RU486 is an artificial steroid that interferes with the action of progesterone, a hormone crucial to the early progress of pregnancy.⁽⁴⁾ Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child. It also suppresses normal uterine contractions which could dislodge the child implanted and growing on the wall of the mother's womb.⁽⁵⁾

RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Sensing what appears to be a drop in progesterone, usually a sign that pregnancy has not occurred, a woman's body shuts down the preparation of the uterus and initiates the normal menstrual process. The child, deprived of necessary nutrients, starves to death. The baby detaches and is swept out of the body along with the decayed uterine lining.⁽⁶⁾

No. Those pills operate in a different way and during a different time frame than RU486.

Morning after pills, or "emergency contraception," are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse.^{(7), (8)}

While there have been some limited tests of RU486 as a morning after pill, with mixed results,⁽⁹⁾ the only purpose for which the U.S. sponsor has sought government approval is for use to abort a confirmed pregnancy^{(10), (11)} weeks after the baby has already attached him or herself to the uterine wall.⁽¹²⁾

During the time frame that RU486 is operative, the baby is undergoing a rapid period of development.

It is at about the fifth week of pregnancy (measured from a woman's last menstrual period) that a mother first begins to suspect she is pregnant, so this is likely to be about the earliest that the chemical abortifacient is used. At this point, the child is about three weeks old⁽¹³⁾ and approximately 2mm long (about 1/10 of an inch).⁽¹⁴⁾ Even by this time, however, the baby's nervous system has begun to form⁽¹⁵⁾ and his or her heart is likely to have already begun its first beats.⁽¹⁶⁾ The child's heart will be beating strongly and steadily by the time he or she is just three and a half weeks old..⁽¹⁷⁾

The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy.⁽¹⁸⁾ By that time, the baby will be five weeks old and will have increased in size to 8mm, and his or her face, arms, and legs will be distinguishable.⁽¹⁹⁾

Before the end of the 9^th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone's effectiveness,⁽²⁰⁾ the child's ears, fingers and toes will have formed and he or she will be 18mm, or nearly an inch tall, from crown to rump.⁽²¹⁾

While researchers have proposed a long list of diseases and conditions that RU486 might be useful against, and in some cases, conducted limited testing, the only purpose for which the U.S. sponsor has pursued government approval is abortion.⁽²²⁾

Because of its properties as a antiprogestin (a compound that inhibits the action of the hormone progesterone), some believe that it may be helpful in treating endometriosis, fibroids, breast cancer, and certain non-malignant brain tumors called meningomas.⁽²³⁾ Pro-life groups such as the National Right to Life Committee have never opposed the testing or use of RU486 for such therapeutic purposes, but evidence of its effectiveness in these applications,⁽²⁴⁾ as well as evidence of the pill's promoter's real interest in such applications, is limited .⁽²⁵⁾

Acting alone, RU486 is able to induce an abortion only between 64% and 85% of the time, a rate abortifacient researchers consider "inadequate for general clinical use."⁽²⁶⁾ This is why, two days after taking the RU486, a woman is given a prostaglandin, usually misoprostol (trade name: Cytotec), to induce powerful uterine contractions to expel the shriveled corpse.⁽²⁷⁾ Because the use of a prostaglandin (PG) is part of the standard RU486 abortion protocol, it is perhaps more accurate to refer to this as an "RU486/PG" abortion.

An RU486/PG induced abortion can take days, weeks, or never happen at all. It typically involves 3 (or more) visits to the doctor's office over a two week period.

In her first visit, a woman is "counseled," given a physical examination, perhaps an ultrasound, and if there are no obvious contraindications (common red flags such as high blood pressure, diabetes, heavy smoking, allergies, etc. that could make taking the drug deadly or dangerous for her⁽²⁸⁾), she is given the RU486 pills, which she takes in the presence of the abortionist.

Two days later, during a second visit to the doctor's office, she is given the prostaglandin, which she takes orally or has inserted vaginally. Gradually, as the drug begins to take effect, she experiences powerful, painful uterine contractions which begin to work to expel the baby.

In U.S. trials, about half (49%) aborted during the four hours they spent waiting in the doctor's office following the administration of the prostaglandin. An additional 26 % aborted sometime over the next 20 hours, on the bus ride home, at work, in the shower, etc. The rest who aborted did so at some point during the following two weeks. Between 8% and 23% (depending on how many weeks pregnant the mother was) never completely aborted or didn't abort at all using the drugs.

A third visit some 14 days from the woman's initial visit allows the doctor to confirm whether or not the abortion has been completed. If it hasn't, the abortionist will encourage the woman to undergo a surgical abortion to guard against the possibility that she will give birth to a child who may have been injured by the drugs.^{(29), (30)}

Despite public claims of its ease and safety, the RU486/PG abortion method comes with a long list of contraindications, i.e., conditions that doctors believe should disqualify a woman from using the method or should at least call for heightened caution and monitoring among those selecting patients and administering the drugs because of the increased medical risks faced by such women.

