It is winter in the Frozen North. (Snurfle. Snurflesnurfle. AAAAAchoo.) It is too cold outside for munchkins. We have taken to a daily KICKABALL (as Bug calls it) extravaganza in the basement before dinner. Oh, summer, how I long for thee.
Also: why, whenever it snows more than two inches in Philly, people think they can't go out? I have a friend there who proclaims regularly that they are trapped! and cannot! drive! anywhere! People! Learn to drive in the snow. (Slowly, without any sudden movements.) Your car will slide about, no matter how careful you are; I rear-ended the diaper service van a few weeks ago. At a stoplight, going about 2 mph over ice, and then wham. But Philly is not the South; it snows. GET USED TO IT.
In other news, my brother-in-law has given Bug a two-foot-long bulldozer. He cries every night, because we do not let it have dinner with him.
Thursday, January 27, 2011
Friday, January 21, 2011
Pregnant Humans Who Actually Take Drugs
Part 1 (FDA Categories)
Part 2 (So What Do I Do, Then? Eh?? EH?)
So 2/3 of drugs are Category C and, according to the FDA, the average woman of childbearing age is taking 3 medications.
Say you're pregnant, or about to get pregnant. You go to your doctor to talk about meds. Chances are, your doctor will say, "Oh, well... just to be SAFE, you shouldn't take that! After all, you wouldn't want to hurt your baby!"
This frequently happens over antidepressants- most of which are very safe in pregnancy. Also, I am too lazy to find the articles, but 1) 80% of unmedicated women with a major depressive episode will have postpartum depression and 2) a recent, quite good, study shows that tapering off SSRIs a week or two before the due date does not, in fact, prevent infant respiratory distress. (A month or two is required, which is plenty of time to feel really, really nuts.) Therefore, "stop your meds" is stupid, dangerous, bad advice. For the mother.
This rant is, in fact, relevant. Liability has a lot to do with OB care. If you can convince your medical-professional-of-choice that you are making an informed decision, it reduces their fear that you will sue them.* Plus, they can write it down in your chart and all.
So how do you and your doctor know if something is safe? In order of ease-of-use:
1) Motherisk (pregnancy and breastfeeding): They run trials and write reviews. They also have a hotline. They have good, sensible information on drugs in pregnancy and breastfeeding. Unfortunately, they think one glass of wine MAY HURT YOUR BABY OMG. You can ignore that part if you want.
2) Dr. Jack Newman's book or website (breastfeeding:) Note: I recommend reading through this web page for a truly excellent general summary of when drugs are safe. Example: if they give it to newborns, it's probably safe in breastfeeding and maybe in pregnancy.
3) Common sense. I knew someone whose husband was worried about her taking Tums. They are made of calcium. Like in vitamins. Tylenol? Probably harmless. One glass of wine? Europe's rate of birth defects is no higher than it is here even though about 50% of women report drinking a little while pregnant.** Also, alcohol is proportionally present in breastmilk; if your BAC is 0.02, then 0.02% of your breastmilk is alcohol. If your kid drinks 100 mL of milk right after you drink, they'll get about 0.02 mL of alcohol, which is 0.4 mL of beer, or 8 drops. One cup of coffee in the morning while pregnant? Even March of Dimes, crazy fearmongers though they tend to be, thinks that's safe. Most drugs, about 1% ends up in breastmilk. Think before panicking, that's my motto!
4) The NHS publishes a clinical knowledge summary which is like the Cliff's Notes version of PubMed. (Registration required.) It tends to be conservative, but accurate.
5) There's always PubMed for the hard-core article-readers, (it's an index of all biology and medicine articles published). How do you tell if something's a good study? Well.... that's harder. Is it published in NEJM or Proceedings of the Royal Swedish Academy of Neurotoxicity in Cats? Do the error bars overlap, yet they claim P < 0.05?*** Is it the only article ever claiming that result? Is it a meta-analysis of twenty articles with widely differing methods, controls, and data? If you know a scientist or medical professional... ask them to read up on it for you. We're well practiced in spotting crappy data. Also we have academic-library access to all the darn articles. (Rot in hell, Else.vier.)
* One day, I should perhaps relate my not-very-amusing, three-days-before-Bug's-birth story of double vision, the ER, the MRI, the very cranky neurologist, the ex-military ex-OB specialty ophthalmologist, the lumbar puncture and C-section I didn't get, three most excellent midwives, and a partridge in a fricking pear tree, i.e., how to very firmly refuse treatment even while pregnant. It was, of course, idiopathic.
