Chat Transcript: Dr. Daniel Mishell Discusses RU-486
Sept. 28 -- 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.
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