Monday, September 19, 2005

"Wall Street and Clinical Trials"

We have previously posted (here, here, here and here) about what came to be known as the "drug secrets" story. The Seattle Times revealed that physician-researchers had agreed to talk to Wall Street analysts and investors about clinical research, and were at times alleged to have revealed "drug secrets" from on-going studies. This provoked some indignation about whether these researchers were participating in insider trading.
Lost in much of the media coverage was the issue that the confidentiality agreements (usually between pharmaceutical company trial sponsors and medical schools and academic medical centers) were of questionable ethicality, given that most research subjects in clinical trials are lead to believe that they are participating to advance science, not the commercial interests of the trial's sponsor.
The indefatigable Robert Steinbrook has written a nice summary of all these issues, just published in the New England Journal of Medicine (Steinbrook R. Wall Street and clinical trials N Engl J Med 2005; 353: 1091-3). In particular he notes that the ethics of confidentiality clauses in contracts governing clinical trials are open to question,
These confidentiality agreements - which are meant to protect the business interests of drug companies - can also be the gag clauses that may prevent investigators from examining clinical trials data independently or submitting a manuscript for publication without first obtaining the consent of the sponsor.
I am very glad to see that this made it into the New England Journal, because the furor over revealing "drug secrets" and the evils of insider trading threatened not just to obscure the questionable nature of the confidentiality clauses that defined the "drug secrets," but to make these clauses appear legitimate.

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