**Roughly four times the reported alcohol-in-pregnancy rate here, and yet the birth defect rate is no higher. Therefore, if there is an effect, it is lost in the noise. As another side note, one of the most-cited papers on drinking in pregnancy is a CDC study where they defined "moderate drinking" as 3 drinks. A DAY.
*** Mathematically, virtually impossible. I calculated it out once.
Part 2 (So What Do I Do, Then? Eh?? EH?)
So 2/3 of drugs are Category C and, according to the FDA, the average woman of childbearing age is taking 3 medications.
Say you're pregnant, or about to get pregnant. You go to your doctor to talk about meds. Chances are, your doctor will say, "Oh, well... just to be SAFE, you shouldn't take that! After all, you wouldn't want to hurt your baby!"
This frequently happens over antidepressants- most of which are very safe in pregnancy. Also, I am too lazy to find the articles, but 1) 80% of unmedicated women with a major depressive episode will have postpartum depression and 2) a recent, quite good, study shows that tapering off SSRIs a week or two before the due date does not, in fact, prevent infant respiratory distress. (A month or two is required, which is plenty of time to feel really, really nuts.) Therefore, "stop your meds" is stupid, dangerous, bad advice. For the mother.
This rant is, in fact, relevant. Liability has a lot to do with OB care. If you can convince your medical-professional-of-choice that you are making an informed decision, it reduces their fear that you will sue them.* Plus, they can write it down in your chart and all.
So how do you and your doctor know if something is safe? In order of ease-of-use:
1) Motherisk (pregnancy and breastfeeding): They run trials and write reviews. They also have a hotline. They have good, sensible information on drugs in pregnancy and breastfeeding. Unfortunately, they think one glass of wine MAY HURT YOUR BABY OMG. You can ignore that part if you want.
2) Dr. Jack Newman's book or website (breastfeeding:) Note: I recommend reading through this web page for a truly excellent general summary of when drugs are safe. Example: if they give it to newborns, it's probably safe in breastfeeding and maybe in pregnancy.
3) Common sense. I knew someone whose husband was worried about her taking Tums. They are made of calcium. Like in vitamins. Tylenol? Probably harmless. One glass of wine? Europe's rate of birth defects is no higher than it is here even though about 50% of women report drinking a little while pregnant.** Also, alcohol is proportionally present in breastmilk; if your BAC is 0.02, then 0.02% of your breastmilk is alcohol. If your kid drinks 100 mL of milk right after you drink, they'll get about 0.02 mL of alcohol, which is 0.4 mL of beer, or 8 drops. One cup of coffee in the morning while pregnant? Even March of Dimes, crazy fearmongers though they tend to be, thinks that's safe. Most drugs, about 1% ends up in breastmilk. Think before panicking, that's my motto!
4) The NHS publishes a clinical knowledge summary which is like the Cliff's Notes version of PubMed. (Registration required.) It tends to be conservative, but accurate.
5) There's always PubMed for the hard-core article-readers, (it's an index of all biology and medicine articles published). How do you tell if something's a good study? Well.... that's harder. Is it published in NEJM or Proceedings of the Royal Swedish Academy of Neurotoxicity in Cats? Do the error bars overlap, yet they claim P < 0.05?*** Is it the only article ever claiming that result? Is it a meta-analysis of twenty articles with widely differing methods, controls, and data? If you know a scientist or medical professional... ask them to read up on it for you. We're well practiced in spotting crappy data. Also we have academic-library access to all the darn articles. (Rot in hell, Else.vier.)
* One day, I should perhaps relate my not-very-amusing, three-days-before-Bug's-birth story of double vision, the ER, the MRI, the very cranky neurologist, the ex-military ex-OB specialty ophthalmologist, the lumbar puncture and C-section I didn't get, three most excellent midwives, and a partridge in a fricking pear tree, i.e., how to very firmly refuse treatment even while pregnant. It was, of course, idiopathic.
**Roughly four times the reported alcohol-in-pregnancy rate here, and yet the birth defect rate is no higher. Therefore, if there is an effect, it is lost in the noise. As another side note, one of the most-cited papers on drinking in pregnancy is a CDC study where they defined "moderate drinking" as 3 drinks. A DAY.
