| From eastbayexpress.com Originally published by East Bay Express Dec 17, 2003 ©2003 New Times, Inc. All rights reserved. The Making of a Martyr
Holly's grave doesn't have a headstone, and the grass hasn't yet healed with the surrounding turf. She lies, almost unnoticed, at the very edge of the lot, where the cemetery fades away into lawn, her grave site temporarily marked with a small black placard, some flowers, and a few trinkets. But Holly's passing has received more attention than all of these other young people combined. Her name and the circumstances of her death have become rallying cries in a battle now being duked out in Congress and the halls of the US Food and Drug Administration.
Holly died of septic shock, the result of an infection produced by incompletely expelled fetal tissue following a medically induced abortion. The Alameda County Coroner's report was careful to note that her death was of natural causes -- the abortion caused an inflammation, which caused an infection, which led to her death. The report didn't even list the brand name of the drug she took.
Nevertheless, her death has renewed a fierce political battle over Mifeprex, the only drug in the United States approved for ending unwanted pregnancies. Also known by the generic name mifepristone, or its original lab name, RU-486, Mifeprex is legal but highly controlled. It is available only from doctors who have ordered it direct from the drug's sole manufacturer, Danco Laboratories, and have promised to abide by a long list of regulations. More than 200,000 American women have taken Mifeprex since the FDA approved it in 2000, and it has been widely lauded by abortion providers and pro-choice advocates as a safe and effective alternative to surgical abortion. Indeed, they argue that any abortion procedure carries a risk of death twenty times lower than does carrying a pregnancy to term.
But abortion opponents -- who fought the drug's introduction to the United States and have been agitating for further regulation, if not a total suspension, of Mifeprex ever since it was approved -- say it's a dangerous chemical that is poorly managed both by the FDA and the clinics that dispense it. Over the last three years, they point out, Danco has reported at least four hundred adverse events to the FDA, including severe bleeding and bacterial infections. Mifepristone also has been linked with the death of one other American woman, although she had preexisting medical conditions that should have made her ineligible to take it. Holly's death is arguably the first in which a healthy American woman died after using the pill as intended.
Those seeking a poster girl for their efforts to ban RU-486 seem to have found her in Holly Patterson. Last month, with the blessing of Holly's father Monty Patterson and his new wife, Helen Patterson, South Carolina Congressman Jim DeMint introduced a bill dubbed "Holly's Law," which alleges that the FDA rushed the approval of the drug in order to satisfy the Clinton White House. Introduced the same day that President George W. Bush signed a legislative ban on late-term abortion, DeMint's bill asks the government to pull RU-486 off the market for six months while the General Accounting Office reviews the process by which it was approved. Seventy-six members of the House, including Majority Leader Tom DeLay, have signed on as cosponsors. If the FDA is found to have violated its own rules, RU-486 could be kept off the market indefinitely.
Holly's death also gave new life to a bill that has languished in Congress for years, the so-called RU-486 Patient Health and Safety Act, which would place further restrictions on how Mifeprex is dispensed. The bill was originally proposed in 2000, then reintroduced in 2001, and again early this year by Louisiana Republican David Vitter, but has been hung up in the House Subcommittee on Health. With Holly's death, foes of RU-486 hope Vitter's bill will have the juice to earn a floor vote.
Although Holly Patterson was legally an adult when she took Mifeprex, her father and his wife are supporting the Tell-a-Parent initiative proposed for next fall's state ballot. The measure, sponsored by an Oakland group calling itself Life on the Ballot, would require parental notification 48 hours before a minor has an abortion. Currently, California doesn't require parental consent or notification.
Supporters of these measures insist their efforts are not simply attempts to gain political traction from a girl's untimely death, but rather are much-needed safety checks on medical abortions. John Hart, spokesman for Congressman DeMint, puts it this way: "If this was an accident involving an airplane, you would ground the fleet and review safety procedures."
Pro-choice advocates, meanwhile, are bracing for this onslaught of legislation, calling it part of the right wing's ceaseless antiabortion crusade. "Antichoice forces never wanted this medication to be available," says Vicki Saporta, president of the National Abortion Federation. "They just don't want abortion to be available in the US by any method."
The current clash over Mifeprex is really just another standoff in an epic battle. Holly's death has reignited a complex medical and ethical debate between ideologically fierce opponents who squared off long before she was even born. It's the sort of argument in which the two sides can look at identical statistics and draw opposite conclusions. Is one death out of 200,000 American users a very low adverse-event rate for a prescription drug, as the pill's supporters maintain? Or is one death for the sake of what opponents deride as a "lifestyle drug" one death too many?
At the heart of this fight is a young woman known to so few of the combatants that she has become something of a cipher -- the eye of the political storm. Depending on whom you ask, Holly Patterson was either a child misled and betrayed by adults around her, or a capable young adult exercising the right to make her own decisions. Either way, three factors have conspired to make Holly the ideal poster girl: Her story is tragic, she was unmistakably beautiful, and she could've been anyone.
