LONDON -- British fertility experts have devised a new IVF technique that takes thousands of snapshots of a developing embryo that they say can help doctors pick those most likely to implant successfully and develop into healthy babies.

At a briefing in London before publishing their results, the researchers said they are already using the technique to select "low risk" embryos that are the least likely to have chromosomal abnormalities that could hamper their development.

In their study, published in the journal Reproductive BioMedicine Online, the team's chances of producing a successful live birth after in-vitro fertilization (IVF) were increased by 56 percent using the new technique compared to the standard method of selecting embryos that look best through a microscope.

"In the 35 years I have been in this field, this is probably the most exciting and significant development that can be of value to all patients seeking IVF," said Simon Fishel, a leading fertility doctor and director at the IVF clinic operator CARE Fertility where the technique is being developed.

Independent scientists not involved in the work welcomed it as a significant advance but said full randomized controlled trials - the gold standard in medicine - should be conducted before it is adopted as mainstream practice.

"This paper is interesting because we really do need to make advances in selecting the best embryos created during IVF," said Allan Pacey of Sheffield University, chair of the British Fertility Society.

"The idea of monitoring embryo development more closely is being used increasingly in clinics around the world and so it is good to see the science involved submitted to peer review and publication," he added. "All too often, developments in IVF are trumpeted as advances when they remain unproven."

Experts say that today, as many as 1 to 2 percent of babies in the Western world are conceived through IVF. The standard methods of selecting embryos are based largely on what they look like through a microscope, and many IVF cycles fail because the embryo chosen and transferred to the womb fails to develop.

The scientists who led this study said that using time-lapse images, they had found that developmental delays in the embryo at crucial stages are good indicators of likely chromosomal abnormalities that could result in a failed pregnancy.

"In conventional IVF laboratories, embryo development will be checked up to six times over a 5-day period," said Alison Campbell, Care Fertility's embryology director and the lead researcher on the study being published.

"With time-lapse we have the ability to view more than 5,000 images over the same time period to observe and measure more closely each stage of division and growth."

Using this new knowledge, the team developed what they call morphokinetic algorithms to predict success (MAPS). By applying these MAPS to the selection of embryos, they predict they could reach a live birth rate for patients undergoing IVF of 78 percent - about three times the national average.

Fishel, whose CARE Fertility clinics are Britain's largest independent provider of assisted conception cycles, with around 3,500 a year, said he is charging around 750 pounds ($1,100) for IVF using the MAPS technique - compared to several thousand pounds for a standard IVF cycle.

But Sue Avery, head of the Women's Fertility Centre in Birmingham, said it was too soon for all clinics to adopt it.

"Until the new technique is compared to current practice we cannot know whether different embryos are being chosen," she said. "The IVF community needs a prospective randomized controlled trial to prove that the new approach delivers better results before it can be recommended to patients."

By Andrew M. Seaman
Reuters
Children born after being exposed to the flu during pregnancy may have a nearly four-fold higher risk of later developing bipolar disorder, according to a small new study. 

The senior researcher said the results can't prove that a mother's bout of flu while pregnant causes her child to develop the mental disorder, but the association does suggest that some cases might be prevented.

"The idea is that if influenza is playing a causal role - and we can't say that from one study - there is a vaccine," Dr. Alan Brown, a professor of psychiatry and epidemiology at Columbia University in New York, told Reuters Health.

"It's affordable and also I would argue that there are other things that pregnant women could do. For example, hand washing and staying away from people with the flu," Brown said.

Previous studies had already established a link between a mother's flu infection while pregnant and her child's increased risk of developing schizophrenia, a severe mental disorder that often comes with hallucinations, delusions and paranoia.

Bipolar disorder shares some traits of schizophrenia, but also differs because it includes alternate cycles of mania and depression - although one type of bipolar diagnosis involves mania alone.

Past research into the link between people's risk of bipolar disorder and their mother's flu has produced mixed results, Brown and his colleagues write in JAMA Psychiatry.

