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

What Primary Care Docs Don't Know Can Hurt You

Caleb Alexander is an associate professor at Johns Hopkins Bloomberg School of Public Health and the co-director of school's Center for Drug Safety and Effectiveness.  He and some of his colleagues decided to ask 1,000 primary care physicians about their beliefs and attitudes about opioids.  The results are both unsurprising and unsettling:

First, the good news:

• More than half of doctors recognize prescription drug abuse as a "big problem" in their community; 
• 90% strongly supported requiring patients to get opioids from a single doctor and single pharmacy; 
• Two-thirds supported the concept of physician-patient "pain contracts"; 
• More than half supported the use of urine drug monitoring for chronic opioid patients.  

However, the survey also uncovered significant gaps in knowledge among primary care docs:

• About one-third said they thought most prescription drug abuse occurs by means other than swallowing the pills.  (In fact, crushing/snorting/injecting/etc. happens with far less frequency than simple ingestion.  Multiple studies suggest ingestion accounts for anywhere from 64% to 97% of prescription drug abuse.) 
• Almost 50% believe that abuse-deterrent pills are less addictive than the standard formulation. (In fact, there's absolutely no difference.)  

This last data point is scary.  To me, it shows the success that pharmaceutical companies are having in creating a "halo" of safety around new abuse-deterrent formulations.  There is no "halo" and there's still a great deal of harm that can occur with the use of these medications.  

The primary issue isn't the kind of abuse against which abuse-deterrent formulations can protect patients.  The primary issue 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

Opana, HIV, and Unintended Consequences

With the exception of a great piece on medical billing from back in March of 2013, Time magazine hasn't managed to publish much worth reading.  But the forthcoming issue of the magazine features a cover story titled "Why America Can't Kick Its Painkiller Problem."  And it's worth 15 minutes of your time, albeit not for the most obvious reasons.

Yes, the article offers a fairly thorough overview of the recent history of pain management in this country.  The usual suspects make their appearances (big pharma, Russell Portenoy, the Joint Commission, etc.) and the standard statistics are rolled out ($8 billion painkiller market, 17,000 annual deaths from overdose, more than 200 million annual prescriptions written for opioids, etc.)  You know most of this and it would be easy to scan the article and think (as I usually do), "If Time Magazine is only now publishing a story about the problem, we must be making progress..."

But this article turns out to shine some important light on three issues we normally miss when we contemplate the epidemic of prescription drug misuse and abuse:  First, that there are incredibly harmful unintended consequences that no one could have foreseen; second, seemingly harsh punitive measures taken against pharma companies haven't put a dent in the problem; third, the FDA isn't helping.

Perhaps the scariest among many unintended consequences is the one highlighted in this article - the rise of Hepatitis C and HIV infections among intravenous drug users addicted to opioids.  In January, Scott County reported an alarming jump in new HIV cases: eight new HIV-positive patients in a small, rural community.  By March, there were 81 new cases.  As of June 2, there were 166 HIV cases in Scott County.  Of those patients interviewed by the CDC, 96% reported injecting Opana intravenously.  I wonder if there are any injured workers among them.  And this is being driven by a formulation that Endo claims is abuse-deterrent.  Turns out the supposed abuse-deterrence makes it much harder, if not impossible, to crush and snort the drug.  As for cooking it down to liquid form and injecting it?  Endo hasn't figured that out yet.    

The federal government has taken aim at big pharma's painkiller marketing tactics.  Purdue Pharma, makers of Oxycontin, paid a $635 million fine in 2007 in connection with a guilty plea for misleading doctors about the abuse potential of the drug.  The next year, Cephalon, makers of Actiq, paid a $425 million fine for misleading marketing.  That's more than $1 billion in fines in an $8 billion industry... and it just keeps rolling.  What do you imagine the gross margin per pill is for Opana (which does $1.16 billion in annual sales)?

Finally, the FDA has proven to be a misguided and inconsistent ally in the fight against prescription drug misuse and abuse.  In the midst of an epidemic, they've not hesitated to add new opioids to the market (Zoyhdro and Hysingla come to mind).  They've also focused a lot of energy on "abuse-deterrent" formulations of extended release opioids.  While they did not grant Opana ER that distinction, I've held the view for some time that abuse-deterrence is necessary, but by itself, entirely insufficient to stem the tide of misuse and abuse of opioids.  

We have a long way to go.

Michael
On Twitter @PRIUM1

Don't Be Fooled: Abuse Deterrence Isn't the Answer

One of the consistent themes of this blog is a critique of abuse deterrent formulations of opioids.  While absolutely necessary as one tool among many to stem the tide of prescription drug misuse and abuse, such technology runs the risk of creating a perception of safety among both patients and prescribers that is downright dangerous.

The best discussion I've seen on the topic came out last week on Forbes.  In an article and video by Matthew Herper, the pros and cons, risks and rewards of abuse deterrent opioids are covered quite thoroughly.  The video, in particular, is worth 5 minutes of your time.

And, of course, I would never miss a chance to restate my own position on the matter:

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

@PRIUM1 on Twitter

Zohydro Is Now Abuse-Deterrent... And It Doesn't Matter

Zogenix, the makers of Zohydro - the first "hydrocodone only" opioid analgesic - announced last week that the FDA has approved a new formulation of Zohydro that now includes abuse-deterrent technology.  For frequent readers of the blog, here's a warning: I'm about to repeat myself.  For what must be the fourth or fifth time in the past year.  That said, I will continue to repost these thoughts on abuse deterrent opioids every single time one is approved.

So... once again, here's your friendly public service announcement:

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

Generic Drugs Are Not the Answer

I've written on several occasions that I believe abuse-deterrent opioids to be a potentially dangerous distraction.  Specifically, I've said:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  To me, though, this conversation is a distraction. 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.  

We saw in 2014 a plethora of drug trend reports noting cost savings associated with generic medications.  We'll see more of the same in 2015.  Like abuse-deterrent technology, generic medications represent a potential Pyrrhic victory in the battle against misuse and abuse of prescription drugs.  Yes, we're saving money.  No, we're not really solving the problem.  Here's a reprise of the language above with GENERIC substituted for ABUSE-DETERRENT.

I am 100% supportive of GENERIC formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is GENERIC 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.  GENERICS [are] great, but if we focus on GENERICS over medical necessity, we will have missed the mark and the crisis will continue.  

Don't let a single digit % drop in drug costs fool you.  There is a lot of work to be done.  Cheap drugs can still be dangerous drugs.

Michael
On Twitter @PRIUM1