Holly had wide-set pale-blue eyes, fine blonde shoulder-length hair, creamy skin, and a snub nose. On at least one occasion she'd been mistaken for Britney Spears and had mischievously obliged the autograph hunter by signing "Christina Aguilera." Debbie Patterson, Holly's mother, describes her as a teenager who was easy to love, fiercely loyal, and literally a friend to the underdog -- last year she rescued an abandoned pit bull despite everyone's warnings not to. "She said, 'If I was ever in that position I would want someone to rescue me,'" Debbie remembers.
The girl was deliberately headstrong, even carrying with her a slip of paper bearing Thomas Jefferson's injunction that "a little rebellion is a good thing now and then." Holly was no tomboy, her mother says, but she was always active, taking gymnastics and belly-dance lessons, playing powerpuff football, and snowboarding. She inspired loyalty in others, too. At the funeral, one of Holly's friends showed Debbie how she'd had Holly's birth and death dates tattooed on her arm so she would remember to think of her friend every day. Cody, Holly's twenty-year-old brother, got her name inked on his chest after she died.
Apart from the way it ended, Holly's life was pretty normal. She was born in Walnut Creek, and grew up in Livermore. Her parents divorced when she was in elementary school, and she lived with her mother, who works as a caterer, and her brother. It wasn't until this past January, nine months before her death, that she went to live with her dad, custom-home builder Monty Patterson, and his then-fiancée Helen Wilson, who were married shortly after Holly's death. After Holly moved in with her dad, her mother moved to Southern California. Monty and Helen Patterson declined to be interviewed for this story.
Two years ago, over her mother's objections, Holly had transferred from Granada High to Del Valle Continuation High School so she could graduate last spring, one year ahead of schedule. "She said she didn't like school too much," Debbie remembers. "I asked her why, and she said she didn't like all the drama that went on in high school. ... I really discouraged it because I wanted her to go through the twelfth grade to experience all the memories such as Disneyland and the prom and Senior Ditch Day as well as finish up at the same high school, but she said 'If you don't let me, I'm going to quit school.'"
Like most teens, Holly's future plans were vague -- one day she wanted to study forensic medicine and become an FBI agent, the next she wanted to be a makeup artist, a psychologist, or a police officer. In the meantime, she worked a series of teenage jobs, holding down the men's fragrance counter at the local Macy's, doing stints at Jamba Juice and Longs Drugs, babysitting, and cleaning houses.
Holly's boyfriend, Ehsan Bashi, was six years her senior. He is described harshly in a recent open letter to the media written by Monty and Helen Patterson, who dismissed him as simply "the 24-year-old man who had unprotected sex with her, impregnated her, and then proceeded to facilitate the secrecy that surrounded her pregnancy and abortion."
To hear Ehsan tell it, he and Holly had a sweet romance. "I used to call her my dream girl; she was everything I wanted in life," he says. "Anyone that was around her for more than five minutes could see we were absolutely in love."
The couple had their first date on a Wednesday, and during their eight-month relationship they always cleared their work and school schedules to spend that day together. When Ehsan recently took on a new marketing job, he says he told his supervisors, "I don't work on Wednesdays. That's the day I spend with my Holly."
Holly's mother, who is close to Ehsan, says he was a positive influence. Holly had enrolled in classes at Las Positas junior college, then stopped going, but at her boyfriend's urging had decided to go back. "I think he got her back on the right track," Debbie says. "He encouraged Holly to go to school. In fact, the days she wouldn't go to class he went and took notes for her."
Ehsan says Holly struggled with motivation to stay in school. She seemed to always be getting grounded, and with her car privileges revoked, she had difficulty getting to class. If she couldn't complete her coursework perfectly, he says, she got frustrated and wanted to quit. "She was always very, very down about her life," Ehsan says. "One of the first things she said when I met her is, 'I don't think I'm going to do anything. I have all these dreams, and I don't think it's going to happen.' I would tell her, 'I wish you could see how amazing you are through my eyes, and then you could see your true potential.'
"She always snickered at that," he recalls. "She thought I was a smooth talker."
Ehsan, who'd also considered joining the FBI, says the two would often talk about ideas for Holly's career, and that he would advise her on the classes she'd need to take to transfer to a four-year school. He believed in her. "Holly said Ehsan treated her with respect and no one had treated her better, and he said she deserved to be treated that way," her mother remembers. "It was nice to hear them say that."
But trouble arose when Holly got pregnant this past summer at age seventeen. Although she and her mom had talked about birth control, abortion was a topic that rarely came up. "I never thought about abortion," Debbie Patterson says. "I've never been faced with it myself, or been close to anyone who confided in me about it."
Debbie did know that Holly had secretly gone to a clinic and gotten birth control pills, had later gone off them, and was in the process of getting a new prescription. She felt this kind of secrecy was normal for a teenager, even in a home where the parent had made it clear it was okay to talk about sex. "You have this idea that your daughter is going to go, 'Mom, I had my first kiss,'" Debbie says, a bit wistfully. Then her tone changes. "How many times do daughters not tell their parents they had sex or want to have sex? I know very few of my friends' daughters who did it the way we want them to."
