Wednesday, November 30, 2005

The 2005 Medical Weblog Awards




It's that time of the year again: medGadget is hosting the 2005 Medical Weblog Awards. Please send in your nomination for your favorite medblogger. You can view the categories by clicking on the image.

I must say it was great to see that TWTP has been nominated (in the Best Health Policies/Ethics Weblog). Thank you Professor Myers!

Bottom line: It goes without saying that it's an honor just to be nominated. [Yeah, right! Kids, don't lose sight of the fact that TWTP is on a quest to rule the world. What can I say, the Brain and I have aspirations of world domination in common. So, vote for me because the only thing that matters is winning...um, and ethics. Mwahahaha!]

Grand Rounds

This week it's a double treat: the current edition of Grand Rounds, and a Medscape article by the founder of Grand Rounds, Nick at Blogborygmi.

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Sunday, November 27, 2005

Does New Hampshire's Parental Notification Law Open the Door to Forced Abortions?

Since 1996 the abortion rate in New Hampshire has declined by 14%.

In 2000, there were 250 abortions performed on a minor in New Hampshire.
[<15 yo...20 procedures; 15-17 age group...230 procedures.]

The Supreme Court will consider whether to reinstate a New Hampshire law that requires parental notification 48 hours before an abortion can be performed on a minor.

I took a look at the text of this law, House Bill 763-FN, AN ACT requiring parental notification before abortions may be performed on unemancipated minors, and here are the three main problems I have identified: exemption, consent, and confidentiality.

First, the exemption problem. HB 763-FN allows for only one medical exception to the parental notification rule--the patient's imminent death ['cause that's the way to practice medicine: bring the patient to the brink of death, then intervene. And you people wonder why physicians have a God complex!]:

I. No notice shall be required under RSA 132:25 if:

(a) The attending abortion provider certifies in the pregnant minor's medical record that the abortion is necessary to prevent the minor's death and there is insufficient time to provide the required notice; or

(b) The person or persons who are entitled to notice certify in writing that they have been notified.


(emphasis mine)

According to the New Hampshire Medical Society:

There is no exception in the law to address health of the mother....Such omissions in the law puts both the physician and the minor female at risk. Is it ethical for a patient with a serious health condition to have to wait until her health status becomes near death? Is it ethical for a physician to allow a serious health condition to adversely affect a pregnant patient because the condition is not life threatening?


Never mind ethics. What about the medical standard of care? Is the standard of care for a patient with a serious health condition to have to wait until her health status becomes near death? Is the standard of care for a physician to allow a serious health condition to adversely affect a pregnant patient because the condition is not life threatening? According to New Hampshire legislators, if the patient is a minor, and if the patient is female, and if the patient is pregnant, and if the patient wants to terminate the pregnancy, then, and only then, the answer is a resounding Yes!

Second, the issue of consent. HB 763-FN clearly spells out the reasons for enacting a parental notification law:

I. ...further[ing] the important and compelling state interests of protecting minors against their own immaturity, fostering the family structure and preserving it as a viable social unit, and protecting the rights of parents to rear children who are members of their household.


The problem is all these reasons apply equally to a pregnant minor carrying a pregnancy to term. If a minor's immaturity, fostering the family structure, and protecting the rights of parents to rear their children are the basis for requiring parental notification, this notification is needed for any pregnancy-related decision, period. Pregnancy outcome--termination, or carrying to term--is irrelevant. Actually, since carrying a pregnancy to term is orders of magnitude more dangerous for a pregnant minor than terminating a pregnancy, the State should have a stronger interest in requiring parental notification before a pregnancy may be carried to term. Except, it doesn't.

For pregnancy-related decisions, a pregnant minor is considered emancipated and can give consent. This is true in almost all the states. [A few states have no law on topic. New Hampshire is one of them.] The reason pregnant minors are allowed to consent:

The nature of these health issues is such that some minors would choose to go without treatment rather than seek parental consent (i.e., adolescents may not want parents to be aware of the problem). Allowing minors to give consent in these instances ensures unrestricted access to care for those who otherwise might have been deterred from seeking help (Brody & Waldron, 2000).


So, a pregnant minor can consent to carrying a pregnancy to term, despite immaturity, family structure, and the right of parents to rear their children. However, according to HB 763-FN, this same pregnant minor cannot consent to terminating a pregnancy because of immaturity, family structure, and the right of parents to rear their children.

Judge for yourself. According to the New Hampshire law, parental notification should be required based on the following five findings of "fact" [I used quotes because the Bill offers no studies to establish a) - e) as facts, as opposed to popular belief or the legislators' opinion]:

II. The legislature finds as fact that:

(a) Immature minors often lack the ability to make fully informed choices that take account of both immediate and long-range consequences.


If true, this applies equally to minors deciding to carry a pregnancy to term, or to terminate a pregnancy.

(b) The medical, emotional, and psychological consequences of abortion are serious and can be lasting, particularly when the patient is immature.


The consequences of carrying a pregnancy to term are far more serious and lasting vs. those of having an abortion [e.g., risk of death associated with abortion is about one-tenth that associated with childbirth].

(c) The capacity to become pregnant and the capacity for mature judgment concerning the wisdom of abortion are not necessarily related.


If true, this applies equally to the wisdom of carrying a pregnancy to term.

(d) Parents ordinarily possess information essential to a physician's exercise of best medical judgment concerning the child.


I hate to repeat myself, but, if true, this applies equally to carrying a pregnancy to term, and to terminating a pregnancy. In any case, while an accurate and complete history is always desirable and most helpful, it is by no means essential to the patient receiving appropriate care. Physicians routinely [I've done it more times than I care to remember] care for, and deliver pregnant teenagers without knowing any prenatal history whatsoever, with optimal outcomes.

(e) Parents who are aware that their minor daughter has had an abortion may better ensure that she receives adequate medical attention after the abortion.


They may, or they may not. Either we have data to back up this assertion, or we're just making reasons up as we go along. [And just to be clear, receiving adequate care after an abortion is independent of parental involvement; it's the standard of care.]

In the end, there is the medical, and logical, inconsistency of allowing a pregnant minor to consent to carrying a pregnancy to term, but not to terminating a pregnancy. But what I also find troubling is that the very reasons used to justify parental notification before an abortion may be performed--the minor's immaturity, and the right of parents to rear their children--are equally valid when used to justify forcing a minor to have an abortion. Given a pregnant patient, parents who want to protect their child from the increased health risks, up to and including the risk of death, associated with carrying a pregnancy to term, have to, and may very well choose to, force their minor child to abort.

