Just Say Nohydro

Alas, neither the Globe nor the T&G would take this, so on the blog it goes:

            “Sinaloa cartel sues US government for ban on heroin” is not a newspaper story we are likely to see.  However, “Zohydro maker sues to block Massachusetts ban” has recently appeared in news reports across the country.  Why does the former seem ridiculous and the latter like a legitimate business seeking to defend its legal product?

            Governor Patrick’s banning of Zohydro is one action to address the public health emergency he declared over opioid addiction.  Vermont Governor Peter Shumlin devoted his entire State of the State address this year to Vermont’s opioid addiction problem.  Nationally, over 80% of abused opioids are estimated to be prescription opioids, not heroin.  So if we want to address the addiction crisis, we have no choice but to address prescription opioids.  But why single out Zohydro?

            A little history is helpful to understand why Zohydro, a slow-release formulation of hydrocodone, is particularly deserving of attention.  Our current crisis in opioid addiction has its roots in Zohydro’s older sibling, Oxycontin, a slow release form of oxycodone.  The manufacturer of Oxycontin, Purdue Pharma, initially marketed it in a form that had no measures to prevent grinding it up for an immediate high instead of the slow release it was designed to have when swallowed.  They also poured millions of dollars into campaigns pushing the idea that we are undertreating chronic pain and opioids were safe and effective for chronic pain not caused by cancer or other terminal diseases.  Prescriptions and abuse soared and it was dubbed “hillbilly heroin” due to the massive addiction problem it created in Appalachia.  After many years – somehow, just shortly before the original patent expired – a new version of Oxycontin was introduced that actually was more difficult to abuse and, not incidentally, extended the manufacturer’s monopoly.  Street prices of Oxycontin dropped as, while it could keep someone out of withdrawal, it was harder to use for a high.

            So, why wouldn’t the makers of Zohydro bring out a tamper-resistant version like the current Oxycontin, rather than one with no safeguards at all, like the original Oxycontin?  It is technically feasible – in fact, Zogenix, the company marketing Zohydro, says it plans to do so in about 3 years.  Why not now?  They offer no answer.

            Perhaps they are addressing the urgent need for more options for treating chronic pain.  As a family doctor, I can certainly testify that we need new and better pain treatments.  But is there a pressing need for another long-acting opioid?  I don’t think so.  We have sustained release oxycodone, sustained release morphine, methadone, fentanyl patches, and buprenorphine.  The FDA’s advisory panel voted overwhelmingly against approving Zohydro, raising the as yet unanswered question of why the FDA chose to overrule them and approve it at all.  However, marketed without any protections against abuse, there will be immediate demand for Zohydro and it will gain substantial market share and generate huge profits far exceeding what a tamper-resistant version could bring in – the lessons of Oxycontin have clearly not been lost on Zogenix and Alkermes, the actual manufacturer of the drug.

            The courts have ruled that the FDA approval of Zohydro trumps the state’s decision to ban it.  But Zohydro is a drug whose time should never have come.  It will do far more harm than good.  The massive increase in US opioid consumption has not solved the chronic pain problem, but it has killed thousands, harmed millions, and generated huge profits for the pharmaceutical industry.  The question should not be whether a state like Massachusetts can ban Zohydro, but what went on at the FDA that they approved this harmful, unnecessary pill.  I have yet to find a single colleague in primary care who thinks there is any need for Zohydro.

            As Nancy Reagan might say, “Just Say Nohydro.”

And for those of you who only come here for the nature photos, we had a couple of migratory visitors.

A yellow-rumped warbler bathing in the back yard:

A black and white warbler:

And one of our common chipping sparrows doing some personal hygiene: