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Un-Informed Consent

As childbirth and delivery enter the high-tech, high-speed world, a new drug offers to save the day yet--in some troubling cases--has ended it. What every pregnant woman should know.

By Loren Stein

TATIA MALIKA FRENCH, a brilliant and charismatic 32-year-old, arrived at Oakland's Summit Hospital with her husband, J.B., on Dec. 27, 2001, joyously expecting the birth of their first child, Zorah Allie Mae. They had every reason to celebrate. French had recently earned a doctorate in clinical psychology from the Wright Institute in Berkeley and was preparing to enter medical school. Her dissertation on traumatic brain injury suffered by battered African American women had won a prestigious scholar's award. She was in love and eagerly anticipating motherhood.

Although French was two weeks past her due date, she was absolutely clear that she did not want labor to be induced. She also wanted to avoid having her baby delivered by Caesarean section. But her physician worried that waiting any longer could endanger the baby's health. After several lengthy discussions with her doctor, she was persuaded that it was better to induce labor now than risk an emergency Caesarean section delivery later. When she went into the hospital, both French and her baby were healthy and her vital signs were stable. Although details are sketchy at this time, what is known is that at 7pm French was given a drug called Cytotec to induce labor. Near midnight she was reportedly given a second dose to help her labor progress. But something went wrong, and at 4am French's blood pressure began to drop and the baby's heart rate also plummeted. French then seized and to everyone's horror--including her husband J.B.'s, who was at her side--she suddenly died. CPR failed to revive her. Doctors performed an emergency C-section to save the baby, but the baby was born dead.

French's story is the latest tragedy among dozens of cases throughout the nation that are calling attention to the widespread use of Cytotec, also known as misoprostol. The drug, developed for the treatment of ulcers, is being widely used in labor and delivery rooms in Santa Clara County, the Bay Area and across the country. Although Cytotec has never been approved by the FDA for use in obstetrics, obstetrician-gynecologists passionately defend the drug as an irreplaceable tool for labor induction, and say it is safe when strict protocols are followed. But critics contend that the medical community has come to rely on Cytotec to shorten delivery times and save money, and is ignoring a slew of well-respected studies as well as warnings from the manufacturer about its risks. Moreover, they charge that the drug has left a trail of catastrophes in its wake.

"The unapproved use of Cytotec is a scandal," says Dr. Marsden Wagner, a Washington, D.C., neonatalogist and scientist who served for 15 years as a director of women's and children's health in industrialized countries for the World Health Organization. "It's a tragedy that it hasn't been stopped."

Local doctors however, many of whom have been using Cytotec for nearly 10 years, laud the drug as a safe and noninvasive way to induce labor and prevent C-sections. "If you use it appropriately, it's a wonderful aid for labor and delivery," says Dr. Nadine Graven, former chairman of ob-gyn and current secretary of the governing board at Los Gatos Community Hospital who helped establish that hospital's rules for Cytotec several years ago. "But it's a powerful drug, no question about it. You have to have a rigid set of protocols for its use. You have to be very careful. A little bit goes a long way."

But this, unfortunately, is not what has happened in every labor and delivery room across the country. And somehow, it is not what happened recently at Summit Hospital in Oakland, in the case of Tatia and Zorah French.

DOCTORS BEGAN EXPERIMENTING in the early 1990s with the "off-label" use of Cytotec on pregnant women, often without the woman's informed consent.

They did so without any scientific protocols or consensus on how the drug should be safely used, despite the warning on the manufacturer's package insert, which explicitly states that Cytotec may cause the uterus to rupture in pregnant women if it is used to induce labor. "Uterine rupture," it continues, "may result in severe bleeding, hospitalization, surgery, infertility or death."

There is no agency tracking the use of Cytotec. One expert, however, estimates that every year at least 150,000 women are given the drug to start labor. Others assume the figure must be higher still, since its use by ob-gyns is on the rise.

Manufactured by G.D. Searle Corp., Cytotec hit the market in 1988 as a gastric ulcer medication. A synthetic prostaglandin (a hormonelike substance), the drug reduces stomach acid and protects the stomach lining in people taking nonsteroidal anti-inflammatory drugs, such as aspirin.

It took physicians only a couple of years to discover the drug's effectiveness at softening the cervix and triggering powerful and frequent uterine contractions. It can be also used to treat postpartum bleeding, a problem more common for women in developing countries. (Misoprostol, the generic name of Cytotec, can be used in combination with RU 486 for early medical abortion.)