Abortion researchers have recommended that women with adrenal failure, severe asthma, or receiving long-term glucocorticoid therapy not be given the drugs. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic [bleeding or clotting] disorders, or receiving treatment with anticoagulants. A prostaglandin sometimes used with RU486, sulprostone, has been associated with heart failure in women who were over 35, obese, smoked, or had other cardiovascular risk factors, though these have not yet been reported with the prostaglandin misoprostol.⁽³¹⁾

Other conditions that previous researchers have considered sufficient grounds to exclude women from clinical trials of the drugs include high blood pressure, bronchitis, menstrual irregularity, fibroids, endometriosis, use of IUD or oral contraceptives (in past three months), history of problem pregnancy, current ectopic pregnancy, pelvic inflammatory disease, allergies, epilepsy, adrenal insufficiency, recent intake of steroid or anti-inflammatory medication, or a history of liver, stomach, or intestinal disease.⁽³²⁾

It certainly isn't safe for the baby who suffocates or starves to death.⁽³³⁾ And it strains credulity to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time"safe" and "effective."⁽³⁴⁾

Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged.⁽³⁵⁾ One out of a 100 had to be hospitalized.⁽³⁶⁾ Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions.⁽³⁷⁾ In the broader, less regulated medical marketplace, outside the careful monitoring of a clinical trial, complications could be expected to be both more common and more serious, especially for those women who do not have immediate access to emergency care.⁽³⁸⁾

While tests in France yielded a 95-96% "success" rate,⁽³⁹⁾ the success rate in American trials for the two drug procedure has been considerably lower. Women in their fifth week of pregnancy aborted 92% of the time, while women in their seventh week aborted 77% of the time.⁽⁴⁰⁾ Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the "failure" rate.⁽⁴¹⁾

Yes. According to Mark Louviere, the doctor who treated the woman, she lost between one-half to two thirds of her total blood volume and probably would have died if she had not had emergency surgery.⁽⁴²⁾ The doctor came forward after reading a press report that the Iowa portion of the trials had ended with "no complications"among the 238 women there who took part in the test.⁽⁴³⁾ "If near death due to the loss of half of one's blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication," Louviere told the Waterloo Courier, "I don't know what does."⁽⁴⁴⁾

Nausea, diarrhea, vomiting, and painful cramping are quite often part of the package, and sometimes in clinical trials were themselves severe enough to put women in the hospital.⁽⁴⁵⁾ Less frequent, but potentially more serious, are side effects such as infection⁽⁴⁶⁾ or heart palpitations.⁽⁴⁷⁾

This is simply unknown at this point. It is known that RU486 crosses the blood follicle barrier and gets into the follicular fluid surrounding a woman's ripening eggs.⁽⁴⁸⁾ What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.

Both chemical and surgical abortions have their risks, and it is not clear that they are directly comparable.

Promoters of the abortion pill often speak as if RU486/PG abortions are safer because they are earlier abortions.⁽⁴⁹⁾ While it is true that earlier surgical abortions are safer than later surgical abortions,⁽⁵⁰⁾ owing to the increasing size of the baby and the increasing complexity of the surgical procedure,⁽⁵¹⁾ it isn't clear that early chemical abortions are necessarily safer than later surgical abortions. Because the methods are so different, this is like comparing apples and oranges.

With surgical abortions, a woman faces the risks of cervical lacerations,⁽⁵²⁾ uterine of bowel perforations,⁽⁵³⁾ scarring, infection, and even permanent infertility.⁽⁵⁴⁾ These risks, due to the surgical process itself, may be avoided in a chemical abortion (provided a woman is not in that 8%-23% for whom the method fails⁽⁵⁵⁾). But the woman undergoing a chemical abortion faces a whole new set of risks, ranging from hemorrhage⁽⁵⁶⁾ to heart failure,⁽⁵⁷⁾ typically not faced by the surgical patient.

Variations in the severity and frequency of these complications make it difficult to identify one method as safer than another. Significant injury or worse is possible with either method.

Though no long term studies have yet been done, the descriptions women give of their encounters with their aborted children raise great concern. Women who have undergone RU486/PG abortions talk about seeing tiny fists, eyes, or seeing their aborted babies laying in the toilet bowl or swirling in the shower drain.⁽⁵⁸⁾ Counselors at abortion clinics indicate it is common for women to express a desire to bury the baby, to perform some sort of ceremony to deal with their strong feelings.⁽⁵⁹⁾ These are hardly the reactions of women who consider this a blob of tissue.⁽⁶⁰⁾

Whereas those who undergo surgical abortion only imagine what their unborn children look like and go through, women who have abortions with RU486 have vivid memories of their encounters with their children.⁽⁶¹⁾ And while giving the woman more control over her abortion may assuage the abortionist's guilt, it definitely increases a woman's sense of responsibility for the abortion.⁽⁶²⁾

While a sense of relief is what many woman having surgical or chemical abortions feel immediately after the abortion, we know from experience that the symptoms of post abortion trauma often do not show up until years later.⁽⁶³⁾ When women who have had RU486 abortions begin to deal with their experience, they will have more vivid memories and a greater sense of responsibility to deal with than those who underwent surgical abortions.

Bringing RU486 to the U.S.