Are we really prepared to legalize forced abortions? And who exactly is going to perform these forced terminations; the legislators? Perhaps lawyers, or judges?

Which brings me to the third problem with the New Hampshire parental notification law, namely physician-patient confidentiality. If you read the Bill, you'll noticed that it is the physician's responsibility to notify his/her patient's parents:

This bill prohibits any abortion provider from performing an abortion on certain minors or incompetent females without giving 48 hours' written notice, in person or by certified mail, to a parent or guardian.


But what if your patient, the pregnant minor, refuses to allow you to notify the parents? Well, then you are stuck.

You cannot breach confidentiality and contact the parents [as per my interpretation of HIPAA regulations; feel free to wade thorough the maze of rules on your own to figure out if breaching the confidentiality of a pregnant minor is a violation]. Unfortunately, neither can you go ahead and render appropriate medical care because you'd be violating the law.

The only option allowed by this Bill* is for you to go to court and petition a judge to allow you to practice medicine.

[*It's not clear from the text who exactly is entitled to petition the judge: II. If such a pregnant minor elects not to allow the notification of her parent or guardian or conservator, any judge of a court of competent jurisdiction shall, upon petition, or motion, and after an appropriate hearing, authorize an abortion provider to perform the abortion....]

Again, from the New Hampshire Medical Society:

There is no exception in the law to address...patient privacy. Such omissions in the law puts both the physician and the minor female at risk....Does the lack of privacy breach the Hippocratic Oath or violate federal HIPAA regulations?


[Good to know I am not the only one who finds HIPAA regulations unclear.]

And I couldn't help but notice this delicious irony [delicious, because playing politics with a minor patient's life is always a special treat]:

If said judge determines that the pregnant minor is not mature, or if the pregnant minor does not claim to be mature, the judge shall determine whether the performance of an abortion upon her without notification of her parent, guardian, or conservator would be in her best interests and shall authorize an abortion provider to perform the abortion without such notification if said judge concludes that the pregnant minor's best interests would be served thereby.


When it comes to performing a medical procedure, a physician, a trained medical professional, is not deemed competent to decide what would be in the best interest of his/her patient. On the other hand, a layperson, the judge, is.

Bottom line: The New Hampshire parental notification law would only apply to about 250 patients at any given time, and only to patients who happen to be female, and who have specifically elected the least dangerous medical option for their health. The law would expose minor patients to increased morbidity and mortality, and would force them to go without appropriate medical care unless, and until, their health deteriorates to the point where the only options left are treatment or death. Last, but not least, the rationale used for this law is equally valid when applied to justify forced terminations.

Saturday, November 26, 2005

Transvaginal Eggs Retrieval

You've probably read reports of South Korean cloning pioneer Hwang Woo-suk's resignation:

After more than a year of denying rumors that some eggs used in his experiment came from subordinate scientists, Hwang on Thursday acknowledged two scientists in his Seoul lab donated their own eggs for research.

He also acknowledged he had recently found out a hospital doctor paid some women for their eggs, and stepped down as director of the World Stem Cell Hub that he and international researchers announced just last month.


I haven't followed the story closely enough to comment on it. [As a general opinion, principals shouldn't donate eggs, sperm, or any type of tissue; it's best to avoid the appearance of impropriety. On the other hand, I can understand, and sympathize with, the researchers' zeal.]

In any case, I thought you might be interested to know what is involved in one of the steps of the donation process--the eggs retrieval procedure.

Here is a review of assisted reproductive technology, with some background on the types of procedures used to retrieve eggs:

The 3 basic ways to retrieve oocytes [eggs] are laparoscopically, transabdominally, or transvaginally. The laparoscopic approach was used frequently in the 1980s, especially if a GIFT* procedure was planned. The quality of ultrasonography images was still improving. Often, only the follicles that could be seen on the surface of the ovary were removed, and, if the ovary was very mobile, traction was required to support the ovary as the follicles were aspirated. Associated morbidity occurred with the procedure, which included infection and injury to the pelvic organs. General endotracheal anesthesia was usually used, and the patient's recovery often lasted 2-3 days. As the quality of ultrasonography images and culture media improved, the need for laparoscopy decreased.

The laparoscopic approach has fallen out of favor because of its associated morbidity and need for general endotracheal anesthesia. Laparoscopy is technically more difficult, especially if the ovary is very mobile.

In 1981, ultrasound-guided aspiration was first described. Initially, the transabdominal approach was used, usually with the aspirating needle going through the bladder, which, when full, provided a window of visualization for the person operating the abdominal ultrasound probe. Although still used for retrieval of oocytes from ovaries that are adhered high up in the pelvis or to the fundus [top] of the uterus, the transabdominal approach was superseded by the transvaginal approach. The first transvaginal retrieval was performed in 1984 and has now become the procedure of choice because of its ease and low morbidity.


*GIFT (gamete intrafallopian transfer): 3-4 oocytes are placed via laparoscopy into one of the fallopian tubes along with sperm.

And here is a description, with a good drawing, of the transvaginal retrieval procedure currently used for egg donations. This is a minimally invasive, outpatient procedure:

The oocyte retrieval is performed via transvaginal guidance, under ultrasound monitoring, using very thin needles (16-18 g) which reach the follicles through a simple perforation of the vaginal surface.

During this surgical procedure, the patient is kept under sedation [IV]; therefore the procedure is safe and pain-free. All the follicles found are then aspirated (together with eventual ovarian cysts which could have developed during the stimulation phase) and the fluid retrieved is immediately examined at the microscope in order to detect the egg-cells (oocytes).


As you can see from the drawing, the needle (2) is inserted through an area of the vaginal wall a bit behind the cervix, and the tip of the US probe (1) rests on the wall. The needle insertion is not painful. In fact, this part of the egg retrieval procedure is similar to a culdocentesis--a technique occasionally used to check for blood (from a ruptured ectopic) in the posterior cul-de-sac. The procedure is usually performed in the ER, without anesthesia, and with minimal discomfort to the patient.

Friday, November 25, 2005

Grand Rounds

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

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Thursday, November 24, 2005

Happy Thanksgiving!

Wednesday, November 16, 2005

The FDA, the Patch, and Risk

The other day I posted about the issue of accurate reporting of an FDA labeling update for the patch. Here is a report more to my liking:

The U.S. Food and Drug Administration (FDA) approved new labeling today regarding the increased level of estrogen exposure associated with use of an ethinyl estradiol/norelgestromin transdermal system (Ortho Evra, made by Ortho McNeil Pharmaceuticals, Inc.) compared with most oral contraceptives.

