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Do you hear the same myths or false narratives repeated over and over again? Do you ever wish you had all the information in one place so you can counteract these lies? In this section we list common lies/false narratives of anti-opioid zealots/those profiting off of the opioid elimination industry, and we give you all the tools you need to prove them wrong.

Debunking Lies Table of Contents:

• "There is a difference between cancer and non-cancer pain"
• "Studies show that opioids don't work for chronic non-cancer pain"
• "80% of heroin users started with an opioid prescription from their provider"
• "The CDC didn't know their prescribing guidelines would cause harm"
• "Opioid induced hyperalgesia (OIH) is a proven common condition where opioids make pain worse"
• "Milligrams of Morphine Equivalent (MME) and MME limits are a scientific concept"
• "The USA is 5% of the world's population but consumes 80% of the world's opioids"
• "New study shows opioids don't work for low back pain and should never be given."

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LIE: "New Study Shows Opioids Never Work for Low Back Pain and Should Never be Used"

A new study came out of Australia the end of June 2023 called OPAL. The authors claim this study proves opioids don't work for low back pain and should never be offered, even as a last resort. The study has major design flaws and also is being seriously misapplied by the authors and media. 

This article contains the following information:

• OPAL Study Explained
• Important Links Mentioned
• DPF Patreon Page
• Video Podcast About OPAL
• Audio Podcast About OPAL
• Our Letter to Lancet - and their rejection 

 OPAL Study Explained

A brand new study was published in the Lancet a few days ago. The full pdf of the study is here.

The Opal Trial - Opioid analgesia for acute low back pain and neck pain. This study has already been misapplied and the authors have made inappropriate conclusions based on this tiny flawed study.

This is a brand new study out of Australia. six-week study, around 300 people completed it. They're making the claim that based on this, nobody should ever receive opioids for acute low back pain. No doubt this will be misapplied to all pain, including chronic and post-op.

Dr. Chad Kollas, who is on DPF's board, posted a long helpful thread yesterday, that can help anyone trying to discuss this study. Let us know if you have any questions. This study is already being used as a weapon, so it's helpful to know how to address it.

Here is another updated Twitter thread by Dr. Chad Kollas.

There was a lot of discussion about this study on Twitter. We dug into the study a little bit, and found out that one of the authors of this study also was an author on Australia's deprescribing guidelines that just came out a few days ago. There are a few interesting things about this. First one being a co-author of those guidelines is a  US Psychologist named Jason Doctor, who is anti-opioid. He's co-authored articles with PROP members. More interestingly, though, on those guidelines, if you look at the disclosures, you'll see several of the authors are funded heavily by Indivior, maker of Suboxone. Another ridiculous fact is the Lancet asked for specific comment from Dr. Jane Ballantyne and Dr. Mark Sullivan from PROP. The only reason anyone asks for their input is to get the anti-opioid spin.

We knew this trial was rigged. If you look in this article the following statement exists: "“The OPAL trial is a direct response to one of the main findings from The Lancet series: while we have good evidence on harms with opioid analgesics such as addiction, overdose, and death; we have no evidence on whether opioids are effective for a new episode of spinal pain."

The series of studies in the Lancet this study was based on are listed in the link. The last of the series has Roger Chou and Judith Turner as authors. Also, Jane Ballantyne authored a study with the lead author, Christine Lin in 2019. Ballantyne and another author, Maher, spoke together at a conference in 2014. 

Our org spent the day looking up information to try to figure out the actual motive. The study itself is kind of odd. They use a medication that's isn't even approved for acute pain in Australia, and wouldn't be used for acute back issues. Watch this two-minute news clip from Australia.

DPF found that Australia has been in the process of suing Pharma over opioids. Why does this matter? Well, it just so happens, the medication they chose to use for this study is a product made by Purdue. Our guess? They're pushing toward lawsuits like we did here in the USA. Oh, and Jason Doctor, one of the authors of the guidelines - he's been an expert witness in litigation in USA.

We will add more to this article as we break down the study.

Here are important links with all of the Lancet articles and OPAL along with supplemental information:

IMPORTANT LINKS

March 21, 2018   Lancet article – “Low Back Pain – A Major Global Challenge  pdf

June 9, 2018       Lancet LBP series article – “What LBP is and Why we Need to Pay Attention-    Appendix

June 9, 2018       Lancet LBP series article – “Prevention and Treatment of LBP – Evidence, Challenges, Promising Direction”  - Appendix

June 9, 2018      Lancet LBP series article – “LBP a Call for Action”  - Appendix

December 15, 2018 -  Lancet Article – “LBP Authors Reply”    Appendix

2018 - Editorial by authors of the Lancet LBP series called "The Lancet series on low back pain: reflections and clinical implications"

March 21, 2019  - Article claiming OPAL was part of Lancet LBP series

July 3-6, 2019 - In the updated call to action published in PAIN, they mentioned An international forum that was held in Canada to discuss the Lancet Back Series and research involved "International Forum for Back and Neck Research." 

December 2019   BMJ – Evidence Review –“87 Opioid deprescribing in people with chronic non-cancer pain – a systematic review of international guidelines”

September 2020  - IASP PAIN Journal – “The Lancet Series Call to Action to Reduce Low Value Care for LBP – an Update”

November 14, 2020   Lancet Article – “Lessons Learned from the Lancet LBP Media Strategy”

November 2021 –    “Lesser of Two Evils- Framework Analysis of Consumers’ Perspectives on Opioid Deprescribing and the Development of Opioid Deprescribing Guidelines”

2022    “Opioid Analgesic Stewardship in Acute Pain -Clinical Care Standard (Australia version of AHRQ)

October 2022- Article published about the International Back and Neck Forum held in 2019 about Lancet LBP Series "Back to the Future: A Report From the 16th International Forum for Back and Neck Pain Research in Primary Care and Updated Research Agenda"

June 15, 2023    “Introduction to Clinical Care Standard for LBP – Australia”

June 25, 2023  Wiley Online Journal – “Clinical Practice Guideline for Deprescribing Opioid Analgesics: Summary of Recommendations”

June 28, 2023 – “Opioid Analgesia for Acute Low Back and Neck Pain (OPAL Trial) – A Randomized Placebo Controlled Trial-     Appendix 

June 28, 2023     full pdf of OPAL Study

Link to DPF Patreon Page

Link to Video Podcast about OPAL

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LIE: "The difference between cancer and non-cancer pain is an evidence-based distinction and one that's easy to determine. Cancer pain has adequate pain treatment."

One thing that most opioid prescribing guidelines have in common is they categorize pain into cancer vs non-cancer. At a glance, that distinction makes sense, right? But is it an evidence-based difference? Or, are policies once again being created based on arbitrary distinctions that are actually meaningless? We break it all down for you in this article. We show you the origin of the distinction, petitions where the distinction was requested, meetings where it was discussed, and guidelines where it was used. We also discuss whether actual cancer pain is being treated adequately.

This article contains the following information:

• Where is the cancer vs. non-cancer pain distinction being made?
• Who asked for the distinction to be included in labels and guidelines?
• Did the FDA take PROP's petition seriously?
• What was FDA's written response to PROP regarding their petition?
• What's the origin of the distinction between cancer vs non-cancer pain and is it based on science?
• Should "cancer pain" receive opioids?
• Does "cancer pain" get adequate pain treatment?
• Is there stigma involved with "cancer pain" and opioids?
• Are there studies showing benefits of using opioids in terminal cancer patients?
• Summary 

Where Is the Cancer Vs. Non-Cancer Distinction Being Made?

Let's start with some opioid prescribing guidelines. The 2007 AMDG (Washington State Medical Director's Group Interagency Guidelines) are called "Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain." The 2016 CDC Guidelines state in the summary  "This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care." The updated/expanded CDC Guidelines are due to come out the end of 2022. At the very top of the Opioid Workgroup (OWG) report, they state "this document outlines the observations of the Opioid Workgroup on the updated CDC Guideline for Prescribing Opioids. CDC recommendations for prescribing opioids for outpatients with pain outside of sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care." We actually weren't able to find any opioid guidelines that didn't make this distinction.

Who Asked For the Distinction To Be Included in Labels and Guidelines?

FDA PROP Petition

On July 25, 2012, PROP (Health Professionals for Responsible Opioid Prescribing), led by the then president, Andrew Kolodny, sent the FDA a citizen's petition. The petition had over 35 signatures including would be expert witnesses in opioid litigation such as Anna Lembke and Jane Ballantyne. Soon to be author of both the 2016 and 2022 CDC Guidelines, Roger Chou, also signed it. The purpose of the petition was to ask the FDA to change their labeling of prescription opioids. The following requests were made:

1. Strike the term “moderate” from the indication for non-cancer pain.
2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain. 

As you can see, the concept of pain being put in two groups of cancer vs non-cancer was central to each request in PROP's petition to the FDA.

Did the FDA Take PROP's Petition Seriously?

It is unclear how this one citizen's petition had so much power, but it did. Let's look at some of the discussions that took place due to the petition.

MEETING #1: In May of 2012 the NIH sponsored a meeting with the FDA called "Assessment of analgesic treatment of chronic pain: a scientific workshop." Read through the transcripts for these all- day meetings held on May 30 and May 31, 2012.  You can browse the public comments here. This meeting was not specifically supposed to be about opioid labels and  PROP's requests, but looking through the transcripts of both days, this request to change the opioid labeling seemed to be the main topic of conversation. People like Kolodny, Ballantyne, Rummler all spoke at this meeting, basically demanding the change in opioid labels. FDA pushed back repeatedly claiming there wasn't enough evidence to make such a drastic change. As they stated in the meeting, a main goal of this change in label would be to restrict access to pain medication for patients. So even if a doctor would prescribe opioids "off-label," insurance would refuse it.

MEETING #2: In February of 2013, the FDA held a two-day meeting to address the concerns and requests of PROP's citizen's petition. The meeting was called "Impact of approved drug labeling on chronic opioid therapy. Part 15 public hearing" and was held on Feb 7 and Feb 8, 2013. You can browse some of the 1900 comments that were submitted here. There are some comments from people or organizations that supported PROP's requests, but the vast majority didn't agree with their petition. Here is a quote from one of the comments submitted by American Society of Anesthesiologists (ASA ) "A fundamental flaw shared by all three components of the PROP proposal is the intrinsic difficulty in defining “non-cancer pain.” Improvements in cancer therapy have resulted in increases in survival duration as well as cure rates, although the treatments used to achieve these beneficial results often lead to chronic pain. Who will decide whether the persistent pain, for example, of herpes zoster or nerve damage incurred during an otherwise curative course of chemo- and radiation therapy is or is not cancer-related?"

