Katrina's Aftermath

Hospitals across the city faced deteriorating conditions Tuesday after two levees broke, sending water coursing through the streets of the Big Easy. An estimated 80 percent of the below-sea-level city was under water, up to 20 feet deep in places, with miles and miles of homes swamped.

As floodwaters rose around Charity Hospital, the rescuers needed their own rescuing.

Charity's backup generator was running out of diesel fuel. Nurses hand-pumped ventilators for patients who couldn't breathe. Doctors canoed supplies in from three nearby hospitals.

"It's like being in a Third World country. We're trying to work without power. Everyone knows we're all in this together. We're just trying to stay alive," said Mitch Handrich, a registered nurse manager at the state's biggest public hospital.

U.S. Health and Human Services Secretary Mike Leavitt said 2,500 patients would be evacuated from hospitals in Orleans Parish, but it wasn't immediately clear where they would be moved.

Police were working to get more generators to Charity and its 300 patients. The most critically ill would be evacuated first, with the rest to go later this week.

Outside Charity, water was 3 to 4 feet deep in the street. Inside, halls were dark and slippery. Workers ferried supplies up and down darkened stairs. Everyone needed flashlights.

And yet the injured kept coming.

If you'd like to help, here is a good place to start.

Plan B and Mike Leavitt

Did the FDA trick U.S. Senators, seasoned activists, reporters, and you and me into believing it intended to reach a decision on OTC availability of Plan B by September 1, 2005?

Let us see, shall we?

Health and Human Services Secretary Mike Leavitt today offered an explanation for the FDA's failure to decide if Plan B's may be sold OTC by Sept. 1:

U.S. Health and Human Services Secretary Mike Leavitt on Monday defended the Food and Drug Administration's delayed ruling on over-the-counter access for a "morning-after" pill, saying officials never guaranteed a "yes or no" decision by this week.

On Friday, the FDA postponed a ruling on Barr Laboratories' Plan B emergency contraception because it said officials are unsure how to enforce a prescription requirement for younger girls while easing access for women over 16.

"We did take a step forward in the process," Leavitt said. "Sometimes action isn't always yes and no. Sometimes it requires additional thought."

The FDA, which is part of Leavitt's department, called for 60 days of public comment but gave no further deadlines.

Supporters and critics of the controversial drug expected the FDA to rule by Thursday, when Leavitt and FDA Commissioner Lester Crawford said the agency would act.

"FDA made their commitment to me and I made my commitment to the senators," Leavitt said. "The commitment was they would act. They did."

Democratic Sens. Patty Murray of Washington and Hillary Clinton of New York, who both dropped objections over Crawford's nomination as commissioner based on that pledge, said Leavitt was playing "word games."

"A delay is not a decision and no amount of semantics can change that," they said in a joint statement.

As you may recall, I was quite critical of Sens. Murray and Clinton. I thought they were being disingenuous, pretending to believe FDA's assurances about a decision on Plan B so that they could reach some type of deal on the nomination of Lester Crawford as head of the FDA in order to benefit their political careers .

But what if the two Senators took FDA's promise at face value? In fact, what if the FDA never promised to reach a decision on Plan B by September 1st?

It appears all this talk about a "guarantee" from the FDA is based on a letter from Secretary Leavitt to Sen. Mike Enzi (R-Wyo.). This July 16, 2005 article from the Washington Post has the story [emphasis mine]:

The nomination of Lester M. Crawford, the administration's embattled choice to head the Food and Drug Administration, got a boost yesterday when three senators agreed to lift their holds and allow a vote on the Senate floor.

...

Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) announced their decision to lift their holds on the nomination after receiving written assurances that the agency will decide by Sept. 1 whether to allow sale of the emergency contraceptive Plan B without a doctor's prescription.

...

"While we continue to have concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA's failure to provide an answer on Plan B," they said.

The assurance of a decision by Sept. 1 came in a letter from Health and Human Services Secretary Mike Leavitt to Sen. Mike Enzi (R-Wyo.), chairman of the committee that voted to endorse Crawford's appointment. "I have spoken to the FDA," Leavitt wrote, "and, based on the feedback I have received, the FDA will act on this application by September 1, 2005."