For the new study, Brown's group looked for a connection between flu exposure and children's bipolar diagnoses in data from a study that involved soon-to-be mothers living in Alameda County, California, between 1959 and 1966.

Using the mothers' medical records and follow up information about their children, the researchers had information on 92 kids who were exposed to the flu while in the womb, and on 722 who were not.

Of the children exposed to the flu, about 9 percent were later diagnosed with bipolar disorder. That compared to about 3 percent of the kids who were not exposed.

"What we found is that (schizophrenia and bipolar disorder) share at least this in common. Maternal influenza is related to bipolar disorder," Brown said.

He added, however, that they did not see an association between bipolar disorder and a mother's common cold or other upper respiratory infections.

And until more studies are done, Brown said he and his colleagues can only guess at what is behind the link between flu and bipolar disorder.

"We think there is an inflammation going on in the fetus due to this infection and it can alter key aspects of brain development and function," Brown said.

By The Associated Press

A hospital says a Turkish woman who became the first person to successfully receive a donor womb is six weeks into a "healthy" pregnancy. 

Derya Sert was born without a womb and had one transplanted in August 2011. Using one of her own eggs, doctors placed an embryo into the 22-year-old's womb in March.

A statement from Akdeniz University Hospital on Monday said doctors have monitored a fetal heartbeat and that the pregnancy is going well. 

A successful birth would provide hope for women who were born without a womb or who lose it to disease. 

Related stories:

Hospital plans to offer first uterus transplant

By Genevra Pittman
Reuters
Moms-to-be should get a booster tetanus, diphtheria and pertussis (Tdap) vaccine during each pregnancy to help protect their infants from whooping cough, according to a new vaccine schedule released today by the Centers for Disease Control and Prevention (CDC).

Babies don't get their first pertussis vaccine until two months of age - and even then, they aren't fully protected until after their third shot, at six months. In the interim, they are at especially high risk of getting very sick from the bacterial disease.

During a 2010 whooping cough outbreak in California, for example, more than 9,000 cases were reported and 10 infants died.

Vaccinating pregnant women serves the dual purpose of keeping moms from contracting whooping cough and passing it to their infants as well as allowing some immune cells to pass to babies through the placenta.

"It turns out that immunity wanes pretty quickly," said Dr. H. Cody Meissner, a pediatrician from the Tufts University School of Medicine in Boston who is on the CDC's immunization committee.

"Without boosting with each pregnancy, a mother's immunity will wane and she will have much less immunity to pass on to the baby," Meissner told Reuters Health.

Although not part of the new immunization schedule, experts recommend immunizing a new baby's father, siblings and other caretakers. That strategy is known as cocooning.

"It's a good time to make sure that everyone who will be caring for the child is also up to date on their vaccines," said Dr. Daniel McGee, a pediatrician with Helen DeVos Children's Hospital in Grand Rapids, Michigan, who wasn't involved in the new guidelines.

"You need to make sure if grandma and grandpa are coming to visit, they're protected as well," he told Reuters Health.

Along with the new guidelines for pregnant women, updates to the CDC's vaccination schedule include a routine Tdap shot for adults age 65 and older and a pneumococcal vaccine approved for adults with immune compromising conditions like kidney failure.

Some children who are ill, such as with sickle cell disease, should get meningococcal vaccines starting at two months of age, according to the schedule. Other kids don't have to start those shots until middle school.

The influenza vaccine is still recommended annually, but will now protect against four strains of flu rather than three, said Erin Kennedy, a medical epidemiologist at the CDC.

Parents should educate themselves as best they can on recommended vaccines, researchers said.

"It's quite complicated, and it does change all the time. But it's imperative for people to stay up to date and informed about which vaccines are available," Meissner said.

"There are 16 vaccine preventable diseases that children receive immunizations against in the first 18 years of life," he added. "If vaccination rates fall, we're going to see increases in some of these diseases."

Because the immunization program has focused on children, Kennedy said some adults don't know the schedule also calls for them to get a range of vaccinations based on their age, health or where they travel.

