The data in the Drug Enforcement Administration (DEA) database indicates that the largest pharmaceutical companies in America flooded the country with 76 billion pills of pain medications oxycodone and hydrocodone from 2006 to 2012, amidst the outbreak of the deadliest drug epidemic in the country, according to previously undisclosed company data revealed as part of the largest lawsuit in U.S. history.
DEA Database Information
This information comes from a database managed by the DEA that tracks the movement of every pill of pain medication sold in the United States – from manufacturers and distributors to pharmacies in every town and city. This data provides a unique insight into the dramatic rise in the use of legal painkillers that sparked the opioid epidemic, which caused nearly 100,000 deaths from 2006 to 2012.
Key Points from the Analysis of the DEA Database
During this period, only six companies distributed 75 percent of the pills, namely: McKesson Corp., Walgreens, Cardinal Health, AmerisourceBergen, CVS, and Walmart. Three companies manufactured 88 percent of the opioids: SpecGx, a subsidiary of Mallinckrodt; Actavis Pharma; and Par Pharmaceutical, a subsidiary of Endo Pharmaceuticals.
The volume of pills handled by these companies significantly increased with the outbreak, rising 51 percent from 8.4 billion in 2006 to 12.6 billion in 2012. In contrast, morphine doses, a well-known treatment for severe pain, exceeded 500 million doses annually during this period.
Companies’ Response to Previously Undisclosed DEA Data
State attorneys general have long accused pharmaceutical manufacturers and distributors of facilitating the opioid epidemic by producing and distributing billions of pain pills while raking in billions of dollars. The companies have paid more than a billion dollars in fines to the Justice Department and the Food and Drug Administration due to opioid-related issues, and hundreds of millions more to settle state-level lawsuits.
However, previous cases only addressed part of the problem and did not allow the public to see the scale and scope of the behavior behind the epidemic. The financial settlements made by the companies were accompanied by agreements to keep this information hidden.
DEA Database: A Virtual Roadmap
The Washington Post has sought access to the DEA database since 2016, when the organization filed a Freedom of Information Act request with the DEA. The agency denied the request, stating that some data is available on its website. However, this data did not include the transformative information that companies must report to the DEA every time a controlled substance like oxycodone and hydrocodone is sold.
Manufacturers and pharmacies themselves submitted sales data to the DEA. Company officials testified before Congress that they bear no responsibility for the opioid epidemic in the country.
The number of pills sold by the companies during the seven-year timeframe was staggering, far exceeding what had previously been disclosed in court filings and limited news reports.
Prescription Tourists
The pain pills epidemic began nearly three decades ago, after Purdue Pharma introduced what it promoted as a less addictive formulation of an opioid called OxyContin. Purdue encouraged doctors and nonprofit groups that support patients in pain to help market the drug as a safe and effective means of treating pain.
But
The new drug was highly addictive. As the scope of addiction widened, more and more companies entered the market, manufacturing and distributing massive quantities of pain pills.
Purdue ended up paying a fine of $634 million to the FDA for claiming that OxyContin was less addictive than other pain medications.
Opioid sales nationwide rose from $6.1 billion in 2006 to $8.5 billion in 2012, according to data compiled by IQVIA, a healthcare information and consulting firm.
The revenues of individual pharmaceutical companies in the peak years of the epidemic ranged from $403 million for opioids sold by Endo to $3.1 billion in OxyContin sales from Purdue Pharma, according to a 2018 lawsuit against several defendants by San Juan County in New Mexico.
Over the past few decades, Florida became a hub for pill mills – pain management clinics that operated as fronts for corrupt doctors and drug dealers. They became so brazen that some clinics set up storefronts along highways and advertised their products on billboards next to highway exits. Many people traveled to Florida to stock up on oxycodone and hydrocodone pills, sometimes referred to as “prescription tourists.”
The route from Florida to Georgia, Kentucky, West Virginia, and Ohio became known as the “Blue Highway.” This name was given to one of the most popular street pills – the 30 mg oxycodone pills made by Mallinckrodt which shipped over 500 million pills to Florida between 2008 and 2012.
When highway patrol officers began to stop out-of-state drivers for drug trafficking, drug dealers moved to the air. One airline offered direct flights to Florida from Ohio and other Appalachian states, and the method was dubbed “Oxy Express.”
A decade ago, the Drug Enforcement Administration (DEA) began fighting this industry. In 2005 and 2006, the agency sent letters to drug distributors, warning them that they were obligated to report suspicious prescription drug orders and halt sales until red flags were resolved. The message also went to manufacturers.
The DEA stated in its 2006 letter that “non-compliance with the law by one distributor can cause enormous harm.” DEA officials said companies paid little attention to the warnings and continued to ship millions of pills in the face of suspicious circumstances.
As part of its campaign against this industry, the DEA filed a series of civil enforcement cases against the largest distributors.
So far, companies have paid nearly $500 million in fines to the Justice Department for failing to report and stop suspicious drug orders, a figure that far exceeds the companies’ revenues.
In 2007, the DEA filed a case against McKesson. The agency accused the company of shipping millions of doses of hydrocodone to internet pharmacies after notifying the company of its legal obligations to report suspicious orders.
