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NPR's show, 1A, had our VP, Bev Schechtman on a panel on November 11, 2021. The name of the segment is "Against The Pain: The Opioid Crisis and Medication Access." NPR became interested in the show after reading Maia Szalavitz's article about NarxCare in Wired. Listen to the recording of the show. You don't want to miss this!
"We have these people who have been on these meds for 20-30 years and doctors are under extraordinary pressure to get their numbers down" ~Maia
"In a criminalized environment where doctors are not only afraid of losing their license, but of going to prison, and where patients are being squeezed because they're being told 'you can only have x amount because otherwise my numbers are too high,' you end up with a lot of untreated pain." ~Maia
"I'd like to see context added (to these algorithms), if someone moves 3 times in 2 years, it needs to not look like they're 'doctor shopping,' I'd like to see a return to individualized care and stop these arbitrary guidelines where people are having a hard stop on what they can and can't have and they're not looking at what's actually going on with the patient." ~Bev
"I was treated like a criminal; I was mocked, laughed at, scolded, I was embarrassed...I felt revictimized." ~Bev
"There are tremendous gender and racial bias in these algorithms and in this false narrative." ~Bev
"No one should ever be denied care, that's just cruel and unusual punishment." ~Dr. Dombrowski
"Electronic Health Records are just a billing system, not to make patient care better...if you hit something by accident like malingering, next thing you know it's in the chart permanently. It's dangerous." ~Dr. Dombrowski
Dr. Mark Ibsen, who is a fierce advocate for the CPP community, recorded the show with running commentary.
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.
LIE/FALSE NARRATIVE: "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)."
LIE/FALSE NARRATIVE: "80% of heroin users started with a prescription from their doctor."
LIE/FALSE NARRATIVE: "The CDC Guidelines were created with transparency using a wide range of experts with unbiased views. They were based on strong scientific evidence, and the CDC was unaware that the Guidelines could have a negative impact on pain patient outcomes."
LIE/FALSE NARRATIVE: "Studies show that opioids don't work for long-term chronic non cancer pain."
LIE/FALSE NARRATIVE: "The concepts of MME and MME limits are based on solid scientific evidence, and lowering patients to less than 90 MME is always beneficial."
LIE/FALSE NARRATIVE: "Studies show that opioids make pain worse in a common condition called Opioid Induced Hyperalgesia (OIH)."
LIE/FALSE NARRATIVE: "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."
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:
This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum.
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 studyby 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.
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.
This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated January 10, 2022.
We all know by now that the 2016 CDC Guidelines for opioid prescribing have been weaponized. The CDC claims they were never intended to be used the way they have been.They even issued a warning acknowledging the Guidelines have been misapplied. This was in response to a letter (Word) (pdf) a group of health care professionals, called HP3 (Health Professionals For Patients In Pain) sent to the CDC raising concern about the misapplication of the Guidelines. Around the same time, the FDA also issued a warning about forced tapers.
What many people don't know is that the CDC was warned that the Guidelines would hurt patients. Did they care? No. So when they say "we didn't know this would happen," just know they're lying.
In 2015 several organizations and groups tried to sound the alarm about the potential dangerous impact the Guidelines may have.
At the same time as the CDC Guidelines were being written, another government agency, Interagency Pain Research Coordinating Committee (IPRCC) was asked by HHS to oversee the creation of the National Pain Strategy. We will get into details about that report at another time, but the reason I'm mentioning it is because the IPRCC expressed grave concern about the CDC Guidelines and how they could have a negative impact on patient outcomes.
This IPRCC meeting took place in December 2015. Here is the link to the video for the meeting. Here is an amazing Twitter thread done by Carrie Judy, a researcher with The Doctor Patient Forum, regarding this meeting and comments made about the CDC Guidelines. Here are a few quotes:
It's clear that the IPRCC had concerns about the potential negative impact of the CDC Guidelines as well as the bias that was clearly allowed. Not surprisingly, there was then an investigation done into the members of the IPRCC, calling them "industry funded," as shown in this article. Here are a couple of quotes discussing the IPRCC members and their comments about the Guidelines.