Dr. Bob Twillman, a pain psychologist, spoke at the meeting on February 7. He said "I think creating indications based on whether the cause of pain originates with cancer or not is inappropriate. I think one wrong question is, should we use opioids to treat chronic non-cancer pain?  I think an alternative which may be one of the right questions is, in which patients should we use opioids to treat chronic non-cancer pain? at what doses? for  how long? with which precautions?" He then goes on ask about this distinction stating similar concerns as the ASA made in their docket comment. At what point does cancer pain become non-cancer pain? Is it upon waking up from surgery to remove cancer? Is it once the patient is in remission? 

Dennis Capolongo from the Arachnoiditis Society for Awareness and Prevention (ASAP) said "In a recent letter from PROP to our director, Dr. Kolodny admits that the model for his petition was flawed, since it failed to consider incurable, non-cancerous disorders, such as arachnoiditis. Therefore we wish to propose that a third category be created for these incurable, non-cancerous conditions, one that would recognize, first recognize the severity of the modality and then it exempts sufferers from any restrictive policies that would limit their access to opioid consumption, since there's no other treatment." 

Here is another quote by a presenter at this meeting: "So one of the questions that you've asked of us requests the methods used for distinguishing cancer and non-cancer pain. That's the big theme here. And the short answer from the American Cancer Society is that we don't draw any such line in policy or practice. The opioid receptors, they don't know or care if someone has cancer. Nor do those receptors respond only when someone is nearing the end of life."

What Was FDA's Written Response to PROP Regarding Their Petition?

After these workshops were held and public comments received, the FDA sent PROP a response to their citizen's petition. The response addressed all of PROP's requests. For this article, we will just focus on the part of the letter that involved the cancer vs. non-cancer distinction.

"All of PROP's labeling change requests are linked to "non-cancer" pain, a distinction that is not made in current analgesic labeling. It is FDA's view that a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients. In addition FDA knows of no physiological or pharmacological basis upon which to differentiate the treatment of chronic pain in a cancer setting or patient from the treatment of chronic pain in the absence of cancer, and comments to the petition docket reflect similar concerns. FDA therefore declines to make a distinction between cancer and non-cancer chronic pain in opioid labeling."

So there isn't any evidence supporting this distinction. That didn't stop it from making its way into guidelines and laws based on guidelines. 

What's The Origin Of the Distinction Of Cancer Vs Non-Cancer Pain and Is It Based On Science?

In an article on March 3, 2016 called "Chronic Cancer versus Non-Cancer Pain: A Distinction without a Difference?" the author discusses arguments that were used in political debates. He calls one of these fallacies the “sham distinction,” which is now known better as a 'distinction without a difference."  "This logical fallacy appeals to a distinction between two two things that ultimately cannot be explained or defended in a meaningful way. When it comes to cancer and non-cancer pain, one really must question why we are drawing a distinction between these two entities and whether it is science or politics that that demands there be a difference." 

According to this graph in the article, the terms cancer pain and non-cancer pain are relatively new, really taking off in the past few decades in medical literature. 

An article by Schatman and Peppin in 2016 called "Terminology of Chronic Pain, the need to level the playing field," states "“Chronic cancer pain” and “chronic non-cancer pain” are replete in the literature; however, the distinction here is actually obscure. A patient with pain from a cancer etiology has no different physiology than a patient with pain of non-cancer etiologies." The authors go on to describe the origin of the distinction as a "move in the 1990's to change the way chronic pain in patients without cancer was treated."  Agreeing with the point others made that there isn't evidence of a true difference between the two types of pain, the authors suggest insisting on a difference between the two can be interpreted in the following ways:

1. "We do not care if the patient with cancer suffers from side effects, fatal or otherwise from opioids, and/or develops a substance-use disorder. But we do care if a patient with chronic “noncancer” pain develops these problems."

2. "We do not care if patients with noncancer pain suffer; they are not “worth” the effort of adding opioids to their regimens."

Schatman and Peppin state the purpose of their article isn't to say whether someone with cancer or without cancer should be given opioids, but that it should be acknowledged that the basis for this distinction isn't scientific evidence. They "suggest that the terminology be changed to help us better to understand and treat all of our chronic pain patients who are suffering. Categorization into “cancer” and “non-cancer” does not help us better understand mechanisms underlying pain or guide us to appropriate treatment strategies. Further, these categories are philosophical and neither scientific nor of clinical relevance" "The goal here is to continue to be patient-focused, relieve their suffering (instead of contributing to it), and help improve their lives. Language, in and by itself, is obviously not a “cure” for pain. However, clinicians and society as a whole need to appreciate language’s potential to further stigmatize and marginalize all patients suffering from chronic pain, and accordingly we are obliged to work toward a more language-neutral system of pain classification."

In the article, the author states "From a medical and scientific aspect, it makes little sense to have these two broad categories of chronic pain. But from a political and emotional aspect, it may make ones life a little easier, because who doesn’t want to relieve the pain of a dying cancer patient.  But what about a cancer survivor?  Are they still considered to have cancer pain once the cancer is cured? What if the pain is due to chemotherapy-induced neuropathy? Who will fight their battle politically?" 

"While it may feel wise to distinguish the terms cancer and non-cancer pain from each other, continued promotion of this idea is fraught with logical fallacies, and is best defended by emotions and politics rather than the state of science. The alternative is to abandon the distinction for all of these reasons and use terms that actually help us understand the nature of an individuals pain and how best to manage it, which may or may not include opioids."

We've shown you several articles explaining how the distinction between cancer and non-cancer pain is nonsensical. We've shown you PROP's request for this distinction to be made, and the workshops that were held to discuss this distinction. We've shown FDA's response to PROP explaining how they neglected to show that this distinction is evidence-based. 

AND YET.... it continues to be used in opioid prescribing guidelines and state laws based on these guidelines. We've also seen it make its way into indictments against doctors.

"Should "Cancer Pain" Receive Opioids?

Just for fun, let's pretend there is a clear delineation between cancer and non-cancer pain. Considering this distinction has become common practice, you'd think there is some consensus as to how "cancer pain" should be treated. Sadly, there isn't. We found many articles and presentations from "experts" discussing the idea of not using opioids for cancer pain. I don't have a problem with multi-modal cancer pain treatment. What I do object to is the entire goal of any treatment being "let's use anything and everything except for opioids."

Here is one example of a presentation about not using opioids for breast cancer patients.

"Alternatives to Opioids for Breast Cancer Pain." 

Notice the speaker gives a shout out to Andrew Kolodny, and then immediately quotes a false statistic that "80% of heroin users started with a prescription from their doctor." We've debunked this lie in detail here. The WHO (World Health Organization) has created a step ladder for the treatment of cancer pain. This presentation from Maimonides Hospital in Brooklyn, NY seems to contradict WHO. 

Here is another presentation called "Treating Cancer Pain Without Opioids."  This one seems a bit more balanced and acknowledges that opioids can and should be used in cancer pain. 

Does "Cancer-Pain" Get Adequate Pain Treatment?

Now that we've shown that guidelines continue to make this distinction of cancer vs non-cancer pain, let's talk about  what that actually means for the cancer pain sufferer? Is it truly the holy grail of all painful illnesses that is given adequate opioids when needed? Well, I used to think it was. Until we started to get calls from cancer patients who were being denied opioids. Here is a video of a terminal cancer patient, April, who was denied opioids at the pharmacy. April has since passed away. We are grateful she told her story so people know what's happening even to those with "cancer pain."

• In this article "The downgrading of pain sufferers' credibility," a study was discussed that was conducted by the US Department of Health and Human Services that revealed that “more than 50 percent of cancer patients didn’t receive adequate analgesia, and about 25 percent of them were estimated to die in severe, unrelieved pain.” That should be appalling to read. Yet, we found many articles and presentations discussing the fact that there is over prescribing of opioids even in "cancer pain," and how it needs to stop.

• In the article "US Trends in Opioid Access Among Patients With Poor Prognosis Caner Near the End-of-Life," the author concludes that "Opioid use among patients dying of cancer has declined substantially from 2007 to 2017. Rising pain-related ED visits suggests that end-of-life cancer pain management may be worsening."

Is There Stigma Involved With Cancer Pain And Opioids?

• In this article called "Oncologists' Views on Challenges in Opioid Prescribing for Patients with Cancer-related Pain," the author lists the following challenges in prescribing opioids for cancer-related pain:

1. Patients who receive opioids feel stigmatized by clinicians, pharmacists, and society.
2. Patients fear becoming addicted, affecting their willingness to accept prescription opioids.
3. Guidelines for safe and effective opioid prescribing are often misinterpreted, leading to access issues.

• In this article called "Are Cancer Patients Getting the Opioids They Need to Control Pain," the authors "suggested, measures to make opioids harder to obtain may have prevented some patients from receiving appropriate prescriptions for opioids to manage cancer pain." They also stated “It appears that oncologists are not prescribing opioids as much as they did previously and that "future research needs to focus on whether opioid prescribing guidelines intended for patients without cancer are being applied inappropriately to patients who have had cancer.” 

Are There Studies Showing Benefits Of Using Opioids In Terminal Cancer Patients?

• A recent study came out called "Opioid Use Linked to Survival in Older Patients With Advanced Pancreatic Cancer."  It concluded that "opioid prescriptions are associated with increased survival in elderly patients with advanced disease suggests that symptom mitigation should be emphasized in clinical treatment of pancreatic cancer."

So, once again, we've shown that the basis of these "evidence-based" guidelines are truly opinion based. There is no way to distinguish the two types of pain. When does it switch from cancer pain to non- cancer pain? Is it upon waking up from cancer removal surgery? What about chronic pain the patient has that is unrelated to their actual tumor? Is that non-cancer pain since the cause isn't cancer? We used to think cancer was the "holy grail" of painful conditions that would allow adequate pain treatment. Sadly, non even "cancer-pain" will guarantee that someone will receive needed opioids. Once again quoting Schatman and Peppin, for those who insist on placing all pain into the two categories of cancer and non-cancer, which of the following statements are they actually saying?

1. "We do not care if the patient with cancer suffers from side effects, fatal or otherwise from opioids, and/or develops a substance-use disorder. But we do care if a patient with chronic “noncancer” pain develops these problems." 

2. "We do not care if patients with noncancer pain suffer; they are not “worth” the effort of adding opioids to their regimens."

