plus 4, FDA, Health Plans Begin Study of Drug Effects in Pregnancy - MedPage Today

FDA, Health Plans Begin Study of Drug Effects in Pregnancy - MedPage Today
Bristol Palin, Levi Johnston in heated custody battle over son - Pioneer Press
FDA To Study Safety Of Drugs Taken During Pregnancy - Post Chronicle
War zone pregnancy punishments being dropped - YAHOO!
Shaheen: End war pregnancy policy - Concord Monitor

FDA, Health Plans Begin Study of Drug Effects in Pregnancy - MedPage Today

Posted: 31 Dec 2009 07:36 AM PST

A massive new database-driven study of effects of prescription drugs during pregnancy, called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), is getting under way under FDA sponsorship, the agency announced.

The FDA will collaborate with the HMO Research Network's Center for Education and Research in Therapeutics, based at Harvard Medical School in Boston and Vanderbilt University in Nashville, to collate data from 11 health plan-affiliated research sites.

About half of these sites are part of the Kaiser Permanente system. Others include the research arms of the Harvard Pilgrim and Fallon Community health plans in Massachusetts, the Lovelace Clinic Foundation in New Mexico, the Group Health Research Institute of Seattle, the HealthPartners system in Minnesota, and the Tennessee Medicaid program.

Collectively, these sites have access to data on about 1 million births from 2001 to 2007, according to the FDA.

In a statement, the FDA said about two-thirds of pregnant women take at least one prescription drug, citing a study in the American Journal of Obstetrics and Gynecology.

For ethical reasons, clinical drug trials hardly ever enroll pregnant women. That leaves retrospective and observational studies such as those to be undertaken under the MEPREP as the next best option, according to the FDA.

"Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network," the agency said in a news release.

Lead researchers on the project include Susan Andrade, ScD, of the HMO Research Network; William Cooper, MD, MPH, at Vanderbilt; and Robert Davis, MD, MPH, Craig Cheetham, PharmD, and De-Kun Li, MD, PhD, all of the Kaiser system.

These researchers have already collaborated on studies of medication use during pregnancy and birth outcomes, according to the FDA.

A steering committee to oversee the MEPREP will be chaired by Pamela E. Scott, PhD, an FDA epidemiologist.

The HMO Research Network is a consortium of 15 health plans, most of which are participating in the program. It receives funding from the Agency for Healthcare Research and Quality.

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Bristol Palin, Levi Johnston in heated custody battle over son - Pioneer Press

Posted: 28 Dec 2009 07:14 PM PST

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ANCHORAGE, Alaska — A judge's ruling has revealed a heated legal custody battle between Sarah Palin's daughter and the father of her grandson.

Bristol Palin's request to keep the proceedings closed was denied last week by a Superior Court judge. A temporary order had authorized the use of pseudonyms while the court was considering the request, which stated that no good "could result to the child by an onslaught of media."

Levi Johnston, the father of 1-year-old Tripp, has pushed for open court proceedings, saying he "just wants a simple case on the merits."

"I do not feel protected against Sarah Palin in a closed proceeding," Johnston said in an affidavit. "I hope that if it is open she will stay out of it. Bristol's attorney is her attorney."

Bristol Palin's petition for sole custody and child support, filed in early November, also seeks a visitation schedule for Johnston. Bristol says her ex-fiance has exercised "sporadic visitation rights."

Relations between the Palins and Johnston and his family have frequently been strained since the couple broke off their engagement after their son was born in late December 2008.

Johnston denies in court documents that he has avoided his responsibilities. He is seeking shared custody.

Bristol Palin is the eldest daughter of Sarah Palin, who resigned as Alaska governor in July.

Sarah Palin announced her daughter's pregnancy days after being named the running mate of Republican presidential candidate

John McCain.

Bristol Palin's custody petition calls Johnston's recent nude photo shoot with Playgirl magazine "risque."

The document also notes that Levi's mother, Sherry Johnston, should not be allowed unsupervised visits with the baby following her drug arrest. Sherry Johnston, who is serving out most of her three-year sentence under home confinement, was sentenced last month on a guilty plea to one count of possession with intent to deliver the painkiller OxyContin.

Palin's custody

petition also suggested Levi Johnston may have his own issues with substance abuse, saying he made statements about seeking "weed" on Twitter.

