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January 18, 2019

Reducing the Expert Halo Effect on Pharmacy and Therapeutics Committees

Author Affiliations
  • 1Department of Pediatrics, Oregon Health & Science University, Portland
  • 2Department of Medicine, Oregon Health & Science University, Portland
JAMA. 2019;321(5):453-454. doi:10.1001/jama.2018.20789

At a recent pharmacy and therapeutics committee meeting, a highly respected specialist presented a novel hemostatic drug for addition to the formulary. The drug had been shown in a phase 2 trial to significantly reduce anti–factor-Xa activity in healthy volunteers, and a subsequent uncontrolled, open-label trial showed evidence of hemostasis.1,2 The cost of the drug was approximately $25 000 to $50 000 per treatment course. Additionally, due to a potential increase in thrombotic risk, a boxed warning was required by the US Food and Drug Administration (FDA). The specialist acknowledged the shortcomings of the trials and potential risks but advocated for the addition of the drug to the formulary based on the argument that few other options existed. Discussions about the merits of the drug ensued, and after 15 minutes, the committee was asked to vote.

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    1 Comment for this article
    Advice For The Wrong Problem
    Tom Chau, MD, MBA | Providence St Vincent Medical Center
    I am surprised by the publication of Austin and Halvorson's Viewpoint, "Reducing the Expert Halo Effect on Pharmacy and Therapeutics Committees." It seethed with the essence of sour grapes and missed the mark on the cause of their defeat at their pharmacy and therapeutics committee. While the authors contend they were shot down by the halo of experts, I would argue they lost to the American sentiment for heroism and would have lost if the medication had been presented by nonmedical family members of patients.

    As background, the medication in question is a targeted reversal agent for Factor
    Xa anticoagulants, which have become multibillion dollar drug used by millions of patients. The widespread use of these anticoagulants has, of course, resulted in lots of hemorrhages, which prior to the development of the medication in question, did not have a specific reversal agent. Let us now examine the charges the authors level against the medication: 1. it causes thrombosis and 2. there are no placebo controlled randomized trials of its effectiveness in bleeding patients. Regarding the first point, of course a medication which reverses anticoagulation will cause clots; that is the whole point. Regarding the second point, the FDA is wise in its approval process because it knew an RCT would be next to impossible to conduct. Imagine you are recruiting patients for such a trial in the emergency department. You approach the family of a grandmother who's bleeding out and ask "Do you want to sign up for a trial where grandma could get placebo?"

    We as a nation have it in our psyche to do whatever it takes to help in the face of disaster. Just as we secretly root for those who set out in rowboats in the middle of hurricanes to rescue their neighbors, we find it difficult to stand by and do nothing when our patients are bleeding out from our doing. Pharmaceutical companies recognize this weakness and exploit it to charge exorbitant prices. In truth, the authors' real enemy on the committee was this American sentiment and their real objection is the price of the medication. Only when we face the demon in the mirror can we begin to make progress.