America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012 as the nation’s deadliest drug epidemic spun out of control, according to previously undisclosed company data released as part of the largest civil action in U.S. history.
The information comes from 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 data provides an unprecedented look at the surge of legal pain pills that fueled the prescription opioid epidemic, which has resulted in nearly 100,000 deaths from 2006 through 2012.
Just six companies distributed 75 percent of the pills during this period: McKesson, Walgreens, Cardinal Health, AmerisourceBergen, CVS and Walmart, 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.
Purdue Pharma, which the plaintiffs 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.
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.
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.
The database reveals what each company knew about the number of pills it was shipping and dispensing and precisely when they were aware of those volumes, year by year, town by town. In case after case, the companies allowed the drugs to reach the streets of communities large and small, despite persistent red flags that those pills were being sold in apparent violation of federal law and diverted to the black market, according to the lawsuits.
Plaintiffs have long accused drug manufacturers and wholesalers of fueling the opioid epidemic by producing and distributing billions of pain pills while making billions of dollars. The companies have paid more than $1 billion in fines to the Justice Department and Food and Drug Administration over opioid-related issues, and hundreds of millions more to settle state lawsuits.
But the previous cases addressed only a portion of the problem, never allowing the public to see the size and scope of the behavior underlying the epidemic. Monetary settlements by the companies were accompanied by agreements that kept such information hidden.
The drug companies, along with the DEA and the Justice Department, have fought furiously against the public release of the database, the Automation of Reports and Consolidated Order System, known as ARCOS. The companies argued that the release of the “transactional data” could give competitors an unfair advantage in the marketplace. The Justice Department argued that the release of the information could compromise ongoing DEA investigations.
Until now, the litigation has proceeded in unusual secrecy. Many filings and exhibits in the case have been sealed under a judicial protective order. The secrecy finally lifted after The Washington Post and HD Media, which publishes the Charleston Gazette-Mail in West Virginia, waged a year-long legal battle for access to documents and data from the case.
On Monday evening, U.S. District Judge Dan Polster removed the protective order for part of the ARCOS database.
Lawyers for the local governments suing the companies hailed the release of the data.
“The data provides statistical insights that help pinpoint the origins and spread of the opioid epidemic – an epidemic that thousands of communities across the country argue was both sparked and inflamed by opioid manufacturers, distributors, and pharmacies,” said Paul Farrell of West Virginia, co-lead counsel for the plaintiffs.
In statements emailed to The Post on Tuesday, the drug distributors stressed that the ARCOS data would not exist unless they had accurately reported shipments and questioned why the government had not done more to address the crisis.
“For decades, DEA has had exclusive access to this data, which can identify the total volumes of controlled substances being ordered, pharmacy-by-pharmacy, across the country,” McKesson spokeswoman Kristin Chasen said.
A DEA spokeswoman declined to comment Tuesday “due to ongoing litigation.”
Cardinal Health said that it has learned from its experience, increasing training and doing a better job to “spot, stop and report suspicious orders,” company spokeswoman Brandi Martin wrote.
AmerisourceBergen derided the release of the ARCOS data, saying it “offers a very misleading picture” of the problem. The company said its internal “controls played an important role in enabling us to, as best we could, walk the tight rope of creating appropriate access to FDA approved medications while combating prescription drug diversion.”
While Walgreens still dispenses opioids, the company said it has not distributed prescription-controlled substances to its stores since 2014. “Walgreens has been an industry leader in combating this crisis in the communities where our pharmacists live and work,” said Phil Caruso, a Walgreens spokesman.
Mike DeAngelis, a spokesman for CVS, said the plaintiffs’ allegations about the company have no merit and CVS is aggressively defending against them.
Walmart, Purdue and Endo declined to comment about the ARCOS database.
A Mallinckrodt spokesman said in a statement that the company produced opioids only within a government-controlled quota and sold only to DEA-approved distributors.
Actavis Pharma was acquired by Teva Pharmaceutical Industries in 2016, and a spokeswoman there said the company “cannot speak to any systems in place beforehand.”