The tiny white pill, which comes in 100 or 200 micrograms, must be broken into quarters by hand to create the smaller doses that are typically used to induce labor. The pill fragments are taken orally or, more commonly, inserted into the lining of the vagina near the cervix.

CYTOTEC HAS COME INTO VOGUE for use in labor induction because it is cheap, fast, easy and, for a good number of women, effective. It costs pennies per dose. On the other hand, Pitocin--a FDA-approved drug that has been widely used for labor induction for decades--is given via an IV drip and costs hundreds of dollars. But unlike Pitocin, Cytotec is doubly effective: it can prepare the cervix and provoke strong contractions at the same time--and often more quickly than other methods, shortening the time needed for labor and delivery. This allows busy physicians, who can be under great stress, to attend to other patients.

"The U.S. is the only country in the world where you have highly trained ob-gyns and obstetrician-surgeons trying to manage all births," says Wagner. Also a perinatal epidemiologist, Wagner studies the management of pregnancy and birth worldwide. Unlike other regions, he says, in the United States midwives do not shoulder the burden of prenatal care. Along with births, ob-gyns in this country are responsible for preventive gynecological care, family planning and gynecological surgery. "No other specialist in medicine has that much on their plate," he says. "Births are 24/7, and take 12 to 15 hours on average. The question is, how do you bring some control into that piece of your practice?"

With Cytotec, Wagner says, physicians can instruct a woman to come in at 9am and give them a pill, and at 6pm that evening she'll have a baby--and the doctor will be home in time for dinner. "This is obstetrician nirvana," he says. "There is huge pressure to use that drug."

But Cytotec can be unpredictable. Some women respond well to the drug; others react too strongly to it. If there are complications, some women sense something is going wrong; others know only when it is too late.

TWENTY-THREE-YEAR-OLD Danielle McCraney, who had had a previous Caesarean birth, was the wrong candidate for Cytotec, but in December 1998 when she went to the Eastern Maine Medical Center two weeks overdue with her second child, the on-call doctor, a resident ob-gyn, decided to induce labor with it anyway. McCraney believed she was getting Pitocin. Instead, without telling her, she was given 50 micrograms of Cytotec.

Ten hours later, in the middle of intense contractions, she felt a strange pain. The nurses responded by giving her pain medication intravenously. Getting up to go to the bathroom, McCraney suddenly felt like she was going to faint. "I started to go into shock," she says now. "The pain was constant. It was worse than any pain I have ever felt. It was like a hot knife was cutting me open."

The nurses gave her Terbutaline, a drug used to relax the uterus if contractions grow too severe, but it did not help. Finally a high-risk ob-gyn arrived, quickly assessed the situation, and frantically yelled out, "Why the hell did you wait so long to call me?" Remembers McCraney: "He bent over me and grabbed my hand. 'You've had a uterine rupture. We need to give you a C-section. You'll be fine, don't worry. We won't let anything happen to you.'"

After delivery, her baby was successfully revived, but for several days the infant was unable to breathe on her own. She was effectively brain-dead, after having been deprived of oxygen and blood for 35 minutes during the uncontrolled contractions and rupture. McCraney and her husband made the painful decision to sign a do-not-resuscitate order if the baby stopped breathing. She lived for one week.

McCraney says her own ob-gyn never showed up. He was not called in until after she delivered. Later he was openly apologetic and remorseful. "I didn't blame him for a long time," she says now.

McCraney says her medical chart clearly noted that months before her due date they had already planned to induce her with Cytotec, but she was never informed of this decision or the risks. One of those risks was the fact that the drug can cause uteruses with scars or previous incisions to split apart. McCraney wanted to sue the hospital and doctors, but was told that while she had a good case, the costs of the lawsuit would leave her in debt. Maine, she says, has a $150,000 cap on damages for pain and suffering.

"The manufacturer says don't use Cytotec for labor induction, but doctors just sweep that under the rug; they dismiss it," McCraney says. "My daughter's life was sacrificed unwillingly, unknowingly for their medical advancement. It makes me really, really mad."

