A confidential government database of drug sales has become crucial to the nationwide opioid lawsuit in federal court in Cleveland.
The Automation of Reports and Consolidated Orders System, known as ARCOS, recorded painkiller sales between manufacturers, distributors and pharmacies at a time when overdose deaths surged nationwide.
U.S. District Judge Dan Polster this year ordered the Drug Enforcement Administration to turn ARCOS records over to local governments and the pharmaceutical companies they’ve taken to court.
In a May order, Polster called the data “extremely informative” for those involved in the lawsuits.
“For example, it has allowed plaintiffs in these States to identify previously-unknown entities involved in the manufacturing and distribution of opioids,” he wrote. “Plaintiffs are now in the process of amending their complaints to add these entities as defendants.”
But the public is barred from seeing these detailed records of pill sales. For example, ARCOS numbers are redacted in Cuyahoga County’s complaint against drug companies.
Following The Flow Of Drugs
The law requires about 1,200 drug companies to report to ARCOS, according to a recent government court filing. The system tracks sales of controlled substances, marking down the identities of the sellers, addresses, transaction date and amount sold.
“DEA will be able to see the flow of all opioids, starting at the manufacturer, going down to what we’d consider the point-of-sale areas,” former DEA attorney Larry Cote said, “which would be the pharmacies, the hospitals, the physicians’ offices, things like that.”
Cote, who now represents clients in the pharmaceutical industry, said the government has upgraded ARCOS over the last decade.
“It was manually submitted, or on three-and-a-half [inch] floppy disks, or even on paper. So there were lots of opportunities for data entry errors, both by the registrant and by DEA,” he said. “But I would say over the last 10 years, the reliability of the ARCOS data as an investigative tool for DEA is much stronger.”
Now, companies can upload data to the system electronically, Cote said.
DEA makes limited ARCOS data available to the public. Shipment totals by state and ZIP code prefix are available online. But those records don’t include the names of companies or pharmacies.
Opioid Distributions Revealed
In 2016, the Charleston Gazette-Mail obtained ARCOS records through a freedom-of-information request with the West Virginia Attorney General’s Office.
Using those records, the newspaper illustrated how pain pills flooded West Virginia counties where overdose rates were rising.
“I was blown away when I saw it, it was extraordinary detail,” reporter Eric Eyre said. “They had a listing of every pharmacy in the state, and how many hydrocodone and oxycodone pills” they received.
Eyre won a Pulitzer Prize for his reporting last year. The story also helped to spark a probe by the U.S. House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.
In March this year, Rep. Paul Tonko, D-N.Y., questioned the acting DEA administrator about a pharmacy in the 3,000-person town of Williamson, W.Va.
“According to DEA’s ARCOS data, between 2006 and 2016, Tug Valley Pharmacy received over 10 million doses of opioids from 13 different distributors,” Tonko said. “This includes over 3 million pills just in 2009.”
Tonko then addressed the acting DEA administrator at the time, Robert Patterson.
“Administrator Patterson, this is an unbelievable quantity of opioids for a pharmacy this size in a town of 3,000,” he said. “Does the DEA believe the amount of opioids this pharmacy received is excessive?”
“In 2009, I would say so, sir,” Patterson replied.
Government Objects To Public Disclosure
Late last year, Cincinnati and other Ohio governments sought access to ARCOS as part of their suits against drug companies.
The DEA resisted disclosing the full database. In February, it offered to hand over anonymous transaction records and a list of major manufacturers in each state.
In April, Judge Polster ordered the DEA to turn over nine years of transaction records for six states. A month later, he told the government to share ARCOS records for the entire country. Polster approved a protective order that prohibits the release of the data to the public.
The Washington Post and HD Media, the Gazette-Mail’s parent company, filed records requests with plaintiff local governments for the data.
The government and industry objected, saying disclosure of ARCOS records would expose confidential business details and could harm criminal investigations. Polster upheld those objections in July.
But it’s possible that the ARCOS records could reach a broader audience next year, if lawsuits by Cleveland, Cuyahoga County and Summit County go to trial.
The scheduled March 2019 trial, Polster wrote, “will be open to the public, and the evidence presented will become a matter of public record.”