Sunday, May 27, 2018

Is there any relationship between the opioid addiction epidemic among working/middle class Americans, and the uneven gains from the economic recovery following the 2008-09 financial crisis?


'Is there any relationship between the opioid addiction epidemic among working/middle class Americans, and the uneven gains from the economic recovery following the 2008-09 financial crisis?'.

If the 2008-2009 financial crisis and its continuing fallout triggered and/or exacerbated the ongoing US opioid addiction crisis, a striking increase in opioid overdose deaths post-2008 would be expected. However, epidemiological data does not support such a premise. This answers summarizes
  • Data showing steady year-on-year increase in opioid overdose deaths from 1999 till date, overdose death rates varying widely from state to state, disproportionately affecting whites, and increasing in tandem as opioid prescribing rates rose from 1999-2010, deaths that the CDC already noted with alarm in 2006-07.
  • How starting in the 1990s aggressive opioid marketing and lobbying gestated the roots of the ongoing opioid epidemic by changing how the US medical system treats pain.
Steady Year-on-Year Increase In Opioid Overdose Deaths From 1999 Till Date
  • Opioids prescribed in the US peaked in 2010, decreasing steadily since then (see below from 1) though they're still much higher than in the rest of the world.
'CDC analyzed retail prescription data from QuintilesIMS to assess opioid prescribing in the United States from 2006 to 2015, including rates, amounts, dosages, and durations prescribed. CDC examined county-level prescribing patterns in 2010 and 2015. ..The amount of opioids prescribed in the United States peaked at 782 morphine milligram equivalents (MME) per capita in 2010 and then decreased to 640 MME per capita in 2015.’
  • Drug overdose deaths have steadily increased since 1999, doubling already by 2006 in 45 to 54 year olds (see second figure below from 2).
  • Drug overdose deaths vary widely from state to state, with states with rather different economic profiles such as West Virginia, New Hampshire, Ohio, Rhode Island, Pennsylvania, Massachusetts, Connecticut, Maine and Maryland experiencing substantial increases from 2010 to 2015 (see below from 3).
  • Overdose deaths disproportionately affect whites (see below from 2) though overall, black males continue to have the lowest life expectancy (see below from 4).
  • Opioid prescribing rates steadily increased 1999-2010 with overdose deaths rising in tandem (see below from 5).
  • Already in 2006-7, CDC reported alarming increases in opioid-induced overdose deaths (see below from 6).

Aggressive Opioid Marketing in the 1990s Changed How The US Medical System Treats Pain
A little known drugmaker best known in the 1980s for the painkiller MS Contin, Purdue Pharma morphed into a multi-billion dollar behemoth on the back of OxyContin, its 1990s upgrade, whose unprecedented marketing vaulted the Sackler family, owners of Purdue Pharma, into the ranks of the wealthiest Americans today.

Well worth the reading, Mike Mariani at the Pacific Standard (7) and Patrick Radden Keefe at the New Yorker (8) methodically and comprehensively unravel the process Purdue Pharma used to relentlessly lobby all manner of doctors from general practitioners to pain physicians alike to expand opioid prescription to those with all manner of chronic pain. US doctors in the incalculably innocent pre-OxyContin era tended to view opioids as 'dangerously addictive', limiting their use to those terminally ill, usually terminal cancer patients.

Mariani and Keefe recount how sheer money muscle was used to overturn this restriction in use of prescription opioids to instead render them acceptable to treat an expanding list of pain-related conditions.

In practical terms, this meant serious boots on the ground in the form of intense lobbying by the likes of the now-defunct American Pain Foundation (9), and thousands of highly paid and hence extremely motivated sales reps to relentlessly push all manner of doctors to start applying the fifth Vital signs - Wikipedia during their routine examination of patients to elicit information about their pain levels and then palliatively treat them with powerful prescription opioids (10, 11), all while repeatedly assuring them opioids weren't addictive (see below from 12, emphasis mine).
'Abbott’s relationship with Purdue and its part in building the OxyContin brand are detailed in previously secret court filings unsealed by a Welch, http://W.Va., state court judge at the request of STAT. The records were part of a case brought by the state of West Virginia against Purdue and Abbott that alleged they inappropriately marketed the drug, causing users to become addicted to the opioid. The case was settled in 2004 when Purdue agreed to pay $10 million to the state. Neither company admitted any wrongdoing.
The documents include internal Abbott and Purdue memos, as well as sales documents and marketing materials. They show that Abbott sales reps were instructed to downplay the threat of addiction with OxyContin and make other claims to doctors that had no scientific basis. The sales reps from the two companies closely coordinated their efforts, met regularly to strategize, and shared marketing materials.'
Opioid prescribing inducements included direct payments to doctors as well. One 2017 study estimated as many as 1 in 12 US physicians and ~1 in 5 family doctors accepted payments related to opioids during the course of the 29-month study (August 2013-December 2015) (13).
Such change in prescribing was based not on carefully conducted scientific studies but one mediated by relentless lobbying and marketing, and came into place within the span of a decade from the mid-1990s to the mid-2000s so much so that in 2012, 13 states had more opioid prescriptions than even people (see below from 14, 15). Clearly, change in prescribing (demand) went hand in glove with carpeting of the entire country with a surfeit of opioids (supply).


