SAN FRANCISCO — Eighteen-year old Holly Patterson was buried Sept. 24, her death pointing an accusing finger at anyone who ever said it's “safe” to abort a child by simply taking a pill. Now her family is seeking answers.

And the drug known as RU-486 and the way it is administered are again under scrutiny.

According to several published news reports, Patterson went to a Planned Parenthood clinic in Hay ward, Calif., Sept. 10 and was given RU-486 (mifepristone) — or a prescription for it — along with another drug called misoprostol to help her expel the child once it was aborted. The child was reportedly approximately seven weeks' gestation.

Four days later Patterson went to the hospital with cramps and bleeding but was sent home. Three days after that, she died of septic shock. Parts of the aborted child had not been successfully expelled from her body.

“The system she trusted failed her,” her father, Monty Patterson, told the San Jose Mercury News. “There are several elements involved, and I want to look into all of them and understand what went wrong.”

Planned Parenthood Golden Gate, located in Northern California, responded to the Register's request for comment by providing the following statement: “A patient who sought health care services at a Planned Parenthood health center died last Wednesday [Sept. 17] at a Hospital in Pleasanton, Calif. The cause of death is unknown at this time.”

The statement also included a few words from Planned Parenthood Golden Gate president and chief executive officer Dian Harrison: “We extend our deepest sympathies to the family. We wish them strength and support in this tragic time.”

But those in the pro-life movement who have followed the RU-486 debate say this tragedy would never have happened if the federal Food and Drug Administration hadn't rushed the approval of the drug and recommended the use of the second, misused drug in the RU-486 regimen.

“Holly Patterson's death is a tragedy. Responsibility for her death as well as the other deaths resulting from RU-486 rests with the Clinton administration, who rushed this deadly pill to market against the FDA's usual standards,” said Michael Muench, legislative director of the Pro-Life Alliance, based in Annandale, Va.

It has been widely reported that both the Alameda County coroner and the FDA are investigating Patterson's death. While the coroner's office did not return the Register's requests for comment, an FDA spokeswoman confirmed that the FDA would “investigate any new reports” of deaths associated with RU-486.

“To date the FDA has no reports of actual deaths related to RU-486,” she added. “Deaths have been related to the procedures involved.”

The Second Drug

The procedures involved are a large part of the problem, according to Edward Szymkowiak, national director of STOPP International, a project of American Life League whose acronym stands for Stop Planned Parenthood. It is the drug miso-prostol, marketed as Cytotec, which is taken after RU-486 in a way not intended by the manufacturer, causing many of the problems.

“RU-486 is not [administered] as a single drug but as part of a regimen,” Szymkowiak explained. “If nothing else [this death] will help educate the public that there is not one drug involved, there are two.”

According to Szymkowiak, the second drug is being used to induce labor — a use never intended by the manufacturer.

In fact, a letter on the FDA's own Web site from Searle, the manufacturer of Cytotec (miso-prostol), states: “Cytotec administration by any route is contraindi-cated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.”

It also warns of “serious adverse events reported following off-label use of Cytotec in pregnant women,” including maternal or fetal death, uterine hyper-stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock and pelvic pain.

Previous deaths related to RU-486 include a woman who died in September 2001 after taking part in Canadian trials of the regimen.

In August 2002, three groups — the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America petitioned the FDA to revoke the use of RU-486. Among the reasons cited by the groups was the fact that RU-486 had been inappropriately rushed through the approval process and that Cytotec was being used inappropriately.

The executive summary of the petition explains: “The FDA strives to ensure that drugs are not promoted in ways contrary to the labeling the FDA has approved. In the case of Mifeprex [the brand name for RU-486], this routine understanding was turned on its head. The FDA mandated the off-label use of misoprostol as part of the Mifeprex abortion regimen and did this in the face of strenuous objections from the manufacturer of misoprostol.”

Motives

Muench believes the motives for the rapid approval were a radical abortion agenda and greed.

“The push for the approval of RU-486 by the radical abortion industry and the Clinton administration shows that the pro-abortion movement is not concerned with the well-being of women but with maintaining the multimillion-dollar industry of [abortion],” he said.

Szymkowiak said that in addition to all of the problems with the FDA's recommended use of the RU-486 regimen, Planned Parenthood has gone even further. He pointed out that the August 2002 issue of the Alan Guttmacher Institute's Guttmacher Report on Public Policy details the deviations from the FDA protocol.

The article states, in part: “The medical standards for mifepristone abortion published by [the National Abortion Federation] and by [Planned Parenthood Federation of America] allow the low-dose regimen [of mifepristone] and in-home administration [of misoprostol], and such modifications [to FDA protocol] have become common practice.”

Szymkowiak said he hopes the Bush administration will see Patterson's death and those of other women — and the violations of FDA procedure that occurred in approving RU-486 — as reasons to take the abortion pill off the market.

The Church has taken a strong stand against RU-486 around the world and has worried about the dangers to mother and child alike.

When it was first approved in the United States, then Auxiliary Bishop William Lori of Washington, now bishop of Bridgeport, Conn., stated: “The traditional role of this government agency has been to protect Americans, to evaluate and approve safe drugs that heal and enhance life, not to approve drugs that take life. Not only that, RU-486 poses very serious physical risks for the women who take it to abort their children.”

In light of the Patterson tragedy, Szymkowiak said people need to remember that RU-486 was designed to kill.

“While it occasionally kills the mother and makes headlines,” he said, “it nearly always kills the child.”

Andrew Walther is based in Los Angeles.