Art Opened My Eyes To The Opioid Crisis
By: Stephen Schimpff Md
Tags: Oxycontin, Opioid Epidemic, Art, Appalachia, West Virginia

The Wake-Up Call

My wife and I recently spent a quiet Sunday in Thomas, West Virginia. We had lunch and then wandered through the art galleries. In one of the galleries, one piece caught my eye — a shallow bowl containing gelatin capsules, like the ones used for medicines, filled with a black substance — coal dust. The title was “Sackler Treatment.” As a retired physician and one who had co-authored a history of the area, I quickly understood the meaning. Many viewers probably would not.

The artist, John Ryan Brubaker, shared the story that had inspired him. It is finally becoming known that the coal mining areas of Appalachia have experienced an opioid epidemic that has resulted in thousands of opioid overdose deaths. The term “Sackler Treatment” referred to the owners of Perdue Pharma, the firm that manufactures and markets OxyContin, a key opioid in this epidemic. He informed us that a larger version of this piece containing one capsule filled with coal dust for each person in Appalachia who had died of an opioid overdose was in the Hirschhorn Museum in Washington, D.C. (The photo is by Brubaker and taken at the Hirschhorn.) He explained that he had taken an old meat grinder to grind some hunks of coal to make coal dust. Then a group of his friends sat around a table together and filled these gelatin capsules until they had the required number. I found it a powerful wakeup call; perhaps you will also. Here is a link to a video that accompanies the art at the Hirschhorn.

Background

Early in my career, I took care of many cancer patients with severe pain. The most effective drugs, then and now, are the narcotic analgesics. But now focused on many other health and wellness issues, I have largely ignored the growing opioid epidemic. It took an artist to get my attention. But first, some background.

It was just forest wilderness in the mountains. No one lived there; no thought of living there, no one wanted to live there. But then the railroad arrived in 1884 to access timber and coal. As mines developed to take advantage of the abundant coal in the area, the new town of Thomas, WV rapidly grew. By 1900, it had over 2,000 residents from many countries around the world. Its main street had numerous general stores, grocery stores, bars, restaurants, brothels, and even an opera house. The town continued to prosper thanks to the coal mines and associated coke ovens until the 1920s, when the steel mills in Pittsburgh and Baltimore changed their processes and stopped using coke. Still, the town continued to thrive until coal mining began to diminish in the late 1960s and 70s. With the demise of many of the coal mines, the stores in Thomas began to close. While not quite a ghost town, it was not the thriving community it had been. In the last decade, however, the town has experienced a revival in large part due to the arts, with new restaurants, music, art galleries and antique shops. It is quite a comeback based on a very different economy for this small town in West Virginia.

Opiates and Opioids

The poppy is the source for all of the opiates — opium, morphine, codeine and heroin. Then there are opioids, chemically synthesized, such as oxycodone, hydrocodone and fentanyl. OxyContin, an extended release form of oxycodone, is manufactured by Purdue Pharma. Hydrocodone has also been made in an extended-release formulation called Zohydro ER. Oxycodone in the form of OxyContin was marketed in high dose pills and claimed by Purdue to not be as addictive as other opioids. (See below)

Fentanyl is a semi-synthetic ultra-powered opioid, one hundred times more potent than morphine on a milligram per milligram basis. It is fifty times more potent than heroin. Fentanyl is available by prescription (one brand name is Duragesic from Johnson and Johnson) usually for severe pain such as might be found in late-stage cancer and is often used in end of life care. But it has also been brought in illicitly, often from China, and frequently mixed with heroin. In 2017, 28,000 overdose deaths were related to fentanyl in the USA. The Chinese point out that fentanyl is produced legally in China; that the Chinese do not have an opioid addiction problem; that Americans consume eighty percent of the world’s opioids and therefore the problem is America’s, not China’s.

