The Neat Chemistry of Wool

I love cloth diapers. Love. Them. W has only had diaper rash twice in her whole 8.5 months on this planet, and then only when she (or I) was on antibiotics. I have a really water-efficient washing machine and we line-dry, so I feel good about what we’re doing for the environment, and to be honest (and this is just a weird thing about me) I hate the smell of disposables. We’ve started having trouble with cloth at night, though (which, according to all the Internet forums* on cloth diapering, almost everyone does around this age). She nurses all night long, and pees through everything I’ve tried. Literally, I am pretty sure I’ve tried everything that modern diaper technology has to offer. And I’ve given up. So I’ve decided (again, with the help of all those awesome mommies on the Internet and my amazing local diaper shop**) to take a big step back in time and go with the tried-and-true; I’m putting her in prefolds and a wool cover. Prefolds. Like, those big rectangular things that you associate with cloth diapering from the 1900s. It turns out they’re super-absorbent and awesome. As far as the covers go, I knit, and the covers come out really cute (shorts for summer — see picture — and long pants for winter). She sleeps in these. And wool really, really appeals to the chemist in me. Because there’s no plastic, the pee chemicals don’t get trapped against her skin and start to break down, which can cause diaper rash. The natural lanolin on the wool reacts with the urea in the pee (isn’t that cool!?) and just like fat reacts with lye to make soap, the lanolin and urea literally make soap in her diaper. No, it doesn’t foam. But it doesn’t smell like pee, either! Also, wool absorbs a tremendous amount of liquid, so she doesn’t wet the sheets even though there’s no plastic pant over her diaper. The next day, I air out her wool cover for 24 hours (I rotate two of them), and it’s clean- and fresh-smelling by the following night. I have to wash and re-lanolize her covers about once every 3-4 weeks (which is really, really easy and not nearly as scary as it sounds). That’s it. No more pee in the bed (which, since she’s in my bed, is a really big deal to me). And super-cute wool-covered baby bum.

*The decline of the English language sometimes makes me sad. Like all regular gender-neutral Latin nouns, “forum” should be pluralized “fora.” But no one says “fora,” (in fact, I have to keep fighting with my word processor autocorrect to keep it from changing “fora” into “for a.” Everyone says “formus.” So I will too. But my brain autocorrects it.

**My amazing local diaper shop also has a website, so I just want to say thanks to GoGo Natural.

 

Do you cloth diaper at night? If so, how do you do it?

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Fish Oil And Health

I wanted to follow up last week’s post on DHA supplementation with a look into the research on fish oil supplementation, since while fish oil is a common source of supplemental DHA, there are supplements that contain pure DHA (as opposed to the normal mix of fats present in fish oil). While I concluded that there isn’t scientific research to support supplementing with pure DHA, there’s a fair amount of work that supports fish oil supplementation.

