Thalidomide's Return

By Christine Gorman

Bundled in a stark white hospital blanket, Rafael looks like any other month- old baby. But when his mother, Luciene das Dores, unwraps the snug cover, the sight is shocking: Rafael has no arms or legs. "I got very upset and started to cry when I first saw him," says Das Dores, 23, a part-time cleaning woman who lives in Belo Horizonte, Brazil. "When I saw him with only a head and a torso, I was devastated. I wanted to kill myself." She could not help feeling guilty: unaware that she might hurt her baby, she had taken the powerful sedative thalidomide during her pregnancy.

Her story is a flashback to an old nightmare. Yes, Das Dores took the same medication that made headlines 33 years ago when it produced 12,000 severely deformed children around the world. But while the word thalidomide became synonymous with tragedy and its use as a sleeping pill was banned, the drug did not disappear. In fact, it has made a quiet comeback. For all its dangers, thalidomide has benefits that have made it an increasingly valuable medicine when used carefully. Misuse, however, has caused a grim side effect: the reappearance of "thalidomide babies."

Trouble strikes when patients don't know about thalidomide's dark side -- and when those selling and dispensing the drug don't give adequate warning. Although the U.S. has strict rules governing thalidomide's use, controls are much laxer in some other parts of the world. The consequences are now apparent in Brazil, which has at least 46 new instances of birth defects caused by thalidomide. If there are cases in other countries, they haven't received the same publicity, but given the increasing use of the drug, health officials fear that the problem will be widespread.

A few years after the initial thalidomide disaster, researchers discovered that the drug has an almost miraculous ability to treat complications of leprosy. Then they learned they could use it against some of the potentially fatal side effects of bone-marrow surgery. The past year has brought reports that the drug may help fight tuberculosis, a common cause of blindness called macular degeneration and even AIDS.

Brazil is one of the largest producers of thalidomide because it is home to perhaps 300,000 people who suffer from leprosy. About 30,000 of them take the drug to soothe the excruciating pain and eradicate the lesions that occur in severe cases of the infection. The only alternative treatment, corticosteroids, does not work as quickly or as completely. "The pain was so great that I couldn't walk," says Irani, 24, a former patient at the Santa Isabel leper colony. "I almost died. Thalidomide was my salvation."

Irani was lucky to have doctors who cared enough to take precautions. They administered the drug only after putting her in a hospital, where they could make sure she did not become pregnant. But some doctors give out prescriptions without telling patients of the danger, much less keeping them under observation. In other cases, the patients, who are often poor and barely literate, ignore or misunderstand what they are being told.

Greed also comes into play. Although only two companies are authorized to produce the drug in Brazil, several underground laboratories reportedly sell it to people without a prescription. Health authorities shut down one illicit operation last year, after a TV-news crew showed how easy it was to buy the pills.

The resurgence of birth defects is especially painful for members of Brazil's first thalidomide generation, born around 1960. They believe the government has not done enough to warn women and have started their own education campaign. "People still believe this kind of thing is God's punishment or even a side effect of leprosy," says Rosangela Nascimento, head of the Thalidomide Victims Association.

In the meantime, U.S. scientists are trying to find out more about how thalidomide works. They have learned that the drug, besides having sedative effects, blocks two important processes in the body. The first involves the production of a substance called tumor necrosis factor, or TNF, which fights both malignant cells and infections. But if too much TNF is produced, as apparently happens in leprosy, AIDS and tuberculosis, the body makes itself sicker. The second process stymied by thalidomide is the creation of new blood vessels, which is crucial to the development of arms and legs in the fetus. The eventual goal of researchers is to alter thalidomide somehow so that it continues to inhibit TNF without harming nascent arteries and veins.

Such efforts will be of little comfort to the families of children like Rafael. Until thalidomide is made safe, governments will have no choice but to regulate the drug tightly and publicize its perils.

With reporting by Ian McCluskey/Belo Horizonte and Lawrence Mondi/New York