Opiates and opioids (narcotics) are extremely important legitimate medications for severe pain management. The most common uses are for acute trauma or following a surgical procedure. They are usually used for a few days to a week and then either replaced, if needed, by non-narcotic pain relivers such as ibuprofen (Advil.) Some examples would be the person who has a knee replacement. The pain is generally intense and persists for at least a few days, if not weeks. And since the doctor wants the person to be out of bed and moving to prevent pneumonia and other complications, the pain medicine is truly critical — for a short time. I had a surgical procedure on my little finger a few years ago. It was done with a nerve block that wore off after about 18 hours. I was given a prescription for hydrocodone and acetaminophen with instructions to take one every four hours if needed. Correctly, I was also told to take it on schedule, to not let the pain recur because that often leads to needing a higher dose. As it turned out, I took one tablet the next morning and no more. Some Advil was sufficient thereafter for a day or two. But that left me with 29 hydrocodone pills unused.

Opiates and opioids are also of great value for those with the unremittent pain of advanced cancer and are especially valuable for pain control during the end of life. Here there should be no concern about “addiction;” the need is for pain control, effectively and persistently.

Addiction

Narcotic addiction is nothing new. Opium was common and completely unregulated in the 1800’s. Opium could be found in many if not most “snake oil” remedies peddled by hucksters. Huge numbers of Americans’ were addicted — they wanted more and then more again. Coca Cola is named for the cocaine in the original formulation — changed later to caffeine which along with its sugar are also both addictive.

The terms substance abuse and addict carry very negative connotations. They imply fault, inadequacy; a highly negative judgement. With such a mid-set it is easy to discount the importance of assistance. Legislators know who votes and who does not; nonvoters get little attention. No one speaks for the addicted person and if they are mostly people tucked away in the Appalachian Mountains, who is to notice? Who is to care? The same can be said for those in socioeconomically stressed cities — in the “ghettos.”

Addiction Risks

Who is at the greatest risk of addiction? About 13% of Americans have a genetic predisposition, i.e., a low dose for a short time can create addition. It is clear that all people who take any opioid for a prolonged period of time (just two weeks may be enough for most) are likely to become addicted. Higher doses substantially increase addictive potential. In 2017, the amount per individual prescription written was three times higher than it was in 1999 when measured in “morphine milligram equivalents or MME.” Individuals who are older, or who lose their spouses, their homes, or their jobs, are at greater risk. The risk escalates if there is no hope of getting another job.

Statistics and Three Waves of Opioid Overdose Deaths

According to the Center for Disease Control (CDC), between 1999 to 2017, nearly 400,000 individuals died from prescription or illicit opioid overdosing. Overdose deaths peaked in 2017. There were 47,000 deaths from opioids, more than from guns, car accidents or breast cancer. There were six times more opioid overdose deaths in 2017 than in 1999 — or 130 Americans dying of an opioid overdose every day.

There have been three “waves” of opioid overdose deaths in the last decades (Graphic from CDC.) The first began in 1999, related to prescription opioids including the extended-release form of oxycodone with the brand name OxyContin. These overdose deaths slowly but steadily rose each year. Then in 2010 came the second wave from heroin overdoses. These rose quickly over just a few years to reach a peak in 2017. The third wave began in 2013, when the U.S. saw an explosion of overdose deaths from synthetic opioids such as fentanyl, much of it illicitly smuggled from China. Essentially, prescription opioids led to illicit opioids, then to heroin and finally to fentanyl. It is estimated at about 80% of heroin abusers became addicted through preceding prescription opioids.

Appalachia and Addiction

The hardest impacted by these opioid overdoses were communities that lost significant industries and jobs, such as the coal mining areas of Appalachia. Southern West Virginia and nearby Kentucky have been especially impacted.

Central Appalachia has been especially hard hit because, according to one report, it had “low education levels, high rates of unemployment, and high rates of job related injuries,” all of which “perpetuate risks for substance abuse.” Further, Central Appalachia is an area historically grounded in anti-regulatory beliefs, has limited healthcare and few individuals trained in substance abuse prevention and treatment.

The epidemic received little attention in the general media until more recently, when it spread to communities across the country, including larger, more suburban and wealthy areas. It is now “in your backyard.”

