Digging past the headlines, it’s difficult, if not impossible, to establish a direct correlation between legitimate short-term opioid prescriptions for acute or post-operative pain from orthopedic interventions and illicit trafficking.
The legal and regulatory focus on orthopedic prescriptions has fueled a number of legal and policy changes as well as several unintended consequences.
In Part I, we listed the first three of those changes. In Part II, we pick up the narrative with the Drug Enforcement Administration’s (DEA) slow and apparently misguided attempt to slow the trafficking in illicit opioid drugs.
4. Was upper management of the DEA protecting drug companies from harsh action to stop the illicit pill trade? DEA field agents think so, but maybe that’s changing.
A fundamental question in the opioid crisis is how hundreds of millions of pills have gotten into illicit circulation.
In the early 2000s, DEA field agents began cracking down on major drug companies and distributors for selling opioid pills to Internet pharmacies and other pharmacies ordering illogically huge batches. In all, 13 companies, representing 85% of the prescription opioid business, were charged with at the very least looking the other way.
McKesson in 2008 paid $11.3 million to settle a case in which three of its warehouses were accused of failing to report hundreds of suspicious orders. (“How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’,” Washington Post, 10/22/2016).
In the settlement, McKesson agreed to closely monitor its warehouses.
Cardinal Health paid a $34 million settlement in 2008 for similar failures. Then, in 2017, Cardinal agreed to pay $44 million for failures to alert the DEA to suspicious orders from its Lakeland, Florida warehouse from 2009 to 2012 (“Cardinal Health fined $44 million for opioid reporting violations,” Washington Post, January 11, 2017).
Then, agents in the field thought they’d discovered the mother lode of cases: McKesson again, according to Washington Post and other news stories.
Field agents thought the case was so big and solid that they wanted a billion-dollar fine, immediate shutdowns of more than one McKesson warehouse, and criminal charges against unnamed executives, given that this was a repeat violation.
McKesson had never bothered to monitor its warehouses after the 2008 settlement, claims an October 2017 stockholder lawsuit (“McKesson Records Show Failed Opioid Oversight, Lawsuit Says” – Bloomberg News, December 8, 2017.
McKesson says the claims in the lawsuit are just unproven claims.
However, McKesson settled the second case for $150 million in January 2017—but with no immediate suspensions of opioid sales and no criminal charges. At least three senior DEA agents in Denver and Detroit, with 29, 30, and 43 years’ experience, were so upset that they retired.
A $150 million fine seems gigantic to most of us. However, it’s just 1.5 times what McKesson’s chief executive made that year.
Orthopedist are routinely discharging patients with far TOO many Opiod pills in the bottle. 60! Even 120!