Chat Transcript: Dr. Daniel Mishell Discusses RU-486
Sept. 28, 2000 -- This week the U.S. Food and Drug Administration decided to approve the sale and distribution of the controversial drug mifepristone or RU-486 — the so-called abortion pill. RU-486 was created more than 20 years ago and is widely marketed in Europe, but advocates in this country have faced many obstacles in their battle to bring RU-486 to American women. What are the medical concerns for women regarding the use of RU-486? Will abortion opponents be able to continue to keep the drug out of this country?If RU-486 is approved, how will this redefine the pro-abortion-rights and anti-abortion movements?
Dr. Daniel Mishell Jr., chairman of obstetrics and gynecology at the Keck School of Medicine of the University of Southern California joined us today in an online chat to discuss the FDA decision.
Mishell has been a principle investigator in RU-486 trial research and has been a leading researcher and developer of birth control pills over the past 30 years.
Moderator at 4:29pm ET
Welcome Dr. Mishell.
Dr. Daniel Mishell Jr. at 4:30pm ET
The US Food and Drug Administration today approved the distribution of the pill mifepristone, which, when given with another pill, can effectively and safely induce abortion in women who are less than seven weeks pregnant. This means less than seven weeks since the onset of their last menstrual period, which is actually five weeks after conception.
Patty at 4:31pm ET
What side effects if any are there with this drug?
Dr. Daniel Mishell Jr. at 4:31pm ET
The side effects are mainly related to the second drug that's given, which causes contraction of smooth muscle. Contraction of the uterine muscle causes cramps and abdominal pain. Contraction of the muscles in the gastrointestinal tract can cause nausea, vomiting, and diarrhea.
Dr. Daniel Mishell Jr. at 4:32pm ET
Another side effect is excessive blood loss from the uterus. The average duration of bleeding after the pills are given is about nine days, but some people can bleed for two to three weeks. Some people can bleed fairly heavily, and have to have a surgical procedure to stop the bleeding.
Moderator at 4:33pm ET
R.M. asks:Hurray-it's approved! How will the public get access to the RU-486 pill? Will it be a prescription drug or over-the-counter? The cost is very steep. What are the differences in using the RU-486 and "double-doses" of regular birth control pills "the morning after"?
Dr. Daniel Mishell Jr. at 4:34pm ET
This drug -- mifepristone or RU-486-- is effective as a morning-after pill, but that's given before pregnancy. It has to be given 24 hours after mid-cycle sexual intercourse. That's not what the drug was approved for by the Food and Drug Administration. It was approved to terminate an already established pregnancy that was in the uterus, after a woman knows she is pregnant and has a positive pregnancy test. This is totally different than the morning-after pill, which is emergency contraception, which occurs before the egg is fertilized.
Dr. Daniel Mishell Jr. at 4:35pm ET
The other question was how will it be available: not over the counter, not from pharmacists. It will only be available from a physician or from a clinic at which a physician is present. It probably will not be available for at least one month from today.
Aaron at 4:35pm ET
I'm concerned with backlash from this decision. Is there a framework for protecting information about which doctors will be dispensing the drug? How about protecting the firm that has agreed to market it?
Dr. Daniel Mishell Jr. at 4:36pm ET
The firm that did market it knew about the concerns of people who are against abortion before they obtained the rights to market the drug from the Population Council. As far as physicians are concerned, they can write a prescription, and this is information is not accessible to the general public.
Moderator at 4:37pm ET
Eileen asks:May RU-486 be used regularly after sex, as a form of birth control?
Dr. Daniel Mishell Jr. at 4:37pm ET
No. This is not a contraceptive, and it is not approved to prevent pregnancy. It's approved to terminate an early pregnancy that's already been established with a positive pregnancy test.
Susan E. at 4:37pm ET
What are the reasons it has taken ten years to get approval for RU-486 in the United States after approval in Europe. Are there real medical concerns or are the issues more political?
Dr. Daniel Mishell Jr. at 4:40pm ET
I'm not working for the Food and Drug Administration, so I can't answer that question, except that the agency wanted a study done in the United States, which was completed in 1997, and then they gathered that information to determine the safety and effectiveness, and then made their decision for approval. Now, in the clinical studies in the United States, the two drugs were given up to nine weeks gestation. Because of the decreased effectiveness after seven weeks, the approval was only given for pregnancies of less than seven weeks.
