Wednesday, December 29, 2004

House of coxibs: a fragile house of cards

From Arthritis Medicines and Cardiovascular Events—"House of Coxibs" by Eric Topol, M.D., JAMA. 2005;293:(DOI 10.1001/jama.293.3.366).

... Third, there are major concerns about how an entire drug class has gone awry with respect to unleashing significant cardiovascular hazard. A "house of cards" is defined as a flimsy situation that is in danger of collapsing or failing. From the outset, the coxib class of medicines seemed destined for potential collapse. These drugs were mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection, and safety. Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative "real world" population, the unbridled promotion exacerbated the public health problem. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication. Furthermore, one has to question the wisdom of allowing direct-to-consumer advertising for lifestyle medications that have no capability of preserving life or preventing major events such as MI or stroke. Here the paradox of actually promoting these events is all the more difficult to accept.

Difficult to accept, indeed. I would add that the inability I experienced at one pharma company to secure a few million dollars/year for acquisition of standard informatics tools for R&D, despite rigorous justification, concurrent with spending in the hundreds of millions of dollars/year for direct-to-consumer (DTC) advertising, is an indictment of the business model whereby the MBA's run the science.

As quoted at Matthew Holt's Health Care Blog, one unnamed "Industry Veteran" relates this solution for Big Pharma's current major problems:

Eject from business departments the ignoramus, Ivy League MBAs who know nothing about the industry but feel they can comprehend the universe with spreadsheets.

On a related note, those MBA's and executives, in their dogged pursuit of "efficiency" (a.k.a. increased margins), do not have the expertise and ability to differentiate a haircut from a scalping. I am reminded of the healthcare research IT VP with only a bachelor's in math and master's in computer science from a second-rate school (and no training or credentials in biomedicine) who demanded cuts in expenditures for specialized biomedical knowledge databases serving R&D scientists as an "efficiency measure." The metric of "cost per user per database" was demanded for decisions about cuts. The "most expensive" ones would go.

However, considering there existed all of the following: 1) individual users of specific databases, 2) groups and teams of users that varied in composition and database selection over time depending on R&D direction, and 3) entirely-automated use by computer applications of the databases to drive user-customizable alerts for individuals, groups and teams in ever-varying and complex patterns, the simplistic metrics requested were, quite frankly, meaningless, damaging and actually deranged from the Medical Informatics perspective.

Cleverness without wisdom, a hallmark of too many non-healthcare "healthcare business specialists" and the "House of Cards" they engineer, kills companies ... and patients.

-- SS

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