Scientific imperialismBMJ 1997; 314 doi: http://dx.doi.org/10.1136/bmj.314.7084.840 (Published 22 March 1997) Cite this as: BMJ 1997;314:840
If they won't benefit from the findings, poor people in the developing world shouldn't be used in research
- Peter Wilmshurst, Consultant cardiologista
This week the BMJ carries a debate on whether drug companies conducting clinical trials on patients infected with HIV in South Africa should continue to supply the drugs after the trial ends to the subjects who show benefit and who cannot afford to buy them (p 887).1 Dr Peter King of Roche Products concedes that subjects in clinical trials in Britain may be treated differently from those in Africa and South America (p 890). This inequality of treatment prompts other questions. Should research be conducted in a country where the people are unlikely to benefit from the findings because most of the population is too poor to buy effective treatment? Are poor people in developing countries being exploited in research for the benefit of patients in the developed world where subject recruitment to a randomised trial would be difficult?
The marketing policies of multinational drug companies proves that they do not treat developed and developing countries equally. The Medical Lobby for Appropriate Marketing, an international lobby group based in Australia, repeatedly criticises companies which market in developing countries drugs that are denied a product licence in the developed world because of lack of efficacy or safety, or both.2 A multinational drug company continued to market a drug as “an over the counter product” and advertised it directly to the public in Africa and rural areas of the Philippines years after admitting to the Food and Drug Administration that the drug was unsafe and long after its withdrawal from sale even on a doctor's prescription in the developed world.2
If poor people in a developing country have adverse effects from an unsafe drug, they are unlikely to sue a multinational company. If they sue, litigation costs will be less than in the developed world. Either the poor of developing countries differ dramatically in their pharmacological handling of drugs or their lives are valued lower by risk analysts and policy makers, including doctors, in some drug companies.
These double standards extend to drug research. Drug companies have performed research on children and adults in countries such as Thailand and the Philippines that do not conform to the Declaration of Helsinki and could not be conducted in the developed world.3 Reasons quoted for conducting research in Africa rather than developed countries are lower costs, lower risk of litigation, less stringent ethical review, the availability of populations prepared to give unquestioning consent, anticipated underreporting of side effects because of lower consumer awareness, the desire for personal advancement by participants, and the desire to create new markets for drugs.4 5 These reasons apply in other developing countries. The commercial secrecy that surrounds early clinical research, and safety and dose ranging in phase I trials in paid normal volunteers (that is, poor volunteers), means that much preliminary research is unpublished, particularly when adverse effects are high and further development is abandoned. Therefore, the extent of exploitation of poor people cannot be gauged easily.
Drug companies are not alone. I am aware of a researcher from a British institution who has conducted invasive research abroad after the morality of similar research in his own institution was challenged. The chairman of the ethics committee at the institution has assured me that such research would no longer be permitted at their institution. Doctors from academic institutions in the developed world travel to developing countries to perform invasive research in specialties such as cardiology and oncology when subjects with the same disease exist in their own country.6 7 8
The requirement that visiting foreign researchers obtain ethics approval from their employing institution as well as from the institution they are visiting may be inadequate. The Indian government recently announced that it will no longer tolerate trials of new or unproved treatments by foreign organisations when they are carried out exclusively on Indian subjects. This announcement came after the Indian Council of Medical Research rejected an application for funding of fetal tissue transplantation in retinitis pigmentosa to be performed only on Indian patients by American and Indian doctors.9 There remain a large number of developing countries that will permit their citizens to be subjects in foreign trials.
In some experiments in developing countries it is difficult for patients to refuse to participate. In the developed world most patients can refuse to take part in randomised trials and opt for the best available proved treatment instead. In developing countries participation in a trial may be the only chance of receiving any treatment.
If investigators are unable to obtain ethical approval for a research project in an institution in their own country is it acceptable for them to perform the research in another country that has less stringent requirements? Do trials performed exclusively in developing countries, when the disease is also prevalent in the researchers' own country, confirm that researchers attach different values to some lives? Do trials which require participants to be foreign and poor differ ethically from experiments such as American radiation experiments in which the subjects were chosen because they were poor, black, uneducated, or sick?10
Rules are required to govern the way that international research may be performed ethically. Licencing authorities refuse to accept data from overseas research unless they are satisfied that it is scientifically sound. They must also insist that its ethical integrity is above reproach. Attempts to prevent unethical trials being conducted on subjects in developing countries will face opposition from those profiting from the research. Paradoxically, developing countries which are former colonies of an overseas power may resent a return to imposition of external controls.11 Such objections must be overcome by universal agreement. The scientific community has a responsibility to ensure that all scientific research is conducted ethically.