Notice they didn't address any of the IPRCC's concerns regarding the CDC Guidelines, instead they just attacked the members of the IPRCC, trying to discredit them. Ad-hominem, is what that debating technique is called. Remember that because it's not the only time they used that technique.
In addition to the IPRCC, there were many other organizations who expressed serious concerns about the upcoming CDC Guidelines. These concerns were not only regarding the content of the Guidelines, but the secretive manner in which they were crafted. The following are links and information about a few of those organizations who expressed concern about the Guidelines in 2015:
American Academy of Pain Management (AAPM) wrote a letter (pdf) on 10/20/15 to the Honorable Fred Upton, who was Chairman of the House Energy and Commerce Committee at the time. This letter included the following comments:
The Committee on Oversight and Government Reform, a House Oversight Committee wrote a letter (pdf) to Dr. Tom Frieden on 12/16/15. This letter included the following comments:
The American Cancer Society wrote a letter (pdf) to Dr. Frieden and Dr. Houry on 10/1/15. The letter included the following comments:
The Washington Legal Foundation wrote a letter (pdf) to Dr. Tom Frieden on 11/17/15. This letter included the following comments:
I'll briefly explain FACA, and why WLF questioned the process CDC was using to write these guidelines.
The government's website defines FACA as "The Federal Advisory Committee Act that was enacted in 1972 to ensure that advice by the various advisory committees formed over the years is objective and accessible to the public. The Act formalized a process for establishing, operating, overseeing, and terminating these advisory bodies and created the Committee Management Secretariat to monitor compliance with the Act." If you're interested in reading more about it, here is the link.
The CDC responded to the WLF in a letter, and announced they'd have their Board of Scientific Counselors (BSC) as the Federal Advisory Committee (thus complying with FACA) , to review the draft guidelines and published this announcement about an upcoming public commenting period. Richard Samp, the lawyer at WLF, wrote this article explaining this information. Although this appeared to be a step in the right direction, looking back it was really just lip service, making things look like they were trying to create balanced guidelines, when in fact they needed to push these unscientific guidelines through to be used as evidence in opioid litigation. This is what you'll hear us call the "litigation narrative."
Remember how CDC's response to IPRCC's concerns was an ad-hominem attack instead of addressing the actual concerns they had? Well, they did the same thing with the concerns of these organizations.
Instead of addressing the actual issues brought up by the various organizations, they published an investigation into the 158 groups themselves, claiming they were all industry funded. These claims can be seen in this article by PROP (Health Professionals for Responsible Opioid Prescribing) member Adrienne Fugh-Berman. This is ironic considering Fugh-Berman herself is "industry funded" by the endlessly lucrative opioid elimination industry. She, Andrew Kolodny, Jane Ballantyne, and other PROP members have received millions of dollars as "expert witnesses" in opioid litigation. Two of the authors of the paper about this investigation were Andrew Kolodny and Caleb Alexander, both have been expert witnesses in opioid litigation. Caleb Alexander also owns a compliance company, hence making more money off of the opioid elimination industry.
Looking back, it's easy to see that the purpose of the CDC Guidelines was to be used as evidence for opioid litigation. This was the end-game. Their main reason for creating this litigation narrative. Billions of dollars made off of litigation. Peter Pitts, former FDA employee, discussed this very issue in an article in 2015.
When Kolodny was pressed on why Ballantyne working for a law firm with a financial interest in the guidelines is different than input from doctors with financial ties to pharmaceuticals, he said: “I’m not sure how I would understand that to be a conflict if somebody is an expert and they’re asked for their expertise.” He then went on to make millions as an expert witness in litigation that used the CDC Guidelines as evidence.
Washington Legal Foundation predicted in 2016 that the Guidelines would be used in opioid litigation. Read Richard Samp's prediction in this article called "CDC's New Opioid Guidelines Will Be Used By Plaintiffs Bar, WLF says." '“Will the plaintiffs bar use these guidelines in their pending litigation? I have no doubt that, yes, they will,” Samp told Legal Newsline.'
