WASHINGTON — Monty Patterson will not wade into the abortion issue. He will take neither the pro-life nor the pro-abortion side. What he wants is scrutiny of the abortion pill, RU-486, which killed his 18-year-old daughter on Sept. 17, 2003.

Pro-life activists are asking questions as well. They want to know: Why was the abortion pill sped through the U.S. Food and Drug Administration's approval process? And why isn't the public being made aware of the hundreds of reported cases of adverse effects and near-death experiences women taking the drug have had?

Patterson specifically wants to know why the FDA isn't monitoring variations on the way RU-486 is administered. His daughter, Holly, a healthy young woman who had become pregnant by her boyfriend, died a week after taking the drug, an alternative to surgical abortion approved by the FDA during the Clinton administration.

Patterson traveled to Washington last month to meet with officials at the White House and the FDA about what happened to his daughter in California. He later spoke at a conference sponsored by a conservative women's public-policy group, Concerned Women for America.

“I am concerned about the health and welfare of women with the drug,” he said in an interview the week after the conference.

Patterson is trying to focus attention on the drug's impact on the mothers who take it, but any discussion of RU-486 gets bound up in the ongoing furor over the killing of children via abortion. Cathy Cleaver Ruse, spokes-woman for the U.S. Conference of Catholic Bishops’ Secretariat for Pro-Life Activities, said deaths resulting from RU-486 and Ortho Evra, the “birth-control patch,” are not treated like deaths from other drugs.

“Because they are wrapped up with pro-abortion politics, they're treated differently,” Ruse said. She noted that RU-486 was approved by the FDA under an “expedited” schedule normally reserved for crucial, life-saving drugs.

“They have not only put the lives of unborn children who are killed by RU-486 at risk,” she said, “they have put the lives of women at risk.”

The New York Post has reported that at least 17 women have died since 2002 from using the contraceptive patch, which is attached to a woman's skin.

Patterson, a contractor in California, said his daughter turned 18 less than a month before her death. “She was still living with us,” he said.

Patterson didn't know that Holly had become pregnant. She and her boyfriend secretly “went to the Planned Parenthood clinic in Hayward (a suburb of San Francisco) on September 10,” he said, where she was given 200 milligrams of RU-486, often referred to by the name mifepristone. “That's one-third of the FDA-approved dose,” he said.

She was then supposed to take, on her own, another drug. “Holly was told to take at home the next day, misoprostol, 800 micrograms, which is twice the FDA-approved dose, and it's taken vaginally, not orally,” he said.

‘Don't Worry, It's Normal’

Patterson said his daughter took the drug the next day as directed, though at the time, he did not know what was happening. “By Sunday, the 14th, four days after she started the regimen, she went to the emergency room,” he said. “She told them she was having an abortion through Planned Parenthood. They checked her out. They gave her a shot and some pain pills and sent her home.

“By Wednesday morning, the 17th, she was back in the emergency room,” he recounted. “I got a call, and I went to the hospital. I asked the nurse what was going on. She said, ‘I can't tell you because she's an adult.’ Holly couldn't even talk to me she was so sick. …The doctor told me it was complications from the abortion pill. She had a retained placenta from an incomplete abortion. She had a serious bacterial infection.”

That day, Holly, who had been perfectly healthy a week before, died from septic shock. No one could explain to him why she died, Patterson said.

He later found out Holly had been calling Planned Parenthood's hotline repeatedly as she became sick. “She kept calling, and they said, ‘Don't worry, it's normal,’” he said. That's one of the problems with RU-486, he said: “Bleeding, cramps, pelvic pain are normal.”

A website run by Danco Laboratories, sole U.S. manufacturer of RU-486 (under the name Mifeprex), confirms that bleeding and cramping are common side effects.

Patterson asserted that regimens other than that approved by the FDA are commonly used by abortionists. The FDA-approved regimen prescribes 600 milligrams of mifepristone followed by 400 micrograms of misoprostol taken orally two days later. Danco's website recommends that regimen and that women return to the abortion clinic to receive the second drug.

A 2001 article in Current Women's Health Reports called “The Mifepris-tone-Misoprostol Regimen for Early Medical Abortion” says that other, non-approved regimens are common. It is not illegal for doctors to prescribe off-label regimens.

“Variations studied to date include lower doses of mifepristone (200 mg total instead of 600 mg); vaginal insertion of 800 (micrograms) of misoprostol (double the oral dose); at-home self-administration of misoprostol, either orally or vaginally. …,” the article says. “Although these variations are not yet FDA-approved, many providers in the United States already use them routinely based on current evidence. Planned Parenthood Federation of America, for instance, permits its providers to use 200 mg of mifepristone followed by home use of misoprostol (Planned Parenthood Federation of America, unpublished data).”

Advocates of RU-486 claim it has a low complication and death rate, and the information that is publicly available confirms the drug falls within the range of safety used to judge similar drugs.

“Approximately 325,000 women in the U.S. have used the mifepristone and misoprostol regimen safely since its approval by the FDA in September 2000,” said the National Abortion Federation in a Sep. 20, 2004, fact sheet. “Millions of women worldwide have used mifepristone/misoprostol safely since it was first approved in France in 1988.”

Six deaths have been documented worldwide from RU-486.

Though off-label dosages and uses of RU-486 are common, the National Abortion Federation notes that is true for other drugs as well — 40-60% of drug prescriptions do not follow the FDA-approved regimen. Planned Parenthood allows its clinics to use what combinations they see fit, and abortionists rely on studies using non FDA-approved regimens to evaluate other ways of using RU-486 and misoprostol.

Asked about Holly's case, spokes-woman Erin Kiernon of Planned Parenthood Golden Gate, the Hayward clinic's parent, said, “We decline to comment based on patient confidentiality.”

No One Responsible

At the White House, Patterson said he met with a domestic-policy advisor and a legislative-affairs official. A White House spokeswoman declined to comment for the Register.

At the FDA, Patterson met with Dr. Steven Galson, acting director of the Center for Drug Evaluation and Research. “The FDA says it can't comment on an unapproved regimen,” Patterson said. Indeed, an FDA spokeswoman would only say the discussion involved “how we monitor drugs and their adverse effects.”

“If it's being used according to the label, it's safe to use,” she said.

She said she had no information on different regimens or their effects.

Patterson believes the FDA should be collecting and publishing such information. “No one's claiming to have any jurisdiction to deal with” this situation, he said. The state (of California) says, ‘We have no jurisdiction.’ The FDA says, ‘We have no jurisdiction.’”

Spotty reporting means the death toll could be much higher than the official tally of six deaths worldwide, Patterson said. For example, both Planned Parenthood and the hospital where Holly died initially failed to report the circumstances of her death, he said. The 650 reports of adverse effects in this country that have been reported to the FDA have not been made public, as Patterson would like them to be. Susan Wills, associate director for education at the bishops’ pro-life secretariat, said there have been numerous “near-death experiences” from RU-486.

Republican Sen. Sam Brownback of Kansas and Republican Rep. Jim DeMint of South Carolina have sponsored bills to revoke the approval of RU-486. “The political agenda behind RU-486 was to drive abortion into mainstream medicine, to move abortion out of clinics — which have been ostracized, rightly so — into doctors’ offices,” Ruse said.

“I've given the FDA my opinion,” Patterson said. “They have not offered any conclusions.”

Joseph A. D'Agostino writes from Washington.