The agency also wanted to determine that the clinicians prescribing it had the ability to care for the complications, particularly excessive bleeding, so included that in the labeling, that the clinicians either needed to have skills in emptying the uterus surgically, doing a curetage, or had the ability to refer the patient to another physician who could perform this procedure for women with extensive blood loss. I'm sure the agency wanted to protect American women from the complications that can occur with this medication.
Moderator at 4:40pm ET
Who should not take this drug? Are there other medical conditions that could cause complications when RU-486 is taken?
Dr. Daniel Mishell Jr. at 4:42pm ET
Remember this is two drugs, it's not just one. The contraindications that occur with women with ectopic or tubal pregnancies, patients who have an IUD in their uterus, patients who have failure of their adrenal glands, patients who have had corticosteroids for a long time, and those with an allergy to both mifepristone and the other drug, misoprostol; and women with bleeding disorders who are taking blood-thinning medication.
Moderator at 4:42pm ETHow do you respond to the comment that the pill will increase the number of abortions in the United States?
Dr. Daniel Mishell Jr. at 4:45pm ET
Each year there are about 1.2 million abortions done in the United States. 42% of women in this country will have had an induced abortion by the time they reach age 45. One out of every four recognized pregnancies is terminated by abortion right now-- it's about six million pregnancies each year in the United States, and I guess about 1.5 million are terminated by abortion. It's estimated that about a third of the pregnancies that end in a birth are unwanted or unplanned.
Many women do not have access to surgical abortion. So it is possible that distribution of this agent will allow more unplanned, unwanted pregnancies to be terminated by abortion, because many women in the United States do not have access to surgical abortion. But this is a very common phenomenon in our country. The abortion rate in the United States is higher than any other Western country, including Japan. All I can do to respond to that question is say that, by making abortion easier, maybe there will be less unwanted pregnancies and unwanted children born.
Moderator at 4:45pm ET
Why isn't the drug recommended after seven weeks?
Dr. Daniel Mishell Jr. at 4:47pm ET
It's not as effective after seven weeks. In the studies that were done, the effectiveness was-- the drug was 92% effective less than seven weeks, and it dropped down to less than 83% between seven and eight weeks, and dropped down 77% between eight and nine weeks. That was in the United States study.
Lisa from dsl.austtx.swbell.net at 4:48pm ET
I just read an article in which women who were in the RU-486 clinical trials talked about their experiences. Some of them said there was significant pain (similar even to labor pain) after they inserted the second set of pills which cause the contractions (even though most said they would choose this method again). Is this method of abortion more painful than a traditional surgical abortion? Does it have less risk of complications?
Dr. Daniel Mishell Jr. at 4:49pm ET
Women have pain because the medication makes the uterine muscle contract. In the studies, the further along the pregnancy the greater the pain. So that in the clinical studies almost -- let me just say 98% of the women had abdominal pain. 68% received some type of medication for this pain. 29% received some type of codeine with the painkiller. So the pain is one of the side effects, as I mentioned earlier. With surgical abortion, usually some type of anesthetic is given, so it's not as painful, and it's over more rapidly. So that's the difference between the two techniques.
belinda at 4:50pm ET
Has there been any reported deaths from this pill?
Dr. Daniel Mishell Jr. at 4:51pm ET
Not with this pill by itself, or with the other pill that's being given in the United States. That second pill is called a prostaglandin. With a more potent type of prostaglandin that was used in Europe a few years ago, there were a couple of deaths. But not with the agents that have been approved by the FDA.
Moderator at 4:52pm ET
How do the two drugs actually work?
Dr. Daniel Mishell Jr. at 4:54pm ET
There are two drugs. One is the mifepristone, and that blocks the action of the hormone progesterone. Progesterone, in early pregnancy, maintains the lining of the womb where the fertilized egg implants, and also prevents the uterus from contracting. That's why the uterus gets so soft as pregnancy goes on.
But this agent blocks the action of progesterone. There's a separation of the lining of the womb from the embryo, and its surrounding tissue. Then, two days later, the other pill is given, which causes the muscle of the uterus to contract. Then bleeding occurs and the embryo is released from the wall of the uterus and is expelled. That's why two different pills are given.
