Africa's scientific elite should speak out against the instigation of clinical trials that exploit their countries' vulnerable populations, says an editorial in the current issue of the online version of the African Journal of Neurological Sciences (http://ajns.mine.nu).
The article draws attention to the HIV and AIDS prevention trial being conducted in Cameroon, Ghana, Botswana, and Malawi by Family Health International (which is funded by the Gates Foundation) and Gilead Sciences. The trial is a randomised, placebo controlled trial of oral tenofovir, an established antiretroviral drug. Its efficacy in preventing the onset of AIDS is being assessed in HIV negative volunteers.
In Daala in the Cameroon the study has been carried out among sex workers. Women found to be already infected with HIV have not been treated. The trial has provoked controversy, but ethical concerns, the editorial states, have been “swept under the carpet.” The editorial contrasts this trial with the situation in Cambodia, where trials of tenofovir were stopped last year.
The involvement of African doctors in ethically dubious clinical research trials may, the editorial acknowledges, stem from lack of information, resources, expertise in clinical trials, and knowledge of research ethics.
This is a widely recognised problem and earlier this month the South African Research Ethics Training Initiative (SARETI) (http://shsph.up.ac.za/sareti.htm), which is supported by the United States, launched a new training programme offering fully funded fellowships to train African health professionals in bioethics and health research ethics.
Meanwhile an article in the New England Journal of Medicine (2005;352:1633-6), entitled “A new colonialism? Conducting trials in India,” explores the reasons behind the trend for drug companies to carry out clinical trials in poor countries.
Strict regulations, elaborate safety and compensation requirements, and small populations make recruitment of research participants in Western countries slow and expensive, the article says. It adds that India's attraction lies in its large population, English speaking doctors, cheap labour, and low infrastructure costs, which can cut the cost of clinical trials by up to 60%.
The article says that a minority of the trials conducted in poor countries are of drugs to treat diseases that are endemic in these countries and that most trials are of relatively expensive drugs offering only marginal benefit over existing ones.
Speaking informally at a meeting in BMA House, London, last week, the author of the paper, Dr Samiran Nundy, former editor of the Indian Journal of Medical Ethics , expressed misgivings about the effect of the Indian government's recent decision to relax the laws governing drug trials by foreign companies. He said the decision will increase the number of large scale drug trials conducted in India and put more patients at risk of exploitation.
“Too many researchers fail to declare conflicts of interest, and it is only too easy to buy up poor illiterate patients, who are unable to give truly informed consent, and recruit them to trials which are of little or no benefit to them and which fail to safeguard their interests,” he said.