BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., MARTIN NDJOU, RPH., WALTER L. SMITH BS., MS., TYRONE HUMBLES, SHELLEY HIGHTOWER PHARMD, ALFRED EVANS RPH., MS., ADRIENE EDMUNDSON, LYNN MICHELLE CLARK, BELINDA PARKER-BROWN, REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, DEBRA LYNN SHEPHERD, BS., CUDJOE WILDING, BERES E. MUSCHETT, STRATEGIC ADVISOR
Bishop Lester Love, City of Love Temple New Orleans ________
“THE UNINFORMED WILL ALWAYS BE ON THE WRONG SIDE”
Norman J Clement, Aaron Howard, Lynn Michelle Clark, Rick Fertil demand the return of our DEA pharmacy Control Substance Registrations Immediately.
DEHUMANIZATION OF PEOPLE AND WITHHOLDING HEALTHCARE
https://www.wesh.com/article/special-report-pharmacies-denying-legitimate-prescriptions/4439866#
STATEMENT OF FACTS
The story of how the “War on Drugs” is being used to target Black family-owned pharmacies and how a small group of these pharmacist-owners, (grads of FLORIDA A&M UNIVERSITY,) who had found themselves, victims of targetted designed racist DEA policies, are fighting back every day because Black pharmacist lives do Matter too.
CHIEF COMPLAINT
“It has been said many times, there are two systems of Justice in America… however, we must include the third system of injustice, FOR UPPITY, ARROGANT NEGROES, THOSE WHO DARE TO BECOME EDUCATED IN MEDICINE.”
” Let it further be recognized patients being treated for chronic pain who travel to a Black-owned pharmacy are called “RED FLAGS” by DEA, Florida DOH, and these pharmacies are classified as imminent dangers to the “Public Health.” While the same patients traveling to non-black owned pharmacies, with the same prescriptions, using the exact same payment methodology, the fictitious label of “red flags” does not exist.”
“WE ARE PHARMACIST NOT DRUG DEALERS”
THE DEA’S BIG LIE
DEA USED TO TARGET AND DISRUPTED PROTESTORS OF GEORGE FLOYD DEATH, OPERATING OUTSIDE THE SCOPE OF THEIR MISSION
According to Frank Figliuzzi, former Assistant Director for Counterintelligence at the Federal Bureau of Investigation states:
”We are in trouble the DEA has been given permission investigate people protesting George Floyd’s death” (HEAR BELOW VIDEO FRANK FIGLIUZZI/XM-127- STEPHANIE MILLER SHOW)
FORMER FBI INTELL EXPOSES DEA BEING USED SPY ON PROTESTORS
The Drug Enforcement Administration has been granted sweeping new authority to “conduct covert surveillance” and collect intelligence on people participating in protests over the police killing of George Floyd, according to a two-page memorandum obtained by BuzzFeed News.
The DEA is limited by statute to enforcing drug-related federal crimes. But on Sunday, Timothy Shea, a former US attorney and close confidant of Barr’s who was named acting administrator of the DEA last month, received approval from Associate Deputy Attorney General Bradley Weinsheimer to go beyond the agency’s mandate “to perform other law enforcement duties” that Barr may “deem appropriate.”
Citing the protests, Shea laid out an argument for why the agency should be granted extraordinary latitude.
“In order for DEA to assist to the maximum extent possible in the federal law enforcement response to protests which devolve into violations of federal law, DEA requests that it be designated to enforce any federal crime committed as a result of protests over the death of George Floyd,” Shea wrote in the memo. “DEA requests this authority on a nationwide basis for a period of fourteen days.”