One more thing of note from the article:

Leavitt's statement that the Plan B application will be acted on by Sept. 1 was welcomed by women's health advocates, who said a decision is overdue.

"President Bush's FDA has 46 days until they must decide whether to side with the doctors and scientists who overwhelmingly support giving women over-the-counter access to the pill or, once again, cave in to the anti-birth-control radical right," said Nancy Keenan, president of NARAL Pro-Choice America. "The 'morning-after' pill is a safe, effective way to help women prevent unintended pregnancies."

So, Secretary Leavitt's letter clearly states that the FDA will act on Barr Labs' application.

Two career politicians, one experienced NARAL president, and countless others understand FDA's stated intention to act on this application by September 1, 2005 to mean that, by that date, the FDA will make a decision (of the "yes or no" variety) regarding the OTC availability of Plan B.

Finally, today it is explained to us by Secretary Leavitt what the meaning of act on this application by September 1, 2005 is. [What is it with these politicians and their penchant for redefining common words to suit their scheme du jour?]

According to the FDA, act on this application [to allow Plan B to be available OTC] by September 1, 2005 means 1) make no decision about allowing Plan B to be sold OTC, 2) ask for 60 days of public comment, and, last but not least 3) give no further timetable or deadlines for deciding if Plan B should be available OTC.

Secretary Leavitt calls FDA's latest action on the availability of Plan B a step forward in the process. [Ah, the warm, tingly feeling one must get from being a powerful politician condescending to the peons!] I beg to differ.

Here's the timeline for Barr Labs' FDA application for OTC availability of Plan B:

April 22, 2003

FDA receives Barr Labs' supplemental new drug application proposing nonprescription (OTC) availability of Plan B.

According to the Prescription Drug User Fee Act (PDUFA), the FDA has until February 20, 2004 decide if Plan B can be sold OTC.

[Basically PDUFA is a type of legalized extortion (whatever would we do without the hard work of our beloved politicians!): the Pharmas "agree" to, and do pay the FDA hundreds of millions of dollars in "fees" (~$137.7 million for FY 2000). In return, the FDA agrees to, you know, have some standards. (The FDA agrees to a set of performance standards intended to reduce the approval time for drug applications.)]

December 2003

Following a meeting of the FDA's Nonprescription Drugs and Reproductive Health Drugs Advisory Committees, two FDA advisory panels vote 23-4 to recommend approval of the sale of Plan B without a prescription.

Feb. 13, 2004

FDA extends the original 10-month PDUFA deadline for completion of its review of the Plan B application. According to Barr: The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.

May 2004

FDA issues a "not approvable" letter, which cites inadequate data on the use of the pills among girls ages 16 and younger. According to this: FDA scientists disagreed with the agency's finding that there was not enough information on how Plan B would affect the sexual behavior of younger women....

January 5, 2005

JAMA study concludes: Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

July 22, 2004

Following FDA's suggestion contained in the "not approvable" letter, Barr Labs resubmits its application to the FDA to sell Plan B OTC to individuals age 16 and older. [Can you say age discrimination?]

Aug. 26, 2005

FDA informs Barr Labs of its decision to delay any action on Barr's application seeking OTC status for Plan B.

According to Barr Labs, the letter they received from the FDA states that "the Center for Drug Evaluation and Research ... has completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product ... for women who are 17 years of age and older."

FDA informs Barr Labs that it intends to seek public comment on issues related to the approval of a product that has OTC status for patients 17 and older and prescription status for patients 16 and under.

Finally, according to Barr Labs (emphasis mine): In its communication with the Company, the FDA did not commit to any timetable for initiating or concluding the rulemaking proceeding.

One step forward in the regulatory process of Plan B, according to HHS Secretary Mike Leavitt and the FDA. One giant leap backward for women's health, according to reality.

Mouse Advice

I need a new mouse for my PC (Gateway), something simple and functional. [I'd love to get a wireless one, but not sure if it'll work.] Any suggestions?

Grand Rounds

Make sure not miss this week's Grand Rounds.

Katrina

Good luck to the people in its path, and fingers crossed.

A Dilemma

I am torn between the Mousians and the Pastafarians. I'm considering going the MousiPastaf way.

Hmm, haven't even joint yet and I'm already splintering.







