Sepsis Drug: Anatomy Of The Way Big Pharm Manipulates

by SP

One of the most striking discoveries for me was the ways in which the ideals of “science” can be used for power and profit.

For example:  The Cochrane Collaboration will not include “scientific” studies funded by an industry that profits from the studies conclusions–such studies are designed to be overwhelmingly favorable.

In a lecture on hypertension management, a side-bar included on tricks used so that head-to-head randomized drug trials can be structured to produce the outcome desired.  Assume that a company has a patented NEW DRUG that promises to pay billions in revenues.  But the OLD DRUG is a cheap generic and actually works pretty well.   How can we convince doctors to prescribe NEW DRUG?  We need a “scientific sturdy” published in a “scientific journal” endoresed by a “panel of experts.”

1.  If NEW DRUG doesn’t last quite 24 hour, then, structure the protocol so that NEW DRUG is given at bedtime and blood pressure checks are done in the early morning, 12 hours later while effect is at its peak.

2.  If NEW DRUG tends to cause nausea, give on a full stomach.

3.  If OLD DRUG causes nausea, insist that it be given on an empty stomach (“to ensure consistent absorption”) and which maximizes the reported side-effects and study dropout rates.

4.  Give OLD DRUG at too high a dose (too give lots of side-effects) or too low a dose (so that efficacy is less.)

5.  If NEW DRUG’s side effects (like liver inflammation) show up in the 4-6 month time frame, run the study for 3 months only so you can report “no evidence of liver inflammation.”)

The New England Journal of Medicine, October 2006,;355(16)1640-1642 Published a wonderful analysis of the high jinks used by the Eli Lilly company to sell its new drug for sepsis, Xigris.  (Xigris turned out to be a really crappy drug with minimal effectiveness and is now off the market.)

Lilly hired a PR firm to guide its marketing.  Its approach:

A.  Marketing initiatives aimed at physicians.

B.  Spread the word that the drug was being rationed because of the drug’s cost and physicians were being “systematically forced” to decide who would live and who would die.  As a part of this effort, Lilly awarded a $1.8 million grant to form a task force to address the ethical issues raied by rationing in the ICU.

C.  A panel of “experts” (who just happened to all love Xigris) was convened to author guidelines for sepsis management prominently featuring Xigris which were published in Critical Care Medicine in 2004.   The managing editor of Critical Care Medicine who decided to publish the guidelines did not disclose that he was dual salaried at both the magazine and Eli Lilly.  In the accompanying editorial, CCM also did not mention that the ISDA explicitly refused to endorse the guidelines citing conflict of interest, bias, and lack of evidence for the drug’s effectiveness in the role it was recommended for.

D.  Lilly awarded grants for the development of performance assessment bundles which were later embraced by the Center for Medicaid and Medicare Services (CMS).   (A “bundle is a check list of quality measures.)  To ensure high quality care, physicians and hospitals who complete 100% of the CMS sepsis bundle checklist are reimbursed at a higher rate by Medicare.  This is called a “pay for performance” initiative to incentize high quality care (and allows the CMS to define exactly what constitutes such “high quality.”)   The sepsis bundles included use of Lilly’s drug Xigris.  Physicians and hospitals would then need to use this expensive and useless drug inorder to capture full reimbursement for their ICU sepsis patients.  (Xigris has now been dropped from the bundle.)

This is a story where a Big Pharm company captured a prestigious medical journal, an advisory board of experts, published quality guidelines, and the Medicare reimbursement system.

 

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