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Abortion Pill's Potential Use on Tumors
Adds to Debate Over U.S. Market Entree
By Ron Winslow
Staff Reporter of The Wall Street Journal
SO WALL STREET JOURNAL (J), PAGE B8
LP LOS ANGELES -- Medical researchers are studying a potential new
* use for the controversial French abortion pill RU-486: treatment
* benign brain tumors.
A large-scale clinical trial was launched at the University of
* Southern California last week to determine whether the drug
effectively slows or halts growth of meningiomas, tumors that
* on the surface of the brain and spinal cord.
TX The answer won't be known for several years, but the study adds
another dimension to the debate over whether the drug, known as
mifepristone, should be allowed on the market in the U.S.
Rousell-Uclaf, its manufacturer, hasn't sought marketing approval
the U.S. because of the heat of the political battle over
The study raises the possibility that a drug that could benefit
patients won't become available because of a political dispute
"There is a good chance there will be legitimate uses for this
drug outside of contraception and abortion," said Steven Grunberg,
an oncologist at the USC School of Medicine. "Whether U.S.
regulatory officials feel this will be sufficient for licensing
be up to them."
A study published last week found the drug to be effective as a
contraceptive when taken shortly after sexual intercourse. It is
already used in France, the United Kingdom and Sweden to induce
abortions within the first nine weeks of pregancy.
Meningiomas account for 15% to 18% of all tumors in the central
nervous system, and while they are benign -- meaning that they
spread to other parts of the body -- their growth can lead to such
problems as seizures, blindness or paralysis. Most can be removed
* surgery, but some grow so close to crucial brain structures that
surgery isn't possible.
Dr. Grunberg told reporters at a science writers' conference
sponsored by the American Medical Association that the large-scale
* trial of RU-486 for the tumors comes after a small pilot study of
patients turned up encouraging, though not definitive results.
In the small study, eight patients experienced improvement in
* symptoms or had minor reduction in tumor size, according to brain
scans. In a few other patients, growth of the tumor stabilized
treatment began. While not overwhelming evidence of effectiveness,
the results were nevertheless sufficient to persuade the Food and
Drug Administration to approve a large study that will involve 200
patients at several U.S. medical centers, and will be based at
Dr. Grunberg said.
Results from the trial aren't expected for at least four years,
and based on current medical practice, only a small number of
* would probably benefit from use of RU-486 in meningiomas. The
might have broader impact by drawing attention to other potential
benefits of a drug that isn't available in the U.S. because its
primary application is to induce abortion.
Dr. Grunberg said the drug is also being studied as a treatment
for breast cancer, endometriosis and a disorder called Cushing's
disease, which is characterized by obesity and hypertension.
other trials have been approved by the FDA, he added, though none
has progressed as far as the meningioma study.
* He said his research team came upon RU-486 as a candidate for
treating meningiomas because the drug blocks the action of
progesterone, a hormone that appears to promote growth of the
tumors. "We didn't set out to make a political statement for
* RU-486," he said. "It just appeared to fill the bill for what
trying to do."