(pics via Pandagon and Kung Fu Monkey)

Plan B and Crocodile Tears

Plan B

Awww, the plight of these two political naifs is almost enough to bring a tear to your eye:

U.S. officials deferred ruling on over-the-counter sales of Barr Pharmaceuticals Inc.'s "morning-after" contraceptive on Friday, sparking charges that repeated delays were motivated by politics rather than science.

...

Sens. Patty Murray of Washington and Hillary Clinton of New York, both Democrats, charged Bush administration officials with breaking a promise to rule on Plan B by September 1. Murray and Clinton agreed to drop objections to a vote on Crawford's nomination as FDA commissioner in light of that pledge.

"It is a breach of faith to have this administration give us their word that a decision would be made, and have that promise violated. FDA's only criteria for approval should be safety and efficacy, not politics and ideology," the senators said in a joint statement.

It's difficult to decide which is more condescending and harmful: the FDA abandoning science as a criterion for making regulatory decisions, or politicians horse-trading women's health and lives.

At least people like Wendy Wright from Concerned Women for America are up-front about their agenda [Unfortunately, they're also ignorant of the topic under discussion--e.g., pedophiles are attracted to prepubescent children.]:

Concerned Women for America (CWA), a conservative group that opposes over-the-counter sales, welcomed the FDA action.

"It is naive to assume any over-the-counter scheme for the morning-after pill would be effective," said Wendy Wright, CWA's senior policy director. "A 17-year-old could buy it for a 13-year-old girl. Or worse yet, a pedophile could purchase this drug for his victims."

With politicians and misguided people like Ms. Wright shaping health care, and the debate about what constitutes proper care, the future of American medicine [for women] looks bleak, indeed.

Noncontraceptive Use of the Pill

Here's a good example of a noncontraceptive use of the Pill, from a small study on endometriosis pain: the combination Pill as an adjuvant to a cancer drug.

Arimidex, a drug used for breast cancer, is used in the study to reduce the pain of endometriosis. Alesse, a combination Pill, is used to prevent the osteoporosis [loss of bone density] associated with the cancer drug:

A drug used to treat and prevent breast cancer, Arimidex, can significantly reduce the pain of endometriosis when taken daily along with an oral contraceptive, investigators in the U.S. report.

Endometriosis is an often-painful condition in which tissue that normally lines the uterus is found elsewhere in the abdomen. Current treatments for endometriosis are ineffective for many women or have dangerous side effects, Dr. Serdar E. Bulun, from Northwestern University in Chicago, and his associates note in the medical journal Fertility and Sterility.

Arimidex inhibits an enzyme, aromatase, involved in estrogen synthesis, and it was recently found that high levels of aromatase are expressed in endometrial tissue of women with endometriosis.

Bulun's group theorized that Arimidex (generic name, anastrozole) would block aromatase from producing estrogen in the endometrial tissue. An oral contraceptive would prevent the osteoporosis associated with aromatase inhibitor drugs.

In their study the investigators treated 18 women, who had failed at least two other treatments for endometriosis, with anastrozole and the Alesse oral contraceptive daily for 6 months.

Fourteen of the 15 women who completed the study experienced significant reductions in pelvic pain. By the end of the first month, the average pain score on a 10-point visual scale fell from 8.70 to 6.20, and by the end of 6 months it was 3.20.

Advantage: Orac

I know someone who's been blogging about this for quite some time:

The clinical benefits attributed to homeopathic treatment are merely placebo effects, according to the authors of a report in The Lancet medical journal.

Homeopathy is based on the notion that "like cures like," and treatment involves giving a patient small amounts of drugs that, in larger quantities, cause symptoms like those suffered by the patient. It also involves a great deal of interaction between the practitioner and the patient.

In the current article, Dr. Matthias Egger, from the University of Berne in Switzerland, and associates searched 19 electronic databases covering the period from 1995 to 2003 to identify scientific trials of homeopathy, and matched them with trials in conventional medicine.

The team identified 110 trials each of homeopathy and conventional medicine, or allopathy. They used sophisticated statistical analysis to score the results of the studies, with those below 1.0 indicating a beneficial effect of treatment versus inactive placebo.

Including the largest trials, which were considered the most reliable, the overall scores were 0.96 for homeopathy and 0.67 for conventional medicine.