SEE ORIGINAL LETTER IN BUZZ FEED LINK BELOW:
Drug Enforcement Administration f: mvw. don. gov MEMORANDUM FOR THE DEPUTY ATTORNEY GENERAL FROM: Timothy J. Shea Acting Administrator SUBJECT: Drug Enforcement Administration (DEA)
Request for Temporary Designation of Non?Title 21 Authority Pursuant to 21 USC- 8T3(a}(5) PURPOSE: Approval of Temporary Designation of Non?Title 21 law Enforcement Authority ’11th TABLE: Irrunediate
SYNOPSIS: This memorandum seeks approval for the DEA to provide support on a nationwide basis to enforce federal criminal laws in the wake of protests arising from the death of George Floyd- DEA requests this authority on a nationwide basis for a period of fourteen days commencing immediately. DISCUSSION: On May 25, 2020, George Floyd died in Minneapolis, Minnesota, after a police officer kept his knee on the right side of Mr. Floyd’s neck for over eight minutes while Mr. Floyd was handcuffed and lying face down on a city street [hiring an arrest. This incident has spawned widespread protests across the nation, which, in some instances, have included violence and looting. Police agencies in certain areas of the country have struggled to maintain and for restore order- DEA investigative authority, as set forth in 28 CPR. 0.100 and in the Controlled Substances Act. is limited to enforcing Federal crimes related to drugs. As the federal crimes being committed in the wake of Mr. Floyd’s death are largely not drug-related, DEA’s ability to assist our counterparts is limited. Under 21 U-S-C- however, the Attorney General is authorized to designate DEA to perform other law enforcement duties as he may deem appropriate. Accordingly, in order for DEA to assist to the maximum extent possible in the federal law enforcement response to protests which devolve into violations of federal law, DEA requests that it be designated to enforce any federal crime committed as a result of protests over the death of George Floyd- DEA requests this authority on a nationwide basis for a period of fourteen days- If this request is granted, DEA Special Agents and Task Force Officers will, as necessary (1) conduct covert surveillance and protect against threats to public safety; (2) share intelligence with federal, state, local, and tribal counterparts; (3) if necessary, intervene as Federal law enforcement officers to protect both participants and spectators in the protests; and (4) if necessary, engage in investigative and enforcement activity including, but not limited to, conducting interviews, conducting searches. and making arrests for violations of Federal law. – The Attorney General has the authority to assign non-Title 21 enforcement duties to the DEA under 21 [1.513. which provides= in pertinent part, that the Attorney General may authorize any officer or employee of the DEA to perform such other lavIenforcement duties as the Attorney General may designate.” This authority has been delegated to the Deputy Attorney CFR 0-15-
RECOMMENDATION: I hereby certify that this temporary delegation of non-Title 21 law enforcement authority is necessary for the conduct of the activity to which it relates and that the activity is necessary for the public safety and welfare. Therefore, your authorization and approval of the described operation is requested GERARD our: man Concurring Comments None DISAPPROVE: Non continuing Components. None
As reported by Buzz Feed News:
https://www.buzzfeednews.com/article/jasonleopold/george-floyd-police-brutality-protests-government
“The Justice Department gave the agency the temporary power to enforce any federal crime committed as a result of the protests over the death of George Floyd”
RESEARCH BIAS IN MEDICAL SCIENCE SUCH AS REPORTED IN NEW YORK TIMES DECEMBER 5, 2019 BECOMES ACCEPTED SCIENCE WHEN BLACK MEDICAL ORGANIZATIONS FAIL TO PUSH BACK
One of the most troubling examples of research bias appeared on December 5, 2019, New York Times on ” A Rare Case Where Racial Biases,’ Protected African-Americans.
“A ‘Rare Case Where Racial Biases’ Protected African-Americans“
Fewer opioid prescriptions meant fewer deaths (possibly 14,000), but the episode also reveals how prevalent and harmful stereotypes can be, even if implicit.
By Austin Frakt and Toni Monkovic
- Published Nov. 25, 2019
Updated Dec. 2, 2019
“When the opioid crisis began to escalate some 20 years ago, many African-Americans had a layer of protection against it.
But that protection didn’t come from the effectiveness of the American medical system. Instead, researchers believe, it came from racial stereotypes embedded within that system.
As unlikely as it may seem, these negative stereotypes appear to have shielded many African-Americans from fatal prescription opioid overdoses. This is not a new finding. But for the first time an analysis has put a number behind it, projecting that around 14,000 black Americans would have diedhad their mortality rates related to prescription opioids been equivalent to that of white Americans.
Starting in the 1990s, new prescription opioids were marketed more aggressively in white rural areas, where pain drug prescriptions were already high. African-Americans received fewer opioid prescriptions, some researchers think, because doctors believed, contrary to fact, that black people 1) were more likely to become addicted to the drugs 2) would be more likely to sell the drugs and 3) had a higher pain threshold than white people because they were biologically different.
