Opening the black box ...

As reported in a news blurb that nearly escaped my attention because the major newspapers and websites either failed to report it or buried it deep, the US Food and Drug Administration (FDA) is proposing to replace its current pregnancy labels for a new system that clearly lists what is known and not known about use of particular drugs by pregnant or lactating women.

Under the old system, drugs were categorized into one of five categories - A, B, C, D and X – based on the amount of animal and human safety data available. Only a handful of currently marketed drugs fall into category A: safe for use based on extensive animal and human safety data. More drugs fall in category X: conclusive animal and human data demonstrating fetal risk.

The problem is that the vast majority of drugs fall into categories B and C. For most these compounds, there may or may not be data from animal models to suggest that the drug is safe and no good human studies to confirm these pre-clinical results. Use of these drugs by pregnant or lactating women is thus a crap shoot, with women and their physicians given little guidance to help them weigh the risks and benefits of these treatments. The new labeling rules would provide more information about the potential risks and benefits to pregnant or lactating women and their children or fetuses.

Still, I wonder whether the FDA realizes the Catch-22 that many researchers face regarding pregnant and lactating women. In the HIV prevention field, for example, microbicide and PrEP (pre-exposure prophylaxis) studies generally exclude pregnant and lactating women from enrolling, and study participants who become pregnant must discontinue product use. However, in the resource-poor countries when many of these trials take place, women spend approximately one-third to one-half of their reproductive years pregnant or breastfeeding. Not only do unexpected pregnancies adversely impact the power of these studies to detect a protective effect, but these restrictions also mean that a large number of women in the developing world who want to participate in these HIV prevention trials cannot. Alternatively, they be required to use a limited number of contraceptive methods that might otherwise be unacceptable to them.

Finally, it is unclear how HIV prevention researchers can collect the necessary data to demonstrate that these products are safe and effective for pregnant and lactating women to use. Most of these data come from pregnancy exposure registries, in which women who use category B, C and D drugs are monitored for the effect of these compounds on fetal development. But does it make sense to rely on such “natural experiments” rather than collect the necessary safety data in a controlled clinical trial using fully informed and willing participants? … particularly for compounds like topical microbicides and PrEP which, if effective, will be used primarily in countries in which collecting data for pregnancy exposure registries is likely to be difficult at best?

Breakfast - Now Determining the Sex of Your Baby?

When I was in my teens, a few of us used to sit around and daydream about our futures and the families we would have (yes, complete with white picket fences - you can stop laughing any time now). For reasons that I am not really certain of, save to chalk it up to socialized expectations, we always wanted either balanced numbers of children - a boy and a girl, or some combination. But everyone always wanted at least one of each. So, being teens and curious and in the days prior to Google and this fancy "internet" thing that's all the rage these days, we would read books and magazines and whatever else we could get our hands on, scouring for articles on precisely how to best skew the odds in favour of having a baby of the preferred sex.

What time of the month to have sex, what positions were better for X or Y sperm, whether or not the acidity of the vagina changed the longevity of the sperm - we read it all, clipping articles and saving them, writing down the names of books, making photocopies.

I don't remember, really, how much credit we ever gave these ideas. I do, however, remember that we scoffed openly at the idea of what you eat affecting the sex of your child. How naive did the amorphous "they" think we were, anyhow?



Needless to say, it doesn't surprise me that of all the possible wives tales about how to fix the sex of your child, the one that looks to be at least provisionally plausible? What you eat.

A study of 740 first time mothers in Britain shows that whether moms eat breakfast cereal or not might determine whether their bundle of joy is a boy or a girl. ..."Prior to pregnancy, breakfast cereal, but no other item, was strongly associated with infant sex," the researchers write in the journal Proceedings of the Royal Society B. "Women producing male infants consumed more breakfast cereal than those with female infants."

The reason is a mystery, but Mathews speculates that glucose may be key. This type of sugar, converted by the human body into energy, is a by-product of the breakdown of carbohydrates such as those in breakfast cereal. Women who do not eat breakfast tend to have low levels of glucose, and other studies have shown that glucose enhances the growth of male fetuses in vitro.

Lead researcher Fiona Mathews thinks that this might be another way the body gauges whether or not food is plentiful or scarce; in a famine, the less energy intense female fetus makes more sense to biologically invest in, a finding echoed in a lot of animals, which produce more male offspring when food is bountiful. (I would guess it has something to do with future offspring potential - men can create quite a few more children than women, so populations would be checked, to a degree, by having more wombs than sperm.)

But maybe the most interesting thing about the research?

The finding may explain a persistent and puzzling drop in the ratio of male to female births in well-fed industrialized nations, a fact that Mathews ascribes to the decline in the proportion of women eating breakfast.

There's still quite a bit of research that needs to be done, including reproducing it in other countries and cultures, but it's certainly intriguing, as is. And I suppose for those who do want to conceive and are hoping for a specific sex, it's at least a little bit more reliable than much of the stuff I was reading those many years ago.
-Kelly Hills

*********
Kelly--have to jump in to add this item from The Onion.
~Sue

Due April 25th - Surrogacy goes Hollywood

[Hat tip to R. Alta Charo for alerting us to this this!]





Can't wait to hear the reviews...

Boys Suck: Science Proves It

Evolutionary biologist Virpi Lummaa has discovered that Finnish women in previous generations suffered a variety of adverse effects when they bore and raised sons.

