Monday, March 27, 2006

You Will Respect My Authori-tah!

The legislation signed by Michigan Gov. Jennifer Granholm on Friday requires that patients with a nonviable fetus receive prenatal care and parenting information before they're allowed to have an abortion [even coming from a politician, that's contemptible]. The bill also requires physicians to offer patients unnecessary tests, tests for which the patient is financially responsible. It also misleads patients about the risks of undergoing an abortion.

From House Bill 4446:

(e) Provide the patient with a physical copy of the prenatal care and parenting information pamphlet distributed by the department of community health under section 9161.

Why? What is the medical rationale for providing a patient, who either needs or has decided to have an abortion, with this type of information?

Providing prenatal care and parenting information to a patient undergoing an abortion [I can't imagine how you go about presenting this information to a patient with, say, an anencephalic fetus] is as nonsensical as providing abortion information to a term patient before allowing her to deliver via C/S.

(8) If at any time prior to the performance of an abortion, a patient undergoes an ultrasound examination, or a physician determines that ultrasound imaging will be used during the course of a patient's abortion, the physician or qualified person assisting the physician shall provide the patient with the opportunity to view or decline to view an active ultrasound image of the fetus, and offer to provide the patient with a physical picture of the ultrasound image of the fetus prior to the performance of the abortion.

What if the patient either forgets or doesn't want to disclose that she's had an U/S?

Since no exception is provided, it looks like the physician is liable, no matter what the circumstances. [Forget history taking skills; it looks like it's time for Michigan physicians to familiarize themselves with effective interrogation techniques.]

Why should the patient be offered an unnecessary test, and why should she be expected to pay for it?

If the patient undergoes an U/S at an outside facility at any time prior to the performance of an abortion, or if the physician plans to use imaging during the procedure, when the patient is under anesthesia, the physician will have to order an additional scan in order to comply with the requirements of the Bill. Since this would be an elective scan--there's no medical indication for it--there are only three options when it comes to payment: 1) the physician can make up a medical reason for it so that the test is reimbursed by the insurance company [can you say "malpractice and fraud"?], 2) the physician can use his/her own money to pay for the test or 3) the patient has to cover the cost.

The Bill is quite clear that the patient is expected to pay for this politically-indicated test:

(9) This subsection does not prohibit notifying the patient that payment for medical services will be required or that collection of payment in full for all medical services provided or planned may be demanded after the 24-hour period described in this subsection has expired.


There's also a provision requiring the department of community health to

(h) Include on the informed consent website developed under subdivision (g) a list of health care providers, facilities, and clinics that offer to perform ultrasounds free of charge.


So, if you're a patient who either needs or has decided to have an abortion, before you're permitted to undergo the procedure, you must be offered the option to have an unnecessary test, and you are expected to pay for it. Alternatively, you have the option to search for and locate a facility offering free tests in your area, take time off and make arrangements to go to that location and have the U/S performed, make sure the place performing the test and the place where you'll be having the abortion get in touch and somehow coordinate, and insure the proof requirements of HB 4446 have been satisfied [can you say "patient inconvenience", "bureaucracy", "mix-ups"?]. The good news is that, as of yet, the Michigan legislators do not mandated that patient be offered ukulele lessons before being allowed to undergo an abortion.

Last, but not least:

Why show the patient an image of the fetus, as opposed to one of the uterus or the cervix, or even the anesthesia equipment?

If your main concern is medical--the health of the patient and informing her of the risks of the procedure--it doesn't make sense to show her a picture of the fetus. That's not the source of your expected complications. Instead, the patient should be looking at pictures of the uterus or cervix to better understand the risk of perforation, atonia, or laceration. In fact, even showing the patient pictures of anesthesia equipment/drugs [to help the patient better assess her anesthesia-related risk] is more relevant than showing her an image of the fetus.

I wasn't able to find any news article detailing Gov. Granholm's reasons for signing this law. The closest I came to a motive was this speculation from Ed Rivet, chief lobbyist for the anti-abortion group Right to Life of Michigan:

"I think she looked at both the substance of the policy, and at the politics, and determined that a veto was not the prudent thing to do"....

More on the likely political machinations, from an insider:

State Sen. Gilda Jacobs, D-Huntington Woods, said Friday that she thinks the legislation was designed to place Granholm in a politically awkward position in an election year. But Jacobs said the final product does not unduly restrict abortion rights and "is not a very big deal."

Sen. Jacobs, ladies and gentlemen: The One that gets to decide what degree of restriction of our rights is, or isn't a very big deal! [How, oh how, would we ever be able to lead our lives and tie our shoes without this most invaluable oversight from our beloved politicians?]

I don't know why Gov. Granholm signed HB 4446. What I do know is that the health and well-being of female patients were not a consideration. Nor, for that matter, was the competence of medical professionals. All in all, yet another misguided piece of legislation with the potential to negatively impact the medical care of female patients of reproductive age.

