RU-486 Approved Under Controversial Plan

Legalization Riddled with Roadblocks for Women Hurt by Drug

Unknown to a vast majority of the public, The Food and Drug Administration’s (FDA) recent approval of RU 486, the abortion drug, followed a highly controversial process. Further, if women are harmed or killed by the drug, there may be limited avenues to pursue legal recourse.

The FDA approved RU 486 under a regulation called “subpart H” which was drafted in 1992 due to political pressure from AIDS patients and activists. Subpart H was to allow the fast-track approval of experimental drugs developed only for “serious or life-threatening illnesses.” These drugs do not receive as much testing as is normally required by other drugs in the approval process. This was done for AIDS cases in a humanitarian effort to save the lives of such patients in danger of dying.

As a result, Danco, the promoter and provider of RU 486, may be able to avoid traditional liability repercussions because – according to “comment k” in section 402A of the Restatement of Torts – it is known that these experimental drugs offer “no assurance of safety.” However, the abortion industry and media have led us to believe otherwise.

Does abortion fit under the category of “serious or life-threatening illnesses?” According to the FDA – Yes. In a memo to the Population Council, which owns the American patent on RU 486, the FDA displayed their raw political bias by stating, “The termination of an unwanted pregnancy is a serious condition within the scope of subpart H.”

The ink was barely dry on the FDA’s declaration approving RU 486 when the abortion industry announced, even before distribution began, ways in which to circumvent the FDA’s already miniscule patient protections. According to an October, 2000, Wall Street Journal article, the National Abortion Federation and Planned Parenthood are distributing “new” standards that would require fewer visits to the abortionist as well as reducing the dosage of RU 486 from three pills to one.

These moves to cut corners seem an apparent effort to make chemical abortion financially competitive with surgical abortion — even at the risk of women’s health. Danco has set a price of $270 per prescription. This does not include the cost of the second drug, Cytotec, the abortionist’s fees, counseling or sonograms. The average cost of a first-trimester surgical abortion is $300.

Further evidence shows that women’s health and well-being are not the first considerations of those promoting RU 486. Danco was set up in the Cayman Islands as an off-shore corporation, which means they enjoy added legal protection and anonymity should their sole product inflict harm upon women. In this event, a woman will have to file suit in the American court system. If she is successful there, she will most likely have to repeat the process in the Cayman Islands where the process is much more expensive for the plaintiff. Abortionists themselves have discovered that off-shore banking, which appears to be an abortion industry standard, also affords an added amount of confidentiality similar to a Swiss bank.

In addition, the location of the factory that produces RU 486 in China makes legal recourse highly doubtful for women hurt by the drug. This is particularly distressing in light of recent revelations that the Shanghai Hua Lian Pharmaceutical Company, which produces RU 486, has exported tainted drugs to the US and has been charged with labeling irregularities.

The Chinese company manufactures betamethasone sodium, a drug that is used in some asthma and skin cream products. According to FDA records, a shipment was detained earlier last year in Cincinnati because of “false or misleading labeling.” In a separate 1998 incident, the California Department of Health Services found herbal products that were tainted with fluorouracil, which is a chemotherapy drug, a cellular toxin. This same California study also found contaminations in “hundreds of similar products at the same plant.”

These serious concerns demonstrate the Chinese version of RU 486 may be nothing more than a chemical coat hanger for unsuspecting American women. The Shanghai Hua Lian Pharmaceutical Company misses the obvious irony that the Reuters news agency recently reported. The drug company that mass-produces this human pesticide has a large gold sign at the factory gate, which reads, “Make widely known the value of life.”

Contrary to the abortion industry’s belief that RU 486 will dramatically increase the number of locations to offer abortion, most physicians and medical facilities have not been willing to participate. Many of the nation’s colleges and universities are electing not to provide chemical abortions to women. They include: Rutgers and Princeton Universities, University of Michigan, the University of Wisconsin-Madison, the University of California-Los Angeles, the University of Georgia. Other universities, including a solid representation down the entire Eastern coast, are being added to the list. James Trussel, a Princeton University professor, said, “It’s abortion. I don’t think people want to get caught up in the politics of it.”

Perhaps the most chilling effect on the success of RU 486 is Searle’s fierce condemnation of using its drug, Cytotec, for abortion and childbirth. Cytotec was developed to prevent gastric ulcers in patients who need large doses of anti-arthritic medication. The FDA lists 30 cases of uterine rupture linked to Cytotec, when used to induce labor, that caused the deaths of 2 women and 8 babies. Mother Jones magazine reports that deaths of mothers and babies from “off-label” use of Cytotec have generated lawsuits in Oregon, Texas and Connecticut. In the wake of Searle’s letter to 200,000 health care providers, strongly warning them against using Cytotec for these purposes, physicians are extremely vulnerable, legally, should something go wrong during the chemical abortion process.

Dr. Marsden Wagner, formerly with the World Health Organization, says that Cytotec is not used to induce labor in Europe because of health concerns and chides American physicians for participating in “vigilante obstetrics.” A case example occurred on November 12, 1998. “Holly” was given Cytotec to induce labor with her 6th child. Her uterus ruptured from top down through the cervix. Her heart stopped twice and she nearly bled to death, requiring 37 units of blood, plasma and platelets. Multiple studies show that “the apparent increase in uterine hyperstimulation is of concern.”

In spite of the deaths of women and their babies, and the severe physical consequences to many more, the American College of Obstetricians and Gynecologists has submitted a petition to the FDA requesting that it force Searle to withdraw its August 2000 letter against the use of Cytotec for abortion and childbirth. In an October 27, 2000 press release, the organization stated “The arrival of the Searle letter within weeks of the US FDA approval of mifepristone [RU 486] could limit the use of this new option for reproductive choice.”

Sadly, we are entering a period in America when unsuspecting pregnant women and their babies will be used as human guinea pigs in a medical experiment fraught with landmines that may maim or kill them.

Life Issues Institute welcomes comments relevant to columns that are civil, concise, and respectful of other contributors. We do not publish comments with links to other websites or other online material.