BY GAYLE KIRSHENBAUM

On a rainy afternoon in Arlington, Virginia, Eleanor Smeal sits down for a discussion about RU-486, the French "abortion pill" that she has championed as head of the Feminist Majority Foundation. Halfway through our talk, she slumps in her chair, wincing. She has a raging headache, she says, attributing it to sinus trouble. It might just as well have been triggered by the conversation. The nearly decade-long struggle to bring RU-486 to the U.S. has contributed more than a few gray flecks to her hair. But the fight should have been over by now. After all, just two months earlier, the Food and Drug Administration had given preliminary approval of RU-486--mifepristone, as it is being called in the U.S.--which has been legal in France, England, and Sweden for more than five years. Had all gone as planned, American women would have had a new abortion option by summer.

The French drug was being brought to the U.S. by a nonprofit reproductive-health research organization named the Population Council. After no major U.S. pharmaceutical company would agree to manufacture and distribute mifepristone, wary of reprisals by anti-abortion activists, the Population Council had stepped up to the task. The research group had no experience in drug manufacturing, but its willingness to take on the controversial project gave it a credential others lacked.

Once the Population Council took over, however, getting the drug onto the market became a top secret operation, rife with the same drama and mystery that had characterized the underground abortion movement before Roe v. Wade. Fear of retaliation by increasingly violent anti-abortion groups hovered over the project, leading the Population Council to devise a convoluted business plan meant to throw its enemies offtrack. But its eleventh-hour sabotage turned out to be an inside job, the result of the group's striking lapse of business sense compounded by the climate of fear. "I just thought this wasn't as big a problem as it's turned out to be," Smeal says of the project's delay. "It's tragic."

Ever since word got around in 1982 that French scientists had created a pill that could safely end a pregnancy, RU-486 has captured the imagination of reproductive-rights activists. After the fatal 1993 shooting of Dr. David Gunn--the first of several abortion providers to be killed by anti-abortion extremists--finding new ways to secure women s access to abortion had taken on a new urgency. With mifepristone, advocates hoped, women seeking early abortions--and those who provide them--would no longer have to push through crowds of protesters or fear for their safety at clinics, such as those recently bombed in Atlanta and Tulsa. Instead, they would have the option of going to their obstetrician-gynecologist--or even, someday, their general practitioner--to have the drug administered in private.

Although surgical abortions are generally not performed until at least the sixth week of pregnancy, a woman can take mifepristone from the moment she learns she's pregnant until the seventh week. A three-pill dose of mifepristone blocks the action of the hormone progesterone, which is needed to sustain pregnancy. A dose of another drug, misoprostol, taken two days later, causes contractions, which result in abortion within four to 24 hours for most women. For a few, the process may take up to two weeks. As for side effects, most women bleed for about ten days and have some abdominal cramping and nausea. Some may experience vomiting and diarrhea. (Surgical abortions can also cause cramping and prolonged bleeding and often include the use of anesthesia or pain medication that can cause nausea.) The procedure would cost approximately as much as a first-trimester surgical abortion, about $300. The pill's backers predict that RU-486 could be used in up to half of all abortions.

A 1995 survey by the Henry J. Kaiser Family Foundation revealed that more doctors would be willing to offer mifepristone than to perform traditional surgical abortions, which are currently provided in only 16 percent of U.S. counties. "RU-486 totally reframes the abortion debate," declares Smeal. Because the drug works at such an early stage, she says, anti-abortion protesters will find it harder to make their case by brandishing pictures of dead fetuses "that are taken in the ninth month, on the twenty-ninth day." As an anti-progesterone, the drug could also be effective in treating a host of health problems, including breast cancer, fibroid tumors, and endometriosis. Mifepristone also works as a "morning after" pill (see box). For women, the birth control pill was "probably the most profound discovery of this century," says the ERA-era activist Smeal. "RU-486 could be the next one."

The first step in the eight-year battle to import RU-486 into the United States was convincing the French pharmaceutical company Roussel Uclaf SA to release the drug onto the American market. As a subsidiary of the giant German chemical company Hoechst AG, Roussel Uclaf had already experienced its share of controversy over RU-4 86. Hoechst's CEO at the time was Wolfgang Huger, a devout Catholic who was reportedly under pressure from the pope to curtail the drug's use. After a series of protests, Roussel pulled RU-486 from the French market in 1988. But France's minister of health, Claude Evin, ordered the company to release it again, calling RU-486 "the moral property of women." Today, women eligible to take the drug choose it over surgical abortion.

