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Monty Patterson first heard of the drug mifepristone on September 17, 2003, the worst day of his life. A call came while he was at work: His 18-year-old daughter, Holly, was in the hospital and very sick; he needed to hurry. Patterson sped to ValleyCare Medical Center near the San Francisco suburb of Livermore, where he and Holly lived. He found her in the intensive care unit, semiconscious and struggling to breathe. It made no sense. Holly, a beautiful, blue-eyed blonde, was a fitness buff in perfect health. She hadn't felt well over the weekend, but she'd blamed it on painful menstrual cramps, not unusual for her. Now a doctor was saying she might not survive. "Septic shock," Patterson says he was told. "We think it's complications from the abortion pill she took."
Patterson stared at him. Abortion? Holly was pregnant? What pill? Suddenly the crisis deepened. Holly was worsening, she needed a ventilator, her blood pressure was dropping. He heard the panicked words "code blue!" and was hustled from the room. He stood outside the door with his fiancee, his son, Holly's only sibling, and her boyfriend. All of them were crying and calling out: "Don't give up! We love you, Holly!" Holly's mother, Debbie, who was long divorced from Patterson and lived in Southern California and whom he'd phoned earlier, was still on a plane. She would arrive too late. Holly died just before 2 p.m.Complications from Mifepristone
In the nightmarish period following Holly's death, Patterson learned that on September 10 his daughter had chosen to end an unwanted pregnancy with what is called a medication abortion. Medication abortion is pregnancy termination, though it's performed very differently than traditional surgical abortion (usually vacuum aspiration done in a doctor's office or clinic). Approved for use in this country five years ago, medication abortion involves taking two prescription drugs. The first is mifepristone, sold here as Mifeprex but commonly known by its European name, RU-486. It blocks the hormone progesterone, necessary to sustain the pregnancy. The second drug, taken a few days later, is a prostaglandin called misoprostol, which causes the uterus to contract and expel its contents. Medication abortion has been used in Europe for more than a decade and has been promoted as a safe and simple alternative to surgical abortion. (This procedure is not to be confused with the emergency contraceptive known as "the morning-after pill" or "Plan B," which prevents conception after unprotected sex but won't affect a pregnancy that already exists.)
The day Holly died, Patterson says he was told by officials from Planned Parenthood, at whose Hayward clinic Holly had arranged her abortion, that nothing like this had ever happened before. Patterson didn't believe them. "Something's wrong here and I will find out what," he vowed.
In early 2003, Holly Patterson, then 17, embarked on her first serious romantic relationship. Her boyfriend was seven years older than she was and they became sexually intimate. In August she discovered she was pregnant. Holly's boyfriend didn't respond to Ladies' Home Journal's request for an interview, but shortly after her death he told a reporter from the local East Bay Express that she'd immediately decided she wanted an abortion. On September 10, shortly after she turned 18, the couple went to a Planned Parenthood clinic. After receiving counseling and signing a release form, according to records of a court case that was later brought, Holly swallowed a mifepristone tablet at the clinic and was given four tablets of misoprostol with instructions to insert them vaginally at home the next day. She also got an instruction sheet, he said, telling her that she might experience cramps, and that a prescription painkiller could be used to relieve the pain. On September 13 she called the clinic hotline to complain of severe cramping. She was told to take the painkiller. On the 14th her father found her weeping on her bed. She told him she was just having a painful period.
Later, court records show, Holly called the clinic's hotline again. She was told to go to an emergency room if the pain continued. It did, so she went to the ER. The doctor there, whom she told about her abortion, sent her home with yet more painkillers. The pain continued, and by the 16th she was weak, vomiting and unable to walk. Just before dawn on the 17th, her boyfriend rushed her back to the ER, where she died that afternoon.
