Walking Test Tubes

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The tests also can violate the ethical standards that protect subjects in rich countries.

A case in point was a proposed 2001 trial for a drug aimed at treating premature babies with respiratory distress syndrome. Biotech drug company Discovery Laboratories, unable to find experimental subjects in the United States, planned to test its new drug through a placebo-controlled experiment in a poor hospital in Latin America. The company would give 325 deathly ill premature infants placebos instead of life-saving medicines widely available in the United States and Europe.

In the United States, where the FDA already had approved four similar drugs, such a trial would have been ethically and practically impossible. The drugs, after all, reduce mortality in lung-impaired infants by 34 percent. The company feared the new drug would prove no more effective than those of its competitors, and thus wanted to test it against a placebo. It wasn't that Discovery's drug would be much better; it would simply be easier to manufacture, and therefore cheaper.

The FDA discussed the proposed trial in a session titled 'Use of Placebo-Controls in Life Threatening Diseases: Is the Developing World the Answer?' The proposed subjects of the trial were poor and lacked access to the lifesaving medicines, the FDA reasoned, so the trial would pass muster-despite the 17 preventable deaths that Discovery estimated would result.

In that case, pressure from the watchdog group Public Citizen forced the company to redesign the trial. But generally, ethics violations pass unnoticed. 'For the most part,' acknowledged Gustavo Kaltwasser, who monitors trials in Latin America for the Olympia, Washington-based oversight body the Western Institutional Review Board, 'medical ethics committees [in the region] are not aware of . . . FDA regulations and ignore even their own country's regulations. They don't know it's in their power to suspend or terminate research or ask for more protection for subjects.'

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