"Adults need to be aware of the fact that there are vaccines that are recommended throughout the lifespan," she told Reuters Health. "Right now coverage is low for all of these vaccines."

Updates to the CDC's vaccination schedule were published concurrently on Monday in Pediatrics and the Annals of Internal Medicine.

By Trevor Stokes
Reuters
Group therapy can help women avoid risky and costly cesarean sections, especially first-time mothers fearful of childbirth, according to a new study from Finland. 

While nearly half of first-time mothers with an extreme fear of childbirth opted for C-sections before counseling, researchers found, only about a third ended up choosing C-sections after attending therapy sessions.

"Our study showed that group counseling is a very effective way to treat first-time mothers with intense fears of childbirth, in order to decrease the number of C-sections and to have more satisfactory delivery," lead study author Dr. Hanna Rouhe, clinical researcher at the Helsinki University Centralö Hospital, told Reuters Health.

"Many of these women with severe fear of childbirth don't come to any maternity clinic for consultation, they just come to deliver with all the anxiety and fear, so there will be problems in delivery," Rouhe said.

Previous research has shown that giving expectant mothers a forum to voice their fears reduced C-sections, but the Finnish researchers said their randomized clinical trial of a formal intervention to address those fears was a first. 

C-section is the most common surgery in the U.S., and accounted for a third of deliveries in 2010, according to the Department of Health and Human Services.

The C-section rate in Finland is half that of the U.S. Still, several medical groups have expressed alarm at the generally high number of C-sections performed in western countries, because the procedure both increases a woman's risk of bleeding, infection and infertility, and incurs higher medical costs.

It's been estimated that between six percent and 10 percent of C-sections may be scheduled by women with extreme fear of childbirth, according to the Finnish team.

"This study raises the issue that maybe we should pay more attention to why women are opting for primary cesarean sections," said Dr. Laura Riley, an obstetrician who specializes in high-risk pregnancies at Massachusetts General Hospital in Boston and was not involved in the new study. 

A number of initiatives aim to reduce the first cesarean section by waiting longer to induce labor and by allowing longer delivery times before C-sections are offered, she noted. But, Riley wrote in an email, "I am not aware of initiatives surrounding childbirth fear - maybe there should be."

Most hospitals include childbirth counseling in standard prenatal care, but when obstetricians discuss the C-section option, they give unsatisfactory treatment by not addressing any underlying fears, the Finnish researchers conclude.

For their study, which is published in the British obstetrics and gynecology journal BJOG, the team used a standard psychological questionnaire to screen a total of 4,575 first-time expecting mothers for fear of childbirth or a strong desire for C-section, and identified 371 with a severe fear of vaginal birth.

Symptoms of the intense fear included panic that affected daily life, nightmares about delivery and a strong desire for a C-section. 

The researchers then randomly divided the fearful expectant mothers into two groups: 90 women received six two-hour sessions of group therapy led by a trained psychologist and 240 received standard prenatal care.

When it came time to deliver their babies, 66 percent of the women in the therapy group chose to have vaginal delivery, while just 47 percent of the women in the control group chose vaginal birth. More than a third of women in the therapy group also reported afterwards that they had had a "positive" delivery experience, versus 23 percent in the control group.

Still, one expert questioned the study's design and said its results offer nothing new for doctors or pregnant women.

"Education and support of pregnant women works; it decreases C-sections, we already know that," George Saade, chief of the division of maternal-fetal medicine at the University of Texas Medical Branch, told Reuters Health. "That study doesn't prove much because the design is flawed."

Nearly half (106 out of 240) women not assigned to therapy in the study sought out their own support and therapy - including Lamaze classes and consultations with doulas and midwives - Saade pointed out, making the effect of the therapy intervention difficult to distinguish.

During the therapy sessions for the intervention group, would-be mothers underwent imaginary deliveries in calm settings and equated childbirth with peaceful images such as a flower opening. 

