by Christopher Dale

November 1, 2021

A two-decade review shows decisions too suspicious – and Big Pharma’s influence too profitable – to be explained away by sheer incompetence.  

This is a story 20 years in the making, and one dragging on – in boardrooms, courtrooms and cemeteries – day by deadly day. To connect the timeline’s dots, we must trace them in reverse.

We start at today. Last year, a record 93,000 Americans died from drug overdoses – more than car accidents and gun deaths combined. While no formal breakdown by drug is yet available for 2020, experts expect a similar ratio as 2019, when about 70% of all drug deaths were opioid related.

The “how we got here” highlights are common knowledge. In the mid-1990s, pharma companies began touting new versions of synthetic opioids. Led by Purdue Pharma’s 1995 release of OxyContin, Big Pharma peddled what we now know as billion-dollar bullshit, claiming their profitable products were nowhere near as addictive as the heroin they mimicked. They lied – and many people perished.

But while corporate greed is the prime factor, organizations with no official profit motive played critical roles as well. And as we trek further back in time, grieving through the graveyards of an American horror story as we go, we continuously cross paths with one organization in particular: The Joint Commission.

The Joint Commission (JC) is an independent, not-for-profit entity that accredits and certifies health care institutions across the United States, from hospitals, hospices, detox facilities, methadone clinics and rehabs to nursing homes and behavioral health centers. It is the nation’s oldest and largest standards-setting and accrediting body in health care. To earn and maintain the JC’s Gold Seal of Approval^®, health care facilities undergo regular on-site surveys.

Every health care institution strives for official JC accreditation, designed to showcase its sanction by the country’s alleged most trusted, non-partisan accreditor. To do so, they must abide by certain standards of patient care intended to provide consistency across the country.  A cornerstone of these standards is known as the four vital signs: body temperature, blood pressure, pulse and respiration rate.

But it was when The Joint Commission introduced an unofficial fifth vital sign – pain – that its collaboration? with an American tragedy began.

Our first stop through the reverse timeline is late 2017. That’s when four municipalities in West Virginia filed a lawsuit against The Joint Commission for its alleged role in the opioid crisis.

Four years later, the case has yet to be resolved. Asked to comment prior to this piece’s publication, a Joint Commission spokesperson declined, citing the inability to comment on a matter pending litigation. (However, this website (Addiction/Recovery eBulletin) is requesting IRS records that may shed light on this matter, pertaining to untoward financial influence.)

The suit generated some headlines, but little in-depth reporting. However, a December 2017 piece on Drug Watch revealed some damning facts about The Joint Commission’s history.

In this piece, several experts including Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University, said that as opioid painkillers gained prominence, drug companies overwhelmed the medical establishment with multi-faceted marketing campaigns to encourage their utilization.

To effectively reach savvy doctors, the messaging needed to come from peers and authority establishments rather than drug companies themselves. Therefore drug makers like Purdue needed accomplices like The Joint Commission.

To curry favor, Big Pharma pumped big money into a variety of professional societies and organizations. Of these, none were more crucial to their intentions than The Joint Commission, whose status as a not-for-profit healthcare standards-setter meant it had instant legitimacy and, through its accreditation practices, an extraordinary amount of influence and leverage.

Simply put, when the JC spoke, healthcare providers listened – and, in this case, forcefully demanded the new 5^th Vital was measured by asking every patient: “What’s your pain level 1-10?” For children unable to express themselves clearly, this already-subjective assessment was reduced to a selection of cartoon faces ranging in demeanor from smiling to sullen.

Perhaps the biggest coup was Purdue Pharma’s financial support of Dr. Jane Dahl, who played a critical role in persuading The Joint Commission to develop its initial 2001 pain assessment recommendations. During these efforts, Dahl told a reporter that “we’re blessed that Purdue Pharma gave us a significant amount of money to keep things operational here.” 

The result was a new vital sign that simply had no business being lumped in with the others.

“The real problem with the fifth vital sign and The Joint Commission standards is it led to very aggressive use of opioids in the hospital setting,” Kolodny said. “Pain is subjective. It’s a symptom… Vital signs are objective measures critical to life.”