Egger and his colleagues say the results provide "no convincing evidence that homeopathy was superior to placebo, whereas for conventional medicine an important effect remained."

The Lancet editors weigh in on this topic, saying, "Surely the time has passed for selective analyses, biased reports, or further investment in research to perpetuate the homeopathy versus allopathy debate."

They add: "Now doctors need to be bold and honest with their patients about homeopathy's lack of benefit, and with themselves about the failings of modern medicine to address patients' needs for personalized care."

The "Fetal Pain" Fallacy

According to a JAMA review study [d]octors should not be required to discuss fetal pain with women seeking abortions because fetuses likely can't feel pain until late in pregnancy.

No matter. Sen. Sam Brownback, R-Kan, sponsor of proposed federal fetal pain legislation, says the JAMA report seems to fly in the face of common experience and common sense. Well then, off with the scientists' heads, metaphorically speaking, of course. I don't know about you, but I find it quite disturbing that people of Sen. Brownback caliber get to decide what our medical care should be.

If it's true that we deserve the leaders we get, what does that say about us?

On a less philosophical note, here's a good discussion of fetal pain, as well as some background on Dr. Kanwaljeet Anand, the MD quoted in the AP article:

Nevertheless, the [partial-birth abortion ban] trials will have a lasting consequence because of multiple damaging testimonies from Dr Kanwaljeet (Sunny) Anand on the issue of fetal pain. The potential for fetal pain was already becoming a common part of the argument against abortion but it is now guaranteed to form a more central role. Fetal pain

Dr Kanwaljeet Anand made a series of seminal discoveries during the late 1980s that led to a dramatic change in the treatment of neonates undergoing surgical and other types of care. Anand demonstrated that the major hormonal response to invasive practice could be significantly reduced when strong opioids, pain-killers, were added to the anesthetic regimen (7). Accompanying these reductions in the hormonal 'stress response' to injury were dramatic improvements in clinical outcome. Babies prepped for surgery with opioids required less post-surgical ventilatory support and had reduced circulatory or metabolic complications (8).

Anand and his colleagues advanced these impressive findings in a subsequent report indicating that neonates receiving deep anaesthesia during surgery had improved post-operative morbidity, they survived more frequently, compared with those neonates who received lighter anaesthesia (8). An accompanying editorial called on physicians to 'Do the Right Thing', concluding that 'it is our responsibility to treat pain in neonates and infants as effectively as we do in other patients' (9). In an earlier review for the New England Journal of Medicine, however, Anand was more measured, stating that: 'None of the data cited [in this review] tell us whether neonatal nociceptive activity and associated responses are experienced subjectively by the neonate as pain similar to that experienced by older children and adults' (10).

Since that time, Anand has moved further and further towards the view that neonates and late-term fetuses do not merely respond to noxious events but experience pain subjectively.

...

...Anand... [made] the following claim during the course of the trial in New York: 'I can state my opinion to a degree of medical certainty that all fetuses beyond 20 weeks of gestational age will experience severe pain by the partial-birth abortion procedure.'

But the statement is pure hyperbole and nonsense, for many reasons (12).

...

In short, fetal pain is a moral blunder based on the false equivalence between observer and observed that misses the whole point and process of development.

Grand Rounds

Please make sure to visit this week's edition of Grand Rounds.

A Local Voice

If you're not reading The Religious Policeman, you're missing out on a great perspective. Just to get a feel, read this, and this, and especially this.

Doctors and Divine Guidance

When it comes to divine guidance, Psychiatrists and Radiologists are the most practical among us (36% and 27%, respectively). At the other end of the spectrum, Family Practitioners and Anesthesiologists are the ones most likely to look to God for strength, support and guidance (58% and 56%). Ob/Gyns come in at 49%.

Other interesting findings:

Physicians and population members are equally likely to have some religious affiliation, but physicians are much more likely to belong to religious traditions that are underrepresented in the United States. Physicians are more likely than population members to attend religious services regularly, but less likely to consciously make efforts to apply their religious beliefs to other areas of life. Physicians are more likely to describe themselves as "spiritual" as distinct from religious, whereas for the general population, spirituality and religion appear to be more tightly connected. Finally, our data suggest that patients and physicians are likely to differ in their reliance upon God as a means of coping and making decisions in the context of major illness. While most patients will "look to God for strength, support, and guidance," most physicians will instead try to "make sense of the situation and decide what to do without relying on God." How such differences shape the clinical encounter is unknown.

