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Zohydro ER Vs. Deval Patrick: The Latest Gunfight at the OK Corral

Friday, April 18, 2014 | 303 | 0 | min read

The U.S. Food and Drug Administration (FDA) has acknowledged that prescription drug overdoses are now the leading cause of injury-related death in America, surpassing auto accidents. Couple that with the agency's approval last October of Zohydro ER, the first pure opiate painkiller, and you begin to understand why many lawmakers are left scratching their heads. More than half the states' attorneys general have asked the FDA to withdraw approval of the drug. But the agency is unrepentant. FDA Commissioner Margaret Hamburg told the Senate that the drug is a safe and effective option for patients with excruciating pain.

In late March, a stymied Gov. Deval Patrick took the highly unusual step of banning the sale in Massachusetts of the controversial opioid made by California-based Zogenix Inc. Many in the Massachusetts legislature as well as a number of workers' compensation claims professionals thought it was the best thing any governor had ever done, a bold step to protect the citizenry.

Only it's not as simple as that. It's turning out that, however well-intentioned Gov. Patrick may be, he probably can't ban the sale of the drug, after all. Yesterday, U.S. District Court Judge Rya W. Zobel told state lawyers that by Monday she wanted to see a lot more research that would buttress the governor's ban. Nonetheless, she said that she would more than likely grant a preliminary injunction on behalf of Zogenix that would allow Zohydro ER's sale in Massachusetts. Said Zobel, "I think, frankly, the governor is out of line on this."

According to Patrick, his issue with Zohydro ER is that it is not in "an abuse-resistant form," meaning that it is not crush-resistant. Consequently, addicts (or anyone else who has the drug, for that matter,) can crush it and snort it or inject it.

Why would anyone want to do that instead of simply washing it down with a sip of water? Because in its pill form Zohydro ER is an "extended release" medication. That's what the ER stands for. In fact, Zohydro's full legal name is Zohydro ER (hydrocodone bitartrate) Extended Release Capsules. Crushing and snorting or injecting simply bazookas the whole dose at one time, which can be a deadly proposition.

Zogenix's President, Steven J. Farr, attended yesterday's hearing and, afterwards, took pains to let everyone know that Zohydro ER is safer than other hydrocodone drugs because it does not contain Acetaminophen, which can cause liver damage and failure with prolonged, high-dose usage. Farr did not mention that Zohydro ER contains up to five times the hydrocodone found in Vicodin. He did say that the company is in early stage development of abuse-deterrent formulations of the drug. That gave cold comfort to the governor.

Whatever happens, it is hard to believe that Gov. Patrick, a very smart lawyer, actually thinks he's on firm legal footing here, although outside the courthouse that's exactly what he said. As Judge Zobel pointed out (and she was decidedly irate that Patrick banned the drug without ever talking with Zogenix), Patrick cannot blame the Massachusetts opioid epidemic on Zohydro ER because the drug has yet to be dispensed in the state. She urged lawyers for the state and Zogenix to meet before the hearing scheduled for Monday, but she told everyone that Zogenix "probably will prevail."

I have a few thoughts about this little mess:

First, it is not the fault of Zogenix that we have an opioid epidemic in Massachusetts or anywhere else. Yes, there's an epidemic, but drug makers didn't cause it. Irresponsible physicians, doctors who consider the Hippocratic Oath to be a mere suggestion, have placed their patients on the slippery slope to hell by prescribing over and over again strong and addictive narcotics for conditions for which those narcotics were never intended.

Second, the vast majority of physicians would never knowingly over-prescribe any medication. They have not forgotten that Oath and why they went to medical school. The ones I know resent and cannot understand the over-prescribers.

Third, although I wish it had built crush-resistance into Zohydro ER from the beginning, Zogenix did nothing wrong here. In fact, the Zogenix complaint notes: "When FDA approved Zohydro, it considered but rejected the idea of requiring the drug to utilize abuse-deterrent technology." The company did everything it was supposed to do in gaining FDA approval. And that isn't easy. One of the more difficult tasks in the universe is to get FDA approval for a new drug. The camel through the eye of the needle doesn't even begin to describe the process. It takes many years and boatloads of money. So, you can understand that after all those years and money devoted to bringing this drug to market, to have it summarily banned is a bit hard to take.

Fourth, there are many people who suffer with agonizing pain. Think end-stage cancer. Those human beings need and deserve the best pain amelioration they can get, and the goal of the pharmaceutical industry, in addition to making money, is to give them that relief.

Finally, ending the opioid epidemic will require political courage and a much more highly-regulated process to oversee and assure that the relatively few ethically-challenged, weak-kneed and overly greedy physicians who now abuse their privilege are forced to change their bad behavior and follow that "do no harm" rule. If it weren't for them, there would be no epidemic.

Tom Lynch is co-owner of Lynch Ryan & Associates, a Massachusetts-based employer consulting firm. This column was reprinted with his permission from the firm's Workers' Comp Insider blog.

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