Summary of Main Points:

• The distinction of cancer vs non-cancer pain is made in opioid prescribing guidelines.
• PROP requested changes in opioid labels that made this distinction.
• FDA denied much of PROP's requests.
• The concept of cancer vs non-cancer pain has only been around in medical literature for a few decades.
• There isn't scientific evidence showing a clear distinction of how cancer vs. non-cancer pain is felt in the body.
• Many doctors and organizations have expressed concern with the cancer vs. non-cancer pain distinction.
• Some doctors and hospital systems are pushing for opioid-free cancer pain treatment.
• There is stigma involved in using opioids for cancer pain.
• Studies show that giving opioids to some terminal cancer pain patients may increase survival rate.

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated February 7, 2022

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LIE: "Studies show that opioids don't work for long-term chronic non cancer pain."

This article contains the following information:

• Introduction to the SPACE Trial
• Basic facts of the SPACE Trial
• Patients excluded from the SPACE Trial
• Bottom line results of the SPACE Trial
• Problems with Erin Krebs 
• Problems or points of interest with the SPACE Trial
• Problems with how the SPACE Trial has been applied
• Examples of how media misrepresented the SPACE Trial
• Examples of how "medical experts" misapplied and misrepresented the SPACE Trial
• Quotes about the SPACE Trial from a variety of experts in different fields about the SPACE Trial

Introduction

When I first started researching this topic in 2017, I saw people saying "we don't have evidence showing opioids work for long-term chronic non cancer pain (LTCNCP)." Not long after that, I noticed they changed that statement to say "studies show opioids don't work for pain" That's a big difference. Lack of evidence that something works, isn't the same thing as evidence that it doesn't work. When asked to give the source for that claim, the study that's cited repeatedly is "The Strategies for Prescribing Analgesics Comparative Effectiveness, The SPACE Trial." It was a study published in JAMA in 2018 done by Dr. Erin Krebs, funded by the VA. Let's break down this study to show what it does and does not say. There is a lot of information here, with links to all of the sources. I highlighted parts that are extremely important. 

The Study was done based on the following assumptions: 

• "Long-term opioid therapy has been a common approach for managing moderate-severe chronic musculoskeletal pain."
• "Evidence for the effectiveness of opioid therapy for long term non cancer pain has been lacking (few studies last past 3 months)"

The goal of the study was: To have a Quality Random Controlled Trial (RCT) to evaluate the comparative long-term (>3-6 month) benefits and harms of opioids for low back pain, and osteoarthritis of hip and knee.  

Basic facts:

• It was a randomized trial
• It compared opioid therapy vs non-opioid therapy over 12 months for primary care patients with chronic back pain, hip or knee osteoarthritis pain of at least moderate severity.  
• There were 240 patients in the trial.
• Mean age ~58
• 87% were male
• There was an opioid arm vs non-opioid arm 
• There were 3 steps for the non-opioid arm
  • Step 1: Acetaminophen and NSAID (like ibuprofen)
  • Step 2: included adjuvant oral medications (ie, nortriptyline, amitriptyline, gabapentin) and topical analgesics (ie, capsaicin, lidocaine)
  • Step 3 included drugs requiring prior authorization from the VA clinic (ie, pregabalin, duloxetine) and tramadol
• There were 3 steps for the opioid arm
  • Step 1: Immediate release morphine, oxycodone, or hydrocodone
  • Step 2: Morphine sustained-action Extended Release or Oxycodone Extended Release
  • Step 3: Transdermal fentanyl
  • Opioids were titrated to a maximum daily dosage of 100 morphine-equivalent (MME) average dose was 22 MME-(which is about 20 mg of Hydrocodone)-see chart below
• Follow-up visits were monthly until a stable regimen was established, then visits occurred every 1 to 3 months.
• Visits were in-person at 6 and 12 months when possible and otherwise mostly by telephone.

Here is a graphic posted by a chronic pain patient taken from the actual study showing the average MME (Milligram of Morphine Equivalent) dose (22 MME) for the opioid arm in the SPACE Trial

Those Excluded from the study:

• Those with high impact pain conditions (any condition other than low back pain and osteoarthritis (OA) of hip and knee)
• Patients on long-term opioid therapy
• Patients who were physically dependent on opioids
• Chronic pain patients

Bottom line of results:

• Showed that the non-opioid therapy group and opioid groups had similar results
• Both groups had increased function and reduced pain. (See chart below showing this information)
• There was no significant difference in pain-related function between the 2 groups over 12 months. 
• Pain intensity was slightly better in the non opioid group, but the clinical importance of this finding is unclear; the magnitude was small
• Health-related quality of life did not significantly differ between the 2 groups
• In this trial, pain-related function improved for most patients in each group
• Anxiety was significantly better in the opioid group
• There were no significant differences in adverse outcomes 
• No significant difference in issues of misuse between the two groups
• No deaths, doctor-shopping, diversion or OUD were detected

Here is a graphic posted by Dr. Amaraqueye on Twitter showing how in both groups pain decreased and function increased

Problems with Erin Krebs herself (many of these points were made by Pat Anson from PNN in this article):

• She was already a well known anti-opioid zealot.
• She was on the Core Expert Group of the 2016 CDC Guidelines.
• She already had published anti-opioid propaganda.
• She was already a well known advocate of opioid tapering. In 2017 she reviewed 67 studies on opioid tapering. Regardless of the fact that the majority of the studies she reviewed were very low quality, she still came to a conclusion in favor of tapering 
  • Quote by Krebs about the review: “This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms.” 
  • Actual conclusion of the review itself: "Very low quality evidence suggests that several types of interventions may be effective to reduce or discontinue LTOT and that pain, function, and quality of life may improve with opioid dose reduction."
• Her work was praised by Andrew Kolodny, and has been cited to promote forced opioid tapering. 
  • As pointed out in the PNN article, Even Andrew Kolodny himself cited her review as a reason to force tapers by saying "dangerously high doses should be reduced even if patient refuses."
• Rummler Hope (fiscal sponsor of PROP) sponsored a talk she did called "Chronic Pain and Responsible Opioid Prescribing."

Problems or points of interest with the study:

• The average dose for the opioid group was 22 MME (around 20 mg Hydrocodone daily), which is outside typical therapeutic dose for someone with moderate to severe OA pain, yet the non opioid arm had high doses of acetaminophen, ibuprofen, as well as other meds like Cymbalta, Gabapentin, and Tramadol 
• Tramadol, an opioid, was used in the non-opioid arm of the study.
• The scope of the study was quite small, which in and of itself isn't a problem, if it weren't applied to those outside the scope of the study
• As stated above, CPP's other than with OA were excluded, and well as anyone on chronic opioid therapy, which is a problem because it's applied to all CPP's with all painful conditions
• Does not represent or apply to patients with a significant history of using opioids for CNCP, yet it is applied to all CPP's taking opioids
• Initial opioid limit was 200 MED/day; changed/reduced mid-study (so it's quite possible they didn't prescribe enough opioids for adequate pain relief, yet in the non opioid group, the medications were in high doses and many different meds were used)
• Of 4,485 with prior month health record of back or lower extremity pain, only 265 enrolled.1,843 declined to participate and 2,377 did not meet pain diagnosis and severity criteria (common exclusions: fibromyalgia, migraine, opioid or benzo use, mental health condition and substance use disorder).

Problems with how it's been applied:

• 87% were male, yet it is frequently used as a reason to force taper conditions specific to women like endometriosis
• They excluded chronic pain patients yet it's applied to all chronic pain conditions like Fibromyalgia, Lupus, Crohn's, and even Sickle Cell Disease
• They excluded those dependent on opioids yet it's applied to all dependent on opioids and used as a reason to force tapers
• Even though both groups had decreased pain and increased function, it's used to show that opioids don't work for pain yet it's also used to show OTC meds do work for pain
• The study chose chronic pain conditions that don't typically receive opioids for treatment, and then applied it to ALL chronic pain conditions
• SPACE Trial was misapplied by major publications claiming the study proves that opioids don't work for chronic pain. 
• SPACE Trial showed few adverse outcomes in the opioid arm and zero cases of OUD, doctor-shopping, or death, yet it is repeatedly used to show that the risk of addiction is higher than we thought
• SPACE Trial was misapplied by "expert witnesses" such as Anna Lembke, and other "experts" such as Andrew Kolodny
• I've heard it said that Erin Krebs herself wasn't happy with how this was misapplied, but when asked about that, she didn't make that statement. From what I can tell, Dr. Krebs has never released a public statement warning about the misapplication of her study. I will include the citation and quote below.

Example of how media misrepresented the SPACE Trial:

Article in Vox "Finally Proof: Opioids Are No Better Than Other Medications For Some Chronic Pain": "Do opioids help patients with chronic pain in the long run? Are they worth all that risk? The answer, according , is a resounding “no.”'

Examples of how  "medical experts" misapplied and misrepresented the SPACE Trial:

 Here are some quotes from experts in different fields, a pain/addiction doctor, a PharmD, a Psychologist, a Researcher, a civil rights lawyer:

Quote on Twitter from Dr. Stefan Kertesz: "Among patients who volunteered to be randomized to 2 treatments that usually have only modest benefits, both groups improved to a larger-than-expected degree, with the apparent improvement in status persisting a year. Adverse effects that are expected & typical, proved rare. "

Quote on Twitter from Dr. Amarquaye: "They even showed both decrease in pain related function and intensity in both the opioid and non opioid group at 12 months."

Quotes on Twitter from Dr. Michael Schatman: "To call the SPACE study "the best evidence" against prescription opioids for chronic pain is laughable, demonstrating a horrific misapplication of junk science. Thanks for posting. You'll soon be reading a robust responding editorial regarding your false claims."

Quote on Twitter from Kate Nicholson, a lawyer and CPP: "it is one study of mostly moderate severity orthopedic and arthritic pain. Grouping all types and severities of chronic pain together to suggest as 60 Minutes did that there is something illegitimate about the use of opioids for all long-term pain is problematic."

Quote by Red Lawhern, Researcher:'The SPACE study was flawed by selection of patients who would normally not be candidates for opioid therapy, and titrating these patients very rapidly. Likewise, is Tramadol a non-opioid? That's the way it was labeled.'

Read this article in PNN called "Is JAMA Opioid Study Based on Junk Science?"

There have been some reviews of studies of opioids for long term non cancer pain. They are generally discounted to to being weak evidence, which I find odd since the entire CDC Guidelines were based on a similar review of studies by actually the same author also showing weak evidence. Hypocritical? Or just more proof that all of this was done for their litigation narrative? 

