Monsanto Roundup Lawsuit

Tuesday, July 21, 2015

Diclectin and the Redacted Adverse Events





It's certainly been a busy few days.

Earlier this week I learned that celebrity Kim Kardashian was promoting the use of the morning sickness pill for expectant mothers on her social media accounts. The pill, Diclegis, marketed and manufactured by Canadian pharmaceutical company, Duchesnay Inc., has a tainted history, at least the two compounds that make up the drug do.

Just hours after I tweeted about the history of these two compounds I was contacted by Danny Martel, who is a market analyst for Duchesnay. He joined in the thread on Twitter, told me to "educate" myself then, bizarrely, removed all of his comments.

I wrote about the two compounds and how they were, some years ago, the subject of a lawsuit in the United States. That post can be seen here.

Earlier today I learned that Duchesnay's Diclegis has already been causing concern for Canadian doctor, Nav Persaud.

Persaud had asked Health Canada for all of the information it had on Diclectin, what followed was, according to The Star, "a three-and-a-half-year runaround from the regulator and more than 200 censored pages."

Health Canada had liaised with Duchesnay in efforts to decide what to send on to Persaud.

The Star writes...

Finally, more than a year after his initial request, Health Canada provided Persaud with some information on Diclectin. Of the 359 pages provided, 212 were completely censored and other pages had blacked-out sections under titles such as “Adverse Events,” because they were deemed confidential business information.

Since when has adverse events been privy to pharmaceutical companies only? Surely, as a prescribing doctor, Persaud has a given right to see exactly what sort of adverse events have been reported about Diclectin? More to the point, surely patients have a right to see that information.

Furthermore, the article points out that Diclectin is endorsed by Sick Kids’ Motherisk, an organisation that, according to The Star, Duchesnay has or has had financial ties to.

In March, Persaud re-requested the full, uncensored 359 pages of Diclectin information. The Star article, which was published in April, claimed that Persaud had not received the full uncensored version. It's unknown whether or not Persaud has finally received all the documents, including the previously redacted adverse events.

"There are a number of other medications and treatments that are reasonable options for nausea and vomiting in pregnancy, and in my opinion they are better options," he said.

Persaud said he's already changed his own practice, and now recommends his patients try alternatives, including vitamin B6.

If a doctor who has had access to information on Diclectin now recommends vitamins then I guess it's safe to say that he didn't like what he saw in the information provided to him.




The article, Toronto doctor asks Health Canada about pregnancy drug, gets 212 pages of censored information, can be read, in full, here.




Bob Fiddaman.

Back stories

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Is It Just Kim Kardashian on the Duchesnay Payroll?