Source: Reuters

U.S. approval hearings to revive thalidomide demons

WASHINGTON (Reuters) It sounds like a miracle drug, working against such
scourges as cancer, leprosy and AIDS.

But the seemingly wondrous drug being considered for approval by a U.S. Food
and Drug Administration (FDA) committee next week is thalidomide, which
caused thousands of children around the world to be born with horrendous
birth
defects.

The very name of the drug, prescribed with the benign intent of
helping pregnant women overcome morning sickness, evokes images of
people with flippers instead of arms, confined to wheelchairs by
withered legs.

Thalidomide was banned worldwide in 1962, but not before up to 12,000
children were born with deformities.

Now the drug is enjoying a resurgence. The very qualities that make it so
dangerous to developing embryos make it useful against the growth
processes that
lead to tumours.

On Thursday the Dermatologic and Ophthalmic Drugs Advisory Committee will
discuss a request by Santa Fe, New Mexicobased Celgene Corp., which wants
the drug, which it would market as Synovir, licensed for treating leprosy.

Celgene says it has also found positive effects against the wasting that
accompanies AIDS, and other drug companies are lining up behind it.

Rockville, Marylandbased EntreMed Inc says the drug may work
against prostate cancer. Working with the National Cancer Institute,
the company says it has also seen good results with brain cancer,
glioblastoma, a tumour of the central nervous system, and Kaposi's
sarcoma a oncerare cancer that is now one of the markers for AIDS.

BristolMyers Squibb has the rights to thalidomide analogs that are
being developed as oral antiangiogenic drugs drugs that block the
growth of tumors by stopping the blood vessels that feed them.

A study published in the New England Journal of Medicine in May found
thalidomide worked against mouth ulcers in people with AIDS, although it had
many sideeffects.

The mouth ulcers can be serious some of the patients have to be
fed through tubes because they cannot eat normally.

``Thalidomide is the first treatment shown in a scientific study to
heal those ulcers, but the course should be carefully monitored and
limited in its duration because of the drug's potential toxicity,''
said Jack Killen of the National Institute of Allergy and Infectious
Disease (NIAID) Division of AIDS.

Other researchers said it might work in graftversushost disease, which
can kill
transplant patients.

Thalidomide has been used for decades in Brazil, having been given to an
estimated 25,000 of that country's 240,000 patients with leprosy.

Victims of the drug are watching cautiously. They want it carefully
controlled, and warn it may have leave a legacy across the generations.

Brazil's Thalidomide's Victim's Association says illiterate users
are unaware of the risks of the drugs, and often pass it on to
friends. It says thousands of deformed babies have been born as a result.

The Britishbased Thalidomide Action Group says 11 of the 380
children born to thalidomide victims there have limb defects themselves.

It is backing a controversial Australian scientist, William McBride,
who says he has evidence the damage done by thalidomode can be passed
down from generation to generation by altering the DNA in sperm and
egg cells.

McBride was struck off the Australian medical register in 1982 after
he falsified results on another drug. McBride, who first warned of
the dangers of thalidomide 30 years ago, said he was afraid it
``could happen again.''