Debbie, Holly's mother, who'd been estranged from Patterson, retreated into private grief. Filled with rage as well as sorrow, Patterson, who works in the home and commercial building industry and has no degree in science or medicine, turned to the Internet to educate himself about mifepristone. A simple search produced tens of thousands of hits, for the drug was at the center of the battle over abortion that's raged in the United States since Roe v. Wade legalized the procedure in 1973. It was developed in the 1980s by the French pharmaceutical firm Roussel-UCLAF, approved for use in that country in 1988, and by 2002 was widely available in Western Europe. Pro-choice advocates fought for years to bring it to America. It finally was approved for importation, in 1994, though Roussel-UCLAF, worried about consumer boycotts led by pro-life groups, declined to produce it for export. Instead, it donated U.S. patent rights to the Population Council, a nonprofit international research organization focusing in part on reproductive rights, which would conduct clinical trials required by the FDA. Danco Laboratories, a private company, was formed to obtain FDA approval to market it in the United States. Clinical trials involving 2,121 women ran through 1994 to 1995.
On September 28, 2000, Jane E. Henney, MD, the FDA commissioner, announced that after "careful evaluation of the scientific evidence related to [mifepristone's] safe and effective use," the agency had approved the drug for early pregnancy termination. The approved regimen was identical to that being used in Europe: A woman would take three 200-milligram tablets of oral mifepristone on day one and two 200-microgram tablets of oral misoprostol on day three -- both in the doctor's office -- then return for a check-up on day 14. Doctors who prescribed the medication were required to have the ability to diagnose patients for possible ectopic pregnancies, which can't be terminated with mifepristone and can cause internal organ rupture and hemorrhage if allowed to progress. And doctors had to be able to provide surgical intervention if a patient bled excessively or the medication abortion was incomplete, which happened in 2 to 5 percent of cases.
By the time Patterson began his research, approximately 250,000 women in the United States had used mifepristone to end pregnancies, though the majority of women having abortions still chose vacuum aspiration, which is faster and often less painful. (Mifepristone has been called the "abortion pill," which makes it sound like a quick fix, but the reality is that it can cause a week or more of serious cramping and bleeding.) Battle lines over the drug were drawn. To pro-choice advocates, medication abortion was appealing because it could be performed very early -- in fact, it's recommended only up till seven weeks. (Some studies have found it to be effective for up to nine weeks.) But even more important, it was private: Women could abort at home, without the risk of being seen in public going to an abortion clinic -- thereby escaping the picketing and threats of violence that had become so common. It also was a safety net in case surgical abortion became unavailable: Between 1992 and 1996 the number of providers in America had declined by 14 percent.
What drew Patterson's attention to abortion opponents, who were against the drug on principle, was their view that the drug was unsafe. In August 2002, Concerned Women for America, a Washington, D.C.-based group whose stated goal is to "bring biblical principles into all levels of public policy," the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical Association joined forces to file a petition asking the FDA to stop distribution and marketing of mifepristone. Among their claims: that the FDA had rushed its approval of the drug by placing it in an accelerated approval program meant only for medications that treated life-threatening illness and that it had not been tested specifically on adolescent girls, though they would almost certainly use it. The coalition also said that the drug regimen being used in U.S. clinics was not what the FDA had approved. In order to give patients a lower dose of mifepristone, many providers were having them insert the misoprostol themselves at home, vaginally, rather than take it orally at the clinic.
Some of these allegations were disputed. Danco pointed out that approval of mifepristone wasn't granted for more than four years after the application was initially submitted, hardly a rush. And Planned Parenthood said that while it was true the regimen had been changed, studies and clinical practice had shown this method not only was safe but also preferable -- taken orally, misoprostol nauseated a lot of women.
But in April 2002, both Danco Laboratories and the FDA had acknowledged some real problems with the drug. A small number of women had suffered ruptured ectopic pregnancies after mifepristone was used (inappropriately) for termination; one of them had died. In addition, a young woman with a family history of heart disease had suffered a nonfatal heart attack and two women had developed bacterial infections. One of those women, a 26-year-old participating in drug trials in Canada, had died (Canadian drug trials were halted afterward). And it wasn't at all clear that that was all. It's voluntary for physicians to report a patient's bad drug reaction to the FDA; moreover, when complications occur days afterward the connection isn't always made. The FDA itself has estimated that no more than 10 percent of all adverse drug effects are ever reported.
Patterson became more convinced than ever that his daughter's death had been needless. On November 6, 2003, he went public with his sorrow and rage, sending an open letter to multiple mainstream news organizations mourning the girl with "brilliant blue eyes, engaging smile...unwavering determination and sheer gentle beauty" and blaming mifepristone for what had happened to her.