A fourth possibility is that some white doctors were more empathetic to the pain of people who were like them, and less empathetic to those who weren’t. Some of this bias “can be unconscious,” said Dr. Andrew Kolodny, a director of opioid policy research at Brandeis University.
This accidental benefit for African-Americans is far outweighed by the long history of harm they have endured from inferior health care, including infamous episodes like the Tuskegee study. And it doesn’t remedy the way damaging stereotypes continue to influence aspects of medical practice today. “The reason to study this further is twofold,” Dr. Kolodny said. “It’s easy to imagine the harm that could come to blacks in the future, and we need to know what went wrong with whites, and how they were left exposed” to overprescribing.
The prescription-opioid-related mortality rates of black and white Americans were relatively similar two decades ago, but researchers found that by 2010, the rate was two times higher for whites than for African-Americans.”
NO AMOUNT OF PREJUDICES CAN JUSTIFY RACISM IN MEDICAL CARE
There is absolutely no amount of prejudice, that can be justified, in any form of medical care treatment to support racism. Andrew Kolodny MD, has worked as an adviser to DEA, NIH, CDC, and has testified numerous times before the United States House and Senate. Dr. Kolodny’s opinions have shaped United States drug policy as well that found in academia, however, they are seriously flawed.
Dr. Kolodny’s thinkings allow for the withholding and or the denial of medical care, based upon a preconceived racial bias, supported by a foundation of erroneous science. The assertions and conclusions drawn by Dr. Andrew Kolodny and those who conducted this research are seriously flawed and further demonstrates how bias undermines healthcare for all Black people. These misconceptions are ingrained in people at a young age, too, according to Dore, Hoffman, Trawalter et. al., Researchers who asked black and white children to rate each other’s pain determined they’d adopted a“weak racial bias” by 7 years old and a“strong and reliable” bias by 10 years old.
Yet, more disturbingly, there has been very little push-back from Black professional medical organizations, academia, journal, and media debunking these medical stereotypes Dr. Andrew Kolodny et al., have been promoting. The utter silence upon those who profess to represent the concerns of people of color further highlights the saying, “silence is interpreted as consent” and“when one is not present at the table then one is on the menu.”
THE DEPARTMENT OF JUSTICE UNDERMINES YOUR HEALTHCARE:” A Case Against Walmart Mocks Justice – WSJ”
by Michael Krauss
DECEMBER 27, 2020
Alcohol sales to adults are legal in all 50 states, and some substantial percentage of legally purchased alcohol is consumed by alcoholics, to their and society’s detriment. Imagine a federal lawsuit against a grocery chain for selling beer to adults without protecting alcoholics from buying it. Such a case would be groundless: No federal law limits beer sales to adults in this way.
The Justice Department last week announced a similarly groundless civil suit against Walmart.The complaint alleges that the chain’s 5,000-plus pharmacies fueled the opioid crisis by “unlawfully” filling prescriptions.
Like the hypothetical beer case, this case against Walmart mocks the rule of law. State laws require pharmacists to fill prescriptions that have been validly written by qualified medical practitioners. Pharmacists lack the expertise to second-guess doctors’ judgments about the appropriate necessity of a medication and the proper dosing for a particular patient. To write a prescription for a controlled substance—which includes all opioids—a physician must be qualified by the Drug Enforcement Administration, and Walmart complies with that federal rule.
The federal government sues the chain for filling valid prescriptions in compliance with state law.
— Read on www.wsj.com/articles/a-case-against-walmart-mocks-justice-11609103413
When Walmart pharmacists have hesitated to fill legally written opioid prescriptions, they have often been subjected to state sanctions. The president of the Texas Medical Board threatened to issue “cease and desist orders” against pharmacists who “change amounts of opioids prescribed” or “override” a physician’s judgment, on grounds that doing so constitutes practicing medicine without a license. Wisconsin’s Board of Pharmacy threatened disciplinary action against a Walmart pharmacy because it “informed a local clinic that the Pharmacy would no longer fill controlled substance prescriptions from that clinic due to concerns of overprescribing.” Complaints against Walmart and its pharmacists for refusing to fill opioid prescriptions have been filed with or pursued by pharmacy boards in Alaska, Arkansas, Colorado, Idaho, Kansas, Maryland, Missouri, New Hampshire, Ohio, Oregon, Pennsylvania, Tennessee, and West Virginia.