The warning was based on the results of pharmacokinetic studies showing that steady-state [base line] levels of ethinyl estradiol were increased by 60% in patch users compared with those taking once-daily oral contraceptives containing 35 µg of estrogen. However, use of the transdermal patch also yielded a 25% decrease in maximal exposure.

Although use of the weekly patch may reduce the risk of pregnancy in women who are noncompliant with a daily oral contraceptive regimen, the FDA advises that the potential risks of increased estrogen exposure (eg, thrombotic adverse events) be considered prior to use of the product.

The FDA notes that it remains unclear whether women using the patch are at higher risk for serious adverse events compared with those taking oral contraceptives.

Further information regarding the ethinyl estradiol/norelgestromin transdermal contraceptive system may be obtained by contacting the FDA Division of Drug Information at 1-888-INFO-FDA (1-888-463-6332), or by sending an email to druginfo@cder.fda.gov.

Adverse events related to the use of the contraceptive patch devices should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


Not only is the report clear and factual, but, and this is a big plus, the article has information on how to report an adverse event. The one small criticism I have concerns this paragraph:

Although use of the weekly patch may reduce the risk of pregnancy in women who are noncompliant with a daily oral contraceptive regimen, the FDA advises that the potential risks of increased estrogen exposure (eg, thrombotic adverse events) be considered prior to use of the product.


Good advice about risks/benefits analysis, but I am not sure the main point was conveyed. The consideration is between the possible risk (of increased estrogen exposure) with patch use vs. the risk in pregnancy [far riskier, in terms of estrogen levels exposure], not between risk with patch use vs. risk without patch use in a nonpregnant state [lowest risk].

One more interesting finding. I found this message on topic, posted by, I assume, an Ob/Gyn:

By putting a warning label on it, the company is passing the liability on to you. Right now the largest group of law suits are medication problems. If you inform the patient that there may be some risk, have screened for a first degree relative with VTE, and give her the option to switch, and she decides to stay on it anyway, you have met your legal obligation and chances of a sucessful suit is extremely low. (Just attended a meeting on medical legal aspects of hormonal contraception.)


This aspect is something I hadn't considered.

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Carnival of Feminists

A nice surprise: one of my posts has been included in the new Carnival of Feminists.

Placental Weight and Breast Cancer Risk

Interesting report on a positive association between placental weight and breast cancer risk:

NEW YORK (Reuters Health) - For women who have given birth, the risk of breast cancer is directly associated with the weight of the placenta in two consecutive pregnancies, according to a report in the Journal of the American Medical Association this week. Women with higher placental weight in prior pregnancies are at increased risk for breast cancer, the study indicates.

"Our finding of a positive association between placental weight and breast cancer risk may reflect that exposures to elevated levels of hormones influence the risk of breast cancer," Dr. Sven Cnattingius, from the Karolinska Institute in Stockholm, and colleagues note in the report.

Hormonal factors play an important role in the development of breast cancer, the authors explain. "The role of estrogens in breast carcinogenesis is well established, and serum estrogen levels are at least 10 times higher during pregnancy compared with other times of life," they add.

The study included 314,019 women who delivered a single infant between 1982 and 1989 and were followed until 2001 or until breast cancer developed or death occurred. During follow up, 2,216 women (0.7 percent) developed breast cancer, of whom 2,100 (95 percent) were diagnosed before age 50 years.

The investigators found that the risk of breast cancer was significantly greater in women with placentas weighing between 500 and 699 grams in their first pregnancy and at least 700 grams in their second pregnancy compared with those who had two consecutive pregnancies with placentas weighing less than 500 grams.

The risk of breast cancer was doubled among women whose placentas weighed at least 700 grams in both pregnancies.

...

The authors note that the "underlying biological mechanisms responsible for the observed associations may not only be limited to a direct growth enhancing effect on breast cells during childbearing, but also may be due to maternal characteristics or genetic factors associated with placental growth."


I must say, the placenta is quite a fascinating organ. Here are a couple of very nice pictures [WARNING, graphic]: fetal surface, and maternal surface.

Tuesday, November 15, 2005

NuvaRing TV Commercial

Last night I saw the new NuvaRing TV ad and found it to be acceptable.

I wasn't too keen on the depiction of women walking around with what looked like a blue hula hoop around their hips. It left the impression of a large, cumbersome device. Which NuvaRing isn't. [If correctly inserted, neither the user, nor her partner should feel it.]

Also, I'm not sure someone unfamiliar with NuvaRing--a vaginal ring--understood its correct placement by viewing the ad. Taking a pill is common knowledge, and the patch ad shows device placement. Maybe they could have shown NuvaRing in situ, on a plastic model.

Or, even better, NuvaRing on parade:



A woman walking down the runway in a bejeweled panty outfit, a la this one Carrie sported in one episode of Sex and the City. Except, instead of sparkly appliques, it could've had a NuvaRing logo. [Do I have a future as an ad person, or what?]

In any case, I am just glad to see another commercial for a contraceptive on TV. Exposing a wider audience to health information is always a positive development.


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Grand Rounds

This week's edition of the Grand Rounds is up.

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Pregnancy, Postpartum, and Blood Clots

Expected results from a 30-year observational study:

PHILADELPHIA - New moms should get up and start walking as soon as possible to prevent the risk of a potentially fatal blood clot, doctors advise.

Although the chances of such clots are rare, they are four times greater for pregnant women and new mothers, a large 30-year study found, confirming what doctors have long observed.

Mayo Clinic researchers looked at medical records from 1966 to 1995 of 50,000 pregnant women who lived in Olmsted County, Minn., where data has long been gathered for a long-term health surveillance project.

The researchers focused on blood clots in leg veins (known as deep vein thrombosis) and clots that broke loose and lodged in the lungs (known as pulmonary embolism).

The incidences of deep vein thrombosis and pulmonary embolism were small -— only 105 cases occurred over the 30-year period -— but the problem is of concern because it is frequently fatal when it does happen.

...

The top tip for all new moms: Get out of bed and start walking as soon as possible. For women with risk factors - such as obesity, a history of clots, and prolonged bed rest during pregnancy - doctors may consider using leg compression devices in the hospital to get the blood moving.

But blood thinners don't lead the list of possible solutions because of potential complications, like excessive bleeding.

"Anticoagulants should be reserved for a very small group, those only with a significant risk," Hankins said. "We don't want to recommend a strategy that could do more harm than good."

Heit said aspirin has been shown to be effective for preventing stroke and heart attack but it appears not to help prevent blood clots in leg veins.