Read more about the litigation narrative and the CDC Guidelines in this article called "Plaintiffs firm consultant helped develop CDC's controversial opioid guidelines."
Now, Listen to this podcast from 2019 with Tom Frieden, who was the head of the CDC at the time the Guidelines were written, and hear his account of the WLF complaint.
The interviewer, who lost a son to heroin, asked Dr. Frieden about the Guidelines. He said how shocking it was that "pain forums" pressed Congress to investigate the CDC to uncover any influence from special interest groups. He then went on to say that the CDC took a very strict view on conflicts of interest (COI's). Listen to this quote "People's opinions change for reasons they might not be aware of. And, if you're getting a paycheck from someone, or might be in the future, you might in ways you didn't even realize have a different opinion. He then said if anyone had a COI, CDC didn't allow them to be there. I guess the millions Kolodny, Ballantyne, Alexander, etc made as expert witnesses in litigation doesn't count as a "paycheck." Right? Certainly, someone being paid by a lawyer to convince a jury that prescription opioids are fueling this crisis, wouldn't ever want to influence Guidelines that would help them win. Right?
American Academy of Family Physicians (AAFP) wrote a letter (pdf) to Dr. Tom Frieden on 1/13/16, commenting on the proposed Guideline. This letter included the following comments:
American Academy of Pain Medicine (AAPM) wrote a letter (pdf) to Dr. Tom Frieden on 1/12/16, commenting on the proposed Guidelines. This letter included the following comments:
American Academy of Anesthesiologists (ASA) wrote a letter (pdf) to Dr. Tom Frieden on 1/13/16, commenting on the proposed Guidelines. This letter included the following comments:
Of course there were organizations and people who wrote letters in support of the CDC Guidelines. Since those profiting from this false narrative want you to believe that anyone who opposed the Guidelines did so because they were bought by pharma, let's look at those who supported the Guidelines. Attorneys General. Now, why do you think they would care to give their input on the Guidelines? Could it be because this was all part of their plan to get billions of dollars from the pharmaceutical industry in opioid litigation? All you have to do is look at the cases currently in court to see these Guidelines are added as evidence. There are approximately 3,000 cases across the USA.
Let's look at some of these letters. When reading these letters from lawyers, keep in mind the comments physicians and actual pain experts made about the lack of evidence, the tremendous bias, the secretive manner in which the Guidelines were created, and the potential harm the Guidelines could cause on people in pain.
Letter written (pdf) by the Attorney General of NY regarding the Guidelines, written on 1/13/16. This letter included the following quote:
Letter written (pdf) by the Attorney General of Massachusetts regarding the Guidelines, written on 1/13/16. This letter included the following quotes:
Letter written (pdf) by 36 Attorneys General regarding the Guidelines, written on 1/13/16.This letter included the following quote:
Remember that after WLF pushed the CDC to abide by FACA, they opened up a comment period. These comments are listed here (pdf) in the minutes of a Board of Scientific Counselors (BSC) meeting on 1/28/16. The comments start on page 38. Look at the people who commented. Gary Mendell, Gary Franklin, Judy Rummler, Steve Rummler's fiancé, Caleb Alexander, David Juurlink, Jane Ballantyne, and Andrew Kolodny, So you have the same biased anti-opioid zealots who helped create the Guidelines, making comments supporting the Guidelines. Where are all the pain patients and pain doctors? Well, the comment period was not well publicized, so many pain patients and doctors didn't have a chance to comment.
