On May 9-10, 2017, the U.S. Food and Drug Administration (FDA) held a workshop titled “Training health care providers on pain management and safe use of opioid analgesics — exploring the path forward.” I attended the workshop in person to offer comments on behalf of chronic pain patients. A summary of my observations at the time was published by the now-defunct Pain News Network. The following extended extract is from workshop proceedings published on May 9, 2017, by the FDA.

To begin this short presentation, I would draw the attention of the members in front [of the workshop] to the fact that, at present, millions of people either hypermetabolize or poorly metabolize opioid medications. This is due to variations in what is called the CYP2D6 genotype.

As a direct consequence of this reality in the patient population, there can be no universally applicable threshold of risk in MMED. Tens of thousands of patients are now stably maintained with zero opioid addiction risk on dose levels exceeding 200 MMED or even 400 MMED, and there are case reports of patients maintained stably on 2500 MMED. If you deny these people opioid therapy, you might as well shoot them because you will be killing them.

Beyond that, I wish to convey a message from those whom I support. Some FDA participants may find this a bit jarring, but if you’re truly concerned with patient safety, then the first thing you can do in this organization is to adjourn without disseminating one more guideline. This is true because the Centers for Disease Control and Prevention (CDC) guidelines on opioid prescription are egregiously incomplete, scientifically ill-supported, and extremely damaging to patient interests. The document, as … issued last March, is desperately flawed. It needs to be taken down, retracted, and done over from scratch.

Since the CDC released its guidelines, tens of thousands of patients have been summarily discharged without referral. Many have been denied medical care, and some have been deserted in opioid withdrawal. Many more have been arbitrarily tapered down from opioids, which have been effective and safe for them for years; plunged into agony and disability, losing whatever quality of life they had. Suicides due to unbearable pain have occurred in numbers, and you may anticipate more. We are seeing evidence … every day in social media.

Doctors are now leaving practice in part because they fear a campaign of extrajudicial persecution by the DEA. DEA regularly seizes patient medical records before filing indictments and then prolongs legal action for years in a knowing attempt to bankrupt the practitioner or bludgeon them into a consent decree. This is something widely understood and widely accepted by tens of thousands of people who have been affected.

In the seven years since the workshop, all of the conditions reported in my talk have continued and worsened. Although the U.S. Centers for Disease Control and Prevention issued a revised and expanded prescribing guideline for opioid analgesics in 2022, the revised guideline suffers from all of the errors and omissions of its 2016 predecessor.

The CDC has continued to ignore the effects of genetics in opioid metabolism, despite being well aware of these effects. They still advocate for a “one size fits all” policy despite disclaiming that this is what they are doing.

The CDC has continued its scientifically unsupported overemphasis on risk and ignored the benefits of opioid analgesics for millions of chronic pain patients.

Non-opioid therapies have been recommended as “preferable” to opioids, despite the absence of any trials data demonstrating any such thing.

Although the CDC was forced by public outcry to publish a letter disclaiming any intent to make their guideline an inflexible standard of practice, multiple U.S. states continue to treat it as such. The U.S. Drug Enforcement Administration (DEA) and federal prosecutors regularly cite CDC guidelines out of context to demonize clinicians and criminalize even prescribing practices that are approved by the FDA itself.

As of November 2024, the FDA has continued its misdirected updates to their 2018 opioid analgesic risk evaluation and mitigation strategy (REMS) and to a related REMS education blueprint for health care providers. These documents continue the inordinate emphasis on supposed “risks” of opioid analgesic prescribing. Remarkably, the blueprint also mentions the terms “screen” or “screening” 14 times with respect to assessment of risks and benefits in individual patients. But not once is a validated screening tool named. This major weakness is shared with the 2022 CDC opioid guidelines.

While the CDC and FDA have been dithering, pain research has moved on. Unfortunately for both agencies, available research now confirms that the assumptions behind both CDC guidelines and the FDA REMS are scientifically insupportable.

The following summary is edited from a recently published paper aptly titled “An indictment of U.S. public health policy on pain management.”

1. From data published by the U.S. CDC itself – and in direct contradiction to [CDC] public declarations – it is clear that doctors prescribing to their patients in pain are not now and have never been a significant cause of our U.S. opioid crisis. That distinction belongs instead to illegal or diverted street drugs.
2. “Likewise, from analysis of millions of patient records for post-surgical patients treated with opioid pain relievers, it is clear that addiction in medical patients is so rare that it cannot be measured or predicted accurately in individuals. On the very rare occasions when drug overdose or suicide does occur among medical patients treated for pain, previous mental health issues are the dominant risk factors – not opioid prescribing.
3. “It is also clear that both U.S. public health and law enforcement authorities are completely aware that present policy on pain management is profoundly lacking in science, medical ethics, and simple justice …”

As demonstrated in this source, analysis of six years of medical records for over 37 million U.S. patients reveals that the likelihood of addiction or overdose among post-surgical patients who have no recent history of opioid prescriptions and who are then treated with prescription opioids for their pain may be on the order of one in a thousand or less.

A second analysis of near-term overdose or suicide events among a million Veterans Administration patients treated for pain with opioids reveals that factors in mental health history are four to twenty times more significant in such outcomes than a history of opioid prescriptions under medical treatment.

Again, from the same source:

There is no reasonable prospect of ‘solving’ our U.S. opioid crisis by denying pain care to millions of U.S. citizens or persecuting hundreds more clinicians out of pain medicine or into prison. Present U.S. public health policy on regulation of opioid analgesics and doctors who employ them is clearly fraudulent.

[This] policy is in need of major revision and redirection. It is time for U.S. public health and law enforcement authorities to start that process. Public repudiation and withdrawal of U.S. CDC and Veterans Administration opioid prescribing guidelines may be a necessary first step.

To this recommendation may be added my original observation from 2017, updated to the present day: If the FDA is truly concerned with patient safety, then the first thing they need to accomplish in 2024 is to publicly repudiate the existing REMS for opioid analgesics and then to reorient their REMS roadmap to the realities of clinical practice.

Richard A. Lawhern is a patient advocate.