Massachusetts Governor Deval Patrick is trying to ban Zohydro ER, a new prescription painkiller, under a state of emergency he’s declared to combat opiate abuse. I agree with the Governor that opiate addiction is a huge problem in Massachusetts (and many other places) but the attempt to ban sales of Zohydro is a bad idea that’s likely to have a negligible impact on the addiction crisis while potentially harming one of Massachusetts’ most important industries.
The argument against Zohydro ER (the ER stands for “extended release”) is that it promotes abuse by providing a higher dosage in one pill than comparable immediate release products and that it lacks tamper resistant features that could make the pill harder to abuse. That’s probably why the FDA’s own advisory panel voted overwhelmingly against approval and why the drug has taken so much heat.
Historically states don’t attempt to interfere with the FDA approval process, but Patrick argues that approval is only a minimum requirement for sale and that states are free to impose additional restrictions beyond what the FDA mandates.
Here’s why I think Patrick is misguided:
The drug does address an unmet need and has real benefits
- It allows some people who need round-the-clock pain relief and who currently use immediate release drugs such as Vicodin to take fewer pills and to avoid Tylenol (aka acetaminophen or APAP) that is typically combined with hyrdocodone and which can harm the liver
The harms presented by this drug are not unique, and the formulation technologies available to deter abuse are not especially effective
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
- Some painkillers –such as Oxycontin and Opana ER– have been reformulated to make them harder to abuse, but others including the generic version of Opana ER are available without tamper resistance
- Search Google for how to defeat tamper proof Oxycontin and you’ll find simple and effective methods to do so. Sure there’s some value to adding such technologies but it’s no cure-all
It would be bad news to establish the precedent that states could place additional restrictions on approved drugs
- It really perplexes me that Patrick would promote the idea that FDA approval is insufficient to allow a drugmaker to sell its product throughout the US. Is he nuts? It’s a novel idea, laughed at by the first judge –but who knows how other judges will rule and what other states will seek to do if the principle is established
- It’s expensive and difficult to get a product from lab to market as is. And, regardless of the merits of the Zohydro ER situation, it’s a bad idea overall to make marketing a new drug even harder. Add more uncertainty, cost and hurdles and it will reduce investment in R&D and may eventually have an adverse impact on the availability of new products for patients. Massachusetts is home to many pharmaceutical and biotechnology companies, so I’m especially surprised Patrick would take this step, which is so contrary to the state’s economic interests
The FDA’s decision to approve Zohydro surprised me and many others. It may or may not have been the best decision. But it’s a bad idea for individual states to try to overturn the decision through unilateral actions.
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By healthcare consultant David E. Williams of the Health Business Group
