“We Are Licensed Physician, Pharmacists, Healthcare Providers Not Drug Dealers”
CDC LETTER TO WALTER F. WRENN III., MD
AUGUST 31, 2021
Dear Dr. Wrenn:
Thank you for contacting the Centers for Disease Control and Prevention (CDC) regarding the CDC’s
CDC’s mission is to protect the health and safety of all Americans. CDC is committed to supporting patient care and safe and effective pain management options. The purpose of the CDC 2016 Guideline is to support clinicians and patients to work together to create and maintain safe, consistent, and effective personal treatment plans. The recommendations in the CDC Guideline are voluntary, rather than prescriptive standards.
The Guideline includes practical information and provides recommendations about the appropriate prescribing of opioids to improve pain management and patient safety. The inclusion of morphine milligram equivalents (MME) thresholds such as 90MME are not intended to serve as hard limits, but rather as benchmarks to assist clinicians in assessing the risks and benefits to patients and weighing factors such as diagnosis, other treatments, effectiveness, and recommendations based on consultation with pain specialists.
The Guideline does not recommend abrupt, involuntary, or rapid opioid dose reduction or discontinuation to physicians. As noted in the Guideline, such actions can result in patient harm, including withdrawal symptoms, damage to the clinician-patient relationship, and patients obtaining opioids from other sources. The Guideline emphasizes that clinicians have a responsibility to carefully manage opioid therapy and not abandon patients.
Although many providers, health systems, quality-improvement organizations, payers, and states have made efforts to improve opioid prescribing practices and reduce opioid misuse and overdose, CDC recognizes that some policies and practices that cite the Guideline are inconsistent with, and go beyond, its recommendations.
Guideline for Prescribing Opioids for Chronic Pain — the United States, 2016 (Guideline,
www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf).
On April 24, 2019, CDC published a commentary in the New England Journal of Medicine, “No Shortcuts to Safer Opioid Prescribing.” In the commentary, the authors outline examples of misapplication of the Guideline and highlight sections from the Guideline that are sometimes overlooked but are critical for safe and effective implementation of the recommendations, including misapplication of recommendations to populations outside the Guideline’s scope; misapplication of the Guideline’s dosage recommendation that results in hard limits; and misapplication of the Guideline’s duration recommendation that results in ‘cutting off’ opioids or abrupt tapering.
CDC is not a regulatory agency and does not mandate or require implementation of the Guideline. Regardless of specialty, no one is required by CDC to follow the Guideline. This is true for both pain clinics and primary care providers. The Guideline is intended to help clinicians provide safe and effective pain management treatment for their patients, including prescribing opioids when the benefits of opioids outweigh the risks. The Guideline is not a regulation or law, but rather a set of recommendations for primary care providers. The recommendations in the Guideline are voluntary and are intended to support informed clinical decision-making in the context of the provider-patient relationship.
The Guideline emphasizes that doctors should consider the circumstances and unique needs of each patient when providing care. Patient safety is our top concern, and CDC encourages providers and patients to carefully consider both the benefits and serious risks of these medications in making decisions about chronic pain management. Some patients may be on an appropriate opioid therapy for their situation, and that should be considered as part of their care plan. Clinical decision-making should be based on a relationship between the doctor and patient, and an understanding of the patient’s clinical situation, functioning, and life context.
The Guideline is not intended to take away physician discretion and decision-making, but it is designed to help physicians assess how to safely maintain or discontinue opioid use in patients who are currently on an opioid treatment plan or start opioids safely if necessary. CDC is updating the Guideline and carefully considering how Guideline recommendations are framed and written to ensure proper application and to avoid misinterpretation. Information on the specific Guideline recommendations, risks and benefits, and other topics are located here for your reference:
https://www.cdc.gov/opioids/providers/prescribing/clinical-tools.html
We appreciate your interest in this important public health issue and hope you find this information helpful.
Sincerely,
Sandra Cashman, MS
Executive Secretary Office of the Chief of Staff, CDC
Comments by M. Renee Blare, RPh (licensed but disabled pharmacist of Wyoming) — 5th to Comment of Public Comments
CDC’s letter to Walter F. Wrenn III MD:
“CDC is not a regulatory agency and does not mandate or require implementation of the Guideline.”
“Good afternoon, ladies and gentlemen and thank you for the opportunity to comment today. My name is Margaret Renee Blare. I am from Newcastle, Wyoming and I represent the Chronic Pain Alliance of the West and the National Pain Council.
“I am a twenty-five year licensed pharmacist with the State of Wyoming and I became disabled in July of 2019 from Complex Regional Pain Syndrome, Type 2 or Causalgia.
CDC’s letter to Walter F. Wrenn III MD:
CDC’s mission is to protect the health and safety of all Americans. CDC is committed to supporting patient care and safe and effective pain management options. The purpose of the CDC 2016 Guideline is to support clinicians and patients to work together to create and maintain safe, consistent, and effective personal treatment plans.
“In 2015, the CDC released the 2016 Guidelines being revisited and discussed here today. They impacted veterans, Native Americans, and public healthcare similar to the implementation of the “5th Vital Sign” in the late 90’s— with devastating consequences.
