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.

Michael
On Twitter @PRIUM1

Oxycontin for Kids

The FDA has approved Oxycontin for children. 

Before I editorialize, a few important facts:

• Specifically, the approval is for children ages 11-16 that require daily, round-the-clock, long-term pain relief for which no other alternative exists. 
• FDA actually requested that Purdue study this; this isn’t Purdue trying to extend its patent through dubious means.
• The only other FDA-approved long acting analgesic available to kids who have, say, incurable cancer, is Duragesic (or fentanyl).
• I have an 11 year old.  

That last fact turns out to be pretty important.  My first reaction to this news was outrage.  I’ve never pulled punches with my criticism of the FDA and I was fired up to skewer them again for being utterly tone deaf to the greatest public health crisis of our time.  But I first saw this news while sitting at the breakfast table with my three kids, the oldest of whom is 11.  After finishing a few articles on the FDA move, reading emails from several of you who struck tones of anger and confusion in varying degrees, and processing my initial shock, I looked up at my kids and wondered…

I am incredibly blessed to have healthy kids.  But if my kid had incurable cancer and he was suffering from intractable pain, would I want him to have Oxycontin available to him?  Yep.  I sure would. 

On the other hand, I thought… What if he blew out an ACL playing soccer when he’s 15?  Would I want him to have Oxycontin for post-op recovery, even if he was in great pain?  No.  Absolutely not. 

If we trust that Oxycontin will be used only in those extenuating and heart breaking circumstances for which this approval is intended, then I could support that. 

But what if the message coming through armies of pharma reps employed by Purdue is that Oxycontin is now approved for “round the clock pain management, when no other alternative exists… even for teens suffering from post-op pain related to major sports-related surgeries…”?  Do we have proper controls in place to ensure that doesn’t happen?   One need only read this crushing article in Sports Illustrated to understand that we’re already overprescribing opioids to teens, particularly athletes.  How do we make sure this doesn’t make it worse? 

Pediatric oncologists are thrilled. 

Public health advocates are gravely concerned.    

I'm not comfortable with ambivalence, but in the case I have to admit: Both are right.  

Michael
On Twitter @PRIUM1