Thalidomide makes a comeback

Once a symbol of standards gone wrong, the controversial drug hits 50 ? and the shelves. 'Thalidomide babies' plead for caution

By Josh Karpati

"We will never accept a world with thalidomide in it." So says the Thalidomide Victims Association of Canada (TVAC), an advocacy group made up of 125 victims of this most infamous of drugs. Thalidomide is now 50 years old, and remains a symbol of corporate greed and government regulatory failure. Worldwide, tens of thousands of victims have spent decades coping with the medication's fallout. Yet thalidomide is quietly being prescribed today. How is this possible?

It wasn't supposed to happen this way. After it was synthesized in West Germany in the 50s, thalidomide was widely prescribed in Europe as a sleeping aid and anti-morning sickness pill for pregnant women. Tragedy followed when so-called 'thalidomide babies' began arriving with a host of terrible birth defects.

It was belatedly discovered that the medication passed through the fetal barrier and disrupted normal physical development. Many babies were stillborn or died shortly after birth ? around 12,000 babies were affected worldwide. For survivors, the most visible and commonly recognized condition is phocomelia, a word derived from the Latin for "seal" and refers to the stunted limbs of victims resembling flippers.

The fact that there are relatively few victims in Canada (there are around 125 survivors) has deepened the challenges they face. They don't have the wide networks of support that patients with better-known conditions have available. Most have had to struggle alone, and families are put under great emotional strain from coping with societal misunderstanding.

TVAC and its president Randolf Warren stress that though the number of afflicted Canadians is low compared to other countries, the federal government was irresponsible when it came to pulling thalidomide from the market. "Although thalidomide was withdrawn from the West German and United Kingdom markets by December 2, 1961, it remained legally available in Canada until March 2, 1962, a full three months later," he says. Most frustrating for Canadian victims is the fact that there are merely a handful of victims in the US because an alert doctor at the FDA refused to grant regulatory approval.

Until a few years ago, that is.

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As unbelievable as it seems, thalidomide is now a drug of choice for many diseases. In fact, the list of conditions it might help is very long ? over 100, including most cancers and dermatoses ? due to the drug's anti-angiogenic properties. It disrupts the formation of tumours by limiting vessel growth, and significantly heals many skin lesions. In the Third World, thalidomide is used very effectively to treat lepers. It's currently approved for use in several countries, including the US, Brazil, Australia, New Zealand and Mexico. Though it's not approved in Canada, it's possible for doctors to prescribe it through Health Canada's Special Access Programme.

Thalidomide victims are thus placed in a terrible moral bind. The drug that brought them misery now can transform other lives, for the better this time. On the other hand, there remain serious potential side effects, including dangerous neuropathies.

"We cannot deny this drug from those who may benefit with a markedly better quality of life or even longer lives," says Mr Warren. "We are here to specifically address the issue from a 'thalidomide baby' perspective, but we are also equally concerned that all side effects be revealed. We resent the watered-down language surrounding side effects." Thalidomide, insists its maker Celgene Pharmaceuticals, can be safely prescribed, as long as it's never prescribed to pregnant women. The company instituted a program called STEPS ? System for Thalidomide Education and Prescribing Safety ? stressing that education is the best way to raise doctors' awareness of risks and benefits of the drug. They ask why this drug should be approached any differently than other teratogenic medications such as the acne drug isotretinoin. Guidelines, it's reasoned, will prevent disasters from happening in the future.

TVAC members are understandably a little warier. Mr Warren doesn't mince his words: "If thalidomide is truly again a 'wonder' drug, then we must also view it as Pandora's box, never to be fully opened. Thalidomide must be a drug of last resort, and make only a temporary return until replaced with safe analogues."