Good question. Under the Bush administration, the FDA issued an import alert, prohibiting the import of the drug for personal use because of safety concerns it had about the drug.⁽⁶⁴⁾ Three days after being sworn into office, President Bill Clinton signed an executive order directing the Department of Health and Human Services and the FDA to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.⁽⁶⁵⁾

Under the Clinton administration, the FDA took a very active role in efforts to bring the drug into the U.S. In the course of carrying out the president's directive, the FDA:

* actively pressured French manufacturer Roussel Uclaf to submit a marketing application.⁽⁶⁶⁾

* helped negotiate the transfer of manufacturing and marketing rights from Roussel Uclaf to the Population Council of New York once it became clear Roussel Uclaf would not submit an application of its own.⁽⁶⁷⁾

* allowed the Population Council to use data from foreign studies in its marketing application, rather than require the Council to wait until it was ready to submit data from American studies.⁽⁶⁸⁾

* allowed to Population Council to submit its marketing application despite not having a finalized deal with any manufacturer or any finished chemical product from its would-be manufacturer.⁽⁶⁹⁾ The FDA allowed the Population Council to use chemical and manufacturing data from Roussel Uclaf as the basis of the Council's application, knowing that Roussel Uclaf would not be the manufacturer.⁽⁷⁰⁾

* submitted the application to an advisory panel stacked with known abortion activists and RU486 supporters.⁽⁷¹⁾

* processed the application for RU486 in just six months, while potentially life saving drugs were taking as long as 17 months to be processed.⁽⁷²⁾

Hardly. The Food and Drug Administration is supposed to be an objective agency representing the health and safety interests of the American people,⁽⁷³⁾ not an agent for some manufacturer or some group with an ideological or political agenda.

No, never. While there have been drugs, such as pain medications, that might hasten death at certain doses, or other drugs which, if misused, could cause death, if RU486 is approved, it will represent the first time in our nation's history that our government has ever approved a drug for the specific purpose of taking the life of another human being.

Perhaps even the FDA could only bend the rules so far. Having questions about the training program⁽⁷⁴⁾ and lacking any drug sample or file from the firm that was to be the manufacturer,⁽⁷⁵⁾ the best the FDA could do by the time its deadline came to rule on the drug application was to issue an "approvable" letter, declaring that they were satisfied the drug was "safe" and "effective," but saying final approval would await the resolution of certain unnamed "labeling" and "manufacturing" issues.⁽⁷⁶⁾

Soon after the FDA issued its "approvable" letter in September of 1996, the Population Council and Joseph Pike, the man chosen by the Council to set up U.S. production of RU486 and handle financing of the project, became embroiled in controversy when would-be investors discovered in October 1996 that Mr. Pike was a disbarred lawyer with a criminal record.⁽⁷⁷⁾ These investors were also concerned about the unusual corporate structure Pike established and the integrity of his financial dealings and operations.⁽⁷⁸⁾

A series of suits and countersuits between the Population Council, Mr. Pike, and the would-be investors ensued,⁽⁷⁹⁾ tying the drug's sponsor up in court for several months and bringing unwanted negative publicity to the Population Council and the RU486 project.⁽⁸⁰⁾

Just as those suits began to be resolved in the spring of 1997,⁽⁸¹⁾ removing Pike from day to day management of the project, the Population Council received word that the Hungarian manufacturer, Gedeon Richter, that they had lined up to produce the drug for the United States, was pulling out of the deal.⁽⁸²⁾ Gedeon Richter gave no public reason for its withdrawal, but their pull out forced the Population Council to have to begin their search for a manufacturer all over again, setting back the project several years.⁽⁸³⁾

The Population Council announced that it had found new manufacturers in early 1999 and predicted it would forward the information to the FDA needed to resolve outstanding issues on its application and have the drug on the American market by the end of the year.⁽⁸⁴⁾

While the Council did forward data to the FDA sometime in 1999,⁽⁸⁵⁾ the FDA apparently did not find the response sufficient to warrant final approval. Instead, the FDA issued another "approvable" letter in February of 2000, confirming that the application was still active, but indicating there were still "remaining questions" to be resolved.⁽⁸⁶⁾ While the Population Council admitted that these were, once again, "manufacturing" and "labeling" issues requiring resolution, neither the FDA nor the Council gave further details as to what those outstanding labeling or manufacturing issues entailed.⁽⁸⁷⁾

Early on, a spokesman for the Population Council indicated that several of the major drug companies they had originally talked to didn't want to face the internal dissension that producing such a pill would bring.⁽⁸⁸⁾ This is not surprising. Who, having devoted their life to the production of life-saving medicines, wants suddenly to be associated with a drug that kills little children?

Companies may also have looked at what becoming "the abortion pill company" might do to their corporate image and bottom line.⁽⁸⁹⁾ As a product, RU486 offers relatively low profit potential against a rather hefty financial risk.

Unless abortion increases dramatically, the absolute maximal market is only about 1.2 to 1.3 million women a year (the number of abortions performed annually in the U.S.), with these women purchasing no more than three pills at a time. Even here, two-thirds to four-fifths of these women are not likely to be eligible to receive the drug because of the date of their pregnancies (over 7 weeks) or because of other disqualifying medical or physical conditions.⁽⁹⁰⁾

The pill's promoters have spoken of potential revenues from mifepristone sales as high as $100 million a year,⁽⁹¹⁾ yet, at $80 a dose,⁽⁹²⁾ with a potential customer base of only about 430,000 women (see above), the most a company might realistically expect to take in from sales of RU486, before subtracting manufacturing costs or other expenses, would be only about $35 million a year. Even this number may be grossly inflated. Sales of mifepristone in France, Britain, and Sweden for 1996 combined totaled only $3.44 million.⁽⁹³⁾ It is hard to imagine any of the major pharmaceutical makers risking its corporate image and billions of dollars of sales⁽⁹⁴⁾ from its most popular products for such a relatively modest gain and the likelihood of an ongoing public relations nightmare.⁽⁹⁵⁾

See also comments of Hoechst spokeswoman Catherine Euvrard in Joseph Schuman, "Firm Gives Up Rights to RU-486," Washington Post, April 9, 1997, p. C12.