The next stop on our timeline is just a few months earlier, in what might be the most mealy-mouthed mea culpa in medical history.

The Great Un-Apology Letter

On May 5, 2017, The Joint Commission finally admitted that its pain assessment recommendations, by then 16 years old, weren’t perfect. Unsurprisingly, they did so with lengthy legalese leaps that unconvincingly explain its lack of responsibility for the devastating consequences (since 1999, over 851,000 people have died from drug overdoses) these recommendations wrought.

The purpose of the 10-page report, titled “The Joint Commission’s Pain Standards: Origins and Evolution,” was twofold. First, it served as a precursor to updated pain assessment guidelines that would be released in the near future (these revised, more detailed instructions took effect in mid-2019).

Second, the paper was a selectively remembered look in the rearview mirror – a review of modern pain assessment and the JC’s role in it. The document reads like something whose authors have a guilty conscience but for fear of legal retribution, aren’t quite ready to admit official wrongdoing, intended or otherwise. And considering its release at the height of the opioid scourge, the report also reads like a pseudo acknowledgement that revamped guidelines are too little, too late. It is damage control in a situation where the damage has already been done – and done to death.

It begins with classic scapegoating. Per the report, in 1990, Dr. Mitchell Max, president of the American Pain Society, “emphasized the conventional wisdom of the day that ‘therapeutic use of opiate analgesics rarely results in addiction,’ although this was based on only a single publication that lacked detail about how the study was done.”

This publication was, in fact, a five-sentence letter published in the New England Journal of Medicine in 1980. Per a 2017 letter to the same publication, the 1980 submission “was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.” Taken completely out of context, the 1980 letter was used to convince doctors that opioids were not addictive, medically greenlighting the generous prescribing of millions of doses of Oxycontin. Despite barely being a paragraph long, the letter served as a key tool in fueling the opioid crisis.

Despite this, the JC report then discusses how, in 1991, the American Pain Society released quality standards for acute and cancer pain based on Dr. Max’s recommendations. In perhaps the JC’s paper’s starkest understatement, this “later proved to be highly problematic.”

The narrative then abruptly shifts to the early stages of The Joint Commission’s role in pain assessment during the 1990s, without tying these scenarios together. Are we to believe that The Joint Commission wasn’t at all influenced – among other factors like Big Pharma funding – by the exceptionally thinly researched and therefore shoddy pain recommendations from the American Pain Society? Notably, the APS, according to MEDPAGE TODAY, ‘Went Belly Up’ when opioid lawsuits prompted membership to approve bankruptcy filing in 2019.

The Joint Commission goes on to describe its role as more compiler than counselor. The JC, it reads, assembled “a manual that brought all of the standards together into one place. They also provided ‘Examples of Implementation’ to describe how other organizations had successfully demonstrated compliance with a standard, stressing that these were ‘NOT standards, nor are they required ways to meet a standard.’”

Did the nation’s most respected accreditor of healthcare facilities publish a pain assessment guide complete with examples that, somehow, wasn’t intended to be perceived as instructions for the institutions it accredits?

Why would an authority that literally rubberstamps healthcare treatment give directionless direction about healthcare treatment?

A longtime JC employee, who provided insight on the condition of anonymity, has a similar reaction:

“In encouraging healthcare providers to assess pain, it would have been more useful to accompany that recommendation with concrete ways of executing it,” the former employee said. “There’s nothing more frustrating than being told to do something without being given the tools to do it.”

The former employee continued: “They could have done something more about providing people with the next step. Instead, pharma filled that void and acted in their own interests.”

And fill the void they did – with drugs. Per the 2017 Drug Watch article, during 2001 and 2002, the Government Accountability Office (GAO) found Purdue funded a series of programs to teach hospital physicians and staff how to comply with The Joint Commission’s pain standards – the same standards they helped create through clandestine, once-removed funding. Instead of recommending other methods to lesson pain – such as lifestyle changes, weight loss, yoga or other non-medicinal therapies – drugs were the answer.

