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Mifepristone: RU-Ready 4 It?





During the past quarter century, abortion has arguably been the most debatable topic of controversy in the United States. Ethics, religion, and the law are in constant contention with one another over the issue. By definition, abortion is the termination of a pregnancy, resulting in the death of an embryo, or child, depending on one’s viewpoint. The differences of opinions on the issue are too great to compare.

Since the Supreme Court ruling of Roe vs. Wade in 1973, the war between pro-life and pro-choice supporters has raged on. Abortion has been the subject of many court cases since, but still remains a legal procedure in the United States. However, with the recent FDA approval of the French drug, mifepristone, formerly known as RU-486, it can be expected that the issue is about to reach a level of controversy not seen since the monumental ruling in 1973.

In 1988, a French pharmaceutical firm invented the drug, RU-486, known to the world as the “abortion pill.” Since then, around 620,000 women throughout Europe have successfully used RU-486 to abort their pregnancies. Since its inception, the United States has had varied opinions on the matter. Earlier in the decade, the FDA refused to approve the drug for use in the United States, and under the Bush administration, the drug was banned by the FDA from importation for personal use. Bill Clinton removed the ban when he took office in 1994.

Once the ban was removed, the Population Council, which is a nonprofit, medical research institution, as well as RU-486’s main supporter, began to work with Planned Parenthood to test the true effectiveness of the pill. The Population Council works as an organization for reproductive health and family planning. Generally, they conduct research to improve the quality of life for women and their families. From their research, it was found that 92% of the pregnancies that were terminated using RU-486 ended within seven weeks of conception. In France, the same study found this statistic to be as high as 99%. The lower levels of success in the United States have been blamed on the lack of experience that American clinicians have with this drug. Nevertheless, the results proved it to be a success.

In 1996, public hearings on the subject of FDA approval of the drug were held. The FDA Advisory Committee for Reproductive Health wrote a recommendation for the approval of RU-486. For final approval, the Population Council and the distributor, the Danco Group, were required to provide further information, including manufacturing and labeling details, before the drug was given a final approval. However, in early 1997, Danco suddenly backed out of this project.

Finding a manufacturer wasn’t the only hurdle that the drug was going to face. There were many people dedicated to making sure that RU-486 never attained approval. Both in 1998 and 1999, US Rep. Tom Couburn tried to prevent the approval of RU-486 by attempting to pass an amendment that would have prohibited the FDA from spending government money on any drug that would be used to induce abortion. The bill was never passed.

This year, the Population Council and its RU-486 distributor, Danco Laboratories, with the acquisition of a manufacturer, were able to meet all FDA requirements. On September 28, 2000, RU-486 was approved by the FDA to be distributed for prescription under the name, mifepristone. There are very few restrictions on the drug; the FDA has made it so that virtually any family doctor or gynecologist can prescribe it, provided that he/she can provide surgical backup, should the pill fail to work.

Until a recent information leak from employees of the Population Council, the identity of the manufacturer was kept a secret. It is now known that Hua Lian Pharmaceutical, a China-based pharmaceutics company, manufactures mifepristone for the US. This particular company has been producing the drug for nine years, for distribution all over the world. The reason behind maintaining anonymity was a fear of boycott. In 1992, the United States boycotted French manufacturers of the drug because they were making mifepristone for US distribution. Although it did not have FDA approval, which prevented its ability to be prescribed by a licensed physician, it could be bought and sold for personal use. Hua Lian is the first plant to agree to produce mifepristone for U.S distribution. However, to the dismay of the American people, Hua Lian is not without their skeletons.

Hua Lian Pharmaceutical is not the most trusted name in medicine, which is probably another reason why Danco Laboratories didn’t want to publicly disclose them as their mifepristone manufacturer. In 1998, they were accused of drug impurities, involving an herbal remedy and hundreds of other products. The drugs were all contaminated with flouroucil, which is a chemotherapy drug. After serious investigation into the problem, Hua Lian Pharmaceutical deemed the situation, a “data integrity problem,” because the paperwork involving the ingredients of a number of drugs were disarranged. Chemicals that were suppose to go into one drug, which was being produced at the same time as another, got switched with that of the other drug, thus causing the problem. Unfortunately, becuase no other company will produce the pill for the US, Danco Laboratories has no choice but to work Hua Lian. However, being a company based in China, they may know more about mifepristone than any other manufacturer, China having been one of the first countries to begin experimenting with the drug, back in 1983. It’s been verified that Han Lian Pharmaceutical can actually create 1/2 a ton of mifepristone a year, which is enough to supply the entire world’s demand for the drug.