In an effort to cut down on the enactment of misguided/malevolent legislation, I have a suggestion:

If you truly believe in your own version of the FSM and you wish to impose your beliefs on perfect strangers, and/or if you're a politician up for reelection, stop the subterfuge and the pretense. Stand up for what you believe in, and/or your political calculation de jour. Get over your shame, and say it loud, and say it proud: "You will obey my Deity, and/or be a peon in my political games!" Just leave medicine and science alone.

Friday, March 24, 2006

Medical Abortion Regimens: Take Two...Or More And Call Me In The Morning

After looking at blog discussions of recent reports of deaths in women undergoing a medical termination of pregnancy (MTP) I can see that there is still a lot of confusion about the regimens used. Let me try to clarify some facts.

First, there's only one FDA-approved MTP regimen for RU-486 and misoprostol. [There have been no reported deaths in women using this regimen.]

The approved regimen is administered up to 49 days after the first day of the last normal menstrual period (LNMP) and consists of 3 tablets of RU-486 (600 mg) orally, followed by 2 tablets of misoprostol (400 mcg) orally.

FDA-approved regimen: up to 49 days, two drugs [RU-486 and misoprostol], 600 mg RU-486 and 400 mcg misoprostol, both taken by mouth (orally).

Second, several other MTP regimens, for RU-486 and misoprostol, *as well as* for other drug combinations, are in use. All have been studied and found to be safe and effective. [Some are more effective vs. the FDA-approved regimen.] Here are some of these other regimens, in no particular order:

One regimen, let's call it regimen A, is administered up to 63 days after the LNMP and consists of 3 tablets of RU-486 (600 mg) orally, followed by 4 tablets of misoprostol (800 mcg) vaginally.

Regimen A: up to 63 days, two drugs [RU-486 and misoprostol], 600 mg RU-486 and 800 mcg misoprostol, the first orally, the second vaginally.

Another regimen (B) is administered up to 63 days after the LNMP and consists of 1 tablet of RU-486 (200 mg) orally, followed by 4 tablets of misoprostol (800 mcg) vaginally.

Regimen B: up to 63 days, two drugs [RU-486 and misoprostol], 200 mg RU-486 and 800 mcg misoprostol, the first orally, the second vaginally.

Yet another regimen (C) is administered up to 49 days after the LNMP and consists of 1 injection of methotrexate (75 mg) IM, followed by 4 tablets of misoprostol (800 mcg) vaginally.

Regimen C: up to 49 days, two drugs [methotrexate and misoprostol], 75 mg methotrexate and 800 mcg misoprostol, the first IM, the second vaginally.

A final regimen (D) is administered up to 56 days after the LNMP and consists of several tablets of methotrexate (25-50 mg) orally, followed by 4 tablets of misoprostol (800 mcg) vaginally.

Regimen D: up to 56 days, two drugs [methotrexate and misoprostol], 25-50 mg methotrexate and 800 mcg misoprostol, the first orally, the second vaginally.

Bottom line: There are a number of MTP regimens in use. They have been studied and found to be safe and effective (some more than other). The timing of administration, drugs, doses, and routes of administration vary. Being aware of these basic facts is essential when discussing the benefits/risks of MTP regimens.

Thursday, March 23, 2006

NIH Update II

When last we left the saga of the NIH posting incorrect medical information about the progestin-only emergency contraceptive pill (ECP):

  • I had emailed Dr. Marchiano, the last one to review/update the information according to MedlinePlus. [Still no reply from him.]

  • I'd contacted the NIH. [Received a prompt reply from C. Marks, NIH Librarian, National Library of Medicine, letting me know that 1) the info is provided by A.D.A.M., and 2) my email will be forwarded to the publisher.]

  • I had also emailed Dr. Trussell, for an expert second opinion, and to bring the situation to his attention. [Received an uber prompt reply (I must say, I was impressed) verifying the accuracy of my data (well, actually, his data.]

  • Last, but not least, I'd contacted A.D.A.M., using their site Contact form. [Received a fairly prompt call from C. Tenorio, an educational sales rep. He promised to forward the info to Kelly (couldn't remember her last name), a content editor.]

    As soon as I hear from A.D.A.M.'s editor I'll let you know.

    In the interim, I can't help but notice that the NIH site continues to display incorrect information about the emergency contraception pill. I wish I was even marginally skilled in the art of PR, because if this type of news makes the wires, I most certainly think a press release about the government's incompetence/ignorance when it comes to disseminating health information would be newsworthy.

    On a related note, a reader wonders Where did the 10 times risk statement come from? I've asked myself the same question and I must say, I don't know. It certainly looks like it came from a study, but, despite repeated literature searches, I haven't been able to find even one source for the statement.

    I do have a theory, but I must caution you that the underlying assumption--that anyone with any medical knowledge would make such a basic mistake--is quite far-fetched. Here it goes. The prescribing info for Plan B contains this statement (.pdf) [emphasis mine]:

    Ectopic pregnancies account for approximately 2% of reported pregnancies (19.7 per 1,000 reported pregnancies). Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraceptive method. Health providers, however, should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B®.