AS HIGH SPEED AND HIGH TECH become the standard, obstetrics has seen an enormous increase in inductions. Women no longer spend two to three days in labor and delivery or wait weeks past their due date for labor to begin, like their mothers and grandmothers. And drugs like Cytotec may have helped spur this trend. Doctors, as well as some women, are more impatient with long deliveries and are demanding faster labors. According to the American College of Obstetricians and Gynecologists (ACOG), a national medical group representing some 40,000 ob-gyns, the induction rate has doubled in 10 years: now 1 in 5 women have their labor induced.

Although Cytotec is widely used in the United States for labor induction, the drug is not registered for this use by government agencies or obstetric societies anywhere else in the world, notes former WHO official Wagner. Great Britain's obstetric group, for example, does not endorse its use for inducing labor. In Canada, Cytotec can be used only if the woman is a member of a controlled clinical trial.

ACOG is steadfast in its defense of Cytotec for use in labor induction. Dr. Charles Lockwood, chairman of the group's obstetrical practices, has been quoted as calling Cytotec "the predominant agent of choice" for inducing labor.

It wasn't until late 1999--several years after doctors starting using Cytotec to induce labor--that ACOG, the professional organization for ob-gyns, issued practice guidelines for Cytotec's use. It did so only after several studies surfaced that showed women with prior C-sections who were induced with the drug had a far higher incidence of uterine rupture and fetal intolerance. One 1999 study reported a 28-fold increase in uterine tearing. Another influential 1998 study published in ACOG'S own journal, Obstetrics & Gynecology, reported that the clinical trial had to be stopped because of safety concerns.

ACOG advised ob-gyns at that time that the drug should not be used for patients who had undergone prior uterine surgery. The group also recommended using smaller 25 microgram doses to jump-start labor as complications could arise with higher doses. But they also issued a caveat: yet more trials are needed to determine the correct timing and dosage of the drug for inducing labor.

"Doctors [using Cytotec] don't know if they're doing harm or not," says Wagner. "Until they know, they shouldn't use it. You can't assume harmlessness and you can't assume safety. The evidence is not in." Using studies, government data and statistics from ACOG, Wagner estimates that women with previous Caesarean deliveries who are given Cytotec to induce labor are twice as likely to have uterine ruptures as women who are given Pitocin.

But this information came too late for Melissa Emerine, who gave birth in 1999, one year before ACOG's recommendations. Emerine was fearful that her uterus would rupture following her first difficult C-section delivery, so her doctor at Winston Salem Forsythe Memorial Hospital in North Carolina decided to induce her before her due date. Without informing her of the risks, Emerine's doctor gave her 25 micrograms of Cytotec as well as Pitocin. It wasn't long before the pain caused by her contractions became unbearable and she pleaded for an emergency C- section.

"I began having severe chest pains and my arms went numb," recalls Emerine. " I said, 'I'm having a heart attack!' It felt like an elephant was sitting on my chest. I was begging for my life, for her life." The resident ob-gyn arrived, saw the vital signs, and shouted for nurses to get her into the operating room right away.

"Am I going to die?" she asked the anesthesiologist. "I don't know," he said.

When they opened her up, the previous incision had torn and the baby was outside of the uterus. Deprived of oxygen for 10 minutes, her daughter Delaney now has cerebral palsy. Emerine says her ob-gyn never showed up and she has not spoken with him since.

"When women [who've been given Cytotec] find out the drug is not approved for this use, they're shocked," she says. "There's no way to describe how guinea-pigged these women feel. Obstetricians and ACOG want to use it for their convenience. They want to do inductions when they want to do them. It's a dirty little secret they don't want us to know."

NEARLY ALL OF THE OB-GYNS interviewed for this article who use Cytotec say they have no doubts about the drug's safety or its usefulness in their practice. (One physician noted that it would be almost impossible to find a practicing ob-gyn who did not support the use of Cytotec.) Doctors argue that many drugs are used off-label. If physicians were forced to use only FDA-approved drugs it would severely compromise the good they can do. "The FDA can't approve every single use for every single agent in the world," says one doctor.

There's another important trade-off, doctors say. By cutting down the time needed for labor and delivery, the drug can shorten the pain and suffering experienced by many women during the ordeal of birth.

"I would hate to see the drug withdrawn," says Dr. Josephine Von Herzen, an ob-gyn in San Diego and chair of ACOG's California division. "It's so low-cost and it works better than Pitocin"--which, she adds, can also pose dangers to women during labor. "It gets the job done so much faster."