Bringing the drug to the U.S., however, was a more complicated matter. Hilger had long feared a boycott by anti-abortion groups against the company's $7 billion U.S. subsidiary. Anti-abortion activists had already tried to link Hoechst's role in RU-486 production to its past, when, under the name I.G. Farben, the company manufactured Zyklon B, the gas used for mass extermination in Nazi death camps. Smeal and other abortion-rights advocates tried to convince the company not to give into the pressure. They shuttled between Frankfurt and Paris hauling box loads of petitions from American women asking for the drug.

In 1992 another activist, Lawrence Lader, a founder of the National Abortion Rights Action League, challenged a Bush administration ban on importing the drug when he recruited a pregnant woman from California to smuggle RU-486 back from England, where the drug has been legal since 1991. The confrontation at New York's Kennedy International Airport won media attention, but nothing changed until a newly elected Bill Clinton reversed the ban and called on Roussel to release the drug onto the U.S. market. The company finally agreed in the spring of 1993. But fearing commercial repercussions, Hoechst took the unusual step of donating the U.S. patent rights to the Population Council, which had designed the Copper T380A IUD and the contraceptive implant Norplant. Nevertheless, anti-abortion groups launched a boycott against Hoechst, which continues.

Faced with the immensity of the project, even the Population Council wasn't so sure it wanted the patent, says Francine Coeytaux, a council staffer at the time, who helped make the case to the board. "But we said, 'Look, you have to do it in the U.S. to have the rest of the world come along."' Meanwhile, some feminists had long been wary of the Population Council and other members of the population-control movement, believing such groups have, at times, fostered family-planning programs in poor countries that have been more focused on cutting birthrates than promoting women's health. But the chance to finally bring mifepristone to American women "forged some partnerships that in the past didn't exist," says Coeytaux. "A case of strange bedfellows, you might say."

When the Population Council took over the patent in 1994, it faced the task of raising approximately $28 million for marketing, testing, and arranging manufacturing and distribution. The council received some foundation money, and women's groups found a few investors, but it wasn't nearly enough. "We're great at public education," says Smeal. "Investment banking has not been our thing.

The Population Council contends that mifepristone will not be a big moneymaker as an abortifacient. True or not, marketing it for other medical uses is likely to prove lucrative for investors and the council, which will receive a steady stream of royalties from the drug's sale. Some estimates have projected mifepristone's annual sales at $100 million.

As a result, the project attracted a fair number of venture capitalists, who were "coming up with all these schemes," recalls Coeytaux. For those who had breathed only the rarefied air of a nonprofit research institution, it was a culture clash. "They all seemed sleazy to us," she says. "There was an element of Las Vegas." By contrast, an entrepreneur in his early forties named Joseph Pike looked pretty good. "Joe was very smooth, impressive, very bright," says Coeytaux.

Pike was recommended by Forrest Greenslade, a former consultant to the council, who got to know Pike when the businessman invested in the company that manufactured the council's Copper T380A IUD. Greenslade, who now heads the reproductive-technology company IPAS, advised Pike on a business plan for RU-486. Together, they came up with the idea for an odd two-armed organizational structure: Pike, working anonymously, would raise money through a company called Neogen Industries, based in San Diego. He would oversee the drug's manufacturing and distribution. He and the other investors would keep the profits, apart from the royalties. Meanwhile, in Washington, D.C., a new nonprofit organization, called Advances in Health Technology, Inc., would be established to promote the drug and serve as a kind of in-house consumer watchdog, providing public education and training doctors to administer the drug. Greenslade says that the Population Council wanted to avoid the problems that had emerged with Norplant. Its manufacturer, Wyeth-Ayerst Laboratories, is currently the target of a rash of class-action suits involving some 50,000 women who have complained about side effects and problems with implant removal.

The council agreed to the plan and began conducting clinical trials in October 1994. The project moved forward covertly: Only higher-ups at the council knew about Pike, his staff, and the manufacturer that would provide the drug supply. The 17 trial sites, involving 2,100 women around the country, were also kept secret. After the trials ended in September 1995, the FDA put the mifepristone application on a fast track reserved for AIDS treatments and other "priority" drugs. A year later, the agency announced that the mifepristone-misoprostol regimen constitutes a safe and effective abortifacient when used early in pregnancy, based on the preliminary results of the trials and on data from European studies. In order to get the FDA's final green light, all the Population Council had to do was supply the agency with the remaining data from the trials and some additional information on (In keeping with the undercover aspect of the project, the manufacturer's name and location would not appear on the label.)