Certain benefits associated with fish oil supplementation begin during pregnancy. Thorsdottir (ok, sorry for the commentary, but that is a REALLY cool name when you say it out loud!) and colleagues found that Icelandic women who consumed the lowest quantities of fatty fish had smaller babies than those who consumed larger quantities of fish. Interestingly enough, however, those who consumed the most fish (containing more than a tablespoon of fish oil daily) also had shorter babies with smaller head circumferences. These women were getting three times the recommended daily vitamin A, and twice the recommended vitamin D as a result of their very high fish intake, which the researchers speculated might have had something to do with the results (both vitamins A and D are toxic in excessive quantities). Thorsdottir and colleagues recommended moderate fish and/or fish oil consumption during pregnancy (though “moderate” to an Icelandic research team is probably not the same as “moderate” to an American, given dietary norms). Olsen and colleagues found that moderate fish oil supplementation helped prevent pre-term delivery of a singleton baby in a high-risk (earlier pre-term delivery) mother, though the fish oil didn’t prevent pre-term delivery of twins. The researchers noticed no negative effects of fish oil on either mother or infant. Fish oil supplements during pregnancy appear to extend their effects into the first six months of lactation (Dunstan et al, 2007). Polyunsaturated fatty acids (PUFAs) from fish oil clearly pass into breast milk The key PUFAs are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which typically represent a large fraction of the total fish oil in a supplement capsule. In the Dunstan study, women who took fish oil during pregnancy (but not continuing into lactation) had higher levels of DHA in breast milk at three days, six weeks, and six months postpartum. The differences between the women who were supplemented and those who were not supplemented disappeared after six months postpartum. Infants of women with higher PUFA levels in breast milk had higher PUFA status themselves, and scored higher on a variety of developmental tests (both physical and cognitive) at 2.5 years. On the other hand, a very large study by Makrides et al failed to find much benefit associated with fish oil supplementation during pregnancy; women taking fish oil did not have lower rates of postpartum depression, nor did their infants score better on developmental assessments. A commentary on that same study (Oken et al) points out that some of the observational studies suggesting PUFA intake benefits (such as the Icelandic study by Thorsdottir) are based upon intake of whole fish, rather than fish oil supplements. Whole fish could contain more biologically active PUFAs, minerals that affect PUFA action, or other unidentified compounds. Oken and colleagues also note that the Makrides study tested infant development, while other fish oil studies tested toddlers and preschoolers. They point out that tests might not be sensitive enough to detect differences in infant development, and that differences might not become apparent until the babies were older. A further commentary on the Makrides study (Suzuki) points out that there were some differences in postpartum depression levels between women supplemented with fish oil and those receiving a placebo, but that the depression score cutoff value that Makrides et al chose did not allow for detection of those differences. Suzuki suggests that fish oil supplementation may play a role in reducing cases of subclinical (or less easily detected) depression.

Continued fish oil supplementation during lactation also appears to have benefits. Supplementation appears to increase levels of IgA (a type of antibody passed from mother to baby through breast milk) (Dunstan et al, 2004). There’s also evidence that it helps to reduce the risk of allergies (see, for instance, Dunstan et al 2003, Furuhjelm et al). Direct supplementation of infants may also confer benefits; a study by Damsgaard and colleagues noted that infants supplemented with fish oil had healthier blood lipid (fat) profiles at a year of age. Since blood lipid profile is a marker for heart disease risk, this is a potentially important finding.

Developmental benefits aside, fish oil supplements have also been associated with a reduction in several inflammatory disease processes, including rheumatoid arthritis (Kremer et al), asthma (Nagakura et al), ulcerative colitis (Hawthorne et al), and cardiovascular disease (see, for instance, Nestel et al, Geleijnse et al). Many of the studies on the benefits of fish oil refer to doses in the neighborhood of 3-4 grams of fish oil (containing 1-2 grams each of EPA and DHA) a day, with the caveats that while some fish oil is better than none, higher dosages show diminishing returns (and possibly harm).

It’s worth noting that while the benefits above are all conferred by DHA-containing fish oil capsules (and while many of the benefits are directly linked to the DHA in those capsules), supplementation with fish oil isn’t the same as supplementation with pure DHA. This is because fish oil is a blend of many different fats, of which DHA and EPA are only two. Research has shown repeatedly that separating out, purifying, and supplementing with a single compound suspected to be the “active” agent in a healthful food can have unintended (and sometimes detrimental) consequences. This is, for instance, what Miller and colleagues found in their work on vitamin E, which had previously (Knekt et al) been touted as having heart disease-reducing properties. In the case of vitamin E, it’s likely that by separating out a single form (alpha-tocopherol) of a vitamin that occurs in nature as a mixture of several forms, the supplemental vitamin E could be sending an unintended biological signal. Further support for the notion that there’s more to fish than DHA lies in the observation (Oken et al) that habitual fish-eaters note more predictable fish-related benefits than those taking fish oil supplements. With regard to supplements, there are two things to keep in mind: more is not better, and purifying the active ingredient isn’t necessarily an improvement over seeking out a source of that beneficial ingredient.