Moderator at 4:54pm ET
Will RU-486 be available immediately?
Dr. Daniel Mishell Jr. at 4:54pm ET
According to the information submitted by the company, it won't be available until at least four weeks from today.
Tiffany from proxy.aol.com at 4:55pm ET
Wouldn't this pill be much safer than a surgical procedure, because there is no possibility of an accidental uterine lining perforation?
Dr. Daniel Mishell Jr. at 4:55pm ET
That's correct. That happens very infrequently with early pregnancy, but it's always a possibility that the instrument can perforate through the uterus and cause damage. But this usually occurs later on in pregnancy.
Lisa from dsl.austtx.swbell.net at 4:56pm ET
Which method has more risk of complications -- RU-486 or early surgical abortion?
Dr. Daniel Mishell Jr. at 4:57pm ET
There are very few risks with either one, and I don't know if a direct comparison has been done. It would take a very large number of patients, because the serious complication rate is so low with both techniques at this stage of pregnancy. Where the problems with surgical abortion come in are usually with pregnancies of more than twelve weeks gestation. That's where complications start to increase. But less than seven weeks, they're very uncommon.
Cheryl from dsl.lsan03.pacbell.net at 4:57pm ET
Does a woman have to sign a release to allow the pill to be given. How do you protect the doctor if the patient later says she didn't want the pill or she didn't want to terminate the abortion?
Dr. Daniel Mishell Jr. at 5:00pm ET
According to the release from the company, the woman on her first visit receives a medication guide, which explains how this works, and is counseled, and then takes the pills. Now, as far as consent goes, there is nothing in my reading that indicates that there has to be a consent. But the release from the US Dept. of Health and Human Services said that each woman receiving the drug will be given a medication guide that explains how to take the drug, who should avoid taking it, and what side effects can occur. I think it would be appropriate to have a consent form signed by the patient, saying that she wishes to take this medication.
Moderator at 5:00pm ET
What might be the difference in psychological effects of taking this pill compared to the surgical procedure?
Dr. Daniel Mishell Jr. at 5:02pm ET
I can't answer that question. It depends upon the individual woman. What are the effects of terminating a pregnancy surgically or medically- some women would prefer one way and some would prefer another. As I said, the two options are available. Because for the woman who chooses the medical abortion, it's more like a typical miscarriage, and she might prefer that. But I have no idea about the psychological outcome. I will say this: it's more important to prevent pregnancies than to terminate them. And it's important for women who don't want to become pregnant to use effective contraception.
Moderator at 5:02pm ET
Are there any restrictions on who can prescribe the drug?
Dr. Daniel Mishell Jr. at 5:04pm ET
There are restrictions on distribution of the drug. The restrictions listed by the FDA are that it can only be distributed to physicians who can accurately determine the duration of a patient's pregnancy and can detect an ectopic or tubal pregnancy. And they must also be able to provide surgical intervention in cases of a partial abortion or severe bleeding, or they must have made plans in advance to provide such care through others.
Moderator at 5:06pm ET
Doctor tell us about your work with RU-486 during clinical trials.
Dr. Daniel Mishell Jr. at 5:09pm ET
Yes, we treated more than 250 women at this site.
Moderator at 5:09pm ET
Doctor Mishell do you have any final thoughts to share?
Dr. Daniel Mishell Jr. at 5:10pm ET
This drug was developed 15 years ago. It has been used in Europe since 1988. Clinical studies were done in the United States in the mid-1990s. It was found to be safe and effective. And it was approved by the FDA after careful evaluation of the scientific evidence related to the safe and effective use of the drug. And it's an option that should be available to American women, because so many pregnancies- about half the pregnancies in the United States-- are unwanted. And half of those, about a quarter of all pregnancies, end up terminated by abortion.
Many women don't want to have a surgical procedure to terminate a pregnancy. This procedure is more like a miscarriage, and that is preferable for some women. Nearly half of women in the US by the age of 45 will have had an abortion: it's not an uncommon thing. Since science has developed this option, and it's shown to be safe and effective, I think American women should have access to it.
Moderator at 5:11pm ET
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