Saturday, April 30, 2005

Segregated Medical Care

As per our politicians, you might be a woman if you aren't Dr. Condoleezza Rice, First Lady Laura Bush, Senator Clinton, or one of the millions of reproductive age XX persons unable to become pregnant (e.g., 9.3 million who've ever used some kind of infertility service, over 3 million who've had a hysterectomy, etc.).

Unfortunately, just because the state of the lining of some of your internal organs makes you a woman, that isn't enough for you to receive proper medical care.

It appears* the politicians have also decided that, in order to receive appropriate medical care, those persons fortunate enough to qualify as women must pass one more hurdle.

If a woman is raped, just having an anatomically intact reproductive tract, and a functioning pituitary/ovarian/uterine axis is no longer enough to guarantee she will be treated according to the standard of care. No! Only women raped during the follicular phase of their monthly cycle are to be given adequate medical care:

The protocol of six Catholic hospitals run by Centura calls for rape victims to undergo an ovulation test.

If they have not ovulated, said Centura corporate spokeswoman Dana Berry, doctors tell the victims about emergency contraception and write prescriptions for it if the patient asks.

If, however, the urine test suggests that a rape victim has ovulated, Berry continued, doctors at Centura's Catholic hospitals are not to mention emergency contraception.

Hmm, any chance I might have something to say about this? Well, since you asked:

First, assuming [and this is a big assumption] optimal testing conditions, a urine ovulation test only tells you whether or not you have elevated hormone levels, and that is all. It offers no indication [if a viable egg will be released] about fertilization.

Second, when it comes to rape patients and emergency contraception (EC), what is the medical standard of care? Both the American College of Ob/Gyns**, and the American Medical Association*** recommend that physicians treating rape patients inform women about EC, and offer the patient EC.

Third, the available evidence indicates that the EC pill does not prevent implantation [the burrowing of a fertilized egg into the uterine lining]:

Recently, treatment with either 10 mg mifepristone or 1.5 mg of levonorgestrel [Plan B] has emerged as the most effective hormonal method for emergency contraception...

When summarized, available data from studies in humans indicate that the contraceptive effects of both levonorgestrel and mifepristone, when used in single low doses for emergency contraception, involve either blockade or delay of ovulation, due to either prevention or delay of the LH surge, rather than to inhibition of implantation.

Finally, here are some interesting results from a 2002 survey of 589 Catholic hospitals emergency rooms [scroll to bottom of page]:

  • 82% of those questioned in emergency rooms refused to administer emergency contraception- even to women who have been raped.

  • [W]here emergency contraception was not available, only 22% of emergency rooms at Catholic hospitals provided a useful referral.

  • There are currently 91 counties that have a Catholic hospital operating as a sole provider-a 20 percent increase over 1997. Ninety-five percent of these hospitals are in counties with a minority-Catholic population.

    If Catholic hospitals may ignore the standard of care, and treat patients based on religious doctrine, any and all hospitals should be able to do the same. This means we abolish the FDA, and any government regulation of hospitals and the practice of medicine, and allow anybody to set up and run a hospital according to whatever criteria they deem acceptable.

    Bottom line: It will be most interesting to see what happens when men in this country manage to finally achieve equality with women, and can look forward to hospitals where only, for example, men with a sperm density greater than or equal to 20 million per milliliter are to receive adequate medical care.

    [P.S. Despite writing a book about period control, I must admit it hadn't occurred to me that one emerging indication for suppressing the period is to increase your likelihood of receiving proper medical care.]

    *I have not personally verified the information in the article, so it's still possible that the article is a joke. [We can only hope.]

    **American College of Obstetricians and Gynecologists, 242 Educ. Bull. 3 (Nov. 1997).

    ***American Medical Association, Strategies for the Treatment and Prevention of Sexual Assault (1995).

    (via feministe)

  • Wednesday, April 27, 2005

    The Unwomen

    Our beloved politicians tell us what makes a woman a woman*:

    WOMAN- The term 'woman' means a female human being who is capable of becoming pregnant, whether or not she has reached the age of majority.

    *[If the link doesn't work for you, go here and enter SB 51.]

    Our moral pharmacists bestow onto us the gift of meds:

    The Pharmacist's Model Conscience Clause was adopted and approved by the PFLI [Pharmacists for Life International] Board of Directors in 1988. It was the first -- and remains the only -- one of its kind for the profession of pharmacy. It uniquely addresses the needs of pharmacists for recognition of their sincerely held religious, moral and ethical convictions which preclude the misuse of the gift of medications in manners contrary to the God-given dignity of the profession. Nothing less will do.

    And our pharmacy managers prescribe lying to [female] patients:

    Since Gov. Janet Napolitano has vetoed the "conscience bill" that would have allowed pharmacists to refuse to fill abortion and emergency-contraception prescriptions based on religious or moral views, I have a solution:

    The pharmacist should just tell the patient that he is out of the medication and can order it, but it will take a week to get here. The patient will be forced to go to another pharmacy because she has to take these medicines within 72 hours for them to be effective. Problem solved.

    Whatever would we do without these guiding lights?

    (via feministe, feministing, and Disenchanted Forest)

    Tuesday, April 26, 2005

    Grand Rounds

    Make sure to visit this week's Grand Rounds. Lots of interesting posts.

    Just Say No to "Healthism"

    Here's a politician with the right idea:

    Italy's new health minister said he wants more public smoking areas, sharply reduced under a new ban, and slammed what he called a trend towards obsessive health policies, in published comments.

    "There is a real threat that we are heading towards a therapeutic society ... a medical tyranny of doctors and a minister who are the only ones allowed to say what constitues 'good living'," said Francesco Storace in an interview with Corriere della Sera.

    N.B. Just so we're clear: smoking isn't good for you, but neither are nanny politicians.

    Friday, April 22, 2005

    Are You Spongeworthy?

    The FDA has just [re]approved the contraceptive sponge:

    The Food and Drug Administration on Friday approved U.S. sales of the sponge, which was a popular nonprescription birth control product among women when it was withdrawn from the market in 1995.

    The polyurethane sponges, which have been sold by manufacturer Allendale Pharmaceuticals in Canada and over the Internet since March 2003, will be available in the U.S. in two months through a company Web site and in four months at retail drug stores, followed by discount stores such as Wal-Mart Stores Inc.

    Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth Co. of Madison. Wyeth, then called American Home Products, had stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned.

    Great news, but you need to be fully informed before deciding if this is a suitable method for you.

    Here's the short version:

    There are three sponge brands available, Today, Protectaid, and Pharmatex. The first two brands contain the spermicide nonoxynol-9 (N-9). Today has the highest dosage of the two, at 1,000 mg.

    N-9 use has been linked to an increased risk of HIV (the AIDS virus) transmission. Depending on your unique needs, and risk/benefit analysis, using the sponge may be the best option for you. However, Today may not be the best brand for you.

    And here's the [considerably] longer version:

    The sponge is part of the barrier group of birth control methods. Other barrier methods are:

  • Condom (unisex, female, male)

  • Cervical cap [soon to disappear from the market]

  • Diaphragm (modified--Dumas, Vimule)

  • Ovès cap

  • FemCap

  • Lea's shield

    Barrier methods prevent fertilization (the union of the egg and sperm); they provide a mechanical barrier between sperm and egg. Most barrier methods are used together with a spermicide. Why? In order to increase the pregnancy protection effectiveness of the method.

    Some spermicides are also microbicidal--they kill microbes, like the ones that cause sexually transmitted infections, or STIs. This confers the added benefit of [partial] STI protection. [Only continuous abstinence provides complete protection. There are also promising spermicidal microbicides in development.] However, some spermicides can cause problems.

