June 28, 2018
As Congress moves swiftly to address the opioid epidemic, it is vitally important the most meaningful and impactful solutions are enacted, including the Stopping Overdoses of Fentanyl Analogues Act, or SOFA. In testimony last month before the House Judiciary Committee, I urged Congress to consider this critical piece of legislation to halt the spread of fentanyl-related substances. Let me explain.
In my role on the Wisconsin Medical Examining and Controlled Substance Boards, and as an emergency room physician on the front lines of the opioid battlefield for the past two decades, I have witnessed more tragedy than I care to recall. Countless hours have been spent working to identify and implement best practices. One strategy, for physicians to prescribe more judiciously, is already happening in the Badger State -- not with top down mandates, but through education and partnerships with the medical community. The goal is to stem not only the supply of legal, but also illicit, opioids. By far, the deadliest threat in the opioid war is posed by fentanyl-related substances. In fact, deaths from fentanyl-related substances now surpass heroin deaths.
Because so little can kill so many -- a lethal dose of fentanyl is 2mg and one teaspoon is enough to kill 2,000 people -- fentanyl variants are classifiable as weapons of mass destruction. The “bad guys” use loopholes in the existing scheduling laws to create new legal fentanyl variants. These untested chemicals are then produced abroad, mostly in China, and trafficked legally into the U.S. to enter the opioid supply.
As prescription opioid reforms take hold and the medical community returns to more judicious prescribing practices, the market for counterfeit pills will continue to explode. Most illicit opioid users have no idea what they are consuming. With the advent of counterfeit pill production, they believe they’re ingesting a “safe” trade-name manufactured pill, when actually it is a fentanyl-related counterfeit substance. These can be transported legally into the U.S. and even bought online and delivered in the mail. These pills can be alarmingly stronger than what they are purported to be -- up to hundreds of times stronger. The singer Prince died from counterfeit Vicodin pills that were actually fentanyl.
In Wisconsin, we saw this coming and worked closely with the U.S. Drug Enforcement Administration (DEA) to get in front of it. We created and enacted scheduling statutes now being modeled nationally. The SOFA Act controls, by structure, all likely bioactive chemical modifications of the fentanyl molecule. This novel, catch-all legislative language allows us to schedule proactively and not wait for loved ones to die before we can schedule each newly modified fentanyl variant. Essentially, it unplugs the entire fentanyl machine.
The legislation is specific by design: it targets only the likely bioactive modifications of the fentanyl molecule itself; no other opioids or drugs are included. As well, research would not be impeded. The current research approval process would not change and the DEA has streamlined the registration process.
The week after Wisconsin enacted SOFA, the DEA published identical language in the Federal Register as the method of federal temporary scheduling. Chemists around the world must be paying attention. Since the announcement of the intent to schedule using SOFA seven months ago, no new fentanyl-related substances have been found by the DEA. In contrast, during the prior two years, DEA uncovered 17 new fentanyls, representing hundreds of deaths. SOFA is already saving lives, but the language needs to be written into federal law to achieve the best permanent scheduling solution. Thanks to Sen. Ron Johnson (R-Wis.) and Rep. Jim Sensenbrenner (R-Wis.), Wisconsin’s solution is now under consideration as model legislation for the nation.
With the many well-intentioned opioid bills being considered in Washington, it would be a tragedy to leave the fentanyl-related substances loophole open. It’s why I am writing today. I urge Congress to include SOFA in the solutions it enacts in the coming weeks to minimize the scourge of opioids and stop the spread of what are really chemical weapons.
Dr. Tim Westlake is a full-time Emergency Physician; Medical Director of the Oconomowoc Memorial Emergency Department; Vice Chairman of the Wisconsin State Medical Examining Board, where he serves as Chairman of the Licensing and Controlled Substance Committees; member of the Wisconsin State Controlled Substances Board and of the Governor’s Taskforce on Opioid Abuse.