On Tuesday, January 30th, the US Food & Drug Administration asked makers of the anti-diarrheal medication, loperamide to discontinue to sell the medication in large quantities.
The federal government’s decision to intervene in what is generally private commerce seems to be in response to the nationwide opioid crisis, which President Trump recently declared a ‘public health emergency’. Many Americans, including medical professionals, remain skeptical and maintain that the fear of opioids is largely overblown. Despite the actual science, widespread propaganda utilized by government and media have convinced many Americans that opioids have zero place in society, even if administered acutely by a doctor or paramedic in response to a major injury or a heart attack. Make no mistake — far too many Americans are dying of drug misuse, and opioids are likely at the center of these tragedies, but the public may have gone too far in their abhorrence of opioids.
When I was a paramedic concerned about widespread drug misuse in NYC, I attended a meeting organized by my NYC Councilman, a high-ranking NYPD official, and some other government health officers. Before distributing the ‘free’ Narcan kits to everyone in attendance, the speakers condemned every clinician who ever prescribed an opioid and even decried paramedics who administered an opioid to victims of motorcycle accidents, which is something that I myself am guilty of. Anyone who ever administered an opioid was to blame for the tragedy of drug misuse.
(After the speeches, I explained to the misinformed Councilman that in ‘the greatest city in the world’, the protocols that guided paramedics’ care only allowed for two medications to be administered to treat pain: morphine and fentanyl, both of which are opioids. I felt that it would be futile to try to explain to him that people don’t get addicted to opioids from one 5mg bolus of IV morphine after a trauma. His horror grew as I explained to him that all of our neighboring counties allowed their paramedics to administer effective non-opioid pain medications. He promised that he would submit a bill that would force the FDNY (the agency that oversees all of NYC EMS) board of EMS physicians to consider/allow the paramedics to administer ketorolac, and instructed one of his aides to stay in touch with me.)
The above is just one of countless examples demonstrating how ignorant the public (and the political class) remains about what opioids are and what they are not. I could write an entire article detailing every police officer, EMT, and civilian who allowed the disinformation to convince them that they were going to die or that they ‘fainted’ because they touched a pinch of fentanyl in powder form. The ignorance is widespread and could be considered a ‘public health emergency’ unto itself. But that is hardly noteworthy. Non-medical people often know little to nothing about pharmaceuticals, just like medical professionals generally know little to nothing about photography.
What shocks me is that apparently, Food & Drug Administration officials are not actually experts in pharmacalogy, either. The FDA sent out the frantic letter to all manufacturers of loperamide asking that they stop selling it in large quantities because it is an opioid and is contributing to the international drug epidemic. It took approximately one minute of online research for me to learn that while loperamide technically acts by stimulating opioid receptors in the intestine, it does not cross the blood-brain barrier, and therefore has no euphoric effects on humans; its only effect is slowing of GI motility/treating diarrhea. Just in case you can’t click that link, it is NCBI, which is the website for the US Department of Health & Human Services and National Institute of Health/US National Library of Medicine. The last line of the study reads:
CONCLUSIONS: Polysorbate 80-coated PBCA nanoparticles loaded with loperamide enabled the transport of loperamide to the brain.
We can surmise from this that loperamide loaded (administered) alone and withhout ‘Polysorbate 80-coated PBCA nanoparticles’ CANNOT enter the brain. What are Polysorbate 80-coated PBCA nanoparticles? I don’t know, but you can read more about it on NCBI. It does not seem to be an easily obtainable substance.
As mentioned above, the FDA has sent letters to the companies that sell loperamide, asking that they package the medication differently so that people cannot overdose. Similarly to the mistake made by NYC Mayor Michael Bloomberg when attempting to limit the consumption of soda to 20 ounces per day with a NYC law, this concept does not account for the very real possibility that people could buy more than one of a given product. In fact, most websites make it extremely easy to adjust the quantity of an item in their online store, even once the item is in their cart! If the FDA is to take any real action, it would only cause harm to all parties involved. Let’s imagine that the FDA gets serious about the perceived dangers of loperamide and they make it illegal to sell a package with greater than 12 pills and they prohibit stores and websites from selling more than one box to each customer. Let’s say that the FDA also makes it a crime to purchase more than 12 pills per week. The result would be a massive black market of loperamide. The enforcement of the new laws alone would drain tons of money from the FDA and DEA which could be used for more virtuous endeavors. Increasing the black market for ‘controlled substances’ by adding another widely used medication to it? That would grow the war on drugs and the police state to a level so large that the conflict between police and citizens would only continue to grow until tragedies were commonplace. The FDA might choose a slightly different route.
I’m not a pharmacist or FDA official, but I suppose that the FDA could simply create a new law mandating that loperamide only be sold to people with a prescription for it. Whether insurance would cover the medication and what the result of both possibilities would be is beyond me, but this would also likely create a new segment of the black market, make millions of additional Americans into ‘criminals’ (and again, it would send millions of additional customers to ‘online Canadian pharmacies’) and it would likely increase insurance rates and/or the price of loperamide.
As I’ve written about and ranted about on my talk radio show, the government generally CANNOT solve our problems. People are dying from drug misuse and it is a horrible problem. But the answer is not to empower the FDA or any other part of the federal government (do you seriously want politicians appointed by Trump and Obama controlling how we treat our diarrhea??) to create new laws every time something sad happens. For those of you who believe that the federal government should have 100% control over all of healthcare and pharmaceuticals in the US, read the letter that the FDA sent to the loperamide makers. The letter makes it clear that the FDA does not want people to be capable of obtaining more than one week’s worth of loperamide. Would you really trust unaccountable politicians and bureaucrats with that much power?