    In particular, [s]permicides containing nonoxynol-9 do not protect against HIV infection and may even increase the risk of HIV infection in women using these products frequently*

    *[Since a spermicide is a chemical substance, it can irritate the lining of the vagina/cause lesions. STIs organisms can enter the body through a disrupted vaginal lining. Studies have shown that the spermicide N-9, used frequently and for long periods of time, causes vaginal irritation.]

    There are 3 types of spermicides used in birth control sponges:

    - Nonoxynol-9 (N-9)

    Offers no protection against most STIs and, in higher concentrations, increases the risk of HIV transmission.

    - Benzalkonium chloride (BZK)

    Has microbicidal activity--it kills the organisms that cause STIs, including HIV. BZK is widely used as a disinfectant. Studies have also shown that it tends to cause less vaginal irritation than N-9.**

    - Sodium cholate (antiviral)

    The latest recommendations regarding the use of spermicides containing N-9 are:

  • Products containing N-9 should not be used at all to protect against STIs, including HIV.

  • If you are considering using products containing N-9 you should be aware of, and should carefully consider, the proven risk of using N-9 vs. any potential birth control benefits.

    When it comes to using the sponge, here are some of the facts you need to consider:

    Sponge Overview

    The sponge is a little disc, made of soft polyurethane foam; it comes pre-treated with spermicide. The foam has a consistency similar to that of vaginal tissue (neither you, nor your partner should be able to feel the sponge during sex).

    For all sponge brands: one size fits all, so no fitting is required. [Outside the U.S., the sponge is available OTC.]

    All sponge brands are disposable--you use a sponge only once and then throw it away.

    The sponge starts to work immediately after it's inserted and its contraceptive effect lasts for many hours [12 to 24 hours, depending on which brand you use]. You are protected for this entire period of time, regardless of how many times your partner ejaculates (there's no need to reinsert spermicide).

    The sponge prevents a pregnancy mechanically, by blocking the passage of sperm into the cervix, and trapping sperm, as well as chemically, by releasing spermicide.

    To insert the sponge: introduce it deep into the vagina, so that it fits over the cervix. You can insert it up to 22 hours before intercourse. To remove the sponge: depending on the brand used, pull on foam slots, or grasp it between two fingers, and gently withdraw it from the vagina.

    You must leave the sponge in place [at least 2 to 6 hours, depending on brand] after the last act of intercourse, to allow time for the sperm to be killed. [However, don't leave it in beyond the maximum recommended time.]

    The overall 1st year failure rate, for women who have not given birth (nulliparous), is 9% with perfect use, and 20% with typical use. For women who have given birth (parous) the failure rate is 20% with perfect use, and 40% with typical use. [See also specific brand failure rates.]

    If your partner uses a condom, the sponge's ability to protect you against an unintended pregnancy is greatly improved.


    Some of the advantages of using the sponge:

  • no fitting required
  • no prescription needed
  • woman-controlled method
  • easy to insert and remove
  • you only use it when you need it
  • no wide-spread body effects
  • you can use it if you've recently given birth
  • you can use it if you are breastfeeding
  • you can leave it in for up to 24 hrs (doesn't interfere with spontaneity)
  • no need to add spermicide
  • unobtrusive
  • possible protection against STIs
  • immediate return to fertility

    Disadvantages of using the sponge:

  • higher failure rate vs. other methods
  • you cannot use it if you have an abnormal Pap, genital lesions or infections
  • you cannot use it if you're allergic to spermicide
  • some brands can not be used immediately after childbirth, miscarriage or termination
  • you cannot use it during your menstrual period
  • small risk of toxic shock syndrome(TSS)***
  • some brands may be messy because they have a lot of spermicide
  • must feel comfortable with touching genital area
  • for brands containing N-9, increased vaginal irritation, which is a risk factor for HIV infection

    ***TSS - a small risk of TSS is associated with the use of all barrier methods. [TSS is a generalized body infection; it occurs in women, men and children and may be potentially fatal.]

    There are 3 sponge brands currently available: Today, Protectaid, and Pharmatex. The first two contain N-9; Pharmatex doesn't. Let's take a closer look at each brand to help you decide which one best fits your needs.

    Today Sponge

    - a foam disc impregnated with 1,000 mg of nonoxynol-9 (N-9)

    - you have to wet it with water before insertion

    - may be inserted up to 24 hours before sex

    - must be left in place for at least 6 hours after the last act of vaginal intercourse (not to exceed 30 hours)

    The estimated 1st year failure rate is 17% with typical use (14% for nullips, 27% for parous women). [According to the manufacturer, perfect use failure rates are 9% for nulliparous women, and 11% for parous ones.] The Today sponge was introduced, in the U.S., in 1983, taken off the market in 1995, and recently [re]approved. It is also approved in Canada.

    The Today sponge does not protect against STIs. In addition, N-9, the spermicide in the Today sponge, has been shown to increase the risk of HIV transmission.


    - may be left in place for 30 hours
    - extensively studied


    - requires water before insertion
    - sulfa allergy may preclude use
    - contains a high concentration of N-9 (increased risk of vaginal irritation, a risk factor for HIV infection)

    Protectaid Sponge

    - a foam disc impregnated with 5,000 mg of the spermicidal F-5 gel

    - F-5 gel contains 6.25 mg of nonoxynol-9 (N-9), 6.25 mg of benzalkonium chloride (BZK) and 25 mg of sodium cholate

    - may be inserted up to 6 hours, but no less than 15 minutes, before sex

    - must be left in place for at least 6 hours after the last act of vaginal intercourse (not to exceed 12 hours)

    The 1st year failure rate is 23% with typical use. The Protectaid sponge was introduced in 1996, in Canada, and in 2000 in Europe. It is not yet FDA approved in the U.S.

    Like with the Today sponge, don't rely on Protectaid to protect you against STIs, especially HIV. However, unlike Today, there are some studies that show that the F-5 gel might cause less vaginal irritation. [In human studies, the F-5 gel did not cause vaginal irritation up to 12 hours after insertion. The manufacturer also states that the F-5 gel can help prevent irritation caused by intercourse (because the gel forms a protective coating on the wall of the vagina).]


    - no need to wet it before insertion
    - lower spermicidal concentration reduces vaginal irritation, a risk factor for HIV infection
    - may be able to prevent irritation caused by sexual intercourse


    - may only be left in place for 12 hours
    - not as extensively studied as the Today sponge

    Pharmatex Sponge

    - a foam cylinder impregnated with 60 mg of the spermicide benzalkonium chloride (BZK)

    - may be inserted up to 22 hours before sex

    - must be left in place for at least 2 hours after the last act of vaginal intercourse (not to exceed 24 hours)

    The 1st year failure rate is 19% with typical use. The Pharmatex sponge was introduced in 1984, in Europe. It is not yet FDA approved in the U.S.

    Until large-scale clinical studies are available, this sponge should not be relied upon to offer protection against STIs, especially HIV. [I haven't seen any such studies in the English-language literature, and I don't have equal access to French-/foreign-language studies.]


    - does not contain N-9
    - does not require water before insertion
    - shorter exposure to spermicide
    - may be used while breastfeeding
    - may be used after a recent vaginal delivery, or termination


    - some users may be sensitive to the spermicide

    Bottom line: For women who are unable to use other methods, having the option to use the birth control sponge is great. Because of the nonoxynol-9, before you use the Today brand, consider that there are alternatives available (Protectaid, and Pharmatex). For women who are using other birth control methods, the sponge is a great backup method.

