A bitter pill
Health officials weigh the risks and benefits of legalizing the abortion drug RU-486
Posted: December 12, 2012
A nurse shows the RU-486 pill at Broussais Hospital in Paris, in October 2000. The drug originated in France, and has since been approved there as well as in the United States and the United Kingdom, among other places.
The so-called abortion pill could soon be on its way to the Czech Republic after the drug's European manufacturer confirmed it had applied for a marketing license in the country. If testing goes well, the pill will be available to doctors within six months.
RU-486, also known as mifepristone, has already been approved in around 50 countries worldwide, including the United States, the United Kingdom and France, from where it originated. Despite its lack of distribution here, the drug can still be purchased over the Internet, with "abortion kits" costing around 80 euros, according to daily Mladá fronta Dnes (MfD).
Previous attempts to get the pill marketed in the Czech Republic have failed, notably in 1994 when then-manufacturer Roussel Uclaf (owned by German chemicals firm Hoechst AG) pulled out of negotiations with the Health Ministry. At that time, the company refused to explain its decision, although it was widely attributed to opposition from Hoechst Chairman Wolfgang Hilger, a devout Roman Catholic.
The Czech attitude toward abortion, unlike that of its religious-minded neighbors, is largely tolerant, a position that has remained unchanged for several years. More resistance comes from the likes of Slovakia and Hungary, whose Parliament has blocked the use of RU-486, even though the national regulator gave it the green light in 2005. Under Polish law, meanwhile, terminations are strictly controlled and only allowed in certain circumstances, such as rape or incest.
News of the possible license has been praised by health bodies, who see the pill as an important tool in modern medicine, while also warning of the dangers of buying it on the black market. However, pro-life groups have slammed the move to legalize the drug, saying it provides another excuse for abortion.
Both the current manufacturer, Paris-based Exelgyn Laboratories, and the State Institute for Drug Control (SÚKL) declined to give further details on the status of the application, but Lucie Šustková, a spokeswoman for SÚKL, said the goal of the approval process is to ensure the pill is safe and effective.
"The fundamental requirements, as set out under the Pharmaceuticals Act, are detailed descriptions of the drug's characteristics like its chemical structure and quality," she said. "The drug must comply with stability tests, and production methods also have to meet official standards."
When RU-486 first appeared in France more than two decades ago, doctors hoped it would minimize the risks for women, as the procedure is less invasive than a surgical abortion. The drug, which shouldn't be confused with the so-called morning-after pill, is used during the first trimester of pregnancy and works by detaching the embryo from the uterus wall. A second drug, misoprostol, is taken afterward, inducing contractions that expel the embryo from the body.
Sold under the trade name Cytotec, misoprostol - more commonly used to treat gastic ulcers caused by anti-inflammatory medications - had its Czech distribution stopped in 2001 by manufacturer Pfizer for commercial reasons. However, Andrew Widger, a spokesman for the company, said Pfizer currently had no plans to reintroduce the pill here.
Clinical trials in a controlled setting have demonstrated the credibility of both drugs, but opponents argue the testing hasn't gone far enough. They point to an incident back in 2003, when U.S. teenager Holly Patterson died from septic shock just days after taking RU-486 to terminate her pregnancy at home. The 18-year-old's death prompted the unsuccessful congressional bill "Holly's Law," which tried to get the pill banned in the United States.
Anti-abortion groups have also joined the campaign to outlaw mifepristone, citing safety concerns as well as their own ethical issues. Radim Ucháč, president of the Czech Pro-Life Movement (Hnutí Pro život ČR), an organization that runs the annual "March for Life" in Prague, says the debate is heading in the wrong direction.
"Abortions might be legal, but everybody is calling for the minimum amount," he said. "So why should we expand the opportunity to kill a baby? It should be the opposite. The state should start looking at ways to really help pregnant women. Killing the baby doesn't achieve this."
The right to choose
During the communist era, any woman wanting a termination had to seek permission from a special health committee after going to her doctor. However, those rules were relaxed in 1986, opening the floodgates for a wave of abortions. In the latter part of the decade, the average number exceeded 100,000 per year, as authorities turned a blind eye to the practice.
Nowadays, that figure has fallen dramatically, thanks to better sex education and family planning. The liberal approach persists, though, with 72 percent of Czechs sharing the view that a woman alone has the right to decide what happens to her unborn child, according to a June poll by the CVVM agency. Given this apparent support, Radim Uzel, former director of the Family Planning Association (SPRSV), finds it strange RU-486 is still not available on the Czech market.
"I am surprised, because the Catholic Church doesn't have as much power here as it does in, say, Poland," he said. "I asked on several occasions if it was possible to establish the pill here, but the Catholic opposition was always strong."
A U.S. Food and Drug Administration report, published last year, showed that up until April 2011, 14 women had had a fatal reaction to the drug since it was launched in the United States at the turn of the century. Despite this statistic, Prague gynecologist Kateřina Bittmanová maintains both RU-486 and misoprostol have no long-term effects if prescribed correctly.
"I definitely think medical abortion has its place in gynecology today, but only as long as it's for select patients and under strict surveillance," she said. "The aims of medical abortion should be to help the patient, to prevent any damage and to avoid turning it into a form of easy contraception."
That view is echoed by Peter Koliba, an SPRSV board member. "I'm in favor of RU-486 being licensed here, because it's a very efficient way of ending a pregnancy in the early stages," he said. "However, such a drug should be in the hands of experts and administered by doctors."
Women must have a medical checkup 48 hours after ingesting the pill, during which time they will have suffered from heavy bleeding as the uterus cleans itself naturally. Bittmanová says the most common side effects are severe pain, nausea and vomiting, while in rare cases RU-486 can lead to breathing problems or pneumonia.
"This is the main reason these drugs should not be sold over the counter or on the Internet," she added. "Furthermore, one can never be sure about the authenticity of the medication."
Speaking to MfD, Slovak dealer Hana Beckley admitted she had sent out around 400 abortion kits to customers since the spring, some of whom reside in the Czech Republic. Instructions on the packet claim the pills can be taken up to the 22nd week of pregnancy, contravening Czech law (abortion on demand is permitted until the 12th week). The Health Ministry, which says it has no influence over drug licensing, has urged caution.
"The sale of medication online is a global problem," said ministry spokesman Vlastimil Sršeň. "Many of these substances are fake, which represents a potential danger for users. To tackle this issue, SÚKL has promoted a series of educational campaigns in cooperation with the police and customs."
According to the most recent data from the Institute for Health Information and Statistics, some 24,055 legally induced abortions were performed in the Czech Republic in 2011, a slight increase on the year before, although the overall rate continued its steady downward trend. Nonetheless, Ucháč fears that number will rise again unless the abortion pill's progress is halted.
"We'll try to raise awareness with the people responsible and ask them not to grant a license to this drug," he said. "Our lawyers are working on a stipulation against the license, because it's highly plausible current Czech laws are about to be violated."
Jonathan Crane can be reached at