 

Science Bottom Line:* There is a multitude of evidence to support using fish oil (or better yet, eating fatty fish regularly!) if you’re…human. And especially if you’re a human who is pregnant, nursing, growing, and/or affected by an inflammatory disease process. No research suggests that moderate fish oil supplementation is harmful, and since fish oil is typically manufactured from small fish like anchovies, there’s absolutely minimal risk of mercury contamination in commercial capsules (meaning you don’t really need to seek out algae-based capsules, and probably shouldn’t, since the research is largely on fish, as opposed to algae, oil).

 

What has been your experience with fish oil?

 

 References:

Damsgaard et al. Fish oil affects blood pressure and the plasma lipid profile in healthy Danish infants. J Nutr. 2006 Jan;136(1):94-9.

Dunstan et al. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: a randomized, controlled trial. J Allergy Clin Immunol. 2003 Dec;112(6):1178-84.

Dunstan et al. The effect of supplementation with fish oil during pregnancy on breast milk immunoglobulin A, soluble CD14, cytokine levels and fatty acid composition. Clin Exp Allergy. 2004 Aug;34(8):1237-42.

Dunstan et al. The Effects of Fish Oil Supplementation in Pregnancy on Breast Milk Fatty Acid Composition Over the Course of Lactation: A Randomized Controlled Trial. Pediatr Res. 2007 Dec;62(6):689-94.

Furuhjelm et al. Fish oil supplementation in pregnancy and lactation may decrease the risk of infant allergy. Acta Paediatr. 2009 Sep;98(9):1461-7. Epub 2009 Jun 1.

Geleijnse et al. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. J Hypertens. 2002 Aug;20(8):1493-9.

Hawthorne et al. Treatment of ulcerative colitis with fish oil supplementation: a prospective 12 month randomised controlled trial. Gut. 1992 Jul;33(7):922-8.

Knekt et al. Antioxidant vitamin intake and coronary mortality in a longitudinal population study. Am J Epidemiol. 1994 Jun 15;139(12):1180-9.

Kremer et al. Effects of high-dose fish oil on rheumatoid arthritis after stopping nonsteroidal antiinflammatory drugs. Clinical and immune correlates. Arthritis Rheum. 1995 Aug;38(8):1107-14.

Makrides et al. Effect of DHA Supplementation During Pregnancy on Maternal Depression and Neurodevelopment of Young Children: A Randomized Controlled Trial. JAMA. 2010 Oct 20;304(15):1675-83.

Miller et al. Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. Epub 2004 Nov 10.

Nagakura et al. Dietary supplementation with fish oil rich in omega-3 polyunsaturated fatty acids in children with bronchial asthma Eur Respir J. 2000 Nov;16(5):861-5.

Nestel et al. Fish oil and cardiovascular disease: lipids and arterial function. Am J Clin Nutr. 2000 Jan;71(1 Suppl):228S-31S.

Oken et al. Fish, Fish Oil, and Pregnancy. JAMA. 2010 Oct 20;304(15):1717-8.

Olsen et al. Randomised clinical trials of fish oil supplementation in high risk pregnancies. Fish Oil Trials In Pregnancy (FOTIP) Team. BJOG. 2000 Mar;107(3):382-95.

Suzuki T. Maternal Depression and Child Development After Prenatal DHA Supplementation — A Reply. JAMA. 2011 Jan 26;305(4):359-60; author reply 360-1.

Thorsdottir et al. Association of fish and fish liver oil intake in pregnancy with infant size at birth among women of normal weight before pregnancy in a fishing community. Am J Epidemiol. 2004 Sep 1;160(5):460-5.

List Of Reasons The Last Week Of Your First Pregnancy Rocks

My bestest friend, M, is going to have her baby any day now. I’m so excited for her, and also for me, because we’ve been through so much together, and now we’ll be mommies together, too. Also, once she delivers, we can drink together again, which we haven’t been able to do in 17 months, since we carefully timed our pregnancies to overlap by only a single week. Cheers to that. Anyway, M is just a few days away from her due date, and is every bit as uncomfortable and cranky as I remember being when I was in her shoes. For her, and for all women closing in on the birth of their first baby, I present a…

 

List Of Reasons The Last Week Of Your First Pregnancy Rocks:

1. You get to eat at the same time as your partner. Using your dominant hand.

2. You can listen to a joke without having to simultaneously ponder whether the punchline will be funny enough that you need to sit down, cross your legs, or both.

