A FEW years ago Harvard geneticists went to China with what seemed like the best of scientific intentions. They were there to set up studies to track down the genes and environmental factors crucial to diseases such as asthma and obesity. Unfortunately, it went horribly wrong, as an official US investigation published last month revealed in grim detail.
Some studies were conducted without any prior review by an ethics committee. Many of the people who gave blood samples or had their lungs X-rayed were too poor to use Western medicine, and so were unlikely to benefit in the long run from any drugs developed. Some consent forms failed to tell families that participation was voluntary. Others did not list the risks and discomfort involved. There was no offer of medical treatment in return for participating in the research. In short, it was a textbook case of Western scientists behaving badly in a developing country.
It is unlikely to be the last. Just as it鈥檚 cheaper to produce running shoes in Asia or Africa, so it is with biomedical research. Costs are low, regulations lax and there鈥檚 no shortage of diseases or patients. The result is a boom in international research that urgently needs better policing.
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This week Britain鈥檚 Nuffield Council on Bioethics published recommendations that it hopes will form the basis of internationally accepted rules. Much of what it says is well argued and thoughtful. The report reminds scientists that they have a duty to alleviate suffering, respect people and be sensitive to cultural differences. It also rightly insists that Western scientists always get their overseas research cleared by independent ethics committees in their own countries first. At present fewer than a quarter of US companies bother to do this.
Overall, however, the Nuffield鈥檚 detailed recommendations do not go far enough. As well as getting studies cleared at home, the report says scientists must also get approval from 鈥減roperly functioning and independent鈥� ethics committees in the host country, and that countries lacking such committees should be no-go areas. But with virtually all countries claiming to have ethics committees, who gets to decide which ones are up to scratch?
Another recommendation is that research should only be permitted if it brings long-term benefits to the host country. But what qualifies as a benefit? The Nuffield panel says this doesn鈥檛 have to mean directly improving people鈥檚 health: better research infrastructure and expertise can also qualify. And so they might. Yet this creates a loophole for companies that want to use developing countries as medical sweatshops for testing medicines designed solely for the lucrative markets of the industrialised world. Researchers often vanish from the scene without offering even the enrolled patients further access to medicines. While the report says 鈥渞esearchers should endeavour to secure鈥� such 鈥減ost-trial access鈥� before they begin, it falls short of saying this must happen.
But it is on the hot-button issue of placebos and informed consent that the report misses its biggest opportunity. In clinical trials, scientists need to compare their new therapies with older ones or placebos. The Nuffield report appears to retreat from the idea that control groups should get the best available treatment. Instead, it says they need only be given either a 鈥渦niversal standard of care鈥� for the disease being studied or a 鈥渘ational standard of care鈥�, and in exceptional cases, something even lower than this. While most ethicists agree that less effective treatments鈥攅ven placebos鈥攃an be justified for mild conditions, watering down the rules risks creating loopholes that powerful companies and institutions will inevitably seek to exploit.
A few years ago, a storm was raised after pregnant women with HIV in Africa and Asia were given placebos in a trial that aimed to test the effectiveness of AZT treatments in preventing transmission of the virus to babies. Placebos would never have been allowed in the US or Europe, because certain doses of AZT had already been shown to work. Up to 1000 babies born with HIV may have been spared had their mothers been given the drug instead of a placebo.
Perhaps all these women knew there was a risk they would get a dummy pill and fully understood they were being asked to risk their babies for the benefit of others. But it鈥檚 also quite possible that they were plain confused. Consent forms have become lengthy, legalistic documents designed to protect companies and institutes from litigation. 杏吧原创s should have to assess their subjects鈥� true level of understanding before a trial begins, and it鈥檚 a pity the report does not make this one of its key recommendations.
