Tech + Health

04.23.14

Zohydro, a New Pill 10 Times Stronger Than Vicodin, Raises Questions About Pain and Addiction

The FDA-approved painkiller is raising red flags in medical circles and consumer protection groups.

Response came quickly to the recent release of Zohydro, an extremely potent, hydrocodone opioid that boasts between five and 10 times the strength of Vicodin. Along with concerns over potency, health officials report (PDF) that the drug lacks necessary abuse-deterrents like features to discourage crushing and injecting. If swallowed by a child, one single capsule could be fatal.

The FDA—whose own advisory committee barely approved the drug in an 11-2 vote—claims that if used correctly the drug is safe and effective and may reduce the risk of toxic effects on the liver, as it does not contain the acetaminophen found in other hydrocodone painkillers. But a growing chorus of health officials and advocacy groups are criticizing the drug, citing the potential loss of life due to overdose. Massachusetts Governor Deval Patrick unsuccessfully attempted to ban the drug completely in his state, and 29 states have asked the FDA to reconsider their Zohydro decision.

A new perspective on the Zohydro debate published Wednesday in the New England Journal of Medicine identifies a larger issue: the dual challenge of managing both chronic pain and addiction. There has been a substantial public outcry in response to the very real danger posed by drugs like Zohydro, which falls into the same category of extended-release and long-acting opioids as Oxycontin.

But the new drug, the authors say, isn’t the problem. Doctors and authors of the perspective, Yngvild Olsen and Joshua Sharfstein, write that Zohydro is representative of a greater national dilemma: the need for a comprehensive strategy across U.S. health care that accounts for the inter-connected challenges of addiction and chronic pain.

“This strategy need not prioritize chronic pain over addiction or addiction over chronic pain,” they write. “Millions of people with chronic pain are at risk for addiction or overdose when treated with opioid medications. At the same time, many people with addiction also have chronic pain. Approaches to managing these clinical situations effectively should be a significant focus of research funding, a subject for education in medical and dental schools, and a topic for training in accredited residency programs.”

Olsen and Sharfstein write that the Substance Abuse and Mental Health Services Administration should work with doctors to ensure appropriate use of methadone or buprenorphine in treating opioid addiction alongside chronic pain. Similarly, they suggest that addiction-treatment facilities incorporate comprehensive approaches to chronic pain into their programs.

They also suggest payers like Medicare and Medicaid use data-analysis tools to spot instances of inappropriate opioid prescription and alert medical boards or state agencies. Insurers could move to provide the same coverage for treatment of opioid addiction disorder as they do for chronic pain, and the FDA could work to facilitate the treatment of chronic pain and addiction at the same time.

“In the end, pointing the finger at Zohydro is not going to resolve the tension that exists today between chronic pain and addiction,” the authors state. “All concerned about the treatment of chronic pain and all responding to the rise in overdose deaths need to come together to promote high-quality and effective prevention and treatment for both conditions.”

Still, for some advocates, the country’s propensity for addiction is too great to ignore. Though the U.S. only comprises 5% of the world’s population, it now consumes more than 84% of the world’s entire oxycodone supply and more than 99% of the hydrocodone supply, according to statistics from the International Narcotics Control Board cited by FED Up!, a coalition formed in response to the opioid epidemic. Over the same period, overdose deaths have more than tripled.

“Zohydro is an atomic bomb in a pill,” Sherrie Rubin from the FED Up! Coalition Steering Committee and Executive Committee Member of the San Diego Prescription Drug Task Force told The Daily Beast. “Mark my words, there will be loss of life much greater than we’ve seen with other drugs if this remains on the market.”