Safety of Drug, Process, Protocol Being Publicly Questioned

Teen Dead After Taking Abortion Pill at Local Planned Parenthood Clinic

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

When a Food and Drug Administration (FDA) panel recommended approval of RU486 in July of 1996, NRL News wrote "Deaths, avoided in these closely monitored small scale trials, are almost certain if RU 486 is widely used" (8/21/96). We hoped this prediction would be proven wrong. Sadly, it hasn't.

Details are still emerging about a pregnant 18-year-old from the San Francisco area who went to her local Planned Parenthood clinic on September 10 and was given RU486, the so-called "French abortion pill," to end her seven week pregnancy. Seven days later, Holly Patterson laid lifeless at the Valley Care Medical Center in Pleasanton, dead from septic shock brought on by a massive systemic infection, according to the San Francisco Chronicle.

Formal investigations have begun, but the basic outline of the story can be pieced together from various news accounts.

What Happened to Holly

Holly and her boyfriend visited Planned Parenthood of Hayward on Wednesday, September 10, where she was given RU486, her father told the San Francisco Chronicle (9/19/03). If the clinic followed the protocol prescribed by the FDA, she took the abortion drug there in the clinic under a doctor's supervision.

All indications are that the clinic also gave her misoprostol, the second part of the two-drug chemical abortion process, to take at home two days later as a vaginal insert. The FDA protocol specifies that patients are to return to the physician's office for oral administration of this drug, but many clinics have ignored this government guideline.

Holly began using the misoprostol on Saturday, September 13, and went to her job. She came home early, feeling sick. At some point during the day, she began to bleed and cramp.

By the following day, the bleeding and cramping had become so severe Holly could not walk. "On Sunday, she was crying and crying, and she told me she was having cramps, that she had a bad period," her father, Monty Patterson, told the San Francisco Chronicle (9/19/03).

Late that evening, her boyfriend rushed her to the emergency room at the Valley Care Medical Center in Pleasanton. Though she hadn't told her parents, she told the doctors she had taken RU486, NBC11.com reported. They gave her painkillers and released her.

It is unclear whether she went home or to her boyfriend's at that point. According to the Contra Costa Times (9/20/03), Holly stayed at her boyfriend's house Tuesday, "too ill to eat or walk." She was rushed back to the hospital on Wednesday, September 17 in the middle of the night.

Holly's father was called around 10 in the morning and was told that his daughter's condition might be terminal. He found her on oxygen, so sick she could barely squeeze his hand. It was only at this point he learned that from her doctor that Holly was pregnant and had taken the abortion pill. "I felt so helpless," Monty Patterson told the Mercury News (9/20/03).

"I didn't have a chance to be involved."

"We thought that she would be OK," Patterson told CBS News (9/22/03). "After the little time I was able to spend with her, Holly knew that I was there and she knew that it was going to be taken care of, but I know she was very, very weak and wasn't sure that she had the strength to pull through it."

Holly died around 2 p.m. that same afternoon. According to Monty Patterson, Holly's doctor told him that she had not fully expelled the child she was trying to abort, that she had fragments of the fetus still inside her, and that "she had a massive systemic infection and went into septic shock" (Chronicle, 9/19/03).

"She was like an angel to me," her father told the San Francisco Chronicle (9/19/03). Fighting back tears, Patterson said, "She was working earning money, planning to go to college. She turned 18 on August 29. She had a new car, a red Honda Civic which now sits in the driveway."

"[S]he was a strong, courageous and very healthy girl" Patterson said later on the CBS Early Show (9/22/03). "I had actually no idea that she would succumb to dying from an abortion."

While the Alameda County Coroner and officials from the clinic have yet to declare an official cause of death, the girl's father was less cautious. "She just turned 18," Monty Patterson told a reporter for the Mercury News (9/20/03). "They told her it was safe and it killed her."

Helen Wilson, Holly's stepmother, told the Los Angeles Times, "She fought like hell for her life.... We want the word out, we want people to know how dangerous this is."

Claims of Safety Conflict with Reality

Supporters of the abortion pill have long maintained its safety and have continued to do so even in light of this most recent tragedy. Richard Hausknecht, medical director of Danco, the pill's distributor, has maintained that "the drug has turned out to be quite safe, quite effective" (New York Times). Eric Schaff, chairman of the National Abortion Federation, one of the groups which has heavily promoted RU486, just two days after Holly's death, said that studies had shown it could be used "very safely," even up to two weeks after the FDA-prescribed cutoff date (Contra Costa Times).

