Trustworthy? Pt. 1: Choreographing an Epidemic

"Absolute power corrupts absolutely." — English historian Lord Acton (1834-1902)

Ever wonder exactly how big the pharmaceutical industry is? Consider this data from 2020: U.S. pharmaceutical sales reached $514 billion – more than the GDPs of 39 U.S. states;^1-2 global sales reached $1.07 trillion, ranking Big Pharma as the 16th largest economy in the world;³ 6.3 billion prescriptions were dispensed in the U.S. (19 prescriptions for every person);⁴ and OTC U.S. drug sales were 5.99 billion units (18 bottles of pills per person).⁵

What could an industry do with that much power? Start an epidemic? Buy a prestigious international health organization?

How the Opioid Epidemic Started: Its Insidious Beginnings

While everyone is aware of the opioid epidemic, few know how it started. Most trace the beginning of the opioid epidemic to the American Pain Society, which in 1995 released its Quality Improvement Guidelines for the Treatment of Acute Pain and Cancer Pain, laying the foundation for establishing pain as the fifth vital sign.⁶

In 1996, the APS formally instituted pain as the fifth vital sign and the campaign was off and running. Not coincidently, Purdue Pharma began marketing its new painkiller, OxyContin, that same year. Before 1996, the number of opioid prescriptions dispensed in the U.S. was fewer than 90 million. It had climbed to 219 million just 15 years later.

The Department of Veterans Affairs jumped on the bandwagon early, releasing its Pain as the 5th Vital Sign Toolkit with a new logo in October 2000.⁷

In 2001, the Joint Commission on Accreditation of Healthcare Organizations, a nonprofit organization that accredits hospitals and sets standards, released Pain Standards for 2001, which were "scored during on-site surveys of an organization's performance." Implementation included an example that asked all patients about their pain at the time of admission.⁸ Doctors and hospitals felt required to examine every patient's pain level. Hospitals and providers were evaluated on their patients' pain satisfaction scores, with reimbursement tied to those results.⁹

In December of that year, the Joint Commission and the National Pharmaceutical Council (whose members are 21 of the top pharmaceutical companies in the U.S.) combined to issue a 101-page monograph, Pain: Current Understanding of Assessment, Management, and Treatments, which echoed opioid industry marketing verbiage, including: "In general, patients in pain do not become addicted to opioids."¹⁰

Not long after, the American Medical Association, the American College of Surgeons, the American Academy of Family Physicians and many other medical societies followed suit. In 2006, the Centers for Medicare and Medicaid Services (CMS) began using a patient satisfaction survey that included questions about pain management. While the CMS tried to downplay the significance of these survey scores, they did affect both compensation and promotion.¹¹

Damning Congressional Reports

In the wake of almost 500,000 U.S. opioid-related deaths since 1996, two congressional investigations sought to shed light on the origins of the opioid crisis. The first, Fueling an Epidemic – Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups, was published on Jan. 31, 2018 by Senator Claire McCaskill, then-ranking member of the U.S. Senate Homeland Security & Governmental Affairs Committee.¹²

The report describes how five pharmaceutical companies (Purdue Pharma L.P., Janssen Pharmaceuticals, Inc., Mylan N.V., Depomed, Inc., and Insys Therapeutics, Inc.) paid almost $9 million "to 14 outside groups working on chronic pain and other opioid-related issues between 2012 and 2017," including the American Pain Society. Additionally, physicians affiliated with these advocacy groups "accepted more than $1.6 million in payments from the five manufacturers between 2013 and the present." The investigators concluded:

The fact that these same manufacturers provided millions of dollars to the groups described ... suggests, at the very least, a direct link between corporate donations and the advancement of opioids-friendly messaging. By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic.

Almost all of the 14 medical societies and advocacy groups were nonprofit organizations highly dependent on contributions, with some having no membership dues income. When the dust settled, three declared bankruptcy due to lawsuits and scandals related to the opioid epidemic (the American Pain Foundation bankrupted in 2012,¹³ the American Pain Society in 2019¹⁴ and the Academy of Integrative Pain Management in 2019¹⁵).

Clearly, these "donations" were not one-time events, but a vital part of symbiotic relationships. Reading between the lines, the authors suggests uncertainty regarding their ability to uncover all payments between the drug companies and the various organizations. With several of these organizations filing bankruptcy, one has to wonder if they were scuttled after having served their purpose.