    Now, clearly, the statement is about ectopic pregnancies in users of the regular progestin-only birth control pill (different drug, different regimen, etc.; tells us nothing about ectopic risk in users of the progestin-only emergency contraception pill). However, it is possible for someone to misinterpret the information and mistakenly assume it refers to Plan B. I don't know; I told you my theory was pretty out there. All I can say is that, on the off chance that I'm right, someone who makes this kind of mistake has no business providing educational content to frogs, let alone the NIH.

    To be continued.

    Labels:

  • Grand Rounds

    Don't forget to read this week's Grand Rounds.

    Labels:

    Sunday, March 19, 2006

    Yaz, a New Low-Dose Pill Approved

    Good news:

    FRANKFURT (Reuters) Mar 17 - The U.S. Food and Drug Administration has approved Schering's new low-dose oral contraceptive YAZ, the German drugmaker said on Friday.

    Schering said YAZ, a low-dose version of its fast-growing contraceptive Yasmin...is the first pill to combine 20 mcg of ethinyl estradiol with the innovative progestin drospirenone [3 mg], in a dosing regimen of 24 days of active hormone pills and four days of placebo pills.


    Note the triple innovation--low estrogen dose + the newish progestin drospirenone + a shortened placebo interval. [The combination of drospirenone and a shortened pill-free interval is believed to be responsible for the significant reduction of the symptoms of premenstrual dysphoric disorder (PMDD), a more severe form of PMS.]

    Labels: , , , ,

    Deaths Following Medical Abortion: AP, AFP, and Reuters Get The Story Wrong

    Reporting on deaths in women who underwent medical abortions, three major news organizations--AP, AFP, and Reuters--get the central, and most basic, facts wrong.

    Here's a bit of background. One of the early medical termination regimens involves taking two drugs--mifepristone (RU-486, Mifeprex) and misoprostol. According to its manufacturer, ~ 560,000 women have taken RU-486 since its approval in September 2000. A total of 7 deaths have been reported in women using these two drugs. [AP reports one was a ruptured ectopic, but I haven't been able to verify that.] Of these, 4 were caused by sepsis (generalized infection), and the cause of death for the most recent 2 isn't known yet. All these deaths, and this is the key piece of information, occurred in women who used the drugs in an off-label manner.

    Moving on, let's look at what the major news organizations are telling you.

    First, from the AP article:

    In a cluster of four cases in California, the women died from an infection of the bloodstream, or sepsis. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later.

    Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, a so-called "off-label" use of the drug....


    If you even manage to catch the fact that two different drugs are mentioned--the "abortion pill" (RU-486, mifepristone), and the another drug (misoprostol)--the article tells you that the FDA-approved regimen is swallowing (oral) three tablets of RU-486, followed by oral administration of two misoprostol tablets two days later. That is correct. However, what follows isn't. Namely, that the four women who died used an off-label regimen consisting of swallowing three RU-486 tablets, followed by intravaginal (PV) administration of two misoprostol tablets.

    Second, the AFP article:

    The FDA said that four women had died from bacterial infections 2003-2005 after so-called off-label use of the misoprostol, inserted vaginally, rather than orally, as indicated. The mifeprex drug in the regime was given orally, as directed.


    The good news is that AFP makes it clear we are discussing a two-drug regimen. The bad news is that the information about what regimen was used--three RU-486 (mifeprex) tablets given orally, followed by two misoprostol tablets PV--is incorrect.

    Finally, from Reuters:

    Officials cautioned against unapproved dosing regimens. The four earlier deaths occurred after women were given misoprostol vaginally, rather than orally. The approved regimen calls for oral administration of both drugs.

    "The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA," the agency said.


    Again, the regimen information is reported incorrectly. [Bonus points if you can spot the problem. Hint: read the FDA quote carefully.]

    Now, it's clear that all the articles are based on this FDA press release.

    This is what the FDA release says is the approved two-drug regimen for early medical termination:

    The approved Mifeprex regimen for a medical abortion through 49 days' pregnancy is:

  • Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once


  • Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.


  • So, the FDA-approved regimen is 3 tablets of RU-486 (Mifeprex), or 600 mg, orally, followed by 2 tablets of misoprostol, or 400 mcg, orally.

    The AP article reported this one correctly; the other articles didn't go into details.

    Continuing, from the *same* release, this is what the FDA says was the [off-label] regimen used in all four cases of fatal infection:

    All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol.


    So, the off-label regimen used was 1 tablet of RU-486 (Mifeprex), or 200 mg, orally, followed by 4 tablets of misoprostol, or 800 mcg, PV.

    One more time: The FDA-approved regimen is 600 mg of RU-486 (Mifeprex) orally, followed by 400 mcg of misoprostol orally. The off-label regimen used was 200 mg of RU-486 (Mifeprex) orally, followed by 800 mcg of misoprostol PV.

    All three articles correctly report that the off-label regimen involved a different route of administration for one of the drugs, misoprostol (PV vs. orally). What none of the articles mention is that the off-label regimen involved significantly different doses of both drugs. In fact, they all mistakenly report that, for both drugs, the approved dosage was used.

    If you think drug dosage is not essential information, go ahead and take an entire bottle of aspirin for a headache, or take antibiotics for only one day of a seven day course and see what happens. [WARNING! This was a (possibly bad) joke, not an actual suggestion. Don't exceed the recommended daily dose of aspirin, and always finish a full course of antibiotics. And, yes, I do know I'm belaboring the point.]