This is not the first time a death has been associated with the pill, however. A woman in Tennessee took RU486 in September of 2001 and then died when her undetected ectopic pregnancy ruptured. In that same month, a Canadian woman participating in trials of the drug in that country died after contracting a serious bacterial infection.

There have been other close calls. A woman participating in the U.S. trials (1994-1995) in Iowa nearly bled to death after taking the pills. Her life was saved by a quick-thinking doctor who rushed her to emergency surgery. He reported the story only after seeing an article in his local newspaper quoting the head of Planned Parenthood in Iowa saying that the clinical test had ended in Iowa with "no complications" among the 238 women participating in the trial. "If near-death due to the loss of half of one's blood volume, surgery and a transfusion of four units of blood do not qualify as a complication," the doctor said, "I don't know what does" (Des Moines Register, 9/21/95).

According to data released by the FDA in April of 2002, a 21-year-old suffered a heart attack, two other women dealt with ruptured tubal pregnancies, and another developed a serious bacterial infection after taking RU486. The New York Times reported there have been "264 adverse reactions including infections, bleeding, allergic reactions and tubal pregnancies" (9/24/03).1

Danco and the abortion pill's defenders have admitted the occurrence of these "adverse events" but have tried to claim that they are not statistically significant in light of the hundreds of thousands of women who they claim have taken the drug safely in the U.S. That number of patients, reported in some places as 225,000 (SF Chronicle), elsewhere as 200,000 (AP), other places at 160,000 to 165,000 (NY Times), still others at 150,000 (ContraCosta Times,), bears closer examination.

Earlier this year, Danco's Hausknecht published a report2 on the abortion pill's safety record in the first 18 months of U.S. distribution (the pill was approved in September of 2000 and went on the market sometime around November of that same year). Here, the claim was that the pill had been used by some 80,000 women up to that point.

Early on, however, Hausknecht admits that this number is based on the numbers of doses sold, not the number of doses actually used. A clinic buying a thousand doses would thus be counted as performing a thousand RU486 abortions, even if 800 doses were still sitting on the shelf.

Furthermore, because a lot of Danco's customer clinics have cut their standard doses of RU486 from three pills to one (to save money and increase profits on the pills, which run about $90 a pill), Hausknecht has multiplied a large portion of his sales figures by a factor of three. In this case, a sale of 1,000 doses might sometimes get counted as 3,000 abortions.

Not only does the application of both these formulae have the effect of greatly inflating the number of users of the abortion pill, but it also can make the pill appear to be safer than it is, as the denominator of total cases swells to make the numerator of reported adverse events seem mathematically less significant.

The Problematic Pill and Process

The pill's producer, Danco, has tried to claim that the evidence has never explicitly indicated that it was the RU486 that triggered any of the earlier deaths or injuries. After all, there is no evidence that RU486 itself causes ectopic pregnancy or is any kind of bacterial agent. But this ignores the way that this drug, its side effects, and the associated method of administration all contribute to a set of circumstances that quite clearly put a woman's life in jeopardy.

In contrast to the myth, popularized in some women's magazines and winked at by RU486's promoters, of some easy magic pill that makes the baby "disappear," the chemical abortion is actually a long, drawn-out, messy, and dangerous process involving multiple office visits and not one, but at least two drugs.

At her first visit, a woman is supposed to be tested for pregnancy, screened for possible disqualifying conditions, and counseled on what to expect. If she clears the screening, she is given the RU486 pills (also know as mifepristone or by the trade name Mifeprex), which she is to take under a physician's supervision. The RU486 blocks the action of progesterone in the pregnant woman's system, causing a shutdown of the system delivering nutrients to the rapidly growing baby.

At a second visit, two days later, the young woman is given misoprostol (also know as Cytotec), a prostaglandin which initiates powerful uterine contractions to expel the now shriveled, starved child. About half abort within four hours, though some abort days later, incompletely, or not at all. A third visit, two weeks after the first, seeks to confirm whether or not the abortion has taken place and whether a further surgical procedure is warranted.

