Oh Yeah

I've been guest-blogging over at Nashville is Talking for the holiday weekend, preceded by mid-term projects for the grad program, which is my excuse for my extended lack of posts. Will be back soon!

FDA has Named a New Director for its Office of Women's Health

Kathleen Uhl, M.D., FAAFP, has been appointed as the new director of the FDA's Office of Women's Health. The previous director, Dr. Susan Wood, resigned in August in response to the FDA's handling of the Plan B decision. An interview with Wood appears in the current Nerve magazine.

According to the FDA's press release, Uhl is board certified in Family Medicine, first joined the FDA in 1998, most recently as Supervisory Medical Officer in CDER's Pregnancy and Lactation Labeling Team in the Office of New Drugs, and will take on the role in mid-December.
Technorati Tags: FDA
MeSH Tags: United States Food and Drug Administration

GAO issues report on FDA's Plan B Actions

The Government Accountability Office issued a report today titled, "Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual." That is the most humorous title I've ever seen on a government report. Aside from that, the report describes the GAO's findings after the Office was asked to examine "1) how the decision was made to not approve the switch of Plan B from prescription to OTC, 2) how the Plan B decision compares to other proposed prescription-to-OTC switches from 1994 through 2004, and 3) whether there are age-related marketing restrictions for prescription Plan B and other prescritpion and OTC contraceptives." Questions about the process were raised because "the not-approvable decision for the Plan B OTC switch application was contrary to the recommendations of FDA's joint and advisory committe and FDA review staff." The GAO reviewed the FDA's actions prior to the 5/6/04 non-approvable letter for the initial application. The full text of the report is available here as a PDF.

I haven't had time to read all 62(!) pages of the report, but here are a few direct excerpts from the "What GAO Found" section:

The Plan B decision was not typical of the other 67 proposed prescription-to-OTC switch decisions made by FDA from 1994 through 2004

The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval

The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter

Further, there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them

FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application

GAO found that high-level management’s involvement for the Plan B decision was unusual for an OTC switch application and FDA officials gave GAO conflicting accounts about when they believed the decision was made

The Acting Director acknowledged to GAO that considering adolescents’ cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application, and other FDA officials told GAO that the rationale differed from FDA’s traditional practices.

Technorati Tags: emergency contraception; FDA; politics; Plan B; women's rights
MeSH Tags: Contraception, Postcoital; Levonorgestrel; Health Policy: Politics; Women's Health

Feminism is Good for Your Health

Remember the old bumper sticker, "If you're not [angry], you're not paying attention?" Looks like it's time for a new one reading, "If you're not angry, you're hurting your health." A small study published in the November issue of the journal Biological Psychiatry compared "Ninety-two healthy adults engaged in stress-challenge tasks, during which cardiovascular responses, hypothalamic-pituitary-adrenocortical (HPA) axis responses (i.e., cortisol), emotional expressions (i.e., facial muscle movements), and subjective emotional experience (self-reported) were assessed." The authors concluded that "Analyses of facial expressions revealed that the more fear individuals displayed in response to the stressors, the higher their cardiovascular and cortisol responses to stress. By contrast, the more anger and disgust (indignation) individuals displayed in response to the same stressors, the lower their cortisol levels and cardiovascular responses." The abstract of the study is available for free here, and a summary provided by womenshealth.gov is available here.

Okay, the title of this post was a bit of a joke, but I got a chuckle out of it. :)
Technorati Tags: heart disease; stress
MeSH Tags: Anger; Fear; Heart Diseases; Stress, Psychological

Ortho Evra Warnings Issued

CNN has a story today, Warning issued about birth control patch. There is concern about increased risk of blood clots in women using the patch compared to those on the pill. The FDA also issued a press release and a set of questions and answers about the patch. According to the FDA materials, "A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill." The FDA has released a new label for the product, which is available here as a PDF.
Technorati Tags: birth control; contraception
MeSH Tags: norelgestromin

The Last Abortion Clinic

NPT aired the Frontline special, The Last Abortion Clinic, tonight, including interviews with health professionals and activists on both sides of the abortion debate. The program discussed current abortion politics and issues in general, but also provided coverage focused on the only remaining abortion clinic in Mississippi. The website for the program provides general information on the abortion issue in America, a discussion of young womens' attitudes, a map detailing each states' abortion regulations, and the text of extended interviews with those featured in the program. A synopsis of the issues covered in the show is available, and it will be available for viewing online after 5pm on Wednesday.
Technorati Tags: abortion; PBS; reproductive rights
MeSH Tags: Abortion, Induced

Sexual Activity Among Tennessee's Teenage Girls

The Nashville City Paper today published an article entitled, "Teen Sex Activity Rate Jumps." The article actually focuses specificially on teenage girls, as the information comes from preliminary data presented at a recent conference on pregnancy and infant health. Among the findings, comparing girls in grades 9-12 in 2004 compared to 2003 (quoted directly from the article):

"Sex in the last three months rose from 36 percent in 2003 to 41 percent in 2004;

Sex with more than four people rose from 12 percent to 15 percent;

Experienced date violence rose from 9 percent to 11 percent;

Been forced to have sex rose from 13 percent to 15 percent; and

Had sex under the age of 13 rose from 4 percent in 2003 to 13 percent in 2004

Condom use decreased from 48 percent in the last survey to 30 percent in 2004"

Many readers may focus on the opening statement of the article: "Sexual activity among female teenagers grades 9-12 in Tennessee has jumped from 47 percent in 2003 to 55 percent in 2004. About 13 percent of girls under the age of 13 have been sexually active." Josh Tinley astutely points out that the article does not explain how "sexual activity" is defined for the purposes of this study. This document (PDF) from the CDC, the administrator of the Youth Risk Behavior Survey from which the data is gathered, provides the text of the 2005 questions. A reading of the survey reveals that sexual activity is described as "sexual intercourse," although a definition of that term is not provided for the survey participants.

The results are certainly a cause for concern, if only because they seem to indicate that teen girls are having sex more, but using condoms less frequently. I am also troubled by the increase in "date violence" and girls having been forced to have sex. According to the Census Bureau's 2003 American Community Survey, there were 107,755 girls aged 15-17 enrolled in school in 2003. As a proxy for the number of TN girls in grades 9-12 in 2004, it's not perfect, because the age groups don't match up exactly and the population has likely changed. However, if you take 15% of that conservative 2003 figure, that's 16,163 girls who reported having been forced to have sex and 11,853 who reported date violence. In light of these findings, here is a list of sexual assault programs in Tennessee.

The complete national report is expected in spring of 2006; the survey also addresses issues such as weapons, seat belt use, drugs and alcohol, and smoking.

Technorati Tags: abuse; public health; rape; sex; Tennessee
MeSH Tags: Adolescent Behavior; Risk-Taking; Sexual Behavior/statistics and numerical data