PAINKILLER LAW BLOG: Fear, Dread and a Warm Welcome – Here Comes Zohydro

How can a drug about to hit the market be feared, dreaded, welcomed and deemed medically necessary, all at the same time? It’s complicated, so if the new “super painkiller” Zohydro had human feelings, it would definitely be in the midst of an identity crisis. In this post I’ll talk about the Zohydro kerfuffle, and why it’s more proof that in most cases, “blame” for prescription drug addiction lies with the drugs themselves, not the doctors who’ve prescribed them.

First, what is a “kerfuffle?” It’s a brouhaha. Commotion. Turmoil. Uproar. Hubbub. I learned the word from The Onion. Second, why the kerfuffle over Zohydro? Because Zohydro, a new opioid painkiller approved by the FDA and slated for market entry soon, is ten times more powerful than Oxycontin or Vicodin, and it contains no abuse-deterrent formulations. This has policymakers and even some medical societies worried that the drug will – well, how to say it gently? – kill or injure a lot of people who will be using it. Though the drug is slated to be used as a painkiller of last resort for patients who cannot get relief from other medication, its potency and its emergence on the market in an era of high rates of addiction, overdose and death from opioid painkillers are indeed cause for concern.

Last year, an FDA panel opposed approving Zohydro; the FDA itself then went against its panel’s recommendation and green-lighted the drug. The drug’s approval has been the subject of controversy ever since, and this week U.S. Senator Charles Schumer (D – N.Y.) asked the Dept. of Health and Human Services to reverse the FDA’s decision. Good luck, Chuck; the Congressmen from Big Pharma likely have a different view.

The controversy swirling around Zohydro got me thinking about doctors who prescribe opioid painkillers, and of law enforcement efforts to “do something” about the prescription drug crisis. To me, at the core of the Zohydro debate is the widespread belief that the drug’s mere availability will further aggravate an already serious public health problem. Is the worry that doctors, however cautiously, may be prescribing it? Or is it that Zohydro will exist at all? My answer is that people are worried about Zohydro’s very existence. To date, media reports haven’t much discussed the role doctors may play in prescribing the drug; reports instead have focused on how Zohydro’s very presence in the market will automatically impact the prescription drug crisis.

Isn’t this a powerful indicator that the problem could be the drug itself? After all, doctors would be directed to follow protocols, guidelines, safety measures and other steps in assessing patients’ eligibility and need for the drug, its effectiveness, and any problems that might arise in treatment. If that part of the discussion is so irrelevant in the minds of Zohydro critics, then doesn’t it stand to reason that doctors ordinarily aren’t the problem? Yes, it does, in case you’re on the fence about that one. I have long believed that in all but the extraordinary, outlier case, prescribers aren’t the problem so much as the drugs they’re prescribing are. The Zohydro kerfuffle is but one more piece of evidence that aggressively targeting legitimate doctors is the wrong way to go, especially when the same law enforcement agents who self-righteously kick in office doors and hold slanderous press conferences refuse to look past their own noses for the real roots of the problem.

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