    When it comes to reports of deaths in women using RU-486 and misoprostol for medical abortions, what we should be discussing is if either one of these drugs, or both, could be a contributing factor. [So far there is no evidence for that.] But you tell me how we can be informed discussants when AP, AFP, and Reuters can't even get simple information, like dosage regimens, right. Nothing more than reading comprehension was involved in reporting this correctly. The information is clearly spelled out in the FDA press release. How can we expect accurate reporting of truly complex issues (how do we determine if the drugs are involved? What would a hypothetical mechanism of action be?) when the basics are misreported?

    Saturday, March 11, 2006

    Carnival of Feminists

    A bit late, but thank you to Carnival of Feminists 10 for linking.

    Thursday, March 09, 2006

    Can William Saletan Get A Clue?

    Via Professor Lemieux I read The Road From Roe
    Can technology break the abortion stalemate?
    by William Saletan. I shouldn't have bothered. But since I have, here are my comments.

    The article deals with second-trimester (2nd) abortions, with a focus on late 2nd trimester procedures. Mr. Saletan finds these abortions particularly icky, therefore he argues for a gradual, voluntary exodus from at least half the time frame protected by Roe.

    Before I go on, let me point out that nowhere in the article does Mr. Saletan offer even a shred of evidence for his repeated assertion that the public's increasing squeamishness (no evidence this trend even exists) about 2nd trimester abortions is fueling the looming political battle over abortion/Roe. For all we know this battle is driven by a crass power grab by politicians lusting for ever more intrusive interference in our private lives, or maybe even a push by the ruling class towards a theocracy.

    Actually, the fact that the number of abortions performed after the 1st trimester, particularly during the late 2nd trimester, has been relatively constant for over three decades argues against Mr. Saletan's assertion. More on this in a bit.

    Returning to the article, Mr. Saletan asserts that [the way] to end the assault on Roe is to make it irrelevant. And how does he propose we do that? Via the magic of medical technology--improved neonatal survivability, more foolproof contraception, more access to morning-after pills, earlier and fewer abortions. Now if only any of these had any significant impact on reducing the number of 2nd trimester abortions, we might be on to something. Since they don't, we're not.

    Let's look at the improved neonatal survival rates claim first. From the article:

    Roe established a right to abortion through the end of the second trimester. The latter part of that time frame has always been the most controversial. Improvements in neonatal care have made fetuses viable-capable of surviving delivery-earlier than was possible in 1973.


    What is the evidence that late 2nd trimester abortions have always been the most controversial? And, more importantly, for whom? In any case, there are several problems with the implication that improved neonatal survival rates are relevant to our discussion.

    First, an abortion is intended to terminate a pregnancy. The patient who needs or wants an abortion, needs or wants to terminate a pregnancy, not deliver an extremely low birth weight (possibly suffering from the sequelae of prematurity) fetus.

    The only way it makes sense to bring the issue of neonatal survival rates into a discussion of reducing the number of abortions is if you're advocating forced surgery on female patients in order to deliver the pregnancy without their consent.

    Second, the issue of improved survivability of a normal fetus is irrelevant for nonelective 2nd trim abortions. These are done for either maternal, or fetal indications (maternal illness, fetal death, etc.).

    Third, since Mr. Saletan brought up the topic, here's a bit of background on the impact of improvements in neonatal care on the survival rate of extremely low birthweight (ELBW) newborns. As you read the studies, some [very] general guidelines: late second-trimester abortions roughly cover the 18-22 weeks interval; birthweight >500g ~ 24 weeks, and 750g ~ 26 weeks. You should also keep in mind that "trimester" is not an accurate framework when discussing survival rates of ELBW neonates. The combination of estimated gestational age (EGA), maturity, and birthweight is. [As is gender, with lower survivability for males.]

    Perceptions of the potential for survival are inevitably confused by difficulties incurred by imprecisely known gestational age. Most survival data are based upon birthweight, which may vary appreciably between 24 and 26 weeks. For example, infants born between 24 and 26 weeks can vary in weight from 435 g to 1640 g. [Williams, p692]


    From the U.S. (1995/6 vs.1991 and/or 1988):

    [From January 1995 through December 1996] Eighty four percent of 4438 infants weighing 501 to 1500 g at birth survived until discharge to home or to a long-term care facility (compared with 80% in 1991 and 74% in 1988)....The incidence of chronic lung disease [CLD]...proven necrotizing enterocolitis [NEC]..., and severe intracranial hemorrhage [ICH]...remained unchanged between 1991 and 1996." and "[From January 1995 through December 1996] Mortality for 195 infants weighing 401 to 500 g was 89%, with nearly all survivors developing CLD.


    and

    Survival to discharge was 54% for infants 501 to 750 g at birth, 86% for those 751 to 1000 g, 94% for those 1001 to 1250 g, and 97% for those 1251 to 1500g.... Mortality in infants weighing 501 to 600 g was 71%; among survivors, 62% had CLD, 35% had severe ICH, and 15% had proven NEC.


