U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001
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By Randolph Warren
"We will never accept a world with thalidomide in it; however, we are forced to prefer licensing of the drug that disabled us for compassionate reasons and to prevent uncontrolled access to the drug."
This has been the mantra of the Thalidomide Victims Association of Canada since we discovered that thalidomide was back, and, in fact, that it had never left us. The association was created in 1988 to assist its members in living with the disabilities they had. That was the sole focus ... until, in 1992, we discovered thalidomide was being given new life.
Thalidomide was being reborn as the next "wonder drug" for Type II leprosy, HIV/AIDS wasting, and many forms of cancer. The very properties that arrested the development of babies were the ones responsible for arresting progression of many terrible diseases, and even reversing the effects of others.
Around the world, some 10,000-12,000 babies were born with severe phocomelic disabilities as a result of their mothers ingesting thalidomide. Of these, 5,000 adults survive today. No one will ever know how many babies were spontaneously aborted or were stillborn. For the families, the tragedy was massive. For society, thalidomide created change. The field of child prosthetics leapt forward, drug control agencies around the world tightened licensing processes, and no longer was there an "assumption of safety" attached to new substances.
One woman, just doing her job, prevented thalidomide from being licensed in the United States. As a result of Dr. Frances Kelsey's efforts, America was spared the full effect of the thalidomide tragedy. Canada was not so fortunate. The very American company seeking approval in the United States received approval from the Canadian government. Today there are 120 thalidomiders in Canada, 90 percent of whom are disabled because of the American drug company.
Disability instantly shatters any naiveté a person could have and replaces it with skepticism and a full dose of reality. After "60 Minutes" aired a segment showing a woman ingesting thalidomide for macular degeneration, one can well imagine the shock of the thalidomide survivors. Not only was thalidomide back, but it was being taken by a woman on national television. It appeared that the world was preparing to license the drug all over again. And we knew the first place that would undertake licensing was in our own backyard, America! Our largest fear as Canadians was that whatever happens next door, eventually happens here at home.
Having accepted the fact that there was really nothing we could do to prevent the drug's return, we determined that it was our role to ensure that the drug was managed in the safest possible way, and that all the risks associated with it were known. This was a delicate balancing act for us, and often wrenching. Discussing risk versus benefit in cold scientific tones was difficult. Dealing with the drug company who was seeking approval seemed to us to be a betrayal at times of those who died because of ruthless drug companies. Handling a media who wanted a sensational story was taxing. Meeting persons who were saying "thalidomide took me out of my wheelchair," when two thalidomide tablets had put me in mine, was confusing.
In 1996, FDA invited us to participate in its deliberations about returning thalidomide to the marketplace. We brought a human component to the table. We were the visual reminders of why this drug was different.
We took every opportunity to warn people about the dangers of thalidomide. We also reviewed all educational materials about thalidomide, and suggested changes to make things clearer to the public.
Why we undertook this mission is obvious: to prevent another thalidomide tragedy.
The Thalidomide Victims Association of Canada is a group of 120 Canadian survivors who proved that even the small can influence the giant (in this case the FDA and the drug company). By being involved in thalidomide's return, we took over the drug which had haunted us. This has been a cathartic experience for us if nothing else, and has filled our members with confidence and pride. After all, thalidomide is now the strictest regulated drug in U.S. history, and so far there have been no foetal exposures to this substance.
Today, we remain watchdogs of thalidomide. We educate the public of the most notorious pharmaceutical disaster in history, and "dispense" information about the dangers of the drug. Most of all, however, we live daily with the consequences of thalidomide ... and we live our lives!
Randolph Warren is a founder and executive director of the Thalidomide Victims Association of Canada and lives in London, Ontario, Canada.
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