Among the impacts: a reduced lifespan, greater vulnerability to disease due to higher testosterone exposure during pregnancy, daughters who were less likely to reproduce, and smaller subsequent children. Additionally, having a grandmother around was more helpful than having a grandfather (probably because she helped with childrearing while he just sat around and ate food).

While modern reproductive technologies have mitigated a lot of the effects seen in pre-industrial families, it is still intriguing to consider these impacts in light of the strong cultural bias favoring the bearing of sons. Perhaps it is a type of "peacock effect", whereby the individuals who still thrive in the face of handicapping or indulging in risky behavior are considered stronger and more robust. Or, as my mother asserts, the value balances out an apparent difference in general robustness and health between male and female young, where males often are weaker to start with.

Of course, having too many sons can be evolutionarily disadvantageous too...

Is Schizophrenia Passed on From Mother to Newborn?

When I was carrying my daughter Samantha, it was, as the saying goes, "the best of times and the worst of times."

While excitedly anticipating the birth of my first child and enjoying all the first-time experiences that come with carrying a new life, I was also dealing with an in-progress divorce that grew nastier and more bitter with each passing day. I often wondered if the baby could sense the stress I was under, and my obstetrician warned me on more than one occasion that the stress was not good for my pregnancy. I would often sense connections between negative events that were taking place around me, and the baby's character and degree of activity.

Now, according to a study conducted by a team of British and Danish researchers, severe emotional stress in the mother, experienced during the first trimester of pregnancy, may increase the risk of the child developing schizophrenia in later life.

The study, appearing in this week's Archives of General Psychiatry examines the impact of maternal stress — of the extreme variety — on the central nervous system/mental health of the unborn. The research suggests a causal link between extreme stress in the mother, to an increased risk of schizophrenia.

A link between maternal stress and its impact on fetal development was analyzed in a study appearing in the Lancet in 2000, which suggested a relationship between extreme emotional stress in the mother, experienced during the first trimester of pregnancy, and an increased risk of congenital brain malformations that could lead to permanent impairment in the neurodevelopment of the unborn child.

Read the complete article from Time.com

Mandatory HIV testing for pregnant women in New Jersey

AP reports that New Jersey has passed a law that establishes a mandatory, opt-out program for testing pregnant women (and newborns at risk) for HIV.

New Jersey has about 17,600 AIDS cases, according to the Kaiser Foundation. Women represent 32.4 percent of the cases — the third highest rate in the nation. The national average is 23.4 percent.

The state has about 115,000 births per year and had seven infants born with HIV in 2005, according to state health department officials.

Bloomberg also reports:

Health-care providers will test pregnant women for HIV, the virus that causes AIDS, in their first and third trimesters unless they refuse, according to the new law. Newborns whose mother's HIV status is positive or unknown at the time of delivery also will be tested.

The rate of mother-baby HIV transmission has been dramatically reduced due to increased testing and preemptive actions:

The number of children in the U.S. reported with AIDS attributed to HIV transmission during childbirth declined to 48 in 2004 from a peak of 945 in 1992, primarily because of the identification of infected pregnant women and the effectiveness of preventative drugs in reducing mother-to-child transmission, according to the CDC report.

Some questions for consideration:

* Does a woman's right to informational privacy outweigh the state's interest in preventing HIV transmission to newborns?

* Does the incurable nature of HIV lend more weight to the latter?

* Does a woman cede certain personal rights when she decides to carry a pregnancy to term?

* On a finer point - which is more desirable in this circumstance: "opt-in" or "opt-out"?

The Real Science Behind Fertility

You are what you eat...and so apparently is your ability to become fertile. That's according to a recent study done by Harvard doctors, whose findings suggest an apparent connection between women's diets and fertility.

Published last month in the journal Obstetrics & Gynecology, the study found a growing body of evidence linking diets to hormone levels particularly insulin, which impacts fertility.

This Los Angeles Times article details the study's findings and recommendations.

Surrogates from India, the WBP and the Huffington Post

Our founding director, Kathryn Hinsch is quoted on the Beth Kohl's Huffington Post blog, voicing her concern over the exploitation of women in India, ending up on the short end of the surrogacy stick. Kohl writes about "reproductive tourism" at the The Akanksha Infertility Clinic located in Anand, India in the Gujarat State: "To be clear, these are professional surrogates, local women who receive decent medical care and detailed contracts...Using a gestational surrogate in the U.S. can cost $50,000 and up. But an Akanksha surrogate costs only $5,000. The surrogates at Akanksha earn more than 100,000 rupees ($2,250 U.S.) per pregnancy, a massive amount compared to the average daily income of five dollars. Some people consider this a win-win situation..."

After speaking with Hinsch, Kohl writes: "Hinsch also voiced concern over the long term health implications of carrying another person's genetic matter, pointing to the fact that women who gestate even genetically-related multiple boys have increased risks for autoimmune problems, the genetic difference between the male and female of the species being enough to upset our natural physical make up. So what is the physical impact of carrying a non-related fetus? How is that risk compounded when carried out repeatedly which may happen at a place as well-managed as Akanksha in a developing region like Gujarat, India?"

Kohl has immense stores of sympathy for infertile couples and recognizes that there is a cost-effectiveness that is appealing to these couples -- I like the way she concludes, proceeding with caution, taking nothing for granted: "The act of bringing forth life, no matter whose constituent parts, no matter whose uterus or birth canal, is far too complicated to isolate it from history or the world as it is."