The ethics of global trade in human flesh and bone

The Bulletin of the World Health Organization has an interesting article out in its November issue, entitled 'Human cells and tissues: the need for a global ethical framework.' The authors describe the technological advances and growing interest in the field of tissue transplantation, and predictably, the rise of private, profit-seeking companies engaged in the procurement, processing and sales of human tissues. The biggest tissue corporations with the most aggressive and questionable practices, from the looks of the article, appear to be American. Medical and public health uses are only one possibility among others. Private companies have an obvious bottom-line interest in trading tissues for expensive cosmetic purposes such as penis widening or lip enhancement, if not more mundane uses, such as those we normally associate with the flesh of horses or fish: paste, glue, powder and suspensions. As far as current practices of informed consent go, those who donate or trade tissue on behalf of family members may or may not know where the tissue ends up, with the unfortunate possibility that your skin from your Granny's forearm unknowingly ends up on some stranger's foreskin. In addition,

there is the usual ethical concern about flesh and bones from the poor being harvested for the bodies of the rich, similar to concerns about the organ trade, only here there are more body parts in stock: heart values, corneas, patellas, powdered bone, hip sockets, you name it.

The authors call for regulation of the global trade in human tissues through the development of a binding ethical framework from the World Health Organization. However, it is clear that their proposal would be labelled 'socialist' by corporate interests in the United States, seeing as the authors call for 'reasonable profits' to be channelled into improvements in quality, safety, accessibility and R&D, and they insist that the ethical framework should 'prohibit financial gain on the human body and its parts.' If formulated this way, the framework would join the list of international guidelines that the United States would not sign onto. Which might not be so bad, if the US was not already such a dominant player in the human flesh and bone market.

Resuscitating undue inducement

There seems to be such a thing as ethical habit and routine. It goes something like this: someone finds a certain aspect of moral life that perhaps went unnoticed before, and under the light of new attention, it blossoms into an explicit moral concern. One thinks: yes, that is something we ought to care (more) about. This rediscovered concern then gets put into public circulation, and it passes through many hands. It gets standard definitions. It gets slipped into regulations and policies, and repeated. A lot. At a certain point, it becomes something you feel you have to take into account, in certain contexts, even if you are not quite sure what it means anymore.

The notion of 'undue inducement' in international research seems to have gone this route. Researchers commonly induce participants to join their studies by offering them something attractive, something that makes the burdens of research worth their while: the image of themselves as benefitting society perhaps, a key chain, maybe a T-shirt, or cold hard cash. However, the argument goes, what looks like a minor inducement in Chicago may be a whopping big inducement in Kampala, given the socio-economic differences between the two cities. Would the participant in Kampala be free to choose to be in the study, or would he or she automatically agree to join, in order to get whatever was on offer? In that case, aren't the researchers taking unfair advantage of -- i.e. exploiting -- global inequalities to get the poor into their studies? Thus the concern about undue inducements was born. And the concept, which has its legitimate uses, has become a knee-jerk reaction in no time. I have personally experienced discussions in ethics committees where members, in all seriousness, debate about whether $5 in some far-flung land will unravel somebody's agency, and that giving $2 would be better. (I have also heard investigators in central African countries murmuring that 'ethical concerns' about undue inducement are just a con: it is all about saving research money.)

There have initiatives to counteract the fall of 'undue inducement' into ethical habit. Emanuel reasonably proposed that if a study does not pose any great risk, then size does not really matter: give any inducement you want, you won't be making (poor) people act against their better judgment, which is the underlying issue. A researcher who offers a Mercedes to a poor farmer in Zimbabwe if he would join a highly risky phase I tolerance study is unethically manipulative; a researcher who offers a Mercedes to a poor farmer in Zimbabwe to take a simple household survey is just stupid (or a kind of Robin Hood). What makes inducement 'undue' is whether it motivates people take dangerous risks. Being worried about inducements that actually benefit people seems a bit strange.

In this month's issue of Developing World Bioethics, Angela Ballantyne tries to discern what is living and what is dead in regard to undue inducement. The conclusion of the argument is that (a) there is little empirical support for claims that payments distort research participants' assessments of risk in research and (b) that if research sponsors in the developed world are worried about exploitation, they should offer more benefits to research participants (and their communities), not less. It deserves to be read in full, and read widely. Hopefully the paper will help the concept of undue inducement awake from its slumber.

Exploitation in drug safety trials

The New England Journal of Medicine, amazingly, has published a piece on research ethics that you can access online for free. And it is a worthwhile article too: in Exploiting a Research Underclass in Phase 1 Clinical Trials, Carl Elliot and Roberto Abadie describe the basic conditions of those who sign up for safety trials on new drugs, and the analogies with sweatshop labor is never far away. Elliot and Abadie argue that participants in such trials are exploited for three reasons: they are unlikely to gain access to the drugs that are being tested on them, there is little effective regulatory oversight of the clinical drug trial industry, and there is little to no compensation for research-related injuries. In short, it is a bad job, disproportionately done by the poor. Yes, like the positions on offer at the meat-packing plant, you do get money for it. Yes, it is a step up from unemployment and/or living in cardboard box. Yes, you could always argue that this is not exploitation, but merely a fair exchange: the research participant offers his or her body to test drug effects, and gets cash in return. There is no shortage of complex arguments in bioethics that end up defending the status quo in this area. But Elliot and Abadie will have none of it: if participants in phase 1 clinical trials are 'drug tasters' for the more affluent, exposed to the prospect of uncompensated injury and buried far beneath the radar of regulators, that is not a 'negotiating position' for a fair trade of services -- it is a rotten place to be.

The article is a reminder that there are populations in affluent industrial nations analogous to those in the developing world, and equally vulnerable to the corporate model of clinical trial research. It is not that we can do without drug safety trials involving human beings: we can't. But as long as phase 1 clinical trials round up the usual suspects as participants -- low income, without health insurance, immigrants (documented or not) -- the accusations of exploitation will not, and should not, go away.