Johnston denies making such a statement, saying the Twitter account "is a fraud" and that he doesn't have an account on the popular online social networking site.

In a motion opposing closed proceedings, Levi Johnston's attorney, Rex Butler, argued that Bristol Palin had not shown what sort of evidence could stigmatize the child.

"This case presents a custody case with similar facts that attend open cases every day in the Alaska court system," Butler wrote.

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FDA To Study Safety Of Drugs Taken During Pregnancy - Post Chronicle

Posted: 31 Dec 2009 01:24 AM PST

U.S. health officials plan to study the safety of medications taken during pregnancy with an eye toward using the data in future regulations and medical practice, the U.S. Food and Drug Administration said on Wednesday.

Citing a lack of clinical trials to determine how medications affect mothers and unborn children, the FDA said it will collaborate with other researchers in the new study, called the Medication Exposure in Pregnancy Risk Evaluation Program.

The agency said data shows that about two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy.

"Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy," Gerald Dal Pan, a director at the FDA's Center for Drug Evaluation and Research, said in a statement.

The program will work off of data from 11 health plan-affiliated research sites that have healthcare information for about 1 million births over a seven-year period started in 2001.

The FDA did not give a timeline for when the program will complete the safety study.

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War zone pregnancy punishments being dropped - YAHOO!

Posted: 24 Dec 2009 05:02 PM PST

JERRY buzzed up: Rush Limbaugh felt pains similar to heart attack (AP)

59 seconds ago 2009-12-31T23:01:03-08:00

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Shaheen: End war pregnancy policy - Concord Monitor

Posted: 31 Dec 2009 08:58 PM PST

What should the military do to deployed soldiers who become pregnant?

Maj. Gen. Anthony Cucolo, the commander of an Army division in Iraq, recently made headlines when he demanded soldiers serving under him not become pregnant while serving in a war zone under the threat of court-martial.

In a letter to Army Secretary John McHugh, New Hampshire Sen. Jeanne Shaheen, a Democrat, asked that the policy be rescinded.

"We believe the threat of criminal sanctions in the case of pregnancy goes far beyond what is needed to maintain good order and discipline," she wrote in the Dec. 22 letter, also signed by Sens. Barbara Boxer of California, Kirsten Gillibrand of New York and Barbara Mikulski of Maryland, all Democrats.

The senators wrote that the policy could encourage female soldiers to harm themselves by delaying getting medical care. It would also undermine the ability of married couples to both serve, they said.

"We can think of no greater deterrent to women contemplating a military career than the image of a pregnant woman being severely punished simply for conceiving a child," the senators wrote. "This defies comprehension."

Cucolo, who commands 22,000 soldiers including 1,682 women, has since said he would not seek to court-martial women who become pregnant. But he told reporters that a policy remains in place to encourage women to think carefully before leaving their unit shorthanded, according to news accounts. Women who get pregnant are automatically redeployed out of a combat zone and could face reprimands. Cucolo's policy would also punish a man who gets a woman pregnant.

The policy has outraged women's groups, even as it has gained the support of some in the military. Kary Jencks, public affairs director for New Hampshire Planned Parenthood, called the policy "bizarre."

"I think it's unfortunate that once again the natural capacity that a woman's body has is disciplined," Jencks said. "It's always viewed as a handicap, not a normal aspect of being a woman."

Rather than disciplining women for getting pregnant, Jencks said the military should focus on having family planning options available to avoid unintended pregnancies. If a woman does get pregnant, Jencks said, the military should realize that "it's a fact of life." She said the military should be happy that a couple are bringing new life into the world rather than viewing it as a handicap.

Jencks added that the argument that a woman would get pregnant just to get out of serving is not a strong one.

"That's a pretty serious life-changing decision to make just to get yourself out of a tour of duty," she said. "Once again, women are being blamed, and not allowed to be supported, in their reproductive choices."

Pilar Olivo, interim executive director of NARAL Pro Choice New Hampshire, said women in the military face a Catch 22. They don't have access to emergency contraception or abortions. That means if they are assaulted or become pregnant by mistake, they have no option but to carry the baby and leave active duty.

"If they have a contraceptive failure, they don't have any options to deal with their pregnancy," she said. "They're in a terrible bind." (Olivo is the wife of Monitor Publisher Geordie Wilson.)

But some in the military say restrictions on getting pregnant in a war zone are necessary.

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