Religious Affiliation of Physicians Compared With the U.S. Population

Affiliation	Physicians, %	U.S. Population, %
Protestant	38.8	54.7
Catholic	21.7	26.7
Jewish	14.1	1.9
None	10.6	13.3
Hindu	5.3	0.2
Muslim	2.7	0.5
Orthodox	2.2	0.5
Mormon	1.7	0.4
Buddhist	1.2	0.2
Other	1.8	1.6
Total	100	100

Heavy Periods and the IUD

Excellent news from a new study: women who suffer from heavy periods and use a progesterone-releasing IUD (like Mirena) may expect an up to 95% reduction in menstrual blood loss.

The Role of Colposcopy in Rape Exams

Some highlights from an interesting discussion on the role of using colposcopy in rape exams.

Since the 1980s, the technique once reserved for victims of child abuse has been used across the lifespan and has been shown to identify genital injury in up to 87% of women who have been raped.

Several investigators using colposcopy have identified the posterior fourchette* as the most common genital location for injury in women after rape.

*[posterior fourchette=band of tissue that connects the two labia minora. It extends inferiorly as a low tissue ridge that fuses in the middle.]

In one study, the frequency of injury by anatomic sites was posterior fourchette (70%), labia minora (53%), hymen (29%), and fossa navicularis (25%).

Adolescent girls were most likely to experience injuries at the fossa navicularis, hymen, posterior fourchette, and labia minora.

Anal and rectal injuries are known as markers for marital rape.

In married couples the most frequent type of forced sex was vaginal intercourse (82.7%), the second most frequent type was forced anal intercourse (52.8%).

An absence of rigorous studies with large sample sizes limits our knowledge about injuries following rape as compared to consensual sexual intercourse.

When examining women after consensual sexual intercourse, some studies found a 10% injury rate; others have found higher rates of injury (61%).

With consensual intercourse most women have microtrauma (telangiectasia, broken blood vessels, microabrasions with superficial denuding of the epithelium and increased vascularity). The most common types of lesions: petechiae, erythema, abrasions [scrapes], and edema.

The issue of identifying an injury pattern that has a high sensitivity to predict rape remains problematic.

Non-reporting estimates for completed rape in a variety of populations range from 63%-95%.

The level of injury sustained during rape increases the likelihood of the victimization being reported to the police. In addition, whether or not the victim sustained physical injury besides rape injuries (injuries ranged from severe injuries such as gunshot wounds and broken bones to minor injuries such as bruises, cuts, and scratches) was one of two factors (the race of the victim, specifically being African American was the other) that significantly increased the likelihood of a rape victimization being reported to the police.

A recent study suggests that women's knowledge of genital injury, particularly in the absence of non-genital injury, is important to the victim's decision to report to police.

In one U.S. survey, of the 31.5% of rape victims who reported having suffered an injury, only 35.6% of these women received medical care.

Among the most frequently given reasons for not reporting to the police is "lack of proof that the incident happened".

The U.S. Federal Bureau of Investigation reported that 8% of all rape complaints were unfounded by the police nationwide in 1997.

The role of injury is relevant to the police decision to unfound rape cases.

One examination of felony-level cases of rape found that nearly 35% of the victims in the sample agreed to undergo the forensic exam at a local hospital. The police were less likely to unfound a case when the victim agreed to undergo the forensic exam. This increased probability represents either the willingness of the victim to cooperate with the investigation or the usefulness of the examination to provide evidence that could then be used by the prosecutor.

Prosecutors consider the presence of medical evidence in deciding whether or not to prosecute a rape case

Forensic examiners are not decision-makers per se in the criminal justice process, they play a pivotal role in the evidence component of the justice process.

Two primary issues at stake in rape cases are identification and consent.

In the future, colposcopy, depending upon the degree of confidence with which images of consensual sex and rape can be differentiated, may offer valid and reliable scientific evidence that can address the issue of consent and thus could be used to corroborate reports of rape and aid in the prosecution of rape cases.

