Patient or Research Subject?

Off-label prescription, a practice in which a drug is prescribed and used in a manner other than that which is approved by the FDA, may account for as much as 60% of all drug prescriptions written in the United States. Whether this is a good thing is in and of itself debatable, but the practice raises a different ethical question as well: is it human experimentation, and, if so, should it be covered in documents like the Declaration of Helsinki and the Belmont Report? Should there be guidelines dictating when and how prescription drugs can be used off-label?

In some ways, off-label drug prescriptions seem to be a clear case of human experimentation. The doctor prescribing the drug has no solid evidence, or at least no evidence vetted by the FDA, that the drug is safe or effective for treating the patient. Even if a drug works safely to treat one condition, it may not be a good choice for another condition for which it is not an approved treatment. Some doctors prescribe drugs off-label with purely therapeutic intentions; they feel certain that the drug will work for their patient's problem, even though it was not designed to treat it. However, many doctors also want to find out if this intervention will help patients who are in a similar state, and it is these doctors who make off-label drug prescription a borderline case of human experimentation.

I think that defining off-label drug prescription as human experimentation not only misses the therapeutic aspect of the practice, it also legitimizes it as a method of experimentation. This may increase the rate at which doctors use their patients to test new treatments. Although this would create a pool of normal patients that could be used to test drugs, it would also create bad experiments: experiments using one patient at a time, and probably with no placebo case. It would also wreak havoc on the physician-patient relationship, as physicians would start to see their patients as potential research subjects.

For these reasons, I think that it would be a bad idea to treat this issue as human experimentation, despite the undeniable similarities between off-label prescription and what is generally thought of as human experimentation. What is needed is to decrease those similarities, not legitimize them.

http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11/