3. You can go to the bathroom whenever you need to. Alone.

4. One more week of hormone-enhanced pregnancy sex. ‘Nuff said.

5. Continuing on that same topic, you have not yet acquired a very small person with a very accurate sex radar and a very loud alarm.

6. Your pregnancy hair. Because once your baby is born, that hair will be dirty, up in a ponytail, or both. For several months. And then it will fall out.

7. Your absent period. Because once your baby is born, you’ll have about 9 months worth of periods all at once. And as soon as the bleeding stops, you’ll worry that your real period is getting ready to start again. And if it doesn’t, you’ll worry that it’s because you’ve managed to get pregnant again. Already.

8. One more week of getting to say you’ve never been pooped on, peed on, or barfed on by another person. Um, hopefully.

9. You’re a glowing, pregnant rockstar. Strangers give up their seats on the bus for you. Old ladies come toddling across the grocery store to touch your belly. You get special parking at Babies ‘R’ Us and Walmart. After you have that kid, you’ll become invisible. Well, you’ll get special parking at Ikea. Which is nice if you need furniture with pictogram instructions and a side of meatballs. But other than that, yeah, you’re chopped liver.

 

Most of all, though…

10. You can sit in a rocking chair, holding the babe in your belly and dreaming of the amazing things that your body is getting ready to do, and of the sweet little miracle you’ll be holding in your arms…any day now.

 

All my love, M. I know you’ll do great!

 

 

Mama Drama — Make It Stop!

I’ve just come from Facebook, where I was reading a conversation on, ironically, a gentle parenting page. Within the first 10 comments, I saw two instances of mom-on-mom sniping, so I stopped reading. Earlier this week, the sniping abounded on the Facebook page of a local mom’s boutique shop; the owner posted a picture of a new product — a newborn onesie with easy access ports for checking on the umbilicus and on the circumcision site — and it started a huge argument among page fans about circumcision. I hate the sniping. I just hate it. We’re moms. We’re already doing the hardest job there is, and for the most part, we’re doing it without the close circle of female relatives that our ancestors had. This “aunting” that female relatives did was beneficial to both mom and baby, because it gave a new mom the advice and support she needed, and also provided for baby’s care. In many ways, our Internet acquaintances and friends are the new “aunts,” and I’ve seen and experienced instances of tremendous mom-to-mom support online. I’ve also seen sniping, cyber-bullying, and plain rudeness. Why? What’s the point? We all make different parenting decisions, so the fact that someone does things differently is no reason to call them out. We’ve all — let me say that again — we’ve ALL made really bad parenting calls, but in the vast majority of cases, our mistakes are honest and made with the best of intentions. Thankfully, our kids are resilient and they do just fine, despite the blundering. What a mom needs when she reaches out is support, not criticism. Those doing the criticizing might think they’re doing the mom a service by “improving” her parenting, but I’ve yet to meet a mom who benefits from more guilt. Please, can’t we all just support each other as best we can? Can’t we offer advice gently and with love? Can’t we at the very least abide by that ages-old maxim about what to do if you don’t have anything nice to say? If nothing else, by keeping our mouths shut when we might be tempted to snipe, we do our OWN kids a tremendous service, through modeling non-judgmental, kind, humanistic behavior. What a lovely way to raise a child.

 

Why do you think the mom-bullying is so prevalent on the Internet?

 

 

Do DHA Supplements Help Build Brains?