Holly kept her pregnancy hidden from everyone but her boyfriend. She'd decided to seek out the abortion pill from the very day she found out she was pregnant, Ehsan recalls, and he promised to support her no matter what she chose. Holly knew friends who'd had abortions and she felt she wasn't ready for a baby. "It was just too early, she was just too young, and in her own words she just felt like it wasn't an abnormal thing she was doing," Ehsan says.
Together, the couple researched Mifeprex on the Internet and consulted Ehsan's aunt, a gynecological surgeon. Ehsan says he also encouraged Holly to talk to her own relatives, even offering to pay for plane tickets to fly her mom to the East Bay, but Holly refused. "She said, 'There's no reason to worry her about it. We'll get through it and I'll tell her about it later,'" he remembers. "It was obvious there was a certain amount of shame there to tell her dad or mom that this had happened, and she preferred to get it over with and put it behind her."
Holly made her appointment at the Planned Parenthood facility in Hayward shortly after her eighteenth birthday. Looking back, Debbie Patterson says her daughter must not have realized there were other alternatives, or that her family would have supported her through a pregnancy. "Instead of telling our young daughters, 'Don't get pregnant. Go get birth control pills,' the question we should ask is, 'If you found yourself pregnant, what would you do?'" Debbie says. "Because I really felt Holly didn't want to disappoint me or her father or her grandparents or her friends, and when she found herself in a predicament, I think all she heard was, 'Don't get pregnant.'"
Medical abortion, the official term for an abortion accomplished with RU-486, is best described as a regimen, not a single drug. The process used in the clinical trials and then approved by the FDA requires three separate trips to the doctor. On the first visit, the woman receives counseling, signs Danco's release form, and gets her dose of Mifeprex. The chemical blocks progesterone, a hormone that prepares the uterine lining for pregnancy -- antiabortion activists sometimes call this "starving the baby."
The mifepristone is followed two days later with a second drug called misoprostol. It is manufactured by Searle Pharmaceuticals, which marketed it as a treatment for gastric ulcers before the FDA approved it as part of the Mifeprex regimen. Misoprostol completes the process by causing the uterus to contract, expelling the fetus. In the trials, women received the second drug orally at the clinic.
A third visit is necessary about twelve days later to ensure that no fetal tissue remains. In 5 to 8 percent of cases, a continued pregnancy or incomplete expulsion of tissue requires the same type of surgical intervention doctors use in the case of natural miscarriages.
But the FDA-approved method isn't the only way to administer Mifeprex, and it wasn't the way Holly Patterson received it. As with many approved medicines, physicians developed an alternative regimen and published numerous papers in medical journals showing that it was effective and expedient. At many clinics, women now receive a lower dose of misoprostol, and are allowed to self-administer it vaginally at home. For many women, the allure of taking the second drug at home is that it allows them more control over the process, greater privacy, and a more comfortable setting.
A medical abortion mimics a natural miscarriage, in which most women experience something akin to a severe menstrual period, with up to two weeks of bleeding and cramping. Because it's a lengthy process, and because cramps and bleeding can indicate either normalcy or possible trouble, groups such as Planned Parenthood operate 24-hour hotlines for patients.
The process didn't go smoothly for Holly. On September 10, according to the coroner's report, she took Mifeprex at Hayward's Planned Parenthood clinic. The young woman was nearly seven weeks pregnant, the latest stage for which the drug is approved. She also was given four tablets of misoprostol to insert vaginally at home the next day, and a prescription for Tylenol #3, a strong painkiller. Ehsan accompanied her to the appointment. "We weren't even told there was a possibility of infection, and if we were, it must have been in some small print that we overlooked," he says. "Let's just say if they had mentioned that death was a one in a million chance, I would have been freaked out. ... If someone had said this was a possible risk, we would have done things differently, maybe."
The first possible warning sign came on September 13, when Holly called a clinician at Planned Parenthood to report severe cramping. She was advised to take the painkillers; the clinician called in a refill order to Holly's local pharmacy, and later called her at home to check in. Holly said she was feeling better.
The next day, however, she took a turn for the worse. Monty Patterson later told reporters he'd found his daughter crying on the bathroom floor. She was bleeding heavily and unable to walk, but passed the situation off to her father as severe menstrual cramps, which she'd had in the past. He advised her to see a doctor, and Holly got similar advice when she called back Planned Parenthood later that day. She was told to come in the following morning, September 15, for a checkup, but to go straight to a hospital if her pain continued. When a Planned Parenthood clinician called again later that evening, Holly reported that she'd gone to the emergency room at Valley Care Medical Center in Pleasanton that day, had a pelvic exam, and had been sent home with more painkillers. She had told the ER doctors about the abortion, but if she was showing any symptoms of infection at the time, nobody but her boyfriend seemed to recognize them. Ehsan says the idea that Holly might have had an infection occurred to him, but he didn't contest anyone's medical opinion for fear of being kicked out of the ER.
