Science and Sensibility, from bad to worse

I’ve written a number of posts over the years about the ways in which the Lamaze blog Science and Sensibility routinely misrepresented scientific evidence. I blamed it in large part on the editor, Amy Romano, CNM and her apparent inability to even read, let alone interpret scientific studies. Romano has moved on to spread her misinformation at the Childbirth Connection. Lamaze International was evidently forced to scrape the bottom of the barrel to come up with a new editor who is even more incompetent and less knowledgeable.

Kimmelin Hull, “a Lamaze Certified Childbirth Educator, Physician Assistant, American Red Cross First Aid/CPR instructor, novelist and freelance writer for local and international parenting magazines,” is, sadly, grossly ignorant about childbirth, science and scientific evidence. Moreover, she has lots of personal friends who know as little or less than she does and she lets them post guest columns on the website. Today’s post is a case in point. Even the title isn’t true.

FDA Bans Terbutaline for the Treatment of Preterm Labor is written by Darline Turner-Lee, “BS, MHS, PA-C, the owner and founder of Next Step Fitness, Inc” whose main claim to “expertise” in obstetrics is that she experienced premature labor.

Her piece is the classic NCB mix of factually false claims and innuendo. Contrary to Ms. Turner-Lee’s claim, the FDA did NOT ban terbutaline. Here’s a helpful hint for Turner-Lee: when the FDA bans a drug, they use the word “ban” in their press release and the drug is no longer available. If the word “ban” is nowhere to be found, the medication is not banned.

Before we look at what the FDA really said, let’s review the use of terbutaline. Terbutaline is a beta-2-agonist developed for the treatment of asthma and used off-label for the treatment of premature labor. Using an asthma medication to treat premature labor is not as strange as it sounds. Terbutaline works by relaxing the smooth muscle constriction that is part of an asthma attack. The muscle fibers of the uterus relax in response to terbutaline in the same way that pulmonary muscle fibers relax in response to terbutaline.

Terbutaline, like many powerful medications, has side effects. These side effects apply to people taking terbutaline for asthma:

Terbutaline sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Terbutaline sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression…

As with any medication, terbutaline should only be used if the potential benefits outweigh the risks. And like any medication, the risks of terbutaline depend on the dose, route of administration, and length of treatment.

Terbutaline has been used for the treatment of premature labor for more than 35 years. The risks of terbutaline were recognized and acknowledged in the earliest papers on the topic, written in the 1970s. For decades, however, terbutaline was the only treatment option for premature labor, and was therefore used, albeit with caution.

So what has changed in the intervening decades? We’ve learned a lot more about terbutaline and the treatment for premature labor and, in response, the FDA has made new recommendations (February 17, 2011):

The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

Clearly, the FDA did NOT ban the use of terbutaline. It recommended that the use of INJECTABLE terbutaline (more powerful than oral terbutaline) be restricted to the ACUTE treatment of premature labor. Oral terbutaline should not be used for the CHRONIC treatment of premature labor because it is not effective.

The FDA is a little late to the party. ACOG made the same recommendations in 2003, eight years ago, in Practice Bulletin 43, Management of Preterm Labor:

* There are no clear “first-line” tocolytic drugs to manage preterm labor. Clinical circumstances and physician preferences should dictate treatment…

* Neither maintenance treatment with tocolytic drugs nor repeated acute tocolysis improve perinatal outcome; neither should be undertaken as a general practice.

* Tocolytic drugs may prolong pregnancy for 2 to 7 days, which may allow for administration of steroids to improve fetal lung maturity and the consideration of maternal transport to a tertiary care facility.

The FDA has finally caught up with clinical practice.

So contrary to Ms. Turner-Lee’s claims and innuendo, the FDA did not ban terbutaline, and did not create or even suggest new guidelines. It merely codified current obstetric practice. Nothing has changed. Premature labor is still a serious problem. Terbutaline is still appropriate acute treatment for premature labor. Terbutaline is not effective as chronic treatment for premature labor. The risks of injectable terbutaline use rise over time and outweigh any benefits accrued after 48 to 72 hours.

At the end of her piece, Ms. Turner-Lee acknowledges that terbutaline has not been banned by suggesting that it should be banned.

Perhaps the FDA feels that by prohibiting the use of Terbutaline, they will be reducing the number of treatments available for obstetricians to use with cases of preterm labor. But if this treatment has no evidence that it is efficacious, I fail to see the loss…

She fails to see the loss! But, as with many statements from birth activists, it tells us more about her lack of knowledge than anything else. Neither the FDA, nor ACOG, nor anyone else has claimed that terbutaline does not work. Indeed, it is the RECOMMENDED acute treatment for premature labor because it allows for administration of steroids, a treatment that is highly efficacious in preventing respiratory distress syndrome in premature neonates.

And, like most NCB advocates, she has the typical inane “advice” for clinicians:

If the FDA, obstetricians and others are truly concerned that there aren’t enough efficacious treatments available for preventing preterm labor, I believe that their efforts would be better spent canvassing for support and funding for research for effective treatments rather than trying to make a clearly inappropriate treatment suitable.

If they were concerned? What, besides wishful thinking and spite, makes Ms. Turner-Lee believe that they aren’t truly concerned? What, besides wishful thinking and spite, makes Ms. Turner-Lee believe that they are using terbutaline INSTEAD of researching and developing more effective treatments? What, besides wishful thinking and spite, makes Ms. Turner-Lee believe anyone is trying to make an inappropriate treatment “suitable”? Clinicians are doing everything in their power to stop premature labor and terbutaline is still the best weapon in the armamentarium to do that.

I have a few questions for Ms. Turner-Lee. Why did you falsely claim that terbutaline has been banned? Why did you misrepresent the obstetrical treatment of prematurity? Who is served by falsely declaring that terbutaline is an inappropriate treatment for prematurity? How many premature births are prevented by insinuating that obstetricians would rather push an ineffective treatment than develop an effective one?

The answer, or course, is that no premature babies are helped by Ms. Turner-Lee’s attempt at a smear of obstetricians. But of course helping premature babies was never the goal. It’s all about destroying trust in obstetricians and trying to replace it with trust of uneducated lay people who are interested in nothing more than promoting themselves. That’s the purpose of this piece, of the entire blog “Science and Sensibility” and of Lamaze International itself.