Birth Story

Free birth-control and breast pumps? Government subsidies for domestic-abuse interventions? Some people have no trouble conjuring the moral slide those new policies will precipitate.

Modeled on recommendations by the independent Institute of Medicine and announced by the U. S. Dept. of Health and Human Services this week, the new provisions set off a firestorm of protest in some conservative circles, including this diatribe from Stephen Colbert's conservative  character on Comedy Central.

The Institute of Medicine issued a report this week that added eight preventive services for women to the provisions that will be provided free of charge under the Patient Protection and Affordable Care Act.

One noteworthy recommendation calls for free contraception and counseling on how to prevent unintended pregnancy.

In addition, pregnant women would be screened for gestational diabetes and new mothers would receive counseling and equipment to support them in efforts to breastfeed their babies.

The report "provides a road map for improving the health and well-being of women," said committee chair Linda Rosenstock, dean of the School of Public Health at the University of California at Los Angeles.  Each of the eight services "stands on a foundation of evidence supporting its effectiveness," she said.

The recommendations would fill "gaps" in care that bedevil women in the present system, the report said.

The seven additional recommendations are these:

• contraceptive methods and counseling to prevent unintended pregnancies
• screening for gestational diabetes
• cervical cancer screening, including human papillomavirus testing, for women over 30
• counseling on sexually transmitted infections
• counseling and screening for HIVAIDS
• lactation counseling and equipment to promote breast-feeding
• screening and counseling to detect and prevent interpersonal and domestic violence
• yearly well-woman preventive care visits to obtain recommended preventive services

Everybody knows that obstetricians are one of the most-sued medical specialties, but nailing down the details on that truism can be difficult.

CRICO Strategies, an international firm that provides risk-management software to hospitals and insurances companies, last month released a "benchmarking report" on malpractice risks in obstetrics that helps fill out that sketchy picture.

The report looked at 800 obstetrics-related medical-liability suits filed between 2005 and 2009.

Families dealing with the death of a mother or child, a severely damaged infant, or some other effect of a childbirth gone awry most commonly charged "communication failures, judgment lapses, and faulty technique as the reasons behind their injuries and their malpractice cases," the report states.

Sixty-five percent of cases involved "high-severity injuries."

Across the board, about one in 1,000 births involves a "preventable adverse outcome," the report noted.

While those can occur throughout pregnancy and birth, most suits in the study concerned allegations that birth assistants had mismanaged labor and delivery, particularly the second stage of labor — the actual birth.

"Substandard clinical judgment" was the top complaint in the suits, accounting for 77 percent of claims. Most of the suits named an attending physician.

The most common reason for suing was "birth asphyxia," a potentially injurious lack of oxygen, which accounted for 27 percent of the suits, and the most common allegation was that of a "delay in treatment of fetal distress" (25 percent of claims involving small hospitals, 19 percent involving large ones).

Why is the Cesarean rate so precipitously on the rise, from 21 percent of all American births in 1996 to 33.2 percent in 2007? The journal Obstetrics and Gynecology has the results of a new study that examines that question.

The Yale University Schools of Medicine and Public Health in New Haven, Conn., reacted to a spike in C-sections during births at Yale-New Haven Hospital between 2000 and 2002 by setting to work gathering comprehensive data on the 32,443 births that occurred there between 2003 and 2009, even while the hospital's C-section rate ballooned from 26 percent to 36.5 percent.

Not surprisingly, the study found that actual birth complications remained steady, while subjective judgments about the births changed.

The new study, presented at the February meeting of the Society for Maternal-Fetal Medicine, looks at the decision-making on the part of individual doctors that drove that increase.

"In this study, we examined physician-documented indications for Cesarean delivery at a major urban academic medical center in Connecticut, a state with one of the largest rate increases in the nation, to determine which specific indications contributed to the increase in our Cesarean delivery rate over a seven-year period," the researchers wrote.

First-time mothers accounted for half of C-sections during the study.

Indications for Cesarean delivery included "nonreassuring fetal heart tracing," an interruption in dilation, more than one fetus, pre-eclampsia, an especially large baby (which begins to be a concern just shy of nine pounds), and the mother's expressed desire for a Cesarean, the study's authors reported.

Complications like breech presentations, an interruption in the baby's progress into the birth canal and cord prolapse  did not increase significantly over time, the study found.

Slow dilation and those unsatisfactory fetal heart rate reports displayed only slight increases over time but contributed to an outsize degree to the increase in C-sections, the study showed. Concern for the baby's well-being, based on fetal-heart monitoring, was the top indicator for a Cesarean section at Yale-New Haven Hospital during the period studied.

Maternal request, suspected macrosomia (a large baby), more than one fetus and pre-eclampsia also showed big annual increases as indications for Cesareans.

