Reference no: EM133299769

Case: Giving Placebos to Children

(New York Times)-Researchers give a 6-year-old girl who suffers from asthma attacks a promising new drug in addition to her old medicine, then withdraw it to see how she will do without it. A depressed teenager enrolls in a study for an antidepressant, but does not know if he will get a sugar pill or the real thing. The parents of an epileptic youngster enroll her in a test of a new drug that has worked well in adults. But no one knows whether she will get the new medication, or the one that has worked only moderately well for her in the past.

These quandaries, all based on actual experiences, are likely to be faced by an increasing number of parents, children, and medical researchers around the country as the federal government steps up its efforts to test drugs on children.

Over the last three years, largely because of financial incentives that Congress has given pharmaceutical companies, pediatric studies of new drugs have boomed. In December, the Food and Drug Administration will begin mandating that such tests be done on certain drugs, and the agency wants to make sure researchers protect child participants.

"What level of discomfort or risk should a child in a study be exposed to?" asked Dr. Steven Hirschfeld, a medical officer at the F.D.A.'s Center for Drug Research and Evaluation. "If a child gets an asthma attack and starts to wheeze, are people 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, Md., to begin discussions aimed at setting the first guidelines for researchers on the controversial use of placebos in drug trials for children. Placebos are sugar pills, injections, or other treatments that resemble the drug that is being tested without having any of the same effects.

Dr. Hirschfeld said that the particular vulnerability of children often makes placebo controls necessary. "Children are not only very susceptible to their own expectations," he said in an interview. "They are very susceptible to their parents' expectations."

But a panelist, Dr. Charles Weijer, a bioethicist and an assistant professor of medicine at Dalhousie University in Halifax, Nova Scotia, said it was wrong to submit children to risks while providing them no immediate benefit.

"An investigator's chief concern ought to be the health and well-being of her patients," Dr. Weijer said at the hearing... .

The panel of 27 researchers that met today included several researchers from Europe who are working on international standards for clinical trials in children.

"What you people decide will affect directly not only children in the U.S., but children in Europe and the world at large," said Francis Crawley, chairman of a group working to set standards in Europe.

Dianne Murphy, the associate director for pediatrics at the F.D.A.'s Center for Drug Evaluation and Research, said that use of placebos can reduce the number of children needed in a study and can ensure the most conclusive outcome. "If you need a placebo trial to get an answer, and you don't do it, then you've wasted that child's blood, time and possible chance, in a trial that won't give them an answer," she said ...

But experts disagree on the ethics of withholding effective treatment from children when studying nonfatal conditions such as allergies or skin rashes. And there is no consensus for how to treat children with other serious ailments, such as depression, where the best treatment is unknown.*

Is giving children placebos in clinical trials ever morally permissible? If so, under what conditions should placebos be used? What if in a clinical trial some children suffer asthma attacks because effective treatment is withheld from them-is that acceptable? What if no effective treatments for some childhood diseases could be developed without using children in placebo-controlled trials? Would that fact outweigh any objections to such trials? Give reasons for your answers.

* Alexis Jetter, "Efforts to Test Drugs on Children Hasten Drive for Research Guidelines," New York Times, September 12, 2000

Question 1: Please choose ONE of the following three cases near the end of the chapter called "Cases for Evaluation" and respond to the questions underneath the case (in the textbook) in a least a solid paragraph

Question 2: What is something from this week's material that stands out to you, something you found interesting, frustrating, or something you'd like further assistance with?