The Volokh Conspiracy - Bleg About Clinical Trials and Availability of Experimental Medications:

One argument against letting terminally ill patients use experimental drugs is that this will interfere with randomized clinical drug studies. I respond in some measure to this argument in my Medical Self-Defense piece (PDF page 18):

Terminally ill patients' right to use experimental drugs might also interfere with randomized clinical drug studies. It's possible that so many patients will insist on getting a not-fully-tested but promising drug that researchers will be unable to test the drug's effectiveness. If people can just buy the drug, they may do so rather than enroll in a study in which they might get a placebo instead of the drug. [Footnote: For examples of this argument, see] Brief for Appellee in the Abigail Alliance case; Ezekiel J. Emanuel, Drug Addiction, NEW REPUBLIC, July 3, 2006, at 9, 10--12.] ...

[But this] argument justifies limiting medical self-defense only when such limits are necessary for conducting clinical studies and no other alternatives will do. For instance, if the studies require 200 patients, and there are 10,000 who seek the experimental therapy, there is little reason to constrain the self-defense rights of all 10,000. Likewise, if the drug is now being studied only on people who suffer from a particular kind or stage of a disease, the drug should not be legally barred to those who fall outside those studies. If we must strip people of self-defense rights to save many others' lives in the future, we should impose this tragic constraint on as few people as possible and to as small an extent as possible.

[Footnote:] [Note also that] society would [rightly] balk at a law that generally forced people to go into clinical trials, and a law that forces people to go into clinical trials if they want access to the only possibly lifesaving drugs seems to be no less coercive.

But my friend Sally Satel, a resident scholar at the American Enterprise Institute, is looking for further responses, especially scientific ones focused on how clinical trials can effectively coexist with availability of the experimental drugs outside those trials. If any of you know of any studies or arguments that focus on this, please post the references in the comments. Many thanks!

	[Eugene Volokh, May 20, 2008 at 7:06pm] Trackbacks Bleg About Clinical Trials and Availability of Experimental Medications: One argument against letting terminally ill patients use experimental drugs is that this will interfere with randomized clinical drug studies. I respond in some measure to this argument in my Medical Self-Defense piece (PDF page 18): Terminally ill patients' right to use experimental drugs might also interfere with randomized clinical drug studies. It's possible that so many patients will insist on getting a not-fully-tested but promising drug that researchers will be unable to test the drug's effectiveness. If people can just buy the drug, they may do so rather than enroll in a study in which they might get a placebo instead of the drug. [Footnote: For examples of this argument, see] Brief for Appellee in the Abigail Alliance case; Ezekiel J. Emanuel, Drug Addiction, NEW REPUBLIC, July 3, 2006, at 9, 10--12.] ... [But this] argument justifies limiting medical self-defense only when such limits are necessary for conducting clinical studies and no other alternatives will do. For instance, if the studies require 200 patients, and there are 10,000 who seek the experimental therapy, there is little reason to constrain the self-defense rights of all 10,000. Likewise, if the drug is now being studied only on people who suffer from a particular kind or stage of a disease, the drug should not be legally barred to those who fall outside those studies. If we must strip people of self-defense rights to save many others' lives in the future, we should impose this tragic constraint on as few people as possible and to as small an extent as possible. [Footnote:] [Note also that] society would [rightly] balk at a law that generally forced people to go into clinical trials, and a law that forces people to go into clinical trials if they want access to the only possibly lifesaving drugs seems to be no less coercive. But my friend Sally Satel, a resident scholar at the American Enterprise Institute, is looking for further responses, especially scientific ones focused on how clinical trials can effectively coexist with availability of the experimental drugs outside those trials. If any of you know of any studies or arguments that focus on this, please post the references in the comments. Many thanks!