Monday, November 14, 2005

Plan B and the GAO Report

Via this NARAL site, I took a look at the just released Government Accountability Office (.pdf) report Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual [you don't say!].

Of note (emphasis mine):

While FDA followed its general procedures for considering the application, four aspects of FDA‚’s review process were unusual. First, the Directors of the Offices of Drug Evaluation III and V, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter. Second, FDA‚’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications. For example, FDA review staff told us that they were told early in the review process that the decision would be made by high-level management. Third, as documented in the reviews of FDA staff and in our interviews with FDA officials, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed. Fourth, the rationale for the Acting Director of CDER‚’s decision was novel and did not follow FDA‚’s traditional practices. Specifically, the Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents. He also stated that it was invalid to extrapolate data from older to younger adolescents in this case. FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency has considered it scientifically appropriate to extrapolate data from older to younger adolescents.

The decision to not approve the Plan B OTC switch application was not typical of the other 67 prescription-to-OTC switch decisions made from 1994 through 2004. FDA‚’s joint advisory committee considered 23 OTC switch applications during this period; the Plan B OTC switch application was the only 1 of those 23 that was not approved after the joint committee voted to recommend approval of the application. Also, the Plan B action letter was the only one signed by the Director of CDER, in this case the Acting Director of CDER, instead of the directors of the offices or divisions that reviewed the application, who would normally sign an action letter.

There are no age-related marketing restrictions for safety reasons for any of the prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. All FDA-approved OTC contraceptives are available to anyone, and all FDA-approved prescription contraceptives are available to anyone with a prescription. For hormonal contraceptives, FDA assumes that suppression of ovulation would be the same for any female after menarche,13 regardless of age. FDA did not identify any issues that would require age-related restrictions in its review of the original application for prescription Plan B, and prescription Plan B is available to women of any age.

In its comments on a draft of this report, FDA disagreed with three of our findings. First, FDA disagreed with our finding that the involvement of high-level management in the Plan B decision was unusual because their involvement is likely in high-profile and controversial regulatory decisions. Although we agree that high-level management involvement is more likely to occur with high-profile regulatory decisions, we found that the level of high-level management involvement for the Plan B decision was unusual for OTC switch applications. The other examples of high-level management involvement given to us by FDA officials during the course of our work involved decisions about the marketing of prescription drugs. Second, FDA disagreed with our discussion about when the decision to deny the switch application was made. We maintain that the draft report accurately noted that FDA officials gave us conflicting accounts about when they believed the not-approvable decision was made. Third, FDA disagreed with our finding that the Acting Director of CDER’s rationale for denying the application was novel and did not follow FDA‚’s traditional practices. We found that the Acting Director’s rationale was novel because it explicitly considered the differing levels of cognitive maturity of adolescents of different ages, and that, because of the Acting Director‚’s views about these differences in cognitive maturity, he concluded that it was inappropriate to extrapolate data related to risky sexual behavior from older to younger adolescents. The Acting Director acknowledged to us that considering adolescents’ cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application. In addition, other FDA officials told us that the agency had not previously considered whether younger adolescents would use a product differently than older adolescents.


Not to take anything away from these findings, but all one had to do to reach the exact same [obvious] conclusion was to read the medical literature. Think how much taxpayers money could have been saved.

In any case, NARAL's site also has a clock tracking the number of days since more than 70 organizations, including the American Nurses Association, the American Academy of Pediatrics, the American Public Health Association, and the Association of Reproductive Health Professionals, filed a citizen‚’s petition to request that the FDA switch certain emergency contraceptive drug products from prescription to over-the-counter status.

There's also a way to contact your representative to urge his/her support for the Maloney-Shays-Inslee-Crowley "Plan B for Plan B Act." (.pdf) This bill would give the FDA 30 days to approve or deny the application for the "morning-after pill" Plan B®. If the agency continues to drag its feet, the application is assumed to be approved....

For the record, I don't think politicians should have any say in a woman's medical decisions, period. This applies equally to Congress pressuring the FDA to reclassify condoms as special controls devices, outlawing made up medical procedures ("partial-birth" abortions), or passing bills to make Plan B available OTC.

Saturday, November 12, 2005

The FDA, the Patch, and AP

In my last post I mentioned I might have poor reading comprehension skills. Come to find out I'm in good company, that of professional health reporters employed by a major wire service.

Articles from Reuters and AP, out the same day, discuss the FDA's updated labeling for the birth control patch, Ortho Evra.

From Reuters (emphasis mine):

The U.S. Food and Drug Administration said new labeling for the patch will include information about the higher levels of estrogen, but that it was not clear whether women using the once-a-week product were more at risk for clots.


From AP (emphasis mine):

The Food and Drug Administration warned users of the popular Ortho Evra birth control patch that they are being exposed to more hormones, and are therefore at higher risk of blood clots and other serious side effects, than previously disclosed.


I've already discussed most of the claims mentioned in the AP article here. The issue today is the accurate reporting of an FDA labeling update for the patch.

Reuters reports the FDA is saying that it's not clear whether patch users are at increased risk of blood clots. AP reports something completely different. It asserts the FDA warns patch users that they're at an increased risk of blood clots. Did the Reuters and AP reporters even bother to read the text of the FDA update? One of them did. How the other prepared for the article--your guess is as good as mine.

From the FDA warning:

The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.


Bottom line: If you are a health reporter, you need to read the source material before reporting on it.

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Friday, November 11, 2005

The Story Behind Proposed Changes to Condom Labels

When I first read the news about the FDA's proposed draft guidelines for male latex condoms something didn't sound right to me.

New draft guidelines for male latex condoms published on Thursday call for packaging to include information they reduce, but do not eliminate, the risk of pregnancy and sexually transmitted diseases.

The U.S. Food and Drug Administration guidelines also specifically say condoms that contain the spermicide nonoxynol-9 must specify that they can cause irritation and increase the risk of HIV, the virus that causes AIDS.

They also specify that consistent condom use may help protect against some other sexually transmitted diseases, such as human papilloma virus, or HPV, that are transmitted through skin contact.


The article makes it sound like condom labels lack information about the risk of pregnancy and the degree of protection from sexually transmitted diseases (or lack thereof). Not true. The information is already included in the packaging. Also, proposed FDA guidelines for labeling warnings about nonoxynol-9 (N-9) date back to 2003; they were issued shortly after the 2002 CDC guidelines.

