Monday, May 9, 2016

Remember, Effective [Pain] Relief Just Takes Two

I hope you're sitting down.  Turns our Purdue Pharma may have engaged in inappropriate marketing for OxyContin.  Shocking, I know.  But read on... it's worse than you think.

Most of the news coverage around the plethora of lawsuits in which Purdue is engaged focuses on whether or not Purdue leadership and sales personnel misrepresented the abuse and/or addiction potential of OxyContin.  While this is a critical issue that continues to be litigated, my sense is that this particular line of attack has faded into a sort of white noise amidst the overall opioid crisis.

From the LA Times late last week, though, comes a new thing of darkness, a perhaps more clinically dangerous question about Oxycontin.  First, a few quick background facts:

  • OxyContin is a brand name for oxycodone which, according to CWCI's latest (excellent) research, is the 3rd most often prescribed opioid in the California work comp system and the fastest growing opioid from 2005 to 2014.  And OxyContin itself is clearly the opioid on which more money is spent in work comp than any other (according to NCCI, 7.4% of 'total paid' across all drugs, all classes in work comp).    
  • Purdue created a huge competitive advantage over other long acting opioids by submitting (and receiving approval for) an application focused on OxyContin providing pain relief via just twice a day dosing (q12h).  
  • This led to Oxycontin sales reaching a high of over $3 billion in 2010 and total franchise revenue of over $30 billion.
While past allegations of inappropriate marketing led to a $635 million fine paid by senior Purdue executives back in 2007, the issue of appropriate dosing was never a central theme in the public health debate about OxyContin.

Until now.

Turns out a material percentage of patients don't actually get 12 hours worth of relief from an Oxycontin script.  Through access to previously undisclosed records, the LA Times has uncovered the following:

  • Purdue has known about the problem for decades.  Even before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. 
  • The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin's market dominance hinges on its 12-hour duration.
  • When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to "refocus" physicians on 12-hour dosing. Anything shorter "needs to be nipped in the bud.  NOW!!" one manager wrote to her staff. 
Here's where things get dangerous. Purdue reps routinely encountered doctors who were dosing at shorter intervals, typically every 8 hours.  This creates two fundamental issues:

First, when the Oxycontin doesn't relieve the pain for the expected 12 hours and instead only offers relief for 8 hours, this creates a 4 hour gap during which pain comes roaring back... and makes the craving for the next dose all that much more powerful.  If this sounds like a recipe for addiction, it is. Dr. David Egilman, a Brown University professor, described this phenomenon to the FDA and summed it up as follows: "In other words, the Q12 dosing schedule is an addiction producing machine." 

Second, Purdue trained the reps to recommend that prescribing doctors (and this is the part that makes me viscerally angry)... up the dose.  That's right.  OxyContin 20 mg every 12 hours not working?  Try 40 mg every 12 hours.  Or 80 mg every 12 hours.  Safe MED levels?  Overdose potential?  Not a care in the world from Purdue about such matters of life and death.  Just make sure to hang on to the 12-hour dosing competitive advantage.

Take a look at your files.  How many claims do you have with OxyContin?  Lots, right?  So let's ask two critical questions... 1) Was the dose artificially increased over the years because some Purdue rep was telling the doctor to maintain the 12-hour schedule?  2) Or do you have lots of injured workers on 8-hour cycles of OxyContin that fall outside of Purdue's recommended dosing... thus providing further evidence that their 12-hour pain relief claim is fictitious?

Either way, I hope you're as fed up as I am.

On Twitter @PRIUM1


  1. Thanks, Michael. When I read the LA Times article via Twitter last Thu, I had to put my phone down for a second to breathe. Big Pharma has done wonderful things for many people with specific conditions. But when they cross the line into misrepresentation, they need to be held accountable. As expected, Purdue Pharma sought to "clarify" with a Claim/Fact posting on their website ( Interestingly, they don't address the LA Times stories about sales reps, but their responses seem reasonable. Until you read the LA Times rebuttal to the Purdue Pharma rebuttal (, which seems to debunk the debunking. One interesting quote, directly relevant - "In the first clinical trial, more than a third of patients who took OxyContin complained about pain within eight hours, and about half had asked for more medication by the 12-hour mark" and "Many physicians prescribe OxyContin for intervals shorter than 12 hours when patients complain that the effects wear off sooner." You can safely say that the LA Times stands behind their reporting. Is Purdue Pharma responsible (liable) for misuse by individuals? I'm not a lawyer, but I'm guessing they wouldn't. Is Purdue Pharma responsible (liable) for pushing the FDA-approved envelop directly with physicians to influence their prescribing patterns? Again, I'm not a lawyer, but that certainly seems plausible. I wonder if the FDA and/or DEA reads the LA Times?

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