THE PAIN MOVEMENT
The 1980s marked the start of the “pain movement”, which centers on the idea that patients have a right to not be in pain.
An April 2017 paper published in Drug and Alcohol Dependence charts the historical course of this movement. It shows that in the mid-to-late 1980s, palliative care specialists began to advocate for the use of opioids in cancer patients.
At the same time, the World Health Organization created cancer-pain treatment guidelines, which, for the first time, recommended the use of opioids.
The 1986 guidelines reassure patients that they don’t need to worry about dependence stating: “Psychological dependence is not an issue when strong opioids are taken to relieve cancer pain.”
Next, came the American Pain Society’s “Pain the Fifth Vital Sign” campaign in 1996. The society aimed to elevate the importance of pain assessment and measurement to the status of the other four vital signs — pulse, temperature, respiration rate, and blood pressure.
“If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly,” said APS President James Campbell in his presidential address to the Society on November 11, 1996.
He also stated: “We need to train doctors and nurses to treat pain as a vital sign.”
The campaign’s first major success came three years later in 1999 when the Veteran’s Health Administration officially adopted pain as the fifth vital sign.
According to a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States (from manufacturers and distributors to pharmacies in every town and city), the surge of legal pain pills that fueled the prescription opioid epidemic has resulted in nearly 100,000 deaths from 2006 through 2012 alone.
Just six companies (McKesson, Walgreens, Cardinal Health, AmerisourceBergen, CVS, and Walmart) distributed 75 percent of the pills during this period according to an analysis of the database by The Washington Post.
Three companies manufactured 88 percent of the opioids: SpecGx (a subsidiary of Mallinckrodt), Actavis Pharma and Par Pharmaceutical (a subsidiary of Endo Pharmaceuticals). Further, the volume of the pills handled by the companies skyrocketed as the epidemic surged, increasing about 51 percent from 8.4 billion in 2006 to 12.6 billion in 2012.
By contrast, doses of morphine, a well-known treatment for severe pain, averaged slightly more than 500 million a year during the period. Purdue Pharma, which some allege sparked the epidemic in the 1990s with its introduction of OxyContin, its version of oxycodone, was ranked fourth among manufacturers with about 3 percent of the market.
Overall, the opioid epidemic has had three phases: the first was dominated by prescription opioids, the second by heroin, and the third by cheaper but more potent synthetic opioids such as fentanyl (more on that in Part 2 of this series).
THE BLAME GAME BEGINS
Those 10 companies, along with about a dozen others, are now being sued in federal court in Cleveland by nearly 2,000 cities, towns and counties alleging that they conspired to flood the nation with opioids.
The companies, in turn, have blamed the epidemic on overprescribing by doctors and pharmacies and on customers who abused the drugs. The companies say they were working to supply the needs of patients with legitimate prescriptions desperate for pain relief.
As more and more towns and cities became inundated by pain pills, they filed federal lawsuits against the drug industry, alleging that opioids from the companies were devastating their communities. They alleged the companies not only failed to report suspicious orders, but they also filled those orders to maximize profits.
The claim that OxyContin was less addictive than other opioid painkillers was untrue — Purdue Pharma knew that it was addictive, as it admitted in a 2007 lawsuit that resulted in a $635 million US fine for the company. But doctors and patients were unaware of that at the time the claim was made, so they kept prescribing the drug to their patients.
As the hundreds of lawsuits began to pile up, they were consolidated into one centralized case in the U.S. District Court in Cleveland.
The opioid litigation is now larger in scope than the tobacco litigation of the 1980s, which resulted in a $246 billion settlement over 25 years.
In May, Purdue settled with the Oklahoma attorney general for $270 million. The Justice Department announced a $35 million agreement with Mallinckrodt in 2017 to settle allegations that the company didn’t alert the DEA about excessive or suspicious orders of prescription opioids between 2008 and 2012.
In 2008, the DEA brought a case against McKesson and Cardinal Health, accusing the nation’s largest and second-largest drug distributors of shipping millions of doses of painkillers to online and retail pharmacies without notifying the DEA of signs that the drugs were being diverted to the black market.
McKesson wound up paying a $150 million fine, a record amount for a diversion case. Cardinal settled the case by paying a $34 million fine and both companies promised to improve its suspicious monitoring programs. CVS also paid a $22 million fine.
The obvious question to all these previous and pending lawsuits: will they help?
A positive note is that these lawsuits provide a lot of publicity about the problems of opioid overuse and abuse.
Warning the public is a good thing and the opioid epidemic has racked up considerable cost, so recouping some of the costs is seen by the general public to be very reasonable.
But, as with most things, the Opioid Epidemic is a complicated issue and there are many factors to consider moving forward.