Under the Constitution’s Supremacy Clause, when there’s a contradiction between valid federal and state law, the former prevails. But there’s no federal law requiring that Walmart pharmacists refuse to fill prescriptions that state law requires them to fill. The Controlled Substances Act creates only two circumstances in which pharmacists commit a federal crime by filling facially valid prescriptions for controlled substances.
First, if they “knowingly fill” a prescription that wasn’t issued by a doctor “in the usual course of professional treatment”—for instance, if a doctor hands out his entire Rx pad without examining any patient. Second, if they fill a prescription outside the “usual course of” pharmacy practice—for instance, if a “pill mill” dispenses opioids without checking the DEA number of the prescribing doctor. Not only isn’t Walmart being sued for such infractions; it has adopted innovative opioid-stewardship programs and worked with law enforcement agencies including the DEA to root out corrupt doctors.
The Justice Department alleges Walmart isn’t rigorous enough in checking facially valid opioid prescriptions written by DEA-authorized physicians. If this is a problem, let the DEA propose specific regulations requiring pharmacies to conduct increased diligence before filling any opioid prescription. Before being adopted, costs and benefits of such regulations would be subjected to public scrutiny. These rules would require pharmacies to violate state law, and if adopted they would be enforceable under the Supremacy Clause. Until this happens, it’s a travesty to blame Walmart for complying with state law.
Mr. Krauss is a professor emeritus at George Mason’s Scalia Law School.
THE CDC DEA NIH GUIDELINES ARE WRONG AND REPRESENT A BROAD MISCLASSIFICATION OF NARCOTIC ANALGESIC MEDICATIONS
According to research done by Dr. Richard Lawhern,
“The basic premises of the 2016 CDC guidelines on the prescription of opioid analgesics to adults with chronic non-cancer pain are wrong. And CDC KNOWS they are wrong!
Higher overdose mortality from 2010-2020 is a direct outgrowth of socioeconomic factors and the invasion of illegal Fentanyl into US street markets. We also know from State-level analysis of Prescription Drug Monitoring Programs data that when a prescription-type opioid is found in postmortem toxicity screens, it is likely to be only one substance among several, including illegal or diverted drugs and alcohol. Our “drug crisis” is driven by illegal drugs, not prescriptions.”(4)
Doctors who treat pain are NOT at fault in the opioid crisis. They never were. CDC policy seeking to force restrictions on opioid prescribing — at a huge and growing cost to patients — must change NOW, not a year from now. “
THE OPIOID CRISIS IN THREE CHARTS
In a 2017 report by Dr. Richard Lawhern, The Opioid Crisis in Three Charts”. These were published last year in a paper on Dr. Lynn Webster’s blog, and I’ve used them repeatedly in other published work, including a June 2019 editorial in the respected STAT News within the Boston Globe Group. (5),(6)
Taken together, these charts demonstrate that over-prescribing did not cause and is not sustaining our so-called “opioid epidemic”. The original data were published by the US CDC Wonder Database and the National Multiple Cause of Death database. But CDC has actively refused ever to publish these data together in one place to allow an assessment of the implications for policy. I regard this refusal as gross malfeasance.
From data published by CDC, we know that opioids are prescribed three to six times more often among seniors over age 62 than they are to youth under age 19. But overdose-related mortality in youth is three to six times higher than in seniors. Mortality has been stable for the past 17 years in seniors while it has skyrocketed in youth. More basically, there is simply no cause-and-effect relationship between State-by-State prescribing rates versus overdose mortality. Although mortality has risen sharply since 2010, it remains below national average in States with the highest medical prescribing rates.
In short, the basic premises of the 2016 CDC guidelines on the prescription of opioid analgesics to adults with chronic non-cancer pain are wrong. And CDC KNOWS they are wrong!
Higher overdose mortality from 2010-2020 is a direct outgrowth of socioeconomic factors and the invasion of illegal Fentanyl into US street markets. We also know from State-level analysis of PDMP data that when a prescription-type opioid is found in postmortem toxicity screens, it is likely to be only one substance among several, including illegal or diverted drugs and alcohol.
