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04/07/2008

The global scramble for ready-to-consent populations

By Stuart Rennie

Last year, Jill Fisher at Arizona State University wrote a very interesting article on the concept of ‘ready-to-recruit’ populations for biomedical research for the journal Qualitative Inquiry (subscription required, goddammit). The term ‘ready-to-recruit’ is a concept used in the pharmaceutical industry to describe populations that do not really have an attractive alternative to joining a clinical trial, because they live in circumstances of poverty, where there are few doctors, where local medical care is sub-standard and so on. Fisher prefers the more ethically charged term ‘ready to consent’ to describe these populations, because they are not just easy to access, but gaining their consent is a piece of cake. Practically all you need to do is ask. Socio-economic forces do the rest. Which is to say: the whole consent process is a bit of a farce.


I was reminded of this when reading that India has surpassed China as Asia’s most popular venue for clinical trials conducted by pharmaceutical companies. India currently has some 139 clinical trials going on (compared to China’s 98), worth something upward of $300 million, and by 2010 this market is apparently going to be worth 1.5-2 billion dollars. India is attractive for pharmaceutical trials, according to the India Times, because of its diverse genetic pool, large patient numbers, drug naive population, competent medical professionals, high quality hospitals where trials can be undertaken at something like 20%-60% lower costs than in developed countries. What the India Times piece does not mention are some of the gaping regulatory holes in the Indian drug R&D world (though this one does), questions about the effects of the pharmaceutical industry (such as possible ‘internal migration’ of the best clinicians) on Indian primary health care services, or about the benefits (or lack of them) likely to accrue to local communities.

Should Africa steer clear or join the bandwagon? God knows there are enough ready-to-consent communities on the subcontinent. And it’s cheap. Diverse genetic pool? Of course, it is the cradle of mankind. High patient numbers? Yes, if by ‘patient’ you mean anyone with lousy health, instead of someone who has been seen by a doctor. Drug naive? Hardly a problem. Now those other criteria, about the high quality medical institutions and health professionals, are a bit harder to meet. The health infrastructure in many places is in rough shape, and the physicians and nurses keep taking off to more attractive places like United States, Canada or … India. Not to fear, the United Nations Economic Commission for Africa and the African Union recently organized a conference to promote increased clinical trial research in Africa, with a couple big pharmaceutical representatives in attendance. What was agreed on or planned is all a bit vague, though there seems to be a big stress on research ethics guidelines accompanying the promotion of clinical trials in Africa. Reams of guidelines. There is even a suggestion that the guidelines should have an ‘African’ character, in order for the latter to ‘feel a sense of ownership’.

But scratch under the ethics, and you can read the economics. As Francis Crawley, executive director of Good Clinical Practice (GCP) Alliance puts it: “We need to have the pharmaceutical industry there in a really committed way because Africawith the somewhat exception [sic] of South Africareally lacks an industry presence and it needs that. We have seen the difference that this makes in places like India, Singapore, Korea, Thailand and China. And Africa needs to be there too.” Do the ethics and the economics align? Is the pharmaceutical industry good for you? Just say yes. Sign here.

Stuart Rennie is a Research Assistant Professor in bioethics at UNC-Chapel Hill. He’s project manager for the NIH/Fogarty bioethics grant and ethics consultant for UNC-Gap projects in the Democratic Republic of Congo and Madagascar.

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