Short TakesBrief Items of Interest About RU 486
RU 486 Edging Closer to Marketing in U.S.

After over two years of delays, abortion proponents may be close to finding a company that could put the dangerous RU 486/Cytotec prostaglandin (RU 486/PG) abortion technique on the U.S. market in 1999. Final government approval for marketing has been stalled since October, 1996 because of litigation and the lack of a manufacturer.

Since the Population Council, holder of the U.S. patent, and the company it is using to market RU 486, Danco Laboratories (also identified in the press as NeoGen), are being very secretive about the arrangements, an announcement about RU 486/PG licensing and distribution could come without any warning. Therefore, Pro-Life and Pro-Family advocates should be prepared to respond to media inquiries with good “soundbites” emphasizing the dangers of RU 486/PG to women and their children and how the abortion drugs will increase the annual number of abortions. (For the facts against RU 486/PG abortion, see the Mar.-Apr., 1998 The RU 486 Report.)

In September, 1996, the U.S. Food and Drug Administration (FDA) issued an “approvable letter” stating that RU 486 was “safe and effective,” but final approval for marketing in this country depends on inspection of the manufacturing facilities. One of the key reasons that approval has not occurred is the lack of a manufacturer.

Danco/NeoGen signed a contract with Gideon Richter, a Hungarian pharmaceutical company, to manufacture RU 486, but the European firm backed out in February 1997. Three months later, Danco/NeoGen sued Gideon Richter in state court in New York City for breach of contract and other grounds and asked that the company be compelled to fulfill its obligations.

In April, 1998, spokespersons for the Population Council and Danco/NeoGen offered vague and even contradictory information about the status of finding a producer. An April 29 Associated Press story stated that “At Danco, spokeswoman Heather O'Neill said the company has found a manufacturer, which she declined to identify, and is working out details with the FDA to get the drug on the market in 1999.” However, April 30 New York Times quoted O'Neill as saying that “We are focusing on identifying manufacturers, tableters, and distributors,” which would seem to indicate that plans had not firmed up. A reporter for National Public Radio stated during the April 30 “All Things Considered” program that “Council officials say they're close to finding [a manufacturer], though they won't disclose any names.”

Subsequently, a July 18 AP Online article by reporter Nancy Benac quoted O'Neill as saying that Danco is “working with manufacturers toward production.” Benac observed that “Danco refuses to identify the manufacturer and is deliberately vague about whether the drug is actually being made.” O'Neill stated that “We are keeping a low profile on purpose,” wrote Benac.

Meanwhile the court case continues in New York. The August 8, 1998 issue of Scrip, a European drug industry publication, reported that Gideon Richter said in a report to the Budapest stock exchange that it “believes that it has meritorious defences to the claims and is defending itself vigorously in the lawsuit.” Scrip also noted that Danco “has apparently won its bid to `seal' (close all records of) the case.”

Fortunately, the court records of another important lawsuit over RU 486 remain open. In October 1996, Giant Group, headed by financier Burt Sugarman, sued Danco/NeoGen and its associated companies to obtain a piece of the RU 486 investment pie. ( For details, see the Dec. 1996-Jan. 1997, Feb.-Mar., 1997 and Jan.-Feb 1998 issues of The RU 486 Report). Giant Group settled part of its lawsuit some of the defendants, most notably the Population Council. But Giant's fight with the investors' group that controls Danco/NeoGen has continued, and Danco/NeoGen countersued. The depositions, filings, and other papers are now over a foot high. The impact of this litigation on the marketing of RU 486 is unclear except that it could not have helped and has certainly been expensive. In addition, one might speculate that this lawsuit —and the countersuit—may have created some uncertainty about the control of RU 486, which could scare off potential investors.

To Pro-Life and Pro-Family supporters, no news about a manufacturer of RU 486 is good news. The longer the delay in getting RU 486 on the U.S. market the less time that the investors have to make a return on their money, which press reports indicate is at least $14 million. The U.S. patent expires in early 2002, which does not leave much time to be able to charge enough to make back the millions invested before RU 486 goes generic and the price drops. “Chinese Clone” of RU 486 Slated for Non-Abortion U.S. Tests

On October 14,1998, Lawrence Lader, president of Abortion Rights Mobilization (ARM), announced that the “Chinese clone” of RU 486 “will be soon be tested against endometrial cancer, involving the tissue lining of the uterus,” reported his press release on Business Wire. Lader also indicated that experiments will be conducted using RU 486 to induce “quicker labor in difficult childbirth, a treatment already used successfully in Europe.”

Lader is apparently trying a ploy that other abortion supporters have long advocated. Getting RU 486 licenced in the U.S. for a non-abortion purpose would open the door for abortionists to legally use it “off-label” for abortion.

ARM obtained the formula for RU 486 through the People's Republic of China, and is having the drug manufactured at a secret location in the U.S. Lader has claimed in the past that this “clone” is chemically identical to the original. (See the Jan.-Feb. 1997 The RU 486 Report for more details.)

