MANY ANSWERS ... MANY MORE QUESTIONS ABORTION PILL RAISES ISSUES AS IT PROVIDES SOLUTIONS.

Byline: Evan Henerson Staff Writer

As much anticipated as Mifeprex, the abortion pill, is, doctors seem just as anxious to get their hands on an instruction manual.

After extensive testing in Europe and through clinical trials in the United States, the drug was approved by the Food and Drug Administration in September and should be available to doctors in November. While doctors say they know how the pill works medically, still to be worked out are details. How much will it cost? What kind of counseling should accompany its use? Will state or federal regulations governing abortion clarify or cloud the already murky picture?

``The questions are more about what protocol will become common practice,'' says Dr. Stanley Henshaw, a sociologist and senior fellow with the Alan Guttmacher Institute, which tracks abortion data. ``There's a learning curve for doctors.''

Doctors will be able to start prescribing Mifeprex - known as RU-486 in France, the early option or abortion pill - in the next few weeks (no specific rollout date has been set). A two-dose regimen of Mifeprex (the manufacturer's name for mifepristone) and a second drug, misoprostol, allows women to terminate a pregnancy up to the seventh week after conception without a surgical procedure.

Referred to as a medical (as opposed to surgical) abortion, the pills will be dispensed in a physician's office, where a woman will sign a consent form agreeing to end her pregnancy and take the medication. At home she'll basically endure the equivalent of a planned miscarriage. The regimen requires three doctor's visits. Side effects include bleeding, cramping and possibly nausea, headaches and diarrhea.

Don't look for a repeat of doctors freely and openly dispensing the abortion pill as they did with Viagra. Mifeprex figures to enter the marketplace quietly, with few private-practice doctors advertising its availability. Women seeking a doctor to prescribe Mifeprex will probably go through the same channels they used to find a doctor willing to perform a surgical abortion - Planned Parenthood and referrals from family physicians or the National Abortion Federation.

A survey of more than 750 doctors conducted in April by the Henry J. Kaiser Family Foundation revealed that 44 percent of gynecologists and 31 percent of family physicians surveyed would be interested in prescribing Mifeprex to their patients. In addition, 31 percent of gynecologists who were not currently providers or who had never performed an abortion said they would consider prescribing Mifeprex.

Extra responsibilities could keep physicians who didn't perform surgical abortions from prescribing Mifeprex. In addition to being current on all state regulations, providers have to be able to perform a surgical abortion - or make one available - if the Mifeprex/misoprostol regimen isn't successful. Some state regulations require abortion providers to increase their office space, provide beds and even hire additional staff.

``A lot of physicians have never had any experience thinking about these issues,'' said Tina Hoff, director of public health information and communication for the Kaiser Family Foundation. ``Other factors inhibit the medication's use beyond a physician's interest in using it.''

California is one of eight states that requires patients seeking an abortion to obtain state-directed counseling before undergoing the procedure, a mandate that will apply to medical and surgical abortions. Unlike other states, California law does not mandate a waiting period between consultation and the procedure. Thus abortion ``counseling'' is often limited to a description of the medical procedure.

``Counseling and education are highly correlated with satisfaction in all abortion care, but it's particularly true of RU-486,'' said Dr. Miriam Cotler, a professor of medical ethics at California State University, Northridge. ``Who will do the counseling? How will it be done? What sort of follow-up or monitoring will there be?''

Abortion-rights activists believe a thorough briefing on the procedure, including how the abortion will be carried out and what sorts of side effects a woman can expect along the way, is all that's necessary.

``In California, state law does not treat women like children,'' says Deni Robey, spokeswoman for Planned Parenthood Los Angeles. ``It knows some women are clear about this decision without needing a lecture.''

Officials from anti-abortion organizations disagree.

``They need to know about fetal development, about the short-term and long-term side effects and possible psychological consequences, and they need to know that meaningful alternatives are readily available, that there are caring people ready to help them every step of the way,'' says Jenny Biondi, spokeswoman for the Right to Life League of Southern California, which operates crisis pregnancy centers and maternity homes.

And she is concerned the counseling element might be overlooked or ignored by women seeking a medical abortion.

``Abortion is a decision women make in fear and panic. The idea that they can just swallow some pills appeals to women. This doesn't give them a chance to weigh their options.''

At Planned Parenthood, a woman seeking a medical abortion will first undergo ultrasound to verify the pregnancy and determine whether she is within the 49 days since her last period as required by the FDA. A woman who wishes to proceed will review the procedure with a doctor or nurse practitioner - including potential side effects and the necessity of having a surgical abortion if the regimen fails. After signing a consent form, she can take the medication in the office.

Activists and doctors might also take special interest in the outcome of the November election, which could determine whether legislation will enter the picture.

``It's an open question over whether anyone from Congress will pursue restrictions over and above what the FDA has already imposed,'' said Caitlin Borgmann, state strategies coordinator for the American Civil Liberties Union Foundation's Reproductive Freedom Project. She doesn't expect legislators to pursue further regulations. ``I think it isn't really the best target for anti-abortion advocates to be taking up.''

State regulations are another matter, said Borgmann, though residents of California - a state with few restrictions on abortions - probably need not expect challenges to existing laws that would make medical abortions more difficult to obtain than a surgical abortion.

