|
Thalidomide's comeback sparks emotional debate
September 4, 1997
Web posted at: 11:08 p.m. EDT (0308 GMT)From Medical Correspondent Jeff Levine
WASHINGTON (CNN) -- The U.S. Food and Drug Administration is considering whether to approve the use of the controversial drug thalidomide, which was responsible for thousands of devastating birth defects when it was used in pregnant woman a generation ago.
The drug is now being touted as a treatment for both leprosy and AIDS. But given its history, there is still fear and controversy surrounding its use.
CNN's Jeff Levine reports
2 min., 1 sec. VXtreme streaming video
"I can't believe we're talking about this drug," said Randolph Warren, a thalidomide victim who sits on a panel advising the FDA on whether to lift a ban on the drug. "I'll never be happy until there's a world without thalidomide in it. None of us will be."
Countering such sentiments, however, is the testimony of people such as Vicki Walton, who believes thalidomide saved her life after she was afflicted with a rare immune disease.
"Without thalidomide, it would be back to where I was -- wheelchair-bound, bedridden, in the hospital," she said.
'Moral quandary of the decade'
During the 1950s and early 1960s, thalidomide was widely prescribed to pregnant women around the world as a treatment for morning sickness. It was banned in 1962 after some 12,000 babies were born with no limbs or tiny, flipper-like arms and legs, serious facial deformities and defective organs.
"It's the moral quandary of the decade for us," said Canadian Randy Warren, head of North America's Thalidomide Victims Association, who was born with no hips and malformed legs. "We don't want to deny this drug to people. ... But one pill can lop off all four limbs" of a developing fetus.
Thalidomide was never sold in the United States, although some Americans got it abroad or in research trials. An FDA scientist spotted early signs of toxicity that the original manufacturer denied, and blocked U.S. sales long enough for the danger to be proved overseas.
Drug 'very effective' treating leprosy
But thalidomide is staging a comeback, though not as a morning sickness treatment. The FDA is considering whether to approve it to treat painful sores that afflict leprosy patients.
Dr. Leo Yoder, a consultant to Celgene, the drug's manufacturer, says it is "very effective" for that purpose.
"You give them a dose of thalidomide and within days, and certainly within a week, you get a rather dramatic response," Yoder said.
Scientists think thalidomide works by altering the immune system. In addition to leprosy, the drug may work against symptoms of AIDS, cancer and tuberculosis.
But critics say there is an inevitable and terrible downside.
"The committee should realize that infants will be born with preventable birth defects if this drug is approved for prescription use," said Dr. James Hansen of the American Academy of Pediatrics.
To counter that possibility, the manufacturer says women taking thalidomide would be required to use two forms of birth control.
Related stories:
- Drug that caused birth defects may help AIDS patients - November 8, 1996
- Brazil launches media campaign to fight leprosy - October 21, 1996
- Banned drug may heal mouth ulcers - November 1, 1995
Related sites:
Note: Pages will open in a new browser window
- U.S. Food and Drug Administration
- Thalidomide Victims Association of Canada
- World Health Organization: Action Programme for the Elimination of Leprosy
External sites are not endorsed by CNN Interactive.
|
Sound off on our message boards You said it... |
|
© 1997 Cable News Network, Inc.
All Rights Reserved.