"I really do not see the value of the screening test or the intervention described in the study," Saade added.

The total therapy cost about 600 euros ($762) per mother, Rouhe countered. Vaginal birth plus the therapy cost 17 percent less than a 2,500-euro ($3,176) planned C-section, according to Rouhe, but the cost did not factor in the initial psychological test.

To date, three hospitals in Finland have adopted the screening system, which researchers aim to introduce across Finland. Most hospitals in Finland offer counseling, but don't screen and target fearful mothers for specific interventions. 

Fearful pregnant women have alternatives, Saade said, including talking with their doctors, childbirth classes that usually include a tour of the delivery room or using a midwife or doula who can help address the issue.

This month, professional medical associations and federal funding agencies published new guidelines for obstetricians intended to decrease C-sections.

Rouhe and colleagues plan to break down the cost effectiveness and longer-term impacts of the group therapy in future studies.

"We have to look at the larger problems in these women's lives," Rouhe said. Women with little social support and histories of abuse or mental health problems have increased childbirth fears, according to previous research.

"It's not only a problem of delivery," Rouhe said.

Doctors trying to find some of the causes of autism put another piece into the puzzle on Monday: They found women who had flu while they were pregnant were twice as likely to have a child later diagnosed with autism. Those who had a fever lasting a week or longer -- perhaps caused by flu or maybe by something else -- were three times as likely to have an autistic child.

The study of 96,000 children in Denmark raises as many questions as it answers. But it fits in with a growing body of evidence that suggests that, in at least some cases, something is going on with a mother’s immune system during pregnancy that affects the developing child’s brain. Health officials said the finding reinforces their recommendations that pregnant women should make sure to get flu shots.

Autism seems to be a growing problem in the United States. According to the U.S. Centers for Disease Control and Prevention, autism spectrum disorder affects one in 88 children, including about one in 54 boys. The autism spectrum refers to a broad range of symptoms, from the relatively mild social awkwardness of Asperger’s syndrome to profound mental retardation, debilitating repetitive behaviors and an inability to communicate.

Scientists agree that it’s not just a matter of better diagnosis; the numbers seem to be growing because more children are indeed developing autism. But no one is sure why. Genetics are a large factor -- if one twin has autism the other twin is very likely to -- but genes don’t explain it all.

Ron Heflin / Getty Images file

Getting a flu shot during pregnancy is one way to avoid influenza, which has been linked to later diagnosis of autism in children in a new study.

Some studies have pointed towards inflammation -- the mother’s immune response somehow affecting the brain of the developing fetus. So a team including Dr. Hjördis Ósk Atladóttir of the University of Aarhus in Denmark, Diana Schendel of the U.S. Centers for Disease Control and Prevention and colleagues studied a big database of children born in Denmark.

The 96,000 children were born between 1997 and 2003, to about 30 percent of all the women in Denmark who had children during those years. The women were interviewed twice while they were pregnant and then again when their babies were six months old. They were specifically asked about sicknesses they had, and about drugs they took to treat them.

Overall, 976 of the children were later diagnosed with an autism spectrum disorder -- about 1 percent of them.

Moms who said they had influenza while pregnant were more likely to have children later diagnosed with autism, the researchers report in Monday’s issue of the journal Pediatrics.

“We found almost a twofold increased risk of infantile autism in the child after self-reported infection with influenza virus during pregnancy,” the researchers wrote. Children whose mothers said they had a fever lasting more than a week during pregnancy had triple the risk of autism.

Women who reported other infections, such as a cold, a urinary tract infection or herpes, were not more likely to have a child with autism.

That doesn’t mean the infection caused autism and women should not panic if they become ill while pregnant, said Dr. Coleen Boyle, Director of the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention.

“We want to reassure women. In this study, most women who experienced flu or prolonged fever or who were taking antibiotics did not have children with an autism spectrum disorder,” Boyle told NBC News.

"It is important to bear in mind that when you look at the absolute numbers, we see that around 99 percent of women reporting to have had influenza or fever during pregnancy, do not have children with ASD (autism spectrum disorder)," Atladottir said by email "We do not want pregnant women to worry."