Investigative reporting suggests regulator-opioid maker revolving door also helped grease the wheels.
  • A Los Angeles Times report by Harriet Ryan, Lisa Girion, Scott Glover (16) uncovers how Dr. Curtis Wright, the FDA bureaucrat who led its medical review of Purdue Pharma's OxyContin application in 1995 left the FDA shortly after it approved it and within 2 years began working for Purdue.
  • A piece in the Milwaukee Journal Sentinel by John Fauber suggests (see below from 17, emphasis mine) beefing up pain advisory councils with opioid maker-friendly voices also helped smooth the way in expanding usage of opioids in pain treatment,
'Federal health industry regulators and executives of companies that make pain drugs have held private meetings at expensive hotels at least once a year since 2002 through an organization funded by the drug companies, according to emails obtained through public records requests and provided to the Journal Sentinel/MedPage Today.
Each year a handful of drug companies have paid up to $35,000 each to send a representative to meetings of IMMPACT, where they could discuss clinical trial testing procedures with officials from the U.S. Food and Drug Administration and other government agencies. IMMPACT's stated goal is to improve the design of clinical trials conducted to develop new pain treatments.’
  • Such meetings appear to have favored opioid makers even as recently as 2013 (see below from 18, emphasis mine).
'The Food and Drug Administration is under enormous pressure to change its mind about a powerful new prescription painkiller. Forty-two public health groups are urging the FDA to withdraw its support of Zohydro. The drug is similar to Oxycontin, except it comes in significantly higher doses. The FDA approved Zohydro last year, despite its own advisory panel voting against it. And critics are, among other things, raising questions about that approval process.’
  • As late in the US opioid crisis as January 2016, a federal government pain advisory panel of 18 had at least 5 with financial ties to opioid makers, connections that came to light (see below from 19),
'...after the committee last month bashed a federal plan to recommend doctors scale back on prescribing painkillers for chronic pain. The guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to powerful but highly-addictive opioid drugs, including Percocet and Vicodin.'
The Center for Public Integrity - Wikipedia also uncovered evidence of opioid maker lobbying of Congress and state legislatures (20), efforts estimated by Mother Jones to be 8X that of the gun lobby and 200X that of those advocating stricter opioid prescription rules (21).

Raw numbers reflect the spectacular success of such unprecedented marketing and lobbying. In 1996, annual OxyContin sales were $48 million. For OxyContin's inaugural marketing alone, Purdue doubled its sales force to 600 and spent $207 million, so much so that already by 2000, OxyContin sales grew 23-fold to ~$1.1 billion (22).

Already by 2001, OxyContin had become the most frequently prescribed brand name opioid for treating moderate to severe pain in the US, with so much overprescribing that the US GAO issued a 58-page report warning about it all the way back in December 2003 (23).

In recent years, other opioid makers such as Insys Therapeutics Inc. (24) and Mallinckrodt Pharmaceuticals (25) have also come under the public spotlight for their aggressive sales practices, tactics that also applied to antidote makers such as Reckitt Benckiser (26).

Like a burst dam, such intense marketing and lobbying ended up transforming how US doctors treat pain, replacing wholesale old true and tried methods that erred on the side of caution to an approach where it suddenly became acceptable to treat any and all pain with extremely powerful opioids (1, 5, 27, 28), a change that a 2016 study (29) suggests had US family doctors and general practitioners at the forefront.

Could one seriously argue that from the years 1996 onwards, physical pain and/or existential angst increased so much among the US population as to justify such an increase in opioid sales and consumption? Obviously not. Instead, the US opioid epidemic is inextricably linked to an unprecedented medical culture change in how US doctors were carefully and relentlessly persuaded by opioid makers, their lobbyists and sales reps to treat all manner of pain, not just terminal, late stage cancer pain, with highly powerful opioids.