    From NY (1978-2003):

    A review of 25,448 admissions was performed to evaluate the progress of neonatal intensive care at Weill Cornell Medical Center since 1978....Survival of the smallest infants (<600 g) remained poor, but overall survival of all infants improved over time. Length of stay for infants 1000 to 2000 g fell over time while that of other infants remained constant.


    From Chicago (1991-2001):

    Fewer infants in all ELBW [extremely low birth weight/<1000 g/~23-28 weeks] subgroups are dying, compared with a decade ago, and the improvement has been most prominent for BWs of 450 to 700 g, at which mortality was and remains to be greatest. 2) This progress seems to have slowed, or even stopped, by the end of the decade. 3) Although most NICU nonsurvivors still expire early, doomed infants are lingering longer.


    From Canada (1983-1989 [earlier cohort] vs. 1991-1993 [recent cohort]):

    The recent cohort (n = 333) of live birth infants, compared to the earlier cohort (n = 911 ) showed a trend toward an overall improved survival to discharge (72 vs. 65%, p = 0.06). Further analysis showed that improved survival was seen only in 26- to 28-week GA [gestational age] infants (86 vs. 76%, p = 0.01), but not in 23- to 25-week GA infants (44 vs. 44%, p = 0.9), even when adjusted for gender or twin births. In addition, the incidence of major impairment at 18 months (36% in both periods) remained high. Reanalysis of 24- to 25-week GA infants again showed no evidence of improved survival (53 vs. 50%) or improved outcome at 18 months (major handicap rate 32%; vs. 34%). Survival rates improved for 26- to 28-week GA infants, but the survival rate and incidence of major impairment had not improved for of 23- to 25-week GA infants.


    Last, but not least, a study of neonatal outcome of infants born at 23 weeks EGA, from Brigham and Women's (1995-1999):

    About one third of infants delivered at 23 weeks' gestation survived to be discharged from neonatal intensive care. More advanced gestational age was associated with increased likelihood of survival. No neonates survived free of substantial morbidity.


    Moving on, we have this:

    Meanwhile, sonograms and embryology have made people aware of how well-developed fetuses are while still legally vulnerable to abortion. We even do surgery on fetuses now, which makes aborting them seem that much more perverse.


    A 2nd trimester fetus has no more ability to perform any basic life functions (breathing, waste disposal, etc.) than an incipient embryo. Which brings me to what I think is a key fantasy propagandized in abortion discussions. An abortion terminates a pregnancy, not a fetus. There's no free-floating unborn American child in utero.

    In any case, we perform fetal surgery on pregnant female patients who do not need or wish to terminate their pregnancy. What seems extra, super duper perverse [what, you thought only Mr. Saletan gets to grade perversions?] is to deny pregnant patients with an abnormal fetus fetal surgery because some other pregnant women need to abort their pregnancies. Equally perverse would be to deny pregnant patients with an abnormal fetus 2nd trimester abortions because some totally unrelated pregnant patients need fetal surgery.

    Next, we have:

    But if medical technology has helped to expose this moral problem, it can also help us solve it.


    What moral problem, and, more importantly, whose moral problem? And since I'm asking questions, in what *relevant* way has medical technology helped us expose this alleged problem?

    And this gem of an unsupported claim:

    Second-trimester abortions are becoming not just harder to stomach, but easier to avoid.


    Who says 2nd trimester abortions are becoming harder to stomach, and, who exactly is having these stomach aches? More importantly, where is the evidence showing that 2nd trimester abortions are becoming easier to avoid?

    According to the CDC's 2002 abortion surveillance data:

    As in the past, approximately 88% of all abortions for which gestational age at the time of abortion was known and reported adequately (44 reporting areas) were obtained at <12 weeks' gestation....The proportions of abortions performed later in pregnancy (>13 weeks' gestation) have varied minimally since 1992.


    Also, the percent of abortions performed at or >21wks, from 1973 to 2002, has been relatively constant at ~1% (0.8%-1.7%).

    And the assertions keep on coming:

    The same high-resolution ultrasound that makes you queasy about aborting a 12-week fetus has made it safer to perform abortions at four or five weeks instead of waiting, as women were once routinely told to do.


    Thank goodness women everywhere have Mr. Saletan to tell them exactly how undergoing a termination makes them feel. I don't discuss my clinical experience on this blog, but I must say that during all of my many patient encounters I have never once had the presumptuousness to tell a patient how she feels. And what does the high-resolution U/S have to do with the safety of performing 1st trimester abortions?

    In 1993, only 7 percent of abortion providers could end a pregnancy at four weeks or earlier; by 2001, 37 percent could do it.


    This is just a flagrant misrepresentation. Here's what the original says:

    Thirty-seven percent of facilities that offer abortion services provide either surgical or medical abortions at four weeks or less LMP (Figure 1), often for any pregnancy that can be confirmed by ultrasound or even a pregnancy test. This represents a sharp increase from the level of 7% reported in 1993 (not shown).


    Moving on:

    Better yet, technology is helping many women avoid unwanted pregnancies altogether. According to the Centers for Disease Control, "emergency contraception"--high-dose birth-control pills that you can take after sex to block ovulation, fertilization, or implantation--was almost unheard of a decade ago.


