Say the name "ProPublica" in a work comp meeting these days and watch what happens. It's like a pinata at a little kid's birthday party... everyone takes a swing, only a precious few actually connect (but when they do connect, we all get candy... or something like that). Metaphors and Mondays don't always mix.
By way of brief background, ProPublica is an independent, non-profit news organization that focuses on investigative journalism. "Journalism in the public interest" is their tagline. Regardless of how you feel about the organization, they've done good work in the past and the pieces they publish deserve at least a glance, regardless of where you think the organization sits on the political spectrum.
Over the last year or so, ProPublica's Michael Grabell and NPR's Howard Berkes have teamed up for a memorable series of articles on the work comp industry. I chose the word "memorable" carefully - the aim of this post isn't to offer my view of the work. Topics ranged from the state politics surrounding system change to how much one's arm would be worth if one lost it in a work-related accident, from the wisdom of opt-out initiatives to the appropriateness of benefit levels. These articles were the source of much conversation and the target of a great deal of criticism, much of it obviously emanating from our industry.
Another of ProPublica's efforts that made news over the last couple of years was the publication online of a trove of Medicare Part D data in the form of a searchable database. Journalists have used this data to identify trends in prescribing patterns that might be newsworthy. Public health officials have used the data to develop and support both policy initiatives as well as fundamental research. Doctors and health systems have used the data to measure how they stack up against other groups.
And guess who else uses the data? That's right! Opioid seekers aiming to identify doctors most likely to prescribe pills.
First of all, this isn't ProPublica's fault. Secondly, they rushed to both publish their own story on this phenomenon and add additional warnings to their site regarding the dangers of opioid misuse and abuse. So this is obviously a simple case of unintended consequences. And frankly, the benefits of having the prescription data made public still outweigh the risks of inappropriate use. The database is neither good nor bad; it's use makes it so.
But it does beg the question: How many of those "drug seekers" on the ProPublica web site are injured workers? And how many of them went to the site initially to satiate their appetite for complaining about the work comp system... and ended up learning where they might be able to get more opioids?
Michael
On Twitter @PRIUM1
Monday, May 16, 2016
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:
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:
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
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.
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.
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
Monday, May 2, 2016
Because What We Really Need Right Now... Is Another Opioid
A twice-daily, extended release, abuse deterrent formulation of oxycodone, to be exact. And just in time, too. I was becoming concerned that FDA's recent commitment to take a new approach to the opioid crisis might have actually been genuine. I guess you can't have too much of a good thing.
The trade name you'll want to look out for is Xtampza ER. And no, I didn't misspell it. Wondering how to pronounce it? Your guess is as good as mine. The pharma industry appears to be running low on catchy, hip drug names with the letters "x" and "z" that play well in the market. Someday soon, we're going to see a drug called Xyz ER. You won't see Xtampza pop up right away - Purdue (makers of Oxycontin) are (predictably) suing Collegium (makers of Xtampza) for patent infringement (because, really, how many extended-release, abuse-deterrent formulations of oxycodone do we need?) But alas, Collegium appears to have a solid case: you can open up Xtampza capsules and sprinkle the oxycodone on your food without sacrificing its abuse deterrent properties. Science!
First, let's talk mandatory physician education. While you probably hadn't yet heard of Xtampza, you can be excused for that lack of awareness given that you likely have neither the authority nor the inclination to prescribe it. But the doctors who can prescribe it are going to learn about it from the sales reps who are pushing it. We can do better than that. We need to do better than that.
And to celebrate the advent of every new abuse-deterrent opioid formulation, I like to remind readers of this blog, both new and returning, that abuse-deterrence is a tool, not a solution. As I have written before, but share again here:
I am 100% supportive of abuse-deterrent formulations of prescription opioids. These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication. But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).
To me, though, this conversation is a distraction. While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem. The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed. Very little pill crushing. Very little intravenous injections. Very little drug dealing.
The problem as we see it is lack of medical necessity. In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not. If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away. The doctor will be better educated. The patient will get better. The cost of care will go down. Everyone wins.
Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.
Michael
On Twitter @PRIUM1
The trade name you'll want to look out for is Xtampza ER. And no, I didn't misspell it. Wondering how to pronounce it? Your guess is as good as mine. The pharma industry appears to be running low on catchy, hip drug names with the letters "x" and "z" that play well in the market. Someday soon, we're going to see a drug called Xyz ER. You won't see Xtampza pop up right away - Purdue (makers of Oxycontin) are (predictably) suing Collegium (makers of Xtampza) for patent infringement (because, really, how many extended-release, abuse-deterrent formulations of oxycodone do we need?) But alas, Collegium appears to have a solid case: you can open up Xtampza capsules and sprinkle the oxycodone on your food without sacrificing its abuse deterrent properties. Science!
First, let's talk mandatory physician education. While you probably hadn't yet heard of Xtampza, you can be excused for that lack of awareness given that you likely have neither the authority nor the inclination to prescribe it. But the doctors who can prescribe it are going to learn about it from the sales reps who are pushing it. We can do better than that. We need to do better than that.
And to celebrate the advent of every new abuse-deterrent opioid formulation, I like to remind readers of this blog, both new and returning, that abuse-deterrence is a tool, not a solution. As I have written before, but share again here:
I am 100% supportive of abuse-deterrent formulations of prescription opioids. These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication. But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).
To me, though, this conversation is a distraction. While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem. The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed. Very little pill crushing. Very little intravenous injections. Very little drug dealing.
The problem as we see it is lack of medical necessity. In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not. If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away. The doctor will be better educated. The patient will get better. The cost of care will go down. Everyone wins.
Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.
Michael
On Twitter @PRIUM1
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