A short excerpt from the CDC:

Recent studies have found that frequent use of N-9, a spermicide contraceptive, can cause genital lesions (in the vagina) and, therefore, may increase the risk of HIV transmission. It has also been found to cause damage to the lining of the rectum, providing an entry point for HIV and other STDs. According to the guidelines, spermicides -- especially those that contain N-9 -- should not be used for STD prevention. Furthermore, N-9 lubricants should not be used during anal intercourse.

While the level of N-9 used as a lubricant in condoms is much lower than the level found to be harmful, condoms lubricated with N-9 spermicide also are not recommended because they have a shorter shelf life, cost more and have been associated with urinary tract infections in women. However, previously purchased condoms with N-9 can be used, provided they have not passed their expiration date, since the protection provided by the condom against HIV outweighs the potential risk of N-9.


Returning to the new draft guidelines, another area affected by the labeling changes would be that of proper condom use:

The draft labels, required by law, also address incorrect or inconsistent use, saying condoms should be thrown away -- not flipped over -- if not unrolled correctly.


But, again, condom labels already contain this information. According to current FDA requirements for condom labeling:

Latex condoms must also include adequate directions for use to avoid being misbranded (section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR section 801.5)....The following set of statements is an example of acceptable directions for use for latex condoms:

  • If the condom doesn't unroll, the wrong side was placed against the penis. Do not flip over. Throw it away and start over with a new condom.


  • So far it's not clear what is behind these FDA proposed draft guidelines for condom labels. [Possibly a desire to refine some of the language about N-9? But, according to the FDA draft, the guidelines would apply to latex condoms, with or without N-9. And why bury the N-9 language in so much redundant information?]

    The article continues:

    Congress called for the new FDA proposal to ensure condom labels were "medically accurate," but there has been debate between lawmakers and FDA scientists about what should be included.


    Pardon my poor reading comprehension skills, but does this say that Congress asked the FDA to issue a proposal, or does it say that, once the FDA issued it, Congress called for it to be medically accurate? And why on earth is the FDA debating medical accuracy with politicians? Medical guidelines are not some pork-laden bill, to be arrived at through negotiation and compromise. FDA's action doesn't make much sense.

    "The new guidance for condom labels issued today by the FDA recognizes that current condom claims do not meet this medical standard," said Sen. Tom Coburn, an Oklahoma Republican and physician who has pressed for the changes.

    Coburn said he welcomed the new nonoxynol-9 warning but rejected the claims about HPV, a virus that can cause cervical cancer. "The agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse," he said.


    Really: N-9 warning--good, HPV protection claims--bad? Did Sen. Coburn look deeply into the FDA's eyes (or maybe he viewed a tape) and divine that the agency is deliberately placing women at risk for HPV-related diseases? Because the medical literature doesn't support his statement.

    Briefly, from the review studies. No conclusive evidence that N-9 use increases your risk of HIV infection. Consistent evidence that genital lesions are more common in N-9 users. [These lesions are potential portals of entry for the HIV virus.] Conclusive evidence that condom use reduces the risk of HPV-related diseases (genital warts, precancerous lesions, etc.). No consistent evidence it prevents HPV infection.

    Thus, the following language from the FDA guidelines

    Using a condom also may lower your risk of developing HPV-related diseases, such as genital warts and cervical cancer....N-9 can irritate the vagina. This may increase the risk of getting HIV/AIDS from an infected partner.


    accurately reflects the available scientific evidence. In contrast, Sen. Coburn's statement reflects crass ideology. [In my opinion, a serious transgression for a physician.]

    Long story short, in order to figure out what is really going on with the proposed FDA guidelines, I had to go googling for the actual draft. [Curiously, this is not an easy document to locate.] Here it is, in all its glory (.pdf). [And may I just say "Ha!"; my instincts were correct.]

    From the Introduction (emphasis mine):

    This draft guidance will be issued in conjunction with a Federal Register notice announcing the proposal to amend the two existing classifications for condoms from class II (performance standards) to class II (special controls)....If a final rule to amend the classification for condoms is not issued, the final guidance document will not be issued.


    So much for the intrinsic value of the new label changes.

    Bottom line: The story isn't that the FDA is proposing changes to condom labels. It's that there is a (possibly politically instigated) push to reclassify condoms from performance standards devices to special controls devices.

    Anyone who really believed that a politically negotiated (mandated?) FDA action would have anything to do with science, as opposed to, you know, an attempt to exert even more control over our lives and medical decisions, raise your hand.

    Update: Welcome Pandagon readers!

    Veterans Day



    Today is Veterans Day.

    Wednesday, November 09, 2005

    Great Rounds

    Even if you're not a Trekie I have no doubt you'll find this week's Grand Rounds most enjoyable.

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    Reflections of an Almost Nonvoter

    Today is election day and I almost didn't cast my vote. I have never abstained before, but this year I simply didn't think I had a choice. Voting for the current Mayor was out of the question. [Infringing on private property rights and infantilizing adults are deal breakers for me.] And so was voting for the leading opponent. [Too "here's a problem, let's throw a few billions at it", and "it's for the children" for my taste.]

    Because I was very uncomfortable with my decision not to vote, I forced myself to read the entire voter guide for my district. I had to make sure not voting was my one and only option.

    Long story short, I am happy to report that not only have I just returned from my polling site, but I also managed to vote for a mayoral candidate I find most acceptable.

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    Sunday, November 06, 2005

    Why Do You Miss Your Pill?

    One study found somewhat unexpected reasons for women missing their birth control pill (emphasis mine):

    The 3 most frequent reasons cited by participants for missing pills were "away from home" (12.9%), "forgot" (12.9%), and "no new pack" (10.5%) ( Table 2 ). "Health" and "side effects" were the least likely to be cited. Health problems, such as nausea and vomiting, accounted for only 2.4% of missed pill instances, whereas side effects were cited as the reason for a missed pill only five times (1.3%) out of the 372 total instances of missed pills.


    To prevent pills from being unavailable, the study's authors have a few suggestions:

    ...encourage women to keep a spare pack in their purse, at their boyfriend's house, or at other relevant locations. To avoid running out of pills, women might be encouraged to plan in advance and mark a day on their calendar reminding them to make a trip to the pharmacy. If insurance plans allow, these women might also be encouraged to buy more than one pill pack at a time and to fill their prescription at a 24-hour pharmacy. Reminders, such as a watch alarm, involving a responsible partner, or changing the current pill-taking time to a more appropriate time, may help to deal with forgetfulness. Consideration of over-the-counter access to OCs or access to a limited number of pills through a pharmacist might also be warranted, because it would enable women who forget to bring pills while traveling or away from home to continue taking their pills.