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum.

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LIE: "80% of heroin users started with a prescription from their provider"

This lie or false narrative is repeated so often, it seems like it’s everywhere. We’ve seen it used by the DEA, in opioid litigation, as well as in every single presentation given by anti-opioid zealots such as Andrew Kolodny, Anna Lembke, Roger Chou, etc. It's also repeated often on social media by people who don't know any better and just repeat what they've heard "experts" say. Remember, they need to make it sound like all addiction and overdose deaths are the fault of pharma, distributers, doctors, and pharmacies. It is necessary for the billions of dollars they are trying to get in litigation settlement. They want people to believe that the vast majority of all with opioid use disorder (OUD) started from a prescription from their doctor, and that the majority of those who misuse or even just use prescription opioids end up using heroin.

A perfect example of this is this video clip from last year's Johnson and Johnson trial. Look how they phrased it.

First, let's look at where this statistic comes from. In this article in Pain News Network Roger Chriss discusses the origin of this statistic: "The DEA cites the National Institute on Drug Abuse (NIDA) as its source, while NIDAs in turn references a 2013 study by the Substance Abuse and Mental Health Administration (SAMHSA)." I'm going to give bullet points and include sources of the information so you can confidently respond to this false narrative.

• When this statistic is repeated, it’s often implied or even sometimes stated that 80% of those starting heroin were given prescriptions from their doctors. The problem with this is that’s not at all what the source is stating. In the SAMHSA study, they took data from a ten-year period from the National Survey on Drug use and Health and found that around 80% of those who started heroin previously used nonmedical use of prescription opioids. I'm going to repeat the second part of that statement. Those using heroin previously used NONMEDICAL USE of prescription opioids. So, these weren't people who got a prescription from their doctor, took the medication as prescribed, and then turned to heroin. Again, what it actually states is that 4 out of 5 heroin initiates first started with nonmedical use of prescription opioids. That’s a huge difference from what they claim when stating this "statistic."  An excellent source on this topic is an article called "Today's nonmedical opioid users are not yesterday's patients..."  This article states that "The National Survey on Drug Use and Health (NSDUH) has repeatedly found that less than 25% of nonmedical prescription opioid users obtain these drugs from a prescriber." This means that at least 75% or more of heroin users who started by misusing prescription opioids obtained these pills illicitly. This directly contradicts their lie.

• This lie implies that the statistic is uniform throughout the USA. This is false. The statistic is not consistent in every area of the country. In the article in Pain News Network, Roger Chriss states "The abuse of opioid medication by heroin users also varies considerably by time, region, and demographics...prior nonmedical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively." So making a blanket statement implying consistency throughout the USA is wrong.

• One thing this statistic makes people believe is that most people who misuse prescription opioids turn to heroin eventually. In reality, it's only a very small amount. According to this article by National Institute of Drug Abuse (NIDA), less than 4% of those who abuse prescription opioids end up using heroin within 5 years. That is a fact you'll never hear anti-opioid zealots discuss.  For the sake of their litigation narrative, they need people to think the vast majority of everyone who not only abuses but even uses prescription opioids will most likely develop an addiction to it and turn to heroin.

• When they repeat this lie, they love to imply or even state that the vast majority of heroin users of today were pain patients at first. That's blatantly false. In fact, if this were true, then when prescribing doubled in the USA form 2002-2014, heroin use would have likewise increased. Yet, it didn't. As stated in this article I mentioned earlier, “Doubling the amount of opioids prescribed does not seem to have had a discernible effect on the rate of nonmedical use or the rate of pain reliever use disorder.” Blaming OxyContin for the increased drug deaths is misguided. The truth is drug deaths have been increasing since 1979, well before OxyContin ever hit the market. But, yet again, they desperately need to keep people believing that the huge spike in overdose deaths is due to Purdue/OxyContin.

• One last point is that the 80% statistic, even if properly used and applied, isn't even accurate anymore.  As shown by Dr. Bob Twillman in this tweet, 32% of people with OUD actually started with heroin. So the statistic isn't accurate anymore that 80% of those who use heroin started with misusing prescription opioids. This statistic can be found in this article.

I'll list some links to some more articles and studies that discuss this topic in case you'd like to read more about it.

1. How People Obtain The Prescription Pain Relievers They Misuse by Rachel N. Lipari, Ph.D., and Arthur Hughes, M.S.
2. The Myth of What's Driving The Opioid Crisis by Sally Satel
3. Blaming Pharma Alone For The Opioid Crisis is Shortsighted by Brooke Feldman

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated January 10, 2022.

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LIE: "Studies show that opioids make pain worse in a common condition called Opioid Induced Hyperalgesia (OIH)."

This article contains the following information:

• Defining Terms
• What is the origin of the idea of Opioid Induced Hyperalgesia (OIH)?
• OIH in acute pain patients 
• OIH in rats
• OIH in patients on Suboxone or Methadone
• OIH in Chronic Pain Patients (CPP's)
• What do other studies or articles say about OIH?
• Do doctors claim that OIH is a proven common condition?
• Why do "experts" give misleading information about OIH?
• Accurate diagnosis of OIH in CPP's
• Doctors views of OIH
• FDA - updated label for opioids including OIH
• Summary 

Have you ever heard a medical expert say "Not only do opioids not work for chronic pain, but they actually often makes pain worse"? Ever wonder if it's true?

After researching this phenomenon called Opioid Induced Hyperalgesia (OIH), the one thing that's abundantly clear is that nothing to do with OIH is abundantly clear. Some doctors think it doesn't exist. Some think it is relatively common. Some think it is simply a conflation of terms. The definition isn't even agreed upon. Since the information on OIH is so conflicted, let's define some terms for the sake of this article.

Defining Terms

Opioid Tolerance - Physiologic adaptation to the presence of an opioid in the body such that increased doses are required to maintain the same level of analgesia. When someone builds tolerance to opioids, increased doses are needed to achieve the same level of efficacy. The treatment for this is increased opioid dosage, decreased time between doses, or opioid rotation.

Opioid Withdrawal- Produced by abrupt cessation or rapid dose reduction. When a patient develops a physical dependence on opioids and feels pain when opioids are stopped or decreased. There are two phases of opioid withdrawal, an initial, acute phase and a second, chronic phase. Treatment is gradual reduction in opioid dosage.

Allodynia -  Innocuous (non harmful) stimuli that is now painful, meaning something that is not normally painful at all becomes painful. An example of this would if the clothes you're wearing start causing pain just from touching your skin.

Central Sensitization - International Association of the Study of Pain (IASP) defines it as “increased responsiveness of nociceptive neurons in the CNS to their normal or subthreshold input." More simply it is  when a patient becomes more and more sensitive to acute or chronic pain. This phenomenon was first discussed in the 1940's. An example of a condition with increased central sensitization is Fibromyalgia. This is similar/the same as hyperalgesia. 

Hyperalgesia- Stimuli that is typically a little painful becomes extremely painful. An example of this is a small pin prick. In someone with hyperalgesia, the sensation of a small pin prick would be very painful. This phenomenon is basically the same as central sensitization.

Opioid Induced Hyperalgesia (OIH) -  A paradoxical response: administration of opioids for the treatment of pain that actually causes higher pain sensitivity. A state of nociceptive sensitization (pain) caused by exposure to opioids. The idea of OIH is when a patient takes opioids, pain increases. This is different from tolerance, bc in OIH as the dose increases, so does the pain. Treatment is to reduce opioid dose or possibly rotate opioids.

Quantitative Sensory Testing (QST) - A variety of tests used to measure pain response to different stimuli. As long as a test can be quantified or measured, it can be used as QST. Some common QST's are thermal testing (both hot and cold), and pinprick test in humans, and a paw test in animals.

What Is the Origin Of the Idea Of Opioid Induced Hyperalgesia?

Many articles say that the idea of OIH was noted as early as 1870. It was recognized that a potent analgesic such as morphine could actually result in an increase in pain. In 1870 Dr.Albutt said “Does morphia tend to encourage the very pain it pretends to relieve?"

According to an Israeli expert, Erica Suzan, the phenomenon of OIH has been studied in the following groups for over 30 years:

1. Healthy volunteers following acute opioid exposure
2. Acute postoperative pain
3. Chronic nonmalignant pain
4. Cancer pain-end of life
5. People addicted to opioids

OIH In Acute Pain Patients

The concept of Opioid Induced Hyperalgesia in acute postoperative settings is discussed in this presentation given at a meeting of International Association of the Study of Pain. Erica Suzan makes the following points in her lecture:

• Three conditions seem very much alike: acute withdrawal, acute tolerance, acute OIH. Although they seem alike they are very different in terms of treatment.
• In true OIH in acute as soon as opioids are given, pain increases. 
• In her opinion even though many of the findings of studies claim they prove OIH exists in post-op patients, those studies measure acute opioid withdrawal as opposed to true acute OIH.
• "True clinical OIH is quite rare, and is seen mainly in cancer pain patients who receive mega doses of opioids usually at the end of life."
• Dr. Suzan suggests the following clinical criteria for diagnosing OIH:    
  • Increased pain intensity during ongoing opioid treatment
  • No evidence for underlying disease progression
  • No evidence for clinical or pharmacological opioid withdrawal
  • No evidence of opioid tolerance
  • Decrease in pain intensity in response to opioid dose reduction
  • No evidence for addictive behavior

Opioid Induced Hyperalgesia In Rats

When people claim that studies show OIH is common, they are referring to a 1994 study published in The Journal of Neuroscience done on rats by Dr. Mao. This study clearly shows that OIH exists in rats. In this presentation  by Dr.Jianren Mao,  "Mechanisms of Opioid-induced Hyperalgesia," he claims that OIH exists in humans, although he acknowledges that studies don't yet back up that claim. Here are some points:

• The concept of OIH was introduced in 1994 in his study in a lab with rats. 
• He included the following slide showing results from this study:

• Rats were treated with morphine vs. saline and they performed QST's (Quantitative Sensory Tests). 
• The purpose of the study was to test tolerance; he calls the results of OIH a serendipitous finding.
• He claims it was a significant finding in the laboratory but didn't make its way into the clinical area until the early 2000's.
• He speculates possible explanations of OIH.
•  "After 25 years we still don't have a tool in a clinical setting to differentiate between opioid tolerance and OIH."

After listening to Dr. Suzman's presentation, I asked an ER doctor if he had ever seen the phenomenon of OIH in acute pain patients. His response was "I've never had a hospice patient react that way, and I've cared for many people at the end of life. While I wouldn't rule out some incredibly rare paradoxical reaction, I suspect the truth is much simpler: sometimes you give people pain medicine while their pain is getting worse and it's better than it would have been otherwise, but still more than it was the last time you assessed it...anything's possible, but I've never seen that happen." 

