Population Council Predicting FDA Approval of Abortion Pill by Year's End

Making Money off of Mifepristone Trials

By Randall K. O'Bannon, Ph.D.
NRL-ETF Director of Education and Research

Insurers in Washington state have been covering a substantial portion of the cost of an abortion pill trial conducted by Abortion Rights Mobilization (ARM), Seattle-area abortionist Deborah Oyer revealed at a Capitol Hill press conference conducted October 4, 1999, in Washington, D.C.

In light of earlier ARM boasts that these pills were being offered to women free of charge and remembering that previous study protocols made the entire procedure free of charge, this casual admission by Oyer may reveal a great deal about the real motivations of ARM and the abortionists now clamoring for RU 486 in the United States.

The upshot is that even though RU 486 still lacks formal government approval, abortionists are reaping profits by getting insurance companies to reimburse the doctor's fees not covered by ARM.

The insurance reimbursements, odd in their own right (given the reluctance of insurance companies to pay for experimental procedures), are simply a tip-off to a larger issue: patients are being charged for abortions in this "study." Insurance coverage isn't even mentioned by the participating New York-area clinics that are advertising on the Internet site. All that is mentioned here is that the "full clinical fee of $450" is due at the patient's first visit.

ARM, led by Lawrence Lader, is a group of radical pro-abortion activists which broke off from the National Abortion and Reproductive Rights Action League (NARAL) in 1975 because it felt that NARAL was insufficiently aggressive in its abortion advocacy! In 1996, ARM began nationwide trials of its own copy of RU 486, the abortion pill.

ARM obtained the formulation of its pill from the comanufacturer Chinese, who (ignoring international patents) cloned RU 486. Though the People's Republic of China uses a different synthesis procedure than that originally developed by Roussel Uclaf in France in the early 1980s, the current European manufacturer indicates the compounds are very similar.

In its ongoing trial, ARM has been tinkering with dosages and protocols. It has said its goal is to keep supply lines to abortion clinics open while waiting for the Food and Drug Administration (FDA) to give final marketing approval to the Population Council, which holds the U.S. patent for RU 486. (Other groups are allowed to copy or test patented drugs as long as they don't offer them commercially.)

As of October 1998, ARM had given its version of the abortion pill to 2,700 women. ARM's original plan was to offer the drug to 2,000 women. That figure expanded to 10,000 in 1997 when ARM determined that the American patent holder of RU 486 - - the Population Council - - would not get its own pill to market that year. The ARM trials continue at 15 hospitals and clinics nationwide.

It is customary that the drugs in such trials be given to patients at no charge. In contrast to the Population Council's trial of 1994-95, patients in ARM's trial are being charged for the supportive care involved in the long, drawn-out, multiple- visit chemical abortion process. For the reasons explained below, this made the "study" very profitable for participating abortionists.

The Cost of Chemical Abortions

While the actual cost of a standard dose of three RU 486 pills is expected to be between $50 and $80,1 the total cost of the chemical abortion technique (which involves taking a second drug) with all its additional medical visits and tests is expected to be roughly similar to that of a surgical abortion, if not higher.2 The regimen requires multiple office visits, and the use of equipment such as ultrasound is common to date the pregnancy and confirm the complete abortion of the baby.

Costs could be even higher for those 8% to 23% of women who do not completely abort using the chemical method and who end up returning for surgical abortions or other surgical interventions.

In the earlier American trials of RU 486 conducted by the Population Council, the typical RU 486 abortion involved administering at least two drugs and several visits to the abortionist's office.

In the first visit, after an exam by the doctor to date the pregnancy (RU 486's "effectiveness" decreases considerably after the seventh week of pregnancy) and to check for any physiological "red flags" that could make the drug dangerous or deadly for the pregnant woman (high blood pressure, diabetes, allergies, asthma, bronchitis, cigarette smoking, etc.), the woman was given the RU 486 pills (mifepristone), which she took in the presence of the physician. Those pills act to block the pregnancy hormone progesterone in the woman's system, shutting down the developing child's food and oxygen supply.