    Update: Welcome Instapundit, Indiebride, and LiveJournal readers!

    **Mauck CK, Baker JM, Barr SP, et al. A phase I comparative study of contraceptive vaginal films containing benzalkonium chloride and nonoxynol-9. Postcoital testing and colposcopy. Contraception. 1997 Aug;56(2):89-96.

    Richardson BA. Nonoxynol-9 as a Vaginal Microbicide for Prevention of Sexually Transmitted Infections. It's Time to Move On. JAMA. 2002;287:1171-1172.

    Van Damme L. (2000). Advances in topical microbicides. 13th International AIDS Conference, July 9-14, 2000, Durban, South Africa (Abstract WeOr62).

    Hoffman T, Taha TE, Martinson F et al. Adverse health event occurring during an N-9 Gel pilot study: Malawi. 13th International AIDS Conference, July 9-14, 2000, Durban, South Africa (Abstract TuPpC1171).

    Psychoyos, A. Protectaid®: a new vaginal contraceptive sponge with anti-STD properties. In: Mauck C, et al., ed. Barrier Contraceptives: Current Status and Future Prospects New York: Wiley-Liss (1994), pp. 265-270.

    Creatsas G, et al. A multinational evaluation of the efficacy and acceptability of the Protectaid contraceptive sponge. Eur J Contracept Reprod Health Care. 2001 Sep;6(3):172-82.

  • Plan B In The Neighborhood

    Canada has approved the sale of emergency contraception OTC. [They have both the combination pill, and the progestin-only one (Plan B). As a rule, go with Plan B, it has fewer side effects.]

    This is good news: You no longer have to visit a different continent to buy EC. [Hey, at this point I'm looking for a sliver lining in anything.]

    Yet Another Not Very Bright Politician

    A scientific miracle: South Carolina is blessed to have a clairvoyant politician, in the person of Representative John Graham Altman III. This exceptional individual can read minds, and he can predict the future: just ask him a question, and he can tell you're too dumb to understand the answer!

    Here's the context:

    Excerpts from the exchange between WIS-TV reporter Kara Gormley and Rep. John Graham Altman, R-Charleston, over a S.C. House committee's vote to make cockfighting a felony while tabling a bill that would toughen criminal domestic violence laws

    Gormley: "Does that show that we are valuing a gamecock's life over a woman's life?"

    Altman: "You're really not very bright, and I realize you are not accustomed to this, but I'm accustomed to reporters having a better sense of depth of things, and your asking this question to me would indicate you can't understand the answer. To ask the question is to demonstrate an enormous amount of ignorance. I'm not trying to be rude or hostile, I'm telling you."

    Gormley: "It's rude when you tell someone they are not very bright."

    Altman: "You're not very bright, and you'll just have to live with that."

    Hmm, and all this time I was under the [clearly mistaken] impression that the ability to explain, and educate others is the mark of an intelligent person. Actually, truth be told, I was far more deluded than that: I was convinced it is the in-the-know person's obligation to convey complex information clearly [informed consent anyone?].

    But never mind what I think. When discussing such a paragon of intellect as Rep. John Graham Altman one better rely on official sources.

    Thankfully, the South Carolina Legislature has a Kids Page, so there's hope, for those of us who aren't as brilliant as Rep. John Graham Altman, that we, too, might be able to acquire a better sense of depth of things. Here's how the page explains the Rep.'s job:

    The General Assembly is the group of men and women that work to create the LAWS that govern our state. All members of the General Assembly must be chosen by the citizens of South Carolina to represent them and the area where they live.

    So, Rep. John Graham Altman is a public servant. His job is to represent the citizens of his state, and to be accountable to them. For example, when his constituents have a question about laws the Rep.'s been voting on, his job is to *answer* that question, on topic.

    As a member of the South Carolina House of Representatives, Rep. John Graham Altman's conduct is governed by the SC House Rules (.pdf):

    When the House is called to order, every member shall take his seat and shall act with decorum at all times when the House is in session. Every member, when about to speak, shall rise from his seat and respectfully address himself to "Mr. Speaker" and shall avoid disrespect to the House or the Senate and all personalities, observe decency of speech, and shall confine himself to the question under consideration.

    How fortuitous for the Rep. that he was addressing just a lowly reporter/constituent, as opposed to a person that matters. [Boys and girls, can you say double standard? And, boys and girls, allow me to take this opportunity to remind you these politicians are the people who decide what your medical care should be.]

    Bottom line: Since Rep. John Graham Altman has all these super duper powers, I say we make good use of them. Here is the Rep.'s contact information:

    District 119 - Charleston Co.
    Contact Address:
    (H) 77 Folly Rd., Charleston, 29407
    Bus. (843) 747-6461 Home (843) 763-5313
    (C) 306B Blatt Bldg., Columbia, 29211
    Bus. (803) 734-2947 Home

    Send him your questions and watch in awe how this intellectual giant bedazzles you with his snappy, snazzy ability to determine just how dumb you really are.

    (via feministing)

    Wednesday, April 20, 2005

    Human Papillomavirus (HPV)

    Via the excellent Alas, a Blog, I read an item about the human papillomavirus (HPV) vaccine and the Family Research Council, and I meant to post about it. FRC opposes the HPV vaccine because:

    "Abstinence is the best way to prevent HPV", and "Giving the HPV vaccine to young women could be potentially harmful, because they may see it as a licence to engage in premarital sex".

    FRC's stance is too uninformed to merit comment, and I'll leave it at that--there's just too much material to cover, to waste time on frivolous pronouncements. [Although, I must say, it would be interesting to know why reporters insist on getting quotes from FRC-type groups. They contribute nothing to the discussion. It doesn't seem like they have the conviction of their beliefs, and as such, can't be candid ("Based on our religion, we believe sexually active women, as well as random neonates are to be deprived of proper medical care."). Nor do they exhibit a knowledge of medical facts (e.g., for women, the proven benefits of genital cancer protection outweigh the potential risks of premarital sex; for neonates, at risk of life-threatening HPV diseases acquired via maternal transmission, sexual activity isn't even an issue).]

    Back on topic, let's go over some facts about HPV, and the HPV vaccine.

    [What follows is a brief, and selective discussion; reference articles used here, here, and here; some original text modified/rearranged for clarity.]

    Before we start, keep in mind that human papillomavirus (genital warts), or HPV, and herpes simplex virus (herpes), or HSV, are not one and the same thing. [There are some pertinent similarities between the two: sexually transmitted, genital and nongenital lesions, different types, etc. For more on herpes simplex, go here.]

    HPV Overview

    Human papillomavirus (HPV) is a group of double-stranded DNA viruses [over 100 HPV types have been detected]; it produces lesions/tumors of the skin and mucous membranes. HPV can infect many different sites, including the larynx, skin, mouth, esophagus, and the anogenital tract.

    The diseases caused by HPV fall into three categories [our focus is on the anogenital one]:

    1. Nongenital Skin Disease (common warts, plantar warts, etc.)

    Note: Common warts are not the same as genital warts and are caused by different HPV types.

    2. Nongenital Mucous Disease (respiratory papillomatosis, cancer of the larynx, mouth, esophagus, etc.)

    3. Anogenital Disease:

    Note: Approximately 20 different types of HPV can infect the anogenital tract.

