Last week Massachusetts Gov. Deval Patrick imposed an emergency ban on Zohydro, an extended-release version of the narcotic painkiller hydrocodone that was approved by the Food and Drug Administration last year. Patrick said Zohydro "poses a significant risk to individuals already addicted to opiates and to the public at large." Zohydro's manufacturer, Zogenix, complains that the "unprecedented" state ban on a specific FDA-approved product "only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen." As Reuters explains, Zohydro's detractors view the absence of that risk as a dangerous drawback:
The company has defended the drug as a necessary option for pain patients who cannot tolerate acetaminophen, a nonsteroidal anti-inflammatory drug linked to liver damage and stomach bleeding.
But critics worry that with no built-in abuse deterrents, Zohydro will be a draw for addicts looking for an easy fix.
You might have thought that hydrocodone products such as Vicodin and Lortab contain acetaminophen with the goal of achieving a synergistic analgesic effect that reduces the amount of hydrocodone required for a given level of pain. But in truth the acetaminophen functions more like the methanol that the government required manufacturers to put in industrial alcohol during Prohibition: as a poison aimed at deterring abuse. In the case of acetominophen, there is no direct mandate, but "combination products" traditionally have been less restricted than straight hydrocodone, placed on Schedule III rather than Schedule II of the Controlled Substances Act because they were deemed to have a lower potential for abuse. Now that the FDA wants to eliminate that distinction, there is not much advantage to mixing hydrocodone with acetaminophen, especially for patients with severe chronic pain who take the pills every day for an extended period of time. But Patrick is basically telling Zogenix that it cannot sell Zohydro to those patients unless it agrees to slowly poison them with acetaminophen or comes up with a tamper-resistant formulation that is harder to crush for snorting or injecting.
Zogenix argues that its product has become a scapegoat for what Patrick calls "an epidemic of opiate abuse":
Contrary to some recent media reports, most other opioid medications on the market today are [either] equal to or more potent than Zohydro ER (e.g., oxycodone, fentanyl, hydromorphone and oxymorphone), and all are available in higher strengths per unit-of-use than Zohydro ER. Claims that Zohydro ER is "more powerful" or "more addictive" than other commonly prescribed opioids are not supported by scientific data.
Over the last 12 months, more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts, and a significant majority did not have FDA-approved abuse deterrent claims. We fail to see how banning the sale of a single new product will achieve the governor's policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state….The [Drug Enforcement Administration] quota for Zohydro ER is less than one percent of the total allotted hydrocodone product that will be manufactured in the U.S. this year.
Even if Zohydro were especially attractive to addicts, that consideration should not override the needs of legitimate patients. As usual with attempts to "balance" drug control and pain control, Patrick's ban sacrifices the interests of patients to protect addicts from themselves, a tradeoff that is not morally justified.