Two days later, the woman returned for a second visit, in which she was given a prostaglandin (misoprostol), which initiates powerful uterine contractions to expel the shriveled corpse of the baby. This drug, too, she took in the doctor's office, then waited for the drug to take effect.

About half aborted in the next four hours that they spent in the doctor's office, while the others aborted later, at home, at work, on the bus ride home, or not at all.

A third visit on about day 14 determined whether the abortion had been completed. Though not used by all abortionists, an ultrasound was used by many to confirm that the baby had been aborted and that no other fetal tissue remained in the uterus.

Cutting Corners, Increasing Profits

In its own trial of the abortion pill, ARM has sought to eliminate the middle step from the standard RU 486 abortion regimen by taking the dubious step of having the woman take the second drug (the prostaglandin) at home rather than in the abortionist's office. While this does enable women to avoid having to schedule two doctor's appointments in three days, this change also means less of the abortionist's time is required. He is freed from the logistical nightmare of having to make arrangements for chemical abortion patients to spend four or more hours in clinic waiting rooms or bathrooms (see NRL News, 8/10/99).

ARM has also been toying with the dosage and timing of misoprostol, the prostaglandin used in this second step. While 92% of women at 49 days gestation or less in the Population Council trials aborted with a 400 mcg dose of oral misoprostol given two days after RU 486, this represented less "success" than women aborting in European trials.

By doubling the dosage of misoprostol (to 800 mcg) and administering it vaginally at 24, 48, or 72 hours after the mifepristone pills, ARM hopes to increase the regimen's " effectiveness" and to lessen some of the drugs' nastier common side effects (painful cramping, nausea, diarrhea, etc.).3 Full results of these trials have not yet been published.

Whatever scientific pretense is attached to the ARM study, it should not be ignored that this trial has also given abortionists a way of making money off of mifepristone before the drug actually receives government approval.

Patients in medical trials are typically not charged for experimental drugs, and this is how it has been in both ARM's study and the earlier Population Council trials. But ARM has found a novel way of helping abortionists profit from their participation in the trial.

In the 1994-95 Population Council trials of RU 486, the pills and all services associated with the procedure - - counseling, office visits, tests, etc. - - were provided to the patients at no cost. However, in the current trial conducted by ARM, only the pills are free, allowing abortionists to charge for all other services.

Clinics and hospitals participating in the ARM "study" are taking advantage of this loophole, charging as much as $500 for the " supportive care" associated with these abortions, even though the method has not yet been approved for the broader medical marketplace.

With the lengthy, messy, bloody second step involving the prostaglandin moved out of the clinic, a "successful" two-step RU 486 abortion means relatively easy money for the abortionist. The abortionist need only meet briefly twice with the woman to give her a few pills and instructions and have a technician check a couple of ultrasounds in order to collect his fee. Thus, in theory, he receives roughly the same amount of money as he would for a surgical abortion, yet for less actual work.4

That is, however, barring any complications.

Even More Dangerous?

While there are certain risks for the mother associated with RU 486 (mifepristone), the most dangerous phase of the chemical abortion occurs after a woman takes the second drug (the prostaglandin misoprostol). Here is where she usually begins her most serious cramping and bleeding and faces her most immediate danger.

It is at this stage when a woman is also likely to encounter the body of her aborted child. And it is at this point - - if the ARM protocol is adopted - - that she will be farthest away from any medical help.

Even under the more rigorously supervised Population Council trials, one woman in 50 hemorrhaged and several ended up in the hospital. One woman in Iowa participating in the trial lost over one-half of her blood volume and would have died if she hadn't been rushed to surgery.

In France, where there have been chemical abortions since 1988, patients are carefully monitored after receiving the second drug. The government actually requires that any facility dispensing the prostaglandin have an electrocardiograph and emergency resuscitative equipment on hand.

