Pubdate: Tue, 10 Jan 2017
Source: Washington Post (DC)
Copyright: 2017 The Washington Post Company
Author: Christopher Ingraham


The reformulation of the powerful painkiller OxyContin in 2010 is the
chief driver of the explosion in heroin overdose deaths in subsequent
years, according to a new working paper from researchers at the RAND
Corp. and the Wharton School.

OxyContin, released by Purdue Pharma in 1996, is a powerful
extended-release opioid designed to provide 12-hour relief to patients
suffering from severe pain. The original formulation was particularly
prone to abuse, as drug users found that they could crush the pills
and chew, snort or inject them in order to deliver 12 hours of
powerful painkiller dosage all at once.

In 2007, Purdue pleaded guilty to misleading consumers about the risk
of abuse associated with the drug. The company paid $600 million in
fines, and in 2010 it released a new formulation of the drug that made
it extremely difficult to crush or dissolve the pills in an attempt to
make it harder to abuse. It was the first drug to receive an
"abuse-deterrent" designation from the FDA.

That reformulation was one of a number of steps taken by authorities
across the country to limit the number of prescription painkiller
overdose deaths, which by then had been trending sharply upward for
more than a decade. Other interventions included the use of
Prescription Drug Monitoring Programs (PDMPs) to track the sale of
prescription painkillers, and a "pill mill" law in Florida passed in
2010 putting tighter regulations on pain clinics that in some cases
dispensed painkillers recklessly.

Taken together, these interventions have been widely credited with
staving off the rise of prescription painkiller deaths. But they came
with an unintended side effect: a subsequent heroin epidemic that now
kills more people each year than most prescription painkillers combined.

The working paper, published this week by the National Bureau of
Economic Research, shows that the Oxycontin reformulation was by far
the single largest driver of the shift to heroin, accounting for "as
much as 80% of the three-fold increase in heroin mortality since
2010," the authors found.

They arrived at this estimate by looking at the differences in heroin
deaths, post-2010, in states that had differing rates of OxyContin
abuse prior to the 2010 reformulation.

If heroin deaths increased more in states that had large rates of
OxyContin abuse before 2010, the authors reasoned, that would be a
strong indicator that the reformulation drove more Oxycontin users to
abuse heroin. And that's exactly what they found.

"States with the highest initial rates of OxyContin misuse experienced
the largest increases in heroin deaths," they write. "Results show
that this differential increase in heroin deaths began precisely in
the year following reformulation."

Moreover, prior to 2010, there was no correlation between OxyContin
abuse and heroin mortality. "Both the levels and trends in heroin
deaths were nearly identical across states with high or low initial
rates of OxyContin misuse before 2010," the study found.

The study determined that the OxyContin reformulation was indeed
successful at reducing OxyContin abuse. But, "each percentage point
reduction in the rate of OxyContin misuse due to reformulation leads
to 3.1 more heroin-related deaths per 100,000."

The authors are confident the effects they observe are from the
OxyContin reformulation and not from other efforts to crack down on
prescription painkillers during that time. They controlled for the
presence of Prescription Drug Monitoring Programs in different states
and found it had little effect on their numbers.

They also re-ran the numbers to exclude Florida, as well as states
like Kentucky and West Virginia, where people were known to buy drugs
from Florida's "pill mills" which were largely shut down in 2010. But
even then, their observed effect remained.

Overall, they estimate that the OxyContin change was responsible for
80 percent of the increase in heroin mortality after 2010. They stress
that the change didn't appear to have any effect on the total number
of overdose deaths observed after 2010 -- if fewer people died from
OxyContin, more were killed by heroin. The overall trajectory
essentially remained unchanged.

The authors position the effects of the OxyContin reformulation as a
lesson in the limits of "supply-side" drug policies -- those that
attempt to reduce drug abuse by cutting the supply of abused drugs,
rather than the demand. "The findings from this study provide yet
another example of how supply-side strategies alone are inadequate for
dealing with the drug problem, particularly when substitute drugs
exist," they write.

"That doesn't mean supply reduction is bad, you just need broader
supply reduction policies," said co-author David Powell of the RAND
Corp. in an interview. With the OxyContin reformulation, "they were
basically just taking out one component of this abuse chain."

The FDA is actively encouraging the development of more
abuse-deterrent opioids similar to the reformulated OxyContin. That
could create a "tipping point," Powell said -- if an overwhelming
majority of prescription opiates become harder to abuse, in the long
term that may reduce the likelihood that people get hooked on any
opioids to begin with. That could eventually lead to opioid overdose
death rates declining.

On the other hand, "you're not gonna reformulate heroin," he added. As
long as heroin remains an available substitute for opioid painkillers,
cracking down on the latter will likely only lead to an increase in
use of the former.

He and his co-authors would rather see a more holistic approach to
drug enforcement that focuses more attention to reducing demand for
illicit drugs to begin with -- treatment and prevention programs that
either help people stop using drugs completely, or prevent them from
starting in the first place.

"Treating underlying demand may prove to be the more effective
strategy for dealing with the current opioid epidemic, particularly
because substitutes are readily available," they conclude.
- ---
MAP posted-by: Matt