Interestingly, the C-section rate among patients of physicians in private practice was 33.2 percent. For "university patients," who received care from the hospital service's residents and faculty midwives, supervised by attending physicians, the rate was 25.6 percent. The rate for "high-risk" patients (whose care was provided by some of the same maternal-fetal specialists who supervised in the "university" cases) was 44.6 percent.

Fourteen of 105 obstetrics-gynecology practices surveyed by the South Florida Sun-Sentinel last month said they will not take on obese women as patients.

Representatives of six of the practices cited higher rates of complications in women who are obese, but other respondents said heavier women tax their exam tables and other equipment.

"People don't realize the risk we're taking by taking care of these patients," the paper quoted Dr. Albert Triana as saying. Dr. Triana is one of two physicians in a South Miami practice that turns away obese patients, according to the article. "There's more risk of something going wrong and more risk of getting sued."

Seventy-two million Americans — about one in three — meet the criteria for obesity, according to the Centers for Disease Control and Prevention in Atlanta, Ga.

"If I had that policy, I wouldn't have a practice. I'd lose half my patients," Dr. Maureen Whelihan, a West Palm Beach ob-gyn, told the Sun-Sentinel's Bob LaMendiola. "We never turn down anyone."

In a followup article in American Medical News, reporter Christine S. Moyer asked doctors to comment on the practice of turning patients away because of their weight.

"This is [primary care physicians'] patient population, and [they're] here to serve the patients," said one of them, Dr. David Bryman, a Phoenix family physician specializing in bariatric medicine, which deals with the causes, treatment and prevention of obesity. Dr. Bryman is president-elect of the American Society of Bariatric Physicians. "If that requires getting a little extra equipment to accommodate them, it's just part of the practice of medicine."

This week is National Women's Health Week, the U.S. Department of Health and Human Services' observance of the importance of women doing the things they need to do to stay healthy. The theme this year is "It's Your Time."

Today was National Women's Checkup Day, on which women are urged to make appointments with their health-care providers and to find out what screenings and immunizations they need.

The general message from Uncle Sam to the women of America is the usual good stuff: Eat a nutritious diet, get plenty of sleep and exercise, wear your seatbelt, don't smoke.

This is a great idea, setting one week aside for women, who often are too busy taking care of others to take care of themselves, to concentrate on doing what they need to do to maintain their own health.

What are you doing for yourself this week? I would love to hear from you.

The Women's Health Initiative, a series of randomized controlled trials begun in 1991, was supposed to be definitive in terms of the role hormone-replacement theory would play in managing the health of post-menopausal women. However, the WHI has yielded unexpected and sometimes apparently inconsistent results.

The medical establishment expected the WHI to show that HRT, which had been popular for years, helped prevent cancer, heart disease and osteoporosis in older women.

Instead, in 2002 researchers announced in the Journal of the American Medical Association that they had stopped the trials, which involved more than 160,000 women, because participants receiving estrogen combined with progesterone were developing invasive breast cancer at substantially higher rates than were women receiving a placebo, and their rates of heart disease were also high.

HRT, which to that point had been prescribed liberally for post-menopausal women, virtually disappeared as a therapy, in spite of the fact that it did seem to be helping women avoid hip fractures and colon cancer.

Just last week, though, again in JAMA, a group of WHI researchers reported that a smaller study of women who have had a hysterectomy, who were treated with estrogen alone for a median of 10.7 years, showed a decreased breast cancer risk with the treatment, with no significant increase in heart disease.

Well, that's disconcerting. Should post-menopausal women be asking their doctors about HRT after all? Probably not most of them.

“Women are different — it’s relevant to almost every medication and almost every intervention,” Joann E. Manson MD told Tara Parker-Pope in a story in last Sunday's New York Times.

“With this study, in many ways, science worked the way it’s supposed to work. It’s a little like watching sausage being made. It may seem on the surface that the study was a real problem and had many, many flaws, but in reality, it ended up giving invaluable information,” said Dr. Manson, a WHI investigator who is also chief of preventive medicine at Brigham and Women’s Hospital in Boston.

Adds Pope, "The most compelling lesson of the research should be that science is always worth the wait. Consumers should insist that doctors make recommendations based on scientific evidence, say investigators, rather than allowing drug companies or marketing hype to dictate patients’ health care choices."

That's true for middle-aged women, pregnant women, men and parents as well.

Image: Vincent Van Gogh's "L'Arlesienne"

The World Health Organization has published a list of 30 medicines that can make the difference between life and death for mothers and children younger than 5 years of age.

This list of "priority medicines" was developed by the WHO, the United Nations Population Fund and UNICEF. It is the first such list, the sine qua non for mothers and children regardless of where they are , according to an editorial in the Lancet. (This list should not be confused with WHO's Model List of Essential Medicines.)

"An estimated 8.1 million children under the age of five die every year and an estimated 1,000 women — most of them in developing countries — die every day due to complications during pregnancy or childbirth," states the introduction to the list.