Add to that the enormous liability risk⁽⁹⁶⁾ if just one of those women suffers permanent injury or bleeds to death,⁽⁹⁷⁾ and association with the abortion pill becomes an increasingly unattractive option to any manufacturer tempted to take on the drug.

The National Right to Life Committee (NRLC) and its pro-life allies launched a consumer product boycott of Roussel Uclaf's American subsidiaries in 1994. People ordered tens of thousands of postcards from NRLC to send to Roussel's subsidiaries to protest Roussel's collusion in efforts to bring RU486 to the U.S.⁽⁹⁸⁾

One week after NRLC published an advertisement in USA Today highlighting the consumer boycott of Allegra,⁽⁹⁹⁾ one of Hoechst Marion Roussel's top sellers, Roussel Uclaf announced it was stopping European production and giving up all remaining rights to the drug. Hoechst AG, the parent company of both Roussel Uclaf and their joint drug conglomerate, Hoechst Marion Rousssel, told the Wall Street Journal that "its decision to transfer RU-486 production was already in the works, thanks to similar pressure, but admitted the boycott threats had an impact." Speaking directly, a spokeswoman from Hoechst told the Wall Street Journal, "Hoechst cannot take the risk of a U.S. boycott."⁽¹⁰⁰⁾

The Companies Involved

It is confusing, but we'll try. The blanket of secrecy with which the Population Council has tried to cover all of its activities, as well as all the mergers and acquisitions going on in the world pharmaceutical market, make it difficult to determine precisely who is doing what.

Roussel Uclaf is the French pharmaceutical company which first developed RU486 in the early 1980s.⁽¹⁰¹⁾ They were owned, first partly, then later, wholly, by German chemical giant Hoechst AG.⁽¹⁰²⁾ Together, Roussel and Hoechst owned several American subsidiaries - Hoechst Roussel Pharmaceuticals,⁽¹⁰³⁾ Copley Pharmaceutical,⁽¹⁰⁴⁾ and Hoechst Roussel Agri-Vet.⁽¹⁰⁵⁾

Under pressure from the U.S. government, Hoechst and Roussel donated the American patent for RU486 to the Population Council of New York in 1994.⁽¹⁰⁶⁾ Roussel retained all remaining rights (those outside the U.S.) to RU486 and continued to manufacture the drug for European use until at least 1997.⁽¹⁰⁷⁾

In 1995, Hoechst purchased American drug manufacturer Marion Merrell Dow (MMD), forming a new pharmaceutical company Hoechst Marion Roussel (HMR),⁽¹⁰⁸⁾ then supposed to be the world's third largest pharmaceutical maker.⁽¹⁰⁹⁾ As part of the acquisition, HMR acquired several of Marion Merrel Dow's best selling drugs such as Cardizem and Seldane, as well as rights to a new non-sedating antihistamine being developed by MMD called Allegra. HMR also got MMD's manufacturer of generic drugs, the Rugby Group.⁽¹¹⁰⁾

HMR sold off The Rugby Group in 1998⁽¹¹¹⁾ and Copley Pharmaceuticals in 1999.⁽¹¹²⁾

In 1999, Hoechst and HMR merged with another European pharmaceutical giant, Rhone Poulenc, to form Aventis.⁽¹¹³⁾

After receiving the U.S. rights to RU486 from Roussel Uclaf and Hoechst AG in 1994, the Population Council, working with a lawyer/entrepeneur by the name of Joseph Pike, set up a series of companies to handle various aspects of the production, distribution, and marketing of RU486.

Pike and the Council first established a non-profit called Advances in Health Technology to promote the drug and provide public education and handle doctor training.⁽¹¹⁴⁾ Advances also received the license to manufacture and distribute mifepristone which it turned around and granted as sub-licenses to two other for profit companies set up by Pike, Danco Laboratories and Neogen Pharmaceuticals, Inc. Though neither was to be the actual manufacturer, Danco was supposed to be responsible for setting up the manufacturing and distribution of mifepristone as an abortifacient while Neogen was to arrange manufacturing and distribution of the drug for all other medical indications.⁽¹¹⁵⁾

Pike controlled both of the sub-licensees through a company called N.D. Management.⁽¹¹⁶⁾ N.D. Management, in turn, was the sole general partner of a Neogen Investors and a limited partner, along with Neogen Investors, in a group named Neogen Holdings, L.P. Neogen Holdings was the sole shareholder of Danco, while Neogen Investors was the sole shareholder of Neogen Pharmaceuticals.⁽¹¹⁷⁾ Outside investors thus gained some stake in both the abortifacient and non-abortifacient uses of mifepristone through their participation in Neogen Investors.⁽¹¹⁸⁾

Some confusion about the names of the various entities involved in the mifepristone project arose when Pike kept changing the name on the bank account in which cash proceeds from the Neogen Investors offerings were held. From 1995 to 1996, the name on the account was changed four times, from Neogen to Neogen Pharmaceuticals to Neogen Industries to Neogen Pharmaceuticals to Neogen Industries again.⁽¹¹⁹⁾

Pike was exposed as a disbarred lawyer and convicted forgerer in October 1996, leading to a series of lawsuits between the Population Council, Pike, and would-be investors. In announcing the settlement of suits between Pike and the Population Council, removing Pike from the project's day to day operations in February of 1997, the Council also announced a change in the project's corporate structure.

