FDA Redraws the Rules for International Drug Trials

The U.S. Food and Drug Administration recently decided to no longer hold pharmaceutical companies to the standards of the World Medical Association’s Declaration of Helsinki while conducting human drug trials. The Declaration, first adopted in 1964, is a statement of principles for medical research, and stipulates that in pharmaceutical trials, a control group should not be given an ineffective placebo in place of another drug that is known to be effective, as this would leave a sick patient without treatment. The Declaration defines and requires that the patient give “informed consent” for participation in a trial. However, the FDA has recently revised its guidelines to require that pharmaceutical companies comply only with local regulations where the trials are conducted. But when trials are conducted in a country with little or no existing health care infrastructure, the “local standard of care” to which the new FDA guidelines refer may not even exist. According to a scathing editorial in Nature, the FDA risks sending the message that “ethical considerations are expendable when research subjects live half a world away.”

This U.S. policy development is of special concern to Russians, as an increasing number of U.S. pharmaceutical companies conduct their drug trials in Russia, which currently lacks extensive regulations. Merrill Goozner is currently reporting on that country’s health care system, which he explains has the potential to become “ground zero” in the discussion over the FDA’s withdrawal from the Declaration.

Russian health care and longevity has fallen dramatically since the end of communism, and in some areas is just now starting to recover. In some of the most rural parts of Siberia, the first health clinics are just now being built. Even with the recent improvements, the lack of regulations regarding pharmaceutical companies conducting trials concerns Sergey V. Smirnov, the Russian director of the nongovernmental organization, Community of People Living with HIV. Goozner spoke with Smirnov for Scientific American about his activism on the regulation of pharmaceutical trials:

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 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 patient privacy and safety in the trials, including requiring that they give their (noncoerced) consent to participate.

Smirnov hopes that the bill will be voted on sometime this year, remedying the current lack of effective regulations for clinical trials.

The decision by the FDA to withdraw from the Declaration of Helsinki has evoked much criticism, both at home and abroad. In recent years, the FDA has noticed that even with the Declaration in effect, many international drug trials run by American pharmaceutical companies are not reported until after they are conducted, and as such, the FDA cannot regulate them. The new guidelines may be an attempt to reassert control over these pharmaceutical companies, rather than rely on international law. By relaxing the rules, the FDA may either encourage more international drug trials—and therefore increase the number of drug trials that go unreported and unregulated—or it may find that companies are more likely to adhere to the slightly lower testing standards.

Tags: bioethics, drug companies, pharmaceuticals, Research ethics

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