CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

August 4th, 2011

Yale Receives $2.5 Million from Medtronic for Independent Evaluation of rhBMP-2

Responding to intense criticism from the government, the press, and the academic community, Medtronic announced that it was giving $2.5 million to Yale researchers to oversee independent reviews of the safety and effectiveness of rhBMP-2 (Infuse). Criticism of the spinal growth product was the sole topic of the June issue of the Spine Journal. Yale’s Harlan Krumholz (editor-in-chief of CardioExchange) will assemble a steering committee of 12 to 15 advisers and will commission two independent clinical research organizations to conduct the analyses.

Furthermore, Medtronic said it would place rhBMP-2’s clinical trial data on the ClinicalTrials.Gov website, including data from trials completed before September 2007, when publication on the site became mandatory. In addition, Krumholz will spearhead a novel initiative that will provide researchers with access to the complete patient-level data from clinical trials of the drug.

You can read more about the announcement in the Wall Street Journal, the New York Times, and the Milwaukee Journal Sentinel.

 

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3 Responses to “Yale Receives $2.5 Million from Medtronic for Independent Evaluation of rhBMP-2”

  1. Harlan M. Krumholz, MD, SM says:
    August 6, 2011 at 10:58 am

    Seems funny to have an orthopedics story on this site – but this is about a new model for independent data evaluation and transparency. There is a big problem with the fact that data relevant to clinical decisions are commonly out of public view and there is no opportunity for independent analysis of the totality of evidence. This is an effort to test the feasibility of a new approach. Very relevant to cardiology!

  2. Saurav Chatterjee, MD says:
    August 6, 2011 at 11:32 pm

    Another resource for independent analysis of scientific data for public knowledge and interpretation.

    Competing interests pertaining specifically to this post, comment, or both:
    none.

  3. Saurav Chatterjee, MD says:
    August 6, 2011 at 11:33 pm

    http://effectivehealthcare.ahrq.gov/index.cfm/guides-for-patients-and-consumers/

    Competing interests pertaining specifically to this post, comment, or both:
    none.