The following day, a frustrating series of missed phone calls ensued. Planned Parenthood clinic staff called four times to check up on Holly, who called back once to say she had some questions, but got the clinic's voicemail.
Ehsan remembers agonizing as he watched his girlfriend's health deteriorate. "I was monitoring her heart rate, her temperature, and I was getting really fed up with them telling me it's normal," he says. "It was one of these things where you are trying to take care of this person and you're torn between the fact that there are doctors, professionals telling you things are okay, but your better judgment is telling you things are not okay."
Holly's final call to Planned Parenthood came at one in the morning on September 17. She wanted to know whether it was okay to take more Tylenol, since she'd vomited after her last dose. She told the clinician she'd been to the Pleasanton ER on September 14, but hadn't visited Planned Parenthood the next day as advised. But she did have a clinic appointment scheduled for the afternoon of the 17th. The clinician stressed the importance of keeping the appointment, but by that time Holly was truly sick: nauseated, vomiting, and unable to walk or to come home from Ehsan's house, where she was staying.
"I was really worried all that day. I was just constantly like, 'Please, let me take you to the emergency room,'" Ehsan remembers. "She kept saying, 'No, it's going to get better, I just need to take some pain meds.' Finally, she had just finished throwing up and I picked her up and brought her onto the bed and laid her down and just held her in my arms a little while, talking to her, comforting her."
As dawn approached on September 17, Ehsan realized it was their eight-month anniversary. "What a great way to spend it," Holly managed to joke.
Her condition kept worsening. At around 4 a.m., Ehsan drove her back to the emergency room. "I was very adamant about it," he says. "When I took her to the ER, she still didn't want to go. I was like, 'Please, for my sake, let's go.' I was going nuts. I can't remember when I cried so much. I was terrified. I was so mortified. I hated myself so much because you feel like, okay, you both got yourself into this but she's the one who's paying for it. I prayed: 'Okay, what do I do now? She's depending on me, nothing is working.' These professionals were telling me it's okay, but I knew deep down in my heart it wasn't. It was constant fear, constant confusion, constant frustration at how slow things were moving. I was like, 'I brought her in a couple of days ago: Do something now!'"
By the time Holly was admitted to intensive care, she was in septic shock. Her respiration was distressed, her pulse racing. Doctors put her on a ventilator, but her condition waned throughout the night. Oxygen wasn't adequately reaching her tissues, and her lungs and breathing tube began to fill with a clear fluid. Ehsan recalls trying to comfort her. "I held her hand and said, 'I still need to take you to our anniversary breakfast,' but she had the tube in her mouth, and she couldn't say anything."
Holly's family was summoned, and learned for the first time about her pregnancy and abortion. Ehsan called Debbie Patterson himself, saying she needed to fly up immediately. The idea that Holly might die seemed unreal, Ehsan remembers, and yet the hospital staff began to prepare the family for the worst. "When the nurse came to me, I said, 'Be straight with me. Tell me what's going to happen. Is she going to make it or not?' She shook her head no, and I lost it," he says. "Even at that minute I was like, 'No, this is not a possibility.' ... Just twelve hours before she was talking to me, joking with the nurses, admiring someone's perfume."
In their letter to the press, Monty and Helen Patterson described their vigil as the hospital staff gave Holly CPR and shots of epinephrine and atropine in their futile attempt to revive her. "In those last moments of her life feeling utter disbelief and desperation we formed a circle just beyond the curtain and prayed aloud, cried and screamed, 'We love you, Holly,' hoping beyond hope that those words would ring out and save her life."
Holly's mother, meanwhile, raced to be with her, but the end came too quickly. "I was outside of the airport when it got really bad," says Debbie Patterson, who'd been checking in by phone with Ehsan and hospital staffers. "I stepped inside and made my way through the X-ray machine. I had to take my shoes off and put my water and cell phone down, and in less than a minute Holly had passed."
"All of a sudden they called Code Blue," Ehsan recalls. "I used to be a hospital volunteer; I knew what it meant -- respiratory therapy. A huge majority of the time, the patient never makes it. So I lost it. The world just seemed to go in slow motion. I remember running into the ICU -- I think I knocked someone over. I saw her last seconds, I stood there and watched them do CPR. I watched her flatline. I just stood there, and somebody grabbed me before I hit my knees."
Holly Patterson was pronounced dead just twenty minutes before her scheduled follow-up appointment at Planned Parenthood.
It was a Wednesday.
It's no exaggeration to say Holly's Law existed in one form or another long before her death. RU-486 has a contentious and highly politicized history, although the drug is by no means obscure. It is approved for use in 29 countries and has been taken by an estimated one million women over the last decade. Developed in the early 1980s by French pharmaceutical company Roussel Uclaf (the "RU" in RU-486), the drug had two clinical trials in France and was approved for distribution in 1988, albeit with tight controls governing its administration. Roussel Uclaf, however, was partially controlled by -- and later merged entirely with -- Hoechst AG, a German company perhaps more sensitive than most to its public image, having once manufactured Zyklon B, the poison gas used by the Nazis in their concentration camps. Hoechst also had a Catholic CEO, and between fears of boycotts and concerns that making an abortion pill clashed with company philosophy, Hoechst decided to halt its attempts to market the drug shortly after it was approved.