**This article addresses the science associated with DHA supplements, not fish oil capsules. DHA is a component of fish oil, but fish oil contains other components as well, and is addressed in another article on this site**

 

We live in a supplement-obsessed culture. Otherwise healthy men and women take multivitamins as “insurance” against nutritional deficiencies and to elicit supposed health benefits. Prenatal vitamins are no longer reserved for pregnant women; these days, women start taking them well before trying to conceive, and some non-pregnant women take them under the (erroneous) impression that they’ll promote hair and nail growth, improve complexion, and regulate hormones. We even dose our infants with supplements; formula companies try to outdo one another with their list of included “beneficial” nutrients, and even manage to sell products to breastfeeding mothers (the formula company Enfamil is the manufacturer of one of the most widely available vitamin D preparations for breastfeeding infants). We’re not just obsessed with supplements, however; we’re also obsessed with brain-building. This is why the Baby Einstein products have done so well, despite evidence that they do no good (and a statement from the American Academy of Pediatrics specifically advising against screen time for the under-two set).

DHA, docosahexaenoic acid, allows us to indulge both our supplement obsession and our brain-building obsession at the same time, so it’s no wonder DHA has started showing up everywhere. It’s packaged with prenatal vitamins, added to formula, sold in capsules for breastfeeding mothers, and put in gummy candy form for children. What is DHA, though, and do we really need it? More importantly, could it hurt us or our children?

DHA is one of the omega-3 fatty acids, where the latter are essential fatty acids. This means that the human body requires them to maintain function, but can’t synthesize them, so they must be consumed. Omega-3 fatty acids have many different roles in the human body, but can generally be said to promote normal metabolism and help counteract inflammation. DHA, in particular, is a major component of the human brain, which is why it’s said to be important to brain development (Singh). Diets too high in omega-6 fatty acids (another class of essential fatty acids) result in increased inflammation, including higher rates of cancer, asthma, and cardiovascular disease. It appears that the ideal ratio for omega-6/omega-3 consumption is 1/1, but studies suggest that ratios of 2-3/1 are nevertheless quite helpful in reducing inflammatory disease processes (Simopoulos). The typical Western diet, however, has a ratio of closer to 15-17/1.

The problem is that omega-3 fatty acids are harder to come by than omega-6 fatty acids are. Grains and grain oils, ubiquitous in the Western diet, are sources of omega-6 fatty acids. Omega-3s, however, come from only a few vegetable sources (flax, pumpkin seeds, and soybean oil, to name a few), in addition to coldwater fish and algae. The omega-3 fatty acids in vegetable sources, however, aren’t in the form of DHA or EPA (eicosapentaenoic acid), which are the omega-3s responsible for most of the important health effects. Instead, plants are sources of ALA (alpha-linolenic acid), which has to be converted into DHA and EPA. Humans aren’t efficient at this conversion, so even though flax and other plants technically contain omega-3 fatty acids, they’re not actually useful sources. The best sources of biologically active omega-3 fatty acids are fatty fish and algae. Since most Westerners don’t eat these very often, manufacturers of DHA supplements rush in to fill the dietary gaps.

However, while research strongly supports the inclusion of dietary sources of DHA (University of Maryland Medical Center has a comprehensive list of research references), there isn’t any research support for using pure DHA supplements. For instance, a non-randomized, non-placebo-controlled study (this negatively impacts study power, because the study design allows factors outside the variable being tested to impact results) showed that infants fed DHA-containing formula for the first six months of life didn’t end up any smarter (Gale et al). However, because mothers were allowed to choose whether they gave their babies DHA-containing formula or not, the researchers did see a bit of correlation between DHA formula consumption and intelligence. Subsequent analysis, however, suggested that mothers who were concerned enough about brain development to give DHA-containing formula were also more intelligent themselves, better educated, and were more likely to engage with their children in brain development-promoting ways, which the researchers felt explained the difference.

While research doesn’t currently support using DHA supplements, however, neither does there appear to be research that indicates DHA supplements do harm. There’s been some suggestion that cultures that eat larger quantities of DHA have higher incidence of stroke, but it seems that this may be due more to the potential for mercury contamination in coldwater fatty fish than to the DHA itself (Wennberg et al). Several studies suggest increased intake of omega-3 fatty acid decreases risk of stroke when mercury contamination is removed as a confounding factor (see, for instance, Bouzan et al, He et al).