Lawmakers have lacked any sense of urgency. Certainly, if an equal number of people were dying in train accidents or plane crashes, media attention and therefore attention from Washington would be instantaneous. Rob Portman, a senator from Ohio, is quoted as saying, “I think it’s just inertia. It’s hard to bring people [representatives and senators] together. Hard to get stuff done around here.”

Huntington, West Virginia is near the center of coal mining in southern West Virginia. A town along the Ohio River, it had a 100,000 population during the coal boom. Now its population is down to about half of that and experts estimate that a quarter of that population — or some 12,000 people — have substance abuse disorders. In just one day, August 15, 2016, there were twenty-eight overdoses, of which two were fatal.

A resident of Huntington said,

“the money had gone with the coal,

people began selling dope to get money,

and then selling dope to get dope,

and then selling dope to do dope.”

Why did this happen?

Why has opioid addiction and overdoses been so prevalent throughout Appalachia?

A friend who grew up in a small town in the coal belt near Huntington, West Virginia, helped to explain. She describes the town as having been vibrant, with a busy main street and even a small hospital. More than fifty years later, when she returned for an uncle’s 87th birthday, what she saw was highly distressing. Many of the shops were boarded up and the hospital was in ruins. “Those who could leave had left — all that remained was the old, the infirm, and the disabled,” she said. “It was total devastation for the bulk of the townspeople. Despair was everywhere.” Such is the common fate of many towns that once depended upon coal mining to power their economies.

Why did miners get addicted? They would come out of the mines tired and in pain from the constant bending over and traumas associated with their work. Their pain was significant and long-term since each day would bring more of the same. Pain medications, including the new long-lasting opioids like OxyContin, eased their pain and made it possible to sleep so they could return to the mine again the next day. Not working was not an option when each paycheck was critical. And once the mines closed and they felt impotent to provide for their families on top of enduring the persistent pain from the mines, continued use of pain meds was almost natural. And there were doctors that were more than willing to overprescribe.

A miner who found himself out of work, not able to provide for his family, hopes, probably unrealistically, that the mines will reopen. He may experience hope if a politician promises to bring back jobs. But mostly, he is likely to experience despair, accompanied by persistent pain that likely leads to long-term use of pain medications and ultimately to addiction.

It is often said that laid-off coal miners should “just move elsewhere” such as to areas that have fracking industries. But these are proud people with roots that run wide and many generations deep. Family and community are important to them. Moving is not so easy. For example, if one moves, who will replace grandmother for childcare while the parents work? Like so many seemingly easy answers, the real situation is much more complicated.

It is in this environment that opioids became commonplace medications for persistent pain. Soon the pain pills of choice became the extended release high dose forms such as OxyContin. Once addicted and with no access to legal opioids, it was natural for people to look to imported heroin and then to illicit fentanyl. Overdoses multiplied.

Who is at fault?

Who is at fault for the opioid epidemic and the associated overdose deaths? The “blame,” if one wants to call it that, needs to be shared widely. It is easy to blame the drug smugglers and the deep pocketed pharmaceutical companies. But that omits many actors that need to share responsibility — including doctors, pharmacies, drug wholesalers, the FDA, the DEA, and state, city and federal governments. Lawyers looking for an entity to sue for damages can get little from an individual doctor or small pharmacy; governments can’t be sued and the drug smugglers may be in jail but are not good targets for money. The result is that the pharmaceutical companies and the drug wholesalers/distributors are at the forefront of legal claims. It’s the old Willie Sutton rule — go where the money is.

It’s easy to say that the abuser should have ‘just said no.” With that, we can wash our hands of responsibility. Too often, substance “abusers” are considered morally deficient, lacking in will power, or just stubbornly committed to their addiction. What is forgotten is that addiction is a disease, just as is a heart attack, diabetes, or obesity. We don’t or at least should not judge people who get lung cancer by thinking that it’s their fault because they smoked. Huge numbers of Americans are addicted to sugar and have become obese, but we don’t label them as substance abusers even though the toll from obesity will far surpass that of opioids. And, yes, people die from obesity, just not suddenly from an overdose.

