Diclegis, a pill against morning sickness for pregnant women, is making the headlines and its effectiveness is being scientifically questioned.
New research suggests that the trials involved in the approval of the drug were based on flawed data.
The study, published Jan. 4 in the journal PLOS One, by researchers in Toronto, analyzed 7,200 pages from the clinical trials' data used in the 1970s, based on which the drug was approved.
Trial Of Diclegis Pregnancy Drug, Ineffective
This data has never made public before. However, the information on the efficacy of medicine against morning sickness was obtained by the FDA through the Freedom of Information Act, as part of a worldwide initiative to solve abandoned trials.
The FDA and the federal department Health Canada seem to have used flawed data when they approved the drug, which was then known under the name of Bendectin, according to the research.
"The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias," concluded the study.
After having examined the papers and having analyzed the original study, the researchers discovered that 31 percent of the 2,359 patients who were enrolled in the study failed to complete it.
"This is a flaw, because the missing data could change the findings and conclusions depending on what happened to those women," noted Dr. Nav Persaud, co-author of the present research.
Aside from this flaw, a placebo trial was also conducted as a system to validate the rates of success of the drug among pregnant women. However, according to this recent data, the placebo system was also unclear, as were its results.
For almost half a century, there have been medical attempts to solve women's morning sickness, which remains a top pregnancy problem. Approximately 75 percent of the pregnant women suffer from nausea and vomiting, symptoms which interfere with their quality of life during the first months of pregnancy. Additionally, approximately one percent of pregnant women suffer from the extreme sickness called hyperemesis gravidarum, which involves severe symptoms of nausea.
It is believed that roughly 35 million people took the medication, which is endorsed by famous figures as well as health agencies and obstetricians.
Diclegis And Failed Publicity
Before leaving social media for good, Kim Kardashian posted a picture of her and a bottle of the medication on Instagram, during her pregnancy in 2015, thus being one of the most famous endorsers of the product. The photo was also followed by a Tweet.
— Kim Kardashian West (@KimKardashian) July 20, 2015
Following her picture at the time, the FDA requested her to take the photo off Instagram, due to the lack of complete information on using the drug. The FDA mentioned, as part of its request, that the star should have noted all the possible side effects of the drug before uploading the picture.
"To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated," noted [pdf] the FDA request.