The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Make Hair Great Again - The Real Reason for FDA Reform

Posted by Brian Overstreet on March 3, 2017

A personal note:  About a month ago, we published a blog post titled Drug Safety Progressives.  While 99.9% of the readers understood that this wasn’t a political statement, we did get hit with some great trolling that accused us of, among other things, pushing “Alt-Left Propaganda on a Left Wing Socialist website.”  How or why someone reached that conclusion is beyond me.  Regardless, I’m dedicating today’s blog post to those 0.1% of our readers who troll for an internet fight.  I’m confident that the rest of you will enjoy it too.

Trump_Hair.png

We know that with the fake news circulating these days, you may have missed the most important breaking story concerning President Trump in February.  That’s right, he’s taking something to maintain that famous hair – Propecia.

A number of articles have been written in recent weeks about the known side effects of Propecia, with sexual dysfunction and memory impairment consistently highlighted as two of the big ones.  In an article titled Should the Leader of the Free World Be Taking Propecia? Men’s Journal also cited the following doozies among the drug’s known side effects: “Users report that its side effects — inability to orgasm, painful erections, chronic depression, insomnia, brain fog, and suicidal thoughts — can last long after patients stop taking the pill.” 

Just the basic stuff you wouldn’t really wish on your worst enemy, let alone on the person tasked with leading the country.

Here at Advera Health, we’re pretty well versed on the known risks of many medications.  It’s the unknown (unlabeled) risks that we really care about.  So we couldn’t help but look into our data on Propecia to try to discover what other serious, unidentified side effects are happening at a higher than expected rate.

Our RxSignal algorithm is a disproportionality-based calculation that looks at all of the adverse events reported for each drug and highlights the ones we know are most likely to lead to some future FDA action (labeling changes, warnings, etc).  In a published study in Drug Safety, we validated our methodology as 74% accurate.

What do we see for Propecia’s unlabeled risks?  There are 12 specific risks that we rate as Active Signals – meaning they are likely to trigger FDA review and action.  There are another 18 Watchlist Signals – not quite full alert status, but rising in that direction.

The full list is below, but a few stand out.   Three of the Active Signals effect hearing – with deafness and Meniere’s Disease.  Could failing hearing be behind our President’s all-cap tweetstorms?  Or alternative facts?   Or the fact that he seems to yell a lot?  It’s an interesting theory.

On the Watchlist Signal list, there is an interesting combination of both penile and rectal hemorrhage – a nasty combination if there ever was one.  Vice President Pence would likely have to step into the big chair for a few days if President Trump got hit with either – or both! – of those horrendous side effects.

 

propecia active-2.jpg 

 

propecia watchlist-1.jpg

 

When taken in combination with the known and labeled side effects, you do have to wonder if taking this drug is really worth the risk for our president (or anyone).

I’m about as bald as they come, so I certainly empathize with the desire to have a full head of hair.  But is that really what President Trump has now?  I’m not sure what’s going on up there, but I certainly wouldn’t trade hairstyles with the guy.  And I certainly wouldn’t take Propecia.

Maybe President Trump already knows all of this, but doesn’t see a viable alternative on the market.  Could that be what’s behind President Trump’s recent calls for speeding up the drug approval process at FDA?   

Listen, if that’s the impetus for regulatory reform, then I say let’s Make Hair Great Again!

 

If you’d like to learn more about our data on unlabeled side effect risks and its impact on patient safety and healthcare costs, contact us here.

If you’d like to accuse us of being part of a left-wing cabal intent on undermining the American way of life, please direct your comments to putie@adverahealth.com

Topics: Drug Safety, FDA

Subscribe to Email Updates