[The following was written by SciAm's guest blogger in the field, Merrill Goozner.] MOSCOWâ¬The U.S. Food and Drug Administration's (FDA) recent decision to withdraw from the World Medical Association Declaration of Helsinki that protects human subjects in clinical trials drew fire in a recent Nature editorial. The crux of the issue: whether patients in clinical trials conducted by pharmaceutical firms outside the U.S. will be guaranteed at least the global standard of care for treating their diseases that are not life threatening. The new FDA guidelines known as Good Clinical Practices (GCP), which will govern overseas placebo-controlled trials (for conditions that can be treated with existing drugs), refer only to compliance with local regulations, which are all but nonexistent in some countries. Russia is one such country, and it is has the potential to become ground zero where this issue may eventually play out. Moscow-based Synergy Research Group, which conducts clinical trials here for foreign drug firms, says 174 trials began in Russia in the fourth quarter of last year. That is just 4 percent of the global total, but the number is growing fast. In November seven major contract research organizations (CROs) operating in Russia, including the U.S.-based giants Parexel and Quintiles, established the Association of Clinical Research Organizations to further develop Russia as a leading clinical research country/market and to "shape the professional environment" here. One attraction, at least in the short run, may be the relative lack of regulation. On my first day of interviews here for ScientificAmerican.com, I dropped by the office of Sergey V. Smirnov, director of the Community of People Living with HIV, one of nearly 100 Russian nongovernmental organizations that have popped up in the past 15 years to deal with HIV/AIDS and other pressing health care issues. Two years ago, Smirnov joined an informal working group of scientists and bioethicists in drafting legislation designed to beef up clinical trial patient protections. Among backers: representatives of the Russian government's Bioethics Commission, the Russian Academy of Sciences, and the local UNESCO office. "The regulation of clinical trials here leaves much to be desired," Smirnov told me. "Russia has still not signed the European Convention on Human Rights⬦[and]⬦Biomedicine. We want to replicate that system in Russia." The issue crossed his radar two years ago when an HIV-positive Russian receiving government-sponsored antiretroviral therapy was told that his treatment would cease if he did not enroll in a clinical trial. "People from the patient community and the physician community didn't know anything about informed consent and ethical review boards," Smirnov said. "Even though this (the action of the CRO running the trial) was prescribed by existing law, no one knew anything about it and it wasn't enforced." The Community of People Living with HIV has to tread carefully when weighing in on the ethics of clinical trials. Although the lion's share of its funding comes from outside sources (such as the Global Fund, various United Nations agencies, the Elton John AIDS Foundation and the U.S. Agency for International Development), it also receives money from global pharmaceutical firms that sell the Russian government drugs to treat the estimated 560,000 to 1.6 million people in Russia diagnosed with HIV/AIDS, only 390,365 of whom are registered with the government. The legislative draft would give the government power to require greater disclosure of sponsors of and participants in clinical trials. It also provides a framework for protecting the patientprivacy and safety in the trials, including requiring that they give their (noncoerced) consent to participate. . "We wanted to avoid being specific on technical issues so⬦[the measure]⬦will not be attacked in the Duma" (the Russian legislature)," Smirnov said. "It opens the door to create technical regulations of particular practices." Smirnov hopes the Duma will vote on the bill later this year. Two years ago, in the run-up to the Saint Petersburg G-8 summit meeting, Russia dramatically increased its support for HIV/AIDS patients (to demonstrate its commitment to the international community. Activists here say financial resources are no longer the major stumbling block to treatment. Smirnov is cautiously optimistic Duma will agreeâ¬and vote to approve patient protections.

 

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