Problem is so far opioid makers haven't been held accountable for their willful recklessness (slaps on the wrist in the form of relatively piddling monetary fines obviously don't count) even as they've saturated the US market. Rather, a report in the Los Angeles Times by by Harriet Ryan, Lisa Girion, Scott Glover suggests that as their profits in the US market start to dry up, their ongoing intense lobbying around the world may end up replicating the US opioid crisis in other countries as well (30). For governments, policy makers and regulators the world over, how to avoid 'globalization of the prescription opioid epidemic' (31) thus becomes a matter of urgency.

Bibliography
1. Guy, Gery P. "Vital signs: changes in opioid prescribing in the United States, 2006–2015." MMWR. Morbidity and mortality weekly report 66 (2017). https://www.cdc.gov/mmwr/volumes...
2. Hedegaard, Holly, Margaret Warner, and Arialdi M. MiniƱo. "Drug overdose deaths in the United States, 1999-2015." NCHS data brief 273 (2017): 1-8. Welcome to CDC stacks
3. Rudd, Rose A. "Increases in drug and opioid-involved overdose deaths—United States, 2010–2015." MMWR. Morbidity and mortality weekly report 65 (2016). https://www.cdc.gov/mmwr/volumes...
5. Centers for Disease Control and Prevention (CDC. "Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008." MMWR. Morbidity and mortality weekly report 60.43 (2011): 1487. https://www.cdc.gov/mmwr/pdf/wk/...
7. Mike Mariani, February 23, 2015. Poison Pill
8. New Yorker, Patrick Radden Keefe, October 30, 2017. The Family That Built an Empire of Pain
9. Propublica, Charles Ornstein, Tracy Weber, December 23, 2011. The Champion of Painkillers — ProPublica
10. Tompkins, D. Andrew, J. Greg Hobelmann, and Peggy Compton. "Providing chronic pain management in the “Fifth Vital Sign” Era: Historical and treatment perspectives on a modern-day medical dilemma." Drug and Alcohol Dependence 173 (2017): S11-S21. http://www.sciencedirect.com/sci...
11. Harris, Matthew C., et al. "Prescription Opioids and Labor Market Pains." (2017). http://cber.haslam.utk.edu/staff...
12. Stat News, David Armstrong, September 22, 2016. Secret trove reveals Abbott's bold 'crusade' to sell OxyContin
13. Hadland, Scott E., Maxwell S. Krieger, and Brandon DL Marshall. "Industry Payments to Physicians for Opioid Products, 2013–2015." American journal of public health 107.9 (2017): 1493-1495. https://www.researchgate.net/pro...
16. The Los Angeles Times, Harriet Ryan, Lisa Girion, Scott Glover, May 5, 2016. http://www.latimes.com/projects/...
17. Milwaukee Journal Sentinel, John Fauber, October 6, 2013. Emails point to relationship between drug firms, regulators
19. Associated Press, Matthew Perrone, January 27, 2016. Federal pain panel rife with links to pharma companies
20. Public Integrity, Liz Essley Whyte, Geoff Mulvhill, Ben Wieder, September 18, 2016. Politics of pain: Drugmakers fought state opioid limits amid crisis
22. Van Zee, Art. "The promotion and marketing of oxycontin: commercial triumph, public health tragedy." American Journal of Public Health 99.2 (2009): 221-227. https://www.ncbi.nlm.nih.gov/pmc...
27. Boudreau, Denise, et al. "Trends in long‐term opioid therapy for chronic non‐cancer pain." Pharmacoepidemiology and drug safety 18.12 (2009): 1166-1175. 6 (2017). https://www.cdc.gov/mmwr/volumes...
28. Schuchat, Anne, Debra Houry, and Gery P. Guy. "New data on opioid use and prescribing in the United States." Jama 318.5 (2017): 425-426. https://www.issup.net/files/2017...
29. Chen, Jonathan H., et al. "Distribution of opioids by different types of medicare prescribers." JAMA internal medicine 176.2 (2016): 259-261. https://jamanetwork.com/journals...
30. Los Angeles Times, Harriet Ryan, Lisa Girion, Scott Glover, December 16, 2016. http://www.latimes.com/projects/...
31. Humphreys, Keith. "Avoiding globalisation of the prescription opioid epidemic." The Lancet 390.10093 (2017): 437-439.


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