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The
back corner of Livermore's Memory Gardens, where Holly Patterson was interred
in September just a few weeks past her eighteenth birthday, is strewn
with tributes to those who died before their time. Mourners have decorated
grave sites with toy cars and motorcycles, sports pennants, plastic medallions
bearing the Corona beer logo, and animal-shaped Mylar balloons that wave
in the breeze. While headstones in the rest of the cemetery tend towards
the religious or the floral, these are engraved with electric guitars,
Jet Skis, and horses, or inset with photos of boys in Little League uniforms
or smiling high-school girls on Picture Day. The photos are recent, their
colors still fresh. And most of those pictured are very, very young.
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 abort ion 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 wrote. "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.
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