Once upon a time, in the magical land of U.S. Government Regulatory Wonderland, a group of bureaucrats gathered to solve a great mystery, how to create a single, unassailable number to compare all opioid chemical substances. “Eureka!” they cried, inventing Morphine Milligram Equivalents (MMEs), the metric that would supposedly make controlled substance prescribing as simple as a fairy tale. But like all poorly thought-out Government fairy tales, this one didn’t have a happy ending, unless you were a fan of Kafkaesque nightmares.  The U.S. Government failed to call the Great philosopher, Gottfried Wilhelm Leibniz. Leibniz had a little rule, known as the Identity of Indiscernibles, which holds that two things can only be considered the same if they share all properties.

In the context of U.S. Government chemical equivalence, the Government argues that even though two compounds may not be identical in structure, they can be functionally equivalent in a defined context (e.g., producing the same physiological effect). Morphine and oxycodone, those darling protagonists of the U.S. Government’s opioid saga, might be cousins in the great pharmacological family tree, but identical twins? Not so fast.  Morphine is water-soluble, metabolized largely by the liver, and loves a good receptor party in the central nervous system. Oxycodone? Oh, it’s a bit of a maverick. Lipid-soluble, metabolized via different pathways, and often more potent, milligram for milligram. Yet the U.S. Government’s MME metric smugly declares, “Eh, close enough!” It’s as if someone tried to sell you a banana as a pineapple because both happen to be yellow.

Enter Goldilocks: A Parable for the Ages

Now, imagine Goldilocks, wandering into the U.S. Government’s fun-house of Opioid Pharmacokinetics. Instead of porridge, she encounters three bowls labeled “Morphine,” “Hydrocodone,” and “Fentanyl.”  She takes a sip of Morphine. “Hmm, not quite right,” she says, feeling a bit drowsy.  Then she tries Hydrocodone. “Oh, this one’s much sweeter, but still not right,” she muses.  Finally, she tastes Fentanyl. “Oh, this is just perfect!” she exclaims, right before falling into a dangerously deep sleep.  The moral of the story? The properties of each opioid vary dramatically, depending on the dose, the person, and the context. But in the land of MMEs, Goldilocks would be told that all three bowls are exactly the same, so long as you adjust the spoon size.  MMEs don’t just flunk basic philosophy, they also wreak havoc on ethics. Take the principle of double effect, which recognizes that actions can have both intended and unintended consequences. MMEs were ostensibly designed to help clinicians safely prescribe opioids, but the unintended consequence? They’ve become a cudgel for criminalizing doctors and terrorizing patients.  Imagine if Goldilocks were put on trial for “reckless porridge consumption” because her spoonfuls didn’t conform to the state’s approved porridge-to-spoon ratio. “But I was hungry!” she’d cry. “Irrelevant!” the U.S. prosecutors would shout. That’s the world MMEs have created, one where intent, context, and nuance are irrelevant, and arbitrary numbers rule supreme.

The Real Fairy Tale Villains

The CDC and DEA, playing the roles of the Big Bad Wolf and the Wicked Stepmother, have used MMEs to turn U.S. medicine into a dystopian farce. Doctors, afraid of surpassing arbitrary MME thresholds, now hesitate to treat patients in pain. Meanwhile, patients who genuinely need relief are left to suffer, their humanity reduced to a flawed number on a chart. This U.S. Government functional perspective challenges strict interpretations of Leibniz’s principle by focusing on specific properties rather than all chemical properties.  If Leibniz were alive today, he’d likely be shaking his powdered wig at this Government absurdity. Two things cannot be identical if they do not share all the same properties. Yet MMEs persist, pretending that opioids with different pharmacodynamics, patient responses, and societal contexts can somehow be flattened into one U.S. Government metric.  And Goldilocks? She’d probably burn the U.S. Government’s fun-house of Opioid Pharmacokinetics to the ground. Because no one deserves porridge, or pain management, unless it is “just right” in the eyes of a U.S. Government bureaucrat.

