Drug that caused birth defects may help AIDS patients
November 8, 1996
Web posted at: 9:50 p.m. EST
From Correspondent Jeff Levine
WASHINGTON (CNN) -- Thalidomide, the drug that caused birth defects back in the 1960s, may be staging a comeback. The drug now looks promising for treating AIDS symptoms and many other conditions.
Back in the 1950s and '60s, pregnant women used thalidomide to treat morning sickness. Before scientists discovered the danger, as many as 12,000 children worldwide were born deformed, some with missing arms or legs. The U.S. Food and Drug Administration won praise for keeping the drug out of the United States.
Now, the agency is actually encouraging the medical community to take another look at the controversial drug, and an FDA advisory panel is considering whether to recommend thalidomide for FDA approval.
One of the women taking thalidomide, a 22-year-old AIDS patient, supports the drug's approval wholeheartedly. Before she started taking it, huge mouth ulcers left her barely able to eat. "If you saw me before and, like I said, we tried every other thing, this was the only option, the only thing that helped," she said.
Some doctors also support the drug's introduction. "It looks like the drug is extremely promising for some AIDS indications, as well as for other indications where patients have serious and life-threatening diseases," said the FDA's Dr. Debra Birnkrant.
In addition to keeping aids patients from drastically losing weight, thalidomide's anti-inflammatory qualities might be useful for a variety of diseases, such as rheumatoid arthritis, to lupus, or even organ rejection after transplant.
Up to 1,000 AIDS patients are taking thalidomide in research studies. Others are getting the drug illegally through underground sources. The AIDS community is pushing the FDA to rule quickly on thalidomide's merits.
"Anything that's an effective therapy, that creates an opportunity to reduce the suffering and pain that AIDS causes, is something that needs to be looked at," said Jeff Bloom of Project Inform.
Nevertheless, many are concerned about whether women who are of childbearing age can take thalidomide safely. The FDA's Birnkrant says that the agency is "comfortable" allowing women with childbearing potential to take the drug, "given the fact that they are monitored carefully, that the side effects are clearly explained to them."
Dr. Yvette Butler of Howard University disagreed. "I wouldn't recommend thalidomide for women who are still sexually active and who are planning on having children," she said.
And an organization of Canadian women who took thalidomide before the risks were known released a statement saying it wanted the discussions opened to thalidomide victims.
"It is outrageous and disgraceful that any discussions could occur regarding...thalidomide without including the victims. Thalidomide must always remain the drug of last resort," the statement from the Thalidomide Victims Association of Canada read.
The FDA says it did invite the Canadian group to speak to the advisory panel, and an FDA official says the agency will try to make sure that a thalidomide tragedy never occurs again.
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