The Federal Register issued “A Request for Information: Ensuring Patient Access and Effective Drug Enforcement”. The comments are being sought to ensure (patients have) legitimate access to controlled substances, including opioids, while also preventing diversion and abuse, as well as how federal, state, local, and tribal entities can collaborate to address these issues.

Here’s a link.

Chronic Pain Patient Advocate Dr. Richard “Red” Lawhern of the Alliance for the Treatment of Intractable Pain has filed a 4500-word referenced comment to HHS. While the entirety of his report is too lengthy for publication here, we thought an excerpt where he discussed the obstacles to legitimate patient access to controlled substances would be of interest to many of you.

The primary obstacle to legitimate patient access to controlled substances is a draconian program of regulatory over-reach and intimidation of healthcare providers in pain management practice. This program is being conducted by the US Drug Enforcement Agency, Department of Justice, and State drug enforcement authorities. Healthcare providers are being driven out of practice by what often amounts to frivolous or malicious investigation and prosecution.

Doctor offices are being raided by armed SWAT teams that seize patient medical records and threaten practice employees with prosecution if they do not offer evidence of misbehavior by the principal healthcare providers. In some cases, civil assets have been seized. Frequently, drug enforcement authorities prominently announce their investigations, many months before any court proceeding, thus driving away patients and ruining providers financially even if the physician is eventually proved innocent of any wrongdoing. The resulting hostile climate has resulted in the desertion of hundreds of thousands of patients to agony, disability, and increasingly death by suicide among people overwhelmed by untreated or under-treated pain.

A related obstacle to patient access is the practice of national pharmacy chains, pharmacy benefit management companies, and/or health insurance companies of issuing “high prescriber lists.” As noted in AMA Board of Trustees Report 22 (June 2019), such lists “do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having the prescription filled at the pharmacy of their choice.

In three years since publication of the CDC guidelines, over 30 US states passed legislation restricting dose rates and/or duration of opioid analgesics in both acute and chronic pain treatment. Restrictions have become so severe and the damage to patients so widespread that CDC itself was forced to publish a “clarification” in April 2019. They asserted that the guidelines were never intended to be applied as mandates or to prompt the involuntary tapering of legacy patients who are otherwise stable and benefitting from opioid therapy; rather, that they were intended as precautionary guidance for general practitioners.

In the same month, US FDA published a safety alert, warning against rapid taper or unsupported discharge of patients being maintained on opioid pain relievers. Grounds for this alert were concerns that significant numbers of patients involuntarily or rapidly tapered off opioids are experiencing withdrawal symptoms, depression and medical collapse, with evidence of increasing numbers of suicides due to overwhelming pain.

There is ample published evidence that these “clarifying” steps are too little and too late. It is now well established that the basic rationale of the CDC guidelines was factually wrong. The guidelines falsely conflated an absence of long-term trials of opioids with a lack of effectiveness; strong recommendations were made on the basis of weak evidence or anti-opioid bias; effects of genetically mediated variable opioid metabolism between patients were outright ignored; there is a wide natural variation in minimum effective dose levels for useful analgesia, over a threshold range of perhaps 50 Morphine Milligram Equivalent Daily Dose (MMED) up to — in a few patients — over 1000 MMED.

Thanks to Dr. Lawhern not only for his hard work to benefit chronic pain patients, but also for allowing us to publish part of this comment.