THALIDOMIDE APPROVAL ALARMS VICTIM

Notorious drug on sale in U.S. for leprosy treatment

WASHINGTON (CP-AP) - Thalidomide, the notorious drug that caused
horrific birth defects around the world decades ago, won approval
yesterday in the United States as a treatment for leprosy.

And although access to the drug will be severely restricted, the
decision by the U.S. Food and Drug Administration frightens some
Canadians who are all too familiar with the effects of the drug.

``I am afraid. I can't stress that enough,'' said Randolph Warren,
co-founder of the Thalidomide Victims Association of Canada from his
home in London, Ont.

``I knew this decision was coming so I am a little shocked at how
frightened I am.''

Thalidomide, most commonly prescribed as an anti-nausea drug for
pregnant women, was banned in the 1960s after 12,000 babies worldwide
- - including about 100 in Canada - were born with no limbs or
flipper-like arms and legs, and facial deformities.

But Warren said smuggled thalidomide is being sold underground by
desperate patients excited by early signs that it also could treat
such illnesses as AIDS-related wasting and some cancers.

His concern is that Canadians will be able to hop across the border
and get the drug.

``There will be no control over the use of this drug. If they want it,
Canadians will get the drug,'' he said. ``Just look at Viagra.''

Warren, who refers to himself as a ``thalidomider,'' testified at the
U.S. Food and Drug Administration hearings into thalidomide use in the U.S.

``I feel like we pulled the fire alarm but no one left the building,''
he said.

However, in the end, Warren's association decided FDA-regulated
thalidomide was preferable to no regulation or monitoring, and helped
design the safety rules.

The FDA's approval comes with unprecedented restrictions aimed at
avoiding a repeat of the tragedy of the 1960s. They include mandatory
pregnancy testing for women, and contraceptive use by men and women on
the drug.

``We await the birth of more thalidomide babies'' said Warren, 37, who
was born with shortened legs, inverted fingers or ``flipper'' hands,
some fingers missing and hearing problems. ``Is the world ready for
more thalidomide babies? They weren't ready for us.''

Thalidomide effectively treats a small number of leprosy patients who
suffer an agonizing inflammation.

Warren's association wants Canada to follow the U.S. lead and approve
thalidomide, arguing that having the drug out in the open would make
it easier to monitor.

``Thalidomide was never banned, like we all thought,'' he said. ``It
was just put into doctors' and scientists' secret closets.''

In Ottawa, Lynn LeSage of Health Canada said thalidomide is an
unapproved drug in this country.

``However, it is available through the special access program'' which
allows Canadian doctors to prescribe it to certain patients, she said.

In the U.S., the sale of thalidomide will be severely restricted.
Every user, male or female, will be required to enroll in a registry.
And its maker, New Jersey-based Celgene Corp. - which will market the
drug under the brand name Thalomid - will allow prescriptions to be
dispensed only by pre-certified doctors and pharmacists.

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Dave Haans Graduate Student, University of Toronto WWW:
http://www.chass.utoronto.ca:8080/~haans/

Checked-by: "Rich O'Grady"