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Entries in Premature Birth (17)

Thursday
Apr072011

Progesterone Gel Reduces Rate of Premature Birth By 45 Percent

Photodisc/Thinkstock(WASHINGTON) -- The medical community was sent into an uproar recently when KV Pharmaceuticals jacked up the price of 17P, one of the only drugs currently approved to treat preterm birth.  But hope for a new, affordable alternative treatment for certain women at risk of preterm delivery may be on the horizon thanks to new research from the National Institutes of Health.

Unlike 17P, which delivers synthetic progesterone by injection, the drug in question is a naturally-derived progesterone gel applied vaginally.  According to results published Wednesday by the NIH, the gel reduced the rate of preterm birth by 45 percent in women identified as having a short cervix, one of many risk factors for premature delivery.

One of the hardest parts of predicting and treating preterm birth is that early delivery can occur for a number of reasons, and each may require different treatment approaches, says lead author on the study, Dr. Roberto Romero, program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch.

One risk factor is having had a preemie baby already -- the risk factor that makes a woman eligible for 17P.  The problem is, about 60 percent of preterm babies come from a mother who does not have a history of preterm birth, so "the question becomes, how else can we assess risk?" says Romero.

This is where testing for a short cervix comes in.  Using a simple ultrasound, doctors can screen for a short cervix during pregnancy and identify a woman as at risk for preterm birth.  By daily applying the gel, which currently costs between $10 and $15 and is prescribed during in vitro fertilization, the rate of these preterm births before the 33rd week of pregnancy can be nearly cut in half.

Though this will only address a small portion of all the preterm births, Romero says that this study argues for universal screening of cervix length to prevent what he estimates will be thousands of premature births annually in the U.S. 

Copyright 2011 ABC News Radio

Friday
Apr012011

KV Pharma Cuts Price of Costly Premature Birth Prevention Drug

Paul Tearle/Thinkstock(BRIDGETON, Mo.) -- Bowing to heavy pressure from the medical community and the Food and Drug Administration, KV Pharmaceuticals slashed the cost of its expensive drug to prevent premature births, Makena, Friday by half.

KV cut the price of a dose of Makena, its branded version of a progesterone shot that previously sold for $20 a pop, from $1,500 per dose to $690. The company also announced an expanded financial assistance program for obtaining the drug.

But many advocates and organizations working on behalf of maternal health -- such as the March of Dimes, the American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine -- say this pricing Band-Aid won't cut it.

The March of Dimes, which has had a corporate relationship with KV for years, announced it would sever all ties with the pharmaceutical company over the Makena ordeal.

"The company's handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent," the organization said in a press release.

But a recent move by the FDA could open a low-cost way to obtain the progesterone shot.

Under FDA exclusivity rules, production of the cheaper version of the drug by specialty compounding pharmacies would ordinarily have to cease. Following the public outcry over KV's pricing, however, the FDA announced Wednesday that it had no intention of enforcing its own rules, reopening the doors for women to continue to obtain an affordable version of the drug, known clinically as 17P.

KV had sent cease-and-desist letters to compounding pharmacies regarding 17P in error, the FDA said Wednesday, saying it would only step in to halt production when the safety of the product was in question.

The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and he pharmaceutical company has backpedaled on its pricing.

Even if doctors continue to use compounding pharmacies to get 17-P for their patients, Medicaid and health insurance providers will have to contend with the high price of Makena, leaving maternity care experts asking about patients' access to this important drug, said Dr. M. Kathryn Menard, director of the Center for Maternal and Infant Health at the University of North Carolina School of Medicine.

Several letters were sent to the company in past weeks by leading maternity advocates and public officials, voicing concerns that the price would prevent many women in need from receiving the drug and put a heavy burden on the health care system as a whole, especially Medicaid.

"KV wanted to listen to our concerns. They apologized sincerely for the way this was handled, said they were working with incomplete information. Basically, they're going to take all that listening and go back to the board and make a decision," Menard reported from a meeting with KV.

Copyright 2011 ABC News Radio

Tuesday
Mar222011

Texas Proposal Looks to Curb Elective Deliveries Before 39 Weeks

Photodisc/Thinkstock(AUSTIN, Texas) -- Texas health officials estimate they could save $36.5 million in Medicaid costs by curbing convenient, but risky, baby deliveries before the 39th week of pregnancy, while reining in use of expensive neonatal intensive care units.

For a variety of reasons -- some as mundane as moms-to-be wanting to guarantee that their obstetricians won't be on vacation when they go into labor, or that Grandma will be able to plan her trip to help out in the nursery -- some obstetricians agree to early deliveries, either by Caesarean section or induced labor.

However, early elective childbirth can subject newborns to many of the stresses of prematurity, which studies have shown can include blindness, underdeveloped lungs and long-term emotional, intellectual, developmental and behavioral issues.

These can include attention deficit disorder, said Dr. Frank Mazza, chief patient safety officer for the Austin-based Seton Family of Hospitals.