    I think spare packs, and OTC access, particularly for women already using the Pill, would be the most practical solutions to this problem.

    More from the study:

    Oral contraceptives (OCs) are the most popular reversible contraceptive method available in the United States. An estimated 10 to 18 million women currently use OCs. ... The reported consistency of OC pill use varies widely among studies.[5-7] A retrospective study ... found that only 42% of OC users said they took a pill every day, and only 20% said they took a pill within 2 hours of the same time every day. Another study[9] reported that 19% of a convenience sample of 6676 European women between the ages of 16 and 30 stated they generally miss one or more pills per cycle. Those who reported missing pills were more than three times as likely to experience an unintended pregnancy than were women who took their OCs consistently. Factors associated with poor compliance included a lack of established routine for pill taking, failure to read and understand written material accompanying the OC package, not receiving adequate information from a health care provider, and the occurrence of side effects, such as nausea and bleeding irregularities. More recently, in a study of 992 women ... 47% of users missed one or more pills per cycle and 22% missed two or more. Women who did not have an established routine for pill taking were nearly four times as likely to miss two or more pills per cycle than were women who did have a routine.

    Friday, November 04, 2005

    Judge Alito's Dissent - Part Deux

    This discussion--a must read--from Professor Scott Lemieux is most illuminating:

    Alito's nomination also comes at a pivotal time for abortion jurisprudence. The Court'’s upcoming docket includes Ayotte v. Planned Parenthood, in which the Bush administration is seeking to make it far more difficult to raise "“facial challenges"” -- that is, challenges to a law as written, not just as applied in an individual case -- to abortion regulations. While this may seem like a mere technicality, is has very significant potential consequences for the survival of abortion regulations. Challengers would have to show that such laws are illegal in every possible case -- rather than just among, for example, the vulnerable women the Supreme Court previously sought to protect. Adopting this new standard would allow states to pass broad regulations that would remain in place while the expensive and time-consuming process of fact-intensive, case-specific litigation winds its way through the courts, and may also lead to opinions that allow regulations to remain on the books even if individual applications are unconstitutional. The standards for a facial challenge that Alito articulated in his Casey dissent make it all but certain that he would vote to apply this more difficult standard.

    ...

    There is more than one way to skin a precedent, and Roe's protections could be extenuated out of existence quite easily. During the deliberations in the pre-Casey abortion case Webster v. Reproductive Health Services, then-Chief Justice William Rehnquist attempted to essentially overturn Roe while technically maintaining it by articulating a new standard that would permit virtually any state regulation short of the almost-total ban struck down in Roe. This transparent ploy failed. (In response, Justice John Paul Stevens circulated a memo acidly critiquing Rehnquist's gambit. "I am not in favor of overruling Roe v. Wade,"” he wrote, "but if the deed is to be done I would rather see the Court give the case a decent burial instead of tossing it out the window of a fast-moving caboose."”)

    It failed, however, only because Rehnquist lacked the votes. It is very likely that Alito would go along with such a sub silentio overruling of Roe, and -- particularly if George W. Bush makes another appointment or if the Republicans retain the White House in 2008 -- he may well carry the five votes that Rehnquist could not.



    (via Pandagon)

    Thursday, November 03, 2005

    Legislating Plan B

    Drugs and treatments should be available based on medical merit, not legislation. Nice gesture, but still the wrong way to go about it:

    WASHINGTON (Reuters) - Lawmakers frustrated with U.S. regulators' slow pace introduced a bill Thursday to force the
    Food and Drug Administration to decide whether the "morning-after pill" can be sold without a prescription.

    The measure says the Plan B pill, made by Barr Pharmaceuticals Inc., would be automatically be approved for over-the-counter sale 30 days after the bill's passage, until the agency makes a decision.

    The bill's sponsors said the FDA had repeatedly refused to grant over-the-counter status for Plan B despite overwhelming scientific recommendations that it do so.

    "Some of the FDA's own scientists have charged that politics, not science, is behind the FDA's actions," Democratic Reps. Carolyn Maloney and Joseph Crowley of New York, Jay Inslee of Washington, and Republican Rep. Christopher Shays (news, bio, voting record) of Connecticut said in a statement.


    And, once again, Plan B is not a "morning-after pill". It is postcoital birth control. You can take it up to 120 hrs after unprotected intercourse. Also, mifepristone (RU-486) is not an "abortion pill". It is an antiprogestine. Depending on dosage/regimen, it acts to prevent a pregnancy, or to terminate it.


    Technorati tags: , , , , ,

    Legislating Plan B

    Drugs and treatments should be available based on medical merit, not legislation. Nice gesture, but still the wrong way to go about it:

    WASHINGTON (Reuters) - Lawmakers frustrated with U.S. regulators' slow pace introduced a bill Thursday to force the
    Food and Drug Administration to decide whether the "morning-after pill" can be sold without a prescription.

    The measure says the Plan B pill, made by Barr Pharmaceuticals Inc., would be automatically be approved for over-the-counter sale 30 days after the bill's passage, until the agency makes a decision.

    The bill's sponsors said the FDA had repeatedly refused to grant over-the-counter status for Plan B despite overwhelming scientific recommendations that it do so.

    "Some of the FDA's own scientists have charged that politics, not science, is behind the FDA's actions," Democratic Reps. Carolyn Maloney and Joseph Crowley of New York, Jay Inslee of Washington, and Republican Rep. Christopher Shays (news, bio, voting record) of Connecticut said in a statement.


    And, once again, Plan B is not a "morning-after pill". It is postcoital birth control. You can take it up to 120 hrs after unprotected intercourse. Also, mifepristone (RU-486) is not an "abortion pill". It is an antiprogestine. Depending on dosage/regimen, it acts to prevent a pregnancy, or to terminate it.


    Technorati tags: , , , , ,

    Grand Rounds

    I'm late in mentioning this week's Grand Rounds (not surprising, perhaps, seeing how this edition was the one time I submitted a post two days in advance and still managed to miss the deadline somehow). Also, Dr. Charles is hosting Tangled Bank.

    Correction: I have Grand Rounds ADD; I didn't miss the deadline. My apology to the host at KidneyNotes for the confusion.

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    FDA Still Silent on Morning-After Pill

    You don't say!

    WASHINGTON - The morning-after contraception pill known as Plan B reached a regulatory milepost Tuesday with still no word from the Food and Drug Administration whether it will be sold without a prescription.