While a number of noted childcare and healthcare experts with large Internet presences (including Dr. Michael Roizen) recommend giving DHA supplements to pregnant women, breastfeeding women, and children, it’s worth bearing in mind that these experts aren’t free from conflict of interest. For instance, Dr. Roizen is a scientific consultant for Martek, a supplement manufacturer that makes several DHA supplements.

Science Bottom Line:* There isn’t sufficient evidence to support using a DHA supplement. Since some dietary supplements (even those once thought beneficial or safe) can turn out to be harmful, it’s probably best to steer clear of unproven supplements like DHA. There is ample evidence to support consuming DHA-containing fish, however. The Environmental Protection Agency provides information about safe seafood consumption and reducing the risk of mercury intake. For those who are interested in making seafood decisions that support sustainable fishing practices in addition to minimizing risk of mercury and toxin exposure, the Monterey Bay Aquarium provides excellent resources.

 

Do you use DHA or other supplements?

 

References:

American Academy of Pediatrics Babies and Television. Accessed 17 Oct 2011.

AskDrSears.com DHA Supplements. Accessed 17 Oct 2011.

Bouzan et al. A quantitative analysis of fish consumption and stroke risk. Am J Prev Med. 2005 Nov;29(4):347-52.

Gale et al. Breastfeeding, the use of docosahexaenoic acid-fortified formulas in infancy and neuropsychological function in childhood. Arch Dis Child. 2010 Mar;95(3):174-9. Epub 2010 Feb 4.

He et al. Fish consumption and incidence of stroke: a meta-analysis of cohort studies. Stroke. 2004 Jul;35(7):1538-42. Epub 2004 May 20.

Martek Dr. Michael Roizen Accessed 17 Oct 2011.

Simopoulos, A. The importance of the ratio of omega-6/omega-3 essential fatty acids. Biomed Pharmacother. 2002 Oct;56(8):365-79.

Singh, M. Essential fatty acids, DHA and human brain. Indian J Pediatr. 2005 Mar;72(3):239-42.

University of Maryland Medical Center Omega-3 Fatty Acids. Accessed 17 Oct 2011.

Wennberg et al. Fish intake, mercury, long-chain n-3 polyunsaturated fatty acids and risk of stroke in northern Sweden. Br J Nutr. 2007 Nov;98(5):1038-45. Epub 2007 May 31.

The Zombie Apocalypse, The CDC, and The FDA

The U.S. Centers for Disease Control and Prevention, in their continuing effort to promote public health and health awareness, has outlined the basics of zombie apocalypse preparedness. Yes, for real.

As it turns out, preparing for the zombie apocalypse is similar to preparing for any other disaster: stock up on non-perishable food, water, and medications, have copies of important documents gathered together in a safe and accessible place, have a “family meeting place” picked out, and so forth. The CDC outlines emergency preparedness elsewhere on their website, but apparently no one really wants to read about preparing for a mudslide, a hurricane, or a fire evacuation. What people do want to read about, apparently, is the zombie apocalypse. Thus, figuring that getting the message out was more important than the mechanism by which they got the message out, the CDC went with a partially tongue-in-cheek, partially no-nonsense discussion of the undead and what happens when they attack. Good for them for their fun-loving and light-hearted approach to a serious matter. Particularly as, until the publication of the zombie article, “fun-loving” and “light-hearted” would not have been high on the list of adjectives I’d apply to the CDC, or any government agency, for that matter.

If zombie preparedness made the CDC the government’s equivalent of a cool kid, the Food and Drug Administration (FDA) is the class nerd: both an object of contempt and a scapegoat. I have to admit I feel sorry for the FDA, because they have one heck of a balancing act to perform, and they’re given less credit for their actions and more credit for autonomy than they deserve (the FDA’s actions and powers are determined by congress, so where they “fail” to provide for public safety, it’s often because they literally can’t take action.)

In an article published in the Journal of the American Medical Association, Dr. ­Joshua Sharfstein addresses the dilemma the FDA faces. They are an organization responsible for overseeing the safety and regulating the approval of both pharmaceutical and over-the-counter drugs (as well as a large portion of the food available in the U.S., which increases their workload). On the one hand, they’re under tremendous pressure to approve drugs, both from consumers (who want to see potential treatments for diseases become available) and from pharmaceutical companies (who want to make money — more on this later). On the other hand, we live in a society that is not willing to accept risk, and we find it completely unacceptable when an approved drug causes harm. The FDA thus has to balance quick drug approval with appropriate safety precautions.

Long ago, the FDA didn’t require drug manufacturers to prove that a drug was safe or effective before bringing it to market. The proverbial “snake-oil salesman” could sell anything (even something ineffective, dangerous, or both), and make any claim he wished, and he wouldn’t be crosswise with the FDA. As of 1906, the FDA required that manufacturers label their wares correctly and that the medications be contaminant-free, but there were no further requirements. In 1937, a pharmaceutical company marketed sulfanilamide elixir (a solution of sulfanilamide antibiotic in diethylene glycol solvent). Diethylene glycol is sweet and did a good job of dissolving the antibiotic, which made the elixir popular with parents, since it was easy to give to children. Unfortunately, diethylene glycol is chemically similar to antifreeze, and just as toxic. Of 353 children who took the medication, 100 died of kidney failure. The public outcry was phenomenal; as a result, congress passed the 1938 Food, Drug and Cosmetic Act, which was the first legislation to require proof of safety in marketed drugs. Further acts and amendments followed, shaping the legislation that outlines the responsibilities of the FDA today.

Obviously, this legislation has improved the safety of drugs brought to market. Even “failed” drugs that are pulled off the market for poor safety records do nowhere near the damage sulfanilamide elixir did. Take Baycol, for example (a cholesterol drug), which was pulled off the market in 2001. While Baycol appeared safe during extensive drug trials, post-marketing surveillance revealed that it increased risk of potentially fatal muscle weakness. 52 people died in all. How many total took the drug? Hard to know for sure; those are difficult numbers to come by. Maybe tens of thousands, maybe more. Regardless, compare Baycol’s “unacceptable” safety record to that of sulfanilamide elixir to get an idea of how successful the FDA is in helping to prevent large-scale pharmaceutical disasters. The FDA did everything right. They required Bayer (the pharmaceutical company) to provide evidence of safety and efficacy in animals before the drug was even approved for human trials. They required years and years of human trials before the drug was brought to market. Everything looked good. All this to the background noise of consumers complaining that the FDA takes too long to approve new drugs for marketing to the public, but the agency took its time and released Baycol only when it appeared truly safe and effective. And then the FDA continued to do its job; they monitored the safety of the drug post-marketing, because some side effects are so rare they don’t show up in human safety trials (even large ones), and others take years to show up. When adverse reactions to Baycol started cropping up in the public, it was removed from the market. Let me say it again: the FDA did its job. But Baycol is often cited as an example of an FDA “failure.”

We want our drugs, and we want them NOW; we aren’t willing to wait years and years for testing. We also want our drugs completely safe, so FDA had better ensure that companies test for safety carefully (but quickly!). Oh, and we don’t want our drugs tested on animals (because that’s cruel), but neither do we want them tested on people (because they could be dangerous, and no one should be exposed to that. Or they could be effective, in which case it’s not fair that some people get randomly assigned to the placebo). We’re unhappy with the FDA no matter what they do. And to boot, we’re unhappy that all the safety testing costs pharmaceutical companies millions and millions of dollars per drug, which they have to recoup, which increases drug prices. So we want our drugs SAFE, FAST, and CHEAP, and we resent the FDA for “standing in the way” of our safe, fast, cheap drugs with a checklist that they insist on filling out before they allow all those (undoubtedly perfect, life-saving) drugs that they’re “withholding” to come to market. Yes, I feel sorry for the FDA. As Sharfstein astutely notes, “Some claim the FDA is captive to manufacturers…others assert the agency [moves too slowly]. Sometimes stories outlining conflicting perspectives appear on facing pages of the same newspaper.”

