Sunday, April 06, 2008

The global scramble for ready-to-consent populations

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 Africa—with the somewhat exception [sic] of South Africa—really 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.

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Blogger Francis Masiye said...

I would like to agree with both Jill and Stuart that most pharmaceutical companies consider Africa as a "haven for ready-to recruit populations or ready-to-consent communities" . Indeed pharmaceutical companies are scrambling for sub-Saharan African populations to participate in clinical trials. However, I disagree with the assertion that poverty is behind people's willingness to participate in clinical trials. In other words, I do not think that people are motivated by monetary incentives when they accept to participate in clinical trials. And I do not think people consent without comprehending and reflecting on the disclosed information. Instead I think people accept to join clinical trials in order to access better medical care, which is usually given to participants and their families during their participation in clinical trials. And my opinion is that if people join clinical trials on this ground, then it is ethical. For example, in our own context (Malawian context), I feel that it is reasonable for one to make a decision to save his/her own life by joining a clinical trial as failure to take the offer to participate in such a clinical research is tantamount to one harming himself/herself and yet African morality does not allow a person to harm himself/herself. In other words, I feel it is ethical and perhaps economical for people to choose to participate in clinical research in pursuit of better medical treatment (ancillary medical care).

The issue of ethics (ready-to consent) becomes important only if one does not consider the risks of participation and ends up harming herself/himself in the process. However, I am convinced that clinical trial participants make their decisions autonomously, fully aware of the benefits and risks, but out of desperacy and it is clear that the main reason is that of promoting their health rather than the pursuit of monetary benefits (economics). In a scenario where the national health delivery system is overburdened and fails to adequately respond to individual’s health needs, individuals are forced to take the best available option –in this case, joining clinical research. Hence, I view this decision as a very rational one as it is made after considering the available options as well as the due costs of deciding not to join the clinical trial on offer.
Having said that, I think it is very economical for pharmaceutical companies to conduct clinical trials in developing countries. It is cheaper for them to conduct trials in developing countries (resource poor countries) than in developed countries (resource rich countries). However, they must ensure that they conduct their clinical trials with the same ethical and scientific standards as in developed countries. This will ensure that they do not exploit clinical trial participants in developing countries.

9:55 AM  
Blogger Stuart Rennie, Editor said...

Many thanks for your comments. I fully agree with you that participants do not enter these trials for monetary gain (there usually is not much gain available) but more likely for better medical care. But that is may be due to the person's inability to pay for a good local standard of care, so poverty (either individual or social) may not be too far away. In addition, the idea of entering clinical trials for medical benefits may be problematic, for different reasons. If the trial is a randomized controlled trial with a placebo arm, the participant may not receive the intervention. Even if the participant gets the intervention, it may not provide a benefit. Even if the person gets the intervention, with some benefit, it may not provide a significant benefit. And what is being tested may not correspond with the participant's most pressing health needs. Perhaps in the case when the intervention does turn out to be very beneficial, it is rational to join the study, but that is the rationality of a gambler. Whatever benefits there might be must also be weighed against the risks. I do agree with you that the participants probably have a pretty good understanding of the trials enter, i.e. that information is not the biggest issue. But it is worrying if they do so in the desperate hope of direct medical benefits for themselves. Research, in the end, is experimental.

4:01 PM  

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