Thursday, October 31, 2013

Tales from the organ trade: trick or treat?

Human organs for transplantation are a desperately needed scarce resource worldwide. When any resource is scarce and desperately needed by human beings, like our thirst for oil, all sorts of things can happen. There is great potential for corruption, manipulation, irrationality, and violence, but also for some party to exact some gain, some advantage, some profit. The trade in human body parts -- bits of ourselves conventionally considered too precious to have a price -- is an bioethical conundrum custom-built for Halloween.

This time around, I did not have to reach far to find something about the global organ trade. I could look in my inbox, where lo and behold I found a message from one of HBO's publicists. HBO is screening a documentary on the global organ trade next week narrated by -- appropriately enough -- the Canadian film director David Cronenberg. As the press release goes:

This 83-minute documentary explores the legal, moral and ethical issues involved in the complex life-and-death drama or organ trafficking. More than a simple black-and-white story of exploitation, TALES FROM THE ORGAN TRADE is a nuanced and complex film that challenges moral and ethical beliefs. It delves into a world where “villains” often save lives and the medical establishment, helpless to its own rules and bureaucracy, too often watches people die. In the best scenario, victims walk away content and safe, and buyers of organs (the recipients) return home with a new lease on life. From Manila to Istanbul, Colorado to Kosovo, Toronto to Tel Aviv, this film spotlights a compelling cast whom fate has brought together, where the gift of life meets the shadow of death.

Tales of the Organ Trade airs Monday, November 4th on HBO as part of its HBO Documentary Fall Films Series at 9pm EST. And no, HBO is not giving me a red cent for plugging their business. It just looks like something that might be worth watching.

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Monday, October 21, 2013

Declaration of Helsinki 10.0

A revised, 50-year anniversary edition of the Declaration of Helsinki was released this week. The Declaration is often described -- especially in your standard ethics training sessions -- as the most influential research ethics guidance document on our planet. Its reputation may even have gone to its own head, considering that it states (Paragraph 10) that "No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration." More authoritative than international requirements? That sounds downright awesome. Or maybe a bit too awesome. It was not too long ago that the FDA abandoned the Declaration of Helsinki as the ethical standard for evaluating data from clinical trials conducted abroad. Which suggests you don't have ultimate authority just by stating that you do.

The Declaration has been revised 10 times over the last 50 years, and more frequently as time has gone on. The latest revision is more like a tweaking, without too much in the way of novelty and excitement. The document's structure has been spruced up, making it less burdensome to read. The emphasis on compensation for research-related harm is relatively new and welcome, though the Declaration provides little concrete guidance on what fair compensation would look like. The Declaration reiterates that, in order to fulfill the most basic ethical requirement of research, research results must be disseminated, including negative results. The section about the use of placebos in clinical trials, which usually is good for a firestorm of dispute, seems to be unchanged this time around.

The Declaration of Helsinki has increasingly become a contested document. Not everyone is happy with the Declaration in its present form. The Journal of the American Medical Association has published, with open access, both the new Declaration and a critical commentary, here and here. Despite its aspiration to super-international authority, perhaps the real power of the Declaration lies in the translation of its precepts into more concrete national regulations, particularly when they are backed by the force of law. That means, of course, if there are problems with the Declaration itself, they will be reproduced around the world. That is why this modest, 4 page document has to be kept under close scrutiny.