One of Canada’s most used morning sickness medications, prescribed to millions of pregnant women, is ineffective and the prior studies that supported its use were sponsored by the same company that produced the drug, according to a bombshell analysis of the drug’s original clinical trial that was published Wednesday in online journal PLOS ONE.
Toronto doctor and researcher Nav Persaud, who has previously authored papers exposing misleading results in studies advocating morning sickness drug Diclectin’s effectiveness, said he had been fighting to gain access to the results of the drug’s 2009 clinical trial for years. Health Canada ultimately agreed to release the results to him after making him and his co-authors sign a confidentiality agreement stipulating that they would not publicize the trial’s 9,174 pages of hidden data because the information was confidential and belonged to the drug company Duchesnay — which also just so happens to manufacture Diclectin. A prescription for Diclectin is filled for half of all live births in Canada, according to The Toronto Star.
“It’s disturbing that the company that sponsored the study has hidden the information. It’s also disturbing that the federal government that’s charged with protecting the health of Canadians has decided to hide this information,” said Persaud.
According to Persaud, the trial’s records showed a near insignificant difference between the reduction of symptoms of women who took the drug over placebo, and that even then the study appeared to have cherry-picked data in order to exaggerate the drug’s effectiveness. By the study’s own criteria, a 13-point scale, only a three-point difference should have been considered clinically important. The recorded difference between women who took the drug and those who took the placebo turned out to be only 0.7 points — a difference that Persaud said would not even be noticed by women who took the drug.
A 2015 investigation by The Star had also uncovered that Duchesnay had financial relationships with Dr. Gideon Koren, the co-author of the medical journal in which the results of the clinical trial were published, as well as the Society of Obstetricians and Gynecologists of Canada. Koren, who now works in Israel, left his job at Sick Kids hospital in 2015 after it was discovered that his Motherisk program, which also has financial ties to Duchesnay, had sold faulty drug and alcohol tests that were used on at least 25,000 people across Canada — including in thousands of child protection cases.
Despite Persaud’s findings, which he’s been sounding the alarm on for years, Canada Health, as well as the U.S. Food and Drug Administration, continue to insist that the drug is both safe and effective.
Below, watch a video report by Canada’s CTV News in which Persaud speaks out and expresses his concerns about the drug being completely ineffective.
Read the full story at The Toronto Star.