The great state of Massachusetts is in the news again and this time, I couldn’t be prouder. Governor Deval Patrick made an announcement last week about the state’s ban of Zohdyro, a brand new FDA-approved opiate that is 10 times stronger than Vicodin. While I’m not the first to point out the dangers of this approval, it’s safe to say that we objectors can all get behind this ban, which was inspired by New England’s rapidly growing opiate abuse problem. Patrick has in fact declared a state of public health emergency and ordered the allowance of first responders to carry naloxone (brand name Narcan), a nasal spray that reverses the effects of opiate-based drug overdoses like heroin.
Zohdryo Not Going Quietly
Of course the makers of Zohdyro, a pharmaceutical outfit by the name of Zogenix, are none too pleased. They have filed a federal lawsuit in response to Patrick’s decision, claiming the ban denies patients in need a legitimate option for pain management. And since I can’t claim to know what it’s like to live with chronic pain, I’m not wholly confident insisting they don’t have a point. But should the lobbying for this cause really be coming from the manufacturer? Can we say bias alert? If there are such pressing demands for more powerful opiates on the market, it might be more digestible if we heard it from pain management doctors and chronic pain patients rather than the people who stand to lose millions from the ban.
Furthermore, the reason there’s a demand for a drug like Zohydro is that chronic pain patients have built up a tolerance to other opiates and continue to have to up the ante when it comes to the potency of their medication. So isn’t a product like Zohydro just a temporary fix until it, too, becomes not powerful enough and we are on to the next monster sedative? Where and how does this end?
How Is It Legal in the First Place?
But really, the heavily sedated elephant in the room while we’re in the midst of a national opiate addiction epidemic is why in on earth the FDA would approve a drug like Zohdyro. According to a piece in The New Yorker last December, the FDA stamp of approval for Zohdyro was pushed through despite its advisory committee’s recommendation against it. Seems the folks over at Zogenix are no dummies. When lobbying for the approval of Zohydro (which appears to be the company’s only approved drug to date), they played right into the FDA’s ego, arguing that a new drug like Zohydro would be better controlled than Vicodin or Norco because of the new FDA requirements obligating pharmaceutical companies to educate health-care providers about how to appropriately use high-risk medications. Ohhhhh okay, yeah, that should be fine then.
Regulating the Pill Pushers
If you ever saw the movie Love and Other Drugs (based on the non-fiction book Hard Sell: The Evolution of a Viagra Salesman), you might have a pretty good idea about the world of pharmaceutical sales (albeit with a twist of Hollywood theatrics). So I’m certainly relieved to learn that the FDA has made an effort to put some regulations in place by requiring reps to inform their doctors of the proper use of drugs they’re pedaling. But why this hasn’t been happening anyway? Why have doctors who prescribe meds they’re unfamiliar with not been slapped with huge ethics violations and most importantly, why does no one seem to be coming down on doctors enough in the first place? After all, they’re the drug dealers in this scenario.
The upside to all of this could be that while a ban is currently in place in Massachusetts, more will be revealed on a national level as to how well the new FDA regulations on product education and abuse monitoring are working. Who knows? Maybe the release of a shiny new drug like Zohydro could be a test product in controlling the lack of control we’ve had on controlled substances. But of course the reality is that once the drug is out there, it will spread—regardless of a ban—and it will be abused. Let’s just hope we’re able to handle it.
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