Since introduced in the 1990s, opioid pain relievers have been increasingly produced and distributed by pharmaceutical manufacturers. The medications were determined to be highly effective for their stated purpose, but also, in spite of manufacturer claims, highly addictive.
The year 2017 saw a dramatic rise in the number of overdose cases involving opioid drugs. The Centers for Disease Control and Prevention (CDC) reported through their National Vital Statistics System (NVSS) (https://www.cdc.gov/nchs/nvss/index.htm) over 47,000 opioid overdose deaths occurred in the United States. In the same year, according to a report by the Center for Behavioral Health Statistics and Quality, now called the Substance Abuse and Mental Health Services Administration (SAMHSA), some 1.7 million Americans were diagnosed with substance abuse disorders as a result of improper use of prescription opioid pain relievers. Heroin use disorder also skyrocketed with some 652,000 suffering.
A 2013 report published by the National Institutes of Health (NIH) put the total economic burden due to the misuse of prescription opioids alone at $78.5 billion annually. These costs include healthcare, lost productivity, addiction treatment, and criminal prosecution.
A number of university researchers collaborated on another report published by the International Association for the Study of Pain (PAIN) two years later in 2015. This report found that between 8 and 12 percent of those using opioids for pain relief develop an addiction to the drugs. Further, 21 to 29 percent misuse their prescribed pain relievers.
These reports could be seen as foreshadowing the opioid crisis that has since taken over the nation.
NVSS shows that the increase of deaths due to opioid overdoses has continued, with almost 50,000 succumbing to overdose deaths involving opioids in 2019. The trend was reaching such a level of concern that the U.S. Food and Drug Administration (FDA) drafted guidance on August 6, 2017, for the development of drugs to fight opioid use disorder.
In 2019, the FDA again took further measures to protect the public against the misuse of fentanyl. These measures strengthened safety requirements in prescribing fentanyl and other opioids.
The next year, December 23, 2020, the FDA “finalized modifications” to its Risk Evaluation and Mitigation Strategy (REMS) for fentanyl products. The REMS included monitoring prescribing practices and adverse events coming as the result of opioid use.
Through these measures, the FDA has sought to crack down on so-called pill mills where doctors ‘take the money and run’ by writing prescriptions for opioids and other narcotics while generating fake symptoms and diagnoses to collect health insurance and Medicare/Medicaid payments. Known officially as “Nontherapeutic Dispensing,” the practice has come under fire from state agencies, as well. Some, such as the Texas State Board of Pharmacy, have developed online libraries of resources regarding pill mills.
As the FDA and states, along with the U.S. Drug Enforcement Agency (DEA), sought to limit the illicit use of prescription opioids, new fronts on the fight against addiction began to emerge.
Over the years, Mexico had become a prime source for illicit drugs such as marijuana and heroin, a derivative of morphine, to the United States. Both of these are developed using plants, so time has to be taken to grow the plants, harvest their leaves or seeds for use in the production. After harvest, the leaves and seeds, or buds, have to be dried then further processed to create both marijuana for smoking or heroin to be used in a variety of manners.
At the same time that the production costs associated with the processes above were increasing, a number of states have legalized or decriminalized marijuana use. This led to a decrease in the street value of marijuana in many areas and a decrease in the number of customers for the Mexican suppliers of illicit marijuana.
Fentanyl use, on the other hand, was increasing, as evidenced by the reports. This increased use combined with more-stringent regulations on prescribers and dispensaries led to a ‘perfect storm’ for those who would provide illicit fentanyl, particularly if a low-cost source could be found.
As has been documented by the U.S.-China Economic and Security Review Commission (USCC), China has provided the low-cost sourcing of fentanyl ingredients to the Mexican drug cartels. This has seen a substantial rise in trafficking illicit fentanyl in multiple forms across the U.S.-Mexico border. This trend has reached the point that Scottsdale (AZ) Police Chief called it a national security threat in a December 16, 2021, press conference held with DEA Special Agent in Charge Cheri Oz of the Phoenix Field Division.
As the illicit fentanyl trade from Mexico is on the rise, the FDA and states have continued to focus on the legitimate manufacturers, prescribers, and dispensers, with the Government seeming to focus less on cross-border trafficking.
The U.S. Customs and Border Protection agency (CBP) does report multi-million dollar-value shipments that are seized. Often these seizures include pounds of illicit fentanyl. With as little as 2mg of fentanyl being considered a lethal dose, some of the seized shipments have had the potential to create more than 150,000 deaths in those single seizures. As CBP reports these seizures, one has to wonder how much is making its way into the U.S. unfettered.
1 pound = 453,592mg, or enough fentanyl to cause 226,796 overdoses; 1 kilogram = 1,000,000mg, or enough to cause 500,000 fentanyl overdoses.
While the flow of illicit opioids from Mexico increases, states are continuing to file suits and gain settlements that are totaling near $1 trillion against and from legal manufacturers, distributors, and dispensers of legal opioids. This is happening as the FDA is increasing efforts to prevent abuse of the legal forms of opioids such as morphine, heroin, and fentanyl.
In many cases, though, such as the case with the State of Texas and its Opioid Abatement program, the funds from the settlements are directed to the state’s General Fund, and not specifically to any true abatement program.
While it can be said that the settlements reimburse states for funds that were spent as a result of the opioid crisis instead of being used elsewhere, it seems that these funds could be better used to provide true relief and to fight against the opioid epidemic instead. By using the funds to fight the dependence on these drugs, the states would seemingly be able to save money in the future and then resume providing for all of their citizens and residents instead of having to rely on settlements from those who may have less to do with the epidemic that the public is led to believe.
By reducing the dependence on these drugs through the use of these funds to truly and directly combat addiction, promote recovery, and help find alternatives for so-called ‘recreational’ users, states will utilize the proceeds from these suits as the public has been to believe they would have. Otherwise, it seems that the states attorneys general are merely seeking additional funding for their states and finding the ‘deep pockets’ of pharmaceutical companies, distributors, and nationwide pharmacies to do that.