Cytotec should be used conservatively and within the proper practice guidelines, she says. If uterine contractions grow too strong, the pill can be taken out by hand (if it hasn't yet dissolved), or the doctor can administer the uterine relaxant Terbutaline (also not FDA-approved). "There's a level of comfort with [Cytotec] because it's been well studied," she says.

When asked whether Cytotec is safe, Dr. Philip Darney, professor and chief of ob-gyn at San Francisco General Hospital, UC-San Francisco, responded: "There is no evidence [Cytotec] is not safe." Although his hospital no longer uses the drug for inducing women with previous uterine incisions, he says, "I wouldn't condemn physicians who've used it [on women] with or without uterine scars."

Darney is co-author (along with Dr. Alisa Goldberg and Dr. Mara B. Greenberg) of an oft-cited study published in the New England Journal of Medicine in January 2001. The authors write that Cytotec is "one of the most important medications in obstetrical practice" and, after reviewing some 200 studies, conclude that "results support its continued use"--although not in women with previous uterine incisions or scars.

But according to studies it cites, women induced with Cytotec as opposed to Pitocin had a significantly higher incidence of stronger, more uncontrolled contractions (called hyperstimulation) and increased fetal distress. One of the reports they included was issued by the Cochrane Collaboration, a highly respected international group of independent physicians and researchers that analyzes the effectiveness of drug treatments. While the group agreed that Cytotec seems to be more effective than conventional methods for cervical ripening and labor induction, they also uncovered numerous reports of uterine rupture involving the drug. Cytotec "cannot be recommended for routine use at this stage," they concluded.

The Cochrane Collaboration's most recent 2002 review of the vaginal use of Cytotec likewise concludes that the increase in uterine hyperstimulation and fetal heart-rate changes "is a matter for concern" and again recommends against using the drug for labor induction. "Further research is needed to establish safety," the review states. (It also adds, "Information on women's views is conspicuously lacking.")

What's more, there have been reports in the medical journals of women with unscarred uteruses having uterine ruptures after being given Cytotec. A 1997 study in Obstetrics & Gynecology reported that a 34-year-old woman without a prior C-section or uterine surgery had a uterine rupture and hysterectomy after receiving Cytotec. A 2001 study published in the Journal of Maternal-Fetal Medicine reported that a women with an unscarred uterus had a uterine rupture after being given Cytotec; her baby also died. To date, no controlled clinical trials on this group of women have been published, doctors say.

"IT'S A WONDERFUL DRUG, IT'S a terrible drug," says Dr. Barry S. Schifrin, a perinatologist and director of the ob-gyn residency program at Glendale Adventist Medical Center in Glendale, Calif. "It can do a great deal of benefit and a great deal of harm. My notion is to tell colleagues that what they do really matters. These drugs are powerful and can cause adverse reactions. Vigilance and judgment are really important."

Doctors must take special care when using Cytotec because it is so strong, he says. And unlike Pitocin--which is given intravenously and can be adjusted precisely or, if needed, stopped quickly--Cytotec is harder to control. "The problem is not the safety of the drug but the safety of the conduct [of the physician]," he says. There have been uterine ruptures with and without prior C-sections, fetal problems, and perhaps even deaths involving Cytotec at his hospital, he says. "I'm no great fan of Cytotec but it does have a place. I'm against it not being available."

Dr. Rudolph Fedrizzi, an ob-gyn in private practice in Taos, N.M., uses the drug but only if routine methods of induction fail or cannot be used. He also attributes most Cytotec complications to physicians using it unwisely. It's critical that the drug only be used in settings where doctors can respond quickly to complications with emergency backup, he says.

What's more, patients must have full informed consent before the drug is used, he says. "Did the patient and the family going into their choice really understand the outcome and potential risks? Because they bear the brunt of the outcome, whether good or bad, it's necessary that they participate in the decision-making. It's owed them. Medicine is a service. It should be done with people, not to them."

Adds Fedrizzi, "There's a real paternalism in medicine, the idea that we choose for people because we decide what's best. In the case of Cytotec, it seems to have resurrected that paternalism. That's worrisome to me."

IN A SURVEY OF 14 HOSPITALS in Santa Clara County and the Bay Area, 10 reported that their facility has a protocol in place for the use of Cytotec in labor induction. While some hospital personnel were much more forthcoming than others, there were areas of general agreement in the guidelines--especially since hospital groups often share information.

