A number of international documents set ethical standards for drug trials, including the World Medical Association’s Declaration of Helsinki and the WHO’s Good Clinical Practice Guidelines. They stipulate that medical experiments with human subjects must uphold the highest respect for the rights and welfare of study participants.
Some drug companies say they do meet ethical standards. For instance, the U.S.-based Pfizer company has its own guidelines. They include allowing independent ethics institutions to validate the process before the trials begin and obtaining informed consent from trial subjects. They also call for limiting risks as much as possible and guaranteeing healthcare for participants who emerge with complications.
But the international guidelines and strong ethical frameworks are not mandatory.
Critics point to controversies that they say involved wealthy Western drug companies and poorly informed subjects. An official in Cameroon’s Ministry of Health who wished to remain anonymous said researchers testing new drugs in the country have sidestepped both national and international guidelines.
One case in 2005, an antiviral AIDS medication, made headlines around the world, and other clinical trials have led to abuses as well.
In that case, ethics violations in Cameroon put an end to clinical trials for tenofovir, an antiviral AIDS medication that was being developed by the U.S. pharmaceutical company Gilead Sciences. Among other complaints, French-speaking trial subjects were given questionnaires written in English. Critics say the company was using Cameroonians as guinea pigs for profit-making.
Reasons for Testing
Until about 1995, most clinical trials were conducted in Europe, the United States and Japan. Today experts estimate that more than 100,000 trials are conducted in different countries every year, with 10 percent of them in the developing world and one percent in Africa.
There are several reasons why drug companies are relocating clinical trials.
Some researchers note that to obtain valid and timely results from HIV trials, the companies must test people in areas with high rates of infection. They also say the genetic variability of HIV requires that candidate vaccines be tested in different areas of the world where different strains are present.
Dr. Mona Khanna of the University of Illinois College of Medicine, says for the drug companies, there’s also a large number of willing participants.
"I think the reason so many clinical trials are being done in Africa is because they have a lot of people," said Khanna. That’s the first thing. So you can find many men, women and children, whatever you need, very quickly. They also have low cost. In other words, for companies to conduct trials in the US there’s a lot of cost associated with it, whereas in Africa, you go and set up a clinic; it’s much less cost."
Sonia Shah, author of the book Body Hunters, says many subjects are not aware of the procedure, or their rights, thus reducing the risk of expensive litigation.
Critics say many subjects also do not understand the rules of the trials: literacy rates are low, written agreements are misunderstood and many come from cultures that accept authority without question. In some cases, subjects are pressured into the trials by local committees, some which may receive pay from the companies. They may also feel they can not quit a clinical trial because they or their children would lose out on good health care or treatment.
Calls for change
One of those advocating change is Professor Ames Dhai, director of the Steve Biko Center for Bioethics in Johannesburg and a lecturer at Witswatersrand University. She says Africa must stop blaming the West and assume responsibility for monitoring the trials.
"I think we need to blame ourselves if nothing is changing," said Dhai, "and I think it’s time we stopped blaming the West and started looking at ourselves and how we can approach the issue. We all spend a lot of time looking at informed consent, regulatory and administrative issues. But we don’t spend enough time looking at justice in terms of what’s going to happen after the trials – have our populations been exploited in the process of research?"
Dhai mentions poor governance, corruption, conflicts, illiteracy and lack of knowledge about drugs as factors contributing to the inability of many African countries to review the proposals and monitor the trials.
Dr. Mona Khanna of the University of Illinois says African countries must set up effective ethics committees and establish sanctions.
"If there are no penalties associated with enforcement," she said, "people will do whatever they want to do. If the local authorities or regulatory bodies find companies that are doing ABC or D, you have to fine them or tell them [they] can never come back."
Author Sonya Shah says African leaders should introduce legislation requiring drug trial funders to contribute to local scientific research with medical equipment and programs that would benefit communities.
Others say because the US Food and Drug Administration lacks the resources to monitor overseas trials, countries should form their own ethics committees to ensure drug testing benefits the communities involved.
They also say some procedures could be changed.
Today, many test a new drug against a placebo, a treatment known to be ineffective. That’s cheaper for the companies, but patients taking placebos are not receiving any treatment. Critics say a better idea would be to replace a placebo – when possible -- with an older or less effective drug. At least that way, they say all of the subjects will get some type of treatment that may benefit them.
But even critics like Professor Khanna agree that the trials, when scrutinized more effectively, can help advance the fight against HIV, malaria and other diseases on the continent.
Today Africa is one of the biggest beneficiaries of free and discounted medicines from the West. The Global Fund for the Fight against HIV/AIDS, Malaria and TB, and the U.S.-backed President’s Emergency Plan for AIDS Relief (PEPFAR) are among several programs working to ensure that Africans get medication at affordable rates.