In case you hadn’t heard the Vioxx news, it was pulled off the market in Sept of 2004 when it was confirmed that it increased the risk of having a heart attack.
I’m pretty sure none of us think that the drug companies have the best of intentions when it comes to our health. But outright lies, deceit and death in the name of profit? Sounds like a perfect Hollywood plot.
But it’s not. It’s far too real.
Given that society has a very short memory, I’ll refresh you on what happened as it relates to the selective COX-2 inhibitor story.
The problem with anti-inflammatories is that they had this nasty side effect called bleeding ulcers that kills about 16-21,000 people per year (depending on the year). Not something you want prominently displayed on the front of the pill bottle. (As a side note–I always find this little tidbit of deaths associated with NSAID use pertinent to a discussion of risks vs benefits as it relates to chiropractic care).
This tiny little problem of bleeding ulcers and death is the result of the blockage of an enzyme called cyclo-oxygenase (COX). Now, COX has several isoforms–consider them close cousins. The COX-1 cousin actually protects the lining of the stomach and gut and keeps bleeding from occuring. Block this and you get your GI bleeds.
The other cousin, COX-2, was the version that played a role in the pain cycle.
So, block COX-2, but not the protective cousin COX-1, and you’ve got a blockbuster drug. Thus was born Bextra, Celebrex and Vioxx. And boy did they take off. The drug company advertising on this class of drugs kept the media people in BMWs and Porsches for several years.
There were some low level grumblings about concerns over heart disease risk, but these were brushed aside by the company line and well-prepared pharmaceutical reps.
It wasn’t until a whistle-blower came forward that the dam broke. Only then was the true carnage of this class of drugs understood.
You see, unbeknownst to all, the enzyme COX-2 also effected the production of a compound called prostacyclin that thins the blood. Block this and you run the risk of strokes and heart attacks. So much so that we believe in excess of 100,000 heart attacks and who knows how many deaths occurred.
Not to mention to fact that these drugs really weren’t all that much more protective to the stomach lining.
In the lawsuit that followed, much information came to light about just how subversive Merck was with their product Vioxx. The two major concerns focused on:
- The hiding of known data that there were increased cardiac risks
- The promotion of faked studies (called seeding studies) produced by the marketing teams to get doctors used to prescribing the drugs
To look a little closer at item number 1, in this particular study, researchers tore through the data in studies done by Merck. Studies that Merck claimed did not show any early warning signs of the coming storms.
Turns out, they DID know. To the tune of a 357% increase in the risk of cardiac deaths taking place in those taking Vioxx. And they knew this a full 40 months prior to Vioxx being pulled from the market.
Just under 3 1/2 years. The number of deaths may never truly be known.
So, the pertinent question is…
It is very likely that this is not an isolated scenario at an isolated drug company for an isolated class of drugs.
Just how many other bombshells have been quietly suppressed, never to be revealed, or how many are yet to come to light in the future of this “blockbuster drug” society we live in?