OIH In Patients On Methadone or Suboxone:

If OIH exists in pain patients, it would be logical for it to exist in patients with OUD. There have been many studies about this. Some have concluded that OIH does exist in OUD patients on opioid therapy. After reading many of them, it seems like it's impossible to tell if the patient was experiencing true OIH or if the patient just had built a tolerance to opioids. A study called Buprenorphine Maintenance Subjects are Hyperalgesic and Have No Antinociceptive Response to a Very High Morphine Dose concluded "buprenorphine subjects, compared with controls, were hyperalgesic, did not experience antinociception (pain relief), despite high morphine concentrations." Remembering the criteria Dr. Suzan discussed for diagnosing true OIH, I would say this study didn't differentiate between tolerance and OIH. Pain didn't worsen with opioids, but pain relief was not achieved with high doses. 

Here is a quote from an article "This relative pain intolerance has been ascribed to the phenomenon of opioid-induced hyperalgesia. Unfortunately, a causal role for opioids in producing hyperalgesia has yet to be conclusively demonstrated in patients, both those receiving opioids for the treatment of addiction or chronic pain. The data reflecting hyperalgesia in opioid-dependent patients at this time are cross-sectional only, comparing opioid-dependent and opioid-free samples, but not comparing the same individuals before and after opioid administration. For compelling clinical and ethical reasons, it is near impossible to design such a pre-post study, leaving open the question of whether the hyperalgesia suffered by methadone and buprenorphine patients is, in fact, opioid-induced." 

I spoke to two Harm Reduction experts to see if they've seen OIH in patients on methadone or Suboxone. Both said they've never seen anyone experience this.That doesn't prove it doesn't exist, but if it does, it seems to be exceedingly rare.

 Opioid Induced Hyperalgesia in Chronic Pain Patients (CPP's):

Dr. Norman Harden, a doctor known for his work in CRPS (Complex Regional Pain Syndrome), gave a  presentation at Painweek in 2016 called "Opioid 'Induced' Hyperalgesia and Allodynia: The description of the lesson was "Prolonged exposure to opioids hypothetically activates a pro-nociceptive mechanism resulting in opioid induced hyperalgesia (OIH). Opioid hysteria doctors are causing payors and governing bodies to rush to bring the OIH concept into law and protocol, but are finding a lack of any scientific evidence for this process, at least in humans. The FDA is now requiring pharma to run extensive and expensive trials to demonstrate OIH associated with opioid therapy, but the construct is vaguely defined, the mechanisms are poorly understood, and the outcomes and methods for studying OIH are very poorly developed."

Here is a short synopsis of this presentation from Dr. Harden.

A few years before this Pain Week presentation, Dr. Harden gave a similar presentation at a 2015 AAPM (American Academy of Pain Medicine)  annual meeting. This article in Medscape called "Complexities of Opioid-Induced Hyperalgesia Poorly Understood," is an excellent summary and explanation of his talk.

• "Opioid-induced hyperalgesia is among the most pressing concerns in the national discussion of opioid addiction, underscored by the US Food and Drug Administration's (FDA) call for clinical trials to better understand the risks."
• There is very little agreement and a lot of confusion surrounding the idea of Opioid Induced Hyperalgesia (OIH).
• Studies are clear that OIH exists in rats, and many have made the assumption that it also works the same way in humans. Yet, there is limited data backing up this claim.
• The confusion is due to frequent conflation with tolerance, Hyperalgesia/Allodynia-which is central sensitization that can normally be found in chronic pain patients, and true OIH. (See definitions above),
• In order to better understand OIH and the frequency of it , Dr. Harden and his colleagues conducted a study that was supported by Northwestern Memorial Hospital. It compared pain test responses among patients with chronic low back pain. The following is a break down of the study:
  • 10 patients were receiving opioids and 10 were not.
  • "The results showed no significant differences between the groups in terms of sensory tests for pain."
  • Of all the tests only one test showed statistical significance, which actually showed a greater sensitivity in the non opioid group, so in this Quantitative Sensory Testing people on opioids had lower pain than the non opioid group.
  • "The early findings appear to support the assertion that hyperalgesia (central sensitization) in many cases may be part of the natural progression of chronic pain."
  •  "It very difficult to demonstrate hyperalgesia in pain patients on opioids because you do not know what the hyperalgesia is from."

What Do Other Studies Or Articles Say About Opioid Induced Hyperalgesia?

The phenomenon of OIH has been studied and written about, but very little true evidence exists. As we said earlier, nothing about OIH is standard or agreed upon by medical experts or scientists. Let's look through some articles/studies that discuss OIH:

Opioid Induced Hyperalgesia, a Research Phenomenon or a Clinical Reality? Results of a Canadian Survey

The background of this study: "Very little is known regarding the prevalence of opioid induced hyperalgesia (OIH) in day to day medical practice. The aim of this study was to evaluate the physician's perception of the prevalence of OIH within their practice, and to assess the level of physician's knowledge with respect to the identification and treatment of this problem."

Results of this study: "In this study, the suspected prevalence of OIH using the average number of patients treated per year with opioids was 0.002% per patient per physician practice year for acute pain, and 0.01% per patient per physician practice year for chronic pain."

The conclusion of this study: "The perceived prevalence of OIH in clinical practice is a relatively rare phenomenon. Furthermore, more than half of physicians did not use a clinical test to confirm the diagnosis of OIH. The two main treatment modalities used were NMDA antagonists (such as ketamine) and opioid rotation. The criteria for the diagnosis of OIH still need to be accurately defined."

Analgesic Tolerance Without Demonstrable Opioid-induced Hyperalgesia: A Double-blinded, Randomized, Placebo-controlled Trial of Sustained-release Morphine for Treatment of Chronic Non radicular Low-back Pain

Abstract of the study: Although often successful in acute settings, long-term use of opioid pain medications may be accompanied by waning levels of analgesic response not readily attributable to advancing underlying disease, necessitating dose escalation to attain pain relief. Analgesic tolerance, and more recently opioid-induced hyperalgesia, have been invoked to explain such declines in opioid effectiveness over time because both phenomena result in inadequate analgesia."

Key point: "It is not possible to distinguish between tolerance and opioid-induced hyperalgesia solely based on the clinical observation of the need for dose escalation. Furthermore, although treatment of opioid tolerance usually involves dose escalation, opioid-induced hyperalgesia is treated by dose reduction and initiating alternative analgesic strategies. The prevalence and relevance of these 2 distinct phenomenon or the efficacy of chronic opioid therapy for the treatment of chronic painful conditions remain inadequately investigated."

Results of the study: "After 1 month of oral morphine therapy, patients with chronic low back pain developed tolerance but not opioid-induced hyperalgesia. Improvements in pain and functionality were observed." Our study provides the first high-quality prospective evidence for the development of tolerance and absence of opioid-induced hyperalgesia after 1 month of chronic opioid therapy."

Conclusions of the study: "This study is not meant to discount the abundance of data from animals and case studies documenting isolated cases of severe opioid-induced hyperalgesia. Clinicians may still suspect expression of opioid-induced hyperalgesia when opioid treatment becomes entirely ineffective and pain becomes increased and widespread, even in the absence of disease progression." 

Misuse of Hyperalgesia to Limit Care

In this article a doctor discusses the case of one of his patients who was a CPP diagnosed with stage IV lung cancer.

• His insurance company was concerned about the expenses of his medicine and asked the doctor to arrange a second opinion.
• "The report stated 'given his high doses, the patient is likely suffering from opiate-induced hyperalgesia and would actually benefit from weaning his daily opiate intake.'”
• The insurance company refused to pay for his medicines until the doctor gave them a report on his plan to take him off his medicines.
• The doctor stated :
  • Fishbain et al did an evidence-based structured review of 504 articles on OIH in humans and animals. They addressed ten hypotheses that had been utilized to test for the possibility of OIH in humans. Only studies performed on opioid naïve, pain-free volunteers that were given opioid infusions met criteria for quality evidence—and even those studies showed inconsistent results."
  • "I am afraid that our concern with the laboratory curiosity of OIH will end up feeding opiophobia and will be used as an excuse by clinicians to avoid the complexities of opioid analgesia or by insurance companies to limit access to care for “expensive” chronic pain patients. In our attempts to optimize therapy for chronic pain patients, we must be careful not to “throw out the baby with the bathwater.”

Do Opioids Induce Hyperalgesia in Humans? An Evidence-based Structured Review

• Published in 2009, a systematic review of other studies. These included 30 studies and 18 case reports or case series studies.
• "There was insufficient evidence to determine the existence of opioid-induced hyperalgesia in humans, except for normal volunteers receiving opioid infusions, but these data were inconsistent."

Opioid-induced hyperalgesia (OIH): a real clinical problem or just an experimental phenomenon?

• "Although opioid-induced hyperalgesia (OIH) is mentioned as a potential cause of opioid dose escalation without adequate analgesia, true evidence in support of this notion is relatively limited."
• "Thus far evidence for OIH in patients with chronic or cancer-related pain is lacking."

Do Doctors Claim That OIH is a Proven Common Condition?

Yes!! It seems like this has become a common talking point of people like Andrew Kolodny and other members of PROP. I'll list some examples:

New Opioid Guidelines - How Colorado Can Revolutionize Pain Management

A presentation was given by Dr. Don Stader, an ER doctor who owns a compliance company called Stader Opioid Consultants and has created an opioid free approach to ER medicine called ALTO (Alternatives for Opioids for Pain Management). 

• Strangely enough, he gives a lecture on the danger of prescription opioids while drinking a beer.(We had linked to a video of his lecture, but he must have removed it from the internet).

"Here is the mind bending thing. Opioids cause chronic pain is what we're discovering." ~ Dr. Don Stader

Opioids - The Big Picture - Two doctors in Canada give a history and overview of opioids. They repeat all of the major lies/false narratives of Andrew Kolodny and PROP .

• "100 years ago Dr. Calkinis already knew that opioids cause pain."
• "When I teach and I talk to residents and medical students about the fact that opioids cause pain, they look at me like I have two heads, yet 150 years ago we already knew this."
• "We already know that it causes hyperalgesia."

The Psychological and Physical Effects of Pain Medications

This article is written by Dr. Don Teater for the National Safety Council (NSC). 

• "Though the frequency of opioid-induced hyperalgesia is unknown, it is believed to be fairly common and significant.

