Question

in giving children placebo in clinical trails ever morally permissible? If so under what condition should placebos be used? What if in a clinical trail some children suffer asthma attacks because effective treatment is withheld from them-is that acceptable? what is no effective treatments some childhood disease could be developed without?

254 PART 2: MEDICAL PROFESSIONAL AND PATIENT entitled to the same level of care that subjects in developed countries get. Dr. Hirschfeld said that the particular vulner ability of children often makes placebo controls necessary. "Children are not only very susceptible to their own expectations" he said in an inter view. "They are very susceptible to their parents Cases for Evaluation CASE I cxpectations." But a panelist, Dr. Charles Weijer, a bioethicist (New York Times)-Researchers give a 6-year-old gil wrong to submit children to risks while providing it to see how she will do without it. A depressed health and well-being of her patients," Dr. Weijer Giving Placebos to Children and an assistant professor of medicine at Dalhousie University in Halifax, Nova Scotia, said who suffers from asthma attacks a promising new them no immediate beneft. drug in addition to her old medicine, then withdraw "An investigator's chief concern ought to be the enager enrolls in a study for an antidepressant, said at the hearing but does not know ifhe will get a sugar pill or the real thing. The parents of an epileptic youngster enroll cluded several researchers from Europe who are her in a test of a new drug that has worked well in working on international standards for clinical adults. But no one knows whether she will get the trials in children. new medication, or the one that has worked only "What you people decide will affect directly not moderately well for her in the past. The panel of 27 researchers that met today in only children in the U.S, but children in Europe and These quandaries, all based on actual experiences, the world at large," said Francis Crawley, chairman are likely to be faced by an increasing number of of a group working to set standards in Europ parents, children, and medical researchers around Dianne Murphy, the associate director for pedi the country as the federal government steps up its atrics at the F.D.A.'s Center for Drug Evaluation efforts to test drugs on children and Research, said that use of placebos can reduce Over the last three years, largely because of fi the number of children needed in a study and can nancial incentives that Congress has given pharma ensure the most conclusive outcome. "If you need a ceutical companies, pediatric studies of new drugs placebo trial to get an answer, and you don't do it, have boomed. In December, the Food and Drug then you've wasted that child's blood, time and Administration will begin mandating that such tests possible chance, in a trial that won't give them an be done on certain drugs, and the agency wants to answer," she said. make sure researchers protect child participants. But experts disagree on the ethics of withhold "What level of discomfort or risk should a ing effective treatment from children when studying child in a study be exposed to?" asked Dr. Steven nonfatal conditions such as allergies or skin rashes. Hirschfeld, a medical offcer at the F.D.A.'s Center And there is no consensus for how to treat children for Drug Research and Evaluation. "If a child gets with other serious ailments, such as depression, n asthma attack and starts to wheeze, are people where the best treatment is unknown. willing to tolerate that to get complete information about a potentially helpful drug for children?" Today, an F.D.A. advisory panel met in Bethesda, Is giving children placebos in clinical trials ever Md., to begin discussions aimed at setting the first morally permissible? If so, under what conditi guidelines for researchers on the controversial use should placebos be used? What if in a clinical trial of placebos in drug trials for children. Placebos are some children suffer asthma attacks b sugar pills, injections, or other treatments that re- tive treatment is withheld from them semble the drug that is being tested without having ceptable? What if no effective treatments for some any of the same effects. ons cause effec- childhood diseases could be developed without

Answer 1

The use of placebo controls in clinical trials remains controversial.

Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases:

(1) when there is no proven effective treatment for the condition under study

(2) when withholding treatment poses negligible risks to participants

(3) when there are compelling methodological reasons for using a placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially

(4) when there are compelling methodological reasons for using a placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive.

Withholding treatment is unethical, we are not having any right to withhold the treatment in any of the condition.

If the child is suffering from an asthma attack instead of going for a placebo, we can go for evidence-based treatment for an asthma attack.