Which leads us to the impending Analogue Act, the brilliantly murky piece of U.S. legislation that criminalizes substances that are “substantially similar” to those already banned. It’s almost like the U.S. legal system took one look at chemical compounds and thought, “Why not treat these as identical, even when they’re not?” And just like that, we have the U.S. Analogue Act, a masterstroke of Government functional equivalence, right out of the Alchemy 101 textbook. The law operates under the assumption that substances with “comparable effects” are, in some magical way, interchangeable, much like how we lump together two distinct opioids (with totally different chemical structures) into a convenient “morphine milligram equivalent” (MME).

Now, isn’t that cute? Just like two compounds that aren’t identical, yet somehow, mysteriously, function the same, like hydrocodone and oxycodone being treated as chemically the same, even though their molecular makeup could make a chemist blush with confusion. But hey, if the outcome is pain relief, who cares if they’re totally different substances with distinct chemical properties? After all, the end goal is pain relief, not molecular fidelity. And so, in the Government’s legal world, “substantial similarity” reigns supreme as the gold standard for equivalence. The fact that one substance could leave you with a different set of long-term effects or unintended consequences? A mere detail!  But wait, what about Leibniz’s Law? Ah, yes Leibniz law strikes again. The timeless principle that tells us that two things are identical only if they share all the same properties. Now, you could argue that two different chemical substances, while giving the same result (e.g., pain relief), are not truly identical in any meaningful way. I mean, morphine isn’t hydrocodone, just as an apple isn’t an orange, no matter how much you want to compare them in terms of their effects on a hungry person. But then, this would be a strict application of Leibniz’s Law, which we are, of course, too clever to follow in the context of the U.S. Analogue Act. No, let’s go with a more pragmatic approach, where function trumps structure, and substance doesn’t have to match the definition of what it is, only what it does.

In this spirit, the U.S. Analogue Act merrily dances with Leibniz’s Law like it’s a dress rehearsal for a performance that will never quite make sense. Sure, substances are chemically distinct, but if they produce the same effect, why not treat them as identical? It’s practically functionalism, where the outcome is the only thing that matters. After all, whether you’re popping hydrocodone or oxycodone, your goal is simple, pain relief. So why get bogged down by the fact that the molecular machinery behind the magic is totally different?

And let’s not forget the U.S. Government’s pragmatic approach to the situation. Why bother distinguishing between chemical substances if the real goal is just to get results? What does it matter if the chemicals don’t perfectly align? The goal is relief, and if the law says something works, who cares how it gets there, right? This is where pragmatism shines, who needs pesky technicalities when a little U.S. judicial creativity will do the job just fine?  So here we are, stuck in the legal equivalent of a funhouse mirror. Is it really a “substance”? Or is it just something that feels like one? With the U.S. Analogue Act, we get to have both. Sure, it might not strictly follow Leibniz’s Law, but it will certainly follow the logic of Government pragmatism, after all, results matter, not the little details.

So, if you’re ever uncertain whether a substance is “substantially similar,” just think back to that magical U.S. Government legal principle: “If it looks like a duck, and acts like a duck, it’s definitely a duck, even if it’s actually a goose with a makeover.” And there we have it, the U.S. Analogue Act, a legal equivalent to putting two distinct compounds in the same boat and calling it equivalence, no matter the molecular makeup. Let’s raise a glass to U.S. Government legal vagueness, because why would we want clarity when we can have substantial similarity?

About the Author Blue Lotus, MD

The Author received an honorable discharge from the U.S. Navy where he utilized regional anesthesia and pain management to treat soldiers injured in combat at Walter Reed Hospital. The Author is passionate about medical research and biotechnological innovation in the fields of 3D printing, tissue engineering and regenerative medicine.

Social Media Auto Publish Powered By : XYZScripts.com