A rebuke to the new god of primary prevention

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Note: Herb Fred and I published an editorial inspired by this blog post. You can find it here.
In the name of JUPITER, scribes everywhere1,2 now advocate adding CRESTOR to our daily bread to take away the consequences of sloth and gluttony.  But will this truly bring about a healthier life on earth?  Common objections to the proposed ritual point to the high price of the drug or invoke the dubious calculus of QALYs to generate cost-utility analyses.

Such socio-economic qualms are off the mark.  The emptiness of the Jovian promise is better exposed by examining the effects of a quotidian rosuvastatin from the perspective of the individual soul poised to receive the new host.

Hailed as a landmark study at the November 2008 meeting of the American Heart Association, the JUPITER trial showed that among a population of ostensibly normal middle-aged men, a subset with an elevated hs-CRP level could have fewer cardiovascular complications and fewer fatalities when treated with rosuvastatin, as compared with a similar group given a placebo pill.

The absolute risk reduction in cardiovascular “events” achieved with the administration of CRESTOR amounted to 1.2 percent, enough for a leading authority to hail the results as “paradigm shifting.”  With strong endorsements by the academic community, JUPITER is well positioned to promote the life-saving powers of statins in general, and of CRESTOR in particular, to populations of tens of millions.  As Mark Hlatsky put it in his editorial accompanying the publication of the paper in the New England Journal of Medicine, “Guidelines for primary prevention will surely be reassessed on the basis of the Jupiter results.”

But what the eager advocates of primary prevention too often fail to clarify is that in the realm of population medicine the subject being treated is in fact the population.  The intervention, which must be applied to everyone in the group, almost never benefits its individual recipient.  Every Richard Roe must take his daily dose of CRESTOR to spare one John Doe his heart attack.  That is the meaning of risk reduction in this context and not, as is frequently implied, the minimization of an individual person’s own risk of undesired outcomes.  Furthermore, in clinical trials of pharmaco-prevention, the overwhelming majority of the subjects (98.8 percent, in the case of JUPITER) go on to have or, more likely, not to have their “event,” irrespective of the substance, inert or active, they are made to ingest.

This, of course, renders the problem of adverse side effects particularly vexing since such complications invariably affect the unsuspecting enablers of the preventive maneuver who are oblivious that the costs they incur come almost certainly at no benefit to them.  JUPITER may claim that the 15 percent rate of major side effects associated with CRESTOR was equal to that recorded with the placebo, but it is probably of little consolation to Mr. Brown to know that the muscle pain he endures after starting the treatment is statistically unrelated to the drug, especially if he should realize that his suffering is, in all likelihood, for the benefit of his anonymous neighbor.  He might then also conclude that the daily ingestion of a substance devoid of nutritional, pleasurable, or spiritual value must necessarily bring the number needed to harm to 1 if one considers all possible physical, financial, and psychological costs, and not just those deemed worthy of tabulation by the trial investigators.

But such considerations seem to be lost on those whose careers are built on analyzing the evidence of “evidence-based medicine.”  In a recent issue of the Journal of the American College of Cardiology, for example, we can read that “The JUPITER study showed the benefits of statin therapy in individuals with normal-to-low LDL-C but an elevated marker of inflammation.”  It did not occur to the authors to qualify their statement as applying to “a few” or to “some” individuals.  Do we owe this implicit exaggeration to the funding of their study by Astra-Zeneca, the makers of Crestor?

I don’t think so.  The lofty esteem in which clinical trials are held reflects instead the state of affairs in a health care system whose built-in incentives must invariably lead to promoting medicine for the masses, even if it amounts to naught for the individuals that compose them.

Does that mean that JUPITER should be shunned altogether?  Of course not.  But since population medicine has little to do with individual medicine, and since the application of primary prevention requires no diagnostic skills to identify the subjects of interest, the advocated intervention need not be practiced in the doctor’s office.

I propose that JUPITER’s precepts be promoted in specialized “Centers of Excellence,” public health dispensaries where competent preventionists could directly indoctrinate the public to the many values of the modern wisdom, unfettered by the chaotic environment of a clinical practice.  And thus relieved from the burdens of a task at which they are so woefully inefficient, the primary care physicians could then return to their humble original calling, the care of a patient with a chief complaint.

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