CDC’s letter to Walter F. Wrenn III MD:
“Patient safety is our top concern, and CDC encourages providers and patients to carefully consider both the benefits and serious risks of these medications in making decisions about chronic pain management.”
“My clinical experience includes Veterans Health Administration at the VA, Indian Health Service, retail, hospital at the staff level, ADPAC, and managerial. I am practiced with Veterans, Native Americans, and most races and cultures of this country.
CDC’s letter to Walter F. Wrenn MD:
“Some patients may be on an appropriate opioid therapy for their situation, and that should be considered as part of their care plan.”
“My comments today come from the viewpoint as a healthcare provider and a rare and severe pain patient. I am open to questions at the end of my statement.”
——
CDC’s letter to Walter F. Wrenn III MD:
“The Guideline is not a regulation or law, but rather a set of recommendations for primary care providers. The recommendations in the Guideline are voluntary and are intended to support informed clinical decision-making in the context of the provider-patient relationship.”
“Escalating suicide and overdose rates, misapplication of the guidelines by political, state, and federal agencies including the DEA, led to a traumatic impact on chronic, severe pain patients in America including rare disease, post-surgical, and disabled patients.
CDC’s letter to Walter F. Wrenn III, MD:
“The Guideline emphasizes that doctors should consider the circumstances and unique needs of each patient when providing care. Patient safety is our top concern, and CDC encourages providers and patients to carefully consider both the benefits and serious risks of these medications in making decisions about chronic pain management.”
“Regardless of specialty, no one is required by CDC to follow the Guideline.”
“The last seven years have led to the destruction of Wyoming’s severe pain and rare disease healthcare. The medical patient in this class has little to no options or access to care while their specialists have “retired,” left the state, stopped practicing, been incarcerated by the DEA, or ceased to prescribe opioids at all due to restrictions to their DEA license. In addition, the suicide rate in Wyoming overall has climbed to dramatically past the overall rate of 17% this year.
CDC’s letter to Walter F. Wrenn III., MD:
“The Guideline is not intended to take away physician discretion and decision-making, but it is designed to help physicians assess how to safely maintain or discontinue opioid use in patients who are currently on an opioid treatment plan or start opioids safely if necessary.“
CDC’s letter to Walter Wrenn MD:
“Although many providers, health systems, quality-improvement organizations, payers, and states have made efforts to improve opioid prescribing practices and reduce opioid misuse and overdose, CDC recognizes that some policies and practices that cite the Guideline are inconsistent with, and go beyond its recommendations.”
“No matter the intent, goal, or method that the CDC may desire with these guidelines and their purpose and the American Healthcare System, the DEA will still manipulate them to their own desires and intent.
“As long as they (the guidelines) exist, they can and will be “misapplied.” I contend the only way to stop the drastic harm to patients, providers, and the system is to repeal the guidelines and trust the system. PUBLISH, ADVISE, BUT DO NOT REGULATE.
CDC’s letter to Walter Wrenn MD:
“CDC is updating the Guideline and carefully considering how Guideline recommendations are framed and written to ensure proper application and to avoid misinterpretation. Information on the specific Guideline recommendations, risks and benefits, and other topics are located here for your reference:”
https://www.cdc.gov/opioids/providers/prescribing/clinical-tools.html
Thank you for your time,”
M. Renee Blare, R.Ph. (Disabled)
CDC SHOULD HAVE NEVER ISSUED GUIDELINES FDA IS THE GOVERNMENT AGENCY
Over the last several years there has been an increase in arrests, convictions, and incarceration of physicians who prescribe opiate pain medications. This increase is associated with the 2016 CDC guidelines and the misapplication of those guidelines by DOJ/DEA.
In the guidelines 90 MME’s is mentioned as a goal. The DOJ/DEA has decided that these are not guidelines but laws or rules.
At a recent trial, the government’s star witness Dr. Timothy King said that 90 MME’S was the ” absolute ” threshold when prescribing opiate pain medication. Nothing could be further from the truth.
CDC’s letter to Walter Wrenn MD:
“The Guideline includes practical information and provides recommendations about the appropriate prescribing of opioids to improve pain management and patient safety.
The inclusion of morphine milligram equivalents (MME) thresholds such as 90MME are not intended to serve as hard limits, but rather as benchmarks to assist clinicians in assessing the risks and benefits to patients and weighing factors such as diagnosis, other treatments, effectiveness, and recommendations based on consultation with pain specialists.”
I have enclosed an official statement from the CDC regarding the 2016 guidelines and its misapplication.
Jeff Singer MD, Cato Institute podcasts on “Following the Science:” On the “junk science behind Morphine Milligram Equivalent (MME):”
https://www.cato.org/multimedia/cato-daily-podcast/follow-science-opioids
The AMA has written several articles questioning the validity of this measurement. The CDC should never have issued guidelines concerning medications in the first place. The FDA is the government agency responsible for approving medications.
FOR NOW, YOU ARE WITHIN
THE NORMS
Guideline Resources, Provider and Partner Tools:
https://www.cdc.gov/opioids/providers/index.html
Clinical Tools for Providers:
More information on the specific Guideline recommendations:
https://www.cdc.gov/opioids/providers/prescribing/guideline.html
