MORNING SICKNESS PILL ENDORSED BY KIM NOT PROPERLY TESTED
IN 2015, a pregnant Kim Kardashian posted an unusual Instagram photo of herself holding a bottle of pills.
“OMG,” she wrote in the caption. “Have you heard about this? As you guys know my #morningsickness has been pretty bad … I talked to my doctor. He prescribed me #Diclegis, I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”
The photo made headlines when the Food and Drug Administration cracked down on the drug’s manufacturer for not disclosing risks in its marketing. Diclegis is in the news again today, but this time it’s not just the advertising that’s in question: It’s the effectiveness of the drug itself.
For more than 40 years, pregnant women around the world sought help for morning sickness through a combination of the two main ingredients in Diclegis: pyridoxine and doxylamine. About 35 million are believed to have taken the medication. Could their faith in the treatment be based on flawed data?
That unsettling question is raised by an analysis published on Wednesday in PLOS One by researchers in Toronto who reviewed more than 7 200 pages of data from a clinical trial in the 1970s that had never been made public before.
Nav Persaud, a family physician and researcher at St Michael’s Hospital who is the main author of the new analysis, said the trial in question was key to obtaining the drug’s approval in Canada, where it is sold as Diclectin.
The old clinical trial was conducted by Merrell-National Laboratories, which no longer exists, and involved 2 308 patients at 14 clinics in the US who were in the first 12 weeks of pregnancy who complained of nausea or vomiting. Women were asked to take two tablets at bedtime and, if necessary, another in the morning and midafternoon for seven nights. Doctors were asked to note the frequency of vomiting and hours of nausea.
In the medical literature over the past few decades, Persaud said this study, which was never finished, had been referred to as being a success but with no details.
However, he said, when he looked at the raw data it contained critical flaws, including the fact that some information that was supposed to be obtained during patient visits was not, and about 30% of the patients were lost to follow up despite the fact that the trial lasted only a week.