A half dozen Seton hospitals helped pioneer a highly successful program that drastically reduced NICU use by following American Congress of Obstetricians and Gynecologists guidance to stop performing elective deliveries before 39 weeks.  The program had no effect on medically necessary early deliveries.

By strictly adhering to that cutoff, Seton hospitals reduced NICU costs associated with prematurity and traumatic delivery from $4.5 million a year to "somewhere in the neighborhood of $186,000 a year," Mazza said in an interview Monday.  The hospitals have consistently posted NICU savings for the last seven years, he added.

That test program, which also led to more healthy births, provided much of the impetus for the cost-saving proposal put forth last month by the Texas Health and Human Services Commission.  That measure seeks to reduce early elective deliveries and more closely scrutinize which babies are admitted to NICUs.

"We just really want to put an extra check and balance in place, and have doctors or hospitals call in and verify why that baby needs NICU treatment before they put them in," said Stephanie Goodman, a spokeswoman for HHSC in Austin, which administers the Medicaid program in Texas.

"We feel like that extra step may just help make sure that the babies in NICUs really need that level of care, and that any other baby that could be better-served or as well-served in just the regular nursery, would."

While it's unclear how many cash-strapped states might follow suit and try to find similar savings in the delivery room and NICUs, any such actions could cut deeply into hospital revenues. 

Copyright 2011 ABC News Radio

Friday
Mar112011

Price of Preventing Premature Births Skyrockets

Comstock/Thinkstock(NEW YORK) -- Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.

Though KV Pharmaceuticals plans to offer financial assistance to low-come households in need of the drug, how private health insurance companies and Medicaid will respond to this price spike remains to be seen, leaving many doctors fearing that access to this treatment will become severely limited or interrupted for those currently mid-treatment.

And because FDA laws prohibit compounding pharmacies from making FDA-approved products, doctors will be legally obligated to stop using the cheaper version of this drug, a representative for the company told ABC News.

KV Pharmaceutical's response to the price controversy has been to announce a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, drugmakers KV Pharmaceuticals and partner company Ther-Rx, write: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually who "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

Dr. Alan Fleischman, medical director of the March of Dimes, which supported the FDA approval, says that the company has promised to make Makena available to all, regardless of ability to pay and the March of Dimes "stands ready to watch that process and hold them to their promise."

Copyright 2011 ABC News Radio 

Wednesday
Jan262011

Up to 40 Percent of US Births Induced Early

Photo Courtesy - Getty Images(WARRINGTON, UK) – A new report suggests that an alarming number of births in the U.S. are induced early without a good medical reason, according to HealthDay News.

Leapfrog, a hospital quality watchdog group, said Wednesday that a hospital-by-hospital report revealed that as much as 40 percent of births are induced early, but that the figure varied greatly by hospital. 

"This is the first real evidence that the practice of scheduling newborn deliveries without medical reasons is common and varies among hospitals," said Leah Binder, CEO of Leapfrog. "The information is extremely disturbing," she continued. "We are calling on hospitals to put policies in place to prevent early elective deliveries."

The group pointed to consequences of early deliveries and the importance of the final weeks of a pregnancy in a child’s development as reasons to decrease the number of babies being induced early. 

Copyright 2011 ABC News Radio

Wednesday
Nov242010

Mom Fights Cervical Cancer and Accusation That She Killed Her Daughter

Photo Courtesy -- WTVD(APEX, NC) -- A woman who served a year in prison after pleading guilty to killing her frail infant has angered police by now denying she is guilty, and claiming she only pleaded guilty to involuntary manslaughter so she could get out of jail and treat her cervical cancer.

The statements, by 24-year-old Nicole Richards, have prompted police in Apex, N.C., to speak out.

"I am just shocked by her at this point, after having pled guilty to involuntary manslaughter, to reach out to this lengths to try to make the point that she didn't do anything inappropriate," said Apex Police Chief Jack Lewis.

"It appears to me she has desires of being seen as a victim," said Lewis. "She is not a victim."

"The victim is Autumn, who was 100 percent dependent on others to care for her," the chief said. "And the standard that you would expect somebody to meet with a child who has health issues is far higher than what took place."

Autumn was born last year two months premature. She had health problems throughout her short life, including a heart condition and hyperthyroidism.

Richards was convicted of involuntary manslaughter in 2009 after authorities said she put Autumn to sleep face down, despite knowing the potential risk that could cause to her breathing.

Copyright 2010 ABC News Radio

Tuesday
Nov092010

Early Education Can Help Prevent Preterm Birth

Photo Courtesy of Getty Images(WHITE PLAINS, N.Y.) – Women who are pregnant should discuss their risk of preterm birth by the 12th week of pregnancy, according to a commentary published in the November issue of Ob. Gyn. News.

The commentary stemmed from a study by the March of Dimes and BabyCenter that found that more than two-thirds of new or expectant mothers had not discussed the risks and consequences of preterm birth with their healthcare provider.

Preterm birth, or birth before 37 weeks of pregnancy, is the leading cause of newborn death. It can also lead to serious health challenges such as learning disabilities and cerebral palsy.

The commentary suggested that early detection can help prevent premature birth.

Copyright 2010 ABC News Radio

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