By Ed Coghlan.
The National Pain Report published its story over the past weekend that the Drug Enforcement Administration wants to have the authority to impose quotas on companies who manufacture opioids. It opened a public comment period on Friday April 19 that will run until May 4.
For many chronic pain advocate groups and individuals, this proposed regulation could further impact the supply and the resulting prescription of opioids that chronic pain patients use.
If you wish to leave a comment about the regulation, click here.
Richard “Red” Lawhern is the public face of the Alliance for the Treatment of Intractable Pain. He has submitted his organization’s comments to the DEA. He contacted the National Pain Report this weekend asking that we publish his letter for your review, which felt like a reasonable request.
Here’s what he submitted:
I write as a non-physician subject matter expert on chronic pain and prescription opioid policy. I co-lead the Alliance for the Treatment of Intractable Pain, an organization of over 250 medical professionals, healthcare writers, knowledgeable patients and caregivers, with an outreach in social media of about 80,000 daily.
Our unified message to DEA is “cease, halt and desist”.
The proposed DEA measures to restrict supplies of scheduled drugs based on “diversion” can aptly be compared to an effort to reduce America’s “obesity epidemic” by reducing food supplies. This is simple foolishness on a grand scale. Proposed DEA regulation changes have potential to further damage health and quality of life for millions of chronic pain patients who have already been harmed by biases, errors and omissions of the 2016 CDC opioid guidelines, mandated refusal of opioid therapy to millions of US Veterans, and imposition of arbitrary and scientifically unsupported restrictions on so-called “high dose” prescribing by HHS/CMS.
DEA has no reliable measures for diversion at the individual medical practice level, given a wide range of “normal” prescribing practices between individual doctors acting in good faith to serve different patient populations. Prescribing levels as such are not a viable basis for restricting medical supply, absent a detailed knowledge of the patients and conditions serviced by the medical practice. Likewise, restriction of medical opioid supply has already been tried and failed. Prescriptions are now at a 10 year low, while overdose deaths continue to climb (see attachments).
By contrast, DEA has clearly failed in its public duty of oversight on major corporate drug distribution companies, notably McKesson. DEA representatives in effect refused to testify before the Senate Judiciary Committee when asked to explain how DEA missed the distribution of huge volumes of opioid medications into zip codes which lacked any credible medical markets for such distribution. DEA investigators have publicly complained of refusals by DEA and DOJ prosecutors to take aggressive action against McKesson, with the clear implication that corporations bought the compliance of DEA officials with promises of later lucrative jobs on leaving government service. It would appear that DEA is unwilling to prosecute the knowing suppliers of major pill mills, but quite willing to harm millions of patients who have never abused a medication.
The urgency invested in the so-called “opioid crisis” has long been distorted by CDC false attribution of overdose-related deaths to “prescription opioids” which were in fact caused by illegally manufactured fentanyl. CDC analysts have admitted publicly that CDC inflated prescription opioid deaths nearly 100% for years. The dominant causes of the current opioid crisis are illegally manufactured Fentanyl and Heroin - with prescription opioids a distant fifth in overdose statistics.
DEA is straining at gnats and swallowing camels.
Diversion is an issue, but not in the context suggested by DEA. According to the National Survey on Drug Use and Health, 75 percent of all opioid misuse starts with people using medication that wasn’t prescribed for them — obtained from a friend, family member or dealer. However, there are no data to support the idea that further restriction of supply will change this dynamic. We are already seeing widespread reports of hospital shortages of analgesics needed in surgery. The proposed DEA action will only exacerbate these shortages while doing nothing to moderate the real public health problems of addiction and overdose death.
It is known from NIDA reports that addiction among medically managed patients is rare. Likewise, risk of opioid abuse or chronic opioid prescription is less than 0.6% among patients prescribed opioids after surgery. Fewer than 1% extend a prescription beyond 13 weeks. Many extended prescriptions reflect emergence of chronic pain due to failed surgery.
We also challenge the often heard hype that so many prescriptions are written that every American adult could receive a bottle of pills. Such statements are dangerously over-simplified anti-opioid propaganda. When prescribing patterns are analyzed among millions of chronic and intractable pain patients, it is found that volumes are insufficient to adequately medicate people for whom no other therapies work. There is emerging evidence that refusal of pain management is driving patients into unsafe street markets.
Thus, our message to the DEA is to stand down. You are chasing phantoms with supply restrictions which will harm millions of people while helping none.
Regards and well wishes,
Richard A. “Red” Lawhern, Ph.D.
Co-Founder and Corresponding Secretary, Alliance for the Treatment of Intractable Pain
(Editor’s Note: If you file a comment with the DEA, you are invited to leave a copy in our comments section to this story. Whatever you feel about the issue, it is important to have the voice of the chronic pain patient heard as public policy is drafted)