Massachusetts Tackles an ‘Epidemic of Opiate Abuse’ by Banning One Version of Hydrocodone

Last week Massachusetts Gov. Deval Patrick
imposed an
emergency ban on Zohydro, an extended-release version of the
narcotic painkiller hydrocodone that was approved by the Food and
Drug Administration last year. Patrick
said Zohydro “poses a significant risk to individuals
already addicted to opiates and to the public at large.” Zohydro’s
manufacturer, Zogenix,
complains that the “unprecedented” state ban on a specific
FDA-approved product “only serves to unfairly restrict patient
access to the only hydrocodone pain reliever available for
long-term, daily, severe chronic pain patients who are obtaining
relief with short-acting hydrocodone combination products, but who
are at risk for potentially fatal liver toxicity due to their daily
intake of acetaminophen.” As Reuters
explains, Zohydro’s detractors view the absence of that risk as
a dangerous drawback:

The company has defended the drug as a necessary option for pain
patients who cannot tolerate acetaminophen, a nonsteroidal
anti-inflammatory drug linked to liver damage and stomach
bleeding.

But critics worry that with no built-in abuse deterrents,
Zohydro will be a draw for addicts looking for an easy fix.

You might have thought that hydrocodone products such as Vicodin
and Lortab contain acetaminophen with the goal of achieving a
synergistic analgesic effect that reduces the amount of hydrocodone
required for a given level of pain. But in truth the acetaminophen
functions more like the methanol that the government required
manufacturers to put in industrial alcohol during Prohibition: as a
poison aimed at deterring abuse. In the case of acetominophen,
there is no direct mandate, but “combination products”
traditionally have been less restricted than straight hydrocodone,
placed on Schedule III rather than Schedule II of the Controlled
Substances Act because they were deemed to have a lower potential
for abuse. Now that the FDA wants to
eliminate that distinction, there is not much advantage to
mixing hydrocodone with acetaminophen, especially for patients with
severe chronic pain who take the pills every day for an extended
period of time. But Patrick is basically telling Zogenix that it
cannot sell Zohydro to those patients unless it agrees to slowly
poison them with acetaminophen or comes up with a tamper-resistant
formulation that is harder to crush for snorting or
injecting. 

Zogenix argues that its product has become a scapegoat for what
Patrick calls “an epidemic of opiate abuse”:

Contrary to some recent media reports, most other opioid
medications on the market today are [either] equal to or more
potent than Zohydro ER (e.g., oxycodone, fentanyl, hydromorphone
and oxymorphone), and all are available in higher strengths per
unit-of-use than Zohydro ER. Claims that Zohydro ER is “more
powerful” or “more addictive” than other commonly prescribed
opioids are not supported by scientific data.

Over the last 12 months, more than 360,000 prescriptions for
extended-release opioids were dispensed in Massachusetts, and
a significant majority did not have FDA-approved abuse
deterrent claims. We fail to see how banning the sale of a single
new product will achieve the governor’s policy objectives when all
of the products that are currently part of the epidemic remain
available for sale in the state….The [Drug Enforcement
Administration] quota for Zohydro ER is less than one percent of
the total allotted hydrocodone product that will be manufactured in
the U.S. this year.

Even if Zohydro were especially attractive to addicts, that
consideration should not override the needs of legitimate patients.
As usual with attempts to “balance”
drug control and pain control, Patrick’s ban sacrifices the
interests of patients to protect addicts from themselves, a
tradeoff that is not morally justified.