Now Researchers Cannot Even Tell You about Dangerous Drugs

Dr. Nav Persaud is a physician and drug researcher at St. Michael’s Hospital in Toronto, Canada. He has been researching a drug called Diclectin, which is manufactured by Duchesnay Inc. It is the only drug on the market which has been approved by Health Canada to treat nausea and vomiting in pregnancy (NVP). There is controversy surrounding this drug on all sides. Dr. Persaud has been on a search to find out the truth about this popular drug, but the Canadian health authorities and the drug manufacturer seem to be intent on denying Dr. Persaud the opportunity to discover the truth and then share what he knows with his patients and the public.

Understanding the controversy

The NVP drug, Diclectin, has had a controversial history including birth-defect litigation and its removal from international markets. Dr. Persaud, along with some colleagues, authored a study in 2013 which recommended non-prescription vitamin B6 alone for NVP, contending that Diclectin’s benefits were overstated.

In 2015, the plot thickens when Kim Kardashian endorsed the Diclegis (the version of the drug approved in the U.S. by the Food and Drug Administration) to her 42 million Instagram followers, which inevitably led to an uptick in sales. What Ms. Kardashian failed to mention were the drugs dangerous side effects, which included:

• Drowsiness
• Headaches
• Urinary problems
• Stomach pain
• Heartbeat irregularities

Dr. Persaud had been negotiating with Canadian health officials to gain greater access to clinical data about Diclectin, and the agency agreed to give him 35,000 pages of documents, but only if he agreed to sign a confidentiality agreement which would bar him from speaking about it and that he would face legal action if he were to speak about it. So, now this physician and drug researcher who is trying to inquire about the efficacy and safety of a drug that is prescribed to roughly half of the pregnant women in Canada, finally had the information he needs and no freedom to discuss it.

Everything old is new again

Bendectin, a NVP drug with a similar compound to Diclectin, was at the center of a controversy in the United States in the 1980’s. The drug may have had a possible link to birth defects – an issue that Dr. Persaud is now raising with Diclectin. Firm founder Barry Nace, one of the first attorneys to win a Bendectin case, told Maclean’s that “Bendectin’s litigation history was coloured by politics and the mishandling of several high-profile cases.” Now, we fear the research into Diclectin, and eventually the potential victims, may face the same hurdles.