Note the quote near the end - a clinician reports 2/3 response in 100 brain cancer patients with 1/3 having cancer "disappear."
Headline: Infamous Drug Is Making a Comeback
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By PHIL GALEWITZ
AP Business Writer
NEW YORK (AP) - Diagnosed with brain cancer, Elizabeth
Narcessian did not hesitate when her doctor prescribed thalidomide
- the drug banned a generation ago after it led to thousands of
deformed babies.
''When you have a life-threatening illness and you are with a
doctor you trust, you do anything,'' said Narcessian, 40, of
Ridgewood, N.J., who credits the drug with helping to shrink her
tumor.
Thalidomide, approved by regulators in July to treat a
complication from leprosy, is making a comeback extending well
beyond that rare disease.
Narcessian's doctor is one of a growing number prescribing it
for some of the deadliest cancers even though tests have yet to
definitively prove it works.
Wall Street seems to have already decided. Shares in Celgene
Corp., now the only U.S. seller of thalidomide, have more than
doubled in the past month from $8 to about $16 after the company
bought marketing rights to the drug from its closest rival.
Analysts predict that thalidomide will post $45 million in sales
this year, $70 million in 2000, and possibly $300 million within
five years. While those are figures are tiny compared to the $3
billion in sales generated by the world's top-selling drugs, the
money would still represent a huge payday for Celgene. The
12-year-old company has lost more than $40 million in the last two
years. The drug costs $7.50 to $30 per day, depending on the
dosage.
''Thalidomide has a lot more potential that most people
originally thought,'' said Maureen McEnroe, an analyst with HCFP
Brenner Securities in New York. ''People who did not believe in it,
are now jumping on the bandwagon.''
Not everyone in the medical community is convinced.
''Thalidomide does not yet appear to be a shining star,'' said
Dr. Ajrmon Eyre, executive vice president for research at the
American Cancer Society. Eyre said it hasn't always worked and he
prefers to see final test results before reaching a conclusion on
its effectiveness.
In addition, even the doctors prescribing it are doing so only
after other less dangerous drugs fail.
Thalidomide, originally intended for morning sickness and as a
sedative for pregnant women, was banned worldwide in the 1960s
after causing 12,000 babies to be born with no limbs or flipperlike
arms and legs, serious facial deformities and defective organs. The
pill had been sold in 48 countries - but not in the United States
because an FDA scientist uncovered early danger signs.
Then, in the early 1990s scientists discovered thalidomide could
be a potent treatment. In addition to cancer, testing is now
underway in patients with AIDS, lupus and other diseases.
Thalidomide, which Celgene sells under the brand name Thalomid,
works by cutting off the blood supply to tumors, which inhibits
their growth. When combined with chemotherapy or radiation therapy,
the cancer cells, in theory, die of starvation.
Narcessian, who is a physician specializing in rehabilitation
medicine, said taking the drug gives her a psychological edge
because she feels as if she is actively fighting the cancer even
after completing six weeks of radiation therapy. She said she has
experienced no side effects and her insurer, Aetna, is paying for
the pills.
About 200 thalidomide prescriptions are being written a week,
according to IMS Health, a market research firm. Nearly two-thirds
of the prescriptions were written for cancer patients.
Celgene essentially cornered the U.S. market on thalidomide last
month, signing a collaboration agreement with chief rival EntreMed
Inc., which did not have federal approval for Thalidomide, but was
further ahead in cancer research. The agreement gives marketing
rights to Celgene, requiring it to pay EntreMed royalties.
Celgene has prepared for the obvious legal risk in selling
thalidomide by enacting strict rules to make sure pregnant women
don't take it. All women must undergo repeated pregnancy tests, and
men and women must sign statements acknowledging they were
instructed to use effective birth control.
Celgene allows prescriptions to be dispensed only by doctors and
pharmacists that the company trains about thalidomide's dangers. So
far, more than 2,000 physicians and 2,000 pharmacists have signed
up.
Will patients take a drug with such a notorious past?
''You are talking about people on death's door,'' said Dr.
Michael Gruber, director of neuro-oncology at New York University
Medical Center. He said about two-thirds of the roughly 100 brain
cancer patients he has treated with thalidomide have responded
positively, including one-third who have seen their cancer
disappear.
Narcessian knows she made the right decision with thalidomide.
''I have an 8 year-old-daughter,'' Narcessian said. ''And last week
she said 'Mommy, you don't look sick anymore.'''
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