Hidden studies and hush-hush findings may be business as usual in Big Pharma’s world… but where innocent babies are concerned, all bets are off.
Uncovering the secrets about the frequently prescribed morning-sickness drug Diclegis (an old drug with a new name that’s come back to haunt us) led a Canadian doctor to fight tooth and nail for seven years to wrestle old studies on this med out of the tight fists of regulators.
Finally, he was recently given the right to review those documents (after signing a confidentiality agreement with Health Canada stating that he would never share or show that data).
And his conclusion?
“It’s not effective, and therefore, women should not be taking it,” he said.
Of course, not being effective is one thing. But when you’re pregnant, you don’t want to take any chances at all.
And where Diclegis is concerned, safety is a whole other story. One that started decades ago… and is still going on as you read this.
What are they hiding?
You could say that Dr. Nav Persaud was a man on a mission.
For nearly a decade, this practicing family doctor attempted to shake loose the original drug trial data for the med Diclegis (called Diclectin in Canada), which is prescribed to hundreds of thousands of women during pregnancy.
And when he finally got a look at some of those records, he was shocked.
The information that the drugmaker (in cahoots with Health Canada) kept hidden all that time paints a picture of the worst of the worst when it comes to pharma’s tactics — cherry-picked findings to make the drug look more effective, poorly kept records, and a high drop-out rate of volunteers that totally skewered the results.
The tiny difference in morning-sickness symptoms between the women taking a placebo and Diclegis was not enough “to be noticed,” Dr. Persaud said. On top of that, most women in the group taking the placebo “sugar pill” had “little to no” nausea or vomiting by the end of the trial.
Needless to say, not only does Dr. Persaud no longer prescribe Diclegis (which is also approved by the FDA), but he recommends other doctors stop doing so as well.
But what about the most important thing every mom-to-be agonizes over — is it safe? Most expectant mothers don’t let a breath mint pass their lips if they think it might harm their unborn babies!
Well, that story started back when Diclegis was sold in the U.S. under another name! That’s right — in 1952, the FDA approved a pill for morning sickness called Bendectin, which was available to women right up until 1983.
That was the year drugmaker Merrell yanked it off the market due to hundreds of lawsuits claiming that it caused terrible birth defects. At the time, the company said that the drug was quite safe, but it was just too expensive to keep “defending” Bendectin in court.
Fast forward to 2013 and Bendectin makes a return in the U.S., only this time it has a new name (Diclegis), a new company making it (Duchesnay), and a new advertising campaign featuring pregnant celebrities such as Kim Kardashian.
But wait! What about those lingering safety questions — have they all been solved?
Not exactly. In fact, there are still more questions than answers.
What we do know is that:
- One of the ingredients in Diclegis, a potent antihistamine called doxylamine, carries an FDA “pregnancy category” B, meaning that the drug’s “safety has not been established during pregnancy.” However, the FDA apparently waved its magic wand over Diclegis (a combo of doxylamine and another med, pyridoxine), and somehow says that when taken together, the pair is a category A — meaning it’s perfectly safe!
- In the first round of secret documents released to Dr. Persaud, numerous pages titled “Adverse Events” were blacked out.
- Over three decades ago, when Bendectin was withdrawn from the market, even the FDA said that a “residual uncertainty” remained over how it might affect an unborn baby.
And what about all those lawsuits from heartbroken parents? Were they secretly settled, allowing the drugmaker to hide even more documents away?
We simply don’t know these things. And while the drugmaker proudly boasts about how many women have been prescribed Diclegis, remember that just 20 percent of the babies exposed to the well-known, harmful drug thalidomide suffered birth defects.
Look, I don’t care if it’s just a shadow of a doubt — where the safety of a child is concerned no measure of protection is too extreme.
So, if there’s a mom-to-be in your life, please share this eAlert with them. The stakes are just too high to leave anything to chance — or to the mistaken belief that a doctor knows about the history of Diclegis.
“Popular morning sickness drug is not effective, new analysis finds” Jesse McLean and David Bruser, The Toronto Star, January 17, 2018, thestar.com