The researchers are not sure what may be going on. They also found that women who took certain antibiotics were more likely to have a child with autism, but it’s not clear if it’s the drug itself, or if women who took antibiotics were perhaps sicker than the other women.

“Animal studies suggest that when the mother’s immune system is triggered during pregnancy, such as when she is fighting off an infection… that immune response might affect a child’s developing brain,” Boyle said. Vaccines do not stimulate a similar immune response, doctors note.

It’s also not clear if there is something special about the influenza virus. “Misreporting of influenza is likely to be considerable; any episode of fever may be mistaken for influenza, and not all women infected with influenza virus might have been aware of this,” the researchers wrote. They did not cross-check what the women said against medical records to see who may have been diagnosed with flu.

Another study done in Sweden earlier this year found no association between flu or any other infection and autism. But a study published in May in the Journal of Autism and Developmental Disorders did find a connection. That study, done in the United States, found that women who had fevers while pregnant were twice as likely to have a child with autism or a developmental disorder.

"Growing evidence suggests inflammatory processes may be interfering with brain development at critical stages, leading to changes in behaviors  such as those associated with autism, as well as cognitive deficits," Dr. Irva Hertz-Picciotto of the University of California-Davis MIND Institute, who conducted that study, told NBC News by email.

Each study adds a piece to the puzzle but none of them can answer the questions on their own. “We just need more research,” Boyle said.

So what can women do if they are worried?

Pregnant women are already strongly urged to get flu shots. The immunization protects them -- because a pregnant woman’s immune system is suppressed -- and it protects the baby for the first six months after birth.  Pregnant women are much more likely to become severely ill with flu than other women. In Denmark, women are not routinely vaccinated against influenza.

“All women need to get their flu shots regardless of whether they are pregnant,” Boyle said.  “And if a woman is pregnant and experiencing flu-like symptoms, she should call her doctor right away. If she has a fever, that fever can be treated with Tylenol. We know from other studies that fever (during pregnancy) can lead to other serious health problems in a child, such as a birth defect.”

Some people have been wary of vaccines since a study published in the 1980s linked autism to the combined measles, mumps and rubella vaccine. But that study has been debunked and the doctor who wrote it stripped of his license. Many researchers have tried hard since to find any possible evidence that vaccines could cause autism and they have been unable to.

The CDC is doing a large study into the possible causes of autism. So far, 2,700 children are enrolled.

“We don’t know what causes autism,” said Dr. Marshalyn Yeargin-Allsopp, chief of the Developmental Disabilities Branch at CDC.

“We know that genetic factors are extremely important. If a woman had flu and she has a child with autism, even with the results of this study, it doesn’t mean that the child’s autism is due to the fact that the mother had flu. There are a lot of factors that may be responsible for autism.”

(This story corrects Dr. Irva Hertz-Picciotto's affiliation. She is at the University of California-Davis MIND Institute)

Related stories: 

• Experts: Wide autism 'spectrum' may explain diagnosis surge 
• Autism survey for parents may catch disorder early
• Sudden OCD in kids? Culprit may be strep throat, other infections

By Julie Appleby, Kaiser Health News

When a brand-name drug to help prevent premature births was approved last year, its $1,500-a-dose-price alarmed state and private sector insurance officials.

Many restricted use of the FDA-approved Makena in favor of $20- to $40-a-dose versions that had been made for years by pharmacies, saying that would give more women access to the treatment. Federal officials, sympathetic to such arguments, allowed the pharmacies to continue making the unapproved drugs.

But those decisions are now getting a second look following a deadly meningitis outbreak linked to a different pharmacy-made drug that has sickened hundreds of people and killed at least 28. No one has been reported injured by the pregnancy drug knockoffs. But the judgments made about Makena offer a window into the difficult tradeoffs between cost, safety and access sometimes confronted by policymakers and insurers at a time of growing angst over drug prices.

