On September 16, 2015 the Centers for Disease Control and Prevention released – unexpectedly – a draft opioid prescribing guideline via an online ‘webinar’. Several things about this development were highly unusual.
- There was no prior public notice that an opioid prescribing guideline was underway by CDC, and the draft of the guidelines was not made available publicly prior to the ‘webinar’ launch on Sept. 16, 2015.
- CDC typically focuses on infectious disease, food borne pathogens, environmental health, occupational safety and health, health promotion, injury prevention, and educational activities. Prescription safety and efficacy falls squarely within the purview of CDC’s sister agency: the Food and Drug Administration (FDA).
- The invitation to the online ‘webinar’ went out to a select list of invitees: dozens of organizations representing physicians, pharmacies, insurance companies and other special interest groups. But there were only two seats at the table for groups representing pain patients. Details available here, at this excellent coverage at the time.
- The media was not notified of the guidelines nor the webinar in advance. “Media were not directly included because this public engagement period is part of the guideline development process and was intended to invite feedback specifically from providers, patients, and clinical organization that would be impacted by these recommendations.” according to a CDC spokesperson.
- The CDC initially planned for only a 48 hour public comment period. After threats of lawsuits, the CDC eventually delayed the release of the guidelines and opened a 30-day public comment period.
- During the ‘webinar’ the CDC accepted public comments but did not answer any questions.
- The CDC recorded the ‘webinar’ but had no plans to make it available for viewing afterwards for those who did not know about it. The draft guidelines were also NOT available on the CDC website.
- Technical problems plagued the ‘webinar’ on September 16th, leaving many groups and patients unable to access it. CDC eventually made the ‘webinar’ available again the following day.
Why were these draft guidelines shrouded in secrecy during their development and why were names of the ‘experts’ the CDC had engaged not disclosed? Was this unusual for a federal agency charged with protecting the public health? In fact, it was. Several interesting things developed shortly after the CDC draft of opioid prescribing guidelines were publicly disclosed:
- November, 2015: The CDC is accused of ‘blatant violations’ of the Federal Advisory Committee Act (FACA) of 1972 by the Washington Legal Foundation, a conservative non-profit, pro-business organization in Washington, D.C. These alleged violations include failing to open all meetings the public, failing to publicly release all documents which the CDC made available to its Core Expert Group (CEG), and failing to prepare and release meeting minutes.
- December 11, 2015: CDC delays the release of the opioid prescribing guidelines. Apparently responding to the threat of lawsuits and growing criticism – plus perhaps the realization that CDC was in violation of federal transparency laws – the CDC files formal notice in the federal register that it was opening a 30-day public comment period.
- December 18, 2015: Congress questions the CDC about who, exactly, drafted the ‘controversial opioid guidelines’. A letter to then-CDC-Director Tom Frieden from the Congressional Committee on Oversight and Government Reform detailed specific questions and concerns, and required a reply from CDC by January 5, 2016.
Where, you might ask, was the mainstream media coverage of this clandestine effort to limit access to pain medication for everyone in America? That’s a great question. It appears that so many eyes were focused on the addiction/overdose crisis that people failed to consider the millions of Americans who live with constant, incurable pain every day.
It is also clear that people wanted to be seen to be making a difference with addiction and overdose deaths. While controlling the illegal drug trade – and the influx of cheap, pure, and deadly illicit fentanyl – is challenging, trying to control medical providers and chronic pain patients is far simpler. Which is precisely what elected officials, policy influencers, agencies, boards, and commissions all did: limit prescriptions to people in pain to try to reduce the amount of addiction and overdose deaths.
Did it work? It depends on how you define success. Did it dramatically decrease the production of opioid analgesic pain medications in the United States, impacting supply for surgeries and people in palliative care? Yes. Did it dramatically decrease the number of opioid prescriptions written all across the country? Yes. Did it decrease the number of opioid overdose fatalities in any way? NO. Not one bit. Opioid overdoses continue to skyrocket to unprecedented rates in the United States even though fewer opioid prescriptions are now written than any time prior to 2012.
Can it be that it’s never been about prescription opioid medications at all, something various experts have been saying – with data – all along? Stay tuned.