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

Two Reasons You Should Care About Hepatitis C

Let's talk about Hepatitis C for just a moment.  

Hep C is a disease of the liver.  It can be mild, nearly asymptomatic... or it can be a lifelong battle, requiring a potential liver transplant.  Hep C isn't genetic or environmental - rather, it's contagious. The virus is spread when the blood of someone with Hep C enters the body of someone who is not infected.  The two most common methods of transmission both involve needles and both impact workers' compensation: 1. accidental needle stick injuries in a health care setting; 2. the sharing of needles and syringes among drug addicts.  

Regarding injuries to healthcare workers... while most payers won't see many Hep C cases that are work comp related, it's best for payers to be prepared if and when a case does arise.  Why?  Because treatment is both complex and enormously expensive.  The recently released Drug Trends Report from pharmacy benefit manager Healthcare Solutions has an excellent section on specialty drugs and a very informative sub-section on Hep C.  "The new Hepatitis C medications, such as Harvoni, Olysio, and Sovaldi, have a treatment success rate of 94-100%, or double that of previous therapies," says the report. "These medications cost $90,000 to $226,000 for a 12 to 24 week course of therapy.  Effectively, a client with a $1 million drug spend could experience a 2% increase in overall drug spend with one claimant receiving these medications." (Emphasis added).  

Regarding Hep C transmission among drug abusers... the CDC's Morbidity and Mortality Weekly published a piece on Friday regarding the growth of Hep C in Kentucky, Tennessee, Virginia, and West Virginia.  Surveillance data from these four states showed a 364% increase in Hep C cases from 2006 to 2012 among persons <= 30 years of age.  This rise was strongly correlated with opioid misuse and abuse rates as well as substance abuse treatment admissions.  While I've often pointed out that the work comp population is not a primary driver of the type of drug abuse that involves drug tampering and needle sharing, we should nonetheless recognize that work comp is a significant source of diversion (both intentional and unintentional), and therefore the drugs being paid for by work comp payers are, at some level, likely contributing to the rise in Hep C cases.

Hep C is complicated and expensive.  Two lessons for payers:

1. When a work-related Hep C case pops up, put your best clinical resources to work on that claim to ensure prompt, appropriate, adherent, and thorough care; 
2. Make sure you're doing everything you can to stem the tide of prescription drug misuse and abuse. 

Michael   

Follow me on Twitter @PRIUM1