Lader also provided an update on ARM's research trial using the “clone” RU 486 and Cytotec for abortion. So far, 2,700 women have participated in ARM's test, and the press release indicated that ARM's long-term goal continues to be 10,000 women at 15 sites around the country. Since ARM does not have the patent rights, the women in the study receive the drug free.Chinese Marketing RU 486 Technique

In 1988, the People's Republic of China was one of the first countries to license RU 486 for abortion, and little information has been available since then except for a few medical research studies.

Apparently, the Chinese did not put RU 486 into large-scale production until 1997. A report in the May 12, 1997 China Medipharm Insight indicated that the Beijing No. 3 Pharmaceutical Factory had received approval from the State Planning Committee to manufacture one metric ton of bulk RU 486 and 40 million RU 486 tablets per year. The RU 486 (registered name XI YIN) plus prostaglandin combination is approved for use for abortion up through 7-weeks of pregnancy (49 days), according to the Internet website of the Shanghai Hua Lian Pharmaceutical Co. Ltd. Since the publication did not specify the dosage of RU 486 in each tablet, it is not possible to estimate exactly how many women the Chinese expect to abort with RU 486 each year.RU 486 Marketing May Spread Across Europe

In Europe, the new owners of the patent for RU 486 are planning to widen distribution to more countries. Currently, RU 486 is licensed only in France, the United Kingdom, and Sweden. Other countries have expressed an interest, but were turned down. Press reports indicated that the reason was resistance from officials of Hoechst AG, the German parent company of Roussel Uclaf, the manufacturer and distributor of RU 486.

When Hoechst AG and Roussel Uclaf announced plans in April, 1997 to get out of the abortion pill business, Dr. Edouard Sakiz, former Roussel chief executive, formed a new company named Exelgyn to handle the abortion drug. Roussel Uclaf initially provided Sakiz with a substantial supply of RU 486. The February 14, 1998 The Independent, published in the United Kingdom, indicated that production had been suspended and “existing supplies will last only until the end of the year.” However, a spokeswoman for Exelgyn in the UK “claimed a deal with a manufacturer had been done and production was expected to resume in the autumn,” said the story.

An August 3, 1998 Associated Press (AP) story reported that Sakiz had found a “small company in France” to produce RU 486, but he was keeping its name secret “fearing reprisals from abortion opponents.”

According to a June 28, 1997 Detroit Free Press story, Sakiz's “agreement with Roussel mandates that he sell RU 486 only in countries where the government requests it and an established health-care system is able to provide follow-up care.” These restrictions limit “his territory, Sakiz said, to western Europe and a few places in the former Eastern bloc,” explained the story. The drug executive “planned to apply in September to market RU-486 in further European countries as of Jan. 1,” reported the August 3rd AP story.

Germany was not on his list because the government of Helmut Kohl had not requested introduction of RU 486, said AP. But the outcome of the recent German national election could change that. The opposition Social Democrats and their chancellor candidate, Gerhard Schroeder, did not take a formal position on RU 486 during the campaign, but the Social Democrats in parliament traditionally supported introduction of the abortion drug, observed the story. In August, Sakiz told AP that if Schroeder won the election and announced his government's support of RU 486, then Sakiz would add Germany to his list.

Schroeder did win decisively and took office in October. RU 486 Labeled Abortion Drug in “Emergency Contraception” Publicity

In a rather curious turn of events in September, 1998, many media accounts about the FDA's approval of the first regimen for so-called “emergency contraception” called “Preven” emphasized that RU 486 causes an abortion. This publicity may help to dispel a long-standing myth which has persisted since the late 1980s even among Pro-Life and Pro-Family supporters that RU 486 is a “morning-after pill” or a “contragestive” or causes “miscarriage.”

For example, an Associated Press story published in the Sept. 3 New York Times stated that the “morning-after pills are different than RU-486, the French abortion pill, which actually ends a pregnancy several weeks after it has begun.” Likewise, a Los Angeles Times story the same day explained that RU 486 disrupts “a pregnancy after fertilization.” In the electronic media, the medical correspondent on the CBS television show “Saturday Morning,” Dr. Emily Senay, told her audience on September 5 that RU 486 is used “after a woman already knows she is pregnant.” A few weeks later, on the September 20 NBC “Sunday Today” show, Dr. Donnica Moore made a similar observation.

The point of talking about RU 486 was to draw a distinction between the newly approved “emergency contraception pills” (ECP) and RU 486. The RU 486/PG technique cuts off the nutrition to the unborn baby several weeks after fertilization. At that time, the mother has missed her menstrual period and knows that she is pregnant.

In contrast, ECP functions much earlier in the woman's menstrual cycle (or pregnancy) before there is an outward signal that the woman is pregnant, such as a missed menstrual period. The Preven regimen requires a woman to take two pills within 72 hours after “unprotected sex,” followed by two pills twelve hours later. The crucial issue is the effect of those pills.

To most Americans, pregnancy begins at “conception,” which occurs at the union of the ovum (egg) and sperm (which is also known as “fertilization”). In this context, a “contraceptive” prevents the ovum and sperm from coming together. “Implantation” of the developing human embryo in the lining of her mother's womb (uterus) occurs about six or seven days after fertilization. Drugs or devices that prevent implantation cause an abortion by killing the developing human embryo.