Most of the hospitals currently follow ACOG's guidelines of 25 micrograms per dose every four to six hours, but some, such as Summit Hospital, where Tatia French and her baby died, allow their doctors the discretion to decide the dosage.

Local hospitals no longer allow physicians to administer Cytotec to women who have had prior C-sections or uterine surgery under any circumstances. Cytotec should also not be used if the baby has any health problems or is showing signs of fetal distress; if the woman has already started having contractions; or if she is having multiple births, noted hospital staff.

Hospitals established their Cytotec protocols at different times. Stanford Medical Center drafted its protocol as early as 1990 and then continued to revise it; others, such as El Camino Hospital, developed its protocol as late as 1999. Some hospitals adhere to very strict standards of use, and if physicians want to deviate from the protocol, they have to get a supervisor's permission. Others refuse to allow any deviation, as is the case at Kaiser Santa Clara. Most of the hospitals surveyed do not have a written informed consent for the specific use of Cytotec and instead rely on a general written consent for all drugs used during labor and delivery. They also tend to rely on the individual physician's judgment as to whether a women is verbally informed as to the benefits and risks of Cytotec and how that information is conveyed to her.

California Pacific Medical Center, for example, established its protocol for Cytotec in 1998, says Dr. Elliot Main, the hospital's chairman of obstetrics and gynecology. "[Cytotec] works better to induce labor in women with unfavorable cervices than any medication we had before," he says. "It took awhile to establish the right dosage" of 25 micrograms, he adds; they did so that same year following the recommendation of a series of studies by clinicians at USC. "Like any medication used in labor, Cytotec can be overused or used improperly, which is not a good thing. But when used within the proper guidelines, it's a very safe drug," he says.

IF SAFETY PROTOCOLS are so widely used, then how and why did Tatia French and her baby die early this year at Oakland's Summit Hospital? And why did the primary investigator on the case disagree with his superiors on the finding?

According to the Alameda County Coroner's Bureau report, French died from an amniotic fluid embolism, an extremely rare and often fatal obstetric emergency. Amniotic fluid and debris enters the mother's bloodstream through tears in the uterus or placenta, causing cardio-respiratory collapse in the mother and often the death of the baby. (According to Searle, which makes Cytotec, one of the possible complications of Cytotec use in labor induction can be amniotic fluid embolisms.)

Even with this information, the coroner's office, which renders judgments by committee on difficult cases such as this one, decided French died from "natural" causes. "It's in a gray area--it's not real clear cut," says Sergeant Mike Harper of the Coroner's Bureau. Still, "[French's death] fell within the accepted risk associated with this type of medical procedure," he says. "This is a medication [Cytotec] that's routinely used for this purpose."

But the primary investigator on the case, Darrell Harris, disagrees with their conclusion. "I just felt if a side effect of the drug is an amniotic fluid embolism, how could you know if [Cytotec] caused it or not? I feel the finding should be 'undetermined.'" Adds Harris: "This is the first case I've heard of involving this drug and it had me concerned right from the start. I know it's legally used, but from my moral standpoint, for God's sake, [Searle] makes the drug, they should know better."

Despite their finding, the use of Cytotec and its non-FDA-approved status raised red flags among Coroner's Bureau top officials, who referred the case to the California Medical Board for further review --specifically, to determine whether French's physician used Cytotec within the standard of care.

J.B., French's husband, told Harris that he felt they had not been fully informed about Cytotec's risks before French was given the drug, according to the report. J.B. and French had first heard of the drug in their birthing classes, says Harris. Within three hours of French's death, JB had already asked a family member to research the drug and told Harris that Cytotec was not FDA approved for labor induction for an expected live birth, says Harris.

French's physician appeared stricken and depressed, says Harris. The family, as expected, was in "absolute shock."

Amazingly, there doesn't seem to be much concern at the Coroner's Bureau as to how much Cytotec French was given. The report only states that she was given two dosages, with no amounts specified. (Hospital medical records note she was given at least one dose of 25 micrograms, Harris says. French's physician, however, told him she gave her two doses--still within the protocols established by most hospitals.) Given that Cytotec may have contributed to French's death, it seems like a serious omission.

