Is there a Plan b for Plan B?

Plan B One-Step is a single-dose emergency contraceptive pill that contains higher levels of levonorgestrel, a hormone found in some birth control pills, and has been available in the U.S. since 2009. Its effectiveness is linked with timeliness of use: the drug should be taken within 72 hours of intercourse. The Food and Drug Administration (FDA), after reviewing the scientific evidence on its safety and effectiveness, recommended that it be available–without prescription–to females of any age.

On December 7, 2011, Secretary of Health and Human Services (HHS) Kathleen Sebelius overruled this FDA recommendation. While the Secretary of HHS has the authority to override the FDA, The New York Times reported that this issue was the first time a HHS secretary has publicly overruled the FDA. Secretary Sebelius’ action limits an attempt by the FDA to improve the accessibility of Plan B One-Step among young girls, but it does not affect the legality of the drug. Plan B One-Step remains available, without a prescription, to women who are 17-years old and older; and it is still approved for use, with a prescription, for females who are younger than 17.

Sebelius argued that there should be no change in the current law requiring females younger than 17 to obtain a prescription for Plan B One-Step because they require health-care provider guidance to use the pill properly and safely (to see Sebelius’ counterstatement to the FDA’s recommendation, click: http://www.hhs.gov/news/press/2011pres/12/20111207a.html). However, as FDA Commissioner Dr. Margaret Hamburg stated, “Based on the information submitted to the agency, [the FDA’s] CDER [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” Further, young girls are able purchase a variety of over-the-counter medications and personal products that could be harmful in large doses, such as Tylenol, with no ill effects. President Barack Obama had the opportunity to overrule Sebelius’ decision, but instead agreed with her, noting that he felt uncomfortable, as a father, with the FDA’s decision.

What’s at play here?  What’s going on in this dance between science and good health policy? Did upcoming presidential race play a role here? Are there additional moral or ethical considerations about the proper age for emergency contraception? What’s going on?

How much should, or do,  data really matter in creating health policy? How we talk about – frame – this and other politically charged health issues matters. Consider the language used in various news sources covering the issue. The emotionally charged responses to this specific drug from both evidence-based and ethical-based sides merge to create a unique and complicated discussion. As we launch into an election year, how can we expand the conversation on the topic with our peers and colleagues to further consider the multiple dimensions influencing the availability and accessibility of Plan B for women of all ages across the U.S.?

December 13, 2011 Coverage Update:  14 U.S. Senators, including Minnesota’s Al Franken, have called for further explanation of Sebelius’ decision made on December 7, 2011. The letter–defending the importance of using science to create policy—asks Sebelius for “specific rationale and scientific data” behind limiting Plan B’s accessibility. To see the letter and co-signers, visit: http://murray.senate.gov/public/index.cfm/newsreleases?ContentRecord_id=77e3d54b-bb6b-4c7c-9f05-bfe8c8d3b304. Sebelius has not yet released a response.

Controversy over Co-Sleeping: A PubH Campaign

A controversial public health campaign coming from Milwaukee targets infant and caregiver bed sharing. 20% of Milwaukee’s infant mortality rate is attributed to Sudden Infant Death Syndrome (SIDS) and Sudden Unexplained Death in Infancy (SUDI); it is the 7th worst in the country, with also large disparity rates (Black infant mortality rates are almost 3 times higher than whites in the city). 51% of these cases have been found to be related to bed sharing.

Outrage over the advertisements from mothers and other citizens include criticism over the provocative ad and Mayor Tom Barrett’s approval of its running. However, bringing attention to the issue was the campaign’s main objective; national news sources have started discussions even outside the Midwest.

The American Academy of Pediatrics recommends that babies be brought back to their own crib to sleep after feeding and/or comfort and advises against caregivers using in-bed co-sleepers. No studies have found bed-sharing protective of SIDS. Their policy report opposes bed-share especially if a parent is a smoker, overly tired, uses substances, if the infant is under 3 months of age, if the bed is soft/old, or if other children share the bed. However, there are also some conflicting messages; as public health campaigns increasingly encourage breastfeeding more parents are sleeping with their child. In order to prevent SIDS and other health risks to the infant, being sure to breastfeed in other areas or putting the baby back in the crib is necessary.

Coming from an MCH background, what are your thoughts on the advertisement? Too controversial? Too demanding? Just right? Leave some thoughts below. For more information on Infant Mortality Rates, see the Maternal and Child Health Bureau’s annual Child Health USA 2011 dataset: http://mchb.hrsa.gov/chusa11/city/pages/502im.html.

New Research on Birth Spacing and Child Maltreatment

In connection to yesterday’s blog for increased visibility of child abuse in the U.S., newly published research in the Maternal and Child Health Journal assessing the relationship between birth spacing and child maltreatment may broaden our understanding of how to combat the problem.

Rationale: An objective of Health People 2020 states that births should be spaced greater than 18 months (Objective FP-5), based on evidence of improved maternal social and infant health outcomes in increased lengths between births.

Methodology: Using a home visiting Healthy Start program, eligible participants were recruited via a family stress checklist to see if they were at-risk for child maltreatment. Researchers focused on the index child of a rapid repeat birth (RRB)—“the child born immediately prior to a subsequent child in a birth interval.” A baseline interview was conducted within a month of delivery and follow-up collected at age 2 and 7.  RRB was defined as a child born within 24 months of an index child for mothers age 20 and older, and as subsequent birth before age 20 for females age 19 and under.

Variables:

• Parental stress tactics—adjustment problems, child abuse (physical), neglect
• Child Protective Service (CPS) reports
• Child behavior—adaptive behavior and social skills
• Child development—memory, verbal, abstract and quantitative reasoning

Results: RRB did not influence parenting behaviors, including stress and child physical abuse. However, there was an association between RRB and parental neglect. In addition, women with a RRB were more likely to have a substantiated CPS report in their name (after controlling, there was a relative risk of 1.8 compared to women without a RRB).

In addition, index children who had mothers with a RRB had poorer behavioral outcomes and poorer developmental outcomes compared to families without a RRB.

Implications for MCH professionals: These associations can be used to help educate health departments for interventions on increasing birth spacing. Findings are consistent with other research that has reported birth spacing associated with neglectful rather than abusive parenting. Targeting subgroups of children, including index or subsequent children, and mothers who are at risk or show neglectful behavior, may be necessary.

Shea Crowne, S., Gonsalves, K., Burrell, L., McFarlane, E., & Duggan, A. (2011). Relationship Between Birth Spacing, Child Maltreatment,and Child Behavior and Development Outcomes Among At-Risk Families. Maternal and Child Health Journal.