Randy Flick MD
I read with a great deal of interest your recent post to the SPA Article of the day. As much as I agree with the spirit of the post/lecture, I would like to make a few comments. My comments are based primarily from my experience as a member and Chair of the FDA advisory committee that was and remains responsible for opioid approval and policy. They are not made as an expert in pain management.
Allow me to enumerate my comments in keeping with the flow of what you and Elliot posted.
Please forgive me if I have misstated or misunderstood some of your points.
1. The point was made that overdose deaths are “related to opioids and that many deaths occur in the setting of multiple drugs rather than an opioid alone. Although this is certainly the case, I think all of us are aware that opioids are the class of drug most responsible for these deaths. One way to look at this is to consider how many overdose deaths occur in the absence of opioids. Based on data from the WONDER database roughly 70,000 0f the 90,000 deaths are opioid related highlighting that although drug abuse is and has been widespread the death rate from overdose tracks very closely to the rise in opioid use and abuse. The typical proportion is about 80% of OD deaths are opioid related.
2. The lecture compares deaths from opioids to deaths from other causes. One presumes that is done to create context rather than to suggest that addressing opioid deaths should not be a priority. A comparison is made to motor vehicle crash/pollution deaths which I think is instructive. Deaths from pollution and motor vehicle crashes have both been reduced by nearly half due to the imposition of federal regulation addressing air quality and auto safety. Federal regulation of opioids (abuse deterrent ERRLA class formulations, opioid REMS, tighter regulation of pharmacies…) have also been effective in reducing prescription drug abuse although that, as you point out, has not impacted drug overdose deaths, it has helped remove physicians from the supply chain. The transition from prescription to illicit non-prescription opioids occurred well in advance of the opioid regulations and reductions in opioid prescriptions you allude to. The transition occurred based purely on economics. Black tar heroine was a much cheaper alternative to prescription opioids and began taking over the market well over a decade ago. For those who are interested I would suggest reading the book “Dreamland”.
3. Although it is correct that opioid abuse is not a new problem (lest we forget the opium wars of the 19th century) it is maybe a bit of a stretch to suggest that attention to the opioid crisis only occurred because white people were impacted. Racism is surely a factor in this as it is in many things but let’s not ignore the numbers. Overdose (all types) deaths increased from well below 10,000 per year in 1980 to now approaching 100,000. Those deaths cross all lines of race, gender, social status etc. impacting most those who are poor regardless of race. Death rates for whites and blacks are roughly equal whereas by far the highest death rate is among the native American/Alaskan native population. Hardly a group that receives much attention from congress. On the contrary those earning less than 40,000 USD per year are nearly 3 times more likely to die from opioid overdose as compared to those earning more than 84,000 USD per year.
4. Implicit in the lecture is a suggestion that most overdose deaths are or were related to pill-mills. It is unclear to me how one can draw this conclusion. As you might expect it is difficult to determine the source of prescription drugs involved in OD deaths as data sources are unreliable. One can safely state however, that pill mills are not and were never the primary source of opioids involved in OD death. That is not to say they were not an important source of opioids. My recollection is that friends, family, and “legitimate” physician prescribers are the most common source of opioids involved in deaths especially among teen-agers.
5. Indeed, most opioid drug deaths are now related to illicit non-prescription drugs. This was not the case until about ten years ago. Prior to 2010 most opioid drug deaths were secondary to prescription drugs. It might be splitting hairs a bit to differentiate illegal prescription drugs from legal prescription drugs and to differentiate legitimate patients from those that are not so. Keeping in mind that a large source of opioids abuse is secondary to drugs obtained from friends, family, left over from a previous prescription or obtained for chronic or acute pain from a family doctor, E.R., dentist… A physician prescription is a common denominator.
6. Opioid consumption (and death) in the U.S is markedly greater than in Europe. For example, in 2010 oxycodone consumption in the U.S. was about 250 mg /capita /yr. In Europe the figure was about 10 mg/capita/yr. Let’s remember that the U.S. consumes more than a quarter of the worlds legally produced opioids and 99% of all oxycodone produced. Americans consume 50,000 doses of opioids per day which is more than twice that of any European country and 5 times that of most.
7. Despair can be found in any corner of the world. Only in the United States is despair routinely treated with opioids. Little or no social safety net exists in most of Asia nonetheless opioid deaths are extremely rare in those cultures. I doubt additional spending on social programs is likely to have a profound impact on drug abuse in the U.S. That is not to say I don’t support social spending, I do.
Absent from the discussion is a differentiation between acute and chronic pain and the question of the efficacy of opioids for chronic pain. Increasingly the efficacy of opioids for chronic pain have been called in to question. Fundamental to CDC and other recommendation is a realization that these drugs work poorly for chronic pain and use should therefore be limited. ERRLA class opioids (Oxycontin) were the genesis of the prescription opioid epidemic and fueled the problem until they were priced out of the market by cheaper alternatives and abuse deterrent formulations made them less attractive. That said they remain a problem for many as well as a solution for a relatively small number of individuals such as those with cancer pain or terminal illness.
Let me finish by emphasizing that I respect the views of my friends and colleagues and recognize how challenging this issue is for all of us. My years at the FDA taught me to deeply respect those who serve our country as public servants even when I did not always agree with them. In every aspect of this difficult issue there are good “guys” and a few bad “guys”. Most are doing the best they can each and every day to make sure the drugs they create, produce, prescribe, dispense, or regulate do more good than harm.
Thanks for raising difficult issues.