[In the News]:Testing of Drugs


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

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

The study was designed to learn how people with healthy lungs andpeople who have the breathing problem, asthma, react to particles orsubstances. The medical researchers at Johns Hopkins University hada number of healthy people breathe into their lungs a drug calledhexamethonium. Twenty-four year old Ellen Roche was one of the ninepeople who agreed to take part in the study. She died on June secondas a result of inhaling the drug.

In July, the federal government criticized the university'ssystem that is supposed to protect people involved in such studies.An investigation found that the researchers failed to considerinformation about the possible harmful effects of the drug on thelungs. The people who took part in the study were never told thatthe drug is not approved for human use. And they were not warnedabout possible dangers.

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

People involved in clinical trials are those who suffer thedisease the drug is designed to treat. The scientists divide theminto two groups. One group gets the drug being tested. The secondgroup gets an inactive substance. Neither the scientists or thepeople involved know who is getting what. The researchers followboth groups to see what effect the drug has on the disease.

People who volunteer to be part of a clinical trial usually do sobecause they want the new drug. They hope it will improve theirhealth. Yet scientists say there is no way to make sure this will bethe result. The drug may help. But it could make their conditionworse. Or the volunteers may be in the group that gets the inactivesubstance.

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

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

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

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