For more than a decade, patients who’ve needed certain controlled medications have suffered from ill-advised, untenable policies the U.S. government has instituted, allegedly to mitigate the ever-surging numbers of drug overdose deaths. These policies have been a dismal failure on multiple fronts: Not only have deaths continued to surge, but the terrifying intrusion of the Drug Enforcement Administration (DEA) into the practice of medicine has had a chilling effect on patients and their physicians.
As the DEA relentlessly tightens production quotas on medications for pain and ADHD, it has begun tracking every pill, making doctors increasingly reluctant to prescribe any controlled drugs and leaving many patients in a lurch. Perhaps worse, DEA production quotas have caused the back-order of multiple drugs—an increasingly common burden for patients, even those fortunate to have doctors willing to risk a DEA drug bust for simply doing their job.
The ill and disabled suffer the most. Virtually all patients who have diseases or chronic pain conditions will say that the emergency department is the single worst place to go for relief from severe pain. Doctors and hospitals are often more concerned about law enforcement looking over their shoulders than patient care. Patients desperate for pain relief often turn to street drugs, where they fall victim to counterfeit pills that contain fentanyl (or worse) instead of a legal opioid.
By contrast, doctors in Australia, Canada, the United Kingdom, and throughout Europe have been using a fixed-dose, inhaled general anesthesia medicine that effectively reduces acute pain—a medication denied to Americans by a seemingly indifferent Food and Drug Administration (FDA).
Doctors commonly used methoxyflurane (Penthrane) as a general anesthetic in the 1960s and 1970s. But, because it had toxic effects on the liver and kidneys, anesthesiologists gradually stopped using it and turned to safer anesthetics. In 2005, the FDA removed methoxyflurane from the market.
However, an Australian company, Medical Developments International, has been marketing a lower-dose, self-administered, single-use nasal inhaler version of methoxyflurane for 30 years. Its brand name is Penthrox, though many people refer to it as the “green whistle,” because of the package it comes in. People living in Europe have had access to the green whistle since 2015, and Canadian patients have had it since 2018.
In 2020, a randomized controlled clinical trial in the U.K. demonstrated that the drug saved an average of 71 minutes in providing pain relief to accident and emergency department patients. Likewise, a 2020 Australian trial found that a methoxyflurane inhaler “was associated with clinically significant lower pain scores compared to standard therapy.” While it may cause drowsiness in some people, methoxyflurane at this low dose has few adverse effects, such as liver and kidney toxicity, and there are no reported cases of addiction or abuse.
In 2022, the FDA finally lifted its “clinical hold” on methoxyflurane nasal inhalers and has allowed its manufacturer to resume FDA-supervised clinical trials. Unfortunately, this is an unnecessary waste of time.
Hellbound and Down 