Patterson did not then -- and has not still -- taken a political position on abortion. "I'm not pro-life or pro-choice," he insists. "I'm only pro-Holly." Still, it wasn't surprising that as Holly's death became news -- Patterson's letter was widely circulated on the Internet -- he was contacted by anti-abortion groups eager to publicize his story. To get his daughter's story out he accepted some of the invitations but was never allied with any special-interest group. He addressed 500 members of Concerned Women for America. When he heard that Representatives Jim DeMint (R.-S.C.) and Roscoe Bartlett (R.-Md.) and Senator Sam Brownback (R.-Kan.) were introducing legislation that would suspend the FDA's approval of mifepristone, he endorsed the effort, asking that the bill be known as "Holly's Law." He announced support for a California initiative requiring that parents be notified when minors sought abortions. (Although Holly had been legally an adult when she'd had her abortion, she'd been 17 when she obtained her first pregnancy test, and Patterson believed that a notification law "would have brought [her] activity to our attention.") Then he returned to his Internet research. In fact, he and his second wife, Helen, took turns taking leaves from their work to pursue research full-time.
By early 2004 Patterson thought he was on to something. One of the articles he read in a medical journal described the symptoms and rapid deterioration of the young woman who'd died during mifepristone drug trials in Canada. "I said, 'This sounds just like what happened to Holly!'" Patterson recalls. He began sending letters to the FDA and Department of Health and Human Services: Was what these studies claimed true? Why weren't patients warned of possible complications from the pill? Why hadn't the ER doctors who'd treated Holly known more? "I said, 'I want to know exactly what kind of infection killed my daughter,'" Patterson remembers. He even traveled to Washington, D.C., to meet with FDA officials at one point. (When contacted, FDA spokeswoman Susan M. Cruzan would say only that the agency "does not discuss specific cases.")
A preliminary report by an Alameda County, California, coroner investigator had listed Holly's cause of death as septic shock due to endomyometritis (infection of the lining of the uterus) brought on by a drug-induced abortion. But perhaps because of Patterson's persistence -- again, the agency won't comment -- the FDA obtained samples of Holly's tissues from the coroner and sent them to the Centers for Disease Control and Prevention, in Atlanta, for further analysis. By April Patterson learned that Holly had died from a uterine infection that had flooded her system with toxins. By October the strain of bacteria had been identified: Clostridium sordellii.
It was a curious finding. Clostridium sordellii is an "anaerobic" bacterium, meaning it grows only in environments with little or no oxygen. It's most commonly found in soil but for unknown reasons about 10 percent of women also harbor the bacteria in their intestinal and genital tracts. Normally it causes them no problems. But in just a handful of documented cases it has made its way to an internal organ, where it has flourished and produced toxins that have caused tissue death, affected the body's ability to maintain blood pressure, sent patients into shock, and killed them with frightening speed. A Clostridium sordellii infection can also fail to cause one of the cardinal signs of trouble that every emergency room doctor looks for -- a fever -- and its symptoms, such as abdominal pain and nausea, are the same as those to be expected after a medication abortion. Some of the Clostridium sordellii infections that had occurred in the past had followed pelvic, abdominal, or bone surgery and deep-skin infections. But virtually all the fatal cases had resulted from infections of the uterus or perineum following childbirth.
Then came the real shocker: The rare bacterium responsible for Holly's death was the same one that had killed the Canadian woman in 2001.
On November 15, 2004, the FDA announced it was strengthening the warning label for mifepristone in order to include new information on the risk of serious bacterial infections, sepsis, bleeding, and death and to advise physicians to watch patients carefully for signs of infection, excessive bleeding, and ectopic pregnancy. (It did not advise doctors to prescribe preventive antibiotics, which carry their own risk.) For Patterson the victory was bittersweet. On the FDA's Web site, where the announcement appeared, he read that the agency had received 676 reports of "adverse events" among the 350,000 women who'd so far used mifepristone. Seventy-two had suffered blood loss severe enough to require a transfusion; seven had had serious bacterial infections. And he was stunned to read of "another death...that was recently reported to the FDA." Another woman had died after Holly. After some detective work, he found her mother.