  • Genital warts [condylomata acuminata] (HPV types--6, 11, 30, 42, 43, 44, 45, 51, 52, 54)

  • Bowenoid papulosis (16, 18, 34, 39, 42, 45)

  • Bowen disease (16, 18, 31, 34)

  • Giant condylomata (Buschke-Löwenstein tumors) (6, 11)

  • Unspecified intraepithelial neoplasia (30, 34, 39, 40, 53, 57, 59, 61, 62, 64, 66, 67, 68, 69)

  • Low-grade intraepithelial neoplasia (6, 11, 43)

  • Intermediate intraepithelial neoplasia (31, 33, 35, 42, 44, 45, 51, 52)

  • High-grade intraepithelial neoplasia (16, 18, 56, 58)

  • Cancer of vulva (6, 11, 16, 18)

  • Cancer of vagina (16)

  • Cervical cancer (16, 18, 31)

  • Cancer of anus (16, 31, 32, 33)

  • Carcinoma in situ of penis (erythroplasia of Queyrat) (16)

  • Cancer of penis (16, 18)

    Note: About 90% of genital warts are caused by 2 specific HPV types (6 and 11) and are the least likely to have cancer-causing potential.

    Other less common types have been strongly associated with premalignant and malignant cervical cancers in women. HPV-16 is responsible for about 50% of cervical cancers, and types 16, 18, 31, and 45 together account for 80% of cancers.

    Now, in order to understand the thinking behind the HPV vaccine, you need to understand HPV replication, lesions, and their malignant potential, especially in women. [What follows is a gross oversimplification.]

    HPV Replication

    HPV infection results in local infections* which can be clinical (grossly apparent--e.g., the warty lesions on the labia/penis; subclinical (can't see lesion with naked eye--e.g., cervical lesions); or latent (detected only by DNA tests). Most HPV infections are latent; clinically apparent infections usually result in warts rather than cancers.

    *[In men, genital warts can infect the urethra, penis, scrotum, and rectal area. Lesions can also be hidden or undetectable (e.g., in the inner aspect of the uncircumcised foreskin).

    In women, genital warts usually occur in the moist areas of the vulva (e.g., on the labia, or vaginal lips), and in the anorectal area. Subclinical lesions are common on the cervix, and in the vaginal canal.]

    The viral particles are able to penetrate the skin and mucosal surfaces through microscopic abrasions in the genital area, which occur during sexual activity. Once cells are invaded by HPV, a latency (quiet) period of months to years may occur. [The exact incubation time is unknown, but most investigators believe the incubation period is 3 months.]

    Once inside the infected cell (the host), the virus starts to replicate. Low risk HPV types (6,11), the ones associated with the clinical, genital warts, lesions replicate without incorporating their genetic material into the host cell's DNA.

    In contrast, the high-risk HPV types (16,18) incorporate a portion of their genetic material into the host DNA. So what, you might ask?

    The incorporated viral genetic material can alter the host cell's growth regulation. [A healthy host cell has tumor suppressor genes; these genes inhibit the cell's unregulated growth. The virus inactivates the cell's tumor suppressor genes, resulting in unregulated host cell proliferation and cancerous transformation.] OK, but how does this explain preferentially vaccinating girls vs. boys? Two words: Transformation zone (TZ).

    If you recall your basic anatomy, the cervix, the lower part of the uterus, is partly located inside the vagina. Somewhere on the cervix there's an area of transition--from the vaginal-type tissue, to the uterine-type tissue. This area is called the TZ, and it's an area of active cellular change. Approximately 90% of cervical cancers occur in this small anatomic region. There is no TZ equivalent on the penis.

    So, the virus "likes" active tissue, like the TZ, and younger women [pregnant women also] tend to have a more active TZ vs. older women. But that is not the only HPV-related disadvantage young women have. They are also less likely to have developed immunity to HPV.

    To place immunity to HPV in context, we need to look at the type of lesions caused by the HPV virus.

    HPV Lesions

    The major complication from exposure of the vulva, vagina, or cervix to HPV is the development of dysplasia [the abnormal host cell changes caused by the virus]. This dysplasia is graded**--from low-grade, to high-grade, and cancerous changes.

    **[Progression of cervical dysplastic change to cancer occurs in a predictable pattern. The latent period between infection with a cancer-causing HPV virus and demonstration of Pap smear abnormalities can be measured in years. Once dysplastic changes are initiated, the degree of dysplasia typically slowly worsens as the cellular changes progress toward cancer. The host's cells first become atypical then demonstrate low-grade dysplastic changes followed by high-grade changes, and, ultimately, cancer develops. Spontaneous resolution of lesions at each level of dysplasia has been demonstrated, but this becomes less likely as severity increases. Rapid progression of dysplastic lesions to invasive cancer also has been described. (This is why all irregularities, regardless of lesion grade, need to be evaluated!)]

    Recall that the HPVs that infect the human cervix fall into 2 broad categories. The low-risk HPV types (6, 11), which usually cause genital warts, are associated with low-grade lesions but are rarely, if ever found in invasive cancer. These HPV infections are associated with mild dysplasia that is often transient in nature. Many patients with mild dysplasia of the vulva, vagina, or cervix experience spontaneous regression of these lesions. [The majority (78.3%) of low-grade lesions regress spontaneously. Genital warts may go away on their own in about 10-20% of people over a period of 3-4 months.]

    In contrast, the high-risk HPV types (mostly 16 and 18) in subclinical, cervical lesions, are found in 50-80% of dysplastic lesions, and in up to 90% of invasive cancers. Patients who are exposed to these high-risk HPV types are at risk for developing high-grade dysplasias or carcinomas. [The development of cancer occurs in a small percentage of these patients who do not have therapy for dysplasia.]

    So, HPV infections are transient in the vast majority of patients [infections clear spontaneously within months to a few years]. How is that possible?

    If you are immunocompetent***, your immune system kicks in and stops the viral replication. [Unless the woman is constantly exposed to different HPV types, the prognosis of immunocompetent women diagnosed with condyloma acuminata is excellent. Patients who do not develop immunity to HPV can develop potentially serious sequelae.]

    ***[Women who are immunocompromised due to immunosuppressive drugs or HIV infection are at higher risk of developing persistent disease. These women have a higher incidence of developing dysplasia of the vulva, vagina, or cervix.]

    Pregnancy and HPV

    During pregnancy, there is an increased prevalence of anogenital HPV infections--from the first to third trimester. [In the postpartum period there's a significant decrease; the warts often disappear on their own after pregnancy.] Dormant (quite) infections may become activated, and rapid growth can be observed.

    Factors responsible include suppression of immunity during pregnancy and hormonal changes.

    The risk of condyloma acuminata in pregnancy is 3-fold. First, the lesions can become large enough to obstruct labor. Secondly, the virus can be transmitted**** to the infant, resulting in laryngeal warts. [HPV can cause a very serious condition in children called recurrent respiratory papillomatosis (RRP). This is a life-threatening disease of the respiratory tract.] The warts appear and spread quickly, sometimes dangerously blocking the child's airway. Thirdly, pregnancy is a cofactor in the malignant transformation of HPV-infected tissue

    ****[Vertical transmission of HPV can occur via in utero exposure to amniotic fluid or transmission of HPV from the maternal genital tract. An incubation period of several months usually is required between virus infection at delivery and clinical manifestations in the infant. The average latency period is 3 months, but periods as long as 20 months have been reported.]

    Approximately 5% of all births in the U.S. are at risk for neonatal HPV exposure. But the good news is that the frequency of childhood laryngeal papillomatosis is extremely low (~ 2000 cases/year). This would imply the transmission rate from mother to infant is low


    A few words about HPV treatment.

