Today’s PAAD is based on 2 articles that recently appeared in the New York Times and an announcement of a special lecture dedicated to Ron Litman’s memory entitled: “The Opioid Crisis: Pain Profits and Regulatory Failures” (the lecture requires pre-registration which can be easily accomplished thru the provided link). I’ve asked Elliot Krane, a frequent PAAD contributor and good friend, to assist me today and provide us with his insights. Elliot is a Professor at Stanford University and the Director of the Pediatric Pain Management Service. Myron Yaster MD
NY Times article: Were these doctors treating pain or dealing drugs?: https://nyti.ms/360F2gh
NY Times article: What the Opioid Crisis Took From People in Pain
https://www.nytimes.com/2022/03/07/opinion/opioid-crisis-pain-victims.html
Special lecture in memory of Ron Litman. https://bit.ly/3KuFsKR
We live in an era in which opioid overdose deaths are rising. This is a big problem to be sure, but how big is it compared to other preventable causes of death? In the United States, there are approximately 75,000 drug overdose deaths annually, the majority of which are opioid related – that is, deaths in which opioids were thought to play a role, or were found by toxicology in the blood of the deceased (but in fact about half of these deaths are not from opioids per se, but from polypharmacy, the number of drugs found on autopsy being 6, on average). But assuming that all these opioid related deaths are opioid deaths, let’s put the magnitude of the problem in perspective. According to CDC statistics, in the U.S. there are annually about 90,000 deaths from alcoholic liver disease, 90,000 from motor vehicle accidents and motor vehicle pollution, 99,000 from nosocomial infections, 220,000 related to obesity and 480,000 from tobacco related cancers. Of course, it hardly needs to be said that we’ve seen nearly 1,000,000 COVID-19 deaths 2 years into the pandemic and are still seeing 1,500 every single day. Yes, 70,000 preventable deaths are quite a lot but remember this is only 7% of all deaths from preventable causes today. In fact, opioid-related deaths do not even make the top-10 list of deaths in America.
Neither is the opioid overdose crisis a new one, it dates back at least to the post-prohibition era in which organized crime pivoted from alcohol to narcotics, targeting the inner cities. This was a smart marketing decision because the inner cities were where poverty, suffering and hopelessness were endemic, and therefore where there was a market for opium and heroin as a means of escape from despair. But in the 1990’s poverty, suffering, hopeless and despair metastasized to White coal miners, blue collar industrial workers, farmers and the communities that supported them, and a new market for opioids was created. And, a cheaper and more easily procured alternative to heroin became available, OxyContin, made by a pharmaceutical company that was happy to pour millions of doses into communities now in poverty and people in despair. And White folks started dying, which quickly got the attention of Congress and the press. These people are our constituents! These people elect us! Houston, we have a problem!!
Pill mills sprang up all over the country, most particularly in the state of Florida, which had the laxest opioid prescribing regulations in the country. In fact in 2010, 500 “pain clinics” opened in Florida, nearly 10 every week! And the first 6 months of that same year, drug distributers shipped approximately 41 million doses of oxycodone to Florida, while every other state combined received only 4.5 million.
That was the year, 2010, that the DEA finally cracked down on Florida and other pill mills, something that had been delayed for years at least in part by the DEA lobbying efforts of Purdue Pharmaceuticals, (led by their lobbyist Rudy Giuliani) and the recalcitrance of the Florida governor (now Senator, R Fla) Rick Scott, to enforce Florida legislation to monitor and regulate opioid prescriptions.
In 2010 the long overdue crackdown on oxycodone and other opioid distribution as well as the coincident repackaging of oxycodone with abuse deterrence led to an increase in the price of abusable, snortable, injectable oxycodone, which simply shifted the demand to a cheaper and ubiquitous alternative, heroin ($26 vs $80 per dose).
In a neighboring state, Alabama, as reported by the New York Times, Dr. Xiulu Ruan and his partner prescribed 300,000 prescriptions for controlled substances between 2011 and 2015, and filled them through their own pharmacy, prescriptions that were often dispensed in exchange for cash in their parking lot by their office manager. Ruan is now serving 21 years in federal prison. Last week lawyers for Ruan and another pill mill “doctor” serving 25 years for dealing opioids in Arizona and Wyoming are appealing their sentences to the U.S. Supreme Court, asking the court to overthrow their convictions and establish a uniform standard that permits doctors to raise a “good faith” defense (though there is a vanishingly small chance that the defendants will convince any court in the land that they were acting in good faith). The Times states that,“The cases are being argued during a period when investigations of prescribing habits have increased, in an effort to curb the rise in overdose deaths that began more than 20 years ago, as prescription painkillers became readily available. Authorities saw doctors as a significant source of the problem.”
Indeed! Once the DEA woke up, they went after both unethical doctors as well as ethical but perhaps naïve doctors. In fact, I (EK) know one well, an old college chum who practiced OB/Gyn in Santa Fe, NM until he was prosecuted by the DEA, fined and lost his license to practice. My friend was bamboozled by a patient who claimed ongoing pelvic pain, taking home prescriptions for oxycodone month after month from him as well as other doctors in New Mexico. She was apprehended, and her doctor, my friend, who acted in good faith, who took a medical history and examined his patient as required by state law and the standard of care, was swept up in the effort by the DEA to make examples of doctors, good and bad.