Advances in Health Technology, the non-profit which originally held the license for manufacturing and distributing mifepristone, was eliminated and replaced by a new company Advances for Choice, headed by Dutch former pharmaceutical executive Jack Van Hulst. Advances for Choice was supposed to pick up the training and education functions performed by Advances in Health Technology, and was to be publicly identified as RU486's U.S. seller and distributor. The identities of the manufacturer and other involved companies were still to be kept secret.⁽¹²⁰⁾

Court documents filed in May of that year, however, showed that Danco, the sublicensee charged with arranging the manufacturing and distribution of RU486, continued to exist, along with Neogen Investors, the group of investors putting money into the abortion pill project, and N.D. Management, the entity set up by Pike to oversee all aspects of the project handled by Danco and the various Neogen incarnations. Those documents further clarified that Danco was simply supposed to be the "marketer/seller of the finished product," with other unnamed companies responsible for manufacturing the raw product and pressing it into tablet form.⁽¹²¹⁾

The name of the company the Population Council had originally contracted in 1996 to manufacture the raw mifepristone, Hungarian pharmaceutical firm Gedeon Richter, also surfaced in June of 1997, when the press learned through those same court documents that Richter had notified Danco and the Population Council of its intention to pull out of the deal at the end of February 1997.⁽¹²²⁾ Danco sued Richter in May to try to force Richter to fulfill the contract; the case and the identities of the litigants became known when a New York judge refused to seal the records.⁽¹²³⁾

In the process of responding to press inquiries about the case and its implications for the timing of the abortion pill's release, spokespeople for the Population Council let it be known that the name of the marketing arm had been changed once again, from Advances for Choice to Advances/Neogen, with the status of Jack Van Hulst, the gentleman originally tapped to be the CEO of Advances for Choice, in limbo.⁽¹²⁴⁾ Whether the new name represented a melding of the marketing, management, and investment functions, or a further joining of the abortifacient and the putative non-abortifacient divisions of the mifepristone project, the Council did not say.

A 1998 document referred to the Council's licensee as Advances/The Neogen Group, though it is unclear whether this represented any further change or simply a variation on the latest designation.⁽¹²⁵⁾

Reports appearing in 1999 and 2000 have referred to the Danco Group, rather than Advances/Neogen, as "the company licensed to to market RU-486" or the "company sponsoring mifepristone in the United States."⁽¹²⁶⁾ Other reports vary the name, referring to this company as "Danco Laboratories,"⁽¹²⁷⁾ or Danco Laboratories, LLC.⁽¹²⁸⁾ Mother Jones magazine indicates that the Danco Group received this license in 1998. While articles have identified the Danco Group as "a start-up pharmaceutical company" in New York⁽¹²⁹⁾ (the original Danco Laboratories was set up in California⁽¹³⁰⁾ and incorporated in the Cayman Islands⁽¹³¹⁾), these reports and others suggest that other unnamed firms are the actual manufacturers.⁽¹³²⁾

Hardly. Court documents that came to light in 1997 reveal that despite Roussel Uclaf's claim that its donation of patent to the Population Council in 1994 "eliminates its involvement in the manufacture and distribution of RU 486 in the U.S.,"⁽¹³³⁾ Roussel did several things to assist the U.S. mifepristone project after giving the U.S. patent to the Population Council.

Despite its claims of non-involvement, RU:

* supplied the pills used in the U.S. clinical trial conducted by the Population Council in 1994 and 1995.⁽¹³⁴⁾

* functioned as the "stand-in" manufacturer on the Population Council's marketing application to the FDA in 1996, supplying the Chemical, Manufacturing, and Control section of the Council's marketing application, because the Council had yet to sign a firm contract with a manufacturer or obtain any product samples from a new manufacturing source.⁽¹³⁵⁾

* furnished Gedeon Richter, the Hungarian firm that was to be the manufacturer of the drug for the Population Council, with Roussel's complete Drug Master File (DMF) on mifepristone and contacted Richter directly "to offer any assistance it needed in completing its own DMF."⁽¹³⁶⁾

Roussel Uclaf, which gave away the U.S. patent to the Population Council in 1994, transferred its remaining RU486 rights (those outside the U.S.) to Edouard Sakiz, one of Roussel's former chief executives, in April of 1997.⁽¹³⁷⁾

Sakiz, who ran Roussel Uclaf back when RU486 was first developed and sold on the French market,⁽¹³⁸⁾ set up a new company, Exelgyn, to handle manufacturing, marketing and distribution of the drug. Though Roussel claimed that it was "ending its involvement with mifepristone" with the April 1997 transfer,⁽¹³⁹⁾ Hoechst [through Roussel Uclaf] continued to produce the pill while Sakiz was setting up his company and arranging for other companies to do the production and distribution.⁽¹⁴⁰⁾

Roussel Uclaf is supposed to have actually stopped production and turned over its remaining stocks to Exelgyn in September of 1997.⁽¹⁴¹⁾

The Rest of The World

Until recently, only France, Britain, and Sweden offered the drug. However, in 1999, mifepristone was approved for use in several new European countries.

