The Columbus Dispatch

76 billion opioid pills flooded US in 7 years

- By Scott Higham, Sari Horwitz and Steven Rich The Washington Post

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 data from companies that was released as part of the largest civil action in U.S. history.

The informatio­n comes from a database maintained by the U.S. Drug Enforcemen­t Administra­tion that tracks the path of every 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 resulted in nearly 100,000 deaths in that 2006-to-2012 period.

Just six companies distribute­d 75 percent of the pills during that period: Mckesson Corp., 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 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 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.

Dublin-based Cardinal Health said 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. But the database shows that after Cardinal settled a 2008 DEA case by paying a $34 million fine, the company attracted renewed DEA attention in 2012 because it was again shipping unusually large amounts of painkiller­s to Florida customers. The company had sold 12 million oxycodone pills to four pharmacies over four years.

The companies have paid more than $1 billion in fines to the Justice Department and Food and Drug Administra­tion over opioidrela­ted 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. 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 yearlong 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 database.

In statements emailed to The Post on Tuesday, the drug distributo­rs stressed that the data would not exist unless they had accurately reported shipments, and they questioned why the government had not done more to address the crisis.

A DEA spokeswoma­n declined to comment Tuesday “due to ongoing litigation.”

Amerisourc­ebergen derided the release of the 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 tightrope of creating appropriat­e access to Fdaapprove­d medication­s while combating prescripti­ondrug diversion.”

Mike Deangelis, a spokesman for CVS, said the plaintiffs’ allegation­s about the company have no merit.

Dublin-based 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.

The database shows that after Cardinal Health settled a 2008 DEA case by paying a $34 million fine, the company attracted renewed DEA attention in 2012 because it was again shipping unusually large amounts of painkiller­s to Florida customers. The company had sold 12 million oxycodone pills to four pharmacies over four years.

For example, in 2011, Cardinal shipped 2 million doses to a pharmacy in Fort Myers, Florida. Comparable pharmacies in Florida typically ordered 65,000 doses per year.

The DEA also noticed that Cardinal was shipping unusually large amounts of oxycodone to a pair of CVS stores near Sanford, Florida. Between 2008 and 2011, Cardinal sold 2.2 million pills to one of the stores. In 2010, that store bought 885,900 doses — a 748 percent increase over the previous year. Cardinal did not report any of those sales as suspicious.

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