The mantra of capitalism is that you have to spend money to make money. Must the same be true about human life? The exploitation of human beings for drug testing in developing countries is becoming an increasingly common practice. Major drug companies make experiments on people in the developing world in unregulated tests that are often carried out without full patient consent and beyond the reach of United States law. Ethical guidelines for drug testing dictate the benefits of research must be tempered by a respect for the welfare of the research subject. That is, unless those being injured and killed are from the "Third World" and the lives being saved are American.
Drug researchers seeking approval from the United States Food and Drug Administration (FDA) for medicines for illnesses as diverse as AIDS and schizophrenia turn to developing nations in Africa, Asia, Latin America and Eastern Europe. There they find great numbers of afflicted people with few medical alternatives and, too often, little understanding of the dangers accompanying the tests they undergo. Because of the lack of alternatives and the poverty of the people involved, the costs of holding experiments are much lower. Additionally, in the developing world, the time required to perform the tests is generally much less, since often there are little to no regulations in place in these countries regarding human drug research. The result is that unsuccessful drugs are quickly discovered and abandoned and successful ones are pursued. While it is important to acknowledge that the increased speed of the testing process can make life-saving drugs available sooner, we cannot disregard the lives lost because of uninformed patient consent, shoddy medical practices and drug companies’ insistence on high profits. The bottom line is that experimenting with human life is cheaper for drug companies in developing nations, and the pursuit of the bottom line often results in inexcusable breaches of basic medical ethics.
According to the Washington Post, in October of ’98 in Estonia, a clinic run by Van Tx Research Ltd. attracted recruits in the city of Parnu by advertising the trial as a spa retreat of sorts. After flying the recruits to Switzerland, participants were given consent forms to sign in German, making it nearly impossible for non-German speaking participants to ascertain the conditions to which they were consenting. Eventually, Swiss authorities shut down the clinic when it was discovered to be recruiting drug addicts, those who were unaware that they were in a drug study, and refugees seeking political asylum in Switzerland. Before it closed, however, this clinic performed 161 research experiments for several global drug companies. While no lives were lost in this particular instance, the blatant dishonesty of the clinic’s practices indicates the existence of a serious problem.
An especially challenging ethical question concerns AIDS drug testing in the Third World. Thailand, especially, has become a popular country amongst researchers, because of its incredibly high HIV-positive population and because of its increasingly open policies regarding Western researchers. However, that openness has not resulted in the same amount of protection and care that Western patients enjoy. Instead, passive studies that simply map the growth of the epidemic, instead of providing any medical assistance, are prevalent. Additionally, placebos are used with much greater frequency than in the West, meaning that much fewer participants actually have a chance of receiving real medicine. For instance, in two maternity wards in Bangkok, an American drug test in which half the participants (HIV-positive pregnant women) were given placebos resulted in 37 babies being infected with HIV, when they might have been spared.
While the FDA has established stringent requirements for drug research in the United States, its regulatory powers only apply within American borders. The FDA may examine results from tests performed outside the U.S. when the safety of the drug is at issue, but this process of investigation often begins years after the tests have been performed ? if at all. Furthermore, efforts to determine informed consent and adherence to ethical standards are nearly always unsuccessful. By conducting their tests in developing nations, drug companies can shield themselves from FDA regulation, saving money and time; the often-injurious consequences of these unchecked trials are inexcusable.
The central precept that individuals give their informed consent before participating in drug tests is one that, while widely upheld by international guidelines, presents the most difficulty to drug companies and research universities when they seek to perform tests in the developing world. Sometimes, test leaders simply ignore the requirements, while other times the ethical question is not so unambiguous: can an individual with no other health care options and unable to read a consent form, make an informed consent regarding a drug test? Many would say no. Still, tests are carried out that are contingent on such an individual’s consent. To complicate the problem, drug researchers themselves often decide what information the patients receive about a specific drug. Thus, a drug that has been found to have harmful side effects in one country may be tested in another without the requirement that the patients be made aware of this.
Perhaps because of the economically advantageous results of overseas drug tests, the number of these tests is growing at an alarming rate. In ’99, 27% of new drug applications to the FDA included a foreign test result, a number three times that in ’95. A mammoth drug company, Eli Lilly and Co., experimented on 590 patients in Africa, the Middle East, and Eastern and Central Europe in ’94. This year, the company’s expectation was to experiment on 7,309 patients in those regions. While these available numbers illustrate a disturbing trend, statistics regarding drug testing in developing countries are otherwise almost completely unavailable in the United States. This lack of information allows for greater exploitation of developing nations’ citizens without arousing American outrage, or even suspicion. While overseas drug testing is not inherently harmful, the lack of regulation for this testing clearly is.
Harmful and life-threatening consequences can ensue when pure capitalist practices are unregulated by domestic governments or international agencies. It is time to make the drug companies conform to regulations that protect the rights of individuals; regardless of nationality or economic class.