BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
FINAL IN 4 PART TOPIC SERIES
JULY 23, 2021
The American Medical Association wants a major overhaul to the CDC’s 2016 opioid prescription guidelines, charging that the guidelines are unintentionally harming patients and accelerating the opioid epidemic.
“Patients with painful conditions need to be treated as individuals,” Mukkamala wrote in a letter to the CDC Injury Center’s Board of Scientific Counselors. “
The U.S. opioid epidemic no longer appears to be primarily driven by opioid prescriptions, and the AMA pointed out that physicians reduced opioid prescribing by over 44% since 2012. However, the drug overdose epidemic has gotten worse, now primarily fueled by illicitly manufactured fentanyl, fentanyl analogs, heroin, methamphetamine, and cocaine—a development that AMA Board of Trustees Chairman Bobby Mukkamala, MD, argued was triggered by undertreatment of pain as a result of “arbitrary” dosing and quantity thresholds recommended in the 2016 guidelines.
“The AMA is urging the CDC to remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” the AMA wrote in a statement.
A major issue, according to the AMA’s June 2020 letter to the CDC, is that many states, health plans, and pharmacy chains misapplied the CDC guidance to institute strict, specific limits on opioid prescribing—for example, Walmart and CVS Caremark placed a 7-day hard threshold on prescribing,
and more than 30 states have enacted laws with opioid prescribing restrictions ranging from 3 to 14 days, including many with morphine milligram equivalents (MME) limits and other restrictions. “CDC’s threshold recommendations continue to be used against patients with pain to deny care,” Mukkamala wrote:
“We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”
- Much of the guideline’s supporting text was not balanced and was missing key studies, and it focused heavily on the risk and potential harms of opioids while paying less attention to the potential benefits, or the risks of not taking opioids or undertreating pain.
- There were several points at which the guidelines could be misapplied and potentially lead to patient harm.
- The guideline paid too little attention to racial/ethnic disparities and inequities in how pain is perceived, valued, and managed.
- While it is important to have opioid prescribing benchmarks, specific opioid dose thresholds can be misapplied as absolute cutoffs.
- Certain specific conditions are named in the guidelines, while others are not, potentially leading to interpretation regarding whether pain is “real” or “worthy” of certain types of treatment.
“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala told the Board of Scientific Counselors. “We have an opportunity here to care for these patients responsibly with your help.”
OCTOBER 05, 2021
OCTOBER 15, 2015
-CONTINUE-
Unnecessary secrecy and extremely limited opportunities to provide comments
FROM:
Robert Twillman, Ph.D., FAPM
Executive Director
American Academy of Pain Management
TO:
The Honorable Fred Upton
Chairman
House Energy and Commerce Committee United States House of Representatives Washington, DC
We acknowledge that, because the document in question is a guideline, and not a proposed rule, the ordinary standards for obtaining and considering feedback from anyone who wishes to comment do not apply.
We also note that members of the Senate Health, Education, Labor, and Pensions Committee have very recently expressed concern about government agencies using a guideline development process as a means of circumventing the standard requirements for transparency and public comment.
(http://www.help.senate.gov/chair/newsroom/press/senators-challenge-department- of-labor-regulatory-actions).
That said, we are at a loss to explain the extraordinary secrecy and extremely limited opportunities for comment attached to this guideline development process.
Within both the medical and regulatory fields, it is axiomatic that transparency and vigorous debate considering a wide variety of viewpoints produce the best results.
To that end, when most government regulatory bodies propose new policies, they fully disclose the expert consultants advising them, and they accept comments from a wide array of sources, allowing at least 30, and more often 90, days to receive those comments.
This allows all stakeholders concerned with the content of the proposed policy to
a) be aware of the proposal so they can ensure that their concerns are communicated, and b) have time to carefully consider and discuss the proposals so that they can offer well-reasoned comments and suggestions for approval.
Due to the strict secrecy and limited participation in the development process established by CDC in this case, neither of those was possible, except as it concerns the expert groups.
Consider:
- To this date, CDC has not publicly identified the members of any of the three expert groups
- Every communication we receive as a stakeholder group reminds us to maintain confidentialitywith respect to the content of the draft guideline
- The comment period provided to webinar participants was extraordinarily limited, to such anextent that it was challenging even for experts in this arena to construct well-reasonedcomments in time to submit them
- There will be no further review by stakeholders after the next draft of the guideline is written
- Comments received by CDC will be stripped of information identifying their source, and mayalso have their content edited so as to allow presentation of a summary of the comments, rather than the actual comments.
- This contrasts sharply with the practice of regulatory agencies that post all comments, with attribution, on their websites.
- In the end, this guideline doesn’t give us anything we don’t already haveAs our prior work with CDC demonstrated, there is no shortage of clinical practice guidelines, issued by a variety of professional organizations and regulatory bodies, with a variety of patient populations in mind.
- All of them are consensus guidelines, reflecting primarily the opinions of experienced clinicians because of the paucity of evidence regarding long-term use of opioids to treat chronic pain.
- The recommendations contained in the existing guidelines vary to some degree, but most of them are consistent with the recommendations in CDC’s draft guideline.
- So what have we accomplished, if CDC issues another such guideline?
- In one sense, we will have achieved nothing, because it won’t contribute something new to the discussion. In another sense, though, the potential for unintended negative consequences for people with pain is substantial.
Experience with similar clinical practice guidelines has shown that many clinicians treat them as rules, not as guidelines and that a substantial portion of primary care providers (the stated targets of this guideline) will simply opt to stop prescribing opioids to their patients with chronic pain. What will these people do to address their pain?
Our request:
In light of the concerns we have detailed here, we respectfully request that your committee looks into CDC’s actions with respect to this guideline development process. We think that questions need to be asked and answered, with respect to:
The poor-quality evidence underlying these “strongly recommended” “evidence-based” guidelines; the process of selecting experts to participate in the various groups involved in developing these guidelines; potential sources of undisclosed bias from a variety of sources;
The implications of CDC issuing a clinical practice guideline developed without the benefit of appropriate peer review, that could limit access to pain medications for people who benefit from them; and the reasoning behind the lack of transparency and opportunity for comment from the public found in this process.
Unless these questions are adequately addressed, the organizations with clinicians who strive to treat chronic pain, and in fact do so with opioids, will not support them but will, by necessity, be forced to actively oppose them, ensuring that clinicians understand why.
As we mentioned above, we believe that this is a situation in which transparency and robust academic debate will produce the best outcome. We urge you to strongly encourage CDC to withdraw this draft guideline and, should they decide to start over, to engage in a process that is more transparent and inclusive of the needs and views of all clinicians and patients—both those with pain and those who misuse opioid pain relievers.
Sincerely,
Robert Twillman, Ph.D., FAPM
Executive Director
American Academy of Pain Management
cc: The Honorable Frank Pallone, Jr. Ranking Member
House Energy and Commerce Committee
The Honorable Joseph R. Pitts
Chair, Health Subcommittee
House Energy and Commerce Committee
The Honorable Tim Murphy, Ph.D.
Chair, Oversight, and Investigations Subcommittee House Energy and Commerce Committee
FOR NOW, YOU ARE WITHIN
THE NORMS