    Emergency contraception (EC) has been in common use (off label) since the 1970s. Also, based on the available evidence, there is no indication that the EC pill works by preventing fertilization or implantation. It works by preventing ovulation. [Hmm, maybe I should check out the CDC site to correct them as well.]

    More importantly, in a discussion of ways to eliminate 2nd trimester abortions, the only way the topic of EC is relevant is if it can be shown that a) the majority of 2nd trimester abortions are elective, and b) restricted access to the ECP is one of the main reasons women delay obtaining a 1st trimester abortion.

    Along the same lines:

    The most widely accepted moral solution, short of abstinence, is contraception that's taken before sex. Here, again, the news is basically good: Contraceptive use rose 11 percent from 1982 to 2002 (though progress was uneven), and during this period, the abortion rate dropped by about 30 percent.


    A moral solution to a medical problem? Oh, yes, I have seen the light! That's definitely the way to go!

    There's no evidence that abstinence is a solution to anything. [Please, we don't even know the typical-use failure rate for this method. Can you imagine any other contraceptive method where such a gap in knowledge would be overlooked?]

    Just because Mr. Saletan believes that one way to eliminate 2nd trimester terminations is use of regular birth control, doesn't mean his belief has any basis in reality.

    First, in the real world, a significant number of unintended pregnancies occur in women already using birth control:

    Results of a 1994-1995 national survey of 9,985 abortion patients ...The proportion of abortion patients who had been using a contraceptive during the month they became pregnant increased from 51% in 1987 to 58%.


    Second, just because birth control use rose while the overall abortion rate dropped doesn't mean that contraceptive use is a solution to doing away with 2nd trimester abortions. As I mentioned before, the rate of 2nd trimester abortions has been relatively constant over the years. And just like with EC use, birth control use would be relevant to the discussion only if a) the majority of 2nd trimester abortions were elective, and b) if not using birth control were one of the main reasons women delayed obtaining a 1st trimester abortion.

    This is also problematic:

    Birth control isn't just more common; it's more effective...


    First, just because a birth control method is more effective in theory, doesn't mean it is so in practice:

    More than one in five U.S. pregnancies ended in abortion, according to a national sample survey conducted by AGI during 2001--2002 among women having abortions. Inconsistent method use of the pill (75.9%) or condoms (49.3%) was the most common reason that women became pregnant and obtained abortions.


    Second, methods like Implanon are great (although one must note that Implanon isn't yet FDA approved), but just because it's available and it's quite effective in no way means that using more common/effective contraception can reduce 2nd trimester abortion.

    In the context of reducing abortions, the relevance of the availability/effectiveness of any particular birth control method is limited by the fact that not all women (possibly, not even a significant number) can and/or will use that particular method. A very good example of this problem is the intrauterine device (IUD). The IUD is widely available (worldwide), and is more effective at preventing pregnancy than sterilization. But just because it's a common and most effective method doesn't mean it will have an impact on abortion rates. It all depends on the patient population. Not only are there acceptance problems with this method in the U.S. (a possibly surmountable problem), but not everyone (not even a majority of women in certain groups) can use an IUD (an insurmountable problem). [For example, the ideal patient, as well as her partner, should be monogamous.]

    Also, for the availability/effectiveness of birth control to be relevant to our discussion you'd still have to show that a) the majority of 2nd trimester abortions are elective, and b) birth control unavailability and lack of effectiveness are main impediments to women obtaining a 1st trimester abortion.

    Finally, we come to the grand assertion:

    Technology can't avert all our failings or tragedies. There will always be abortions. But when you look at the trends--more foolproof contraception, more access to morning-after pills, earlier and fewer abortions--you can begin to envision a gradual, voluntary exodus from at least half the time frame protected by Roe....Maybe that six-month window made more sense in 1973 than it does today. Maybe, if we spend the next 10 years helping women avoid second-trimester abortions, we won't have to spend the next 20 or 40 years defending them. Maybe the best way to end the assault on Roe is to make it irrelevant.


    And maybe Mr. Saletan is clueless (and, quite possibly, malevolent). Before we all embark on this voluntary exodus from 2nd trimester abortions, we most definitely need a reality check.

    Speaking of reality, I must say that I find this Technology can't avert all our failings or tragedies. There will always be abortions. particularly odious. The degree of impertinence exhibited by Mr. Saletan--telling patients with a fetal demise in utero, or an anencephalic fetus that their pregnancies are a failing or a tragedy--is mind-blowing.

    Back to teaching mode. First, we must keep in mind that there are nonelective and elective terminations. Second we must look at the indications/reasons for 2nd trimester abortions and see if more foolproof contraception, more access to morning-after pills, earlier and fewer abortions are in any way relevant.

    Let's start with nonelective 2nd trimester abortions. Some of the common indications for performing these procedures are: fetal demise; chromosomal or structural abnormalities; preterm premature rupture of membranes (PPROM); false-negative findings [of a fetal anomaly] in the 1st trimester. Better birth control, improved access to EC, and performing an earlier abortion have no impact on these indication. But by all means, let's all "help" women voluntarily relinquish access to medical care, ideally, with a smile on their faces and a thank you in their hearts!