Proponents of ECP claim that the drug regimen does not cause an “abortion” because they redefined the meanings of the words “conception” and “pregnancy.” In the late 1960s, some medical organizations stated that “conception” (the beginning of “pregnancy”) is no longer synonymous with “fertilization” but with “implantation,” which takes place about six days after fertilization. Therefore, in this framework, EC advocates contend that a “contraceptive” can prevent “pregnancy” up until the time of implantation.

For example, Roderick Mackenzie, chairman and president of Gynetics, Inc. of Somerville, New Jersey, which produces Preven, flatly declared to the Los Angeles Times that “We're not dealing with abortion, we're dealing with pregnancy prevention.” In fact, the pills “will not hurt the fetus or harm the pregnancy,” he said.

But ECP spokespersons do know the truth. Dr. Anita Nelson, professor of obstetrics and gynecology at UCLA, was quoted as an expert on the effects of the “ECP” regimen in several news accounts. A Sept. 3 Los Angeles Times story said that “No research has been conducted to determine whether these pills have an effect on the process of implantation of a fertilized egg [sic, developing human embryo]. `We have no data, but if any woman was concerned about this, I wouldn't push this product on her,' UCLA's Nelson said.”

But in an October 26 Fortune magazine story, Nelson acknowledged that “It actually takes a few days for an egg to get fertilized and lock itself onto the uterus. And ECPs work to stop ovulation from taking place, stop the sperm from coming down the tube, or stop a fertilized egg from becoming implanted” (emphasis added).

MacKenzie and others proponents of ECP are misleading the public. They should own up to the fact that ECP can either prevent “conception” (in the sense of how most Americans think of it) or cause an abortion by preventing implantation.

RU 486 Prominent in Congressional Deliberations

The Food and Drug Administration's handling of licensing of the RU 486/PG technique came under Congressional scrutiny twice in recent months. Pro-life Senators quizzed President Clinton's nominee for commissioner about her position on approval of RU 486 for abortion, and the House of Representatives voted to block the FDA's approval of the abortion method.

Senators Quiz FDA Nominee

In June, President Clinton nominated Jane E. Henney, an administrator at the University of New Mexico, to be FDA commissioner. She had served as a deputy to then-Commissioner David A. Kessler from 1992 through 1994. At her confirmation hearings in August and September, several key pro-life senators queried her sharply about her role in the agency's promotion of the U.S. licensing of the RU 486/PG abortion technique and how she planned to handle approval. She replied that she was not involved in the review process, which focused evaluating the safety and effectiveness of the “intended use” of causing an abortion, reported the August 24 Pink Sheet, a drug trade newsletter. Therefore, the FDA did not take into account the effect on the embryo, she said. Unfortunately, Henney's statements indicated that she will continue the politicization of the FDA by abortion advocates who abandoned the agency's usual strict scientific and medical standards in evaluating RU 486. As one of its last acts in October, the Senate voted to confirm her as FDA chief.

Bill To Ban FDA Approval

On June 25,1998, the House adopted an amendment offered by Rep. Tom A. Coburn (R-OK), an obstetrician, to an agriculture appropriations bill that would have banned the FDA from using federal money to regulate or approve RU 486. The amendment passed 223-202. Unfortunately, the Senate did not go along with the bill as passed by the House. In October, Coburn's amendment was eventually dropped as part of the negotiations in the massive omnibus spending bill.

Actions Needed To Stop RU 486 Abortion

There is still need for action:

• Write Gedeon Richter company officials to urge them to stay out of the abortion business. Address: Lajos Pillich, Chairman, Gedeon Richter, 19-21 Gyomroi Ut, Budapest H 1103, Hungary.

• Boycott the products of Hoechst Marion Roussel drug company products, especially the antihistamine Allegra. This company and its parent control the use of RU 486 worldwide. The boycott is aimed at pressuring them to withdraw the abortion drug from the market.

• Inform others about the dangers of RU 486/PG abortion.

The dangerous “RU 486" abortion method which kills an unborn baby whose heart has started to beat actually uses two drugs: First, the powerful synthetic steroid RU 486 (generic name “mifepristone”) starves the unborn baby to death by causing the lining of the uterus to disintegrate. Second, another powerful synthetic hormone, a prostaglandin known as Cytotec (generic name: “misoprostol”), causes contractions of the womb which expel the dead baby and bloody contents.

Some key facts form the “core message” that pro-life and pro-family advocates need to keep repeating at every opportunity. Contrary to what the general media has usually been saying, the RU 486/PG abortion technique

• is not a “contraceptive” because it causes an abortion by killing an unborn baby whose heart has started to beat;

• is not “safe” and “easy;”

• will injure, and possibly kill, women;

• will possibly deform babies who survive;

• is being rushed on to the market by President Clinton to appease the abortion lobby; and

• will increase the number of abortions beyond the already appalling 1.5 million per year.