Why Do "Experts" Give Misleading Information About Opioid Induced Hyperalgesia?

Insurance companies want to save money

 An article, "Demystifying Opioid-Induced Hyperalgesia," discusses this point. 

• "Some insurance companies have declined to continue paying for opioid medications, citing OIH."
• "In cases like these, many insurance companies state that patients should have their doses tapered in order to decrease their pain. However, clinicians may find that attempts to reduce the opioid dose often result in increased pain."
• "Despite these experimental studies, no published studies have either specifically evaluated the relevance of OIH to clinical populations of chronic pain patients or provided evidence that OIH actually contributes to increased opioid need in chronic pain patients."
• "There are several well-established reasons other than possible OIH to explain why prescribers often find it necessary to increase the opioid dose in a patient with chronic pain. If a patient is functioning with adequate pain relief on his/her current dose of opioid, decreasing the dose, as the insurance company may suggest, is not in the patient’s best interest. The outcome of such a decision is likely to be increased pain and decreased function."

Used as part of the litigation Narrative

We frequently refer to the litigation narrative. Most of the people who repeat common false narratives such as OIH are also paid expert legal witnesses in opioid litigation. Some of the repeat expert legal witnesses in litigation are Andrew Kolodny, Jane Ballantyne, and Anna Lembke. All three discuss OIH as if it were common and backed by science. The existence and prevalence of OIH can be found in most of the opioid litigation lawsuits. I'll list two of them:

Colorado vs. Purdue and Sacklers

• Page 24  "Although opioids may be effective for alleviating pain in the short-term, clinical studies indicate that opioids are not similarly effective for relieving chronic or long lasting pain. Patients are at risk of increased pain sensitivity (known as hyperalgesia) when using opioids for a prolonged period."
• Page 111 "At least one of L.S.’s patients suffered from “hyperalgesia from excessive opioids. L.S.’s medical license was revoked in October 2018."

A complaint filed against a doctor in NJ

• Page 11- "As explained by Lewis S. Nelson, M.D. opioids “have been increasingly documented to promote the development of ‘opioid-induced hyperalgesia.’” Dr. Nelson clarifies that these risks “are acceptable for the management of end-of-life cancer related pain, but are not acceptable for the management of a pain syndrome expected to last decades."

Doctors Are Afraid To Prescribe Opioids

I received hundreds of comments from CPP's on social media saying their doctors used OIH as a reason to deny opioids:

• "My doctor has used that as an excuse to cut my meds and force me off methadone. I haven’t experienced it. The only thing I experienced was plateauing on my dose after 20 years." ~CPP on Facebook
• "Supposedly the new pain management office I went to in 2013 diagnosed me with that. I had overuse injuries and herniated disc in my neck." ~CPP on Facebook
• "I was told that that was why my pain was so much worse OFF the drugs when I was cut. It was months later and they said it was still the aftereffects of the drug and that being on opiates MAKES ones pain worse so give it time." ~CPP on Facebook
•  "I was told I don’t actually have the rare disease I've been diagnosed with and had major surgery for, I just have pain BECAUSE of opioids." ~CPP on Facebook
• "They tried saying they were tapering because of hyperalgesia." ~CPP on Facebook
• "Yep! My doctor swore my meds made my pain worse." ~CPP on Facebook
• "I was told that. I was taken off oxycodone 6 months ago. Pain is still there. It is not hyperalgesic pain. It is pain from a failed cervical spine surgery." ~CPP from Facebook
• "That was used on me to cut me off after my 35 years my retired." ~CPP on Twitter

Accurate Diagnoses of OIH in CPP's

I asked on the National Don't Punish Pain Facebook group (over 21,000 people) and on Twitter if any CPP's had experience actual OIH. I received a message from one pain patient saying she absolutely experienced OIH. She said it started after about one year on opioids.

Doctors' views of OIH

Dr. Chad Kollas, a palliative care doctor who is also on the AMA Opioid Task Force:

His view of OIH: "OIH is very uncommon in our Clinic. I would feel very safe in saying that it affects less than 1% of our patients. I believe OIH is rare, but over-diagnosed by prescribers who are conflating it with other conditions (withdrawal in physical dependence, actual addiction, etc)." 

How many patients has he seen with it?: Maybe 5 out of 40,000 patients "That said, critics will point out that a cancer center is not representative of the general population"

How did you treat your patients with OIH?: "When I have experienced patients with OIH, they have responded well to opioid rotation, especially to methadone."

Dr. Stefan Kertesz, a VA doctor who works with both pain patients and patients with addiction:

His view of OIH: "As I see it, the words "Opioid Induced Hyperalgesia" are now used to refer both to a narrow laboratory phenomenon that can be exhibited in animals and humans, and also generalized to refer to any and all situations where patients report worse pain while receiving opioids...I believe that it's possible for opioids to make pain more volatile. That's totally separate from the relatively uncommon phenomenon of "hyperalgesia." 

Dr. Bob Twillman, a Pain Psychologist:

His view of OIH: "It's so hard to say definitively if it exists in an individual, and the only practical way to know is to taper them and see what happens. I'm not interested in that exercise unless there is a really good reason to think there's something there to be discovered. In no way do I think it's as common as the PROPagators think.-I've never seen a large-scale study proving that it's a 'thing' in humans, only rat studies." 

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LIE: "The concepts of MME and MME limits are based on solid scientific evidence, and lowering patients to less than 90 MME is always beneficial."

The article contains the following information:

• What is MME?
• What is the purpose of MME conversions?
• Where did the MME conversions originate?
• What are some limitations of MME conversions?
• What is the origin of 90 MME and other MME thresholds?
• Do the CDC Guidelines use MME thresholds?
• Do data analytics use MME thresholds?
• Does lowering MME decrease adverse events like addiction or misuse?
• Does lowering MME reduce risk of overdose?
• Do forced tapers of high dose opioid" patients lower the risk of adverse events or death?
• Did CDC's updated/expanded guidelines use MME thresholds?

What is MME?

MME means Milligram of Morphine Equivalent, the amount of milligrams of morphine an opioid dose is equal to when prescribed." Why does it affect pain patients? "MME's are increasingly being used to indicate abuse and overdose potential and to set thresholds for prescribing and dispensing of opioid analgesics."

On June 7-8, 2021 the FDA held a workshop discussing MME. They discussed in depth the benefits of MME, the limitations of MME, how the calculations are done, etc. Much of the information you'll read here is from that workshop. There is a recording of both days (June 7 and June 8), in case you're interested in listening. Here is the link to all of the information from the presentations, including pdf documents and comment periods. 

The purpose of the FDA meeting was "to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs), which are widely used as metrics in multiple areas throughout the healthcare system." We will add some information to their points to show the origin of MME thresholds and how they are being applied and enforced. In summary, this article will discuss the benefits and limitations of MME, if there is a standard way to calculate MME, what thresholds they use, where the first threshold came from, how these thresholds are being enforced, and how all of it is affecting people in pain. I'll link sources to each point. Ok, here we go.

 What is the Purpose of MME Conversions?

The original purpose of the MME conversion (taken from FDA presentation from Grace Chai, PharmD) was to assist clinicians in determining initial dose when converting an individual patient’s opioid therapy. The conversion factors were based on a small clinical study done in limited populations.

Where Did the MME Conversions Originate?

In the FDA presentation by Mary Lynn McPherson, she explains that “The conversion factors were based on information from multiple sources. After reviewing published conversion factors, consensus was reached among two physicians with clinical experience in pain management and a pharmacist pharmacoepidemiologist.” Here is the publication by Von Korff she's referring to. Von Korff is also a member of PROP

What Are Some Limitations of MME Conversions?

Calculations

Is there truly a standardized way to calculate MME? Not really. Dr. Dasgupta presented this information at the FDA meeting. His talk was called "Inches, Centimeters, and Yards: Overlooked Definition Choices Inhibit Interpretation of Morphine Equivalence." In this discussion, he explains there are actually four different ways to calculate MME based on different definitions used. The results are quite varied. Dr. Dasgupta presented a study to prove this point using the 4 different definitions of MME to calculate dosages of patients. He used the 90 MME threshold as "high dose" since that is a commonly enforced amount. The results illustrate that the method of calculations produced different MME amounts. So, the same patients who were considered "high dose" patients with one calculation method was not with the other. If you're interested in learning all the factors that go into the different methods of calculations, please listen to Dr. Dasgupta's presentation. He shows the limitations of each method and explains which method the CDC uses. You can find a conversion calculator on the CDC app. Read what they have to say about the importance of MME. 

Listen to a new podcast where Dr. Joshi and Daily Remedy interviewed Dr. Dasgupta.

Pharmacogenetic variability, drug interactions and other limitations of MME

In Dr. Fudin's FDA presentation called "Individual Patient & Medication Factors that Invalidate Morphine Milligram Equivalents," he discusses limitations of MME including pharmacogenetic variability. In Dr. Fudin's paper called "The MEDD myth: the impact of pseudoscience on pain research and prescribing-guideline development." he explains limitations of MME conversions including pharmacogenetic variability and drug interactions. Referring to the limitations, Fudin states "these include patient-specific attributes, such as pharmacogenetics, organ dysfunction, overall pain control, drug tolerance, drug–drug interactions, drug–food interactions, patient age, and body surface area. The bottom line is that as the scientific concepts upon which prescribing guideline authors depend are flawed and invalid, so are the guidelines themselves. As a result, we posit that these guidelines are disingenuous and highly unethical...just as prescribing guidelines are based on flawed formulas and evidence, invalid concepts can make research invalid. We are thus compelled to consider whether outcome research that continues to rely upon the concept of MME is also invalidated by such. Our hope as researchers is that our colleagues will acknowledge this imbroglio and convert their processes of outcome research in a manner that will produce more valid and meaningful results for individual patients, rather than meaningless cohorts."

What is the Origin of 90 MME and Other MME Thresholds?