Doctors who treat pain are NOT at fault in the opioid crisis. They never were. CDC policy seeking to force restrictions on opioid prescribing — at a huge and growing cost to patients — must change NOW, not a year from now.
Methodological Errors in “Treatments for Acute Pain – A Systematic Review” (AHRQ)
By Richard A Lawhern PhD
January 2021
Abstract:
This paper expands on comments by the author, offered to a September 2020 circulated draft of Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review 240, titled “Treatments for Acute Pain: A Systematic Review” [Ref 1, 2]. Author’s original comments to the draft were transmitted online to AHRQ and by email to the Director and senior staff of the Agency. This updated communication presents an evidentiary basis for a mandatory and substantial revision of Comparative Effectiveness Review 240 by AHRQ, followed by a window for public comments, before its republication. There is no other recourse to mitigate stigmatizing depictions of patients in pain who require opioid analgesia, as well as misleading and false interpretations of available opioid trials incorporated into the recently published review.
Analysis of Medical Evidence
From the AHRQ Report Structured Abstract: “Meta-analyses were conducted on pharmacologic therapy for dental pain and kidney stone pain, and likelihood of repeat or rescue medication use and adverse events….”
“Results: One hundred eighty-three RCTs on the comparative effectiveness of therapies for acute pain were included. Opioid therapy was probably less effective than nonsteroidal anti-inflammatory drugs (NSAIDs) for surgical dental pain and kidney stones, and might be similarly effective as NSAIDs for low back pain.”
Author’s comments:
Study Design [Ref 3, 4]
In meta-analyses, mean changes from baseline to post-treatment on pain measures are pooled for the opioid and comparator, from which pooled opioid–comparator group differences are derived.
Randomized controlled trials (RCTs) and meta-analyses measure central tendency, with a core assumption and necessary pre-condition being normal distribution (e.g., the “bell-shaped curve”) in treatment/comparator/placebo response.
Analgesic response in chronic pain patients shows bimodal distribution with pain reduction either substantial or near-absent/absent. Bimodal distribution in opioid response appears within 2-4 weeks of randomization and treatment initiation. [Ref 3] A clinical population with bimodal distribution in treatment response violates the core assumption of normal distribution in RCTs and meta-analyses.
Meta-analyses and systematic reviews, when appropriately used, are powerful tools for understanding efficacy and safety in many areas of medicine. However, few understand that they are not useful in analgesic response. With meta-analyses and systematic reviews, the authors decide what is “evidence.” Roger Chou MD was a lead author of the 2016 CDC Guideline and its derivative systematic review – a document considered by many patients and medical professionals to be the exemplar of conclusions based on evidence selected and defined with prejudicial intent.
The conclusions of the December 2020 AHRQ review are not helpful to clinicians treating pain patients. This Review should be disqualified from incorporation in ongoing efforts by the CDC to expand and revise its 2016 guidelines for prescription of opioids to adults with chronic non-cancer pain.
Opioid Selection [Ref 6-8]
Excluding (1) trials in acute renal colic pain with parenteral delivery of opioid and nonopioid, and (2) trials comparing opioid agonists to multimodal (e.g., tapentadol) or partial agonist (e.g., buprenorphine) opioids, 47 trials reported in this review compared opioids to NSAIDs or acetaminophen, with codeine or tramadol as the selected opioid:
All oral opioid vs NSAIDs or acetaminophen comparisons: 38 of 47 trials (80.8%)
Acute post-operative pain: 5 of 11 trials (45.5%)
Acute low back, musculoskeletal, and dental pain: 33 of 36 trials (91.6%)
Thus, in trials comparing opioids to NSAIDs or acetaminophen (excluding parenteral delivery), the selected opioid was codeine or tramadol in 80.8% of trials overall, and in 91.6% of acute low back, musculoskeletal, and dental pain trials. There are several implications in this selection:
- Codeine and tramadol are both weak opioid analgesics. Both require hepatic enzymatic conversion to an active analgesic metabolite. A significant proportion of the patient population possesses a genetic variation of cytochrome 2D6 that causes polymorphism. Consequently, these individuals poorly convert codeine or tramadol, and experience side effects rather than analgesia. For this reason, codeine has fallen into relative disuse in pain management practice.
- Genetic variation in CYP450 expression alters opioid pharmacokinetics and may contribute to bimodal distribution in opioid response, along with pharmacodynamic variation and other factors.