In 2008, McKesson agreed to pay a fine of $13.25 million to settle the case and pledged to better monitor suspicious purchase orders from its customers.
In the same year, Cardinal Health attracted renewed attention from the DEA when it was discovered that the company was shipping an unusual amount of pain medication to its customers in Florida. The company had sold 12 million oxycodone pills to four pharmacies over four years.
In 2011, Cardinal shipped 2 million doses to a pharmacy in Fort Myers, Florida. Similar pharmacies in Florida typically requested 65,000 doses annually.
Noted
The Drug Enforcement Administration also indicated that Cardinal was shipping unusual quantities of oxycodone to a pair of CVS stores near Sanford, Florida. Between 2008 and 2011, Cardinal sold 2.2 million pills to one pharmacy. In 2010, that pharmacy purchased 885,900 doses – a 748 percent increase from the previous year. Cardinal did not report any of those sales as suspicious.
Cardinal later paid a $34 million fine to settle the case. The Drug Enforcement Administration suspended the company from selling drugs from its Lakeland, Florida warehouse. CVS paid a $22 million fine.
While the companies were paying fines and promising to do better at stopping suspicious orders, they continued to manufacture, ship, and distribute large amounts of pills, according to newly revealed data.
Closing Notes
The Drug Enforcement Administration’s database reveals the scale and scope of the opioid epidemic in the United States, which began with prescription pills, led to increased use of heroin, and ultimately resulted in the current fentanyl crisis that claimed more than 67,000 lives from 2013 to 2017.
The transfer data maintained by the Drug Enforcement Administration’s database contains very detailed information. It includes the seller’s name, DEA registration number, address, and business activity for each seller and buyer of controlled substances in the United States. The database also includes drug codes, transaction dates, total dosage units, and grams of drugs sold.
The data tracks dozens of different opioids, including oxycodone and hydrocodone, which account for three-quarters of the total shipments of pills to pharmacies.
Under federal law, drug manufacturers, distributors, and pharmacies are required to report every transaction of a controlled substance to the Drug Enforcement Administration, where it is logged in the DEA database. If company officials notice orders for drugs that appear suspicious due to their size or unusual frequency, they must report those sales to the DEA and withhold the shipments.
As the number of towns and cities flooded with pain pills grew, these communities pushed back. They filed lawsuits in federal courts against the drug industry, accusing companies of destroying their communities due to opioids. They accused companies of failing to report suspicious orders but also fulfilling those orders for maximum profit.
As the number of lawsuits increased, they were consolidated into a single central case in federal court in Cleveland. The opioid-related lawsuits have become larger in scope than the tobacco-related lawsuits of the 1980s, which resulted in a $246 billion settlement over 25 years.
Judge Dan Polster now oversees the central case that encompasses nearly 2,000 lawsuits. The case is part of a wave of actions that includes lawsuits filed by more than 40 states and tribal nations. In May, Purdue reached a $270 million settlement with the attorney general of Oklahoma.
In the Cleveland case, Polster urged pharmaceutical companies and cities and towns to reach a global settlement so that the communities could obtain financial help to mitigate the damage inflicted by the opioid epidemic.
To facilitate the settlement, Polster allowed pharmaceutical companies and cities and towns to review the DEA database under a protective order that prevented public access to the materials. He also allowed certain court files to be submitted under seal and excluded the public and press from the global settlement conference at the start of the case.
Last June, The Washington Post and Charleston Gazette-Mail requested Polster to lift the protective order on the DEA database and court files. A month later, Polster denied the requests, although he had previously stated that “the excessive supply of painkillers in the United States has caused an epidemic among its citizens” and that the DEA database reveals “how and where the virus spread.” He also said that disclosing the DEA database’s data is “a reasonable step toward defeating the disease.”
The appeal was filed.
The lawyers for The Washington Post and Charleston Gazette-Mail have decided on Polster. They stated that the materials contained in the Drug Enforcement Administration’s database will not harm companies or investigations because the judge has already allowed local prosecutors to collect information from 2006 to 2014, withholding the most recent years starting from 2015 regarding the lawsuit.
The lawyers for The Washington Post and Charleston Gazette-Mail said, “Access to data from the Drug Enforcement Administration’s database cannot harm public trust that the epidemic and emerging lawsuits are being handled appropriately now – even if they were not handled appropriately earlier.”
It was also noted that the Drug Enforcement Administration did not object when the West Virginia Attorney General’s Office provided partial data from the DEA database to Charleston Gazette-Mail in 2016. This data showed that pharmaceutical distribution companies shipped 780 million doses of oxycodone and hydrocodone to the state between 2007 and 2012.
On June 20, the Sixth Circuit Court of Appeals in Ohio decided to side with the news organizations. A panel of three judges overturned Polster’s decision, announcing the lifting of the protective order for the DEA database with reasonable reservations and directing the judge to reconsider whether any of the records in the case should be sealed.
On Monday, Polster lifted the protective order on the DEA database, announcing that all data from 2006 to 2012 should be released to the public, withholding data from 2013 and 2014.
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