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Sunday, November 1, 2020

Opioids, the Hot Seat, and More

The American Medical Association released an October update on America in the midst of COVID-19. Early in this pandemic, it was apparent to many of us that social isolation and other impacts might create stress and challenges for us. Stress in the time of COVID (03.19.20). Overdose is not a new topic to this blog: Dying to Me Don't Sound Like All That Much Fun (10.16.13); What Worthwhile Can You Do in 11.2 Minutes (12.20.15); Does Farr's Law Bring us Good News (07.09.17). The fact is that we lose more Americans to overdose every year than were killed in the entire course of the Vietnam War (57,939).

We know now that the overdose deaths continue even in the time of COVID. The AMA acknowledges that since COVID-19: "the nation’s opioid epidemic has grown into a much more complicated and deadly drug overdose epidemic." The organization expresses concern regarding "an increasing number of reports from national, state and local media suggesting increases in opioid- and other drug-related mortality—particularly from illicitly manufactured fentanyl and fentanyl analogs." This October 6, 2020, Issue Brief includes a variety of links to data that was considered in reaching the conclusions. 

Later in October, Fox News reported that Opioid deaths have risen in 2020. The headline includes the conclusion that "social isolation, loss of jobs, and disruption of treatment services are possible factors in the spike." Fox proceeds to cite results from various jurisdictions that are troubling. These include:
a county in New York where "Opioid deaths" are "nearly double the reported 44 fatalities in the first half of 2019."

Oregon opioid deaths increased 70% "in April and May 2020 compared to the same time" in 2019. 

Maine, "overdose deaths from January through June" were increased 27% "over the second half of 2019."

The California Attorney General noted that “in some of our counties, there are more deaths from overdoses than there are from COVID-19.”
This is generally consistent with the warning of the AMA Issues Brief. The AMA noted that more effort is needed to "remove barriers to evidence-based treatment for those with a substance use disorder." It also suggests that public health funds should be allocated more generously for facilitative prevention such as "sterile needle and syringe services and naloxone (the opioid overdose antidote). 

The AMA also acknowledges that there is a conflict inherent in the opioid challenge. That is, there are patients that experience pain. Certainly, there is also a population of people who use opioids for recreational purposes. However, there are also those who experience pain that is both unrelenting and debilitating. As the Mayo Clinic notes, "Chronic pain is a serious health condition," the experience and even treatment of which can produce a multitude of impacts on a patient's life and livelihood.

The challenge of opioids is complicated further by the tendency to become accustomed to their effects. According to Spine Health, "taking opioid medications over a long period of time may increase your sensitivity to pain, known as opioid-induced hyperalgesia." There are some who suggest that it is possible for a patient suffering from this to perceive the same, or similar, pain complaints with or without opioids (and therefore with or without the risks of opioids). Spine Health notes that "the exact mechanism for how this increased pain sensitivity develops is still being studied," and the explanation "likely involves multiple factors."

Pain is thus a complex and personal issue. What is appropriate for a particular patient is dependent upon a variety of facts and circumstances. There will therefore likely be instances of dispute as various entities strive to do what they perceive is best in a given situation. Patients may have advocates, either physicians, attorneys, or otherwise who strive for their well-being. Similarly, payers and pharmacies may harbor concerns about persistent or increasing use of opioids, and the impacts they may have on the patient, progress, and recovery. Either the patient or the payer could be motivated by ancillary influences or could behave inappropriately in a particular setting. 

The opioid producers and distributors are also experiencing repercussions of the drugs and their impacts. According to the British Broadcasting Corporation (BBC), one of the large producers of opioid medication, Purdue Pharma, "has reached an $8.3bn (£6.3bn) settlement and agreed to plead guilty to criminal charges" against it related to production and merchandising of opioids. There has long been concern among the Sackler family, according to Reuters. The report suggests that tens of billions of dollars have been paid to that family and related entities in recent years. Some contend that is related to concerns that a lawsuit might one day pierce the corporate veil and expose the individuals to liability. 

Following the announcement of the settlement, two members of Congress (Rep. Carolyn B. Maloney, and Rep. Mark DeSaulnier) released documents obtained in the Congressional investigations of opioids, according to a government website. The representatives expressed disappointment that members of the Sackler family were not held "fully accountable for their role in fueling the devastating opioid epidemic.” Among the communications released was one in which a company official lamented that sales representatives were "calling on non-high potential prescribers." Another questions how to "energize the sales and grow at a faster rate?” Some believe that charges against the company's owners should be considered.

There have also been actions against distributors of these medications. Earlier in 2020 FierceHealthCare.com reported that opioid lawsuits have included some of America's largest retailers as defendants. However, those retailers complain that smaller pharmacies, pill mills, and even the prescribing physicians have not been included in the litigation. More recently, Walmart apparently anticipates some potential for more direct government action against it, and has filed a "lawsuit against the federal government" in hopes of preempting government action, according to CNN.

In all, it is a troubling discussion. There is no doubt that people suffer pain. There is no doubt that there are physicians who appropriately seek to bring relief to their patients. There are advocates who want the best for their patients/clients, and without a doubt, there are payers who want the same. Opioids, however, have become a tangled debate that includes allegations of inappropriate motivations, greed, and failures on multiple fronts. The unfortunate fact is that a great many have died from prescription opioids. And, a great many are dying of illicit ones as well. Where did this crisis come from, and where are we going? What are the ethical concerns for patients, advocates, payers and more?

How will the workers' compensation community deal with these implications and challenges? This is the next subject for the Workers' Compensation Hot Seat. In a program featuring a renowned workers' compensation attorney and a physician who has made a career of being a patient cheerleader and champion, we will discuss the many challenges of opioids.  Join us on November 13, 2020, for more.