"This is a huge tragedy; there's no other way to express it," says Summit Hospital spokesperson Carolyn Kemp. "It's just terrible. Our hearts go out to the family." She says the hospital conducted its own internal, confidential review and agreed with the Coroner's Bureau that French died of natural causes. Their physicians will continue using Cytotec, she says.

DUE TO AN FDA LOOPHOLE, it's perfectly legal for doctors to use drugs, including Searle's Cytotec, off-label--in other words, for purposes not intended or approved by the manufacturer.

"We have little control of off-label use, and we don't promote it," says Searle's spokesperson. "We recognize that physicians use their own professional judgment in prescribing drugs outside of its FDA-approved indication. The best we can do when we receive adverse event reports is to remind physicians that the product has a "block box" warning--the strongest warning a prescription pharmaceutical can have--against use for women who are pregnant, because of its potential to cause miscarriage." He adds, "We take adverse events reports regarding the situation very seriously."

Searle, for its part, has never had any intention of submitting Cytotec to the FDA for testing or approval for obstetric use. While Searle is well aware that Cytotec is being used by ob-gyns across the country to induce labor, the drug is so inexpensive it's not cost-effective for the company to invest in FDA approval for use in delivery rooms. A Searle spokesperson said the company would prefer to focus its limited research and development budget on "meeting unmet medical needs," instead of doing more research on Cytotec, when there are viable substitutes like Pitocin available.

More importantly, it's not in Searle's interests to submit Cytotec for approval as a labor-inducing drug because it could leave the company vulnerable to legal action.

And legal action is what it hopes to avoid. In 1998, as reported cases of disastrous outcomes with Cytotec mounted, the FDA and Searle decided to revise the drug's labeling and draft a "Dear Doctor" letter. (Through a Freedom of Information Act request to the FDA, Mother Jones magazine found that from 1997 to 2000 the agency had received reports of 30 cases of uterine rupture in connection with the use of Cytotec and eight cases where the baby died in utero.)

Two years later, in August 2000, the letter was sent to 200,000 health care professionals around the country. Searle may have felt a genuine responsibility to warn doctors of the drug's risks. But the true motivation, say some observers, was twofold: to distance the company from the abortion debate (as misoprostol, the generic name for Cytotec, is used with RU 486 to induce abortion) and to protect Searle from legal liability.

The letter reminded physicians that Cytotec is not approved for induction of labor or abortion and that Searle has not done research to support those uses. It noted that reports of serious adverse events from off-label use of Cytotec in pregnant women include uterine rupture, hysterectomy, amniotic fluid embolism, and the death of women and babies. The letter also states that Cytotec's effect on a child's development was unknown.

Many hospitals pulled Cytotec off their shelves after receiving the letter, ACOG reported. Others established or updated protocols for its use. However, even more hospitals and physicians apparently ignored the warning.

ACOG's leaders responded to the "Dear Doctor" letter by reaffirming their faith in Cytotec. ACOG did not deny the "potentially serious but relatively rare risks" of Cytotec when used for cervical ripening and labor induction, their statement read. The vast majority of bad outcomes for women and babies, the statement continued, are the result of doctors giving women inappropriately high doses, too many doses, combining it with other drugs, and failing to take into account other risk factors, such as prior Caesarean deliveries or other uterine surgery.

Schifrin of Glendale Adventist Medical Center says his hospital put an embargo on the drug after they got the letter. They are now ready to "cautiously" reintroduce it because of its potential benefits, he says, but will be "scrupulous" about the circumstances in which they use it, excluding women who have previous uterine scars, incisions or other high-risk conditions. "That's one of the lessons we've learned," he says.

Do the lawyers suing Searle stand a chance? (See sidebar at right.) Attorneys say the strongest cases are those that involve harm done to women and infants before the release of the August 2000 letter. "Unfortunately, Searle has protected itself, even though it's fairly clear the drug is not appropriate for this use," says attorney Michael Koskoff.

"Searle is turning a blind eye to [the use of Cytotec for labor induction]," says John Budlong, an attorney in Seattle, Wash., who is representing Christine Malone in her lawsuit against her doctor.

"It would not surprise me in the slightest if Searle is profiting from having the drug used for labor induction while preparing conspicuous warnings on labels," he says. "They're shifting the risk of liability to the doctors and the victims. All such calculations are part and parcel of modern health care."

Adds Budlong: When it comes to drug companies and medical experts, "almost nothing surprises me that comes out of this mix."

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