Daddy Discrepancy

When it comes to establishing paternity, the widely used (but unsubstantiated) figure of 10% paternal discrepancy may be an overestimate for most populations:

New British research is rattling the roots of the family tree, citing paternity "discrepancy" in perhaps 4% of fathers studied.

"Paternal discrepancy" is a delicate term for a loaded subject. It refers to a man who wrongly thinks he's a child's biological father.

Paternal discrepancy was studied by researchers including Professor Mark Bellis, director of the Centre for Public Health at Liverpool John Moores University in England.

...

Bellis and colleagues checked studies from the 1950s through 2002 that mentioned paternal discrepancy. The studies came from the U.K., U.S., Europe, Russia, Canada, South Africa, South America, New Zealand, and Mexico.

Over the years, few studies directly tackled the topic. For instance, some researchers set out to screen for multiple sclerosis or cystic fibrosis, noting paternal discrepancies along the way.

Some studies were large; others included a handful of people. Paternal-discrepancy estimates varied wildly, from less than 1% to more than 30%.

But those numbers don't tell the whole story.

Some research centered on paternity disputes. Daddy discrepancies were probably overrepresented in those studies, writes Bellis.

Setting those studies aside, the remaining research showed an average paternal discrepancy of 3.7%, or a little less than one in 25 dads, write the researchers.

Don't Jump to Conclusions

That number doesn't necessarily mean that out of 25 dads at the ballpark, one isn't really his child's biological father.

Because the researchers extrapolated some information from studies involving topics other than paternity, they say that the percentage is not a true indication of paternal discrepancies in the general population. However, "it does suggest the widely used (but unsubstantiated) figure of 10% paternal discrepancy may be an overestimate for most populations," write the researchers.

In other words, paternal discrepancy might be rarer than commonly thought.

Ban Reproduction!

Wow, I had no idea (fee article):

In the last decade, the number of students entering the specialty [Ob/Gyn] has plummeted. In 1996 and 1997, applicants for obstetrics and gynecology residencies were lined up around the block. Since then, the number of applicants has gone into free fall. Only 743 graduating medical students in the United States applied for 1,142 residency slots in 2004. More than a third of the slots went to foreign medical graduates or remained empty.

On the bright side, once the push to ban terminations and contraception succeeds (fingers crossed), all we need to do is enact some strict governmental limits on intercourse and reproductive organs, and, voila!, problem solved. Fewer Ob/Gyns because.....no unregulated reproduction function.

More Ways to Bleed Than One

Here's an interesting case report of a woman who experiences period-related nosebleeds:

I have a patient with polycystic ovarian syndrome (PCOS) who has had epistaxis but always in the premenstrual phase. She is 45 years of age and has had epistaxis only for 4 years, although she was diagnosed with PCOS at age 16. Local examination was normal. Could menstruation or PCOS or menopause be a reason for epistaxis in this patient?

Three possible explanations for this problem are:

1. Endometriosis. Implants in the nasal lining could be the cause of the cyclic bleeding. [Other distant sites where endometrial implants have been found: lung, skin, and brain.]

2. Bleeding problems. Abnormal bleeding (coagulation problems) could be the result of the cyclical hormonal changes associated with the period.

3. Nasal mucosa abnormalities. The period-related hormone fluctuations could cause changes directly to the nasal lining, making it prone to cyclic bleeding.

European Catholicism

The finding of this small study looking to see if there's a connection between failure of the emergency contraception pill (the progestin-only one) and adverse neonatal or pregnancy outcomes--no association--isn't remarkable. The affiliation of the study's author is:

Failure of levonorgestrel as emergency contraception is not associated with adverse neonatal or pregnancy outcomes, according to a report in the August issue of Fertility and Sterility.

Although the results stem from a small study, "we believe that periconceptional exposure to this drug does not warrant a voluntary abortion for fear of teratogenic risk, such as after an inadvertent exposure to other sex steroidal drugs in the same period," lead author Dr. Marco De Santis, from the Catholic University of Sacred Heart in Rome, and colleagues note.

The study involved 36 pregnant women who were exposed to levonorgestrel and 80 unexposed controls. A total of 25 deliveries took place in the exposed group and 69 occurred in the nonexposed group.

