By R Carter
When trying to define accountability or the lack thereof, to which groups played a role in how the opioid overdose problem grew to such proportions, I’ve often used this analogy.
Image the Federal Government providing funds to build an interstate highway system through your state, combined with funds from the State. Once completed it’s the responsibility of both Federal and State agencies to place police officers on those roads and enforce the speed limits and safe driving. Now imagine what would happen if both Federal and State agencies failed at providing enough police to monitor compliance with these laws. Eventually there would be a large number of people speeding and driving recklessly. Traffic accidents would increase; the death toll would rise and continue to rise until it reached an alarming number of deaths.
Caught unprepared for the number road fatalities, there would be an overreaction, a knee-jerk response of sorts, to ensure drivers followed speed limits and safe driving practices. Now imagine that overreaction going to a level where all drivers were restricted to driving under 55 mph and others were denied a drivers license or from driving at all.
Then State and Federal officials began suing auto manufactures for making autos capable of exceeding the now 55 mph speed limit and car dealerships both new and used, were prosecuted for selling cars the government now deemed as unsafe.
No doubt all forms of business related to automobiles would be adversely affected, some dealerships would close and the travel industry would suffer. People would lose their jobs because they could no longer commute from home to work or conduct business affairs with others businesses. But we would be told that these are necessary steps in an effort to control those who drive in an unsafe manner.
This is essentially what we have in this nation with regards to the opioid overdose problem. We have Federal and State agencies which are charged with monitoring the legal use of these medications and law enforcement groups charged with monitoring for criminal activity.
Yet when the problem finally got out of hand, the knee jerk response was to punish everyone and lay the blame on every doctor for what a few were doing. Then some in government mount a misinformation campaign with bogus research denounced by most experts and issue Federal and State prescribing guidelines for chronic pain without considering the impact on chronic pain patients.
While it may be reasonable to assume that liberal prescribing is a contributing factor, it’s still unknown as to what level. Then, still acting with some level of presumption, whip the nation into a frenzy about prescription opioids. When in fact, the agency responsible for monitoring our legal drug supply, doesn’t really have an iron clad picture on what role prescribed opioids have had on the problem.
Reality of the DEA’s Role
It now appears this fictional story is not too far from the truth as the real facts are documented in this Department of Justice summary report. The DOJ investigation was an in-depth review of the DEA’s role in opioid overdose crisis which has plagued this country since 2000. The report documents an agency ripe with interagency strife and turmoil, poor communication between divisions, and an inability to work effectively and prudently with other agencies, lacking general coordination and control at several levels.
All this raises the question. Having lost sight of its operational mandates, has the agency gone too far at trying to restore its credibility by raiding some doctors? Doctors who were treating patients responsibly and in good faith prior to the 2016 CDC guidelines. More importantly, were those CDC guidelines part of a fabricated ruse, published so that this law enforcement agency could regain its credibility? In light of the CDC’s retractions published since 2016, this seems like more than a reasonable consideration.
In reading through the DOJ’s report, there are multiple references to prescribers prescribing outside the limits of accepted medical practice. But nowhere in this report will you find a definition for what is, acceptable medical practice. At best the report cites the fact that each State has a slightly different definition, adding to the difficulties the agency has faced in developing actionable target packages for prosecution.
In other parts of the report there is sufficient conflict documented between DEA and State level AG’s or US Assistant Attorneys to suggest that not all efforts taken by the agency were seen as probable cause for prosecution. What is clear though, is that the DOJ believes these barriers to prosecuting prescribers should be removed, giving the DEA more latitude in going after suspected prescribers who may be prescribing outside an as yet undefined standard of acceptable practice.
But, for its role prior to 2016, the DEA continued to raise production levels for opioids until the overdose death rate hit a new high of roughly 70,000 in 2017. Furthermore the manner in which the agency implemented its monitoring program essentially relied on manufacturers and distributors to police themselves. While regulations state that reporting was mandatory, the agency had minimal resources for acting on that information or ensuring that companies were compliant in filing reports. Making reports on lost, stolen or unexplained diversions essentially a voluntary process rather than a compulsory one. The report goes on to say that the DEA failed to hold registrants accountable or prevent the diversion of pharmaceutical opioids during this time.
Quotes from DOJ report
“DEA Was Slow to Respond to the Dramatic Increase in Opioid Abuse and Needs to More Fully Utilize Its Regulatory Authorities and Enforcement Resources to Detect and Combat the Diversion of Controlled Substances.”
“We found that the rate of opioid overdose deaths in the United States grew, on average, by 8 percent per year from 1999 through 2013 and by 71 percent per year from 2013 through 2017. Yet, from 2003 through 2013 DEA was authorizing manufacturers to produce substantially larger amounts of opioids. For example, the Aggregate Production Quota (APQ) of oxycodone in the United States, which DEA established annually, increased over 400 percent between 2002 and 2013. It was not until 2017 that DEA significantly reduced the APQ for oxycodone, by 25 percent. In 2018, DEA further reduced the APQ for oxycodone by 6 percent.”
“We also found that the SORS database, developed in 2008 to house suspicious order reports that federal regulations require manufacturers and distributors of controlled substances to send to DEA, is incomplete and therefore cannot be used effectively to detect diversion. We determined that this was due to the fact that most suspicious order reports are sent to DEA field divisions and that those reports are never uploaded into the SORS database. As a result, of the approximately 1,400 manufacturers and distributors required to report suspicious orders to DEA, the SORS database included reports from only the 8 manufacturers and distributors that had agreements with DEA to send such reports to DEA headquarters. When we asked DEA for records of suspicious orders reports sent to field divisions rather than headquarters, DEA was unable to locate them.”
From 1990 –2013 the number of legal opioids manufactured in this country nearly quadrupled and the agency which is tasked with understanding their true risk to health, kept approving larger and larger production quotas.
The primary database used by the DEA, ARCOS didn’t track diversion activity, consequently prior to 2013, there were in some cases, truck load sized shipments which simply disappeared without so much as a notice from regional offices to the home office in Washington.
Each of the 50 States also has an equivalent agency or agencies to the DEA or FBI. These agencies likewise are responsible at a State level, for monitoring compliance and investigating issues of lost or stolen inventory or suspicious diversions.
And yet we have State Attorney General’s wanting to sue pharmaceutical companies for over production, claiming they are responsible for creating the overdose crisis. Isn’t this like suing auto manufactures for making cars that go faster than 55 mph? Whether or not the revelations from this report will give state AG’s a moment of pause is another question. But for government to claim they are innocent in how our nation got here, is a claim which falls hollow on some ears. What’s wrong with this picture and I ask again, Who Are the Bad Actors in this opioid overdose crisis?