The second report, Corrupting Influence – Purdue & the WHO, was published on May 22, 2019 by the offices of U.S. Representatives Katherine Clark and Hal Rogers. The purpose of this report was to expose "dangerous opioid manufacturer influence at the World Health Organization."¹⁶

The authors note that the WHO published two documents aligned with Purdue's marketing messages. The first, in 2011, Ensuring Balance in National Policies on Controlled Substances: Guidance for Availability and Accessibility of Controlled Medicines, "corroborated the oft-repeated Purdue claim that (opioid) dependence occurs in less than one percent of patients, despite no scientific evidence supporting this claim and a multitude of studies contradicting it." It included the statement:"Opioid analgesics, if prescribed in accordance with established dosage regimens, are known to be safe and there is no need to fear accidental death or dependence."

This was followed in 2012 by Pharmacological Treatment of Persisting Pain in Children with Mental Illness, which uses a term coined by the opioid industry: opiophobia, defined as an "unreasonable fear" of prescribing opioids. According to the report, the WHO claimed "there is no maximum dosage of strong opioids, like OxyContin, for children."Congressional investigators determined:

[E]vidence shows that the content in Ensuring Balance and Persisting Pain in Children was influenced by many organizations and individuals known to have financial ties to Purdue and to other players in the opioid industry. ... The web of influence we uncovered, combined with the WHO's recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry. Moreover, we are disturbed that the WHO, a trusted international agency, appears to be lending the opioid industry its voice and credibility.

After overwhelming criticism, the WHO announced it was "discontinuing [both] these guidelines in light of new scientific evidence that has emerged since the time of their publication."

Despite these reports and the known dangers, opioids still enjoy sales of $18 billion annually – at a cost of almost 70,000 opioid-related deaths in 2020 in the U.S. alone.¹⁷

The opioid epidemic is just one example of how the powerful drug industry is able to manipulate various trusted organizations and their leaders in an effort to increase sales by billions of dollars. These types of opportunistic sales campaigns are well-choreographed and generate dramatic increases in revenue that last for decades.

References

1. Global pharmaceutical sales from 2017 to 2020, by region. Statista, February 2021. Click here
2. List of US States by GDP, 2010-2020. Knoema. Click here
3. Gross domestic product 2020. World Development Indicators database, World Bank, July 1, 2021. Click here
4. The Use of Medicines in the U.S. The IQVIA Institute, May 27, 2021. Click here
5. Total OTC sales volume in the United States from 2017 to 2020. Statista, April 7, 2021. Click here
6. Max MB, Donovan M, Miaskowski CA, et al. Quality improvement guidelines for the treatment of acute pain and cancer pain. JAMA, 1995;274(23):1874-1880.
7. Pain as the 5th Vital Sign Toolkit. Department of Veterans Affairs, October 2000. Click here
8. Joint Commission on Accreditation of Health Organizations Pain Standards for 2001. JCAHO, Dec. 18, 2001. Click here
9. "Joint Commission Sets New Pain Agenda." Relias Media, April 1, 2000. Click here
10. Pain: Current Understanding of Assessment, Management, and Treatments. National Pharmaceutical Council, Inc., Joint Commission on Accreditation of Healthcare Organizations, December 2001. Click here
11. Adams J, Bledsoe GH, Armstrong JH. Are pain management questions in patient satisfaction surveys driving the opioid epidemic?. Am J Public Health, 2016;106(6):985-986.
12. Fueling an Epidemic - Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups. U.S. Senate Homeland Security & Governmental Affairs Committee, Ranking Member's Office. Jan. 31, 2018. Click here
13. Ornstein C, Weber T. "American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics." ProPublica, May 8, 2012. Click here
14. "US Medical Group That Pushed Doctors to Prescribe Painkillers Forced to Close." The Guardian, May 25, 2019. Click here
15. Shagoury K. "Academy of Integrative Pain Management Ceases Operations." Integrative Practitioner, Feb. 7, 2019. Click here
16. Corrupting Influence – Purdue & the WHO. Offices of U.S. Representatives Katherine Clark and Hal Rogers, May 22, 2019. Click here
17. Baumgartner JC, Radley DC. "The Drug Overdose Toll in 2020 and Near-Term Actions for Addressing It." The Commonwealth Fund, Aug. 16, 2021. Click here

Read more findings on my blog: http://blog.toyourhealth.com/ wrblog. You can also visit me on Facebook and Twitter (donpetersenjr, @donaldpetersen).