    Moving on, what are some of the risk factors that could be associated with presenting for an elective 2nd trimester abortion? From the CDC:

    The gestational age at which an abortion is obtained can be influenced by multiple factors in addition to those for which surveillance data are available (age, race, and ethnicity). These additional factors include level of education, availability and accessibility of abortion services, timing of confirmation of pregnancy, timing of personal decision-making, timing of prenatal diagnosis, level of fear of discovery of pregnancy, and denial of pregnancy (34--36).


    Also,

    Delays in suspecting and testing for pregnancy cumulatively caused 58% of second-trimester patients to miss the opportunity to have a first-trimester abortion. Women presenting in the second trimester experienced more delaying factors (3.2 versus 2.0, P < .001), with logistical delays occurring more frequently for these women (63.3% versus 30.4%, P < .001). Factors associated with second-trimester abortion in logistic regression were prior second-trimester abortion, delay in obtaining state insurance, difficulty locating a provider, initial referral elsewhere, and uncertainty about last menstrual period. Factors associated with decreased likelihood of second-trimester abortion were presence of nausea or vomiting, prior abortion, and contraception use....However, accessible second-trimester abortion services will remain necessary for the women who present late due to delayed recognition of and testing for pregnancy.


    Last, but not least, this study from Mississippi:

    After enactment of the law [a woman seeking an abortion must first receive, in person, information about the fetus and alternatives to abortion. She must then wait at least 24 hours before having an abortion.], the proportion of second-trimester procedures increased by 53% (from 7.5% of abortions to 11.5%) among women whose closest provider is in-state, but it increased by only 8% (from 10.5% to 11.3%) among women whose closest provider is out-of-state....The proportion of abortions performed later in pregnancy will probably increase if more states impose mandatory delay laws with in-person counseling requirements.


    Again we see that some of the main reasons for not obtaining a 1st trimester abortion--delayed recognition of and testing for pregnancy, mandatory delay laws--are not affected by more foolproof contraception, more access to morning-after pills, earlier and fewer abortions.

    Finally, the cherry on top of the cake:

    Five hundred years from now, people will look back on our surgical abortions the way we look back on the butchery of medieval barbers. Like the barbers, we're just trying to help people to the best of our ability. But our ability is growing. So should our wisdom, and our ambitions.


    Wow, where does one even start? I realize this isn't a medical article, but if you're trying to be taken seriously and you wish to safeguard the pretense of basing your argument on facts, you simply cannot bring puerile, uninformed, personal speculation into the discussion [Barbers, really? Are we even sure of the historical accuracy of the butchery of medieval barbers? I mean, why not medieval dentists, or even executioners. But I digress.] Although, I must say, it's a pity Mr. Saletan didn't go on with his fantasy, so that we, too, could gain some insight into how The People of the Future(TM) will look back on various contemporary surgical procedures, like, say, operative deliveries.

    That's it. I told you in the beginning, the article wasn't worth reading. Mr. Saletan tries quite hard to gain some measure of credibility by discussing medical matters (unfortunately, without much insight), but he keeps tripping on his puny "Me, Me, Me" agenda which rears its ugly head (perverse, barbaric, butchery) at almost every turn.

    Bottom line: Mr. Saletan finds abortion icky, therefore female patients should voluntarily relinquish their right to adequate medical care/certain internal organs. What is it with all these people and their desperate attempts to pass off as knowledgeable and objective, not to mention Truly Concerned(TM)?

    Tuesday, March 07, 2006

    The NIH Responds

    Reply from the U.S. National Library of Medicine (NLM):


    Thank you for your message about the Medical Encyclopedia on MedlinePlus.
    It is provided by A.D.A.M..
    We will forward the information you provided to the publisher.



    Thank you for your interest in NLM products and services.

    C. Marks
    NIH Contractor Librarian
    Customer Service
    National Library of Medicine
    8600 Rockville Pike
    Bethesda, MD 20894
    custserv@nlm.nih.gov
    1-888-346-3656 (within US)
    301-594-5983 (international)

    Points to the NIH for the prompt reply. Possible demerit for outsourcing its job to an outside company. I mean, the NIH has direct access to the best and the brightest, the experts, the lead scientists in the field. Wasn't it possible to get the information directly from them, instead of having to hire an outside company, which then has to go out and hire its own experts to verify the information (more or less successfully)? Ugh, I hate bureaucracy.

    OK, off to contact the A.D.A.M. people.

    (Background on the story here.)

    Labels:

    Grand Rounds

    Don't miss this week's Grand Rounds.

    Labels:

    NIH Update

    The story about the NIH posting incorrect information about the emergency contraception pill is here.

    I emailed the person responsible for last updating the site, Dr. Dominic Marchiano, as well as the Reference and Customer Service Section at the National Library of Medicine (custserv@nlm.nih.gov). So far, no reply. I've also emailed Dr. Trussell to let him know about this problem. I'll update once I have something.

