Early Options Gaining Ground: Q&A on Medical Abortion With Dr. Elizabeth Newhall

Interview byArielle Lutwick

In September 2000, the U.S. Food and Drug Administration approved mifepristone, the drug also known as RU486, for medical (non-invasive) early abortion. Mifepristone works by blocking the hormone progesterone, which is needed fora pregnancy to continue. When used in conjunction with another drug, misoprostol, the method is effective for ending unwanted pregnancy between 92 and 98 percent of the time.

The FDA-approved treatment regimen for mifepristone—brand name Mifeprex® —is for use up to 49 days after a woman's last menstrual period. Once pregnancy is confirmed, the woman takes 600 mg of mifepristone orally. Two days later, she takes 400 micrograms of. misoprostol, which stimulates uterine contractions to expel the pregnancy. She is required to return for a follow-up visit approximately 14 days after taking mifepristone to confirm that the pregnancy has been terminated. More recent studies have shown the safety and efficacy of modified regimens, including lower doses of mifepristone, administering misoprostol one, two or three days after mifepristone, and administering misoprostol at home.

I recently spoke with Dr. Elizabeth Newhall, an obstetrician-gynecologist in Portland, Oregon. She is the medical director at Downtown Women's Center, a 25-year-old abortion clinic, as well as a private practice ob-gyn at Everywoman's Health, P.C. Dr. Newhall began providing medical abortions in 1994 while serving as co-principal investigator for the Population Council's clinical trials on mifepristone. She was a key presenter to the FDA at its advisory committee meeting in July 1996.

Arielle Lutwick: Dr. Newhall, how long have you been providing medical abortion?

Elizabeth Newhall: I began work on mifepristone medical abortion in 1994 in my practice at the Downtown Women's Center as part of the clinical trials conducted by the Population Council. About 200 women participated in the initial study. Later, I worked on research protocols exploring simplified regimens and ways to expand access to the method.

AL: Do you continue to use the same protocol as was used in the clinical trials?

EN: No. The FDA-approved protocol was already outdated by the time mifepristone was approved in 2000. During the clinical trials, patients had to come to the clinic for three visits—first for counseling and mifepristone, second for misoprostol and monitored expulsions, and third for follow up. Research has shown that three visits are just not necessary. Experience has permitted us to establish evidence-based regimens that extend the method up to 9 weeks after a patient's last menstrual period with fewer failures and arguably fewer side effects than we had in the first trial.

AL: How is your protocol different from the FDA-approved regimen?

EN: Our regimen is 200 mg of mifepristone by mouth, followed by 800 micrograms of misoprostol 24 to 48 hours later (four tablets that are placed vaginally). We advise women to do it in two visits. Women come in for an initial counseling and mifepristone, and are given the misoprostol to administer at home two days later. They return to the clinic two weeks later for follow up. We used to give them the choice of returning to the clinic for the misoprostol but no one ever did. Research from both the U.S. and abroad shows that women can safely and effectively administer misoprostol without clinic staff or facilities.

AL: When patients come to the clinic, how do you help them prepare for a medical abortion?

EN: When a woman comes in, she is counseled by a nurse about the procedure and her options. The nurse explains how mifepristone works, the possible side effects, and what she can expect related to bleeding. We document the location of the patient's nearest hospital and make sure she will have someone with her during the process. We don't do this because medical abortion is a dangerous process, but rather because it is more comfortable and reassuring for her to have company.

We instruct women to take a day off to administer the misoprostol and to begin the process in the morning. Some women take two to four hours to expel the pregnancy, some six to eight hours. The vast majority of women will expel the pregnancy in this amount of time. We advise beginning the process in the morning, so if there is a problem or they have concerns, they can easily contact the clinic. We give them a prescription for pain medication, advise them to stay hydrated, and to rest. Some women experience a few hours of hard cramping. Others may experience a minimal amount; it's hard to predict. The more comfortable and patient a woman is, the easier it is likely to be.

AL: What is the success rate?

EN: The success rate has been very good. We have had to do suction curettage on only 2 percent of the over 1,000 medical abortions we have performed since 2000. It's interesting because 1 to 2 percent is also the likelihood of having to do a repeat aspiration with surgical abortion. [Suction curettage is a method of surgical abortion usually performed in the early stages of pregnancy. The cervix is dilated, a small, flexible plastic tube is inserted into the uterus, and the contents of the uterus are gently removed by manual vacuum aspiration or by a suction machine. A repeat aspiration is a vacuum or suction abortion performed a second time to remove any tissue that remains in the uterus.]

AL: Media reports sometimes play up the risks of heavy bleeding. Has this been a problem for your patients?

EN: The angst over safety, like bleeding and other serious adverse events, has not come from women or providers. It has come from the antichoice groups, who are the only ones wringing their hands about the dangers of medical abortion. We do give precautions about normal blood loss associated with the procedure and try to educate women about what to expect. We tell women if they bleed through more than two pads an hour for more than two hours they should come in. This almost never happens. Acute bleeding cases are extremely rare—only about .4 percent. Most women who need d&c after medical abortion are having ongoing bleeding. [D&C (dilation and curettage) is sometimes used if another abortion method fails to completely remove the contents of the uterus. The cervical canal is dilated with a small probe, and a curved instrument (curette) is inserted into the uterus and used to gently scrape the uterine lining.]

AL: How have your patients found the method?