The new publication is something of a "wish list," the Lancet notes, in that five of the medicines to protect young children have not yet been developed.

These are the generic treatments on the list that address conditions that threaten the lives of mothers:

* For post-partum hemorrhage — oxytocin and sodium chloride

* For pre-eclampsia and eclampsia — calcium gluconate injection (for treatment of magnesium toxicity), magnesium sulfate

* For puerperal infection —  ampicillin, metronidasole, gentamicin, misoprostol

* For sexually transmitted diseases — azithromycin for chlamydia, cefixime and, for syphillis, benzathine benzylpenicillin

A great deal happened today in the amazing unfolding drama of a decades-old drug that has been shown to prevent preterm birth:

* KV Pharmaceutical more than halved the cost of Makena, approved by the FDA in February, which debuted at a price of $1,500 per dose. KV Pharmaceutical dropped the price today to $690, and vowed to make sure clinically eligible pregnant women would be able to afford the drug.

* However, the action wasn't enough to stop the March of Dimes from saying it would "step away from" its relationship with Ther-Rx, a subsidiary of the drug company.

"Access (for women) to 17-P is and always has been our paramount concern," Jennifer Howse, March of Dimes president wrote in a letter today to Greg Divis, president of the Ther-Rx Corp., employing a generic term for the drug, hydroxyprogesterone caproate.

In her letter, Howse acknowledged considerable financial support Ther-Rx has given the March of Dimes.

* Sen. Sherrod Brown (D-Ohio) said he was releasing "previously unreported figures showing the scope of taxpayer investment in the development of preterm pregnancy drugs."

A press release from Sen. Brown's office detailed the $21 million he said went into bringing Makena to market, including these costs:

* An initial trial, showing that the injection prevented preterm births in women who have previously had a preterm birth, cost taxpayers $5 million.

* A second trial, at $1.1 million, showed no side effects in children whose mothers had used the formulation.

* A third trial, costing taxpayers $5.1 million, found that the drug did not work to prevent preterm birth in women carrying twins and triplets; according to the NIH, this study was critical for Makena’s orphan drug status determination because an alternative result could have widened the number of potentially eligible women to use the drug.

* A fourth trial, which is still ongoing, cost $7.5 million through Fiscal Year 2010 and aims to find whether 17P treatments are effective at preventing preterm birth in women with shortened cervixes. This is the largest study of 17P by the National Institutes of Health, and could create another category of women eligible for Makena.

But the cost to the public doesn't end there.

In an article in the New England Journal of Medicine last month, Joanne Armstrong MD laid out the cost of treating the roughly 139,000 women she said were likely to need the drug every year. A course of 20 treatments with 17P at $300, the likely price for the drug compounded by a pharmacist, would cost $41.7 million. A course of treatment with Makena (at the original price of $1,500) for one woman would cost $29,000, or $4 billion for all 139,000, many of whom would need to resort to Medicaid to pay for the drug.

The March of Dimes, as saintly in the public eyes as an organization can be, felt the heat from the public for backing KV Pharmaceutical's push for FDA approval of Makena.

"Only after our threats (to boycott March of Dimes fund-raising events) did the MOD firm up their stance," one man wrote on March 25 on the March of Dimes' Facebook page.

But critics, including the Society for Maternal and Fetal Medicine, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatics, saved their strongest language for KV Pharmaceutical.

Sens. Brown and Amy Klobuchar (D-Minn.) asked the Federal Trade Commission to investigate the drug company for "price gouging at the expense of pregnant women."

The U.S. Food and Drug Administration on Wednesday took the unusual measure of saying it would allow pharmacists to continue to compound a drug after a new FDA-approved version of the drug debuted in February.

The drug in question is hydroxyprogesterone caproate, which has been around for decades, and has been shown to prevent preterm birth.

The FDA moved to make the drug available in an affordable mode, in light of the fact that the newly approved synthetic progestin, brand-named Makena, produced by KV Pharmaceutical, is going on the market at $1,500 a dose.

When pharmacies compound the "generic" form of the drug, also known as 17P, it typically costs $10 to $20 per dose, according to a press release from the Society for Maternal Fetal Medicine.

In the past, physicians could ask pharmacists to make up a batch of the sterile injectible. However, the FDA ordinarily forbids pharmacy compounding of a drug it has approved.

Indeed, KV Pharmaceutical reportedly sent letters to pharmacies indicating that the FDA would no longer tolerate pharmacy compounding of the drug.

"That is not correct," the FDA declared in its statement.

"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient" as long as the drug is compounded according to "appropriate standards," the statement said.

Drug companies often charge high prices for newly approved drugs to offset the expense of the typically costly, research-laden approval process.

However, KV Pharmaceutical "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness," the FDA statement said.

"It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA's accelerated approval program, and received expedited review," the statement said.

More on this tomorrow.