Monday, November 18, 1996
WASHINGTON - Over the years, the FDA and its supporters have
used the word "thalidomide" - like a cross to ward off Dracula - as an incantation
to prevent any diminution in the agency's powers. That single word alone has
usually been sufficient to stop debate. But the drug has taken on new life as
its potential to treat a number of serious diseases is increasingly being recognized,
and as work continues on novel analogs.
Thalidomide occupies a unique niche in the popular imagination.
It is virtually synonymous with birth defects and unintended negative consequences.
In a larger sense, it has come to symbolize disillusionment with the power of
technology. If it is approved soon for use in the U.S., the drug will have to
be de-coupled from all that it has come to represent.
Even more than with other drugs for AIDS and other life-threatening
diseases, patients and their advocates may play a vital role in building public
acceptance of thalidomide.
Making its safe
Public concerns about thalidomide-induced birth defects sparked
changes in regulatory regimes for medical products worldwide, especially in
the U.S., where it was never approved for marketing.
Ironically, the measures that have been instituted in the three
decades since the thalidomide tragedy may provide the bureaucratic cover to
allow the product to be marketed in the U.S. to help cope with another tragedy,
AIDS. Under its thalidomide-induced powers to determine safety, FDA now has
the power to regulate marketing and distribution of the drug in ways that can
limit the risks.
The agency has been working closely with several companies
and with AIDS advocates on the development of thalidomide for several AIDS indications,
including cachexia (wasting) and aphthous ulcers. The drug, which suppresses
tumor necrosis factor (TNF), also is being tested for tuberculosis, rheumatoid
arthritis, lupus, inflammatory bowel disease, graft-versus-host disease, and
a several cancers.