Addiction to narcotics is powerful. The brain literally changes and although it changes easily to form addiction, it reverts back only with long periods — months and years — of abstinence. Two years is the magic number; if a person can be drug free for 24 months, they can probably persist. Anytime less and a single dose might turn them back again. Narcotic addiction is powerful. It cannot be easily overcome.

No question, the physicians who wrote numerous prescriptions with little attention to the consequences are at fault. Here are three examples:

1. Dr. Joel Smithers of Martinsville, Virginia was recently sentenced to 40 years in prison for illegally prescribing “more than half a million doses of oxycodone, hydromorphone and fentanyl.”

2. In February, 2019, 14 physicians and physician assistants were indicted for “operating ‘pill mills,’” specifically for having “sold opioid prescriptions to individuals without any legitimate medical need in exchange for cash.” One of these physicians owned a ski resort in West Virginia.

3. In September, 2019, federal indictments were handed down for prescribing huge numbers of opioids “in pill mill” clinics. The case includes charges against 48 defendants, of which 15 are physicians or other medical professionals. Among the cases, “[Drs.] Malik and Kundi wrote prescriptions for controlled substances using blank prescriptions that were pre-signed …. Anand and Makarova provided over 10,000 prescriptions for Schedule II controlled substances, of which over 7,000 were for oxycodone, for a staggering total of over 634,000 oxycodone tablets distributed from this scheme.” Until recently, no agency tracked physicians who were writing outrageous numbers of prescriptions.

And then there are the drug wholesalers, the ones who buy from the drug companies and then sell and distribute to pharmacies. The Washington Post reports, based on DEA data, that 65 million pills were distributed between 2006 and 2012 in Cabell County, WV, home of Huntington. In other parts of West Virginia, wholesalers such as H.D. Smith and Miami-Luken shipped 780 million hydrocodone and oxycodone pills between 2007 and 2012.

Two pharmacies in Williamson, West Virginia, a town with a population of 2,900, received 10.2 million hydrocodone and 10.6 million oxycodone pills. Kermit, West Virginia, with a population of 400, received 2 million prescription pain pills in 2008 alone. These numbers are shocking, yet authorities did not pick up on what was happening for far too long. Across the country, wholesalers clearly knew that they were supplying huge numbers of narcotics to select individual pharmacies — numbers that could not possibly be appropriate for the local population. And neither the Drug Enforcement Agency (DEA) nor any other agency tracked the large shipments to individual pharmacies.

Some would also indict the Joint Commission on Accreditation of Healthcare Organizations (The Joint Commission) for insisting that hospitals measure pain levels in addition to pulse, blood pressure, respirations and temperature. By implication, someone with pain deserved and should receive appropriate pain control. Unfortunately, too often patients were given pain medication without addressing the underlying cause. This contributed to more liberally prescribing opioids for severe chronic pain, without strong justification and opened the door to less appropriate usage.

There are others who should share in the “blame.” States and the federal government offer unemployment insurance, foods stamps, and other safety provisions. But they have been lax at developing retraining programs for out-of-work miners and manufacturing employees and very lax in developing and implementing rehabilitation programs for those that are addicted.

America has an incredible healthcare paradox — combining well-trained professionals, effective pharmaceutical and biotechnology innovation, and superb diagnostic technologies with a care delivery system that is dysfunctional at best. Here again, there are many causes, but among the worst offenders are the insurers (including governmental insurers Medicare and Medicaid) who grossly underpay primary care and mental health practitioners but overpay proceduralists (e.g., surgeons, endoscopists, etc.) Medicaid’s very low reimbursement levels create a situation in which many physicians don’t accept patients covered by Medicaid because their collections won’t cover their overhead costs.

And finally, the pharmaceutical companies need to share the blame, especially those that aggressively marketed their drugs with well-recognized abuse potential. Most of the attention has gone to Purdue. Purdue developed OxyContin, an extended release form of oxycodone, with the intent of creating a drug that could be taken just one or twice per day instead of every four hours.

