Sunday, November 13, 2011

Unhealthy ethical signals in India's clinical trial world

Maybe I have been in this business a bit too long: I am starting to regard journalistic exposes about exploitive global health research in developing countries with (at least initially) with a jaded eye. This week The Independent newspaper is featuring a piece entitled Without consent: how drug companies exploit Indian 'guinea pigs'. The title itself is pushing all sorts of buttons: big Pharma + bad ethics + the vulnerable poor. But, as it stands, the content of the article only partially lives up to its vivid title. For those who read the original, consider the following:
  • The authors accuse researchers in India of not obtaining proper informed consent; participants are said to be not fully understanding what they sign up for. But full understanding is ever achieved in clinical trials conducted anywhere, including those with well-off, literate participants. There is more than a decade of bioethics literature on this.
  • A number of times, the authors state that there have been a number of deaths in clinical trials in India, and then later state that there has been no confirmed link between the deaths and study participation (including the use of the investigational drug). Unless a link is empirically proven, this is guilt by innuendo.
  • A number of persons provide soundbites about the Indian regulations of clinical trials being violated 'at every level' and on a regular basis. But concrete examples demonstrating grievous and widespread abuse -- or even detail on precisely what guidelines are being violated -- are not really on offer.
On the other hand, the journalists may have unearthed a couple of unethical nuggets. The Gates Foundation permitted local health authorities to empower headmasters to consent for their teenage girl students, i.e. the students were vaccine research participants without their or their parent's knowledge. If true, this is wrong. Since early this year, there have been accusations of 'enrolling' former victims of the Bhopal disaster into clinical trials without their knowledge. Again, if true, this is wrong. The editor of the Indian Journal of Medical Ethics states that he encountered fellow research ethics committee members unfamiliar with the practice of reading the protocol of the study they were reviewing. The practice of researcher/doctors investigating serious (fatal) adverse events in their own studies -- rather than having an independent body do so -- is cause for alarm. The concern about drugs being tested on those least capable of affording them is not new, but is still worth pointing out. And there have been numerous articles about the ethics of the clinical trial culture in India over the past five years: all this accumulative 'noise in the system' may reflect some serious and systematic wrongdoing. But you need verified and detailed facts to make it all stick.

There is an ethical tension in journalism between the pursuit of truth and the marketing of a compelling story. The whole narrative of global health research as a form of neo-colonialism, where the bodies of the poor are used and abused to make medicines for the bodies of the rich ... this story may be too attractive to pass up. The dodgy relationship between big Pharma and developing countries should be continually investigated, but we also need journalists who rake up some real dirt.

Tuesday, November 08, 2011

A struggle over samples in Taiwan

Taiwan is experiencing an interesting confrontation about biorepositories. In some cases, it appears that, in the past, biospecimens were obtained and stored for research purposes without gaining consent for their use. In other cases, people consented to have their samples studied for some specific use, but researchers went on to use the samples to explore something else without informing them. Both practices run afoul of a rather conservative law has newly come into force, and that requires written informed consent of all biospecimens. In order to be compliant with the law, researchers must go back and locate the persons whose specimens were collected, and 'reconsent' them in order to use their samples for specific purposes. If they do not or cannot do so, they must destroy the specimens, and here we are talking about millions of specimens. Researchers are understandably concerned about the loss of a valuable scientific resource; advocacy groups are worried about exploitation and violations of human rights, given recent scandals of unconsented use of biological samples from indigenous populations in Taiwan.

Globally, issues about consent and biorepositories are still a work in progress: should there be consent for all specimens, including blood leftover from routine clinical examinations? When there is consent, should it specify certain limited uses of the specimen for research, or leave it unspecific and open to any kind of future research? The Taiwan example shows that the ethical and policy issues are best thought carefully through before biorepositories are created, and not when the horse has already left the stable.

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