Severe pain, nausea, diarrhea, and vomiting are common side effects. Heavy, prolonged bleeding is expected. The risk of infection, always a possibility, is increased whenever the abortion in incomplete.

The "effectiveness" decreases as the pregnancy progresses. In the U.S. trials, between 8% (for women aborting at seven weeks from their last menstrual period, or "LMP") and 23% (for those aborting at nine weeks LMP) never completely aborted. With every incomplete abortion, there is the possibility of the sort of retained fetal tissue that led to the septic infection in Holly Patterson's case.

Things are awful enough for the women who go through this process "successfully." The problem, however, is that the expected bleeding, pain, nausea, etc., are also some of the symptoms of ectopic pregnancy and septic infection, and it takes a lot of special training and careful monitoring to be able to tell the difference.

Those who don't know better, such as clinic counselors on the phone or staff at a local ER, may simply consider her symptoms part of the process and send her home with some pain medication.

The Clinton FDA considered requiring special training and ultrasounds to screen for ectopic pregnancies when it looked at the drug, but dropped these proposals when the abortion lobby and its allies in the medical establishment balked.

Since approval, the pill's promoters have ignored what minimal guidelines the FDA did lay down, recommending lower dosages, suggesting clinics drop the second visit in favor of allowing patients to self administer the prostaglandin at home, promoting vaginal vs. oral administration of that prostaglandin, and extending the deadline past the seven weeks prescribed by the FDA.

Who's to Blame in Holly's Death?

A number of the elements considered above may potentially have factored into Holly's death.

According to reports, Holly was right at seven weeks of pregnancy, the outer limit prescribed by the FDA, but one which is frequently ignored by clinics promoting the pill. As mentioned above, the two-drug combination's "effectiveness" diminishes as the pregnancy progresses. If the dating of Holly's pregnancy was off by a week or two, she faced a greater likelihood of an incomplete abortion, leaving the sort of "fetal fragments" that could provide opportunity for an infection of the sort that killed her. There has been no indication in any of the press accounts so far that she had an ultrasound at the clinic to date her pregnancy (or to rule out the possibility of ectopic pregnancy).

It isn't clear whether Holly Patterson ever saw a doctor at Planned Parenthood in the first place. Erin Brooks, spokeswoman for Planned Parenthood Golden Gate, told the San Francisco Chronicle that "midlevel clinicians," under the supervision of a physician, often administer the drugs at its clinics, rather than the doctor himself or herself.

Media reports have not clarified whether Holly received the full three pill dose of RU486 or just the single pill. The abortion pill's promoters have claimed that the method is just as effective with the lower dose, but the FDA has never authorized the reduced dose. According to its web site, the agency "strongly encourages the use of mifepristone according to the approved regimen."

If there is any drop-off in "effectiveness" with the lower dose, this factor, coupled with Holly's pregnancy being at the outer edge of the timing window, may have contributed to her having an incomplete abortion.

It does appear from press accounts that Holly took the misoprostol, the second drug in the process, at home rather than returning to the clinic, and that she may have employed the vaginal (rather than the oral) administration of the prostaglandin, according to the AP.

This means she began the painful and bloody process in a situation where she had no medical supervision, and that she got help, not from the clinic where staff members should have been familiar with the pill and been prepared to address her complications, but from her local ER, where such expertise may have been lacking.

Danco's Dr. Hausknecht said though he was reluctant to criticize how the hospital had handled things without knowing what they had done, he believed that "a pretty standard gynecologic evaluation" would ordinarily have been sufficient to determine whether or not something more than pain-killers were needed, according to the San Francisco Chronicle.

"Under normal circumstances," Hausknecht told the Chronicle, "a patient would have to be evaluated, have her vital signs taken, her temperature, a pelvic exam, and evaluation of any bleeding. White blood cell count. Those are the standard things I would do."

To medical professionals familiar with the drug and trained in obstetrics and gynecology, these steps might have appeared obvious. But Danco and its pro-abortion allies in the medical establishment fought FDA attempts to impose any formal training or specialized skill requirements. The substitute rule they pushed on the FDA required only that the prescribing doctor have the skills to handle any complications or be able to refer the patient to someone who did. The limits of this medical strategy appear to have been exposed in this case.

Promoters of chemical abortions have maintained that vaginal insertion of misoprostol, instead of the oral administration recommended by the FDA, is based on "solid science" and that the risk of bacterial infection from this method of administration is not common (SF Chronicle).