Another controversial issue surrounding the Chinese manufacturer is its nation’s one child policy. Because of China’s dangerously high population, couples are limited to having only one child. If a woman becomes pregnant after the birth of her first child, the state imposes a mandatory termination of her pregnancy. Anti-abortionists are irate enough with the FDA approval of mifepristone—the drug being manufactured in a nation which imposes abortions only adds to their discontent.

Hua Lian hasn’t been the only one with problems. Many people feel that there have been many lies and cover-ups involving mifepristone. In an Ohio study of 238 woman, researchers claimed that there were “no complications.” However, some time later, one of the doctors, Dr. Mark Louviere, came forward and admitted that one of the woman had lost nearly half of her total blood content, and would have died if she had not received immediate emergency surgery. While doctors admit that bleeding is normal, needing to transmit 4 pints of blood into a person is not only ridiculous, but also horrifying.

As of right now, many colleges and universities are involved in heated debates over whether or not their on-campus health centers will be prescribing mifepristone. Most schools, such as UB, do not offer abortions as it is, in order to avoid the serious controversy that it would cause on campus. It would, however, be very possible for college health centers to prescribe mifepristone, since it is a non-surgical procedure. However, any campus choosing to allow this, will indeed have to be ready for a fiery debate. Many people who oppose offering the pill to college students feel that it will be advocating abortion as, “the easy way out.” Will the abortion pill be available at UB? According to Dr. Samedi of the Student Health Center, located in Michael Hall, on South Campus, there’s not a chance we’ll be seeing it here anytime soon. This is despite the fact that Michael Hall does offer emergency contraceptives. The reasoning behind Dr. Samedi’s concerns the well being of the students. The course that a woman must take to have an abortion by way of mifepristone takes at least three doctors visits at appropriate times throughout the ordeal. According to Samedi, “With the amount of follow-up needed, to provide adequate care, it would be difficult to ensure proper care.” The Student Health Center will, however, give student referrals to doctors and clinics, such as Planned Parenthood, where they may obtain an abortion by way of mifepristone.

Mifepristone is basically a steroid, which interferes with the actions of progesterone, a natural hormone that is critical to the early stages of a pregnancy. It interferes with the contractions of the uterus and detaches the embryo from its walls. Birth is induced at such an early stage that the embryo is basically “miscarried” and flushed out of the woman’s system, along with the lining of the uterus.

Mifepristone isn’t as easy as popping a pill, as some may think. The process of obtaining an abortion by the use of mifepristone is a three-step process, which at times can be very strenuous. The only way that a woman can be allowed to take mifepristone for an abortion is when she is between 3 and 9 weeks pregnant, because that is the only time that the drug has proven to be significantly effective. A woman is given three mifepristones on her first day. It has been proven that 3% of women will actually have the miscarriage within 48 hours of their first dose. If the abortion does not occur, the woman will go back to the doctor to receive her second dose, which will include 2 mifepristones, and a prostaglandin (a drug that works with the mifepristone to induce birth). From the time the woman takes this dosage, and for up to 2 weeks, the abortion may occur at any time. It is impossible to know when it will take place; some women have experienced it on the car ride home from the doctor, in the shower, or even at work. In 5% of cases, however, the consumption of mifepristone does not work. The woman must then obtain a surgical method of abortion, which is be preformed for her by either the same doctor who prescribed mifepristone for her, or another medical doctor previously arranged to perform the abortion.

Side effects can vary, depending on the health condition of the woman. There are direct dangers for women who have some forms of diabetes, severe anemia, and for people who have hemorrhagic disorders. Women with high blood pressure, bronchitis, and a history of pregnancy-related problems may be at risk for side effects as well. Problems that have occurred directly through the use of mifepristone have been cases of severe bleeding.

The cost of a medical procedure (the process of taking mifepristone) is between $200 to $350. This is similar to (and somewhat less expensive then) a surgical abortion which costs anywhere from $250 to $450.

The FDA’s approval of mifepristone has been the catalyst for both praise and denunciation. Pro-choice supporters are raving about the availability of the drug as a medical break through in women’s health. Many antiabortion advocates consider it much more detrimental than the surgical procedure. Every local doctor in town will have the opportunity to supervise over an abortion using mifepristone. There will be no need anymore to solicit the services of a clinic—just your local pharmacy. Antiabortion protestors will have a much harder time finding abortion providers. So, when protesters set out to demonstrate against this new type of abortion, where will the picket lines be formed?

 

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