Lynn Bryant's daughter, Chanelle, of Pasadena, California, had been 22, a third-year college student with plans to become a teacher, and like Holly had been vigorous and healthy when she became pregnant. Her fiance was in the Marines, and on January 8, 2004, she chose to terminate their unexpected pregnancy with mifepristone and misoprostol. On the 13th she went to a local emergency room with bad cramps. She called her mother to say that she'd been admitted to the hospital but conveyed no sense of urgency. She was still in pain the next morning, and her mother made plans to visit on her lunch hour. By noon Chanelle called to say the pain had become extreme, and by the time her mother arrived, after 1, she'd been moved to the critical care unit. "They told me that her vital signs had dropped and that she had an infection, but that they'd be on top of it shortly," Bryant recalls. Several hours passed and Chanelle's pain grew even worse. "I could barely stand to see it," she says. "Then she gathered her body in an inward position due to the pain and said, 'Hug me, Mommy.' As I laid her back, her eyes opened wide." Chanelle never regained consciousness. She was rushed to the operating room for exploratory surgery and died there. The FDA and CDC investigated her death. The cause: infection with Clostridium sordellii.
In the spring of 2004 Oriane Shevin, 34, a Sherman Oaks, California, attorney who had two young children, reportedly chose to end her pregnancy with a medication abortion. She died in a local emergency room several days later. On July 19 the FDA issued a public health advisory, warning medical abortion providers and ER personnel to suspect infection in patients who'd taken mifepristone and complained of nausea, vomiting, diarrhea, weakness, and abdominal pain -- even if they didn't have a fever. And it recommended that doctors seeing these symptoms "consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii." Neither Holly nor Chanelle had been treated this way, because Clostridium sordellii infection was so rare no one had considered it.
Then, as news stories focused on the most recent deaths, an earlier one came to light. On December 29, 2003, a week after she'd terminated a pregnancy with mifepristone and misoprostol, 22-year-old Hoa Thuy (Vivian) Tran, an Orange County, California, wife and mother of a 3-year-old, became very ill in a Las Vegas hotel and died in a nearby emergency room. An autopsy revealed evidence of some kind of infection and her family had hired a lawyer. Until now, however, they hadn't known of other fatalities associated with the drug. Tissue samples from Tran's autopsy were sent to the CDC for analysis. By November 2005, the FDA reported that these two women had also been infected with Clostridium sordellii.
Five women dead of the same rare bacteria, four of them in California. What had happened? Different lots of mifepristone were tested for possible contamination but none was found. And the women had lived in different cities and gone to different doctors and clinics. In the months after the FDA's announcement, no smoking gun materialized, only theories. One was that the infection was somehow caused by the vaginal, rather than oral, use of misoprostol. On the other hand, medication abortions had been performed with vaginal misoprostol in Great Britain and Sweden, apparently without problems.
Patterson, who by now had amassed what he believed to be "one of the largest collection of articles on mifepristone in the world," had become utterly convinced that the problem was that the drug wreaked havoc on a woman's immune system, leaving her dangerously vulnerable to infection. One of the research studies he found showed that drugs, including mifepristone, may exacerbate the severity or lethality of bacterial infections by interrupting the brain's stress hormones that regulate the immune system.
"We know that one of the things that makes sepsis infection occur is not only the infecting bacteria but the body's response to them," says James A. McGregor, MD, a professor of obstetrics and gynecology at the Keck School of Medicine of the University of Southern California, whose work Patterson cites. "You could make the observation that young, healthy people would have a more vigorous response to sepsis. But the drug blocks the response, thus making the infection worse." In addition, says Dr. McGregor, mifepristone is long-lasting -- it stays in the system a week. Plus it may be prolonged by codeine, the kind of ordinary painkiller that a doctor might prescribe for a woman undergoing a medication abortion. (Holly Patterson took acetaminophen with codeine.)
Yet this idea, too, was criticized as unproved. "To say that this drug, when used just one time at a relatively low dose, would result in infection based on immune system suppression isn't a persuasive argument," says Philip Darney, MD, professor and chief of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco. And indeed, none of the women described in earlier medical literature as having died of Clostridium sordellii infections became infected because their immune systems were disabled by mifepristone -- none had taken it.