- Codeine and tramadol account for most (80.8%) oral opioid comparisons to NSAIDs or acetaminophen, and nearly all (91.6%) in acute low back, musculoskeletal, and dental pain. This needs to be stated clearly in the report, perhaps in this form:
“Weak Prodrug Opioids Accounted for >80% of Oral Opioid Comparisons to NSAIDs or Acetaminophen overall, and 91.6% in Acute Low Back, MSK and Dental Pain.”
- Obvious, yet repeatedly ignored in this and other AHRQ reviews authored by Chou et al., is that meta-analyses are unsuited for evaluating the efficacy of opioids, which require a tailored approach to balance response and side effects.
Additional Discussion
From the AHRQ Report Background:
“The key decisional dilemma in acute pain management involves selection of interventions to provide adequate pain relief, in order to improve quality of life, improve function, and facilitate recovery, while minimizing adverse effects and avoiding overprescribing of opioids.8 Evidence also suggests that adequate acute pain treatment may mitigate factors that promote the transition to chronic pain.3,9,10 However, shortcomings in acute pain care have been documented.11,12 In addition to the underlying cause of pain, patient factors that impact acute pain management include age, sex, race/ethnicity, pain severity, comorbidities (including mental health and substance use), genetic factors, pregnancy, or breastfeeding status.13-16 Timing of presentation and clinical setting can also influence acute pain management. For example, postoperative pain occurs at a specific point in time and is often managed with multimodal strategies in a monitored setting prior to discharge, whereas in outpatient clinic settings, timing of presentation of acute pain is variable, and assessing treatment response is often not feasible. Additionally, access and care options may vary.2,8 Different acute pain conditions (e.g., musculoskeletal pain, neuropathic pain, or visceral pain) may respond differently to treatments. Therefore, a treatment that is effective for one acute pain condition and patient in a particular setting may not be effective in others.” [Reference numbers in the original report]
Author’s Comments:It is highly revealing that despite this acknowledgement of the complexities of evaluating pain therapies, the AHRQ authors proceed to merge data of doubtful quality and to generalize their conclusions using terms such as “probably” and “might be”. A section on “Research Gaps” in both the draft and the final report briefly mentions a wide range of confounding factors – which are then ignored as the authors race to their pre-ordained conclusions, attempting to disqualify prescription opioid analgesics from use in acute pain. A far more supportable conclusion from this review is that the present state of medical literature lacks sufficient rigor and repeatability to arrive at any conclusions at all concerning best practices.
In this context, the following observations apply:
- While the investigators’ desire to limit the scope of their “comprehensive review” is understandable, exclusion of German language studies from the AHRQ review is a significant omission. The German government has invested major resources in evaluating opioid and non-opioid therapies.
- Ketorolac has strong analgesic potency that may be predicted to surpass that of Codeine or Tramadol in four comparative trials reported. Such a match-up seems inappropriate.
- Due to risks of GI toxicity, use of Ketorolac for longer than 6 days is contra-indicated on the FDA information label for this medication. How these patients with persistent pain should be managed is unclear. This significant limitation in “real-world” clinical practice is obscured by meta-analyses and similar big-data methods, and should be highlighted as a basis for disqualifying the selected studies.
- Likewise, all NSAIDs, even with acute use, are associated with potentially serious GI toxicity. Such side effects are nowhere discussed in the published Review.
For acute post-operative pain, it is unclear from the AHRQ report how or in what sense the performance of opioids is “no better” than that of NSAIDs. The Review notes an abundance of limitations which are then ignored in its conclusions:
— “Evidence on how comparative effectiveness and harms of opioid therapy for postoperative pain vary according to patient and prescribing factors was lacking. The number of trials was small for each comparison and most trials had small sample sizes… No study [was] conducted within-study or across-study evaluations of subgroup effects. Evidence was too limited to determine effects of different opioid doses (converted into morphine milligram equivalents) on comparative effectiveness and harms. The trials did not evaluate how effectiveness varied in subgroups defined according to the amount of opioid used.”
Also of note, no trial permitted opioid refills despite study durations up 15 days. This omission increases the potential of poorly or uncontrolled pain at final assessment, improperly biasing conclusions toward opioids being ineffective.
