A friend of mine – and like myself and my family, she is quite interested in products designed for infants, babies and toddlers – recently posted about use of an item called “Babyplus“. Babyplus is self-described as a “a series of 16 naturally derived sounds that resemble a mother’s heartbeat.” It’s a product placed on pregnant mother’s stomach during several months of pregnancy, with the design of stimulating the learning process before the baby is even born. Coming at a cost of between $150 and $200, it’s not a cheap product by any stretch. Still, its a successful business; if the claims of 20,000 units a year in sales are accurate, that’s at least $3 million in revenue. Here’s a picture of a very comfortable woman using Babyplus!
One sentence was particularly interesting: “BabyPlus is based on solid scientific theory, is supported by extensive research, and its value is definitively proven by follow-up studies.” I explored, mostly out of curiosity, some details behind this sentence, the product as a whole, and what I found was disappointing, surprising, and informative all at once.
Issue 1: The Clinical Evidence:
The subject sites a clinical trial, linked here, which “proves” evidence of the effectiveness of Babyplus when compared to musical stimulation or no stimulation, with respect to baby outcomes immediately after birth. A few things stand out. First, the sample size is 31 volunteer mother’s…total! That’s roughly 10 apiece in each of the three treatment arms. None of the results of this trial come close to statistically significant evidence, but that doesn’t matter to the people behind Babyplus, who use these results – and the shoddy bar graphs that go along with it – to back up their product. The website adds, “While this Russian project was limited in scope and substance due to budgetary constraints during a time of profound political upheaval, the results achieved statistical significance in important areas, reinforcing earlier pilot work by both the author and Brent Logan.” Oh okay, I guess that’s fine. There was profound political upheaval at the time – please excuse our small sample!
Not surprisingly, the results shown on the website were not published- there’s no way they would have been accepted as reasonable by the scientific community.
Issue 2: The researchers behind the evidence.
To gain a deeper understanding of why Babyplus would want to mislead the public, its important to recognize the two faces behind the product, Dr Mikhail Lazarev and Dr Brent Logan. Dr. Logan is listed on the website as the current pioneer of the product. However, a quick google search identifies Dr. Lazarev as the actual inventor of the idea behind Babyplus. Specifically, this article, published in 1999, tells the story of how Dr. Lazarev created the system of musical evidence. Why is this an issue? As it turns out, Dr. Lazarev is the the investigator responsible for the clinical trial described above.
It gets better. The website’s technical bibliography lists 22 papers here, which would seemingly be enough to convince anyone that the product is legitimate. Of those papers, however, a whopping 18 were written by Dr. Logan himself. An additional paper was written by Dr. Lazarev. Of the last three citations, one appears to be a reasonable study, but its unrelated to the Babyplus product, and the other two are “Clinical report, Hospital Doctor, April 1990” and “Gifted babies, Malaysian Doctor, September 1994.” This begs the obvious question – were the Hospital Doctor and Malaysian Doctor able to get large sample sizes or was the political upheaval too much for them, too?
To sum up Issue 2, the major problem here is those who are claiming to have found evidence of the success of Babyplus are also those who are financially benefiting from its’ success. Think the Camel cigarette touting the health benefits of smoking (which, ironically, they did half a century ago).
Conclusion: My brief research was not the first to find something fishy with Babyplus. I was glad to see ABC’s Nightline headlined an episode with this product, summarized here. Mysteriously, this report was absent on Babyplus’ listing of media bibliography. I actually tweeted those behind the Babyplus product about this issue (@Statsbylopez), and if they write back to me, I’ll be sure to retweet.
While ABC’s conclusions were less technical than some of what I wrote above, the conclusion is the same. I also found it interesting that the article, uncomfortably, concludes “The government does not require (Babyplus) to meet any special product safety standards.” Further, the article quotes a spokeswoman from Babyplus, who admitted the product had not yet been studied in long term clinical trials.
To conclude, I give the website and the doctors credit. They found a product that may or may not work, created flimsy evidence that it actually is beneficial, and, most importantly, found a target audience that they could sell to. For the rest of us, perhaps this is a careful reminder that scientific evidence for a product is only as valid as the scientists behind the label and the statistics behind the article.