In an editorial published in the December 1, 2005, issue of the prestigious New England Journal of Medicine, Michael F. Greene, MD, a professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, in Boston, observed there was still "no clear pathophysiologic link" between mifepristone and the deaths of Holly and the other women -- though he did note that the risk of death from medication abortion was some 10 times greater than from surgical termination. Soon thereafter the CDC, FDA, and National Institute of Allergy and Infectious Diseases (NIAID) scheduled a public workshop on disease caused by clostridial bacteria. Mifepristone deaths were not the sole focus. Intriguingly, in late 2001 a young man died of a Clostridium sordellii infection caused by contaminated cartilage he received during knee surgery, and in the last few years the CDC has noted emergence of a new, virulent, and more antibiotic-resistant strain of the related Clostridium difficile, which causes colitis and diarrhea.
The political war over abortion continues. Karen Loeb Lifford, medical director for the Planned Parenthood League of Massachusetts, remains a medication abortion advocate, saying "whenever a patient dies after a treatment, it's a tragedy that can't be minimized." But, she adds, the organization still believes medication abortion to be "extremely safe," and it remains an important alternative for women reluctant or afraid to be seen patronizing traditional abortion facilities. Supporters also note that statistically it's more dangerous to carry a pregnancy to term than to have any kind of abortion -- and that each year five in 100,000 men die from Viagra-related drug reactions. On the other side, while "Holly's Law" failed to pass in the last Congress, it was reintroduced in 2005, again by Representative Roscoe Bartlett and Jim DeMint, now a South Carolina senator.
Monty Patterson remains passionate about his personal cause but politically disengaged. He regrets not having talked to Holly about what to do in the event of an unplanned pregnancy but doesn't say how he might have counseled her. "Some people have taken this the wrong way -- that I'm for taking away women's right to abortion, and some pro-life groups have been judgmental, and one woman wrote to me saying I should have been a better father and Holly shouldn't have gotten pregnant," he says. "I've kept to the middle of the road, which is a tough path. I don't have a hidden agenda. Above all I want women and their families to be informed. I've got to tell you: Watching Holly die the way she did, watching her suffer, watching her pain...I don't see how I can say this drug should stay on the market. And if I don't do something about it, who will?"
In his efforts to have the drug taken off the market, Patterson has filed suits against Danco Laboratories, the Population Council, Planned Parenthood Golden Gate, the doctor who treated Holly in the ER, and the hospital where she was treated, charging, among other things, medical negligence, fraud, and violation of business and professional codes. (The families of Chanelle Bryant and Vivian Tran also have filed suit, separately, though they all have the same attorney. Debbie Patterson joined the suit, though with a separate lawyer.) The lawsuit has been scheduled for trial in January 2007.
Meanwhile, the deaths of Holly Patterson, Chanelle Bryant, Oriane Shevin, Vivian Tran, and the Canadian woman whose name has never been released remain unexplained. They are tragedies that leave behind enduring grief and emotional wreckage. Three children are growing up without their mothers. Lynn Bryant still weeps when she talks of her youngest daughter's death and says she "misses her every day. She was my baby." Debbie Patterson keeps a shrine of Holly's photos. "I do not know the words to tell you what this is like," she says. "A piece of your heart is gone, and nothing, nothing, nothing can fill it."
"I will always grieve Holly's death," says Monty Patterson. "I will never get over it."
Editor's Note: On March 17, 2006, the FDA announced that it had become aware of two more women who had died after having medication abortions. One was later determined to be unrelated to an abortion or use of mifepristone; at press time the second was still under investigation. Vanessa Cullins, MD, vice president of medical affairs for Planned Parenthood, said that effective immediately, the group would ask patients to use misoprostol orally rather than vaginally. In May researchers from the CDC, NIH, FDA, and other groups convened to discuss the dangers of Clostridium sordellii. They pointed out that the bacterium is also implicated in the deaths of 10 women following childbirth or miscarriage unrelated to medication abortion and one who died from infection during menstruation. They concluded additional research is imperative.
Originally published in Ladies' Home Journal magazine, July 2006.