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IN THE NEWS - August 11, 2001: Testing of Drugs - 2001-08-10

This is Steve Ember with the VOA Special English program IN THE NEWS.

Earlier this summer, a young woman in Baltimore, Maryland died as a result of taking part in a medical study.

The study was designed to learn how people with healthy lungs and people who have the breathing problem, asthma, react to particles or substances. The medical researchers at Johns Hopkins University had a number of healthy people breathe into their lungs a drug called hexamethonium. Twenty-four year old Ellen Roche was one of the nine people who agreed to take part in the study. She died on June second as a result of inhaling the drug.

In July, the federal government criticized the university’s system that is supposed to protect people involved in such studies. An investigation found that the researchers failed to consider information about the possible harmful effects of the drug on the lungs. The people who took part in the study were never told that the drug is not approved for human use. And they were not warned about possible dangers.

Government officials decided to require stronger controls over the two-thousand other medical studies being done at Johns Hopkins. Some of these studies are different from the one that included Mizz Roche. That study gave a drug to healthy people. Other studies test a drug to see if it can effectively treat or cure a disease. These studies are called clinical trials.

People involved in clinical trials are those who suffer the disease the drug is designed to treat. The scientists divide them into two groups. One group gets the drug being tested. The second group gets an inactive substance. Neither the scientists or the people involved know who is getting what. The researchers follow both groups to see what effect the drug has on the disease.

People who volunteer to be part of a clinical trial usually do so because they want the new drug. They hope it will improve their health. Yet scientists say there is no way to make sure this will be the result. The drug may help. But it could make their condition worse. Or the volunteers may be in the group that gets the inactive substance.

Medical researchers carry out such experiments at universities and medical schools all over the world. They say that such studies must be carefully controlled to make sure they are generally safe. And they warn people considering taking part in such studies to ask questions of the researchers about the possible dangers.

Many researchers say they believe that volunteers in clinical trials are protected as well as they can be. Reports say that about sixty-thousand clinical trials are carried out each year. Only a small number have problems. Most medical researchers say the risks of such tests are the only way to make progress against disease.

This VOA Special English program, IN THE NEWS, was written by Nancy Steinbach. This is Steve Ember.