    One more thing. Someone please do a screen capture of the original paragraph (I forgot how to do that) just to be on the safe side.

    Labels:

    Saturday, March 04, 2006

    I Am Not Fifi...More of a Mimi

    First, let me thank all the people who linked to the NIH post.

    Second, let me also say that, of all my posts, I cannot believe that the one that gets linked by all these luminaries is one in which I refer to myself as Fifi. [Can you say "mortified"?]

    For the record, people, I assure you that in real life I am a most restrained person, and I seldom, if ever, never call myself French names when discussing medical matters.

    Labels:

    Wednesday, March 01, 2006

    Where I Catch The NIH With Its Pantaloons Down

    Is the NIH posting incorrect information about the emergency contraception pill (ECP) on purpose? You be the judge.

    From the entry on ectopic pregnancy at MedlinePlus, a service of the U.S. National Library of Medicine and the National Institutes of Health (NIH):

    The "morning after pill" is associated with a 10-fold increase in risk of this condition [ectopic pregnancy] when its use fails to prevent pregnancy.


    Well, knock me over with a feather and call me Fifi; a 10-fold increase you say?

    The way I see it, there are 3 possible explanations for this statement:

    1) It's a typo.

    2) The information is accurate.

    3) The government is deliberately making stuff up.

    I haven't yet contacted the site operator, so the typo explanation remains a possibility.

    It's also possible that, while I slept last night, the medical consensus has changed and ECP use is, indeed, associated with a 10-fold increase in risk of ectopic pregnancy. This one is easily verifiable; all we need to do is to look at the relevant literature.

    Trussell does the work for us, and reviews the available studies (click on the PDF link):

    [W]e identified five clinical trials of levonorgestrel-only ECPs.3-7 As shown in Table 1, these trials reported a total of 97 intrauterine pregnancies and one EP [ectopic pregnancy]. The proportion of pregnancies that were ectopic was thus 1.02% (95% exact CI 0.02%-5.55%). This proportion is consistent with the reported national rate of 12.4 and 19.7 per 1000 pregnancies in England and Wales and in the USA, respectively.8,9 Therefore, these trials provide no evidence to suggest that progestin-only ECPs increase the chance that a pregnancy will be ectopic. Moreover, because ECPs are so effective at preventing pregnancy in general, they certainly reduce a woman's absolute risk of EP.


    Got that? There's no evidence to suggest that progestin-only ECPs increase the chance that a pregnancy will be ectopic. And do you [I'm looking at you, NIH] also get that when studies show no evidence of risk, telling your readers that there's a 10-fold increase in risk is irresponsible?

    Which brings me to the third explanation. Given that the information about the risks of using the ECP is well known and widely available, coupled with the government's repeated refusals to base ECP-related decisions on science, I am inclined to think that the NIH is deliberately misinforming the public about the ECP.

    And speaking of the NIH deliberately posting inaccurate information, referring to the ECP as the "morning after pill" is incorrect. Yes, the term is in common use and, as such, should be mentioned, in context, next to the actual drug name. But using it as the sole term is not acceptable because it can cause patients to use the ECP incorrectly. [Recall that the effectiveness of ECPs depends on timing of use.]

    If you're interested in [accurate] information on emergency contraception (EC), here's a very informative review article on EC as a coast-effective approach to preventing unintended pregnancies (.pdf).

    Update:

    As per a commenter's suggestion I did try to email Dr. Dominic Marchiano, but it didn't go through. I found a contact page for his office; I'll try to call tomorrow to see if I can get a valid email.

    Another Update:

    I emailed Dr. Marchiano. He's out of the office till Monday. I'll update if he responds.

    Labels:

    President Bush Knows Health, Not

    According to the President of the United States, when it comes to female patients of reproductive age, health is a very vague term.

    I'd love to be able to come up with some clever commentary, but this has left me speechless. Except, to say this: it is most reassuring that President Bush, although unable to clearly understand the concept of "health", is crystal clear on the much more unambiguous concepts of, say, "the War on Terror", or "domestic surveillance".

    And speaking of things that floor me, there's this tidbit about the South Dakota abortion ban:

    [The bill] also prohibits the sale of emergency contraception and asserts that life begins at fertilization.


    What does the sale of emergency contraception have to do with prohibiting abortion? Ugh, I guess I really have to force myself to read the actual bill in order to confirm this particular bit of idiocy. [To be continued.]

    Last, but not least, there's the ongoing mystery of obtaining a quote from Concerned Women for America for every article on female reproductive health.

    In a report on new research from the Guttmacher Institute on state-by-state efforts to reduce unintended pregnancies, we have this:

    The Concerned Women for America, a conservative group, criticized the report. In a statement, the group said that increased funding to prevent unintended pregnancies does not necessarily translate to lower abortion rates.


    What is the rationale for quoting this group? What value do their statements add to the discussion? And why this group, in particular, as opposed to a group of scientists who have some relevant research? Remember, the original article is not about the political or religious propaganda de jour on unintended pregnancies; it's about a research report.

    Grand Rounds

    This week's Grand Rounds is up. If you're like me, playing catch-up, here's where you can find the archived editions.

    Labels: