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The heart.org has the following news report about a Maryland doctor accused of overstenting:

Baltimore, MD – A malpractice lawyer is accusing Dr John Chung-Yee Wang (Union Memorial Hospital, Baltimore, MD), a member of the committee tasked with stopping improper stenting in Maryland, of improper stenting in his own practice [1].

The Baltimore Sun reports that medical malpractice attorney Jay Miller has filed complaints with the state health claims arbitration office against Wang. Miller alleges that Wang, Dr Mark Midei, and Dr Kourosh Mastali wrongfully stented patient John Bowers in 2005 and 2006, when the three interventionalists were partners in MidAtlantic Cardiovascular Associates, a practice that has since disbanded. Miller also charges that Wang overstated the extent of coronary disease in patient Lorie Skillman to justify implanting a stent (…)

As reported by heartwire, the Maryland Medical Board revoked Midei’s medical license after it determined he repeatedly violated the Medical Practice Act by implanting hundreds of unneeded stents while working at St Joseph Medical Center in Towson, MD. Midei is one of several high-profile cases of alleged overstenting in recent years.

Wang is part of the Technical Advisory Group on Oversight of Percutaneous Coronary Intervention Services, a group of experts tasked by the Maryland Health Care Commission (MHCC) to develop recommendations for legislative changes that would improve oversight of coronary intervention labs in the state. The committee is set to report its findings at a public meeting of the health commission today. “The allegations could cast a shadow over the work of the advisory committee,” the Sun reports. Wang was nominated for the committee by the Maryland chapter of the American College of Cardiology (ACC).

We may recall another period of time when committees played a prominent role in regulating safety and security.

In 1793, Georges-Francois Danton was given the task of leading the French Committee of Public Safety to ensure application of the ideals of Liberté, Egalité, Fraternité.  In the months that followed, the committee prescribed treatment with the “National Razor” to thousands of individuals deemed to be a threat to the revolution.  The bulk of the offenders were initially identified from among the aristocracy and the clergy, but it soon became necessary to also purify the revolutionary ranks from the less ardent supporters of rhetoric.  Soon enough, Danton himself was condemned to the same end that had so many before him had met.

In a letter to the MHCC, SCAI and the Maryland chapter of the ACC criticize the committee’s recommendations for not going far enough [2]. “The draft recommendation to expand MHCC ‘oversight’ to CABG facilities is excessively vague. It is unclear what authority this would give the MHCC. . . Voluntary oversight provides no guarantee that all citizens in Maryland are afforded equal, high-quality healthcare. . . Over time, the risk is that the foundation of peer review weakens. Good hospitals have nothing to hide or fear (bad ones do).”

The ACC, the SCAI and countless committees, commissions, and task forces around the country are fervently working to ensure application of the modern medical ideals of Quality, Equality, and Appropriateness.

May the just God protect us all from the zeal coming out of utopian ideologies.

“The artifactual disease” is the phrase George Pickering coined to describe hypertension in the 1950′s and 60′s.  In those days, he dominated the debate about the nature of hypertension, arguing against those who thought hypertensive patients who developed complications comprised a distinct entity of subjects.  “The higher the pressure, the worse the prognosis,” he would repeatedly affirm.  To my knowledge, he did not expound on the J-curve phenomenon, but he surely made a convincing case that defining a disease on the basis of arbitrary cut-off numbers is most foolish indeed.

But since the 1970′s, after clinical trials established the success of anti-hypertensive therapy, and with the growing enthusiasm for “risk-factor modification” and the inexorable rise of population medicine, any attempt to expect rational nomenclature or clarity of thought has seemed increasingly futile.

Instead, we must be impressed by discussions of studies where “Patients were categorized by their mean SBP level over follow-up as very low normal (<120 mm Hg), low normal (120 to <130 mm Hg), high normal (130 to <140 mm Hg), high (140 to <150 mm Hg) and very high (>150 mm Hg). ”

I recently tested myself on a 24-h ambulatory blood pressure monitor.  My SBP varied from 90 to 142 mmHg.

No wonder I was feeling out of sorts.

More on HTE

I am very grateful to Dr. James Gaulte for pointing out the paper by Kravitz et al. on the vexing problem of heterogeneity of treatment effects (HTE).  The article indeed provides a very clear and comprehensive explanation of the issues, and it is apparent that the proposal by Kent et al. discussed in the last post was aimed at addressing some of the challenges described by Kravitz et al.  I agree with Dr. Gaulte that the article should be recommended reading for medical students (and we’re all medical students…), but I will present here additional comments about the specifics of the paper, as well as the general philosophy that the authors seem to espouse.  Interested readers are encouraged to review the paper first. Continue Reading »

I mentioned in the last post a recent proposal by Kent et al. that would improve clinical trial reporting and—in the authors’ words—lead to “actionable” clinical trial results.  The proposal addresses “heterogeneity of treatment effect (HTE)” and the relationship of that effect to the baseline risk of clinical trial enrollees.