    Anogenital HPV is a sexually transmitted infection. Approximately two thirds of individuals who have sexual contact with an infected partner develop genital warts. You have a 60% risk of getting the infection in a single sexual contact with someone who has genital warts.

    The only way to prevent HPV infection is to avoid direct contact with the virus, which is transmitted by skin-to-skin contact. [Because the warts themselves are infectious, avoid touching them.] Latex condoms offer some, but not complete, protection from transmission. However, always use a condom with vaginal, anal, or oral sex, because the virus may be found in the semen in the absence of visible warts.

    If your sexual partner has visible genital warts, avoid sexual contact until treatment is completed. [The sexual partner(s) of a woman with condyloma should be examined by a physician and treated if indicated. Often the examination of the male fails to reveal any visible condyloma. If need be, men can also undergo colposcopy; the examination is usually done by an urologist.]

    No single treatment is effective in eliminating warts and preventing them from coming back. [Here's a patient-friendly list of available HPV treatments.]

    An aside: Based on my clinical experience, let me single out one treatment for special praise: Aldara (Imiquimod). I've used all the available HPV treatments, and, in the medical group, Aldara stands out. In my experience, 100% success rate, and very well tolerated (a few instances of local skin irritation). If appropriate for you, I strongly recommend it. [And no, I have no financial connections to the company.]

    The important thing you should understand about HPV treatment is that when you treat HPV you do not eliminate the HPV infection; you're only eradicating an area of dysplasia. Think of it this way: A house has termites (house = your tissue; the termites = HPV virus). HPV treatment is equivalent to removing the part of the house with the worst termite damage, and the local termites. The rest of the house, and termites stay in place. [No evidence demonstrates that treatment eliminates HPV infection or that it decreases infectivity. In fact, warts may recur after treatment because of activation of latent virus present in healthy skin adjacent to the lesion.]

    Regardless of the mode of therapy chosen, recurrence rates are high for any patient with condyloma acuminata. Most patients who develop recurrent or persistent disease are diagnosed within 6 months of therapy.

    Finally, one more important point about treatment: Not everybody infected with HPV needs treatment. [This is not medical advice; use it as a discussion point with your own Ob/Gyn.] Because most HPV infections regress spontaneously when the immune system controls viral replication, the need to treat subclinical or mild disease is controversial. Treatment is not recommended for subclinical anogenital and/or mucosal HPV infection in the absence of coexistent dysplasia. Treatment usually is reserved for patients with visible vulvar warts.

    HPV Frequency

    Frequency of HPV infection in the population is difficult to estimate accurately. [Genital warts] are clinically apparent in 1% of the sexually active population. Molecular studies indicate 10-20% of men and women aged 15-49 years have been exposed to HPV. Prevalence of HPV is higher in certain populations. Data from sexually transmitted disease clinics indicate a prevalence rate of 4-13%.

    The prevalence of condyloma acuminata seems to be similar in men and women. One study from a sexually transmitted disease clinic in the state of Washington found 13% of men and 9% of women had condyloma acuminata.

    Based on clinical observations, incidence of HPV infection clearly has increased in the last 35 years.

    The highest rates of genital HPV infection are found in sexually active women younger than 25 years, even after correcting for the number of lifetime sexual partners. [The reason for the higher prevalence in younger women is not completely understood.] Most of these infections seem to be transient [One study found that the rate of HPV infection is twice as frequent in women younger than 30 years as it is in women older than 30 years.]

    Bottom line: The HPV vaccine is aimed at preventing persistent high-grade cervical lesions caused by HPV types 16 and 18, as well as low-grade lesions/genital warts caused by HPV types 6 and 11. Interim trail results have been very promising and, once approved, this vaccine will be a very important addition to women's healthcare.

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  • Rounds and Banks

    Don't forget to check out this week's Grand Rounds, as well as the Grand Super-Special First Anniversary Edition of the Tangled Bank.

    Sunday, April 17, 2005

    Plan C

    If the FDA rejects restricted OTC sales of Plan B, what is Barr's next move? According to its CEO Bruce Downey, the plan is to divide and conquer:

    Barr Pharmaceuticals Inc. plans to woo individual U.S. states if the Food and Drug Administration rejects its bid to sell its emergency contraceptive nationwide without prescription, company officials said on Thursday.

    "If for whatever reason we're unsuccessful at the FDA, we'll start a more aggressive nationwide program to get the collaborative program expanded in other states," Barr Chief Executive Officer Bruce Downey said.

    Six states - Alaska, California, Hawaii, Maine, New Mexico and Washington - allow pharmacists to write prescriptions for the Plan B pill, either by taking a special course, or by working with a physician. New Hampshire state lawmakers are considering a similar proposal.

    This move should go over great with certain local pharmacists.

    Thursday, April 14, 2005

    How Soon Is Too Soon?

    In my ongoing "one for the boys" series, here's a report about a new study aimed at setting some standards for premature ejaculation:

    Premature ejaculation occurs in just under two minutes, as opposed to about seven minutes for men able to stay the course, according to a U.S. study aimed at setting some standards for the disorder.


    The researchers timed ejaculations by giving stopwatches to the sex partners of more than 1,500 men.

    Writing in the Journal of Sexual Medicine, they said they were trying to set parameters for a condition that is poorly defined medically.

    About 200 of the men in the study suffered from premature ejaculation, they found. A man with the condition took 1.8 minutes to ejaculate after beginning intercourse compared to 7.3 minutes for most of the men.

    Premature ejaculators and their female partners also had higher ratings for personal distress, interpersonal difficulty with their partner, lack of ejaculation control and dissatisfaction with sexual intercourse, they found.

    For a detailed discussion of premature ejaculation (PE), read this. A few facts:


  • In the US: The prevalence rate of PE in American males is estimated to range from 30-70%.

  • Internationally: Estimates for European countries and India mirror the prevalence in the United States. The prevalence in other parts of Asia, Africa, Australia, and elsewhere is unknown.

  • Mortality/Morbidity: No known direct morbidity or mortality results from PE.

    Race: No reproducible data exist on major differences between racial groups with respect to the incidence or prevalence of PE.

    Sex: PE is a condition that only affects males.

    Age: PE can occur at virtually any age in an adult man's life. It is most common in younger men (aged 18-30 y), but it also may occur in conjunction with secondary impotence in men aged 45-65 years.

    In order to maintain a semblance of professional decorum, there will be no snarky comments [just a couple of, oh, so gentle, hints].


    No drug is approved by the FDA for the treatment of PE. However, numerous studies have shown that SSRIs and drugs with SSRI-like side effects are safe and effective to treat this condition, and many physicians use these agents for this purpose.

    [Think what other meds have been used off-label--say the Pill--and the difference in attitudes. Women can't possibly make beneficial health decisions on their own, and need the (preferably moral) "protection" of assorted busy-bodies. Men, on the other hand, not so much.]

    Second: In the study, most men (those able to stay the course) took 7.3 minutes to ejaculate after beginning intercourse. The average time to climax for a female varies but averages 12-25 min. You do the math.

    Wednesday, April 13, 2005

    Plan B Update And Then Some More

    According to the ARHP:

    The current application to the FDA is for the sale of Plan B OTC for women age 16 and older. FDA has never approved a "mixed marketing" OTC approach requiring pharmacies to check customers’ ages. Carol Cox, a spokesperson for Barr, said that FDA has "given us every indication they’re willing to work with us on this proposal," adding that Barr will seek more safety data that could eventually lead to OTC status for Plan B for women of all ages.

