For the past two years, since he learned that scientists were looking for new ways to use thalidomide, Randy Warren has feared that the drug that left him malformed at birth could soon be available in pharmacies across North America. His nightmare just came one step closer to reality—the U.S. Food and Drug Administration is considering an application from New Jersey-based pharmaceutical maker Celgene Corp. to make thalidomide readily available to treat a form of leprosy. A decision is expected later this year, and if the answer is yes, there will almost certainly be requests to use the drug more freely in the United States and Canada to treat a variety of other illnesses, including some AIDS symptoms and rheumatoid arthritis. “If it is going to stop people from suffering, we do not want to deny them from getting it,” says Warren, 35, of London, Ont., chief executive officer of the Thalidomide Victims Association of Canada, “but I am very scared.” Adds Warren, who was born with deformed legs, no thumbs and other problems, and underwent surgery 24 times by the age of 16: “People do not realize how dangerous this drug is.”
Thalidomide. The very name sends shudders up the spines of the generations who recall the horror it caused in Europe and North America in the late 1950s and early ’60s. Some 12,000 babies were born with deformed or missing limbs and other severe defects after their mothers took the drug as a sedative during pregnancy. Withdrawn from the market after four years, thalidomide is undergoing a cautious rehabilitation more than three decades later. In Canada, about 180 patients a year receive the drug—
mainly to treat marrow-transplant complications, lupus, and AIDS-related ulcers and severe weight loss. But as a substance covered by the federal Emergency Drug Release Program, it requires the federal Health Protection Branch’s approval for each use, and can only be requested when conventional treatments do not work. Now, the prospect
of easing controls has shaken Canada’s 125 “thalidomiders,” as the victims call themselves, leaving them struggling to resolve their loathing of what the drug did with the knowledge that it could help others.
Developed as a sleeping pill in West Germany in 1958, thalidomide was soon available in large parts of Europe and North America without prescription. As malformed babies started to appear by the hundreds, then thousands, regulators traced the problem to thalidomide and banned its sale. But behind the scenes, physicians continued using the controversial drug for specialized uses, and it soon became the drug of choice for treating an inflammatory condition in leprosy that causes excruciating pain, eye and nerve damage, and eventual blindness. For those patients, “thalidomide is like a miracle drug,” says Dr. Jay Keystone, a tropical medicine specialist at the Toronto Hospital who has prescribed it for about 50 sufferers—mainly immigrants from the tropics— over the past 12 years.
Scientists have also identified two properties of thalidomide that could benefit patients with a spectrum of serious illnesses. It stops new blood vessels from forming—an effect researchers hope could be used to shrink cancerous tumors. And it can slow the body’s production of a protein that fights infections and tumors, but, in elevated levels, can also cause fever, weight loss and inflammation. That makes it an effective tool in treating mouth and throat ulcers in AIDS patients and a potentially deadly immune system reaction in bone marrow transplant patients. Anecdotal reports also show positive results for treating autoimmune diseases such as rheumatoid arthritis,
1958 Thalidomide goes on sale in West Germany, Britain and elsewhere in Europe, billed as a “wonder drug” that provides a “safe, sound sleep."
1959 A dozen infants born in West Germany with serious deformities (limbs missing or misshapen, spinal cord defects, cleft lip or palate, eye and ear defects, severe defects of heart, lungs, kidneys and digestive systems).
April, 1961 Thalidomide licensed for sale in Canada.
November, 1961 Linked to thousands of birth defects, thalidomide withdrawn from sale in Germany and Britain.
March, 1962 Thalidomide withdrawn from Canadian market.
1991 Ottawa awards compassionate grants of up to $82,000 to 109 Canadianborn thalidomide victims.
lupus, Crohn’s disease and multiple sclerosis.
In the end, regulators have to weigh the importance of preventing another thalidomide birth against the need to treat illnesses now, says Laura Shanner, assistant professor of philosophy at the University of Toronto’s Joint Centre for Bioethics. “It would be a mistake to be overprotective,” she says. “But we also have to consider how we will explain to a thalidomide baby 10 years from now how we allowed this to happen to him.”
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