In April of 1999, Exelgyn asked the European Drug Agency, which oversees drug approvals for member countries of the European Union (EU), for permission to put the drug on sale in eight of the 12 remaining EU countries. Those countries were Austria, Belgium, Denmark, Finland, Germany, Greece, Spain, and The Netherlands.⁽¹⁴²⁾ Exelgyn chose not to apply to market the drug in Italy, Ireland, Luxembourg, and Portugal.⁽¹⁴³⁾

Members of the EU have mutual recognition procedures whereby the drug authorizations of one country can be extended to others,⁽¹⁴⁴⁾ and it was under this procedure Exelgyn sought clearance in these eight countries. That was granted July 6, 1999. National governments in Germany, Greece, Belgium, and Finland had already given notification of permission for sale of the pill in their countries, while individual governmental notification was still pending in Austria, Denmark, Spain and the Netherlands at that time.⁽¹⁴⁵⁾

Reports also indicate that Israel recently granted a license to the abortifacient,⁽¹⁴⁶⁾ and that Exelgyn also registered the drug in non-EU countries Switzerland and Russia.⁽¹⁴⁷⁾ Exelgyn is also said to be prepared to apply for registration in Canada once the drug receives final approval in the U.S.⁽¹⁴⁸⁾

Even where the abortion pill has full government approval, supply, training, and distribution issues still remain to be worked out, a task made all the more difficult in those countries with institutional opposition and complex nationalized health care bureaucracies.⁽¹⁴⁹⁾

Yes. The export of RU486 to the world's developing countries has been in the minds of the pill's developers and promoters from the very beginning.

Even before discovering RU486 and its unique abortifacient properties, Emile Baulieu admits he was looking for some way to deal with the "demographic," i.e., population, "crisis" of so-called Third World countries.⁽¹⁵⁰⁾

Baulieu's vision had not changed in 1990 after seeing the drug approved in France, Britain, and Sweden. In his history of RU486, The "Abortion Pill," Baulieu declared that, in developing countries, "Women badly need the [contraceptive] backup methods of effective contragestion and abortion. RU-486 has a vital role to play." Beyond personal medical benefits Baulieu projected for the drug, Baulieu indicated he also believed RU-486 had a "broader role" in such countries helping "governments to dampen a population explosion which threatens to outstrip the world's resources."⁽¹⁵¹⁾

Though authorized development and distribution has, so far, been in largely western nations (China being the exception), the hope among abortion pill advocates is that U.S. approval will springboard RU486's acceptance in other nations around the globe who look to America for guidance.⁽¹⁵²⁾

Delegates from Kenya, India, South Africa, Cuba, Vietnam and others countries met in January of 1998 with representatives of Exelgyn and the Population Council to discuss the most effective way of tackling the issue of unsafe surgical abortions in the developing world "by the safe and effective introduction of early medical [i.e., chemical] abortion."⁽¹⁵³⁾

Several of the conference delegates, including the representative of the Population Council, complained that the complex protocol associated with RU486 (multiple visits, ultrasound to date the pregnancies, the need for surgical backup,etc.) inhibited the drug's introduction to developing nations.

Roy Karnovsky, president of Advances/The Neogen Group, the company set up by the Population Council to handle U.S. marketing for RU486, identified developing countries as those "with the most urgent need for this technology" and specifically asked whether the "unmet need for abortion and the morbidity and mortality from unsafe abortion in developing countries merit relaxation of the stringent requirements for quality in place in developed countries."⁽¹⁵⁴⁾

At the time, Exelgyn rejected the idea of a double standard for developed and developing countries, maintaining that medical and surgical care and backup should be available and that there should be strict distribution controls.⁽¹⁵⁵⁾

The legality or illegality of abortion in these countries was not an issue for conference attendees, who declared that "Advocacy for abortion is essential irrespective of the prevailing legal position regarding provision of abortion services."⁽¹⁵⁶⁾

Certainly. With the RU486/PG chemical method, it is essential that a woman have ready access to emergency medical care should serious complications develop.⁽¹⁵⁷⁾ Owing to the dearth of medical equipment or trained medical personnel in many of these developing countries, as well as transportation and infrastructure challenges,⁽¹⁵⁸⁾ disaster probably awaits any concentrated effort to bring this to the third world.

Why an abortion pill?

Abortion has become increasingly unpopular with doctors, women, and the American public.

Ostracized by the medical community and worn out by thousands of abortions, many doctors are dropping abortion from their practice and fewer doctors are taking their places.⁽¹⁵⁹⁾ Women use words like "intimidating,"⁽¹⁶⁰⁾"invasive," "mechanical," "impersonal," "abrupt,"⁽¹⁶¹⁾ and "traumatic,"⁽¹⁶²⁾ to describe their abortion experiences. Increasing majorities, while perhaps not yet ready to proscribe all abortions, nevertheless see abortion as murder or at least the taking of human life, and something that should be limited.⁽¹⁶³⁾

Chemical abortions, like RU486/PG, give supporters of abortion a chance to change the image of abortion, making it seem as simple as taking a pill⁽¹⁶⁴⁾ and concentrating on smaller, less developed babies whose destruction seems an easier political sell.⁽¹⁶⁵⁾ That the reality is far different -- that these abortions offer a whole new set of significant risks, that the objective is still the destruction of a unique human life -- is of little consequence to abortion's promoters as long as their false perception holds.

Even the highest estimates place annual U.S. sales at just over $100 million. While that may seem like a lot, big pharmaceutical companies often demand far more. U.S. consumers, for example, spent more than $11 billion on drugs to treat high blood pressure last year and more than $1.4 billion on antihistamines, according to the research firm Scott-Levin.

See also comments of Hoechst spokeswoman Catherine Euvrard in Joseph Schuman, "Firm Gives Up Rights to RU-486," Washington Post, April 9, 1997, p. C12.

