Opioid crisis left trail of death: Who is accountable?
The origin, evolution and astonishing scale of America’s catastrophic opioid epidemic just got a lot clearer. The drug industry — the pill manufacturers, wholesalers and retailers — found it profitable to flood some of the most vulnerable communities in America with billions of painkillers. They continued to move their product, and the medical community and government agencies failed to take effective action, even when it became apparent that these pills were fueling addiction and overdoses and were getting diverted to the streets.
This has been broadly known for years, but this past week, the more precise details became public for the first time in a trove of data released after a legal challenge from the Washington Post and the owner of the Charleston Gazette-Mail in West Virginia.
The revelatory data comes from the Drug Enforcement Administration and its Automation of Reports and Consolidated Orders System. It tracks the movement of every prescription pill in the country, from factory to pharmacy.
“This really shows a relationship between the manufacturers and the distributors: They were all in it together,” said Jim Geldhof, a retired DEA employee who spent his 43-year career working on drug diversion cases and is now a consultant for plaintiffs in a massive lawsuit against the drug industry. “We’re seeing a lot of internal stuff that basically confirms what we already knew. It just reinforces the fact that it was all about greed and all about money.”
The industry has denied that vigorously, blaming doctors who prescribed opioids as if they were candy and individuals who abused the drugs. The industry also contends that the DEA had all the information it needed to stop diversion of pills into the black market.
The DEA declined to comment this past week, citing pending litigation.
It appears that failures mark every point along the supply chain — from manufacturers to distributors to pharmacies to the doctor all too ready to write a script. The epidemic was not something out of sight, behind closed doors, under a bridge. In full view, it intensified and the companies, health care professionals, law enforcement officials and government regulators were unable or unwilling to stop it.
“We have a tradition of trusting companies, and the [government] is kind of weak here,” said Keith Humphreys, a Stanford professor who served as a drug policy adviser to Presidents George W. Bush and Barack Obama. “Here it was misplaced trust.”
The data shows a trend in pill distribution that, according to the lawsuit plaintiffs, can’t be passed off as reasonable therapeutic medical treatment.
The industry shipped 76 billion oxycodone and hydrocodone pills across the country from 2006 through 2012, the period covered by the ARCOS data released this past week. These pills didn’t flow in a steady stream but were more like a flash flood, spiking from 8.4 billion in 2006 to 12.6 billion in 2012. As a point of comparison, doses of morphine, another mainstream treatment for severe pain, averaged slightly more than 500 million a year throughout the seven-year period, according to the data.
The industry was supposed to self-regulate. Companies have an obligation, under the Controlled Substances Act, to report suspicious orders of prescription drugs. The plaintiffs suing the drug companies allege that the incentive structures were tilted in favor of moving more product.
For example, in a filing released Friday, the plaintiffs alleged that Ireland-based drug manufacturer Mallinckrodt gave the sales people in charge of generic opioids “key roles” in investigating suspicious orders of drugs. The compensation scheme “was weighted heavily to favor sales over compliance,” the plaintiffs allege, adding that bonuses for the sale of opioids could exceed six figures.
“In contrast, there is nothing in the record indicating that [national account managers] were evaluated based on their compliance responsibilities” or “ever penalized for failing to stop suspicious orders,” the lawsuit claims.
After the release of the ARCOS data, Mallinckrodt said in a statement that the company produced opioids only within a government-controlled quota and sold only to DEA-approved distributors.
As of September 2012, Teva Pharmaceuticals, an Israeli-based manufacturer of generic drugs, didn’t have a suspicious-order monitoring system in place, according to the court filing. The company apparently decided it needed a system, and hired an AmerisourceBergen employee in 2014 to design it. He created a system called “DefOps,” short for “Defensible Operations,” which he admitted in a deposition was designed “to keep Teva out of trouble with the DEA and because it ‘sounded good’,” according to the court papers.
From 2013-16, the papers allege, Teva reported only six suspicious orders out of 600,000.
Teva declined to comment Saturday.