Now that we know that there isn't a standardized way to calculate MME, let's look at some of ways MME thresholds are codified into policies and even laws. Actually, before we list those, you may be wondering where the 90 MME threshold even came from. Since it's made into laws, many people might assume this threshold must be based on solid scientific evidence. Yet, that's far from the truth. So before we go into how these thresholds are enforced, let's look at where limits such as 90 MME come from. Years before the 2016 CDC Guidelines came out, a group of doctors got together in Washington state to write opioid prescribing guidelines. Not surprisingly, many of the same doctors who went on the form PROP and help with the creation of the CDC Guidelines, were in the group who wrote the Washington Guidelines. In an article about these guidelines, Dr. David Tauben was interviewed. He was one of the authors of the Washington Guidelines. When asked about the CDC Guidelines, Tauben said “there is not a single thing in the CDC guidelines that we don’t cover in more detail in the Washington Guidelines." The article goes on the explain that Tauben was the first person to come up with the idea of an MME threshold. His idea was a patient should be given no more than 120 mg of a morphine equivalent. "Based on his clinical experience, patients needing more than 80 mg equivalent often did worse, not better. By 2006, at least 10,000 people in state insurance plans were prescribed more than 120 mg a day so the group set 120 mg as a first, more practical top dose limit before the patient should consult a pain specialist." So this was an idea pulled out of thin air based on one doctor's opinion, not solid scientific evidence. The CDC lowered that dose from 120 MME to 90 MME.

Dr. Gary Franklin, another PROP doctor who was involved with writing these guidelines, discussed the origin of the MME threshold in this lecture he gave in 2016.

Franklin said "Washington state did the first guideline in the US with a dosing threshold. We didn't have any clear cut data on what the dosing threshold should be and we came up with 120 MME, we thought it was a reasonable guess because in their experience they didn't think people needed much more than that. If fact, it started out at 90 but there were so many people in the state over 100 that they didn't think it was a practical threshold so we went up to 120 and that was what was implemented."

So the first MME threshold was 120 MME created by Dr. Tauben for the 2007 Washington guidelines. We know the CDC Guidelines came out in 2016. What happened between 2007 and 2016? On July 25, 2012, the anti-opioid zealots in the organization PROP submitted a citizen's petition to the FDA. Here is a pdf copy of the petition. Among the requests of changes to opioid analgesic labels, PROP asked the FDA to "add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain." The FDA responded to PROP in 2013. A copy of their response is here.. Although they did grant some of PROP's requests, The FDA did not agree with their points regarding 100 MME threshold. We've listed a few quotes from their response to PROP:

• "The Agency declines to specify or recommend a maximum daily dose or duration of use for any opioid at this time." 
• "Many professional societies did not support the Petition and stated that the data cited by PROP did not support PROP's requests (particularly those requests for limits on dose and duration of use of opioids)"
• "Professional societies also expressed concern that the labeling changes requested by PROP were not supported by scientific evidence, and that a "one-size-fits-all" approach to a maximum dose or duration of treatment would be problematic and inconsistent with the need for individualized treatment and the variability among patient responses to opioids."
• "The Agency declines to specify or recommend a maximum daily dose or duration of use for any opioid at this time."
• "FDA acknowledges that the available data do suggest a relationship between increasing opioid dose and risk of certain adverse events. However, the available information does not demonstrate that the relationship is necessarily a causal one."
• "The scientific literature does not support establishing a maximum recommended daily dose of 100 MME."

Do the CDC Guidelines Use MME thresholds?

After the FDA denied some of PROP's requests for regulating opioids, another agency took on the task of creating guidelines for opioid prescribing. This produced CDC's 2016 guidelines for opioid prescribing. Recommendation #5 of the Guidelines is the following: "When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day."

When the Opioid Workgroup (OWG) at the CDC met to discuss each proposed guideline, some members had concerns about this specific recommendation. The report (pdf)  included the following comment: "One member of the Workgroup strongly opposes Guideline Recommendation #5 as it is written. This member stated repeatedly that the current recommendation clearly suggesting dose limits is not supported by any data showing a decrease in benefit/risk ratio at the arbitrary numbers stated in the recommendation. This member expresses concern that the current wording of Guideline Recommendation #5 will undermine support for the entire Guidelines from providers and professional organizations."

In order to assist in implementing the CDC Guidelines, the CDC BSC (Board of Scientific Counselors) discussed their plan to track and ensure they are being used. They discussed a plan to do this at the BSC meeting on September 7, 2016.  Their plan was called The Quality Improvement (QI) Initiative. Their meeting notes stated that their plan "begins with creating QI measures that are tied or connected to the recommendation statements in the Guideline. A draft has been created of those measures, and NCIPC will work with a contractor (Abt Assoc.) to reach out to a broader group of stakeholders to test whether the measures are feasible and accurate, and whether health systems will have data available through an EHR to make tracking adjustments. It is not enough to have measures; it is important for health systems to implement the measures in their practice. To that end, NCIPC is developing an Implementation Guide  document with support materials to help a health system implement the QI measures." The is stated in the section of the implementation guide that discusses specific MME thresholds. "Research has found that patients who receive high MME dosages have significantly increased risks of overdose compared with patients receiving low dosages. Establishing a practice wide policy on dosage levels may assist prescribers in making evidence-based decisions and minimizing risks of adverse outcomes. Use extra precautions when increasing to ≥ 50 MME per day, such as: Avoid or carefully justify increasing dosage to ≥ 90 MME per day. Patients already at high levels may be willing to try reducing the dosage. The practice should consider advising prescribers, as a matter of policy, to discuss this with their patients who are taking more than 50 MME per day."

Another part of CDC's implementation plan was with CDS (Clinical Decision Support), which not surprisingly AHRQ was involved with. Their BSC notes stated "Another area, Clinical Decision Supports, links the content of the Guideline to EHRs. If EHRs are an important part of clinical care, it is important that they include codes, artifacts, and alerts that are tied to, for instance, MME thresholds."

Do Data Analytics Use MME thresholds?

Unfortunately, CDC's implementation guide and Clinical Decision Support tools weren't the only places these MME thresholds were measured. Data Analytics companies created AI (Artificial Intelligence) risk scores that used MME thresholds as one of their main measures. NarxCare is one of these risk score algorithms. (Read our article about NarxCare here) As we've discussed, NarxCare is software owned by Bamboo Health. It pulls information from different data sources to spit out a risk score between 0-999. Since the algorithm is proprietary, we don't know exactly what they use, but we know some of the data points that are considered "red flags." One data point is MME. In their user guides, Bamboo Health explains that only 1% of all patients will have a risk score of 650-999. As shown in the following image from their user manual in Virginia if a patient gets 90 MME or higher, the patient's risk score is automatically 650+, which is the top 1% of all patients. Bamboo Health also has a similar scoring system of doctors.

NarxCare isn't the only algorithm that uses MME to give risk scores. OIG (Office of Inspector General) contracts out with a company (Qlarant) that uses an algorithm to give doctors risk scores. This score is also 0-1000. Here is the OIG Toolkit, if you're interested in reading more about this scoring system. The site explains that "These toolkits provide steps to calculate patients' average daily morphine equivalent dose (MED/), which converts various prescription opioids and strengths into one standard value. This measure is also called morphine milligram equivalent (MME)." We know that this risk score was used in cases against doctors. The case that's going to be heard before the Supreme Court on March 1, 2022 involving Dr. Couch, used a risk score to target him. Here is our article about this Supreme Court case. Here is an image from Dr. Couch's court transcript where it shows Dr. Couch had a risk score of 1000 out of 1000.

Unfortunately, even though CDC has repeatedly said that the guidelines were just guidelines and shouldn't be used as law by enforcing MME limits or duration of prescription, as Dr. Dasgupta stated in his presentation ,  MME per day thresholds are "enshrined in state laws, with the assumption that it is a standardized metric." At the time of his presentation in June there were 14 states that had laws based on MME that imposed limits on the dosage of opioids that can be prescribed, ranging from 30 MME to a 120 MME. Here is a complete list of state laws regarding opioids.

As we've shown, these MME thresholds are used to create risk scores for patients and for doctors. We've seen several press releases put out by the DEA mentioning that the doctor they targeted "prescribed outside of the recommendations of the CDC Guidelines," including mentioning MME thresholds. So is it just a suggested threshold? How can it be when laws are created, patients are targeted, and doctors are arrested based on these arbitrary MME thresholds. As we have shown in this article, not only is the way to calculate MME not uniform or scientific, the very idea of an MME threshold was created by the opinion of doctors and not on solid scientific evidence.

Does Lowering MME Decrease Adverse Events Like addiction or Misuse?

In Grace Chai's FDA presentation, she said "Studies have also examined the association between daily dose and adverse outcomes (e.g., opioid use disorder/addiction, misuse/abuse), but causality is unclear."

Does Lowering MME Decrease Risk of Overdose?

A comment given by Friedhelm Sandbrink, who works for the VA: "We also know that in regard to overdoses in veterans, that the role of the actual prescription and the dosage and duration, while linked to higher risk, is actually relatively minor compared to the risk associated with comorbidities of the individual patient. When we look at high dose opioid prescribing, patients that are on more than 90 MME -  those patients represent only 20% of the patients that overdosed from opioids or had a suicide related to being on opioids. While we know that the dosage is a factor, a history of having PTSD or Alcohol Use Disorder  is just as strong as a factor of being on 120 MME. Opioid/benzo affects overdose rate by 1.4 where as depression affects it by 5. We have to get away from concentrating on the prescription and truly look at the patient. We have to see this as a whole person perspective. Train our providers in patient centered care. Taking the pain condition take into account with the comorbidities, in addition to looking at the pain prescription itself."

It is a factor, but not the only or even the most important factor. Using it as the sole factor to cause a patient to be red flagged or a doctor to be targeted isn't based on evidence. Dr. Stefan Kertesz said "If one can actually calculate dose- per Dasgupta- there is an association between the Rx dose and death risk but, this is like many situations in medicine where the overall risk to a patient is the net result of an array of risk factors, with dose prescribed being a modest one among many. " He also said "In most of medicine when we discuss risks we do so with reference to a collection of risk factors and the data we have permit that with Rx opioids too. It is simply a choice by CDC guideline authors not to use that data."

In a video Dr. Kertesz calls "Irrational Exuberance, Incautions Stoppage: Our Prescription Opioid Story"  he reviews that even in VA data, most overdose among prescription recipients is at low prescribed dose. "This means that we are dealing with an event, an event that is driven by multiple factors, and specifically one that is probably best called 'a poisoning event with opioids involved' so that we avoid the incorrect inference that the written dose on the bottle is what causes it."

Do Forced Tapers of "High Dose Opioid" Patients Lower the Risk of Adverse Events or Death?

After the release of the 2016 CDC Guidelines, many pain patients across the country have been forced off of their opioid medications. Some forced off completely, and some forced to taper down to 90 MME. It happened so often that the FDA released a warning about not forcing rapid tapers and the CDC released a warning about misapplication of their guidelines. Neither document helped the situation, though. Rapid and forced tapers continue to occur daily.