They also highlight the increased role of these pharmacies, some of which have begun to function as de facto drug manufacturers mass producing treatments for asthma, menopause and pain, among other conditions, but with far less oversight. 

Vials of a compounded version of the injectable pregnancy drug were among the dozens of products recalled by the now-shuttered New England Compounding Center (NECC) in Framingham, Mass., believed to be the source of the fungus-contaminated steroids linked to the meningitis outbreak. Experts say contracting meningitis from the pregnancy drug is unlikely because it’s administered into muscle, not the spine. But a contaminated dose “could cause a local infection,” said Centers for Disease Control and Prevention spokesman Curtis Allen.

More significantly, potency problems might make the drug less effective in preventing a premature birth.

Earlier this year, the FDA investigated complaints by the brand name drugmaker, KV Pharmaceutical, about the quality of some pharmacy-made products. Testing a small number of samples, the agency said in June that a few failed potency tests, but there were no “major safety problems.” At the same time, it advised that “approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products.”

That didn’t shake the faith of at least a half dozen state Medicaid programs and some large private insurers, which continue to pay for the less expensive compounds. 

Alabama Medicaid officials say they had “not one problem” with the pharmacy-made versions, although they recently began covering Makena after getting deeper discounts from the drugmaker, said Kelli Littlejohn, director of clinical services and support for the state’s Medicaid program.

Neither the federal agency that oversees state Medicaid programs, the state Medicaid directors association, the drug manufacturer or doctors’ groups could say how many state programs restrict access to the FDA-approved drug.

Backlash Over Makena’s Price

Up to 150,000 women in the U.S., at risk of having a repeat pre-term delivery, may be prescribed Makena or the pharmacy-made versions of the progesterone drug. The drug does not prevent premature birth in all those who take it. Tests leading to Makena’s approval found that 37 of 100 women taking Makena still delivered prematurely. But that was an improvement over the control group. Of the 100 women not given the drug, 55 gave birth early.

KV, which did not develop the drug, purchased legal rights to it from another firm for nearly $200 million, and won market exclusivity for seven years. It assumed state Medicaid programs -- and private insurers -- would cover the FDA-approved version and that it would soon recoup its investment.

Almost immediately, however, the drug’s price, called “outlandish” by a March of Dimes official, provoked indignation from doctors’ groups and congressional calls for investigation. In late March, the federal Centers for Medicare and Medicaid Services advised state Medicaid programs that they could continue to pay for the cheaper versions of the drug, which have been available since about 2003. The agency did not return calls seeking comment.

On that same day, the FDA issued what many observers saw as an unusual statement, saying that “to support access to this important drug, at this time and under this unique situation,” it would not take enforcement action against pharmacies that properly and safely made similar versions of the drug.

In the past, the FDA had sent warning letters or pursued other action against pharmacies when it could show they were mass producing copies of FDA-approved drugs.

“The FDA does not usually recommend that patients use compounded versions of FDA-approved drugs,” pharmacists Yesha Patel and Martha Rumore say in an article in the July issue of P&T, a journal aimed at physicians, insurers, hospitals and others developing drug coverage policies. 

Pharmacists who mix or "compound" drug formulations are allowed to make formulations for individual patients who can't use traditional drugs, but not to mass produce compounds. They are generally overseen by state regulators, not the FDA.

Not long after the FDA statement, financially beleaguered KV lowered its price for Makena to $690 a dose -- bringing the total cost to about $14,490 for a woman who needs 21 doses. For some Medicaid programs, that was still too much.

‘Out of Reach’

“Even at this price, it remains out of reach for state Medicaid programs and the women they cover,” Louisiana Medicaid leaders wrote in a letter to health care providers in April 2011. By covering the pharmacy-made version, they could ensure that more women would receive the treatment, reducing the number of pre-term births in the state. Health officials estimated that a premature baby cost the state Medicaid program $33,433 in the first year of life, versus $3,671 for a full-term infant.

Louisiana still requires doctors to get special approval to prescribe Makena.