HTE is the technical term used to reflect the fact that clinical trials (other than N-of-1 trials) are designed to reach a conclusion about an overall treatment effect, usually reported as relative or absolute risk reduction for the treated population when compared to the control group.  Clinical trial results tell nothing specific about an individual subject’s response to treatment.

Clearly, not everyone enrolled in the treatment arm of a given clinical trial benefits from (or is harmed by) the intervention.  Attempts to sort out who benefits most or least is usually done by dividing the trial population into subgroups, one characteristic at a time (eg. male vs female, old vs. young, hypertensive vs. normotensive, etc.), and by performing a statistical analysis on each subgroup.  Traditional subgroup analyses, however, are fraught with many well known limitations and are not practically useful to help identify those likely to benefit.

In this proposal, Continue Reading »

In August 2010, a group of eminent statisticians and clinical trial specialists (Drs. Kent, Rothwell, Ioannidis, Altman, and Hayward) published online a proposal to deal with a major short-coming of clinical trials, the so-called heterogeneity of treatment effect (HTE).  The authors offer a refinement in the way clinical trial results are analyzed and reported.

Perhaps sensing mounting dissatisfaction with the blunt tool of ‘evidence-based medicine,’ and perhaps in an attempt to dismiss any further rebuff, Kent et al. introduce their proposal by characterizing the critics of EBM as mere Luddites: Continue Reading »

1992

The USDA introduces its food guide pyramid

 

2005

The USDA modifies its food guide pyramid to more accurately reflect knowledge in nutrition science…. Continue Reading »

In the current issue of Clinical Cardiology, Nanette Wenger, Professor Emeritus of Cardiology at Emory University and regular fixture on the AHA and ACC guideline-writing committees, offers us a “guide to the guidelines” article that summarizes the pertinent recommendations in the 2011 Update to the AHA Guidelines for Prevention of Cardiovascular Disease in Women.

Now it may puzzle the lay person that a guideline would need its own guide Continue Reading »

A “reader’s comment” on an opinion piece by William C. Roberts in the American Journal of Cardiology, kindly published by the editor.  Roberts’ editorial focuses on the large body of evidence favoring the cholesterol hypothesis and laments what he considers the distracting effect of complementary hypotheses (eg. inflammation, “multifactorial” nature of atherosclerosis, etc.).  I offer a few points regarding the difficulties of dealing with strictly risk-based diagnoses that rely on arbitrary cut-off numbers and have no defining pathological correlates.  Unfortunately not free online, but I’m happy to provide reprints upon request.

…is that it reveals the opaque logic of public interest policies…

While the NIH is tightening its rules concerning what financial ties university researchers must disclose before getting public grants, the FDA may be loosening its own criteria for excluding potential advisors based on their industry connections.  It seems that as a consequence of the disclosure business, the only experts who would pass muster were no experts after all

Meanwhile a story in Cardiology News this month tags yet again Dr. Paul Ridker with the issue of conflict of interest.  It seems the inflammatologist felt obligated to elaborate once more on his “lengthy disclosure slide” before giving a lecture at a scientific meeting.  But Ridker is now taking a more offensive stance and argues Continue Reading »

Neoclassical economists such as Kenneth Arrow and Joseph Stiglitz tell us that the health care market is imperfect (or “Pareto inefficient”), meaning that the allocation of services is not optimal from the standpoint of social welfare.   They point to information asymmetry as an important cause of this imperfection: patients cannot distinguish on their own the physician from the charlatan, the surgeon from the butcher, the remedy from the snake oil, the hospital from the coop.  This may lead to moral hazard where the party with the most knowledge can provide inferior service with impunity.

To provide the necessary counterbalance for this “knowledge gap,” experts must be in charge of social institutions that tell patients where to go, who to see, how to be treated, and how much it should cost.  This has been a principal and virtually unchallenged argument underpinning health care legislation in the last 100 years.  In a famous paper he wrote on the subject in 1963, Arrow declared that “It is the general social consensus, clearly, that the laissez-faire solution for medicine is intolerable.”

But for those who wonder how firmly established the “general social consensus” or how intolerable the “laissez-faire solution” really are, a short booklet published in 1926 may prove instructive.  Continue Reading »

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