Some claim that the Food and Drug Administration (FDA) gave the green light to Purdue to market OxyContin as less addictive. This is partially correct. The original FDA approved “label” in 1996 indicated that addiction from OxyContin would be “very rare.” For Purdue, this meant that it could aggressively market its drug as less addictive. In 2001, as more data became available, the label was modified with FDA guidance to state that the true incidence of addiction was not known. Further, the FDA required that the label refrain from suggesting that the extended release form was less addictive. But the damage was done. Physicians were largely unaware of the new labeling and, believing that the extended release form was less addictive, continued to prescribe it regularly.

Purdue also aggressively marketed OxyContin with a large salesforce who encouraged doctors to prescribe it as the drug of choice for serious pain — chronic, non-cancer related pain included. Over time, Purdue began to market higher dosage forms of OxyContin, telling doctors that they could titrate their patients’ needs with these various options. On a morphine milligram equivalent (MME) basis, Purdue became the largest seller of opioids and OxyContin became a blockbuster, an annual multibillion-dollar drug. And since OxyContin in higher dosage actually had a high addictive potential, many more individuals became addicted.

Should the FDA have taken a more aggressive stance toward Purdue’s marketing? Perhaps. In a careful review in the Journal of Public Health in 2009, “The FDA’s medical review officer, in evaluating the efficacy of OxyContin in Purdue’s 1995 new drug application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing.”

The review also noted that the highly regarded “Medical Letter on Drugs and Therapeutics concluded in 2001 that oxycodone offered no advantage over appropriate doses of other potent opioids.” But neither of these statements addressed the addiction potential. Purdue could and did emphasize the advantage of the long-lasting anti-pain effect while keeping quiet about addition risk.

There was eventually a price to be paid. In 2007, Purdue Frederick, an affiliate of Purdue Pharma, and three Perdue executives pleaded guilty for claiming that OxyContin was less addictive. The company paid a $634 million fine and entered into a long-term monitoring agreement. Still, OxyContin continued to be heavily prescribed and remained the leading high-dose extended-release opioid until the present.

Now Purdue is in bankruptcy, and the Sackler family, which owns Purdue, is being sued; a settlement may be near.

Johnson and Johnson recently was convicted in Oklahoma related to the opioid epidemic in that state for being “engaged in false and misleading marketing of both their drugs and opioids generally.” Of the various pharmaceutical firms being sued across the country, it is by far the largest (and hence best able to pay large judgements, this one being $572 million) yet J&J is one of the smallest opioid manufacturers by volume produced and sold.

Insys was a manufacturer and distributor of a spray form of fentanyl approved by the FDA for cancer patients with severe pain who were in addition having “breakthrough” pain despite their opioid therapy. The company is in bankruptcy and its executives have been given prison time for essentially encouraging doctors to prescribe the drug “off label” and, in effect, buying prescribing habits of these physicians. Note: It is not illegal to prescribe a drug off label if the physician believes it to be the best available therapy; it is illegal for the manufacturer directly or indirectly to in any way encourage such prescribing.

As of this writing, many of the manufacturers of opioids are in talks with state attorneys general and with plaintiff lawyers to strike an overarching settlement of all claims. The major drug wholesalers/distributors (McKesson, AmerisourceBergen and Cardinal Health) are likewise seeking an overall settlement. Combined, the total settlement will probably exceed many tens of billions of dollars.

The critical question is how these settlement dollars will be allocated. Will they actually go towards addiction prevention and treatment or will they end up in various politicians’ pet projects and filling the coffers of litigators? Hopefully, a significant sum will be allocated to the benefit of those addicted and for prevention activities in the hardest affected regions, such as Appalachia.

The Collateral Damage of Opioid Addiction and Overdose Deaths

Beyond the damage due directly to addiction, there are collateral damages such as contracting other diseases as a result of needle sharing. In Huntington, there was first a noticeable increase in deep-seated abscesses. Hepatitis is now not uncommon. Then came enough new HIV cases that the CDC has labeled Huntington and the surrounding county as having an HIV “cluster.”