Similarly, Texas doctors must show there is no pharmacy able to make or deliver the drug to their offices to get coverage. That policy is now under review, a spokeswoman said.

Before Kentucky doctors may use Makena, Medicaid requires them to show that a woman has had a bad reaction to the compounded version – or had previously tried it and delivered prematurely.

Doctors in Wisconsin must explain why a woman might have trouble with a compounded drug, while doctors in South Carolina must show medical necessity for the branded drug.

“Some of these policies are a little more subtle than others,” said Scott E. Goedeke, a senior vice president with Ther-Rx, KV’s marketing subsidiary. “But they have similar effects: Physicians who want to prescribe the FDA-approved Makena learn from experience that process is so difficult or prohibitive they may stop trying.”

Blaming those policies for its financial troubles – along with what it describes as the FDA’s failure to enforce its market exclusivity for Makena – KV has filed lawsuits against Illinois, South Carolina and Georgia, alleging that the rules expose Medicaid patients to “unapproved compounded versions … of uncertain quality.”

The company won a preliminary injunction against Georgia to keep it from enforcing the coverage rules. In August it filed for Chapter 11 bankruptcy protection, a month before its lawsuit against the FDA was dismissed.

Cheaper Versions Favored By Private Insurers

Insurers covering the private market, meanwhile, have a range of rules around the use of Makena. UnitedHealthcare, one of the nation’s largest insurers, says in a policy document that it “continues to support the use of compounded, preservative-free” versions of the drug through “local and national… pharmacies.” However, it also reimburses doctors who choose to prescribe Makena.

Cigna covers Makena, as well as the compounded drugs, according to an April 2012 policy document.

Still, some physicians may feel pressure to prescribe the cheaper versions even when the insurer says it will pay for the brand name drug.

“Most insurance companies say they cover Makena, but they also send letters advising us that in trying to keep down the cost of health care, we are strongly encouraged to use the cheaper alternative, which is the compounded drug,” said Michael Randell, an obstetrician/gynecologist in Atlanta. “Sometimes we can feel forced to comply with wishes of insurance companies, or they might retaliate and take us off their plan.”

Because Makena contains the same active ingredient, hydroxyprogesterone caproate, as the pharmacy-made drugs, there is little debate over whether the drugs are similarly effective – assuming the compounded version contains active ingredients that are mixed at the correct potency and under sterile conditions.

But as the investigation of NECC demonstrates, potency and purity problems have arisen with pharmacy-made drugs. Oversight of pharmacies is inconsistent at best.

A report this week by Massachusetts Rep. Edward Markey, a Democrat, described the unsanitary conditions there as “just the tip of an industry iceberg that has long needed reform and federal oversight.”

Last week, KV filed a complaint with the U.S. International Trade Commission alleging that the New England center and other pharmacies use active ingredients imported from Chinese factories that are not routinely inspected by the FDA.

Patient advocate Amy Allina at the National Women's Health Network in Washington D.C. puts the blame on KV for overpricing Makena, but believes pharmacies making compounded medications need more oversight.

Noting that regulations follow “tragedies where people die,” she predicted the meningitis fatalities “could be the turning point for compounding pharmacies.”

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

Related: 

• 354 cases in fungal meningitis outbreak; 25 dead
• Florida suspends compounding pharmacy operations
• State officials close another pharmacy since fungal meningitis outbreak

Expert government advisers want every pregnant woman to get a whooping cough vaccination.

It's only the second time a vaccine has been recommended during pregnancy. Flu shots are also recommended for pregnant women.

The aim of the whooping cough shot is to protect newborns, who are too young to get the vaccine.

The panel's vote was a reaction to the resurgence in whooping cough. The nation is on track to have the worst year for whooping cough since the 1950s. There have been more than 32,000 cases, including 16 deaths, this year.

The Advisory Committee on Immunization Practices approved the recommendation Wednesday. Federal health officials usually adopt the panel's advice and send it to on to doctors and the public.

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