… UD needs to discuss DSMBs. (The link takes you to an Emory University page informing medical researchers there about Data and Safety Monitoring Boards.)
UD thought she’d covered most of the ways in which some pharmaceutical companies interfere with, compromise, and control university clinical trials and their results. Turns out there’s more. There’s the corruption of DSMBs.
These are supposed to be independent boards (though they’re appointed by the person doing the trial, which already seems odd) which oversee trials as they’re going on, so as to detect problems that might emerge in the midst of a study. The idea is to protect research subjects and, if necessary, call a halt to things if they’re beginning to look dicey.
An editorial in this month’s New England Journal of Medicine (I got the link via the indispensable Alliance for Human Research Protection) notes that the independence of DSMBs is routinely compromised by drug manufacturers who get advance information about a trial going poorly, let’s say, and decide to call it off — to “unblind” the data — before any shit hits the fan. In more than one documented case, write the NEJM editors:
… a commercial entity decided to unblind aspects of trial data rather than let the DSMBs exercise their important and appropriate responsibilities both to the trial participants and to the wider community.
… These and other episodes have undermined public confidence in the ability of trials to operate independently of the sponsor. The current way that DSMBs are constituted and report has resulted in a loss of faith. First, many commercial entities, as illustrated by the above-mentioned examples, have not given the DSMB the independence such a panel requires. Second, outside parties view the DSMB as serving the trial sponsor rather than the selfless volunteers who put themselves at risk to advance our medical knowledge…