Presidential commission to examine clinical trial ethics

President Obama’s bioethics commission has formed an international research panel to examine protections for human subjects in clinical trials.

The President requested a report after scandalous revelations last October that the US Public Health Service had supported dubious research on syphillis in Guatemala from 1946 to 1948. This involved the intentional infection of soldiers, prisoners and prostitutes.

“It does not go without saying that a civilization can be judged by the way it treats its most vulnerable populations,” said Commission Chair Dr Amy Gutmann. “There’s no position of greater vulnerability than to be a subject of a medical experiment.”

She continued: “We have a problem on our hands …. What happened in Guatemala, what happened in Tuskegee, in Willow Brook … whether these people look like us, or they don’t look like us, they are human beings with rights that doctors and scientists are expected to respect and should go by the highest standards.”

The new panel includes experts from a number of countries, including Argentina, Brazil, China, Egypt, Guatemala, India, Russia, Uganda, Belgium, and the United States.

The panel’s brief is to examine:

  • The dominant norms, and competing alternatives, driving the ethics of medical research outside the US.;
  • The conflicts, if any, between US norms and international standards;
  • The challenges facing researchers conducting US-funded research in global settings; and
  • How to address major differences in regional norms for medical research.

The commission – whose official name is the Presidential Commission for the Study of Bioethical Issues – has already started holding public meetings.

At one of them this week, Robert M. Califf, Vice Chancellor for Clinical Research at Duke University, stressed that high costs and red tape in the US was driving research to countries like India, China, Brazil, and South Africa, as well as developing nations. He cited a 2008 study that found if a drug company moved 50% of its trials from high-cost places and had 60,000 people in clinical trials, it would save $600 million a year. ~, Mar 1;

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