Sunday, November 27, 2005

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!

Monday, November 21, 2005

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.
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MeSH Tags: United States Food and Drug Administration

Monday, November 14, 2005

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.

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    MeSH Tags: Contraception, Postcoital; Levonorgestrel; Health Policy: Politics; Women's Health
  • Saturday, November 12, 2005

    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. :)
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    MeSH Tags: Anger; Fear; Heart Diseases; Stress, Psychological

    Friday, November 11, 2005

    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.
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    MeSH Tags: norelgestromin

    Tuesday, November 08, 2005

    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.
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    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.

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    MeSH Tags: Adolescent Behavior; Risk-Taking; Sexual Behavior/statistics and numerical data
  • Saturday, November 05, 2005

    Vinnie Helps Chart Your Period

    Odd book alert: I stumbled across Vinnie's Giant Roller Coaster Period Chart & Journal Sticker Book today. The book description on Amazon says, "The curse, the crimson tide, Aunt Flo-no matter what you call it, menstruation is often a taboo subject. Then along came Vinnie, who’s made it his mission in life to demystify periods for women (and men!) the world over." If I were still in the dark about menstruation, I'm not sure I'd want a male, unibrowed, mechanic named "Vinnie" explaining it to me. It just seems rather strange, but I feel oddly compelled to get my hands on a copy. You really have to view the cover image to appreciate the true and intriguing weirdness of the illustrations. Check out the customer reviews on Amazon, which are split between thinking the book is cool and useful, and thinking it's weird and creepy. The author, an art school attendee, apparently came up with the idea for his tampon cases and the books after his friends complained that their tampons were getting crushed in their backpacks. To which I say, check out the bevy of menstrual product alternatives, or make better use those little zip front/side pockets, ladies.
    Technorati Tags: alternative menstrual products; ; ;
    MeSH Tags: Books, Illustrated; Menstrual Cycle

    Update on Emergency Contraception Bill in House

    The bill number for the proposed legislation to either get the FDA to act on OTC status for Plan B, or, failing that, to go ahead and make it available over the counter, is HR 4229. You can read the official full text of the bill, keep up with Congressional actions on the legislation, and view the list of Representatives co-sponsoring the bill (none from TN), courtesy of the always useful THOMAS site.

    The most recent action on the bill was a referral to the House Committee on Energy and Commerce. Tennessee's Bart Gordon and Marsha Blackburn serve on this committee. To contact the Committee, fill out this form. To write to your Representative, select your state and enter your zip code on this House webpage; it will figure out who your Rep is and allow you to complete an online form with your feedback.

    Thanks to Chris, who gets to be honorary librarian-for-the-day for digging up the bill number.
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    MeSH Tags: Contraception, Postcoital; Levonorgestrel; Health Policy: Politics; Women's Health

    Friday, November 04, 2005

    Former President Clinton Establishes Breast Cancer Fund

    In collaboration with the National Breast Cancer Coalition, former President Clinton has helped establish the Virginia Clinton Kelley Fund. Clinton's mother died from breast cancer in 1994. According to the NBCC's website, the fund will "support NBCCF programs, which educate and train breast cancer survivors to influence research and public policy, foster innovation in research and health care, and expand access to quality care. This fund will also support collaborations among women with breast cancer, researchers and health care stakeholders." The Kaiser Network reports that the fund will also support "high-risk" research.

    Breast cancer resources:
  • Breast Cancer Home Page - National Cancer Institute
  • What You Need to Know About Breast Cancer - National Cancer Institute
  • Breast Cancer - MedlinePlus Medical Encyclopedia
  • MedlinePlus Breast Cancer
  • Detailed Guide: Breast Cancer - American Cancer Society
  • Breast Cancer Glossary - Cleveland Clinic Foundation
  • Y-ME National Breast Cancer Organization
  • Breast Cancer (neoplasms) Clinical Trials - ClinicalTrials.gov
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    MeSH Tags: Breast Neoplasms; Organizations, Nonprofit
  • House Bill to Make Emergency Contraception Available OTC

    Thursday, 4 members of Congress introduced legislation regarding making Plan B emergency contraception available over-the-counter. A summary with links to press coverage/releases is available from Kaiser's Daily Women's Health Policy. The legislation requires the FDA to make a decision on allowing OTC status within 30 days of enactment of the bill; if the FDA fails to do so, the drug would automatically obtain OTC status. The bill was introduced by Representatives Carolyn Maloney (D-NY), Christopher Shays (R-CT), Jay Inslee (D-WA) and Joe Crowley (D-NY), members of the Congressional Pro-Choice Caucus. Maloney's press release is available here, and the text of the proposed legislation is available here (PDF).

    Note: I haven't found this yet in the THOMAS legislative information website. When it's up, I'll post a link so you can follow the bill status.
    See update post for the bill's site (including actions and status) and info on finding and contacting your Representative.
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    MeSH Tags: Contraception, Postcoital; Levonorgestrel; Health Policy: Politics; Women's Health

    Daily Women's Health Policy Report

    I just discovered this gem from the Kaiser Family Foundation, the Daily Women's Health Policy Report. It provides updates on government activities and legislation that affect women's health. Look for a couple of policy-related posts shortly.
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    MeSH Tags: Health Policy: Politics; Women's Health

    Wednesday, November 02, 2005

    Fun with Infectious Diseases

    Your women's health blogger is home with a case of strep throat, and just awoke from a several-hour nap. Apparently only about 5-10% of sore throats are caused by bacteria (rather than viruses); this blogger suffered from enough of these infections as a child to recognize the red throat stripes and miraculously get a clinic appointment this morning. Seriously, I'd rather get 5 shots than a throat culture. Here's some information on the culprit, while the fever has subsided. Ugh.

  • MedlinePlus Medical Encyclopedia article - covers symptoms, treatment, complications (including scarlet and rheumatic fever, and kidney inflammation)
  • Overview from FamilyDoctor.org
  • Lengthier overview from MayoClinic.com

    In other infectious news, the CDC has posted the weekly flu map. Check it out periodically and watch how influenza spreads across the nation.
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    MeSH tags: Influenza; Pharyngitis; Streptococcal Infections