The developing world is a fine place to run a clinical trial. Lower costs, easier recruitment of patient volunteers, and less stringent regulations on human testing are pushing many pharmaceutical companies to send their tests to developing countries. As drug corporations profit, poverty-stricken test subjects pay the price.
A shocking example of this is the death of 49 Indian babies in clinical trials. A number of the trials, performed by the All India Institute of Medical Sciences hospital in New Delhi, were designed and funded by Western Pharmaceutical companies. Some Indian politicians have expressed concern, suggesting that the trials targeted impoverished and illiterate parents who did not understand the risks that their children would face.
Money and time provide motivation for drug companies to subject children to such unreasonable risks. It costs millions of dollars and takes several years to test the safety and effectiveness of many medications before they can be brought to the market. With lower costs and a large population of sick subjects, trials in developing countries are cheaper and faster. For many people without healthcare in developing nations, any treatment, even if experimental, is better than none. Because so few have healthcare, thousands of volunteers can be recruited in a matter of days in India. In the West, recruitment usually takes months.
In the rush to outsource drug testing to developing nations, the basic rights of test subjects are often overlooked. Such was the case in India, where the trials defied the international authority on the ethics of clinical trials – the Declaration of Helsinki.
The declaration states: “in any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study” and that “the doctor should then obtain the subject’s freely given informed consent.” However, to give informed consent, a subject must understand exactly what the trial entails.
Those testing on behaf of drug companies in developing countries often overlook the importance of patient understanding. Many parents of the 49 children who died in India were not aware of the risks their children faced, and it is likely that other outsourced trials also fail to properly educate test subjects as well.
Some maintain, however, that even if patients give informed consent and know what to expect, there is only so much they should have to endure in the name of science. According to the Declaration of Helsinki, “considerations related to the well-being of the human subject should take precedence over the interests of science and society.”
Kathleen Glass, director of the Faculty of Medicine’s Biomedical Ethics Unit at McGill agreed. “Some say anything can be acceptable as long as you inform the subject, but I believe there are limits to the risk someone can take on,” Glass said.
The risks to subjects appear even more unfair given that they will probably never have access to the drugs after the trial. The drugs are marketed to consumers in the West, and are usually far too expensive for the impoverished test subjects in the developing world. Sonia Shah, the author of The Body Hunters: How the Drug Industry Tests Its Products on the World’s Poorest Patients, sees this unequal access as unjust.
“They are being subtly coerced into taking on risks to create benefits that other people will enjoy. That is the very definition of exploitation,” Glass said.
Many of the pharmaceutical companies’ decisions to carry out unethical tests are made behind closed doors. Shah said that positive changes may be possible if the public is better informed.
“A likely salve will be greater transparency, which is something that is happening. At least we can start to know more about these trials so that non-governmental organizations, patients, journalists, and others can play a role in helping protect trial subjects,” she said.