The regulation of desperation

We think sometimes that, when we are terribly sick, medical science must have progressed to a point where there is an effective treatment. That belief (or faith) sometimes turns to be true, and sometimes not. In the latter case, there is a terrible feeling of fear and powerlessness on the part of the patient, family members and friends. Science turns out not offer salvation. So if there is a chance that some new experimental treatment, being tested or offered somewhere, could provide some benefit, this can be a wildly attractive prospect. And the idea that access to a 'last chance therapy' could be prohibited by regulations can seem like unjustified paternalism. It is a bit like the scene in Monty Python's Life of Brian, where a man is about to be stoned to death for saying the holy name 'Jehovah'. As he is lined up to be stoned, he yells 'Jehovah! Jehovah! Jehovah!', and the priest presiding over the stoning exclaims: "You are only making it worse for yourself!" And the condemned man understandably replies: "But how can I make it worse for myself?" Those seeking last chance therapies might ask the same thing: even if the therapy is risky, even if it may not help, how can I make it worse for myself?

A couple of years ago, some of the people working at the National Institutes of Health clinical bioethics program wrote about different periods and paradigms in clinical research and research ethics. According to Emanuel et. al. (2007), there have been four periods and paradigms: researcher paternalism (1940's to early 1970's), regulatory protectionism (early 1970's to mid-1980's), participant access (mid-1980's to mid-1990's) and community partnership (mid-1990's onward). The AIDS crisis in the United States drove the paradigm of participant access, with patient rights groups increasingly demanding that people with terminal illnesses (and not just AIDS) should have the choice to join experimental trials. As Emanuel et. al. write, the desperate search for treatment tends to blur the distinction between experiment and therapy. A clinic offering a new intervention may be part of a clinical trial or it may be simply be offering 'experimental treatment'. Either might help the patient, either might push our medical knowledge further: but both could be dead-ends in any particular case.

Those trying to regulate this new paradigm have their work cut out for them. Not unrelated to the fact that much clinical research is being outsourced around the world, and the rise of medical tourism, people (who can pay for it) are seeking potential therapeutic benefits from cutting edge stem-cell research or clinical practice taking place in countries like China. This research may well not be taking place in the home country of the beneficiary, due to cost or regulatory/legal prohibitions. There is the possibility that such trials or practices may not be in the best ethical shape, for instance involving unnecessary risks and promising to desperate patients more than they can keep. The underlying ethical principle behind the patient access paradigm -- patient autonomy -- is unlikely to capture all of the ethical concerns associated with globalizing experimental therapy.