Nobody disputes that a drug being developed by Discovery Laboratories may become a promising new treatment for respiratory distress syndrome, a sometimes-deadly lung disorder that leaves premature babies struggling for breath.
The problem, CBS News correspondent Sharyl Attkisson reports, is a plan to study the drug in Latin America in a way that would never be allowed in the United States.
Some newborns in the study would get the new drug, Surfaxin, but others would only get a placebo. They would get no treatment--not even with effective drugs already on the market. Critics claim that out of 325 babies to be tested in four countries, 17 on placebo would die preventable deaths.
"What's unacceptable is to use people's poverty as an excuse to not provide them with known effective lifesaving therapy," says Dr. Peter Lurie, of the watchdog group Public Citizen. "We would never encounter such a study in this country. We should not be putting our stamp of approval when the study is done in Latin America."
Yet that's exactly what the US Food and Drug Administration (FDA) seriously considered--in fact, encouraged--doing. Both the FDA and drug companies like placebo-controlled studies because it's easier to prove that a drug works.
Ethical questions are raised when it comes to withholding treatments for deadly illnesses. The FDA debated the dilemma at a secret conference called Use of Placebo Controls in Life Threatening Diseases: Is the Developing World the Answer? They noted that the Surfaxin study plan "is considered unethical in the USA."
Increasingly, pharmaceutical companies test their drugs in places like Mexico and Africa, where the ethical rules are different: There are plenty of untreated patients and research can be much cheaper.
Amid an outpouring of criticism, Discovery Labs reversed course Wednesday. Now, in a newly redesigned study, nobody will get a placebo. "All patients" will get "access to drugs currently used in the U.S."
There is no FDA policy against similar foreign studies, but critics hope the uproar over Surfaxin will make other companies less eager to tread the same ethical ground.
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