A database charting the course of opioid pills across the country is being made public following a judge’s decision, shedding new light on the scope of the drug industry’s alleged role in the opioid crisis.
The Washington Post reports that 76 billion prescription pain pills from the country’s biggest pharmaceutical companies poured into the US from 2006 through 2012.
The database was released after a yearlong legal challenge by the Post and HD Media, the publisher of the Charleston Gazette-Mail in West Virginia. It’s full of detailed transactions by drug makers, distributors and pharmacies – required by law to be submitted to the US Drug Enforcement Administration. It is known by the acronym ARCOS, which stands for the Automation of Reports and Consolidated Orders System.
The numbers paint the fullest picture yet of the massive scope of prescription drug manufacturing and sales that experts say drove the country into its present-day struggle with opioid addiction.
“There’s been massive overprescribing, overconsumption of opioids in the United States,” said Dr. Andrew Kolodny, co-director of Opioid Policy Research at Brandeis University in Massachusetts. “It’s the reason we’re in the midst of this severe epidemic of opioid addiction and overdose deaths.”
Kolodny said the data reflects pills that were produced by these companies, prescribed by doctors and dispensed to patients at pharmacies. And while the role of overprescription by doctors is well known, what’s less understood is how distributors, retailers and drugmakers have worked to keep opioids flowing into the market, he added.
The newly released data shows the path of those opioids, including oxycodone and hydrocodone, at the pill level. And it shows which companies held the largest shares of the market.
In the numbers
From 2006 through 2012, roughly half of the pills were distributed by McKesson (14.1 billion), Walgreens (12.6 billion) and Cardinal Health (10.7 billion). And more than two-thirds were manufactured by Actavis Pharma (26.5 billion) and SpecGx (28.9 billion), a Mallinckrodt subsidiary.
Purdue Pharma, the subject of intense scrutiny over its early role in the opioid epidemic, manufactured just 2.5 billion pills – a 3.3% market share, according to the Post’s analysis.
But this doesn’t tell the full story, Kolodny said, because not all pills are created equal. In the case of Purdue, the maker of OxyContin, “their pills packed an enormous amount of oxycodone in them because of their extended-release, high-dose formulations.”
Kolodny said it’s like equating two objects, one that weighs five ounces and one that weighs five pounds.
Dr. Caleb Alexander, founding co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, said the release of the database is sure to add “a very granular view” of how and where opioids saturated the market. “But the alarm bells have been sounding for years,” he added.
“These data are being released at a time when there’s an enormous amount of interest and scrutiny of the role of manufacturers and wholesalers and pharmacies in this process,” he said.
An evolving epidemic
Between 2006 and 2012, the number of opioid pills originating from these companies climbed from 8.4 billion to 12.6 billion, according to The Washington Post’s analysis.
Data from the market research firm IQVIA Institute for Human Data Science shows that opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed. By the end of 2018, that number had dropped 43%.
Still, the country has continued to grapple with opioid addiction and its consequences. In 2017, roughly two-thirds of the 70,237 drug overdose deaths in the United States involved opioids – about 47,600 deaths. That’s the equivalent of more than 130 people per day, according to the US Department of Health and Human Services. And 36% of those deaths involved prescription opioids.
At the root of the opioid epidemic, Kolodny said, have been mostly well-meaning doctors, swept up in a culture of prescribing drugs they initially thought were safer than they were – in part due to the marketing and reassurances of pharmaceutical companies. Pill mills and drug diversion – where prescription drugs end up in the wrong hands – were consequences that came later, he added.
Drugmakers and distributors have faced a litany of lawsuits in recent years over their role in the opioid crisis, with cities and states alleging that pharmaceutical companies used aggressive marketing tactics, ignored the science on opioid addiction risk and failed on a number of occasions to alert authorities to suspicious activity.
Thousands of lawsuits have been consolidated in a US District Court in Cleveland, where a federal judge on Monday decided to unseal data from the DEA database.
Companies defend their record, criticize regulators
In response to CNN’s requests for comment, companies defended their practices and some laid blame on federal regulators.
McKesson said that it has “consistently disclosed controlled substance transactions to the DEA,” which are catalogued in the ARCOS database.