    Tuesday marked the end of 60 days of public comment sought by the agency after it delayed a final decision whether to approve over-the-counter sales despite substantial agreement among agency scientists that the pill was safe and effective. An FDA spokeswoman said that as of Monday, the agency had received 2,268 comments, but she said they had not been analyzed yet.

    "We will review the public comments as soon as practicable and, taking those comments into account, decide how to proceed," spokeswoman Julie Zawisza said in an e-mail.


    Well, if we're practicing medicine by popular vote, clearly the "pros" have it:

    Clinton and Sen. Patty Murray (news, bio, voting record), D-Washington, on Tuesday submitted a petition to the FDA's acting chief, Dr. Andrew von Eschenbach, calling the agency's inaction "virtually unprecedented." It was signed by more than 9,800 supporters.


    And while we're on the subject of Plan B, let's dispel one more myth. The emergency contraception pill is not the "morning-after-pill". It's postcoital birth control. It is best to take it as soon as possible after the act of unprotected intercourse, but the window is up to 120 hrs. "Morning-after-pill" is a misnomer. Let's all stop using it.

    Tuesday, November 01, 2005

    Judge Samuel Alito's Dissent

    All I wanted to do was to educate myself about Judge Samuel Alito's dissent in the case of Planned Parenthood v. Casey. Big. Mistake. I have nerve cells exploding left and right after reading through some of the relevant legal cases and opinions.

    Exploding neurons aside, here is what I found. Judge Alito wrote a dissent which argued for the validity of a provision in a Pennsylvania law requiring husband notification before an abortion. [I am using "husband notification", rather than "spousal notification" because I'm not aware of any instance where competent male patients are forced by law to notify their wives of their intention to undergo a medical procedure.]

    So, the first thing I did was to read Judge Alito's dissenting opinion (via Pandagon and Whiskey Bar). What jumped out at me was this:

    First, as the district court found, the “vast majority” of married women voluntarily inform their husbands before seeking an abortion. Planned Parenthood v. Casey, 744 F.Supp. 1323, 1360 (E.D.Pa.1990). Indeed, in the trial testimony on which the district court relied, the plaintiffs‚’ witness stated that in her experience 95% of married women notify their husbands. App. at 701.


    Really, 95% of married women notify their husbands? I wanted to take a look at this study because something about it didn't sound right to me. It seems unlikely that the population of married, reproductive-age women in any one given state is that homogeneous. Just based on my clinical experience, I found that voluntary husband notification trends are heavily influenced by the type of patient population you treat.

    I tried to track down the 95% study, but I only got as far as the oral arguments in Planned Parenthood v. Casey. All I could find is this mention from Mr. Preate, Pennsylvania's Attorney General:

    ...we submit that in this particular instance the record reflects that right now, in Pennsylvania, 50,000 abortions, 20 percent of those women are married and 95 percent of those women notify their husbands.


    So I'll have to reserve judgmentment on the validity of the 95% finding until I read the study. [If you know how to find "the record" where this study is cited, please let me know.]

    While I wasn't able to locate the study, I did come across an interesting morsel in the oral arguments. According to Mr. Preate, the reasons for the husband notification law are:

    MR. PREATE: ...If you look at the State interests that are trying to be pursued here -- protecting the life of the unborn, protecting the marriage, ensuring the possibility of communication -- this statute rationally advances it.


    The sate has an interest in protecting the "life of the unborn", but only if the "unborn" happens to be implanted in a married woman's internal organ. If said organ belongs to an unmarried woman, then what? The state no longer considers the "life" of that "unborn" worthy of protection and loses interest? [I'm using quotes for life/unborn because they're neither medical, nor defined terms.]

    Personally, I'm not too keen on the second reason either. Is it the state's business to protect marriage? And, if yes, how intrusive should the state be allowed to be?

    Finally, I must say that the third reason mentioned--ensuring the possibility of communication--takes the cake. As noted by one of the justices in the SCOTUS decision: The State is compelling a woman to say something to her
    husband.
    Forget Web 2.0. The future of human interactions is the Government regulating communications between husbands and wives.

    Anyway, back to Judge Alito's dissent. In Planned Parenthood v. Casey at issue were (emphasis mine):

    ...five provisions of the Pennsylvania Abortion Control Act of 1982: § 3205, which requires that a woman seeking an abortion give her informed consent prior to the procedure, and specifies that she be provided with certain information at least 24 hours before the abortion is performed; § 3206, which mandates the informed consent of one parent for a minor to obtain an abortion, but provides a judicial bypass procedure; § 3209, which commands that, unless certain exceptions apply, a married woman seeking an abortion must sign a statement indicating that she has notified her husband; § 3203, which defines a "medical emergency" that will excuse compliance with the foregoing requirements; and §§ 3207(b), 3214(a), and 3214(f), which impose certain reporting requirements on facilities providing abortion services.


    The provision under discussion is § 3209 which commands that, unless certain exceptions apply, a married woman seeking an abortion must sign a statement indicating that she has notified her husband. [Ah, to be a woman, and to be commanded. What more could any one woman possibly ask for?] SCOTUS found that:

    2. Section 3209's husband notification provision constitutes an undue burden, and is therefore invalid. A significant number of women will likely be prevented from obtaining an abortion just as surely as if Pennsylvania had outlawed the procedure entirely. The fact that § 3209 may affect fewer than one percent of women seeking abortions does not save it from facial invalidity, since the proper focus of constitutional inquiry [505 U.S. 838] is the group for whom the law is a restriction, not the group for whom it is irrelevant. Furthermore, it cannot be claimed that the father's interest in the fetus' welfare is equal to the mother's protected liberty, since it is an inescapable biological fact that state regulation with respect to the fetus will have a far greater impact on the pregnant woman's bodily integrity than it will on the husband.


    An aside. In the SCOTUS decision I also read this bit:

    Because abortion involves the purposeful termination of potential life, the abortion decision must be recognized as sui generis, different in kind from the rights protected in the earlier cases under the rubric of personal or family privacy and autonomy.


    Since male masturbation also involves the purposeful termination of potential life, I take it the decision to masturbate must also be recognized as sui generis, different in kind from the rights protected in the earlier cases under the rubric of personal or family privacy and autonomy. Coming soon to a police department near you, the Squad for Prohibition of, and Enforcement of Rules on, Masturbation, or SPERM.

    Back on topic. SCOTUS finds that the husband notification provision constitutes an undue burden, and is therefore invalid. Judge Alito disagrees with this finding.

    From my reading of Patterico's analysis of the dissent (via Instapundit), Judge Alito has two main problems with the majority opinion.