One reason doctors are forcing patients off of opioids or down to 90 MME is because they are afraid to be targeted by the DEA. They have every reason to be worried, as we've proven in this article. DOJ  is using MME thresholds to target targets. Another reason that doctors give for force tapering patients is they say it decreases risk of adverse events or overdoses. Is this actually backed by science, though? No, it's not. Read all about it in this study that was released showing that forcing tapers of patients who were on "high doses" of opioids causes more deaths than allowing them to remain on their medication. This decline in opioid prescribing has even affected cancer and hospice patients, as shown in this article. "In response to the opioid epidemic, the study authors suggested, measures to make opioids harder to obtain may have prevented some patients from receiving appropriate prescriptions for opioids to manage cancer pain."

Did CDC's 2022 updated guidelines remove MME Thresholds?

The following was information about the updated CDC Guidelines when they were in draft form including discussions with the Opioid Work Group

As we've shown, MME thresholds aren't a good idea and using arbitrary cut-off MME limits have caused great harm. The CDC is releasing updated (expanded) opioid prescribing guidelines this year (2022). Three of the suggested guidelines include MME thresholds. We will list each suggested guideline along with comments of concern from the OWG (Opioid Workgroup) members. Here is the full OWG report.

Recommendation #4: When opioids are started for opioid-naïve patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest effective dosage. If opioids are continued for subacute or chronic pain, clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.

Opioid Workgroup Comment for #4: Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation. In addition, these thresholds are felt to be arbitrary to some degree and could be calculated differently based on different conversion formulas, but when they appear in the statement, they appear to be authoritative.

Recommendation #5: For patients already receiving higher opioid dosages (e.g., >90 MME/day), clinicians should carefully weigh benefits and risks and exercise care when reducing or continuing opioid dosage. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. 

Opioid Workgroup Comment for #5:

• 1. Similar to the observations noted for recommendation #4, many workgroup members felt that the threshold doseshould be removed from the statement and included in the supporting text.
• 2. Several workgroup members noted that the framing of this recommendation is not balanced – that it does not include the risk/benefit calculation of continuing opioids. For example, a more balanced approach is to have one sentence about continuing opioids and one sentence about tapering opioids in terms of risk/benefit analyses. 
• 3. Some workgroup members felt more discussion is needed regarding working with patients or obtaining consent from patients when prior to initiating and prior to tapering opioids, and limiting involuntary tapering. 
• 4. However, there were some specific issues that were noted as concerning by some members, these included: never going back up in dosage during opioid tapering; lack of inclusion of observational studies showing potential dangers of tapering; minimal discussion about risk of tapering; role of patient-centeredness approach; representing the role of buprenorphine as established rather than emerging; an explicit discussion of goals of tapers is needed, particularly related to public health versus individual patient outcomes; there seems to be an underlying assumption that the goal is to get to zero MME, but perhaps it should be to get to a safer dose or better symptoms or function; a section on iatrogenic harms of tapering may be warranted.

Recommendation Statement #8: Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk for opioid-related harms and discuss with patients. Clinicians should incorporate into the management plan strategies to mitigate risk, including offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present. 

Opioid Workgroup Comment for #8: In addition, specifying the 50 MME dose threshold is concerning, and conveys similar risk as the other conditions. The dose threshold is arbitrary and inconsistent with other sections of the guideline (50 vs. 90 MME). As noted in overarching themes, many members recommended that these specific conditions be removed from the recommendation.

Will the CDC BSC take these comments into account when publishing the final expanded CDC Guidelines for opioid prescribing? We can only hope. Here is our Newsletter that explained all about the updated/expanded upcoming CDC Guidelines. Considering they didn't take into account the concerns from the OWG for the 2016 CDC Guidelines, it's doubtful they will this time around. Read our article explaining the way the 2016 Guidelines were written and how there was bias and lack of transparency.

The following is information about the published 2022 CDC Guidelines

Although the CDC repeatedly told media it loosened the updated guidelines by removing MME thresholds, it hasn't helped at all. In fact, all the did was remove the MME thresholds from the main bullet points, but they actually made them appear more strict throughout the document itself. In the 2016 guidelines, CDC mentioned 50 MME 18 times. In the 2022 guidelines, they mentioned 50 MME 23 times. We've had quite a few pain patients tell us they've been forced down to 50 MME due to the updated CDC guidelines. While CDC's Christopher Jones has claimed the updated guidelines removed these thresholds, PROP members such as Dr. Jane Ballantyne shed a different light on the update. 

Listen to Dr. Ballantyne discuss this topic in a recent webinar in April 2023:

Dr. Dasgupta quotes a chronic pain representative named Liz Joniak-Grant “It is disheartening, but unfortunately not surprising. Far too often, we are victims of the good intentions of those wanting to ‘do something’ about the opioid overdose epidemic, but the something that is done oversimplifies the problem and pushes cookbook medicine upon those of us with complicated medical situations. And while everyone debates whether the MME limit was the right thing to do, we are forced to live by it, because medical personnel and others treat guidelines as mandates. So we wait. And we suffer. And we hope it will all get sorted so we can get the care we need.” 

You may be wondering if the FDA has plans to do something with the MME information from their workshop. Dr. Chad Kollas, a palliative care doctor who is also on the AMA Opioid Task Force, e-mailed the FDA to ask that very question. With his permission, we are posting this e-mail thread for you.

From Dr. Kollas to the FDA : "I am reaching out to ask whether the FDA made any sort of summary document or recommendations based on the input from its Workshop on Morphine Milligram Equivalents. Frankly, I don’t even know whether creating a summary document was one of the goals of the Workshop, but I am very interested in any sort of FDA decisions or recommendations that might have arisen out of the session."

Response from FDA to Dr. Kollas:  Thank you for your interest in the MME Workshop and reaching out to us on this. I have checked with the rest of the team and as you guessed, as of right now, we do not have anything additional such as a summary of the workshop, etc., so outside of what is already publicly available on our workshop webpage (Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions - 06/07/2021 - 06/08/2021 | FDA), I have nothing new to share. I note that the transcripts of the meeting have posted to that webpage, but they of course are not a summation. I will let you know that there was a huge amount of interest in this topic and we continued to receive submissions to the docket from many interested parties even after the meeting which now become part of the official record of the meeting.  We continue to feel the topic is important and bears continued discussion and exploration, so we hope to be able to continue exploring and working on it, especially continuing to interact with our other federal and international partners that participated in the workshop, not to mention patient and professional groups. Again thank you for your interest, and feel free to continue to check back periodically to see if we have any new information we can share publicly on this topic."

In addition to the FDA workshop information, if you're still interested in learning more about MME, we also recommend this article by Josh Bloom. Dr. Bloom's comment for the FDA workshop also has great information. 

https://www.acsh.org/news/2021/05/24/comments-fda-opioid-dosing-based-milligram-morphine-equivalents-unscientific-15561

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated May 4, 2023.

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LIE: "The USA is 5% of the world's population, but we consume 80% of the world's prescription opioids and 99% of the world's hydrocodone (Vicodin)"

This is a common statement that people use to show how much our country overprescribes opioids. You'll hear it in opioid litigation, series like Dopesick and Crime of the Century, and webinars from physicians from organizations like Fed-Up Rally, PROP, and Shatterproof. It's said for shock value. Here are some bullet points when responding to this statement:

• The statistic in this Lancet article Lancet article show in 2019 the USA was 8th in ranking. It's probably lower now. 

• According to this article in Pain News Network, the actual number isn't quite that high, and also varies per opioid. For instance the U.S. consumed 57.3% of the world’s morphine in 2013 and 2015 the U.S. consumed 29.3% of the world’s supply of prescription fentanyl. He also says the number is more like 4.4% of the world's population and consumes 30% of the world's opioids. 

• A more recent statistic was posted this week by Dr. Stefan Kertesz on Twitter. He said "The US accounted for 53% of world opioid consumption according to my review of the UN International Narcotics Control Board report of 2020. I converted to MME, from Tables XII/XIII Using raw weights, the US consumes 27%. 80% has never been true." The fact that they keep pushing this 80% and 5% false narrative is not only misrepresentation, but fraud. Why do they keep repeating this false statistic? Mostly for their litigation narrative. Billions of dollars are at stake in the thousands of lawsuits happening as we speak across the country. Litigation against pharmaceutical companies, distributers, and pharmacies. In our opinion, litigation has been their end game all along.

• Jeffrey Fudin addresses the statistic about Hydrocodone in this article called "The Hydrocode Question." He states "Many have said that the United States uses more hydrocodone than any other nation, but that is quite misleading. Most other countries do not report prescription opioid use, so to say that more opioids are prescribed by the United States than by the rest of the world is unsubstantiated. Prescribed indications are also a consideration. European countries use dihydrocodeine more commonly than they do codeine, hydrocodone, or morphine. In Canada, hydrocodone is generally used only in cough syrups or elixirs, not for pain treatment. In Australia hydrocodone has largely been replaced by morphine. Ignoring these factors skews the argument that the United States consumes the most hydrocodone worldwide and the claim that hydrocodone has been prescribed more than any other prescription drug in the United States. Unfortunately, many journalists have chosen to disregard these points in order to sell stories."

• Most of the  world does not have access to pain care at all due to being undeveloped. So are we saying that it's a good thing that there isn't access to pain care or even health care, for that matter?  About 80% of the world has little or no available treatment for moderate to severe pain. Look at this website about this topic called "The Pain Project." This article states "imagine recovering from major surgery or suffering from advanced cancer without any painkillers. That’s the reality for patients in half the countries in the world." In a study discussing cancer pain management around the world, they state "The WHO estimates that in 80% of the world population, there is insufficient access to appropriate opioid analgesics. Lack of proper pain medication prescription to the patient affects patients and the family and friends witnessing the patient's suffering." So, like Maia Szalavitz stated in a tweet from July, "the idea that the 'ideal' level of opioid prescribing is that which denies care to the vast majority of people dying in pain is absurd. Saying we consume 80% of world's opioids w/o mentioning that most of the world dies in pain is means we think dying in pain is good." Here is another study that also discusses this point. Dr. Amarquaye (@GhanaboyPharmd on Twitter) has posted some great threads about this topic. Here is one of them. This study shows that 5 billion out of 7.7 billion people don't have access to pain med. So this statistic is meant to shock and mislead.

• Some opioids are over the counter (OTC) in other countries.

• Germany is the 2nd highest per capita prescribing country, and they don't have an "opioid crisis," which proves the point that our "over-prescribing" is not what's causing this overdose crisis in the USA.

This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum