Opening comment by John Coleman – DWI.

This article raises some good points. While it’s reasonable to compare today’s commercial cannabis industry with the Big Tobacco industry of the 20^th century – indeed there are many similarities – we should also consider comparing it to the prescription opioid “epidemic” (as the White House called it) of the 2000s. We will not be alone in drawing the comparisons –  I’m sure the cannabis industry and their lawyers understand the history and chronology as well as we do but, of course, they are looking at it from a different perspective.

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Putatively, the “first” pill mill was discovered in June 2001 at a “pain clinic” in Myrtle Beach, SC. The official name of the clinic was the Comprehensive Care and Pain Management Center and it was run by a group of physicians led by the owner, David Michael Woodward, MD. In 1994, Woodward opened a sleep center but quickly found that there was more money to be made prescribing opioids and switched his operation to a pain clinic. When his medical license was suspended in 1996 for improper relationships with female patients, he turned to hiring physicians facing difficult personal and financial problems to write his opioid prescriptions for him.

Myrtle Beach is a small seaside summer resort with a permanent population of 35,000 but, as would later be shown in court, it led the region and entire state in Purdue’s sales of OxyContin – mostly the result of Woodward and his band of troubled docs. In June 2001, DEA raided the clinic, arrested Woodward and eight other physicians and charged them with “conspiracy to distribute controlled substances [and] unlawfully distributing and dispensing … oxycodone, a Schedule II controlled substance,[etc.]”(USA v. Woodward)

One of the docs subsequently took his life, another ran off to New Zealand, was captured, and returned to face the music. Most cooperated and testified against Woodward who was sentenced to 15 years in prison (later reduced to 13 years). The others received lesser sentences of two years or more.

Woodward was not the first or only entrepreneur looking to cash in on the burgeoning prescription opioid craze. There were people thinking of doing the same thing in Florida, a state that had few, if any, restrictions on pain clinics. It wasn’t long before Florida became the epicenter of the pain clinic aka pill mill industry. Its pill dispensing docs often had dozens and dozens of people lined up before the mill opened each morning. Some, as shown on TV news, drove to the Florida clinics from as far away as Ohio and further west.

“Patients” would often exit the mills carrying gallon-sized clear Ziploc bags of hundreds of loose pills, mostly OxyContin tablets or a generic form of a 30mg oxycodone tablet made and sold by Mallinckrodt. This was a blue tablet with the company’s traditional “M” logo and quickly became known on the street as “M&Ms.”

For several years, Florida and its lax pharmacy and medical laws led the nation in pill mill activity. At the same time, it was becoming a national scourge, with parents and policymakers from surrounding states demanding action. Even the Florida media mocked the state as depicted in this cartoon (my favorite) from the South Florida Sentinel:

The Florida pill mill era came to an abrupt halt in July 2011 when the state legislature enacted an emergency health act that immediately closed down about half of the state’s estimated 1,000 pill mills and severely affected the status of the other half. The emergency legislation prohibited physician-dispensing of controlled substances, meaning the pill mills no longer could prescribe and dispense pills from the same location at the same time.

Florida’s anti-pill mill act increased penalties for dispensing drugs on an invalid prescription and turned misdemeanor pharmacy offenses into felonies. Pharmacists were required to call the local sheriff to report all fraudulent prescriptions. Clinics were required to have a medical director, a medical physician, in residence or in ownership.

Importantly, Florida’s emergency legislation requires distributors of controlled substances to inform the state health department when distributions over a set amount of drugs are delivered to customers.

The results were dramatic:

While the pill mill era was centered in Florida, corrupt medical professionals in other states operated similar “pain clinics” but with a much lower exposure. Over time, many of these were identified via complaints or PDMPs that revealed improper prescribing practices.

Now, how does this brief history of the U.S. pill mill industry compare with what we now see in the commercial cannabis industry? Several similarities come to mind and I’ll mention them briefly to save time:

1. The pharmaceutical industry, led by Purdue Pharma, spent huge sums of money generating the notion that pain in America was not treated or undertreated;
2. Medical schools in the 1990s were still teaching in the 1940s mode that narcotics should be used only in terminal cancer patients;
3. Modern opioids, like Purdue’s new extended-release OxyContin, were promoted as less addictive;
4. Pain patients, according to JAMA (“Porter & Jick”), rarely became addicted to their opiates;

The industry successfully “sold” these ideas to the public and to Congress, subtly suggesting that obsolete government regulations might be why chronic pain was undertreated in the U.S. Feeling the heat, if not the pain, the government caved and became the pharmaceutical industry’s new best friend. On Halloween (October 31), 2000, industry lobbyists were successful in getting President Bill Clinton to sign into law a bill creating the Decade of Pain Control and Research.

 (Ironically, by the end of the “pain” decade some ten years later, FDA records would show that of 219 drugs and biologics designated and approved during the decade as “new molecular entities,” only nine were indicated for treating acute pain, including three for treating migraine. Only one, Tapentadol®, was indicated for the treatment of moderate to severe acute pain. NONE was indicated for treating chronic pain. Later, after the decade was over, an extended-release form of Tapentadol would receive an additional indication for treating chronic pain.)

 The same month, October 2000, perhaps to curry favor with the President, the Department of Veterans Affairs (VA) published a 57-page booklet titled, “Pain as the 5^th Vital Sign Toolkit.” Authorship was given in the booklet to James Campbell, MD, president of the American Pain Society. Next on industry’s list of who’s nice was the Joint Commission for Accreditation of Healthcare Organizations (JCAHO), a professional organization of medical experts who certify hospitals and clinics in the U.S. Its “best practices” are viewed as important for attracting federal grants and other forms of federal aid for treating the elderly, disabled, and poor under Medicaid or Medicare. Performance reviews of hospital facilities are conducted regularly by JCAHO members and certification is considered a requisite for continued operation.

In 2001, JCAHO issued new standards for pain care in response to what it called “the national outcry about the widespread problem of undertreatment.” Henceforth, upon admission to the hospital, each patient was to receive as assessment of their “fifth vital sign – pain” along with the normal assessment of their other four vital signs.

With the government squarely in the pocket (literally) of the industry, the private sector was covered. Not to be undone by the competition, the prestigious Institute of Medicine (IOM, since renamed National Academy of Medicine) was commissioned by HHS to study pain in America. Its publication, “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research,” was published in 2011 and reported, among other things, that 100 million Americans suffered from chronic pain.

Later, several watchdog groups would show that many of the experts associated with these and other famous public and private pain organizations were secretly on the payroll of the pharmaceutical industry.

By 2011, when the IOM published its report, the industry was moving rapidly and cashing in on the media’s trashing of anyone who dared to be “anti-pain.” It was a movement, an ideology, a belief system, that threatened to excommunicate anyone who differed in any way with the orthodoxy of pain treatment.

Agencies like the DEA that regulated the manufacture, distribution, prescribing, and dispensing of controlled substances was the enemy and the physicians the agency cited were often called “martyrs” by their peers and the public. To counter this, DEA published a booklet for several years (since discontinued) that was titled, simply enough, “Cases Against Doctors.” This booklet was available on the DEA website and catalogued charges and errant behaviors of hundreds of registrant-doctors each year charged and convicted of state or federal law violations involving the prescribing and/or dispensing of controlled substances. (I have an archived copy of this publication if anyone wants to email me for a copy.)

What brought this to an end (or at least to a manageable state) were several factors that can be reduced to these (there may be more but these are what come to mind):

1. The emergency legislation in 2011 in Florida closing up half the state’s 1,000 pill mills overnight and the strict regulation of the remaining 500 clinics to prohibit physician-dispensing of controlled substances;
2. The rising death toll attributed to prescription opioid overdoses (ironically, this was miscalculated by the CDC that until 2016 mistakenly counted all fentanyl-related death cases as involving prescribed or administered pharmaceutical fentanyl, not the street version);
3. The prosecution and conviction of Purdue Pharma and its top three executives (President, Chief Medical Officer, and General Counsel) for federal criminal law violations by the United States Attorney for the Western District of VA in 2007;
4. Item #3 set the stage for the 2017 Multi-District Litigation (MDL) case involving approximately 3,000 plaintiffs, including state attorneys general, private and public health plans, unions, towns, cities, municipalities, individuals, Indian tribes, etc., brought against Purdue and other companies involved in making, distributing, and dispensing prescription opioids. This case was assigned to the U.S. District Court in the Northern District of Ohio (Cleveland) and is currently in negotiations for an omnibus settlement along the lines of what came out of the Big Tobacco settlement of the 1990s. A number of companies have settled individual “pilot” cases thus far and the total settlement is estimated to eventually reach the $26 billion mark;
5. Purdue and Mallinckrodt entered and exited bankruptcy as a result of settlements and judgments related to the MDL;
6. The companies have largely abandoned the freewheeling and unlawful sales of opioids that they promoted in the heyday of the previous decade;
7. Personnel changes at the top of many defendant companies have resulted in folks at the top being more responsible today than ever for what the company is doing at the retail level;
8. While prescription opioid overdose deaths are down substantially compared with what they once were, unfortunately the craving for a substitute drug in the form of heroin or fentanyl-laced heroin has increased leading to only a modest decrease in overdose opiate-involved deaths.

Conclusion:

From the above brief (and this is brief for a story that took almost two decades to happen) analysis, the comparisons with today’s commercial cannabis industry are stark and unmistakable. We have been led (or more correctly, misled) by the previous HHS leadership that our control of cannabis for medical purposes was outdated, too narrow, and did not comport with modern ways of evaluating the safety and efficacy of medicinal drugs.

This, by the way, from the same crowd that told us pain was our “Fifth Vital Sign.” States that have approved commercial cannabis “dispensaries” have done so in the finest tradition of helping entrepreneurs in the early 2000s establish pill mills to care for undertreated pain.

And the DEA? Congress has enjoined appropriations for the agency that might be directed against medical marijuana. The FDA? Forget it. The agency’s “Warning Letters” to online cannabinoid dealers are used by the dealers and published online in some cases, to boast about the high THC/CBD content of their products, according to cited FDA lab tests.

As in the cases of Big Tobacco and Big Opiates, at some point, the commercial cannabis industry will reach a point where going after its resources will take it down or reduce it considerably. The analogy I’ve used before compares this with the fermentation of yeast, a process that any home maker of wine or beer understands well. The single cell yeast consumes the sugars of the starting material and in the process excretes alcohol. This continues until the amount of alcohol in the mix reaches a certain level at which time it kills off the yeast producing it. At some point in the future, hopefully soon, the commercial cannabis industry will reach a point whereby its success kills it off – just as in the Big Tobacco and Big Opiates cases.

Source: drug-watch-international – P.O. Box 45218, Omaha, NE 68145-0218, USA