Maybe what the FDA needs is to spiff up their image a bit. They should take a lesson from the CDC, and incorporate zombies into their policy statements. Or…maybe not, since ultimately, the CDC’s cool image proved as tenuous as Patrick Dempsey’s in “Can’t Buy Me Love.” Now that the buzz about zombie apocalypse preparedness has died down, the CDC’s image is right back where it was beforehand: a geeky institution that we’re morosely convinced is in bed with big pharma (why else would they push all those vaccinations!?), and that overstates the danger of “routine” childhood illnesses. Oh well. I guess you can’t win. Unless you write about zombies.

 

Why do you think it’s so hard for us to believe other than the worst of government agencies?

 

References:

FDA Baycol. Accessed 14 Oct 2011.

Furberg et al. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med. 2001;2(5):205-207.

Sharfstein, J. The FDA — A misunderstood agency. JAMA. 2001 Sept 21; 306(11): 1250-51.

Free-Range Kids — A Great Read

Photo courtesy of Scott Lefler, http://www.scottlefler.com, (c) 2009

On the advice of a friend (in response to a recent post about letting my daughter fall as she learns to walk), I’ve been reading Lenore Skenazy’s Free-Range Kids. It’s been an interesting read, and I’ve found the premise compelling. Essentially, Skenazy advocates, both in her book and in her blog, giving kids the freedom to have the kind of childhood most of us had. She points out that fears (of germs, of abductions, etc) are largely statistically unfounded, and/or based upon the (unrealistic) premise that “proper” parenting can protect a child from every conceivable harm. I was intrigued to learn how many statistically irrational fears I held (hold), though I was not surprised, since humans are notoriously bad at judging risk accurately, which I’ve addressed before. There were two notable areas in which I took issue with Skenazy, however. The first was with regard to her discussion of healthy eating during pregnancy. She rails (understandably and justifiably) against the pregnancy books — especially that ONE…you know which one I mean — that give you to believe that every bite you eat must be carefully scrutinized, because it could make or break your developing baby. Ridiculous, no doubt. However, she goes on to quote an obstetrician who counsels his patients to “…eat like you have your whole life, but eat a little more.” Um, really? Given the terrible diet most Americans consume, which is too high in fat, cholesterol, and refined starch, full of processed foods, and far too low in nutrients, is this a good idea? I would say that while you certainly don’t need to scrutinize every bite (nor even every meal), if there were EVER a good time to evaluate and potentially clean up your diet, pregnancy would be it; both for your sake and for that of your baby. A second issue, in my mind, is that Skenazy suggests that parents can’t really affect their kids much. This is true to some extent, of course; as she points out, research suggests children are born with relatively immutable personality traits that you can’t affect much one way or another. She goes on, however, to cite twin studies (which are intriguing, but are in no way scientific) to strengthen her assertions, pointing out that twins separated at birth and raised apart in two different families/religions/countries end up remarkably similar with regard to odd habits (reading magazines from back to front, for instance, and — she doesn’t mention this trait, but I’m familiar with these studies — dipping buttered toast in coffee). Ah, the nature/nurture debate. It lies at the heart of so many parenting questions. The reality is that scientists don’t yet know how much of what a child becomes is genetic and how much is based upon environment. In fact, the emerging field of epigenetics muddies the waters by introducing the notion that environment can turn genes on and off. If I could write an article summarizing all the nature/nuture research and providing a framework for understanding just how much of your child’s personality/abilities/intelligence you actually affect, I would (I’d love to — it would make me rich). But while the studies would fill a library on their own, there are no broad sweeping conclusions that can be drawn yet, and I have to say I find it a bit trite that Skenazy attempts to suggest that there are (particularly since she does so by citing inconsequential eccentricities that happen to show up certain twins). In any case, read with a grain of salt (as all books should be), I think Free-Range Kids is worth reading, and may help to counteract some of the culture- and media-driven fear that informs so much of First World parenting.

 

What great parenting books have you read lately?

 

 

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