*** Mathematically, virtually impossible. I calculated it out once.
Friday, January 14, 2011
Pregnant Humans And Drug Trials
Part 1: FDA Pregnancy Categories: Who Made These UP, Anyhow?
Part 2: What to do, what to do?
Drugs in pregnancy! One of my favorite topics again.
There are currently five categories: A, B, C, D, and X. There is no standardized labeling for lactation. Categories D and X are pretty good: Proven, serious harm in humans. Category X includes retinol, DES, and thalidomide. Category D includes chemo drugs.
Category A is also pretty good, though fairly useless: Proven not to cause harm. They include folic acid and levothyroxine. Great! Folic acid doesn't cause fetal damage! Who knew??
However. B and C are exceedingly useless. What they say is, well, we don't think it'll do anything terrible, maybe, or maybe it will. The FDA states that 2/3 of currently on-the-market drugs are Category C. Tylenol is Category B.
The biggest problem with the system right now- in my opinion- is that it only looks at double-blind studies. In theory, this is an admirable scientific principle. In practice it doesn't work. At high doses, most drugs will harm animals or animal fetuses, and one purpose of animal studies is to determine the dose that causes harm; therefore, most animal studies will show harm. Many, if not most, Category B and C drugs with proven-harm have used a dosage 5-10x the maximum human dose. Try to get that past an IRB for a double-blind study in pregnant humans! In addition, some drugs cannot be double-blinded: insulin, for example, which is a Category B drug.
For functional purposes, these categories tell you almost nothing about whether the drug si safe. Albuterol is Category B. Fluconazole is Category C. Practically all SSRIs are Category C. Blood-pressure medications which are routinely used, as standard-of-care, to treat pregnant women, are Category C.
For many of these drugs, there is a great deal of data in pregnant women, including Drug X vs. Drug Y efficacy studies. There are large pregnancy registries for many, many drugs, which track adverse events, adverse outcomes, and birth defects. However, if it is not double-blind, the FDA will not consider it while assigning categories. If you or your doctor are interested in a drug, well, read through PubMed and look at the registries. Or trust someone's review.
The FDA, by the way, thinks that these categories are confusing and ineffective and wants to change them.
Next: So That Wasn't Helpful, How Do I Know What's Safe Then???
Part 2: What to do, what to do?
Drugs in pregnancy! One of my favorite topics again.
There are currently five categories: A, B, C, D, and X. There is no standardized labeling for lactation. Categories D and X are pretty good: Proven, serious harm in humans. Category X includes retinol, DES, and thalidomide. Category D includes chemo drugs.
Category A is also pretty good, though fairly useless: Proven not to cause harm. They include folic acid and levothyroxine. Great! Folic acid doesn't cause fetal damage! Who knew??
However. B and C are exceedingly useless. What they say is, well, we don't think it'll do anything terrible, maybe, or maybe it will. The FDA states that 2/3 of currently on-the-market drugs are Category C. Tylenol is Category B.
The biggest problem with the system right now- in my opinion- is that it only looks at double-blind studies. In theory, this is an admirable scientific principle. In practice it doesn't work. At high doses, most drugs will harm animals or animal fetuses, and one purpose of animal studies is to determine the dose that causes harm; therefore, most animal studies will show harm. Many, if not most, Category B and C drugs with proven-harm have used a dosage 5-10x the maximum human dose. Try to get that past an IRB for a double-blind study in pregnant humans! In addition, some drugs cannot be double-blinded: insulin, for example, which is a Category B drug.
For functional purposes, these categories tell you almost nothing about whether the drug si safe. Albuterol is Category B. Fluconazole is Category C. Practically all SSRIs are Category C. Blood-pressure medications which are routinely used, as standard-of-care, to treat pregnant women, are Category C.
For many of these drugs, there is a great deal of data in pregnant women, including Drug X vs. Drug Y efficacy studies. There are large pregnancy registries for many, many drugs, which track adverse events, adverse outcomes, and birth defects. However, if it is not double-blind, the FDA will not consider it while assigning categories. If you or your doctor are interested in a drug, well, read through PubMed and look at the registries. Or trust someone's review.
The FDA, by the way, thinks that these categories are confusing and ineffective and wants to change them.
Next: So That Wasn't Helpful, How Do I Know What's Safe Then???
Sunday, January 09, 2011
Of Very Little Brain
(or time, for that matter).
However! Toddler quote of the week:
"Cheese stick eating Bug."
However! Toddler quote of the week:
"Cheese stick eating Bug."
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