Additional collateral damage has affected those who legitimately need opioids but can’t get them. Today the opioid abuse and overdose epidemic has captured the national media’s attention. States are making medical licensure renewal more complex, with requirements for fingerprinting and background checks. Prescribing opioids also has become more complex for physicians, and many doctors and nurses are reluctant to prescribe narcotics even when opioids would be the best option — they do not want to run afoul of DEA agents questioning their prescribing habits. Here are two sad examples.

A friend’s nephew recently died in hospice from metastatic cancer that caused excruciating pain. Although he was given narcotics, the dosages were too low and too infrequent to adequately control his pain. Certainly, “becoming an addict” was not a concern. He died in agony. It should not have been that way.

Another friend went to visit his elderly sister at her assisted living facility in a distant state. She had substantial osteoporosis which, coupled with repeated falls, had left her with spine fractures and considerable pain that were not amenable to orthopedic repair. The surgeon treating her avoided opioids but prescribed excessive doses of benzodiazepines (Xanax) that left her barely conscious. My friend found her a new physician who stopped the Xanax and placed her on a fentanyl patch administered over her lower back. Now she is alert, out of bed and relishing life once again.

Legal vs Health

As a country, we focus more on the legal aspects of addiction than on the health of addicts and prevention. The addict is looked down upon as a person who cannot control his or her urges and is viewed as “weak” in spirit. We generally treat the problem as largely a legal one. Kurt Schmoke, mayor of Baltimore from 1987 to 1999 and a former frequent prosecutor of drug trafficking, used to say that the narcotics problem was primarily one for “the Surgeon General, not the Attorney General.” He favored a “War on Drugs” approach that focused on the health aspects of addiction, but this approach was largely ignored as America instead chiefly focused on law and order.

The Perfect Storm

The message is straightforward — there is a time and a place for opioids. Without question, they are far and away the best painkillers available. When they are needed, they are appropriate and should be prescribed in the necessary dosage, the most appropriate route (pill, path, shot, patch, etc.) and as often as needed. No one should feel guilty about using opioids when needed. Nor should health care professionals shy away from appropriate prescribing.

Unfortunately, greed on the part of many doctors and pharmacies, willful ignorance from drug wholesalers, and aggressive marketing of drugs with known addictive potential by pharmaceutical firms, and inadequate oversite by government agencies all combined to create a perfect storm in Appalachia at the same time that coal mining was declining and chronic pain was prevalent.

To compound the problem, America is a society that does not accept addiction as a disease, a disease for which we should not offer judgement. Concurrently we do not have a healthcare system that is defined or funded to address the medical, psychological and social requirements for effective prevention and treatment. It is more the failings of society than the individual which has led to the overdose crisis.

The Appalachia overdose crisis and its sister epidemics across the country have been largely ignored by our elected representatives until recently. Surely, if a plane crashed every day with 130 passengers aboard, Congress and the president would act aggressively. But since the overdose deaths have chiefly occurred in areas of minimal public interest, they have gone largely unnoticed until recently. Now the blame game has begun in earnest, focusing on the deep pockets of the pharmaceutical and distributor industries. While there is finally awareness and action, it is unclear that legislators and attorneys general will assure that the proceeds of settlements and tax dollars are used for legitimate, needed interventions along with attention to the infrastructure needs to prevent new addictions.

Returning to John Ryan Brubaker’s art, he has elegantly illustrated the human cost of the opioid epidemic and the many tragic and unnecessary overdose deaths in Appalachia. Hopefully his art in the Hirschhorn in Washington, DC (ironically just down the Mall from the Arthur M Sackler Gallery of Asian Art) will alert, as it did me, citizens and our elected representatives to take the crisis seriously and propose meaningful action.

Stephen C Schimpff, MD, MACP, is a quasi-retired internist, professor of medicine, former CEO of the University of Maryland Medical Center and senior advisor to Sage Growth Partners. He is a graduate of Yale Medical School and is board certified in internal medicine, medical oncology and infectious disease. He has written 6 books for the general public on medicine, health and wellness. Learn more about healthy aging by reading Schimpff’s latest book: “Longevity Decoded — The 7 Keys to Healthy Aging. He is also the co-author of a history of the Canaan Valley/Blackwater Falls area including the town of Thomas, Fortune Seekers in the Promised Land