By Michael Presti, MD PhD, Founder-CEO at SafeRX Pharmaceuticals Inc.
I will never forget the faded blue and green tarps that lingered on rooftops for months after Hurricane Andrew. Less than a year before that storm devastated south Florida, I had been dragged there kicking and screaming in a family move from New Jersey, and those ugly polyethylene house blankets Andrew left in its wake became an emblem of my teen hormone-fueled discontent. The tarps were, of course, innocent of any wrongdoing; they were a reasonable stopgap measure to limit additional damage until proper repairs could be made, like battlefield tourniquets.
Likewise, when the CDC first published its opioid prescribing guidelines near the peak of the crisis in 2016, I felt they represented an important stopgap measure. This was a torrent; we needed the tarp. So I volunteered to serve on my medical group’s Opioid Task Force, which was focused on adapting and adopting those prescribing guidelines. Most of these recommendations were entirely prudent, in no way controversial, and quite frankly- remedial: consider opioids only when alternatives are ineffective; use the lowest dose necessary; regularly assess long-term opioid patients to determine if ongoing benefits outweigh risks; use prescription drug monitoring programs to make sure patients aren’t getting controlled substances from multiple sources, etc.
The only recommendations that generated significant debate among our task force, as well as more broadly across the medical community, were those related to daily dose limitations. These guidelines, based primarily on overdose data across different dosage ranges, called for physicians to “carefully reassess evidence of individual benefits and risks” if raising the daily dosage to ≥50 morphine milligram equivalents (MME)/day, and- most controversially- called for prescribing physicians to “avoid increasing dosage to ≥90 MME/day or carefully justify [the decision to do so]”. To be transparent, I argued in favor of those recommendations at the time and continue to feel they are generally appropriate, but I also appreciated some of the arguments against from my colleagues in Pain Medicine. That is, patients on long-term opioid therapy (like people consuming most any chemical on a daily, long-term basis) almost universally develop what is referred to as tolerance- meaning that with repeated exposure over time, a progressively larger dose of medication is required to produce an equivalent physical response. And by the time most patients are referred to a Pain Medicine specialist, they have been taking opioids for months or years, have developed tolerance, and are already on dosages above those recommended CDC thresholds or require such an increase in dose to achieve adequate analgesia. So my colleagues’ argument against was largely one of self-preservation- if adopted, these guidelines would mean Pain specialists were routinely operating outside the bounds of ‘standard medical practice’, thereby exposing these practitioners to a markedly increased level of medico-legal liability. This argument proved to hold some water, and the increased ‘policing’ of opioid prescribing patterns- and the related dose reductions that ensued- ultimately contributed to many patients turning to the illicit market (including heroin and fentanyl) to satisfy their then unmet physical dependence on opioids. Even more controversial, research- including a recent study of over 60,000 patients (Harder et al., 2021)- has shown that implementation of prescribing limits does not reduce overdose risk.
And while the impacts of the CDC prescribing guidelines warrant further attention and discussion, their controversy has distracted us from the reality that these guidelines were only issued as an emergency stopgap measure- an ugly blue polyethylene tourniquet intended to stop the bleeding until more definitive interventions were available. But somehow, somewhere along the way we started trying to fix the tarp rather than the roof.
So let’s get our eye back on the prize. Because until we truly rebuild and develop an integrative, multidimensional strategy to combat the opioid crisis, this hurricane will continue to tear our communities apart. That all starts with root cause analyses- by identifying the leading factors contributing to overdose, then developing targeted solutions for them.
One critical but previously unaddressed dimension of the opioid crisis involves the combination of opioids with alcohol. According to data from the CDC, 22.1% of fatal prescription opioid overdoses are related to concurrent alcohol consumption, and patients with a history of alcohol problems are 5 times more likely to overdose on their opioid medication. Because when consumed together, these substances interact in the body in a hazardous manner, resulting in much more intense suppression of the nervous system. But despite warnings to avoid alcohol consumption, research has shown that more than one-third of long-term opioid patients admit to drinking with their medication. And physicians currently have no effective means of preventing their patients from making this all-too-often deadly mistake.
I am proud to be a part of SafeRX Pharmaceuticals’ efforts to develop and commercialize its revolutionary, first-in-class platform of Alcohol Resistant Opioids (AROs), designed to prevent patients from making the all-too-often deadly mistake of consuming alcohol with their prescribed opioid. We believe these patented ARO products have the potential to save tens of thousands of lives, and the company has just launched an equity crowdfunding campaign to support the development programs of our two inaugural products, OxARO™ IR and MethARO™ IR. While not a “silver bullet” for the opioid crisis, we believe this new ARO platform of products will have a meaningful impact on overdose risk and harm reduction. I encourage anyone interested in joining SafeRX in this mission to reduce the risk of prescription opioid overdose to consider an investment, for which details can be found here.