- Two large retrospective studies are interpreted in the Review to claim that compared to persons not prescribed opioids, opioids for acute post-op pain impose “risks” of long-term opioid use – in one study 7.7% of patients at 1-year follow-up. The other study described the proportion of patients with opioid fills 90 to 180 days post-surgery (7.1%); opioid use lasting 90+ days in the period from 180 days post-surgery (1.0%) and either 10 or more opioid fills or 120 or more days’ supply (0.46%). As noted in the Review, such studies cannot “adjust for factors not available in administrative claims, such as pain severity, functional status, level of psychiatric distress, or other measures of clinical status following surgery.” [emphasisby the author] These omissions are essentially disqualifying in the context of the AHRQ Comparative Outcomes Review
- That retrospective evidence was allowed for opioid harms, and disallowed for opioid benefits, is telling. Post-surgical pain is a prevalent origin of chronic, life-altering pain. The discourse in this review stigmatizes patients experiencing persistent pain who require opioid analgesia. The Review section using retrospective data needs to be deleted.
- The author suggests that post-operative use of opioids at one year is not a “risk”, but rather an “incidence” related to emergence of chronic pain from failed procedures. Long-term pain is often a consequence of poor analgesic control in the peri-operative or acute post-operative setting. In most patients, pain that becomes chronic is perpetuated by CNS alteration, divorced from peripheral nociceptive input from the original tissue injury. This makes prevention of chronic pain through aggressive analgesic control — which may include opioids — an imperative of practice.
Chronic pain resulting from inadequate control of acute/post-acute pain is no less iatrogenic than recklessly exaggerated claims of opioid use disorder following prescribed opioids. For individuals with OUD, efforts are made to ease access to opioid agonist maintenance. By sharp contrast, patients with chronic pain are punished for needing opioid pain control in the hostile regulatory environment fostered by CDC’s 2016 guideline on opioid prescribing in adults with chronic non-cancer pain.
Contrary to the insinuations of the AHRQ report authors, prescription opioid analgesics do not“cause” addiction in patients who are not already predisposed by other factors. [Ref 4] When pain in the peri-operative period is sufficient to require opioid analgesia, it is to be expected that a diminishing proportion of patients will need opioid pain control over time, with a smaller subgroup in whom pain has become chronic being continued on opioids as the only therapeutic measure that provides sufficient pain management. This reality of practice is ignored – or perhaps deliberately suppressed – in the AHRQ comparative review.
- Genetic polymorphism may be a sufficiently strong effect to account for the bimodal structure of patient responses to opioids. It is at least plausible that poor metabolizers and hyper-metabolizers can explain the low effectiveness of low-dose opioids in millions of patients, while “normal” metabolizers experience significantly better outcomes. Although the AHRQ authors reference two papers that address these effects, they exclude any serious discussion of findings in those papers. Other papers they do not reference are also pertinent. [Ref 5 – Ref 9]
Conclusions
The published version of AHRQ Comparative Effectiveness Review 240 incorporates multiple and disabling errors of analytic methodology. Arguably, the authors of this review have also cherry-picked and misinterpreted data in a manner that reflects a profound and unjustified bias against treatment of either acute or chronic pain by means of prescription opioids. For these reasons, the report must be withdrawn immediately for an independent review by professionals qualified in statistical methods and epidemiology. Given the checkered history of this document, the representation of patients and their advocates should be considered mandatory. The revised AHRQ Review should then be submitted to the Federal Register for a 60-day public review and comment period, followed by a published AHRQ summary of comments.
References
[Ref 1] Roger Chou, Jesse Wagner, Azrah Y Ahmed, et al, “Treatments for Acute Pain: A Systematic Review”, Agency for Healthcare Research and Quality, AHRQ Publication No. 20(21)-EHC006, December 2020.
[Ref 2] Richard A. Lawhern, PhD., AHRQ correspondence by email, subject “Courtesy Copy – Comments Submitted to AHRQ”, September 13, 2020, with attachment.
[Ref 3] Haeuser W, Toelle TR, “Meta-analyses of pain studies: what we have learned,” Best Practice & Research Clinical Rheumatology (2015), http://dx.doi.org/10.1016/j.berh.2015.04.021
Abstract
Meta-analysis is a statistical procedure that integrates the results of at least two independent studies. The biggest threats to meta-analysis are publication bias due to missing studies with negative results and low-quality evidence due to methodological limitations imposed by included studies. Tools to improve the quality of meta-analysis have been developed by the Cochrane Collaboration and by the Preferred Reporting Items for Systematic Re-views and Meta-Analyses (PRISMA). Meta-analyses of trials have demonstrated that pain responses in patients with chronic pain, following treatment, are not normally distributed but have a bimodal distribution with the majority of patients having either very little or very good pain relief. The benefit can be detected within 2-4 weeks following drug administration. Further, the efficacy of drug and physical treatments is hampered by high placebo response rates, with modest average benefits with active treatments over placebo in both parallel and crossover design trials.
[Ref 4] R. A. Moore, S. Derry and P. J. Wiffen “Challenges in design and interpretation of chronic pain trials” British Journal of Anaesthesia 111 (1): 38–45 (2013)
doi:10.1093/bja/aet126
[Ref 5] Nora D Volkow, MD, and Thomas A McLellan, Ph.D., “Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies” . NEMJ 2016; 374:1253-1263 March 31, 2016]. http://www.nejm.org/doi/full/10.1056/NEJMra1507771
[Ref 6] “Post-Op Opioid Prescribing Often Ignores CYP2D6 Pharmacogenics”, December 25, 2020, Anesthesiology News, reported by Josh Bloom, “Recognition of Genetic Differences in Opioid Metabolism, Finally” American Council on Science and Health, January 3, 2021 https://www.acsh.org/news/2021/01/03/recognition-genetic-differences-opioid-metabolism-finally-15238
[Ref 7] Tom Lynch and Amy Price, “The Effect of Cytochrome P450 Metabolism on Drug Response, Interactions, and Adverse Events,” American Family Physician, August 1, 2007 https://www.practicalpainmanagement.com/treatments/genetic-testing-pain-medicine-future-coming
[Ref 8] Howard S Smith, MD, “Opiod Metabolism” Mayo Clinic Proceedings, 2009 Jul; 84(7): 613–624. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2704133/
[Ref 8] Andrea M. Trescot, MD, and Semyon Faynboym, MD “A Review of the Role of Genetic Testing in Pain Medicine”, Pain Physician 2014:17 ISSN 1533-3159
[Ref 9] Bhushan A Kapoor, Prateek Lala, Julie L.V. Shaw, “Pharmacogenics and Chronic Pain Management” Clinical Biochemistry, 2014. http://dx.doi.org/10.2016/j.clinbiochem.2014.05.065
Author Note: Richard A Lawhern PhD is a technically trained non-physician patient advocate, with 24 years experience as a medical literature analyst and forum moderator for social media and peer-to-peer support groups for chronic pain patients and care providers. He has published over 100 papers, articles, and public addresses in a mixture of medical journals and mass media, some of them co-authored with medical professionals.
This paper has benefitted from research assistance provided by Mark Edmond Rose, author of “Are Prescription Opioids Driving the Opioid Crisis? Assumptions vs Facts”, Pain Medicine, Volume 19, Issue 4, April 2018, Pages 793–807, https://doi.org/10.1093/pm/pnx048 . However, any remaining errors herein are those of the author.
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ENDNOTES
4. Richard A “Red” Lawhern is the spouse of a chronic facial pain patient. He has advocated for pain patients and their family members for twenty years with online research, physician referrals, authoring of websites and critical commentaries. From Red’s website:
“I retired as a systems engineer and operations research analyst… In my so-called spare time, I support an online community called “Living with TN” as a moderator and content author, providing literature and internet research to chronic face pain patients. I also mentor young people who are struggling with life in our times.”
Red has been invited to join the Editorial Advisory Board at the journal “Practical Pain Management” as a founding member to advocate for people in pain. In this position, Red will help to establish the editorial focus of the journal. Red’s body of work includes three previous articles at Practical Pain Management.
Red is the Director of Research for the Alliance for the Treatment of Intractable Pain (ATIP.) If you want to join Red in the fight for pain patients’ rights, ATIP is the place to start.
The Facial Pain Advocacy Alliance is proud to present Red’s body of work. Our goal is to arm pain patients with all of the information they need to advocate for themselves and their right to proper medical treatment.
