Discovery Labs is trying to test a new drug that would combat Respiratory Distress Syndrome, an affliction that strikes a significant number of premature infants every year. But because of the way the experiment is set up, it is likely that many of the members of the placebo group - those who receive fake pills - would die of RDS.
The main issue here is not the study itself, which will bring treatment to a suffering population that would usually receive no aid. The ethical dilemma involves the use of a placebo group that will be given no treatments other than placing them on a ventilator. This is simply a case of scientists failing to value human life above experimental results. It is not ethical to condone this kind of action.
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If RDS goes untreated, the afflicted infant has a 40 to 70 percent chance of death. Existing drugs, called surfactants, are sprayed into infants' lungs to reduce the effects of RDS.
The types of experiments proposed by Discovery Labs are considered unethical and illegal in the United States. Medical professionals are not allowed to withhold treatment of patients with life-threatening diseases for the sake of study when proven treatments exist. But in an effort to evade these restrictions, Discovery Labs has found four Latin American countries with no such governmental protections. The company plans to do further studies in Europe as well, but none of the infants in the European group will be forced into a placebo group.
One of the main issues here is the parallel study going on in Europe. The new surfactant is being studied against one of its competitors that has been proven to work. The FDA still is trying to decide whether to approve the Discovery Labs study, which will take place in parts of Mexico, Bolivia, Peru and Ecuador. These are some of the poorest parts of the world today. If the study was approved it would draw an unfair conclusion: It would say that people of poorer countries are not as entitled to being treated as individuals in the same way as those in richer countries.
Some argue that there is no ethical issue involved because the infants would die anyway. But the infants' families will not know who receives the placebo treatment, so it is unethical to give these families hope when there may be no chance of survival.
Setting aside this problem still does not resolve the situation. If Discovery is willing to treat all infants in the European study, they must be consistent and treat all the infants in the Latin American study. If this is not done, it seems as if the poor economic status of some Latin American countries legitimizes conduct that would be deemed unethical in wealthy countries.
The Discovery press release concerning proposed trials in Latin America is chillingly vague. In it, the company says the study is designed to test the safety and efficacy of the synthetic surfactant "when compared to the standard of care in those regions in Latin America where the trial will be conducted." The writers conveniently gloss over the fact that current "standards of care" in poor Latin American countries means no medications. The company willingly proposes to let the infants in that group go untreated, effectively letting them die.
Discovery mentions using a group given comparison surfactants that already are in use, but do not describe the standards of care already in place. Citizens of poor countries may not be able to afford the price of the surfactant treatment. It is frightening how something like preventable death can be masked in corporate jargon.
Paul Lombardo, director of the law and medicine program at the University's Center for Biomedical Ethics, says it seems like the study is sacrificing a group of children to aid the marketability of a product. He says as long as a treatment is available for a study it is wrong to withhold it from terminally ill infants.
Lombardo's critique of the system rings true. Treatment is available for the infants in the study. Two groups have been slated for treatment. Leaving a group out for the sake of research is unethical.
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