NIH pulls clinical trials research out of India: but why?

Last month, the National Institutes of Health (NIH) postponed, delayed or scraped nearly 40 clinical trials in India, and it is still not completely clear why. What is clear that it has something to do with the local, Indian regulations governing the conduct of clinical trials, what is called the Drugs and Cosmetics Act. But what about the Act is making the NIH withdraw or suspend its activities is not receiving a clear answer, and creating a vacuum for speculation to enter. Industry experts are talking about an 'unstable regulatory environment' in India, which could mean anything: contradictory policies, bureaucratic cul-de-sacs, or just obstacles to (potential lucrative) drug development. Maybe the Act requires a regulatory structure that the Indian government is not prepared to adequately bankroll: it is always easier to create shiny new regulations than to establish institutions capable of effectively implementing them. Ethics committee chaos can grind research to a halt. Or maybe it has to do with provisions in the Act regarding compensation for research-related harm, that could drive up research costs, precisely in a country that has attracted biomedical research due to its low overhead, ease of recruitment, drug-naive populations, and so on.

India has been a hotbed of concern about global health research ethics for some time. Typically the concerns are about conducting responsible research there among the vulnerable, impoverished sick. But this time it is about the ethics of pulling up stakes and halting research in such circumstances, including (one supposes) research with current or potential benefits for patients. To tap down adverse speculation, you need transparency. Without that, there is nothing to do but watch the rumors freely breed and spread.

Ethics of medical photography with children in developing countries

Almost back from the summer hiatus, and now staying somewhere (Montpellier) where there is internet to be had. Note: when in France, and you ask for an internet cafe, you will invariably sent to some dreary dungeon that does photocopies, faxes and laminates family photos, and where there is dusty workstation in the back from the year je-ne-sais-quand. You have to ask for an actual coffee-dispensing cafe which -- reluctantly giving in to this century -- is equipped wifi (pronounced WEE-FEE). To this end, I found a sweet little cafe near the Place de la Comedie, equipped with (gasp) air-con. Normally this convenience is a luxury, but after ten days straight of temperatures of 34C, it may be the only thing stopping me from becoming a poulet roti.

Fumbling through my inbox I noticed that BMC Medical Ethics published an article (open access) on the ethics of taking medicine-related photographs of children. Often you see photos of children in presentations at universities, particularly among faculty and students who have gone global, where for 'global' read: low-income countries with high disease burdens. Sometimes the photos are there for obviously medical purposes, e.g. to visually illustrate a morbidity, a symptom. But sometimes you wonder: some photos are just scene setting (and look a lot like tourist snapshots) and others look like decorative features of powerpoint slides, aiming to give a literally human face to some far flung region. And do those photographed know what happens to their images? Do they know that, in our new media landscape, it might be impossible to precisely track where their images may go and what may be done to them? When parents in low-income countries freely allow researchers to take pictures of their children, should that consent be taken au serieux?

The article is partly based on qualitative research, though only samples the views of a small number of researchers and medical practitioners in England who work in the developed world. It would be interesting to get opinions about the ethics of medical photography and push forward a robust debate on  best ethical practices worldwide.