Since the drug's approval, however, the FDA has continued to maintain on its web site that because it has not reviewed clinical trials involving the vaginal insertion of misoprostol, it "cannot offer a conclusion about the safety and efficacy of this route of administration." That vaginal administration of misoprostol by the patient herself might provide the opportunity for the introduction of bacteria into the bleeding area seems at the very least to be a plausible concern.

Hausknecht claims that "Infections do occur with spontaneous abortions, and they occur with medical abortions. They are very uncommon, and they can be managed with antibiotics" (SF Chronicle, 9/24/03).

This is, of course, supposing that the woman gets treatment right away. Whether the pathogen that killed Holly could have been treated by antibiotics if caught in time is unknown at this point. There certainly was little that could be done by the time doctors finally figured out what was going on and understood that this was more than just your standard, painful, messy chemical abortion.

Recriminations and Investigations

While the Alameda County Coroner's office has yet to issue its report, efforts to shift the blame have already begun.

Local Planned Parenthood officials have been silent, beyond issuing a statement acknowledging the death of one of its patients, categorizing the cause of that death as "unknown," and expressing its "deepest sympathies" to the family.

A spokesperson for the national office was quick to divert attention elsewhere. "Until we're able to examine the medical records, and piece together from the medical records exactly what the sequence of events was, we will not be able to know why this woman died," Vanessa Cullins, Planned Parenthood's national vice president for medical affairs told the San Francisco Chronicle. "It may be totally unrelated to the medical abortion."

In addition to defending what he considered to be overall safety of the abortion pill (see above), Hausknecht defended the local clinic. He told the New York Times that he had heard from Planned Parenthood that "There were many phone calls from the time she came into the clinic until that Sunday, when she turned up in the emergency room." Hausknecht did not say whether or not Holly ever spoke to doctor in any of those calls. "She had a great deal of pain and wanted refills of her prescription."

Hausknecht said Planned Parenthood tried, unsuccessfully, to reach her on the Monday and Tuesday before her death. "At least some of the medical people did the right thing," Hausknecht told the New York Times. "Before we jump to conclusions, we ought to have the facts."

As mentioned earlier, Hausknecht said he was reluctant to second-guess the hospital, but he did indicate that he would have given a woman in similar circumstances a full examination before simply giving her painkillers and sending her home.

Hospital administrators said they felt the staff did everything it could to try and save Holly's life and have called on the FDA (as well as California's two pro-abortion senators) to re-examine the safety of RU486. Valley Care Medical Center CEO Marcy Feit told a reporter for the local NBC affiliate that while the hospital continues to investigate things from its side, "We're going to be asking the FDA to give us some answers about the safety of this drug."

Both the hospital and Holly's father issued statements calling for the FDA to take action of a petition challenging RU486's safety and calling for a halt on its use that was issued in August of 2002.

Helen Wilson, Holly's stepmother, told the Los Angeles Times that Holly had apparently decided to use RU486 on the advice of some of her friends. Wilson implied that Planned Parenthood and the pill's promoters had not been forthcoming about the risks involved. "She talked to people she knew would keep her secret, and they operated with information taken from the Internet and Planned Parenthood," she told the Times.

Holly's father elaborated in an interview with the Associated Press (AP). "What's disturbing is these young couples, they are relying upon what they think is good, solid info, and relying on what they think is a supportive network telling them everything is OK," Patterson told the AP. "I would have said, 'You know what, they don't know everything. Let's get more information.'"

Patterson complained in general about the whole process and the attitudes of the medical establishment propping up the pill. "The medical community treats this as a simple pill you take, as if you're getting rid of a headache," her father told the San Francisco Chronicle. "The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. The she's sent home to do the rest on her own. There are just too many things that can go wrong."

The California Department of Health Services has admitted to initiating investigations at both Valley Care Medical Center and Planned Parenthood of Hayward, but would not confirm whether or not the probe was related to Holly Patterson's death (Oakland Tribune).

The FDA has said it is investigating the death.

FOOTNOTES:

1. The 9/20/03 San Francisco Chronicle said Hausknecht puts the number of adverse events the company has reported to the FDA at about 400.

2. Hausknecht, Contraception 67 (2003): 463ff.