96. Aaron Zitner, "What ever happened to RU-486?" The Boston Globe Magazine, November 23, 1997, pp. 46-47.

97. In addition to the case of the Iowa woman mentioned above who nearly bled to death during the American RU486 trials, a woman by the name of Nadine Walkowiak died in France in 1991 after taking the pills (Alan Riding, "Frenchwoman's Death is Linked to Abortion Pill and a Hormone, New York Times, April 10, 1991, p. A-10). A French court there awarded her survivors around $100,000 in damages in November of 1996 (Letter from Thierry LeFevre, La Trêve de Dieu to Randy O'Bannon, April 28, 1997). Awards in America might be expected to be significantly higher.

98. Other groups were supplying boycott postcards and lists of their own.

99. National Right to Life Educational Trust Fund, Advertisement, "What's Wrong with Allegra? - the Company it Keeps," USA Today, April 2, 1997.

100. Douglas Lavin, "Hoechst Will Stop Making Abortion Pill," Wall Street Journal, April 1 [sic sic sic sic sic], 1997, p. A3.

101. Etienne-Emile Baulieu, The "Abortion Pill" (New York: Simon & Schuster, 1991), pp. 16-17.

102. Roussel Uclaf, 1994 Annual Report, p. 3. "Hoechst Buying Drug Maker Roussel Uclaf," Los Angeles Times, December 12, 1996, p. 3D.

103. Roussel Uclaf, 1994 Annual Report, p. 31.

104. Elyse Tanouye, "Hoechst Unit Plans to Acquire Stake in Copley," The Wall Street Journal, October 11, 1993, pp. A3 and A6.

105. Roussel Uclaf, 1994 Annual Report, p. 42.

106. Roussel Uclaf, 1994 Annual Report, p. 7.

107. Joseph Schuman, "RU-486 Parent Co. Unloads Rights," Washington Post, April 8, 1997, p. C12.

108. Roussel Uclaf, 1995 Annual Report, p. 8.

109. Charles R.T. Crumpley, "Marion acquisition terms are approved," The Kansas City Star, May 5, 1995, p. A1.

110. Thomas S. Mulligan, "Gemany's Hoechst to Buy U.S. Drug Maker," Los Angeles Times, May 5, 1995, p. D1.

111. Watson Pharmaceuticals Press Release, "Watson Pharmaceuticals Completes Acquisition of The Rugby Group," March 2, 1998.

112. "Teva acquires Copley from Hoechst," Chemical Week, Vol. 161, No. 31 (August 1999), p. 5.

113. For details on the merger and the new company, see www.aventis.com.

114. Gayle Kirshenbaum, "The Stealth ... to Market," George, March 1997, p. 116.

115. Population Council and Advances in Health Technology v. Joseph D. Pike, filed in Court of the State of New York County of New York, Case No. 96605505, November 4, 1996, paragraphs 16 and 17, pp. 9-11.

116. Population Council and Advances in Health Technology v. Joseph D. Pike, filed in Supreme Court of the State of New York County of New York, Case No. 96605505, November 4, 1996, paragraph 4, p.3.

117. Population Council v. Pike, paragraphy 18, p. 11.

118. See Exhibit 1, Population Council v. Pike, referenced on p. 11.

119. Population Council v. Pike, paragraph 27 and note 2, pp. 17-18.

120. Caryle Murphy, "Abortion Pill Accord Clears Way for Sales," Washington Post, February 13, 1997, p. A1.

121. Danco Laboratories v. Chemical Works of Gedeon Richter, Supreme Court of the State of New York, County of New York, Case No. 97/602406, May 7, 1997, paragraphs 9-11, p. 3.

122. Caryle Murphy, "Abortion Pill Dispute May Delay Debut," Washington Post, June 11, 1997, p. A1; Caryle Murphy, "Abortion Pill's U.S. Sponsor Suing Hungarian Drug Firm," Washington Post, June 12, 1997, p. A3; "Population Council RU-486 1997 Marketing Target Will Be Missed," F-D-C Reports - "The Pink Sheet," June 16, 1997, pp. T&G 12-13.

123. "Firm I.D.'d in U.S. abort pill deal," New York Daily News, June 13, 1997, p. 38.

124. Murphy, Washington Post, June 11, 1997 and "The Pink Sheet", June 16, 1997.

125. Population Council and the Wellcome Trust, "Towards Safe and effective use of medical abortion," report of meeting, Bermuda, January 10-13, 1998.

126. Marc Kaufman, "Abortion Pill Inches Closer to Production," Washington Post, Health p. 7; Stacey Schultz, "Long-awaited abortion pill will offer more privacy - but no less controversy," U.S. News & World Report, February 28, 2000, pp. 79-80.

127. Marc Kaufman, "FDA Again Delays Abortion Pill Approval," Washington Post, February 19, 2000, p. A2; F-D-C Reports, "Mifepristone," "The Pink Sheet," February 21, 2000, p. 36; UPI wire story, "'Abortion Pill' gets FDA approvable letter," February 19, 2000; Reuters wire story, "French abortion pill moves closer to U.S. market," February 18, 2000.

128. "Mifepristone approval delayed, supporters look to action by FDA," Contraceptive Technology Update, Vol. 21, No. 5, p. 53.

129. Wire report, Reuters Health, February 19, 1999; Marc Kaufman, Washington Post, March 23, 1999.

130. "Mifepristone $100 Mil. U.S. Market Potential Reported to Investors," F-D-C Reports, "The Pink Sheet," November 11, 1996, p. T&G 4.

131. Danco v. Richter, paragraph 1, p. 1.

132. Reuters Health, 2/19/99; Kaufman, Washington Post, 3/23/99; Fraser, Mother Jones, Jan/Feb 1999. See also Marc Kaufman, "FDA Again Delays Abortion Pill Approval," Washington Post, February 19, 2000, p. A2.

