I’ve been wanting to write about misinformation and fear marketing for a while now, ever since a friend posted this link as a way to pass information. If you don’t want to click through, it’s an article, hereafter referred to as the article in question (AIQ), from a reproductive health center in New England which says:
Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy.
Scary stuff, especially if you had a child with a congenital heart defect or cleft palate and you took that medicine. You’re probably feeling pretty bad about yourself right now. In fact, one of my friend’s friends was lamenting the use of Zofran after reading AIQ. This was all on Facebook, and the site was helpful enough to post a similar article with completely different conclusions just below it. Out of curiosity, I clicked on it and read the conflicting information. Hmm. That article said that Denmark conducted a study with a sample size of 600,000 that concluded:
[Zofran] taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes.
So this study completely contradicts the assertion made by the AIQ that the FDA issued a warning against using the drug during pregnancy. Time to dig in and do some research! Stay with me! The FDA actually said:
FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.
The FDA didn’t warn against congenital birth defects at all. There is an indication that there could be risk to certain women with serotonin syndrome, but nothing that suggests it will harm the fetus, and it requires further study.
But this all gets more and more confusing and disturbing. The AIQ is dated 11/22/13 and references the “updated warning” which came in May of 2013 and the OBGYNNews article dated 10/25/13. Okay. So the AIQ comes about a month after the OBGYNNews article and it references a “recent study”. What study is that?
I found no increase in the major malformation rate among the 176 pregnancies of women exposed to [Zofran].
The author admitted it was a very small sample size.
The second study came out in January 2012
[Nausea and vomiting of pregnancy] was not observed to be associated with an increased risk of birth defects; however, possible risks related to three treatments (i.e., proton pump inhibitors, steroids and [Zofran]), which could be chance findings, warrant further investigation.
Sample size, 4,524. Not too shabby. No observable increased risk of birth defects.
The third study, published in the New England Journal of Medicine in February 2013, was the Danish study that seemed to contradict the AIQ and led to my digging project. As a reminder, that study did not find any significant increased risk to fetal development.
Finally, a fourth study which supposedly used the same data bank, but with 900,000 cases instead of 600,000, as the Danish study was presented in August 2013. That study concluded
We found a doubling in the prevalence of major congenital heart defects in
children whose mothers redeemed a prescription of [Zofran] in the first
trimester of pregnancy.
Wait what? A doubling? What in the actual heck is going on here. Read further, Lieblings. Read further. What were the actual sample sizes? The Danish studied 1,849 women and the Canadians studied
1,248 1,368 women. (It seems that study isn’t exactly sure how many women it studied. <clucks tongue>). Either way, that’s actually a smaller sample size, my friends, when it’s being reported as larger. Makes you wonder about cherry picking data, doesn’t it?
So what did OBGYNNews, which was cited by the article in question, have to say about the different conclusion of these studies?
…we are left with contradictory results regarding the risk of birth defects associated with [Zofran] exposure in the first trimester, and more studies may be needed.
Basically all this is saying, there may be some correlation, there may not. We just don’t know, so we need to study it some more to be sure.
Let’s go back to talking about my friend’s friend. She shifted the blame from __________to her own use of Zofran to combat her morning sickness. This is the reason I decided to pipe up on this particular comment thread. I know what it’s like to beat yourself up for medicine taken while pregnant that DID cause a defect, so I just couldn’t let this mama continue to needlessly berate herself without saying something.
So the AIQ, why would this doctors’ office pass misinformation? There are two options. The first is that they are too stupid to read the information correctly and they made an honest mistake. The second is fear marketing again. Occam’s Razor says that fear marketing is the logical answer. Is it really easier to market fear than make a mistake? Would OBGYNs really resort to fear marketing? They have multiple degrees and board certifications. They are care givers. They help people. Yes, but it is in their best interest to keep their customers, aka patients, scared. Scared patients don’t question. Scared patients don’t argue. Scared patients will give you all the money they can to make the scary stuff go away. Scared patients don’t cause trouble or throw off busy schedules. Scared patients are easy to control and they do what they are told. Scared patients tell their friends all about it. Now it’s fear marketing gone viral.
Why did I go to all the trouble to look into all of this? I wanted to see why the author of the AIQ came to the conclusion he did, if it was valid (I do not confirm the validity of his claim at all). I wanted to share with you what I found. I also want to educate people about fear tactics that are used to control their lives. In this case by the medical professionals who have sworn to do no harm. I contend that causing fear does cause harm, but that warrants further research. 🙂 This isn’t conspiracy theory, now. Don’t go thinking I’m all cuckoo. It’s a fact. Any time you read something, regardless of the “authority” behind it, if it makes you anxious, scared, guilty, shamed, angry, or causes any intense emotion that hurts you, for your own sake research it to find out the veracity of the claim. If it makes you smile, feel good, brings those happy onion tears to your eyes, roll with it. I can’t think of any harm that comes from thinking the best of the world. Namaste.
Did you stick with me? What do you think? Do you think the AIQ was aimed at creating fear, or was it an honest mistake? Don’t be scared to “like” my post. It’s kind of like a virtual hug. 🙂