In October, 2013, the Food and Drug Administration (FDA) allowed the opiate Zohydro ER to come on the market despite its own Advisory Panel voting 11-2 against it because it was not tamper resistant. Twenty-nine state Attorneys General petitioned the FDA to reverse its decision, but the FDA declined to do so, saying that the drug is safe and effective if used as directed.
We chronicled Massachusetts Governor Deval Patrick’s Quixote to the Windmill charge as he attempted to ban the sale of the drug in the state. The windmill won when US District Judge Rya W. Zobel overturned the state’s ban. Shortly thereafter, just days before his ban was due to expire, Governor Patrick remounted Rocinante and made a less Quixotic charge: he followed the lead of governors in other states by imposing sweeping restrictions on how Massachusetts doctors prescribe the powerful pain killer, the first pure opiate.
The restrictions, which Zohydro ER’s maker, Zogenix, calls “draconian” and “unjstified,” require that doctors:
- Evaluate a patient’s substance abuse history and other current medications;
- Provide a “letter of medical necessity” to the pharmacy;
- Enter a “pain management treatment agreement” with the patient; and,
- Use the state’s online Prescription Monitoring Program, which tracks prescriptions of controlled substances, before prescribing drugs like Zohydro that are extended-release medications containing only hydrocodone and do not come in an “abuse-deterrent form.”
Zogenix is fighting back. On Monday, the San Diego-based company filed a federal lawsuit arguing that the Massachusetts new restrictions impose “draconian” mandates on doctors and “amount to an effective ban of the drug” that is unconstitutional.
The Suit asks that the Court vacate any restrictions imposed on the sale of Zohydro ER.
Governor Patrick says that his problem with Zohydro ER is that it does not come with “abuse deterrent” packaging. Zogenix responds with three assertions:
- The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids;
- There are more than 30 extended-release opioids on the market, and only one has an FDA-approved label indicating it has abuse deterrent properties; and,
- No product on the market today addresses the most prevalent form of abuse, taking an excessive number of tablets or capsules.
Yesterday, things got even hotter in the Bay State when drug abuse prevention groups, state lawmakers and organized labor leaders rallied outside the statehouse on Beacon Hill demanding even more restrictions.
The rally drew more than 150 demonstrators who, in addition to the call for greater restrictions, urged Congress and federal officials to reverse the FDA’s approval of Zohydro ER.
Those who attended the WCRI’s annual conference in Boston in April will recall the stemwinding luncheon speech of Steve Tolman, former Massachusetts state Senator and now President of the Massachusetts AFL-CIO. Tolman, who ardently and passionately does all he can to combat drug abuse in the Commonwealth, was in rare form at yesterday’s rally.
“We don’t need any more opiates! We don’t need any more addiction,” he shouted to the crowd. “Yes, we know that people need pain medication, but they need the right type of medication. And it needs to be monitored.”
Massachusetts Senate President Therese Murray promised the demonstrators that the legislature will take action and is now working on a comprehensive bill dealing with all aspects of addiction, from education to prevention to treatment.
But, with the exception of theft, the only way people get opioids is by doctors prescribing them, and, right now, doctors are cautious and, in some ways, befuddled. They know there’s a big opioid problem, which has prompted Governor Patrick to declare a state of emergency, but they don’t want government invading their patient examination rooms. Nonetheless, shortly after the Governor announced his restrictions, the Massachusetts Board of Registration passed emergency regulations adopting them.
Moreover, in this week’s New England Journal of Medicine, Doctors Yngvild Olsen and Joshua M. Sharfstein present a thoughtful op-ed focused on Zohydro ER and the greater issue of the intersection of chronic pain and pain management medication. They write:
Chronic pain, which affects tens of millions of people in the United States, is associated with functional loss and disability, reduced quality of life, high health care costs, and premature death. U.S. physicians are now more likely to recognize and treat chronic pain than they have been historically, with the number of prescriptions written for opioids having increased 10-fold since 1990.
Over the same period, however, the rate of overdose deaths in the United States has more than tripled. This is not a coincidence. Many doctors have prescribed opioids for chronic pain without following best practices, understanding the risk for the development of substance-use disorders, or recognizing the red flags that can emerge in clinical practice. There is now evidence from states including our own, Maryland, that some individuals whose path to addiction may have started with a prescription for pain are progressing to heroin.
It is becoming crystal clear that re-educating doctors regarding opioid usage is central to any attempt to fix this problem.
It is also clear that this crisis is not about Zohydro ER, although the drug may prove a catalyst for change. Rather, we are witnessing a growing countrywide realization that we are slipping into a public health crisis unlike anything we have ever seen.
In the workers comp field, there is a glimmer of hope. Progressive Medical and PMSI yesterday reported a slight drop in the number of opioid prescriptions written, as well as the costs of those prescriptions in 2013. Other PBMs are reporting similar moderate declines. But that is workers comp, the tiny caboose on the great big health-care train.
This issue demands more than the piecemeal approach it now is getting. Lives, careers and families are being destroyed, while too many constituencies operate alone, unable to achieve any kind of a cohesive and comprehensive solution. It is time for the FDA, the AMA, the US Congress and Big Phama to come together in serious purpose to address this public health emergency, which is rapidly spiraling out of control.
If not, more of America’s humanity will just continue to wither and die. We are better than that.