The effectiveness of Mifeprex - estimated to have a 92 percent to 95 percent success rate - seems to be the least of people's worries. The drug has been used extensively in Europe since it was approved for use in 1988. More than 2,000 women in the United States used the drug during clinical trials.

Misoprostol, on the other hand, has been pulled from certain hospitals since its manufacturer, Searle, sent out a letter - prior to Mifeprex's FDA approval - warning hospitals not to give the drug to pregnant women. The drug had previously been used to treat peptic ulcers.

``That's the huge issue now adding another layer of problems,'' said Dr. Allan Lichtman, a Tarzana-based gynecologist and clinical professor of obstetrics and gynecology at USC Medical Center.

But Dr. Mary Gatter, medical director at Planned Parenthood of Los Angeles, doesn't expect many doctors to heed Searle's warning. Misoprostol, which acts as an agent to expel the embryo, is one of the least expensive and most effective drugs - known as prostoglandins - of its kind, said Gatter.

``There's a lot of data showing it to be safe and effective,'' said Gatter, adding that other manufactured brands of prostoglandins are far more expensive and less easy to use. ``I can't see us using anything else.''

Even so, it's not clear what segment of the population will be able to afford medical abortions. Danco Laboratories, which manufactures Mifeprex, has not set a price for consumers or physicians.

``It's the same argument people bring up for fertility drugs: If a woman truly has a choice, should that choice be dependent upon the pocket book,'' said Cotler. ``Will this be available in public hospitals and to the poor?''

Although Planned Parenthood, like Danco, hasn't settled on pricing, Gatter expects medical and surgical abortions to cost roughly the same so women electing to end their pregnancies don't choose one option over another solely based on cost.

HOW THE ABORTION PILL WORKS

The drug Mifeprex ends a pregnancy during its early weeks by preventing the fertilized egg from developing in the uterus.

1 Must be taken in the first seven weeks of pregnancy (within three weeks after woman misses a menstrual period)

Drug blocks ovaries' creation of the hormone progesterone 

Drug makes lining of uterus break down as it does in normal menstruation 

2 Two days later, she takes misoprostol, a hormone that makes the uterus contract

The uterus lining and embryo are expelled through the cervix 

3 After two weeks, the woman returns for a follow-up exam to make sure pregnancy has ended.

Studies have shown RU-486 is 95.5% effective in causing abortion when taken within the first 49 days of pregnancy.

SOURCES: Alan Guttmacher Institute, Population Council, Associated Press Graphic/LEE HULTENG

What you should know about Mifeprex

What is Mifeprex?

Mifeprex is the Food and Drug Administration-approved pill for ending early pregnancy. When taken in conjunction with misoprostol, Mifeprex is 92 to 95 percent effective in ending an early pregnancy.

Also known as the early option pill and the abortion pill, Mifeprex is the manufacturer's name for the drug mifepristone. RU-486 is the name of the drug in France; the RU refers to Roussel Uclaf, the French manufacturer.

When is Mifeprex appropriate?

The pill can be used to end a pregnancy from the first time a woman knows she is pregnant up to 49 days after the beginning of her last menstrual period.

How and where has the drug been tested?

More than 2,000 women in the United States participated in clinical trials, with results being published in the New England Journal of Medicine and the American Medical Association's Archives of Family Medicine. In the past decade, more than 500,000 women in Europe have used the drug to end early pregnancies. It has been approved for use in 18 countries.

How is Mifeprex administered?

A woman makes three visits to a doctor's office or clinic over a two- week period. At the first visit, she is given a medication guide explaining how the medication will work; receives counseling and signs a statement that she has agreed to end her pregnancy. She takes three 200-milligram tablets of Mifeprex. Two days later, she returns and takes two 200-milligram doses of misoprostol.

During a follow-up visit, approximately 12 days later, a doctor checks to see whether the pregnancy has been terminated.

How does a woman get Mifeprex?

Consult with your physician or a local Planned Parenthood.

Is Mifeprex available over-the-counter or by prescription at a local pharmacy or over the Internet?

Only a physician is authorized to distribute and administer the medication.

What if the regimen doesn't end the pregnancy or if there are complications?

Some women will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health-care providers will communicate to their patients how to handle this possibility.

What are the side effects of Mifeprex?

Bleeding and cramping are considered a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of nine to 16 days. Women who experience severe bleeding should contact their doctor immediately.

Side effects may also include headache, nausea, vomiting and diarrhea.

How much does it cost and will insurance plans pay for it?

Danco Laboratories, which manufactures the medication, has not set a price on Mifeprex. Consult with your insurance carrier to find out if or how much of a Mifeprex regimen is covered.

Is this the same thing as emergency contraception or ``morning after'' medication?

No. Emergency contraception is a high dose of hormones found in birth control pills that prevents pregnancy up to 72 hours after unprotected sexual intercourse. If a pregnancy has already occurred, emergency contraception will not end it and will not harm the developing fetus.

-Evan Henerson

- Sources: Planned Parenthood, Danco Laboratories.

CAPTION(S):

photo, 2 boxes

Photo:

(1 -- cover) Questions remain as abortion pill becomes available

Box: (1) HOW THE ABORTION PILL WORKS (see text)

(2) What you should know about Mifeprex (see text)