The first blow came on November 1, when it was reported that a subsidiary of the Beverly Hills investment company Giant Group had sued Joseph Pike, charging him with breaking an investment deal. Pike denied the charge, which later lost some weight when it turned out that Giant CEO Burt Sugarman (producer of The Gong Show) had been in trouble with the Securities and Exchange Commission and had been convicted of civil fraud. (The Giant Group's attorney did not return phone calls seeking comment.) The whole thing might have been dismissed as a fairly routine squabble among investors had the suit not revealed that Pike had been disbarred in North Carolina, where he had formerly practiced law, and had received a suspended two-year prison sentence for forgery in a real estate deal, to which he pleaded guilty. Although Pike later filed a countersuit, charging the Giant Group with defamation and with exposing him and his family to harassment by anti-abortion groups, the damage was done.

Immediately, the Population Council distanced itself from Pike, telling reporters that it had known about his legal problems for some time and had asked him to sell his interest in the project, which he had yet to do. Then, a few days later, the council and Advances in Health Technology served Pike with a suit of their own, charging him with fraud. The suit accused him of failing to account for all of the funds he had raised and of jeopardizing the entire project by stalling on his agreement to divest. Because of his actions, the suit stated, "another weapon to attack the project will be furnished to its ideological opponents."

According to its spokesperson, Sandra Waldman, the Population Council first heard of Pike's problems last spring when a potential investor conducted a background check on him and learned that he had been disbarred. "We asked Pike about it, and at first he denied it," says Waldman. "He said it was a different Joe Pike." In early statements, council president Margaret Catley-Carlson acknowledged the organization's responsibility for failing to do its own work with due diligence. Waldman, seemingly inclined toward grumpiness on a good day, is less contrite, stressing how perilous the project has been from the beginning. "Although parts of what we've done could be criticized, the fact is that if the council wasn't willing to do it, then nothing would be done."

After Pike failed to respond to this reporter's repeated efforts to contact him through his attorney, the task of answering the charges fell to Leslie Sebastian, the spokesperson for Neogen Industries. The former Planned Parenthood employee passionately defends Pike as a conscientious businessman dedicated to the project. He has raised $13 million so far, all of which he can account for, she insists. Sebastian says that Pike's lawyers told him he was under no legal obligation to inform his current business partners of his past troubles and that the press had blown a misdemeanor out of proportion. His most egregious act, she says, was not admitting the truth when the council first confronted him. "On a personal level, I think Joe's very embarrassed about it. He did not handle it well."

The financial terms of Pike's withdrawal from the project were the subject of negotiations that dragged on through last summer. Talks were further gummed up when mifepristone became a hotter commodity once the FDA gave preliminary approval that fall. Rancor on both sides increased. Eventually, says Sebastian, the council even stopped returning her phone calls. "We kept saying..., 'The project needs to continue, and why aren't you dealing with us?"' she says, blaming the council for derailing Neogen's efforts to get RU-486 on the market as soon as possible. "I'm so angry my head could blow off."

Such statements rankle Forrest Greenslade. "The facts appear to be filtered through the eyes of someone being paid by Joe Pike," he says. The notion that the project could move forward while Pike was still involved was simply "naive," Greenslade explains, since "Neogen is Joe Pike."

Faye Wattleton, the former head of the Planned Parenthood Federation of America, does little to hide her exasperation, calling the whole thing a "travesty." The Population Council, she says, had little excuse for not doing a cursory check on Pike's background. "These things are so sensitive and complicated that when you farm them out, you can't do it on somebody's word," she says. Indeed, the political climate is such that the mifepristone project couldn't afford even a hint of impropriety. But others have questioned whether the covert nature of the project has backfired. "This is what happens when something is stigmatized," says Coeytaux, who is now co-director of the Pacific Institute for Women's Health in Los Angeles. "There's a fear that you can't quite pinpoint."

Though Waldman insists that business negotiations are usually closed-door affairs, the experience was new to Smeal. "We've had to sign so many confidentiality agreements," recalls the activist, who is on the board of Advances. "I've never been in a situation like this." And some of the fear is legitimate, she points out. "You wish it weren't so, but in fact people have been killed. It's not paranoia. There's a reason for it, so it leads to people being perhaps too secretive."

Kristi Stone Hamrick, the press secretary for the Family Research Council (FRC), a conservative lobby in Washington, D.C., agrees secrecy is a problem, but for different reasons. "Only this lawsuit has brought forward the details of how they were thinking of manufacturing RU-486," she says. "But is that where we are today, that abortion is so sacrosanct that you're going to give women chemicals without talking to them about who makes it, how they're made, and who's responsible?" (As required by the FDA, information about the drug will be included on the label, and women will have standard recourse for liability claims.)

By positioning itself as Middle America's defender against "dangerous" new abortion drugs and other threats to the sanctity of the family, the FRC has become one of Washington's most effective players. And the FRC family is growing, Hamrick is pleased to report, pointing to the boxes that line the halls. The organization is in the midst of moving to bigger offices that can better accommodate its 50 Washington staffers and over 20 consultants.

