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.
“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,” said McKesson spokeswoman Kristin Chasen. But each company would only have access to its own data, she said.
AmerisourceBergen, which distributed about 9 billion pills from 2006 through 2012, said in a statement that “this data has never previously been given to anyone outside DEA, and therefore has not been available to inform the order monitoring programs and decision-making of distributors like AmerisourceBergen.” The company said this makes for “a very misleading picture regarding efforts being made around diversion.”
The company said that opioid distributors provided daily order updates to the agency, but said they “have at no time been privy to how this information was used by DEA, despite consistently seeking guidance on how to most effectively walk the tightrope of providing access to needed, FDA-approved medications while playing a role — however limited, given lack of interaction with patients — in combating the diversion of these same medications.”
Mallinckrodt, whose subsidiary SpecGx manufactured more opioid pills than any other company, said through a representative that “the Drug Enforcement Agency determines the total quantity of Schedule II opioids needed each year to meet legitimate medical, scientific and research needs in the U.S.”
SpecGx “cannot and does not produce more opioids than the annual limit set for the company by the DEA,” and the company “sells only to DEA-approved distributors and other entities, who are themselves registered with and monitored by the DEA.”
Cardinal Health said in a statement that it “has stopped suspicious orders for the shipment of hundreds of millions of dosage units of controlled substances over the last decade.” The company said it reported those to the DEA and state boards of pharmacy, but said “we do not know, nor do we have any influence on, what these governments do with those reports.”
Distributors “have no law enforcement power,” Cardinal Health said, “and cannot stop physicians from writing prescriptions for medication nor take unilateral action to block DEA- and state-licensed pharmacies’ ability to dispense medication.” The DEA determines how many opioids can be manufactured each year, the company said, and has “continuously raised the quota” in the past decade.
Kolodny, who is also the executive director of Physicians for Responsible Opioid Prescribing, said the laws determining these quotas are based on opioid use during the previous year.
“There was an assumption built into the law that the medical communities would be prescribing appropriately. I don’t think anyone ever could have anticipated that opioid manufacturers wouldn’t be able to change the culture of prescribing,” Kolodny said. “Because of the way the law was written, as prescribing began to take off, DEA had no choice but to continue issuing higher quotas.”
The DEA declined to comment for this story, citing “ongoing litigation.”
Purdue Pharma said its product “OxyContin constitutes an exceedingly small percentage of the prescription opioids prescribed in the United States.” The company said the trends in opioid-related deaths have fallen in recent years with respect to oxycodone but have risen when it comes to fentanyl and heroin.
Teva Pharmaceutical Industries, which acquired Actavis, did not respond to CNN’s request for comment. Walgreens said it stopped distributing controlled substances in 2014.
The DEA and other federal agencies have gone after pharmaceutical companies, investigating questionable orders, issuing fines and conducting seizures. But asking if authorities could have done more is a fair question, Kolodny said.
“Why do we have a system that relies on the distributors to report suspicious orders?” he said. The DEA has gone after several of these companies, he added, but could they have done so “more systematically?”
But the burden may not just fall on the DEA, Kolodny said. The US Food and Drug Administration, in approving new opioids, opened the gates to other drug companies seeking to recoup on their investments. “Each time a new opioid was approved, you had a pharmaceutical company working very hard to get doctors to prescribe it.” And state medical boards “should be using state [prescription drug databases] in a proactive way just as the feds should be using ARCOS data in a proactive way,” he added.
In a statement Thursday, FDA spokeswoman Lyndsay Meyer said that “federal law does not allow the FDA to refuse an application based on a drug’s class or indication. Each application submitted must be reviewed and is judged on its own merits based on the scientific data and information contained in the application.”
Meyer added that the agency issued new draft guidance last month for the drug industry on assessing the risks and benefits of new opioid drug applications, and that the FDA is also holding a meeting in September “to discuss whether an applicant for a new opioid analgesic should be required to demonstrate that its product has an advantage over existing drugs in order to be approved and, if so, what new authorities the FDA would need to impose such a requirement.”
Still, Kolodny said that a big-picture approach to prescription opioids is necessary to tackle the epidemic.
“All of the different systems that should have stopped this from happening, failed,” Kolodny said. “We shouldn’t have had a system that relied on the fox guarding the henhouse. Particularly in an age with big data, where every single pill could potentially be tracked, we should have done it differently, and we need to change the system.”