THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Sunday, August 11, 1996 TAG: 9608110065
SECTION: FRONT PAGE: A1 EDITION: FINAL
SOURCE: BY MARIE JOYCE, STAFF WRITER
DATELINE: NORFOLK LENGTH: 139 lines
Gary D. Hodgen sets a small bottle on his conference table. Made of yellow-brown glass, it holds whitish pills smaller than aspirin tablets. The label is French. The medication has long since expired.
Hodgen carried this bottle from Paris in the early 1980s. He wanted to run some experiments on the drug inside, which offered potential treatment for a variety of illnesses - cancer of the breast, and cancer of the lining of the brain and the uterus. It might ease childbirth and help make menopause hormonal treatments less unpleasant.
But these pills are RU-486, the controversial French abortion drug. For many years, research has been stalled by the ferocious debate about the medicine's primary use. Now, it's about time the scientific community develops the drug's other uses, says Hodgen, head of the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School.
Last month, the drug was approved for abortions by advisers to the federal Food and Drug Administration. Although the FDA must decide whether to accept the recommendation, it rarely contradicts its advisory panels.
The drug, also known as mifepristone, ends pregnancies by blocking the action of the hormone progesterone, preventing a fertilized egg from taking root in the wall of the uterus.
Hodgen and his colleagues, and scientists elsewhere, have done preliminary experiments that hint at the pill's potential for other uses. But very few in-depth studies have been run.
``The political chemistry has been against doing it,'' Hodgen said.
Although Hodgen and other researchers may be eager for FDA approval, Olivia Gans is not. Gans, an anti-abortion activist and spokeswoman for the National Right to Life Committee, fears it would lead to more abortions in the United States.
``That's far too high a price to pay'' for unproven medical benefits, she said.
Although Americans can't get the drug from their doctors, Hodgen has pressed ahead with experiments, publishing more than 30 articles on possible nonabortion uses for RU-486 and a related class of drugs. All told, scientists have written about 700 journal articles on the subject.
The small studies don't prove much, but they show enough promise to warrant more testing, Hodgen said. He lists several potential uses identified by scientists:
Dilating the cervix during childbirth to reduce the need for Caesarean sections.
Slowing the growth of some types of breast cancer, cancer of the lining of the uterus, and meningioma, a cancer that attacks the membranes surrounding the brain.
Reducing bleeding sometimes caused by estrogen replacement therapy in menopause - a side effect that prompts some women to drop the treatment.
Reducing lesions and pain of endometriosis, a condition in which tissue lining the uterus migrates to other parts of the body.
Treating Cushing's syndrome, a metabolic disorder caused by too much production of the hormone cortisol.
Hodgen first saw RU-486 on a lecture trip to Paris in the early 1980s. A doctor working for the French company that developed the drug showed Hodgen this new abortion pill.
The characteristics of the drug hinted it might have other uses. Hodgen, who worked for the National Institutes of Health at the time, carried a supply of the little bottles home in his briefcase. He didn't realize he would have to rely on that supply for years.
The FDA banned import of the drug for personal use in 1989. Although that action didn't apply to researchers, U.S. scientists found it hard to get the drug from its manufacturer, which didn't want to get sucked into the abortion controversy here.
Hodgen conserved his supply. He never looked at the long-term effects of the drug, because that would require a lot of pills. His longest study was three months.
As word got out that he had a stash, he began getting calls. As many as 200 people asked him for a supply. They didn't want abortions, he said.
He remembers a Chicago women desperately seeking even a speculative treatment for inoperable meningioma. This cancer doesn't spread to other parts of the body, but it can grow large enough to squeeze the brain.
He told her he could supply the drug only if she got dispensation from the FDA. Some patients succeeded in getting permission, but she didn't, said Hodgen, and he wouldn't violate professional ethics by slipping her a batch.
``She died,'' he said. ``The circumstances were so foreboding that people couldn't even get help to try to get the drug.''
President Clinton ordered the FDA to re-examine the ban in 1993. Supply problems eased. But research money has been scarce.
Hodgen believes that if the FDA resolves the abortion issue, the drug's other uses won't spark controversy anymore.
But that doesn't mean the drug will be available for nonabortion uses any time soon. ``Your neighborhood pharmacy will not have RU-486,'' Hodgen said.
Usually, drugs that are approved for a certain type of treatment by the FDA may also be used by physicians for other, unrelated treatments that have shown results in clinical trials. It's known as ``off-label'' use.
However, it's unclear, what, if any, restrictions would be placed on the use of RU-486 if the FDA approves it, said FDA spokeswoman Carole Schiffman.
``We can't speculate on the indications,'' she said.
The National Right to Life Committee does not oppose the drug's nonabortion uses, said Gans, the spokeswoman.
Yet even if the drug proves useful in nonabortion treatments, Gans questions its value when balanced against the cost of allowing it into the United States.
``We must not forget the sole and primary debate before the FDA is use of the drug for abortion purposes,'' said Gans.
But Hodgen considers how much time has been lost by the debate. Without the controversy, doctors might have had new treatments available 10 years ago, he said.
``It's a pity,'' he says.
On his conference table, next to the little bottle from France, he has set a white, plastic container about the size of an ice bucket. Inside, a clear bag bulges with 1,000 tablets of RU-486. He has six of these buckets.
``This whole story revolves around those little pills,'' he says. ``Can you imagine that?'' ILLUSTRATION: BILL TIERNAN color photos/The Virginian-Pilot
Graphic
RU-486
How does it work for abortions?
RU-486, also known as mifepristone, acts by blocking the action
of the hormone progesterone, interfering with a fertilized egg's
implantation on the wall of the uterus. The synthetic drug comes in
pill form.
Two days later, the woman receives another drug, prostaglandin,
that causes the uterus to contract and expel the uterus lining and
fetus.
RU-486 works 95.5 percent of the time when taken within the first
seven weeks of pregnancy. A woman must be examined soon afterward to
see if the abortion has taken place. Although somewhat painful,
serious complications are rare.
What are other potential uses?
Although most research is in very early stages, studies have
shown that RU-486 may be useful in treating endometriosis;
endometrial cancer; some types of breast cancer; meningioma, a
cancer of the lining of the brain; and Cushing's syndrome. It also
may help stop bleeding caused by estrogen replacement therapy, and
help dilate the cervix during childbirth.
KEYWORDS: MEDICATION ABORTION RU-486 by CNB