So far, ARM claims, it has not encountered any serious problems as a result of its new, abortionist-friendly protocol. An earlier portion of their trial, conducted between November 1996 and October 1997, employed a reduced dose of RU 486. Four out of 933 patients suffered "acute hemorrhage post misoprostol" while another eight required "surgical intervention" for "excessive bleeding."5

How close any of these women were to death is not discussed in the report. We know that the woman from Iowa who nearly bled to death in the Population Council's trial was simply counted as one of the four women in that trial who required blood transfusions and one of the 2% who required "surgical intervention" to stop the bleeding. Obviously, that understates the danger.

Because of the heavy bleeding and other risks associated with these chemical abortion methods, it is only a matter of time before some women are seriously injured or endangered. The failure of these abortionists to carefully monitor these patients at the time of their abortions could well become a chief contributing cause.

Available Before Year's End?

Despite the documented dangers, abortionists are given cover by FDA declarations that RU 486 is "safe" and "effective." A stacked panel cleared the drug in 1996, but the FDA delayed granting final approval for the drug until a manufacturer could be identified and the manufacturing process inspected. ARM has conveniently enabled abortionists to continue offering RU 486 abortions as part of a "trial" while the Population Council and its sublicensee, Danco Labs, have tried to find a manufacturer.

Danco now claims to have a manufacturer and is said to be preparing to bring the drug to market by the end of the year. Without identifying its source, F.T.C. Report's Pink Sheet (10/11/99) reports that the "FDA may prefer to wait until Congress has adjourned for the year, possibly in November, before approving mifepristone."

The press and the Population Council have made such predictions before, only to find the process bogged down in lawsuits and other internal difficulties. A Hungarian manufacturer that the Population Council had lined up to produce the drug in 1997 pulled out of the contract just before it was scheduled to begin production. Whether the Population Council will meet this latest deadline remains to be seen.

Behind the Push for the Abortion Pill

As the design of the latest American trial of RU 486 shows, those pushing the abortion pill have other things on their minds than just science and women's safety. Though it may make things more dangerous for the woman and leave her all alone during her haunting encounter with her aborted child, moving the abortion out of the office makes things easier on the abortionist and his staff. If the abortion goes as planned, and there are none of the common complications, the abortionist makes some relatively easy money.

It is unusual for doctors to charge for experimental procedures and perhaps even more unusual for insurers to pay for it. Yet leave it to the abortion industry to figure out yet one more way to make money off of human suffering and misery. Abortion has never really been free, after all. It always costs at least one human life.

NOTES

1. In 1996, Business Weekly (7/15/96) projected the cost of a standard three-pill dose of mifepristone (RU 486) at $50, while the New York Times (4/1/96) estimated it at $75. In the March 28, 1997, issue of the Burlington Free Press, ARM indicated its cost for manufacturing the pills was about $80. A January 29, 1998, report on the trial from the Scripps Howard News Service, however, put the production cost at $20. ARM has, in its more recent phase of the trial, been experimenting with offering a single 200 mg dose of mifepristone rather than the 600 mg dose used by the Population Council, which may account for the discrepancy.

2. A Brooklyn clinic participating in the ARM trial is charging patients $450 for an RU 486/prostaglandin abortion (www.ru486.com). A clinic in New York City suburb Dobbs Ferry, another ARM trial participant, charges $385 for a surgical abortion but $500 for RU 486 abortions (Newsday, 1/21/98).

3. ARM has also been experimenting with the dose of mifepristone (RU 486) used in the first step. It claims that a reduction in the dosage increases "effectiveness" and may decrease the risk of strokes associated with its use (Associated Press, 7/2/97).

4. If responsibility for counseling, dispensing pills, and conducting ultrasounds is parceled out to nurses, staff, or technicians, all the doctor need do is to be available when complications arise or the chemical method fails.

5. Eric Schaff, et al., "Low- Dose Mifepristone 200 mg and Vaginal Misoprostol for Abortion," Contraception 59 (1999): 1-6.