EN: Many women really want to avoid surgery whenever possible. Other women want the process to be as "natural" as possible. For these women, taking a series of pills and expelling the pregnancy— some say, "like a miscarriage"— is a much more comfortable and less invasive process. It's also a huge relief for some women to go through the process at home, in a familiar environment, and where they can be with family members or friends.

For other women, this is clearly not the best method. There will always be those who prefer the speed of suction aspiration. Some women's choices will change from week to week. It's important not to rave about how great one method of abortion is over another. There is more diversity among women than among methods.

AL: As of the second anniversary of FDA approval of mifepristone, there had been approximately 100,000 medical abortions in the U.S. Does this seem low to you?

EN: Not at all. Whenever you introduce something new, it takes time to catch on. It is important to consider the time it takes for methods to become absorbed and acculturated into a society. It took about 15 years for tampons to become really widely used by women in the U.S. The longer something is around, the more accepted it becomes.

On the other hand, as women begin to learn about this new method, they have begun to choose it more and more. Following FDA approval of mifepristone, medical abortions accounted for 15 percent of all the abortions we perform. Since then, that percentage has almost doubled.

AL: You have two practices in which you provide abortion services. How easy was it to integrate medical abortion into your abortion services in general?

EN: Since we were lucky enough to have nurses already trained and experienced in medical abortion in the Downtown clinic, deciding upon and initiating a protocol was very easy. I review every chart, write the prescriptions, and nurses do the rest. They counsel patients, date pregnancies, and review the ultrasounds. Of course I'm available for any patient with problems, but there aren't that many. The level of expertise needed to provide medical abortion is readily found in non-physician providers. The important part of it is not the technical expertise, but rather the counseling, to inform women about the procedure and what to expect.

AL: Has the introduction of medical abortion been similar in your private practice?

EN: In contrast to the Downtown clinic, medical abortion is only rarely used in my private practice. Part of that stems from the small number of abortions we do—probably only about one to two per week. Women are more likely to contact an abortion clinic when they have decided to terminate a pregnancy rather than to call their regular doctors. Many don't think to ask their own doctor if they provide services. I cannot explain the glacial pace of my private practice colleagues to offer medical abortion when they readily provide surgical services to their patients. They are in all ways progressive, intelligent women. I think doctors are still scared this is going to take a lot of my time, and a scheduled case is more to our liking as surgeons! They somehow haven't incorporated the fact that not offering patients all of the available options is a problem. Every time you counsel a patient around pregnancy termination and surgical options, you should mention medical abortion as an alternative; I don't think many doctors yet feel they have the familiarity with the process to do this.

AL: You mentioned that mid-level providers play an important role in the Downtown clinic. How might that influence the provision of medical abortion ?

EN: Most doctors don't realize that just one doctor could facilitate four to five mid-level providers offering the service. That's how I see it fitting into the current health care model. Providing medical abortion requires an hour to an hour and a half of time to adequately date a pregnancy and counsel and educate a patient about the medical abortion process. It is not difficult, but it is very important that nobody goes into this who doesn't think they can handle the range of bleeding and cramping women experience with the process.

Abortion counseling—especially for medical abortion—requires a high level of patient-provider interaction, and in this culture of "drive-through" health care, that doesn't often happen with the doctor. In the Downtown center, the nurses have really loved providing the service. Patients appreciate the time spent with them. My next try for integrating medical abortion into the private practice will be to draft a protocol for our midwife. If a person is interested in learning, the learning curve is not that steep.

AL: Having been involved with medical abortion for almost a decade now, as a provider and an advocate, you must be a useful resource for your colleagues. Besides publishing your research, how you have informed your colleagues and other providers about medical abortion?

EN: I've been so exuberant about providing a new method that women are so integrally involved in for so long now, I confess I'm a little hurt my colleagues in the community are not asking me how to begin offering medical abortion to their patients. Maybe the folks at the university are getting more questions from interested providers, but I am still getting mostly referrals. When we were first setting up our Downtown protocols I sent out flyers indicating availability at our clinic, and offering to help doctors provide this service themselves for their patients. No one took us up on it.

AL: What do you think it will take for other providers to begin offering this service?

EN: The most powerful voice is of the patient. I think women are—understandably— not in a position to want to change the world when they are in the situation of being pregnant and seeking an abortion. That's not really the time for the choice battle. I have been in medicine long enough to know that the best way to change the status quo is for patients to insist that it be different. Doctors really do want to be responsive to patients' needs, but this is a hard topic for many women to initiate if they don't know their doctor's position on abortion, or if they don't trust them to be nonjudgmental about their decision.

While mifepristone is a safe and effective option for most women, it is not effective for ectopic pregnancies. A clinician should confirm that a woman has a uterine pregnancy before using it. It also is not appropriate for women who have an intrauterine device in place. Other contraindications relate to women who have bleeding disorders, certain allergies or have used medications that should not be combined with mifepristone, such as corticosteroids.

To learn more about mifepristone medical abortion, visit the National Abortion Federation's Medical Abortion website (www.earlyoptions.org} or the Reproductive Health Technologies Project's website (www.rhtp.org).

Arielle Lutwick is the programs and policyassociate at the Reproductive Health Technologies Project in Washington, D.C. Previously, as an intern for the Population Council, she worked on projects including expanding access to medical abortion in developing countries. She is a 2002 graduate of the University of Chicago.