    Apparently, some senators aren't as optimistic as Ms. Cox:

    Two Democratic senators plan to block a vote on President Bush's pick to head the Food and Drug Administration over the agency's stalled decision on whether to allow a "morning-after" contraceptive to be sold over the counter, one of the lawmakers said on Wednesday.

    Sen. Patty Murray of Washington state said after meeting with the nominee, Lester Crawford, that he had failed to reassure her and Sen. Hillary Clinton that the agency would make a definitive decision on whether to allow sales of Barr Pharmaceuticals Inc.'s Plan B without a prescription.

    "We will be putting a hold on this nomination when it goes to the (Senate) floor until a decision is reached on Plan B... any decision," Murray said. Sens. Clinton of New York and Edward Kennedy of Massachusetts also participated in the meeting.

    The senators said last month during a hearing with Crawford, who is currently acting FDA commissioner, they wanted answers from him before the Republican-led Senate held a vote on his nomination.

    The Senate Health Education Labor and Pensions Committee is expected to clear his nomination when it meets next week, but Murray and Clinton's hold would block a full Senate vote.

    Murray said Crawford indicated the FDA was concerned about legal issues involving the drug's label and the possibility of riskier sexual behavior. "I think its because of their fear of litigation, not because they don't have the scientific data," she said of the delay.


    "The bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer yes or no," Clinton said in a statement.

    Murray added Crawford would not give the lawmakers a date for the decision. "Soon is all I heard," she said.

    With all due respect to the senators involved, this is not the way to go about it. The FDA should approve Plan B based on the merits of the medical evidence, not because of some political deal/blackmail.

    Bottom line: From various religious doctrines, to politicians on both sides of the isle, from neighbors, to strangers, to assorted health care professionals, and the FDA, when it comes to women's health, we can note a trend: Women are slowly, but surely being phased out of the decision process.

    [On the other hand, if things go as planned, it's possible that in the near future all unbelievers in the U.S., regardless of sex, will be phased out of ... everything. Now that's gender equality for you!]

    Tuesday, April 12, 2005

    Grand Rounds

    Please make sure not to miss this week's edition of the Grand Rounds; as always, a great read.

    Monday, April 11, 2005

    Speaking of Proper Reverence

    This is why he is *the* PZ Myers. The post is something you have to see to appreciate.

    Pregnancy Brain

    Chris Nolan points us to this illuminating article. Read it and learn how to support women by making [insert your own characterization here] statements about their professional abilities:

    O'Donoghue is president of the Residential Builders Association, which turned out in force Monday to a hearing of the Building Inspection Commission. The commission was considering the promotion of Amy Lee into the position of acting director of the Department of Building Inspection, replacing Jim Hutchinson, a popular longtime employee.

    In their zealous support of Hutchinson, O'Donoghue and his boys attacked Lee, citing, in part, her gender and her pregnancy. Lee is due to deliver her third child in August.

    Now O'Donoghue says it never happened, and even if it did happen, which really it didn't, Lee misinterpreted the remarks. He said he would sue me for slander and libel if I suggested he was anything but an ardent supporter of women.

    [Because, as we all know, with pregnancy comes the loss of one's ability to properly process/interpret information.]

    "(Lee's pregnancy) wasn't even an issue!'' he said Wednesday by phone.

    So the reporter checked the tape:

    "If you appoint her,'' another said, "she cannot function as you intend. Given that she is about to go on maternity leave, she cannot function at any capacity whatsoever. That is a reality.''


    One self-employed builder took the mike to say he knows how debilitating pregnancy can be because his wife is expecting a baby in four weeks and she can no longer help him with his billings.

    "My wife refers to it as 'pregnancy brain.' Her mind is on other things, '' he said. "I ask you today, are you going to replace this man with 'pregnancy brain'?

    "That's not disrespect. That's just a metaphor. But when you have a baby, that's all the hormones are about. I'm just making the point.''

    [During residency, all my pregnant colleagues went into labor while on call, after working 80+ hr weeks throughout their pregnancies. I also know quite a few attendings (ob/gyn, peds, IM, surgery, etc.) who went into labor while on call. So, my tolerance for "pregnancy brain"-type judgments about a pregnant woman's ability to function in her professional capacity is quite low.]

    Sunday, April 10, 2005

    Who's More Important?

    Good review of refusal to treat laws, especially the links at the end of the article:

    In particular, Dr. Dunlop does not believe a patient's right to access to care trumps his right to practice according to his moral beliefs. "Is their inconvenience of driving to the next town more important than my conscience?" he asked. "I would say not."

    If a patient asked him to do something he morally objected to, Dr. Dunlop said he would "facilitate transfer of care," which he said does not necessarily constitute a "referral."


    We Don't Live In Perfect

    My recent abstinence-related post has elicited this comment: [When it comes to abstinence] [t]here is no difference between perfect use and typical use. If you have sex, you are no longer abstinent. That is incorrect.

    If you are using the abstinence* birth control method and you engage in sexual activity, it doesn't mean you are no longer using the method. It means you are using the method either incorrectly, or inconsistently; the very definition of typical use.

    [*We are discussing continuous, as opposed to periodic, abstinence.]

    Recall the definitions (emphasis mine):

    Researchers have two different ways of measuring the effectiveness of contraceptive methods. "Perfect use" measures the effectiveness when a contraceptive is used exactly according to clinical guidelines. In contrast, "typical use" measures how effective a method is for the average person who does not always use the method correctly or consistently.

    Let's clear up the confusion by using a case study.

    Assume there are three women--one uses an intrauterine device (IUD), one uses a diaphragm, and one uses abstinence. Now, in a perfect use scenario all three methods are used correctly, and consistently.

    For the IUD, correct use means a versed physician inserts the IUD properly, and its continued correct positioning is checked periodically (the woman feels for the string, the MD checks it, usually during the annual exam).

    For the diaphragm, correct use means, at first visit, the MD fits the proper size, and, subsequently, the woman checks its integrity; inserts it in the proper position (covering the cervical os); uses spermicide properly (e.g., during first use, and before each subsequent ejaculation); and leaves the diaphragm in place for the indicated amount of time.

    For abstinence, correct use means the woman refrains from sexual activity.

    For all three methods, consistent use means the method is used each and every time sexual activity is to take place.

    Of course, like the commercial says, "We don't live in Perfect". In real life (aka typical use scenario) each of our three women has two hurdles to overcome: using the method correctly, and using it consistently.

    The woman using the IUD has the easiest job: assuming proper initial placement, once the IUD is inserted she doesn't have to do anything for the IUD to work. Hence, she's almost guaranteed correct use. I said "almost", because, although rare, it's possible for the IUD to become displaced [it can be expelled without the woman even knowing it; it can perforate the uterus--for the Cu T brand, the incidence is 0.6/1000 insertions].

    Also, consistent use is guaranteed by the IUD's intrauterine location. In other words, since your uterus is present for every sexual encounter, so is your birth control method.

    For this method, perfect use and typical use are almost the same. [One of the many reasons why, in my professional opinion, the IUD is an excellent method of birth control.]

    An aside: The failure rates for perfect/typical use depend on the type of IUD used. To give you an idea, for the copper Cu T brand, the perfect use failure rate is 0.6%, and the typical use one is 0.8%. Keep these rates in mind as we'll come back to them shortly.

    The woman using the diaphragm can run into problems with both correct, and consistent use. Recall all the method requirements for correct use--check for defects, proper fit and placement, time spermicide and method placement/withdrawal. In real life, it's fairly easy to miss any one of these steps, or to make a mistake. These are correct use problems.

