Tuesday, October 18, 2011

More on the Medtronic-Yale "Model"

A while back I commended Medtronic for agreeing to fund an independent review of its controversial bone-regrowth product:

More information on the model that Dr. Krumholz at Yale has pioneered in this case was recently provided in JAMA (subscription required) and also can be seen at:

The model calls for the company to fund a study and to agree to turn over all their raw data, in a form that can be carefully reviewed for the quality of the research, to an independent organization. An steering committee (with public representation as well as experts) then oversees the creation of two separate academic teams to review and report on the data. Drs. Krumholz and Ross argue that the use of two separate teams both provides an accuracy check on each other's work and also further assures independence from the manufacturer.

We must of course await the results of the Medtronic study, but this model appears to be about the best that has yet emerged to restore integrity to the process of pharmaceutical research. An obvious question is how to address and assure integrity on an ongoing basis, and not merely once a scandal has arisen.

Krumholz HM, Ross JS. A model for dissemination and independent analysis of industry data. JAMA 306:1593-1594, Oct. 12, 2011.

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