The rabbit hole goes ever deeper. Per a 2003 GAO report, through an agreement with The Joint Commission, Purdue was the only drug company allowed to distribute certain educational videos, as well as a book about pain management.

These materials were available for purchase – where else? – on The Joint Commission’s website. 

All obvious corporate influence aside, how could a symptom as broad and vague as pain be considered a vital sign? Even a layman realizes that properly assessing pain requires a lengthy list of executable directives that meet its wide-ranging origins, situations and severity. The causes of pain are so enormously varied that guidelines for treating it need to be both extensive and comprehensive. Instead, The Joint Commission offered scant examples… then insisted that even these bare-bones examples weren’t official direction. It then allowed – and endorsed – Big Pharma taking the lead.

The Joint Commission’s omission seems too incompetent to be credible. And it took exactly one year for the JC’s lackadaisical-at-best guidelines-that-weren’t-really-guidelines to raise eyebrows.

Per the report, in 2002 “concerns were raised that requiring all patients to be screened for the presence of pain… could lead to overreliance on opioids. Such concerns were criticized by pain experts as “opioidphobic.”

The report’s next section is an incredible feat of lawyered lingo. The JC proceeds to claim that the increasing incidence of healthcare facilities seeing pain assessment as a fifth vital sign was a complete misunderstanding. “Use of the ‘fifth vital sign’ phrase also proved to be problematic; rather than seeing the phrase as an analogy to draw attention to the need for improved assessment… some organizations interpreted this to mean that pain needed to be assessed every time vital signs were taken.”

With the absurd results that healthcare facilities are recommended to assess pain… but don’t need to assess pain, and examples of how to do so should not be taken as instructions for how to do so – even when they come from the country’s most prominent standards-setting organization.

But alas, the report continues, in short order the pain train had left the station, destination morgue. By 2003, “pain had become the enemy that needed to be eradicated… One study reported that the incidence of opioid oversedation increased from 11.0 to 24.5 per 100,000” – more than double!

How much smoke must there be to yell “fire!”? Well, it’s about to get even smokier, because The Joint Commission’s initial 2001 recommendations were…

… co-authored by none other than the National Pharmaceutical Council.

Is it enough to convict in a court of law? Maybe. But it’s certainly enough to say this:

By far the most prominent healthcare facility accreditor in the United States, whose guidelines are routinely followed to ensure continued accreditation, released recommendations to begin assessing patient pain. They did so through a document that provided, per its own claims, no official instructions on how to execute this exceedingly complex process – and allowed this document to be financially influenced by a leading opioid manufacturer, and co-authored by an organization whose Board of Directors comprises representatives from major pharmaceuticals companies. It then sold the pain assessment guidelines developed by an opioid manufacturer on its own website.

Forget West Virginia. Where the hell is the Justice Department in all this? At what point does incompetence become inconceivable? How misguided must a set of actions seem before sheer stupidity becomes less likely than malfeasance?

Where There’s Smoke…

Ryan Hampton, author of American Fix: Inside the Opioid Crisis, and How to End It, sees The Joint Commission’s role as a list of unanswered yet snowballing questions, one whose answers could involve major, yet-unknown JC donors during the 2001 report’s creation. The whole episode, he surmises, is almost too ridiculous to be explained away by bad timing, bad luck or well-intending failures.

“I don’t think the answer about financial influence on the Joint Commission has really been answered satisfactorily. Why didn’t they give direction about how pain assessments should be implemented? Why didn’t the Joint Commission do this independently? And why do it with the National Pharmaceutical Council, which comes with major conflicts of interest?”

Hampton continues: “It seems like a leap to say that they simply did this out of the blue – and out of the goodness of their hearts.”

Hampton concludes what any rational person would: Believing that The Joint Commission was the only morally clean player at the intersection of an American tragedy is a bridge too far.

Soon, through the Internal Revenue Service, the Addiction/Recovery eBulletin hopes to learn more about what may have influenced The Joint Commission to embark on its lawsuit-prompting misadventure. The dead deserve answers, and the living must demand them!

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