Hoechst announced its decision in October 1988, just as the International Federation of Gynecology and Obstetrics gathered in Brazil for a conference. "It's absolutely unique for a company not to want to market something that's to the benefit of patients," recalls Dr. Malcolm Potts, an embryologist in UC Berkeley's School of Public Health who was at the conference and witnessed the uproar the announcement created. "Normally companies try to market as aggressively as possible." The angry physicians circulated a petition, and French Health Minister Claude Evin stepped in, calling RU-486 "the moral property of women, not just the property of the drug company." At Evin's insistence, the drug was returned to market in 1990.
Once RU-486 became available in France, doctors worldwide sought to prescribe it. Based on Hoechst's recommendations, Roussel Uclaf developed a policy regarding the countries in which it would file for approval: Among other requirements, a cabinet-level or higher official would have to personally ask the company to make the drug available, and abortion had to be not only legal but publicly accepted in that nation. It seemed clear that this ruled out the United States, where pro-lifers were known for targeting abortion clinics and threatening boycotts of any company that agreed to produce the drug.
Despite some internal pressure, Roussel Uclaf refused to set up trials or file RU-486 applications in the United States. Not that anyone was asking it to do so: In 1992, President George H.W. Bush signed a ban on importation of RU-486 for "personal use" -- a symbolic act, since the drug is only available through clinical appointments, but also a clear public signal of his administration's stance on abortion.
The mood in Washington changed quickly after President Bill Clinton was elected. The day after he took office, Clinton lifted the ban and directed Health and Human Services Secretary Donna Shalala to assess how mifepristone could be tested and licensed domestically. Clinton personally wrote to Hoechst, asking that it file a new drug application with the FDA, but the company still refused.
In 1994, the merged company Hoechst Roussel washed its hands of the whole conundrum by handing the drug's US rights over to the Population Council, a nonprofit research group that agreed to conduct clinical trials, submit the results to the FDA, and find an American company to distribute the drug. Since few companies were willing to touch such a political hot potato, a new company had to be created. That was Danco Laboratories. "We were formed to bring medical abortion to the US," says spokeswoman Heather O'Neill. "It is our single product, our entire emphasis and reason for being."
RU-486 underwent clinical trials in the United States in 1994 and 1995, and the data, along with the results of the French tests, were submitted to the FDA. In 1996, the agency ruled that the drug met its safety qualifications but needed further labeling restrictions prior to final approval.
The process then took a somewhat unusual tack. RU-486 ended up being approved under an accelerated FDA protocol called Subpart H, which is normally used to speed approval of drugs for life-threatening illnesses such as cancer or AIDS. Such drugs carry added restrictions that give the FDA more control over their end use.
Both sides of the RU-486 debate criticized the use of Subpart H. The drug's developers felt they already had proposed enough restrictions -- doctors would have to order direct from Danco, attest to their competency to administer the drug, record the serial number of each pill packet used, and promise to give the patient counseling and have her sign consent forms.
The drug's critics complained for a different reason. They claimed RU-486 was fast-tracked under pressure from the Clinton White House at the expense of patients' safety.
Both the FDA and abortion-rights supporters contest this claim. "The reason Subpart H was used and introduced late in the process by the FDA was so they could impose additional restrictions on how it is distributed," says Population Council Vice President Sandra Arnold. "The contention that these were rushed or inferior studies is wrong."
In the end, the FDA agreed to Danco's labeling proposal, and Mifeprex came to market in November 2000. Its availability changed American abortion politics in two very significant ways. First, it meant hospitals and private practitioners, not just clinics, could provide abortions. That made it harder for right-to-lifers to figure out where to picket. "They thought they wouldn't be able to target providers in the same way because there would be more people doing it privately in their practices," says the National Abortion Federation's Saporta.
Perhaps more significantly, RU-486 was designed for use early in pregnancy. While antiabortion activists may believe life should be protected from conception onward, the American public is more accepting of early-stage terminations. "The majority of people in this country are comfortable with very early abortions," says Cynthia Gorney, a UC Berkeley journalism professor and author of Articles of Faith: A Frontline History of the Abortion Wars. "They don't have a giant psychological problem with them when there's no visible body parts or other things we associate with a human life. Most pro-lifers disliked RU-486 because they understood people don't really have a problem with that. How do you counter it? You get at its hazards."
This is what made Holly such an effective emblem -- she went from healthy all-American to terminal ICU patient in a matter of days. Before Holly's death, RU-486 had a solid safety record after more than a decade of use. It had been linked to just three deaths: a Canadian woman who died of a rare clostridium infection during clinical trials, a French woman who used it despite being a heavy smoker -- a known risk factor -- and a Tennessee nurse named Brenda Vise, who died when Mifeprex was administered to abort what turned out to be an ectopic pregnancy. The drug isn't supposed to be used for ectopic pregnancies, which occur in the fallopian tube rather than the womb.