What was lost on everyone concerned about the opioid crisis from 2000 to the present is that back then, and today as well, the majority of opioid deaths have always been from the consumption of illegal drugs, either illegally prescribed or obtained prescription medications, or street drugs. The deaths that concern us all, which now number almost 70,000 annually, were seldom from the legitimate prescription of opioids to legitimate patients in pain. The result of the crackdown by the DEA, the passage of draconian prescribing limits by state legislators, the issuing of restrictive guidelines by the CDC (now being revised to correct restrictive recommendations), and ongoing ironic and hypocritical “oversight” of physician prescribing by Walgreens, Walmart and CVS, all who were willing parties to the wholesale filling of pill mill prescriptions, has been the denial of opioids to patients in acute and chronic pain by physicians no longer willing to risk their livelihoods by prescribing opioids and winding up on the wrong side of the law. Yet even though legitimate opioid prescriptions have fallen since the peak in 2011, opioid deaths continue to increase year upon year, and alarmingly so since 2015 when illicit fentanyl and its related drugs entered the marketplace.
Why? Social scientists and economists tell us that the reason is the economics of our country lead to an insatiable demand for a drug related means of escaping the realities of wealth disparity, poverty, homelessness, and untreated mental health disorders. While the opioid crisis is a multinational crisis, the death rate in the U.S. is an order of magnitude higher than in the countries of Western Europe where social safety nets and national health care exist, salary differentials are lower, yet the rate of opioid prescribing is about the same.
Can we get the genie back in the bottle? Not without addressing the root causes of the problem. The cause was never and is still not physician prescribing (leaving perpetrators like Dr. Ruan out of the category of physicians). The problem is a demand by many in economic and psychological despair to escape the misery of their lives by any means possible, abetted by an army of facilitators who will manufacture, smuggle, and distribute the means to do so. And now while Big Pharma and Big Drugstores are out of the picture, there are plenty of others who fill that void. If the demand were not there, the deaths would stop.
The prescription is clear. It is not to throttle the supply of prescription drugs to patients any more than the solution to drunk driving is to stop selling gasoline (which would work). The solution is to address the economics of poverty, provide mental health care to those with psychiatric disorders, and to treat those with substance use disorder as a life-long chronic illness by methods with evidence-based therapies.
Finally, I (MY) know that Elliot and I have raised many issues that fly in the face of conventional wisdom. Many of you may disagree (or agree) with some of our conclusions. One way or another, I’d (MY) like to hear from you (send to my email: myasterster@gmail.com) and I will post your responses in a future PAAD.
Elliot Krane MD and Myron Yaster MD
References
Barry, C., Frank, R. Evidence for addressing the opioid epidemic: Rounding out the picture. Brookings Institute. https://www.brookings.edu/blog/up-front/2019/02/06/evidence-for-addressing-the-opioid-epidemic-rounding-out-the-picture/
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Ciccarone, D., International Journal of Drug Policy, https://doi.org/10.1016/j.drugpo.2019.01.010
Ciccarone D. The triple wave epidemic: Supply and demand drivers of the US opioid overdose crisis. International Journal of Drug Policy, https://doi.org/10.1016/j.drugpo.2019.01.010
Cicero T.J., Ellis M.S., Kasper Z.A. Increased use of heroin as an initiating opioid of abuse. Addictive Behaviors 74:63-66, 2017 http://dx.doi.org/10.1016/j.addbeh.2017.05.030
FDA Analysis of Long-Term Trends in Prescription Opioid Analgesic Products: Quantity, Sales, and Price Trends.” FDA Reports on Agency Policies and Initiatives, March 1, 2018. https://bit.ly/3IXfJKq
“Florida ‘pill mills’ were ‘gas on the fire’ of opioid crisis,” Los Angeles Times July 20, 2019
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Hollingsworth A., Ruhm C.J., Simon K. Macroeconomic conditions and opioid abuse. National Bureau of Economic Research, NBER Working Paper No. 23192, 2017 http://www.nber.org/papers/w23192
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MMWR Morb Mortal Wkly Rep. 2021 Apr 9; 70(14): 519–522 doi:10.15585/mmwr.mm7014e1
Norati E, Kang-Brown J., et al. Economic decline, incarceration, and mortality from drug use disorders in the USA between 1983 and 2014: an observational analysis. Lancet Public Health 3: 3326-33, 2019
“Online Sales of Illegal Opioids from China Surge in U.S.” The New York Times January 24, 2018
Venkataramani A.S, Bair E.F., et al. Association Between Automotive Assembly Plant Closures and Opioid Overdose Mortality in the United States A Difference-in-Differences Analysis. JAMA 2019, JAMA Intern Med. doi:10.1001/jamainternmed.2019.5686
Good faith vs criminal activity
Erratum: there are about 9,500 Covid deaths a day presently on the US, not 1,500.