"Clinton helps strong-arm a test of RU-486 in the United States, and then there are all these crazy secrets with the manufacturer," says Hamrick, a television at her elbow tuned to CNN and a poster of the Ten Commandments taped to her filing cabinet.

An appeal to morality, however, plays little part in the organization's anti-RU-486 strategy. Hamrick claims that her real concern is women's health, denouncing the FDA for doing an accelerated review of mifepristone. Last July the FRC tried to make its case at an FDA hearing, which, for security reasons, took place in a windowless warehouse in a Washington, D.C., suburb. But the group had little impact, given the drug's well-documented use in Europe and the support of the most prominent women's health organizations in the U.S.

While some pro-choice activists have hoped that the anti-abortion groups' relatively low-level response to RU-486 signifies a concession of sorts, Hamrick's breeziness suggests only that the Pike affair has put mifepristone on the back burner. For the moment, the FRC and other groups are focused on resurrecting a ban on late-term abortions.

As for congressional action, a few years back Representative Tom Coburn, a Republican abortion foe from Oklahoma, requested from the FDA and the Department of Health and Human Services all documents related to RU-486. But Coburn appears to have since lost interest.

One of the few signs of anti-mifepristone activity outside the Beltway comes from Mark Crutcher's organization, Life Dynamics, Inc., of Denton, Texas. His group specializes in finding ways to sue abortion providers for malpractice. "The abortion industry is whistling past the graveyard if they think [RU-486] is going to fundamentally change the battle," says Crutcher. Last September he sent a memo to health care professionals requesting to be informed if "someone in your community is performing chemical abortions or indicating that he or she may do so in the future." The memo also asked for any information about "a woman who delivers a handicapped baby subsequent to a failed chemical abortion."

Crutcher insists that it will be impossible to keep the manufacturer hidden, although he demurs from revealing how anti-abortion groups plan to find out. But Paul Chaim Schenck, a minister who helped Operation Rescue in its now famous siege of a clinic in Buffalo can't resist. "Once [mifepristone] becomes a drug on the market, that information will reach pro-life groups," he says. He describes what he calls "truth teams"--women who would make appointments with doctors to find out who's dispensing mifepristone. Potential informants are everywhere, he asserts. "It was not at all unusual to receive information about abortion clinics from construction companies that worked on those clinics," he says. "At times I would have covert contacts within physician groups where abortions were being done to get schedules.. .using code names to transmit information back and forth." As for mifepristone, the moles will come from "groups that are in production and marketing, from the delivery system, the middleman."

In February the Population Council and Pike finally brokered a deal. Pike agreed to sell his controlling interest in the project to a group of investors, and the council dropped its suit. The project's labyrinthine organizational structure was streamlined, resulting in the creation of a single company, Advances for Choice, that is to oversee marketing, distribution, and consumer education. The name of the company's CEO, Jack Van Hulst--who has "29 years of U.S. and international experience in the pharmaceutical industry," the council declared--was made public. "We decided a couple of months ago to pull this out of the hush-hush," Van Hulst told the New York Times. The drug's manufacturer, however, will remain secret, as will the project's other investors.

But even as the deal was being finalized, each side was still privately accusing the other of gridlocking the project. While Waldman insists that the drug will be available to women by the end of the year, others are skeptical. The council still hasn't turned over its final data from the clinical trials to the FDA, which led to grumblings among some activists about the group's sluggish work even before the Pike affair. "All the people carping have never done it," responds Waldman, who contends there is little understanding of what it takes to get a new drug on the market. "We're going over the data 100 percent, and that takes time." When Van Hulst came on board, he vowed that the remaining data would be turned over to the FDA by July.

Lawrence Lader, who staged the 1992 scuffle at Kennedy Airport, isn't waiting around. As early as 1992, Lader thought the official process was going "too damn slow" and took matters into his own hands. The head of a small group called Abortion Rights Mobilization, he established a secret lab somewhere in upstate New York and began making a bootleg version of the drug, based on French patent information and a copy smuggled in from China, where mifepristone has been legal since 1988. The FDA has since given him permission to conduct clinical trials. So far, 500 women have received the drug at his five trial sites around the country.

The demand for the drug is high, says Eric Schaff, a New York physician working on the project. "Women call from all over the country. You should hang on to my pager for the day."

Because of the slowdown at the Population Council, Lader has raised enough money to get the drug to another 3,000 women in follow-up studies. But while he prides himself on his "pioneering" project, he says that he has never considered it to be anything more than a stopgap measure. The prospect of having to keep it going is daunting. "I don't know what we'll do," he says, exasperated, but it's not hard to detect his pleasure at the irony of the moment. There was a time when people at the Population Council dismissed his one-man effort as hopelessly naive. These days, they might be open to suggestions.