    Moreover, the woman might not use the diaphragm each and every time she has intercourse [for whatever reason--she forgets, diaphragm not handy, she's not comfortable inserting it, partner objects, etc.].

    Finally, all the woman practicing abstinence has to do, to use the method correctly, is to not engage in any sexual activity. Correct use problems can crop up because there might be confusion about, or different interpretations of, what constitutes "sexual activity", etc.

    Also, she might run into problems when it comes to consistent use. Like the woman using the diaphragm, she might not abstain each and every time [for whatever reason].

    Another aside: So, for the Cu T IUD brand the failure rate is 0.6% with perfect use, and 0.8% with typical use. Compare this with the [combination] Pill's failure rates: 0.1% with perfect use, and 5% with typical use.

    The Pill has a lower perfect use failure rate than the IUD. However, the IUD has a lower typical use failure rate. Why? Because in real life it's much easier to use the IUD correctly and consistently. You can't forget "to take" the IUD, nor can you "run out" of it. [Incidentally, for the diaphragm (with spermicide) the failure rates are 6% with perfect use, and 20% with typical use. For continuous abstinence, the perfect use rate is 0%; the typical use failure rate is unknown.]

    This is a good illustration of the "just because a method has a low perfect use failure rate doesn't mean its typical use rate is equally low" concept. You cannot guess the typical use failure rate from the perfect use rate. And, without knowing the typical use effectiveness, you cannot make an informed decision about which method of birth control is best suited to your particular circumstances.

    Just because you know how to use a method correctly--you know how to insert the diaphragm properly, you know abstinence entails not engaging in sexual activity--does not mean you will actually use the method correctly. Neither does knowing you should always use your birth control method, if you do not wish to become pregnant, translate into consistent use. [Any physician who's ever discussed birth control with a teenaged patient has had this conversation: MD "Are you sexually active?"; T "Yes"; MD "Are you planning a pregnancy?"; T "No"; MD "So, what method of birth control are you currently using?"; T (smiles demurely) "Umm...nothing."; MD "Do you know how pregnancy happens?"; T (slightly offended) "Yes, of course I do!"; MD "Well, ...?"; T (smiles meekly, blushes, and develops a sudden, and intense interest in the details of the examining room floor)]

    Bottom line: Like with any other method of birth control, when you use abstinence there is a difference between perfect use and typical use. Since we don't know what this method's typical use failure rate is, any pronouncements about its effectiveness are so much rhetoric. And, when it comes to making decisions about your health [among other things], vacuous statements are a poor substitute for actual information.

    Failure rates: Williams 21ed, p 1520

    Grand Rounds

    No time like the weekend to catch up on your Grand Rounds reading.

    Monday, April 04, 2005

    Not Sex At All


    One in five U.S. teenagers say they have engaged in oral sex, an activity that some adolescents view as not sex at all and certainly less risky than intercourse, a report released on Monday said.

    The survey of 580 children with a mean age of 14-1/2 found 20 percent said they had engaged in oral sex, compared to 14 percent who said they had engaged in sexual intercourse.

    In addition, one-third of the multi-ethnic 9th graders surveyed said they intended to have oral sex within the next six months and nearly one-fourth planned to have intercourse during the period. It was more common for boys to have performed oral sex on girls than vice versa, the report said.

    Previous studies and numerous campaigns aimed at deterring teenaged sex have focused on intercourse, but as many as half of adolescents experience oral sex first, the report said.

    The risk of transmitting infections, including HIV, is significantly less with oral sex than with intercourse but is likely underestimated by teenagers, said the report in the journal Pediatrics.

    Youngsters who engage in oral sex rarely used condoms or dental dams, even though herpes, hepatitis, gonorrhea, chlamydia, syphilis as well as the virus that causes AIDS can all be transmitted orally, it added.

    "Given the suggestion that adolescents do not view oral sex as sex and see oral sex as a way of preserving their virginity while still gaining intimacy and sexual pleasure, they are likely to interpret sexual health messages as referring to vaginal sex," wrote lead author Bonnie Halpern-Felsher, a pediatrician at the University of California, San Francisco.

    "Adolescents also believed that oral sex is more acceptable than vaginal sex for adolescents their own age in both dating and non-dating situations, oral sex is less of a threat to their values and beliefs, and more of their peers will have oral sex than vaginal sex in the near future," she wrote.

    Sunday, April 03, 2005

    The Sovereign Source

    Via Advice Goddess, I came across this piece of proposed legislation:

    'Notwithstanding any other provision of this chapter, the Supreme Court shall not have jurisdiction to review, by appeal, writ of certiorari, or otherwise, any matter to the extent that relief is sought against an element of Federal, State, or local government, or against an officer of Federal, State, or local government (whether or not acting in official personal capacity), by reason of that element's or officer's acknowledgement of God as the sovereign source of law, liberty, or government.'.

    Somebody with a legal background, please tell me this doesn't mean what I think it means. And if it does, I have only one question: Which God?

    Here are a few options:

    Ahura Mazda

    Teenage Spirit

    I haven't read the original article, but this report on the study, looking at what happens when teenagers have easy access to birth control, is interesting:

    If birth control is easy to get, such as from a school clinic, more sexually active teens may use contraception.


    At the same time, the researchers from the Minneapolis Department of Health and Family Support found easier access to birth control didn't encourage sexual activity among teens who were not sexually active.

    "No delays. No hassles. No lectures."

    Illinois' Governor offers a temporary solution to the problem of pharmacists who refuse to fill women's drug prescriptions:

    Gov. Rod Blagojevich approved an emergency rule Friday requiring pharmacies to fill birth control prescriptions quickly after a Chicago pharmacist refused to fill an order because of moral opposition to the drug.

    The emergency rule takes effect immediately for 150 days while the administration seeks a permanent rule.

    "Our regulation says that if a woman goes to a pharmacy with a prescription for birth control, the pharmacy or the pharmacist is not allowed to discriminate or to choose who he sells it to," Blagojevich said. "No delays. No hassles. No lectures."

    Under the new rule, if a pharmacist does not fill the prescription because of a moral objection, another pharmacist must be available to fill it without delay.

    The Illinois Department of Financial and Professional Regulation has also filed a formal complaint against the Chicago Osco pharmacy for the Feb. 23 incident.

    This is good news. However, I still can't help but notice the abject dependence of women's medical care on the benevolence of this or that politician.

    Does Abstinence Work?

    Just because for the past couple of weeks I really, really, really wanted my online connection to work properly, does not mean it actually did. [Apparently there was a problem with the cable box; I now have a new one.]

    And just because various government officials issue [curiously similar] pronouncements about how well abstinence works to prevent pregnancy, does not mean it actually does.

    The president, in his July 2002 remarks to South Carolina high school students, said "Let me just be perfectly plain. If you're worried about teenage pregnancy... abstinence works every single time."

    According to Wade Horn, assistant secretary of Health and Human Services in charge of federal abstinence funding, when it comes to sexual education

    "We don't need a study, if I remember my biology correctly, to show us that those people who are sexually abstinent have a zero chance of becoming pregnant or getting someone pregnant..."

    On the issue of abstinence health department spokesman Bill Pierce said

    "One thing we do know about abstinence is that if you practice it, you will not have an unintended pregnancy..."

    Kids and kidettes, pay attention: When it comes to abstinence we have no data on its typical-use* effectiveness. In other words, based on the available evidence [as opposed to belief, wishful thinking, and/or ideology] we don't know how well this birth control method does [or does not] work.