    The first one is that, in his view, the husband notification had not been shown to be an undue burden because, according to Patterico, a) it appears clear that an undue burden may not be established simply by showing that a law will have a heavy impact on a few women but that instead a broader inhibiting effect must be shown, and b) the appellees challenging the statute had not met their burden of proof — which Justice O’Connor had said rested with those asserting an ‚“undue burden‚” ‚— to show that the law had the ‚“broader inhibiting effect‚”. Patterico continues:

    Judge Alito concluded that, absent any evidence as to how many women would be adversely affected, the appellees had failed to meet their burden of showing that the spousal notification requirement imposed an “undue burden‚” on women.

    But look at what the SCOTUS decision has to say about this:

    A significant number of women will likely be prevented from obtaining an abortion just as surely as if Pennsylvania had outlawed the procedure entirely. The fact that § 3209 may affect fewer than one percent of women seeking abortions does not save it from facial invalidity, since the proper focus of constitutional inquiry [505 U.S. 838] is the group for whom the law is a restriction, not the group for whom it is irrelevant.


    If you are wondering what this "facial invalidity" test is all about, I found the following exchange from the oral arguments somewhat helpful:

    QUESTION: But in the facial context, I don't understand what you -- so there are two undue burden tests. There is one at the facial level in which we consider the statute engross and decide whether, all things considered in the generality of applications, the burden is undue. And then we have a second wave of application of the undue burden test case- by-case, so that even though the law facially may be okay, it may be invalid in its particular application because of -- is that what you are saying?
    MR. PREATE: In the second instance, as applied it --
    QUESTION: I am worried about the first one, not the second one. I thought the --
    MR. PREATE: In a facial challenge, Justice Scalia, you are looking at not the worst scenario hypothesis, but whether this act could be applied constitutionally to anyone, and that is --
    QUESTION: Any single case, not engross, to any single case. Isn't that the normal situation? To challenge a statute facially you have to show that it can never be constitutionally applied, isn't that right?
    MR. PREATE: That's correct.
    QUESTION: That is not looking at it engross. That is asking whether there is any single case where a woman would not be unduly burden.
    MR. PREATE: In this particular instance, we find that there is no undue burden in our statute, anywhere in our statute, and if the undue burden test is, as applied or understood by this Court causes our statute to fall, then we ask this Court to adopt rational basis as the appropriate analysis.
    [In other words, if they can't win on the soundness of the undue burden test, they're asking the Court to just pick another test. Ah, if only do-overs worked in real life.]


    The second disagreement Judge Alito has with the SCOTUS opinion concerns the legitimacy of the state's interest in requiring spousal notification.

    According to Patterico:

    Judge Alito then turned to a discussion of Justice O’Connor’s opinion in a previous case finding unconstitutional a two-parent notification requirement without a judicial bypass. Judge Alito argued that Justice O‚’Connor‚’s opinion (and Justice Stevens’s opinion, which Justice O’Connor joined) had applied a variant of the rational relationship test, which requires only that the restriction be reasonably related to the furtherance of a legitimate state interest. Again, this was a reasonable reading of the precedents at the time.

    Judge Alito concluded with the uncontroversial proposition that the restriction in question furthered a legitimate state interest, ‚“namely, the state’s interest in furthering the husband’s interest in the fetus.” Even the majority didn‚’t dispute that “promoting the possibility of spousal participation is undoubtedly a legitimate state interest.‚” Judge Alito found that the restriction in question reasonably furthered that interest.


    Except that the SCOTUS decisions has this to say about the state’s interest in the husband's interest:

    Furthermore, it cannot be claimed that the father's interest in the fetus' welfare is equal to the mother's protected liberty, since it is an inescapable biological fact that state regulation with respect to the fetus will have a far greater impact on the pregnant woman's bodily integrity than it will on the husband.


    Whiskey Bar has more on the issue of the state's legitimate interest in requiring husband notification (make sure to read the entire analysis):

    [Judge Alito] tries to determine if the state of Pennsylvania has a "legitimate" state interest in requiring spousal notification.

    He starts with Skinner v Oklahoma, in which the Supreme Court held that men have the right not to be forcibly sterilized.... From there, Scalito [Judge Alito] jumps to a string of cases establishing that a husband has an interest in the rearing of his children -- living, breathing-on-their-own-outside-the-womb children. From this, he concludes:

    It follows that a husband has a “legitimate” interest in the welfare of a fetus he has conceived with his wife.


    ...

    Scalito then turns to the Supremes' ruling in Planned Parenthood v Danforth, one of the early post-Roe state regulation cases, and notes approvingly the court's remark that "we are not unaware of the deep and proper concern and interest that a devoted and protective husband has in his wife’s pregnancy and in the growth and development of the fetus she is carrying." Clearly, Scalito opines, "deep and proper . . . interest" is synonymous with "legitimate" interest. Case closed.

    There's just one problem -- the court was ruling against the State of Missouri's legislative bid to give husbands a veto over abortion decisions. So if any inference is to be drawn, it should be that a husband's fetal interest is limited -- no matter how "deep and proper" it might be. That doesn't mean the PA law went too far (although the O'Connor court concluded exactly that) but it's hardly proof for the proposition that it didn't go too far.

    In any case, the test is not whether the husband has a "legitimate" claim on a uterus, it's whether the state has a legitimate interest in regulating that claim. Here Scalita falls back on the exceedingly obvious constitutional principle that:

    "Statutory regulation of domestic relations is an area that has long been regarded as a virtually exclusive province of the States."


    ...

    States have the authority to regulate all kinds of "domestic relations" -- subject to the limitations imposed by the U.S. constitution and that pesky 14th Amendment. But what they do not have the power to do is meddle in the reproductive affairs of their citizens in an overly intrusive or "unduly burdensome" way. Not unless the Supreme Court is going to throw out Griswold and the line of cases stemming from it, including Roe.


    In conclusion, what have I learned so far? Quite frankly, not as much as I had hoped. The claim that 95% of married women notify their husbands appears pivotal to Judge Alito's dissent, but I couldn't locate the study. Also, Judge Alito says that absent any evidence as to how many women would be adversely affected, you cannot show that the husband notification requirement imposes an undue burden on women. Yet, SCOTUS directly contradicts him--the fact that the husband notification provision may affect fewer than one percent of women seeking abortions does not save it from facial invalidity. So, which is it? And what is this magical number alluded to by Judge Alito? When it comes to women, how many would need to be adversely affected by a law, before sage lawyers, judges, and politicians magnanimously allow women not to suffer its undue burden?

    Happy Halloween!






    PS: I just saw the most adorable black pug, dressed as a bumblebee.