Medical abortion is considered just as safe as surgical abortion, which is one of the most commonly performed elective surgeries in the United States -- approximately 1.3 million abortions are performed domestically every year. According to the nonprofit Alan Guttmacher Institute, one in three American women will have had an abortion by age 45. "The risk of dying from having a medical or surgical abortion is far, far less than if the patient carried the pregnancy to term," says Dr. Mark Nichols of Oregon Health and Science University, who participated in the RU-486 clinical trials. "The risk of dying is about 1 in 10,000 when a pregnancy is carried full-term, whereas the risk of dying from an abortion in general is maybe 1 in 200,000."
Mifeprex's supporters also point out that no medicine is completely safe. "All drugs carry some risks. The FDA approval saying a drug is safe and effective does not mean 'without risk.' It means the benefits outweigh the risks," says Danco spokeswoman O'Neill. "Our reported adverse event rate overall is less than 0.2 percent, which is a very low rate."
UC Berkeley embryologist Malcolm Potts concurs that mifepristone has a good safety record. "Every drug -- and we can use aspirin as an example -- has a mortality, and that's always tremendously sad," he says. "Abortion is always one of the most common procedures a gynecologist does, and sooner or later someone's going to die."
Because of politics, Potts adds, Mifeprex has drawn more regulatory fire than other drugs with higher adverse event rates. Potts recently published a study comparing the approval processes for birth control pills and Viagra, which has been linked to more than one hundred fatalities since its introduction in 1998. The professor rhetorically asks why DeMint and his cosponsors haven't taken interest in the drug with the higher death toll. "I think it's just part of the double standard in laws and behavior and attitudes towards male and female sexuality," he says. "If the man from South Carolina is going to be logical, he should take Viagra off the market tomorrow. He should have taken it off yesterday."
But the political forces behind the proposed ban insist mifepristone is a threat to public health. "It's a dangerous drug," says Wendy Wright, senior policy director for Concerned Women for America, one of the key lobbying groups behind Holly's Law. "Even if administered correctly, it still carries very high risks to women."
Last year CWA, along with the Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists, submitted a lengthy "citizens' petition" asking the FDA to withdraw its approval of Mifeprex. The Christian lobbyists contend that 99 percent of Mifeprex users experience some sort of negative effects, whether they be relatively mild ones such as nausea and cramps, or more serious problems such as protracted bleeding. And, as with most drugs, there have been some horror stories, including a 21-year-old woman who had a nonfatal heart attack; two fifteen-year-olds who developed life-threatening infections; and a California woman who is suing her doctor and clinic, but not Danco, over severe bleeding and an infection that sent her to the emergency room.
The petition also criticizes the US clinical trial for not using a control group or including women younger than eighteen, although the drug can be distributed to teenagers. "That's not unusual in clinical trials in the US for any kind of medical product, because of various issues of parental approval," the Population Council's Arnold says of the age complaint.
Another section is devoted to showing how current clinical practice has diverged from the original trial protocols, in which ultrasound exams were required to check for ectopic pregnancies, and clinicians had to have admitting privileges for a hospital within an hour's drive in case a patient needed emergency treatment. The latter concern wasn't unique to pro-life activists, according to author Gorney: "The concern a lot of women's health people had -- people who had no problem with the morality of this -- was what about all the girls who aren't going to get back to the clinic, who are either too scared to go back, or don't have the transportation or have gotten the medication in some underground fashion?"
Mifeprex's critics point out that women end up having to self-diagnose, especially if they are taking the second half of the treatment at home -- thereby reducing the number of clinic visits from three to two. "The woman has to become her own doctor," Wright says. "She's experiencing pain and bleeding -- Holly to the point where she can't walk -- and she has to consider what it might be. If Brenda Vise, a 38-year-old nurse, couldn't diagnose herself, Holly didn't have a chance."
The CWA petition strongly implies that Planned Parenthood skirts the law by allowing women to self-administer the misoprostol. Yet this alternative regimen is "most definitely legal," says Dr. Vanessa Cullins, Planned Parenthood's vice president of medical affairs. "There is an extensive amount of studies in the literature that indicate that women taking the misoprostol at home is safe," she says.
Mostly, Wright's group focuses on bureaucratic procedure rather than medicine. Over and over, its petition alleges that the FDA breached its own rules in its rush to approve Mifeprex to appease the Clinton White House. And although the document was submitted to the FDA more than a year before Holly died, it easily could be mistaken for a rough draft of Holly's Law.
The interesting thing about Holly's Law, despite all the rhetoric about drug safety, is that DeMint's bill would do nothing to improve the safety of Mifeprex. It doesn't seek a clinical review, further trials, or any changes in how the drug is administered -- except that it not be administered. Instead, mirroring the CWA petition, Holly's Law focuses on the timing of the FDA approval. "There are outside constituencies," says DeMint spokesman John Hart, "that helped get [Bill Clinton] elected -- Planned Parenthood, liberal groups that promote access to abortion -- and they expected this in return during his watch."