    *Researchers have two different ways of measuring the effectiveness of contraceptive methods. "Perfect use" measures the effectiveness when a contraceptive is used exactly according to clinical guidelines. In contrast, "typical use" measures how effective a method is for the average person who does not always use the method correctly or consistently.


    [R]esearchers have never measured the typical-use effectiveness of abstinence. Therefore, it is not known how frequently abstinence fails in the real world or how effective it is compared with other contraceptive methods.

    (American Street link via Pharyngula)

    Saturday, April 02, 2005

    Breast Cancer and Race

    Interesting observations about the potential role of genetics in the racial differences seen in breast cancer patterns:

    Based on similarities in breast cancer epidemiology between African-American women and women in sub-Saharan Africa, researchers propose that genetic factors play an important role in the racial differences in breast cancer burdens.

    Although African-American women have a lower incidence of breast cancer than White-American women, mortality rates from breast cancer are higher, Drs. Alero Fregene and Lisa A. Newman note in their report, published in the April 15th issue of Cancer.


    They found that women in Africa had a 5 to 10 times lower incidence of breast cancer compared with westernized populations. The two researchers suggest that gynecologic and reproductive patterns within African populations that minimize estrogen exposure - such as late menarche, multiparity and prolonged lactation - as well as dietary factors may account for these differences.

    However, breast cancer mortality rates are disproportionately high among African women. Although delayed presentation and limited therapeutic modalities may play a role, there may also be a predisposition to biologically aggressive tumors. The latter possibility is reflected in lower age of onset and advanced stage tumors, as is seen among African-American women.

    "As research into interactions among tumor biology, genetics, and socioeconomics and/or lifestyle factors continues, medical professionals and researchers will be in a stronger position to address and to eradicate the disproportionate breast cancer burden that currently affects African-American women," the authors conclude.

    Headaches and the Pill

    Everything you ever wanted to know about the [combination] Pill and headaches, but were too afraid to ask. In particular, the article discusses Pill use in migraineurs, as well as woman with other types of headaches. Briefly, the existing guidelines for:

    Initiating OC use in a woman who has migraine without aura

    World Health Organization (WHO) and American College of Obstetrics and Gynecology (ACOG) guidelines consider that for women under the age of 35 who have migraine without aura, and few or no cardiovascular risk factors, the benefits of OC use typically outweigh the risks.

    The International Headache Society task force on combined OCs and hormone replacement therapy in women with migraine concluded that "there is no contraindication to the use of COCs in women with migraine in the absence of migraine aura or other risk factors."

    Continuing OC use in a woman who experiences worsening of migraine and the development of aura after initiating OCs

    WHO and ACOG guidelines recommend that women who experience migraine with focal neurological symptoms not use OCs. These guidelines also suggest that the risks of OC use are "unacceptable" or "outweigh the benefits" if a woman is a smoker, over the age of 35, has uncontrolled hypertension, a history of stroke, or has had breast cancer within the past 5 years.

    A task force convened by the International Headache Society to assess the use of OCs in women with migraine concluded that "there is a potentially increased risk of ischemic stroke in women with migraine who are using COCs and have additional risk factors which cannot easily be controlled, including migraine with aura. One must individually assess and evaluate these risks. Combined oral contraceptive use may be contraindicated"

    Initiating OC use in a woman with tension-type headache (TTH) and a family history of migraine

    Tension-type headache is not considered a contraindication to OC use by any professional guidelines.

    Use of an extended duration OC regimen to minimize migraine triggered by estrogen withdrawal

    Several studies have assessed the tolerability of extended duration OC regimens. In particular, common estrogen-withdrawal symptoms, including headache, appear to be less frequent.

    Existing guidelines regarding the use of OCs in women with migraine apply to traditional 28-day combination estrogen-progestin OC regimens. ACOG guidelines and International Headache Society recommendations endorse the use of formulations containing less than 50 µg of ethinyl estradiol, while the World Health Organization guidelines recommend the use of OCs containing 35 µg or less of ethinyl estradiol. No professional guidelines or recommendations address continuous or extended duration use of OCs.

    The bottom line:

    Migraine without aura is not a contraindication to OC use in the absence of other risk factors for stroke, and the likelihood that migraine will worsen with use is low. In addition, headaches that emerge during the early months of OC use often improve despite continued OC use. Extended duration OC regimens may be helpful for women who experience headache during the pill-free week of traditional COC use.

    OC use should be reconsidered if patients develop significant worsening of headache or develop neurologic accompaniments to headache. Decisions about OC use in patients who have migraine with aura must be individualized. Consensus-based professional guidelines recommend against OC use for most women who have migraine with aura, but the variable spectrum of aura severity makes such blanket recommendations difficult to apply in clinical practice. TTH is not a contraindication to OC use and does not require discontinuation of OCs if it develops in a current user. There is insufficient evidence to make any recommendations about the use of OCs in women who have cluster headache. The risk of developing headache with OC use may be increased in older women or those with a strong family history of troublesome headaches.

    Recommendations Regarding OC Use in Selected Primary Headache Disorders

    Tension-type headache

  • Not a contraindication to OC use.

    Migraine without aura

  • Not a contraindication to OC use in patients under 35 or without additional stroke risk factors.

  • Clinical judgment should be used in deciding whether advantages of OC use may outweigh risks in selected patients over 35 or with other stroke risk factors.

  • Monitor frequency and severity of headaches during use of OCs.

  • Reassess use if headaches worsen or neurologic accompaniments develop (e.g., aura).

    Migraine with aura

  • Consider alternative forms of birth control.

  • Recognize that there is a spectrum of aura severity, ranging from prolonged, dramatic auras with every headache to aura experienced only once or twice during a lifetime. Common sense and expert opinion suggests that the stroke risk may vary accordingly; definitive evidence on this point is lacking and clinical judgment should be used.

    Cluster headache

  • Insufficient evidence for any recommendations regarding OC use in this rare headache syndrome that is more common in men.

    Women with no personal but a strong family history of headache or migraine

  • Modest evidence of increased risk of headache precipitation with OC use, especially if over the age of 35; monitor closely if OCs are used.
  • Depo-Provera and Bone Loss

    A few months ago the FDA mandated adding a warning about potential loss of bone density to the Depo-Provera (a progestin-only birth control shot) label.

    Here's a good overview of the findings of two recent studies about using Depo-Provera (depot medroxyprogesterone acetate, or DMPA), bone mineral density, and teens. The key points:

  • DMPA suppresses ovulation [the release of the egg from the ovary]; it also reduces ovarian production of estrogen.

  • Bone mineral density (BMD) declines during DMPA use. However, DMPA use has not been linked to menopausal osteoporosis or fractures.

  • The transient loss of BMD associated with DMPA use can be attributed entirely to the reduction in ovarian estrogen production.

  • The transient impact of DMPA on the body's estrogen levels and BMD is similar to trends seen in breastfeeding women.

  • Recovery of BMD is complete within 12 months after DMPA use is discontinued. Duration of DMPA use was not observed to affect speed of BMD recovery.

  • Although 'add-back' estrogen supplementation [taking estrogen while using DMPA to compensate for the reduction in the body's estrogen production] prevents BMD loss in DMPA users, the recovery of BMD that occurs after DMPA discontinuation means that the need for such 'add-back' would be unusual.
  • Friday, April 01, 2005

    Emergency Contraception

    Feministing reports that another state, New Hampshire, is about to allow OTC sales of EC. An encouraging development [if you ignore the fact that politicians are deciding your medical care].

    Some pharmacies in Alaska, California, Hawaii, New Mexico, and Washington will also provide EC OTC.