Based on our combined experience of over 70 years in patient advocacy, pain management, and behavioral neurology, we are convinced that U.S. public perception and public policy on treatment of pain have been driven almost entirely by sociopolitical and legal factors. Seldom in recent years has policy been significantly influenced by science.

The U.S. enjoyed a brief period of scientifically enlightened policy in the late 1990s through 2008. A large number of patients almost certainly benefited from more available pain treatment employing opioid analgesics. However, tragically, patients treated with opioids were soon to become “legacy patients,” prime targets for involuntary opioid tapering. University medical centers might have provided a scientifically based countervailing force to the various nonscientific influences through much more extensive education of students and residents on pain management. By and large, they failed to do so.

Beginning around the year 2000, corrupt physicians collaborated with corrupt pharmacists to create pill mills. A 5-minute visit with a “clinician” could net someone a prescription for 1,000 pharmaceutical grade oxycodone 30 mg tabs, which could then be promptly filled. National drug distributors such as McKesson, AmerisourceBergen, and Cardinal Health, strongly supported the pill mills. Pharmaceutical companies, most notably Mallinckrodt, provided volume discounts to the distributors. A tsunami of opioids flooded the country and vulnerable populations evolved to become the heart of the modern phase of the opioid crisis.

The decade from 2000 to 2010 was thus dominated by business corruption.

In response, the DEA began prosecuting pill mills. However, the reason for DEA actions was not transparent; many (eventually most) pharmacists became fearful that dispensing opioids in any quantity would put them at risk. Thus from 2008 to the present, a “pharmacy shuffle” emerged: Patients who had an opioid prescription issued by a clinician (even one with excellent credentials) could not find a pharmacist who would fill it.

This can be called the “panic phase” of the American opioid crisis. Well-intended pharmacists revealed that, after all, they are human beings, afraid for their own livelihoods.

Pill mills were shut down by the states between 2010 and 2012, mainly by strengthening Prescription Drug Monitoring Programs (PDMPs) and making PDMPs universal and ultimately highly interlinked between states. Closing of the pill mills should have ended debate about public policy bearing on opioid treatment of pain. The big problem had been solved.

The rise of illicit opioids and political influence

However, two other dynamics were percolating.

The first dynamic was driven by the entrance (around 2007) of Mexican drug cartels selling high purity, cheap heroin to addicts who suddenly had been denied an opioid supply or couldn’t afford the rising costs of pharmaceutical grade opioids. Several years later, Mexican cartels were joined by Chinese entrepreneurs selling illicit fentanyl. These two sources of opioids continue to dominate the illicit drug market.

The second dynamic was driven by a group of anti-opioid zealots led by Andrew Kolodny: “Physicians for Responsible Opioid Prescribing (PROP).” Dr. Kolodny proved to be a very skillful schmoozer. He leveraged his friendship with Tom Friedan, then Director of CDC, to arrange for major PROP representation on the advisory board supervising the development of 2016 CDC opioid guidelines. The result was a guideline that was based purely on belief and devoid of science, and one that ignored even the CDC’s own data.

This can be seen as the launch of “the political phase” in clinical management of pain. The enormous gravitas of the CDC (ill-deserved since the firing of its last independent director, David Sencer, in 1977) provided the basis for capturing the VA, the FDA, the DEA, pharmacists, health insurance companies, and state governments in a form of anti-opioid hysteria.

This is the mature political phase of our opioid crisis. U.S. public health policies on pain management are now dominated by it.

Well before 2016 CDC guidelines on pain management were published, health care providers became aware of the guidelines; their attorneys quickly perceived a potential new source of liability. If a patient died of anything and happened to be taking opioids and opioid dosage was not compliant with the CDC guideline, the family could potentially sue for wrongful death. So began the legal phase of the pain treatment crisis. This is where the rubber really meets the road. A health care provider can rescind a clinician’s clinical privileges in a heartbeat.

Buprenorphine and the science gap

The rise of buprenorphine (usually prescribed as buprenorphine 8 mg/naloxone 2 mg (Suboxone) up to 3x daily) represents only the latest non-scientific wrinkle in the ongoing crisis. It appears that “Bupe” has become a favorite with clinicians because it is viewed as a safe harbor. They can treat pain but are highly unlikely to have their clinical privileges threatened or to incur DEA scrutiny.

One could call this “the sociological sub-phase.”

But what about the science? There is robust science supporting the use of buprenorphine (and methadone) as an adjunct in the rehabilitation of addiction. However, the science bearing upon efficacy for treating chronic pain, safety, and most importantly, dosing, is far less robust. Higher doses have been tested, mainly in European studies. They provide some evidence that higher doses may be more effective in pain control, but are also more fraught with side effects. We have long known from studies of other opioids that due to genetic factors, there is enormous inter-individual variability in side effects caused by any given opioid.

The overwhelming likelihood is that buprenorphine has more similarities to other opioids than differences. Doses required to control pain vary enormously. Some patients will achieve adequate pain control when provided the standard Suboxone regimen. Clinicians see plenty of others who tell us that the drug “takes the edge off” or that “it is better than nothing.”

We have long known that opioid dosage required to achieve pain control may vary by a factor of as much as 15. A substantial quantity of this variability can be accounted for by genetically mediated differences in enzymes of the hepatic P450 system. There is also strong reason to suspect that there are substantial inter-individual differences in central nervous system signal transduction when an opioid binds to a receptor.

It is also clear that suffering, which represents a pattern of neural activity in the orbitofrontal-limbic system of the brain, is the major factor that drives patient experience of pain and patient perception of pain control. There may be a substantial disconnect between pain signal and suffering. There is little published science that bears upon this.

As an opioid, buprenorphine has pharmacodynamic effects: Patients experience withdrawal symptoms if the drug is tapered too precipitously. Clinicians have been taught about pharmacodynamics during medical school as far back as the 1970s. Unfortunately, many clinicians (most notably the authors of DSM-5), display confusion about the difference between pharmacodynamics effects and addiction, often conflating the two. The mechanisms underlying the two phenomena are vastly different.

Thus, it seems fair to conclude that current buprenorphine practice, like opioid prescribing over the past 25 years, is not driven by science. Inadequate clinician training, corrupt business, fear, zealotry, political chicanery, health provider concern over legal liability, political institutional dynamics, and clinician and pharmacist sociology, coupled with the psychosocial/economic factors that drive people to addiction to illicit opioids, define current public health opioid policy. But science? Sorry but no.

Richard A. Lawhern is a nationally recognized health care educator and patient advocate who has spent nearly three decades researching pain management and addiction policy. His extensive body of work, including over 300 published papers and interviews, reflects a deep critique of U.S. health care agencies and their approaches to chronic pain treatment. Now retired from formal academic and hospital affiliations, Richard continues to engage with professional and public audiences through platforms such as LinkedIn, Facebook, and his contributions to KevinMD. His advocacy extends to online communities like Protect People in Pain, where he works to elevate the voices of patients navigating restrictive opioid policies. Among his many publications is a guideline on opioid use for chronic non-cancer pain, reflecting his commitment to evidence-based reform in pain medicine.

Stephen E. Nadeau is a behavioral neurologist.