Both documents charge that undue pressure was brought to bear on the drug's inventors. In particular, they cite a letter from Shalala to Hoechst, giving a deadline by which she hoped to make the drug available. Both the CWA petition and Holly's Law also claim the FDA was so frustrated Danco wouldn't agree to the restrictions employed during the clinical trials -- the ultrasound and hospital-admitting privileges, among others -- that it employed Subpart H as a last-ditch mechanism to maintain control over a drug the White House was forcing onto the market. "The FDA buckled," Wright says. "Normally if a pharmaceutical company tried to pull tricks like this, the FDA would clamp down so hard -- they would say, 'Forget it. You're not getting approved, and neither are your next ten drugs.' But this was political, and Danco didn't have a next drug."
When pressed to explain, however, why a federal agency would break the law and endanger women's health at the behest of a tiny startup company, Mifeprex's critics can cite nothing more than the ideology, in Wright's words, of "some people in the FDA." They accuse the drug's defenders of now turning an equally blind eye to the dangers signaled by Holly's death. "The groups that are making excuses now are the same groups that pressured the White House," Hart says.
The response to these accusations from the Population Council, Danco, Planned Parenthood, and other pro-choice organizations is uniform and to the point: "The FDA's review process was always very thorough and very complete. No corners were cut," says Danco spokeswoman O'Neill.
The FDA, likewise, defends its process. "The agency carefully reviewed the new-drug application for mifepristone according to our usual procedural standards and timelines. A decision to approve the application was not rushed," says an FDA spokeswoman, who points out that Danco's application took more than four years to approve. Subpart H, she adds, was employed solely to put additional restrictions on distribution of Mifeprex. "It wasn't to fast-track the drug," the spokeswoman says.
Concerned Women for America describes its mission as to "protect and promote Biblical values among all citizens -- first through prayer, then education, and finally by influencing our society." The group, if you read its Web site, is also concerned about secular humanism, sexual promiscuity, Norplant, child abuse, drug abuse, genetic engineering, the erosion of traditional gender roles, and the "homosexual agenda."
It was also Concerned Women that matched up Monty and Helen Patterson with the authors of Holly's Law. The group sent flowers to Holly's funeral, Wright says, and when Monty Patterson called to say thanks, they offered him information on the hazards of Mifeprex. "Monty Patterson is very interested in any information he can get his hands on because this is what caused his daughter's death," Wright says. "We were the ones doing all the research."
Soon after Holly's death made headlines, DeMint's office contacted the CWA to say the congressman was interested in drafting a bill to suspend RU-486. "We were like, 'Great! That's just what we've been asking for for over a year,'" Wright recalls. "What caught their attention was Holly, so at that point it was me who told them how to get in contact with the parents."
DeMint is a Republican staunchly opposed to abortion. He has written legislation designed to encourage adoption as an alternative, and previously cosponsored Vitter's RU-486 Patient Health and Safety Act. "He has a 100 percent pro-life voting record and he believes the FDA's mission is to protect the health and safety of Americans, not to facilitate the taking of life," DeMint spokesman Hart says. The congressman, he adds, would prefer to suspend RU-486 from the market, not simply place further limits on its distribution. "There were a lot of congressmembers who were discussing doing a bill of this nature," Hart says. "People concluded that ours was the one that was most measured and reasonable and had the greatest chance of enactment."
Having a recent, tragic case in point helped the cause immensely. "Holly Patterson's death has galvanized an effort that was going on for quite a while to encourage the FDA to take a second look at RU-486," Hart says. "It's unfortunate that it took a very public tragedy for that to happen, but it has focused attention on the issue."
Wright, too, acknowledges the public-relations advantage Holly's name and face has given her cause. "We had filed all this information with the FDA in August of 2002, and we couldn't get hardly any attention at all to all these very serious things we'd found," she says. "Holly personalized that. People can see this picture of this beautiful young girl who had everything going for her and think, 'This could be my sister, my daughter.' It's really frightened and saddened people."
The offer to use Holly's name, Hart says, came from Monty and Helen Patterson. In the weeks immediately following her death, the couple had appeared on Buchanan & Press, The Today Show, and the CBS Evening News. In those interviews they were careful to stress that they were neither for nor against abortion rights, but rather "pro-Holly."
But in their public letter, which was drafted in support of DeMint's legislation, the Pattersons come out strongly against the continued marketing of Mifeprex. "As parents, we cannot allow our beautiful Holly's horrible death to be in vain. RU-486 has caused serious injury and has been implicated in the deaths of other young women. Now it has killed our daughter," they write. "We have learned that the initial trials were rushed and the drug was lumped in and approved with drugs designed for life-threatening illnesses such as cancer and AIDS. ... The FDA has failed to carry out its mission to ensuring RU-486 is a safe and effective abortion-drug regimen."
