Sunday, August 14, 2005

Protecting "Research Integrity" By Keeping "Drug Secrets?"

The latest follow-up to the stories about "selling drug secrets" has just appeared in the Seattle Times. Washington state congressman, Rep. Jay Inslee (D), has called for congressional investigation. His rationale was, "we in the Northwest have a great stake in the integrity of the biomedical-research process." Referring to reports that physicians charged consulting fees to talk about ongoing drug trials to Wall Street analysts, he said "this alleged practice violates the ethical and legal walls that needs [sic] to exist between doctors with insider knowledge about clinical drug trials [italics added] and Wall Street. We have a responsibility to protect the integrity of medical and scientific research."
This mirrors what Sen. Charles Grassely (R-Iowa) wrote, "the potential violations of the law and scientific ethics challenge the fundamental integrity of how scientific research is performed and how we proect our financial markets from manipulation."
I agree that it may have been unseemly for the scientists mentioned in the original Seattle Times series to charge large consulting fees to talk about their current research. But, OK, folks, hold the phone here. Since when does protecting "research integrity" mean preventing researchers from talking about their work?
On the contrary, it clearly is unethical to suppress the results of research done on human subjects. Let me quote Dickersin and Rennie from their article calling for registration of all clinical trials. (Dickersin K, Rennie D. Registering clinical trials. JAMA 2003; 290: 516-523.)


Patients who agree to participate in clinical research do so with the understanding that they are contributing to medical knowledge. If the knowledge gained in a trial is never communicated to others, then their contribution is unrealized and the covenant between researcher and patient, indeed, between ethical review boards and patients, is broken.
A crucial question is whether the distortion of available evidence, aside from being unethical, actually harms patients. There is evidence that it does.
If it is unethical to suppress "knowledge gained in a trial," how can one ethically suppress even preliminary, informal conversation about a clinical trial (setting aside whether someone is paid for having such a conversation)?
Part of the issue here is the curious double-standard we now seem to have for research funded by commercial sponsors, as opposed to that funded by government agencies and charitable foundations (see previous post here). Somehow, it seems to have become acceptable to silence researchers who perform research on human subjects but with commercial funding. Amazingly, this censorship is now being done in the guise of "protecting research integrity."
Maybe Congress should be investigating how much the physicians charged the Wall Street analysts to talk about their research. But what they really should be investigating are the confidentiality agreements that commercial research sponsors foisted on universities, academic medical centers, and by extension, the researchers who work for them.
However, if we let suppressing discussion of commercially funded clinical research become acceptable under the guise of protecting "trade secrets," woe to us and our patients.

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