U.S. Panel Recommends Tightly Restricted Sales of Thalidomide
Thalidomide, once the world’s most notorious drug, was recommended by a federal panel Friday for sales at American pharmacies with tight restrictions aimed at avoiding the birth-defect horrors of the 1960s.
The scientific panel urged approval by the Food and Drug Administration just for a small number of leprosy patients. But doctors are expected to prescribe it for a wider range of conditions, and all sides agreed that accidents are inevitable.
Even one of the world’s top leprosy physicians, Dr. Thomas Rea of Los Angeles County Medical Center, told the FDA’s advisory panel that “one day a thalidomide baby will be born.”
“I don’t know what I will do when I look that child in the eye,” Rea said.
If the FDA follows the panel’s advice, thalidomide would become the most severely restricted drug ever sold in this country.
That would be far different from 35 years ago, when the drug was banned worldwide after causing horrific birth defects in 12,000 babies. At that time, it was sold as a sleeping pill and morning sickness cure in 48 countries. No one knew that just one pill in early pregnancy could result in a baby with no limbs or with flipper-like arms and legs.
The drug was never sold in the United States because an FDA scientist uncovered early signs of toxicity and blocked approval. Still, some Americans got it overseas or in clinical trials.
Today, the drug is being studied for a host of diseases, from AIDS-related wasting and ulcers to cancer, lupus and rheumatoid arthritis.
The panel said thalidomide would still pose a danger without approval because it is sold underground. It said the government should set unprecedented curbs on which pharmacies can distribute thalidomide and force any company that makes the drug to educate physicians about the dangers.
A photo of a child thalidomide victim, ideally a videotape, should be shown to every doctor who prescribes thalidomide and every patient who gets it, the panel said.
In addition, the panel endorsed plans by New Jersey-based Celgene Corp., which hopes to become the first of three competitors to sell thalidomide, that would forbid pharmacies to distribute thalidomide until they receive a form signed by patient and doctor that both know the risks, and that a female patient is adequately protected against pregnancy.
The FDA is not bound by advisory committee decisions but typically follows them.
Several other risky drugs have been sold with restrictions, but not as far-reaching as those being recommended for thalidomide. For example, a potent painkiller for surgery patients is only shipped to hospitals that have received proper education about its risk. The hospital must also have equipment that can detect a serious side effect, trouble breathing.
Thalidomide is “a monster-causing drug,” said Randy Warren, head of North America’s Thalidomide Victims Assn. He was born with no hips and with malformed legs after his mother took just two thalidomide pills.
But he told the FDA panel that regulating thalidomide was preferable to today’s underground sales. “Isn’t one thalidomide baby born out of ignorance worse” than letting Americans make “risk-aware choices”? he asked.