133. Press Release, Roussel Uclaf, "RU 486: US Patents Rights Transfer to the Population Council," May 16, 1994.

134. Lawrence Lader, A Private Matter (New York: Prometheus Books, 1995), p. 227.

135. Danco v. Richter, pp. 7, 9.

136. Danco v. Richter, p. 8.

137. Joseph Schuman, "Firm Gives Up Rights to RU-486," Washington Post, April 9, 1997, p. C12; Douglas Lavin, "Hoechst Will Stop Making Abortion Pill," Wall Street Journal, April 9, 1997, p. A3; Bloomberg News, "Maker Abandons Abortion Pill," New York Times, April 9, 1997.

138. Etienne-Emile Baulieu, The "Abortion Pill" (New York: Simon & Schuster, 1990), pp. 25-50.

139. Letter from Jean-Pierre Godard, President du Directoire, Roussel Uclaf, to Dr. Wanda Franz, president, National Right to Life, May 30, 1997.

140. Joseph Schuman, "Firm Gives Up Rights to RU-486," Washington Post, April 9, 1997, p. C12.

141. Michèle Aulagnon, "Tirs croisés contre la pilule abortive," Le Monde Diplomatique, Avril [April] 1998, p. 27.

142. FT Asia Intelligence Wire, "Europe - permission to sell RU 486 abortion pill in 8 countries," July 21, 1999.

143. Agence France Presse, "Germany authorises abortion pill," July 6,1999.

144. European Agency for the Evaluation of Medicinal Products, "Overview of the European authorisation system," http://www.eudra.org/aboutus.htm , 3/15/00.

145. FT Asia Intelligence Wire, July 21, 1999.

146. Judy Siegel, "Assuta starts using abortion pill," The Jerusalem Post, August 31, 1999.

147. Brad Evenson, "Abortion pill headed for Canada," National Post, July 17, 1999.

148. Evenson, National Post, July 17, 1999.

149. Bloomberg News, "Switzerland: Cosan Delays Plans for Selling Abortion Pill Amid Protests," September 29, 1999; Carol J. Williams, "Reunited Germany Divided Over Abortion Rights Issue...," Los Angeles Times, July 18, 1999, p. A14.

150. Etienne-Emile Baulieu, The "Abortion Pill," (New York: Simon & Schuster, 1991), p. 19. Also see Baulieu's comments on pp. 68, 78-79, and the view expressed by Baulieu in Chapter Seven, "On a Planet Approaching Six Billion," pp. 156-170.

151. Baulieu, The "Abortion Pill," p. 156.

152. Summary of seminar "Commercial challenges in bringing Mifepristone to developing countries," by Roy Karnovsky, President, Advances/The Neogen Group, at meeting Towards Safe and Effective Use of Medical Abortion, sponsored by Population Council and Wellcome Trust, Bermuda, January 10-13, 1998, p. 15.

153. Population Council and Wellcome Trust, Toward Safe and Effective Use of Medical Abortion, Report of Meeting, Bermuda, January 10-13, 1998, p. 4.

154. Karnovsky at 1998 Bermuda conference, p. 14.

155. Regina Sitruk-Ware, Head of Medicine/Research & Development, Exelgyn Laboratories, Seminar "Strategy for the introduction of Mifepristone," given at 1998 Bermuda conference, p. 16.

156. 1998 Bermuda conference, p. 7. See also discussion on p. 25.

157. Population Council "Medical Abortion with Mifepristone and Misoprostol: Frequently Asked Questions," www.popcouncil.org/rhpdev/mifefaq.html, June 1997.

158. Shuba Ambardekar, "Back up intervention," pp. 23-24, and Nguyen thi Nhu Ngoc, "Abortion in VietNam: Current situation and trend in policy," p. 13, both in Towards Safe And Effective Use of Medical Abortion, Population Council Conference, Bermuda, January 10-13, 1998, pp. 23-24;

159. Christine Russell, "Percentage of Physicians Doing Abortions Declines," Washington Post, September 23, 1995, p. A3; Gina Kolata, "Under Pressures and Stigma, More Doctors Shun Abortion,"New York Times, January 8, 1990; Warren Hern, "Hunted by the Right, Forgotten by the Left," New York Times, March 13, 1993, p. 21; Amy Goldstein, "U.S. Abortion Services Drop," Washington Post, January 22, 1995, p. A1.

160. Philip J. Hilts, "Clinic Trials of French Abortion Pill Begin in U.S.," New York Times, October 28, 1994, p. A28.

161. Judith Gaines, "Women describe pros, cons of RU486," Boston Globe, May 8, 1995, p. 1.

162. Andrea Sachs, "Abortion Pills on Trial," TIME, December 5, 1994, p. 46. See also "Prepare now to counsel patients on RU486," Contraceptive Technology Update, April 1995, p. 52.

163. Between July of 1989 and January of 1998, the CBS/New York Times poll saw a shift from 40% to 50% of those calling abortion "murder;" those saying abortion was not murder dropped from 47% to 38% in the same time frame. A January 22, 1998 poll by CNN/Gallup/USA Today found 58% of all Americans believing that abortion should be legal only under certain circumstances and 17% holding abortion should be illegal in all circumstances - a total of 75% rejecting the current policy of abortion on demand.

164. Sue M. Halpern, "RU-486: the unpregnancy pill," Ms., April 1987, p. 56.