE report came out, Journal of the American College of Cardiology editor-in-chief Dr Anthony DeMaria called the SHAPE guidelines "a proactive effort . . . for a strategy for which the evidence of efficacy remains unestablished". He also noted that the contribution of "several individuals who hold or have held leadership positions in national/ international medical societies" to the SHAPE report might convey the impression those organizations "approve" of the guidelines. "This is obviously not the case," DeMaria stated.

From opinion to law?

Oliveira first filed his Texas Heart Attack Prevention Bill in February 2007, his first full day back in office after CABG surgery, a procedure he underwent after a CT scan indicated severe coronary blockages. According to his chief of staff JJ Garza, the first time around, the heart-scan bill was rolled into an omnibus bill that was ultimately voted down, although no one actually objected to the heart-scan portion of the proposed legislation. Oliveira intends to introduce his bill again, as standalone legislation, when the legislature meets again in January 2009, although he may opt to "prefile" his bill in November 2008 after compiling the "latest scientific evidence," Garza told heartwire. Garza also emphasized that the bill "is not the SHAPE recommendations," takes other scientific research into account, and may even be redrafted to reflect new evidence before being filed. "The universe covered by the legislation is smaller than the universe SHAPE outlines," he stated.

In the meantime, Jacobson, in his JAMA commentary, points out that there is no proof that adopting the SHAPE guidelines will do more good than harm, particularly since they were neither peer reviewed nor endorsed by the major professional societies in the US or the European Society of Cardiology. The problem here, he argues, is that while clinical practice guidelines form the backbone of evidence-based medicine and are "flexible instruments" that are or should be subject to rigorous scientific analysis, legislative mandates, by contrast, are "inflexible, static, and not as easily changed as science advances" or may prematurely support unproven strategies.
So kudos to Dr. Jacobson for having the gonads to call a spade a spade. But then again, maybe the ACC's ties to Big Pharma had something to do with their namby pamby attitude toward others with similar conflicts of interest.

Let's hope not.


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