Cambodian Prime Minister Orders Stop to Human Clinical Trials of Gilead’s Viread
Cambodian Prime Minister Hun Sen on Wednesday ordered a stop to a planned human clinical trial of Gilead Science's antiretroviral drug Viread because of the possible effects of the drug on trial participants, the AP/ABCNews.com reports. Health Minister Nuth Sokhom said that Hun Sen told him to stop the planned trials because of concern "about the effect on the Cambodian people and on the human values and rights." Sokhom added that the prime minister "is not allowing (the drug) to be tested on humans at all" (AP/ABCNews.com, 8/11). In statements that seemed to be directed toward the Viread study, Hun Sen earlier this month said that he opposes testing HIV/AIDS drugs on Cambodians. The study is funded by NIH and the Bill & Melinda Gates Foundation. In March, NIH awarded a $2.1 million grant to University of California-San Francisco researchers to test Viread in 960 Cambodian women, most of whom are commercial sex workers. The medication, which is known generically as tenofovir, has been shown to boost immune response and reduce viral levels in the bloodstreams of patients who are resistant to other antiretroviral drugs. The yearlong study is a collaborative effort among Cambodia's Ministry of Health, UCSF and the University of New South Wales in Australia. However, about 150 Cambodian commercial sex workers who are members of the Women's Network for Unity have said they will not participate in the study unless they are provided with 30 years of health insurance to cover possible adverse reactions and side effects from taking the drug (Kaiser Daily HIV/AIDS Report, 8/4). Approximately 2.6% of adults in Cambodia are HIV-positive, the highest prevalence in Southeast Asia, according to the AP/ABCNews.com (AP/ABCNews.com, 8/11).
Kao Tha of WNU said that the group is "very happy" with Hun Sen's decision because it does not "want to take part in this drug test," as "there is no safety guarantee for us." She added, "We are so poor that we don't have the money to pay for treatment if we fall sick after the test. ... We are very proud that Prime Minister Hun Sen supports us" (AFP/Yahoo! News, 8/12 ). At last month's XV International AIDS Conference in Bangkok, Thailand, a group of about 30 Cambodian commercial sex workers interrupted a Gilead-sponsored session on antiretroviral drugs to protest the trial. The demonstrators took over the stage for 15 minutes during the session, shouting that the company "uses sex workers for free" (Kaiser Daily HIV/AIDS Report, 8/4). However, individuals involved with the trial said they were "surprised" by Hun Sen's decision and are "assessing their next step," according to the Wall Street Journal. "It's a big disappointment that a well-thought-out study that's been worked on by excellent groups -- Cambodian, Australian and American -- seems to be in limbo," Howard Jaffe, Gilead senior medical adviser, said. Mary Fanning, associate director for clinical research at the National Institute of Allergy and Infectious Diseases, said that offering 30 to 40 years of health care to trial participants -- as members of WNU requested -- is an "undue inducement" and would not "pass an ethics test," the Journal reports. Incentives "so enormous" could "entice volunteers to enroll in a study regardless of the risks," possibly "tainting" consent, Fanning said, according to the Journal.
Human Clinical Trials
Hun Sen's decision "highlights the problems" both researchers and pharmaceutical companies face when creating drugs for "high-risk" diseases such as HIV/AIDS, the Journal reports. Although the development of new drugs "represent[s] perhaps the single greatest near-term hope for the prevention of AIDS," conducting tests on humans who are HIV-negative but at risk of contracting the virus "raises ethical questions," according to the Journal. "Individual rights, balanced against the greater public good -- that's the tension of clinical trials and it always will be," Helene Gayle, director of the HIV/AIDS and Tuberculosis and Reproductive and Child Health programs at the Gates Foundation, said. Human clinical trials in developing countries are "particularly sensitive" because participants may not "fully understand the nature of consent" and may lack adequate funds to obtain after-trial care or the medications they received free-of-charge during the trial, according to the Journal. Moreover, "marginalized" groups such as commercial sex workers are especially "vulnerable" because they "lack bargaining power" to negotiate the terms of a trial as well as the resources to acquire the necessary treatment or insurance if they contract the virus during the test, according to the Journal. In addition, developing countries can benefit from allowing trials by gaining laboratories, equipment and training. If they "impose too stringent demands" -- such as long-term supplies of drugs -- they "risk losing out" on such benefits, according to the Journal. "We should negotiate for a lifetime supply of drugs but then companies would not want to do studies in our country," Kiat Ruxrungtham, an AIDS researcher with the Thailand Red Cross, said, adding, "We have to balance it with reality." According to the Journal, the issue of human clinical trials will become "increasingly contentious" as pharmaceutical companies seek to test new drugs in developing countries because the cost of conducting trials in such countries can be 60% lower than in developed nations (Chase/Naik, Wall Street Journal, 8/12).