Rates of spontaneous and medical abortion were not significantly different between the groups. Pregnancy and neonatal complications were uncommon and of similar frequency in each group. No ectopic pregnancies were seen in either group.

Neonates in the exposed group were of comparable weight and length to those in the unexposed group and were not at increased risk for malformations.

The researchers conclude that the data "showed that there is no increased risk of congenital anomalies or adverse pregnancy outcomes that is caused by the failure of levonorgestrel."

Fertil Steril 2005;84:296-299.

Painful Periods and Adolescents

Painful periods: most women have the pleasure, and most women could do without this experience.

Adolescents, in particular, are affected by, and have to deal with, this problem[dysmenorrhea=painful period; OC=oral contraceptive, the combination Pill]:

Primary dysmenorrhea, defined as painful menstruation in the absence of organic pathology, is prevalent during adolescence and may affect as many as 15% (2 million) of U.S. females age 13 to 19 years.... Fourteen percent of U.S. adolescents with dysmenorrhea, including only 29% of those with severe dysmenorrhea, seek physician help. OCs and nonsteroidal anti-inflammatory drugs (NSAIDs) are the mainstay of treatment for dysmenorrhea in women, but there are few studies targeting adolescents with this problem.... There is evidence for the efficacy of OCs for controlling dysmenorrhea in adults, but the studies mainly focus on high-dose OCs. One study showed that in adolescent females, adherence to OC regimens in those taking OCs for contraception was eight times higher if there was a reduction in dysmenorrhea....

A small study of women 19 years or younger reporting moderate or severe painful periods looked at the effect using a low-dose OCP (20 μg of estrogen and 100 μg of progestin) for three months. The findings:

58% had severe and 42% had moderate dysmenorrhea at baseline. 55% reported nausea; 24%, vomiting; and 5%, syncope. 39% reported missing 1 school day monthly and 14% missed 2 school days monthly because of dysmenorrhea.

By the third cycle, OC users rated their worst pain as less (mean rating, 3.7 vs 5.4; P = .02) and took less pain medication (mean pills taken, 1.3 vs 3.7; P = .05) than did placebo users.

61% of OC users vs 36% of placebo users reported taking no medications for pain during cycle 3 (OR, 0.37; 95% CI, 0.14 - 1.0).

Treatment effects were similar between older and younger participants, among the different ethnic groups, and between those with moderate vs severe dysmenorrhea.

Ratings of worst pain decreased in both groups over time (P = .001).

OC users also reported fewer days of any pain, fewer days of severe pain, and fewer hours of pain on the worst pain day than did placebo users, but these differences were not statistically significant.

Days of missed school could not be assessed because of erratic schedules of participants.

The conclusion:

"Among adolescents, a low-dose oral contraceptive relieved dysmenorrhea-associated pain more effectively than placebo," the authors write.

...

"The results of this unique randomized trial support the use of low-dose OCs for the treatment of dysmenorrhea in adolescent girls," the authors write. "OCs should become an important treatment option for the millions of adolescents who experience high morbidity from dysmenorrhea and are currently undertreated."

Grand Rounds

I'm catching up on my Grand Rounds reading.

Privacy-Invading Low-Life Scum

Inspired by regender, here's my translation of this post from Professor Bainbridge:

I find the Republicans' reported effort to dig into the medical records/decisions of reproductive-age women totally despicable. It's just another example of how the politicians' overweening belief that they are the untouchable masters of the universe blinds them to the privacy-invading low-life scum that they in fact are. [Just because you're] a woman should not mean abandoning all privacy rights, especially when it comes to your [reproductive decisions]. Some things simply ought to be off-limits....

Oh, the irony! It is delicious.


(via Instapundit)

Extreme Ride

If you're looking for some extreme excitement in your life, riding the subway might just be the adventure for you. Turns out police officers can now use deadly force if they have a "reasonable basis" for believing a suspect can detonate a bomb. In case you find "reasonable basis" a tad too imprecise, here's what the officers are looking for:

... wearing a heavy coat in warm weather, carrying a backpack with protrusions or visible wires, nervousness, excessive sweating or an unwillingness to make eye contact ....

Since this profile basically describes every other person using the city's subways, this new tactic should be a resounding success.

Grand Rounds

Don't miss this week's edition of the Grand Rounds.