Debbie Patterson was not pleased to learn that her daughter's name was being used without her input. Although she and Monty retained joint legal custody of their children, their split was acrimonious and they rarely speak. This may explain why -- until she was contacted by the Express -- Debbie had heard neither of Holly's Law nor her ex-husband's public support of it. She was surprised by the national attention her daughter's death has received, angered that she hadn't been consulted about the legislation, and upset that her former husband's new wife was being deferred to as though she were Holly's parent. "Anything done on Holly's behalf needs to go through the father and the mother," she emphasizes.
Nevertheless, Debbie Patterson agrees that the dispensing of RU-486 needs to be reexamined. "I really, truly believe that until more information is found that this pill needs to be stopped dead in its tracks right now," she says. "I'm not saying it's good or bad, but it's not being handled right."
Then she reconsiders her statement. "Is there a safe use for napalm?" Debbie says. "You know, I lost not only my daughter but my grandchild. If I could look back on things I would have said, 'If you didn't want this baby, I want this baby. It's my grandbaby.' But we never had the chance to talk. We were never faced with that. It's hindsight."
For his part, Holly's grieving boyfriend cannot bring himself to speak too harshly of medical abortion. "I'm bitter that Holly is gone, but with all the research that I've done I don't feel that the pill is that unsafe. It seems to have a decent track record," he says.
Ehsan thinks the process, not the pill, was at fault. But while he believes Mifeprex patients should be more closely monitored after leaving the clinic, he has a hard time pinpointing exactly what needs to change. "The FDA and the drug company and Planned Parenthood are in disagreement with each other," Ehsan says with a sigh. "Everyone thinks someone else made the mistake. I'm sure a mistake happened somewhere, otherwise Holly would be alive. But I just don't know who made the mistake and what that mistake was."
Nor does anyone else -- yet. The FDA, Planned Parenthood, the California Department of Health Services, and Valley Care Medical Center are all conducting investigations. The medical center has called on the FDA to respond formally to the CWA's petition and lay down ground rules for how hospitals should handle Mifeprex-related emergencies. "Valley Care feels that we did everything correctly and that we did the best treatment we could for her," spokeswoman Kathy Campbell says. Nevertheless, she adds, the hospital wants better instructions. "If it goes awry, and the patient comes in, we want clearer definitions of what to do," she says.
That hardly seems unreasonable, given the coroner's findings that Holly died not from Mifeprex itself, but from an infection caused by remnants of an abortion. In the eyes of the drug's defenders, this demonstrates that DeMint's proposed legislation is a purely political play, not a genuine attempt to improve women's health. "There is no scientific proof that Mifeprex caused the infection which caused Holly Patterson's death," Saporta argues. "Would a surgical abortion or another surgical medical procedure have resulted in the same outcome? It's a tragic situation, but it's certainly not a reason to take a safe and effective method of early abortion away from tens of thousands of women who would choose it."
DeMint's people insist they're not the ones playing politics. "It doesn't matter whether you're pro-life or pro-choice -- why would you not support the best possible safety guidelines?" Hart asks.
But really, who in the abortion debate isn't playing politics? And the louder the debate gets, the more Holly Patterson risks becoming the next Polly Klaas, the next "Megan" we know only for the law named after her, or the "Amber" behind the Amber Alert System -- just another pretty young woman whose death flattens her into a symbol for a larger cause, devoid of the complexities and nuances that made her a unique person rather than simply a victim.
That process may already have begun -- some of the officials contacted for this story mistakenly pronounced Holly's last name "Peterson," perhaps conflating her with Laci Peterson, the pregnant Modesto woman who was murdered last year and has also become a namesake for legislation designed to protect unborn children.
"The people and groups that are pro-life are using Holly, my girlfriend, as almost a martyr, their way of attending to their own agenda," Ehsan says. "That's fine, because I understand that's just politics and it's nothing personal. But at the same time, this is the United States, the land of the free, and that's why I'm pro-choice. I think women should have the choice of deciding what should happen to their bodies."
Ehsan worries that all the attention will reduce Holly's memory to nothing more than "this person who died from taking an abortion pill." At the same time, it has exposed her most personal affairs to the world. Both he and Holly already have been the target of scrutiny and judgment, much of it unkind, from abortion foes posting on the Internet; these Web pundits have called Holly a whore who deserved to die and portrayed him as a callous opportunist.
The hardest part, Ehsan says, is having to share Holly's memory with millions of people who never knew her. "When you have a relationship with someone, it's very sacred to you, very personal. And when everyone is suddenly demanding to know every aspect of your relationship, there's nothing you can do; you can't hold anything for yourself. It's like none of the memories are left just for you," he says. "She's almost like a celebrity figure in my mind now. Yeah, she was mine, but now she belongs to the entire world."
And as Holly's Law moves through the legislative process, no doubt many people will wonder: Would Holly, who chose to have a medical abortion, wish for her worldly legacy to be the outlawing of RU-486? Or would she, as her namesake bill suggests, want to take enormous precautions to prevent any other family from experiencing the pain hers has endured? In the noisy public debate over who can best speak for women's health interests, only Holly Patterson knows why she made the choices she did, and whether she would want other women to also be free to choose.
But Holly's voice is quiet now. What began with a secret must end with one, too. |