Here are some quotes:
The CDC put together an OWG (Opioid Workgroup) to discuss the proposed guidelines. Here is a pdf of their comments made at the meeting on 1/28/16. Some of the members actually did express concern with some of the guidelines, but it appears that these concerns were not addressed. Here is one of their comments:
As you know, the Guidelines were published without any consideration of the concerns raised about them. Regardless of the fact that they're "just guidelines," they have since been used in opioid litigation and have been cited as the reason for cutting people off opioids. Read this White Paper by National District Attorneys Association. "This working group recommends that the CDC’s guidelines or a similar evidence-based guideline be adopted that would be standard around the country. Prosecutors should familiarize themselves with the CDC standards and advocate for their legislatures to adopt them in the irrespective states." Prescribing is down, 44%, and overdoses have skyrocketed. We need to get these rescinded if we have any hope of returning to individualized pain care. Please read this article written by AMA Opioid Task Force member and palliative care physician, Dr. Chad Kollas, called PROP's Disproportionate Influence on U.S. Opioid Policy, The Harms of Intended Consequences. The Guidelines are being updated and due to be released the end of 2022.This process was also done in a very shady manner with conflicts of interest.
Now that we've gone through the timeline of the creation and the concerns about the 2016 CDC Guidelines, if you're interested in hearing more about it, here is an excellent talk discussing this topic called "If 6 were 9: The CDC's Prescribing Guidelines and the Veil of Secrecy In this discussion, you'll hear the explanation about the Core Expert Group and how it was originally a secret. They discuss this in some detail, including information about the complaints filed by WLF (that we discussed earlier in this article). It is clear that the Core Expert Group (which includes PROP members Ballantyne and Franklin) was originally secretly working on the CDC Guidelines, and their names were not released until pressured to do so. As we mentioned earlier, when their names were released, they didn't properly disclose conflicts of interest such as already having been hired as expert witnesses in litigation.
The CDC explained the role of the Core Expert Groupsaying "CDC sought the input of experts to assist in reviewing the evidence and providing perspective on how CDC used the evidence to develop the draft recommendations. These experts, referred to as the “Core Expert Group” (CEG) included subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline development methodology. CDC identified subject matter experts with high scientific standing; appropriate academic and clinical training and relevant clinical experience; and proven scientific excellence in opioid prescribing, substance use disorder treatment, and pain management. CDC identified representatives from leading primary care professional organizations to represent the audience for this guideline. Finally, CDC identified state agency officials and representatives based on their experience with state guidelines for opioid prescribing that were developed with multiple agency stakeholders and informed by scientific literature and existing evidence-based guidelines."
Interestingly, Andrew Kolodny has been quite outspoken about things he refers to as myths or conspiracy theories. He gave a presentation about this on Marcy 29, 2021., which was sponsored by Pharmed-Out, a group started by Adriane Fugh-Berman-also a PROP member. One of these myths, Kolodny claimed was that "CDC Opioid Guidelines was secretly written by PROP." Kolodny called this idea a conspiracy theory in a Justice article about our protest we sponsored at Brandeis, where he works. His said "One conspiracy theory Kolodny rejected is that he and PROP secretly wrote the CDC guideline calling for more cautious prescription of opioids."
Now that you have the facts, you can decide for yourself. Did PROP secretly assist with the 2016 Opioid Guidelines? We've given you evidence and explanations from experts who claim they did. Kolodny claims that's a conspiracy. What is your conclusion?
This article contains the following information:
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:
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.
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:
Bottom line of results:
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):
Problems or points of interest with the study:
Problems with how it's been applied:
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:
Lembke's testomony given under oath as an "expert witness" in opioid litigation in NY: "Researchers, including those who published an article in the Journal of the American Medical Association in 2018, were forced to conduct studies to counter the pharmaceutical companies’ opioid promotions. Those studies found that opioids were not effective for the long-term treatment of moderate to severe pain, and that the risk of addiction had been understated." Remember, neither statement is correct. SPACE Trial showed that opioids were effective AND showed that none of the 240 developed addiction, so show me how the results showed risk of addiction has been understated? This isn't the first time Lembke lied under oath. Remember the ruling by Judge Wilson in Ca that said her testimony was inaccurate and that she OVERSTATED the risk of addiction? I guess an "expert" would be willing to say just about anything in litigation if the pay rate were high enough. Anna Lembke has made millions as an expert witness in opioid litigation. She is a Psychiatrist, so she's not an expert in pain treatment, anyway. She testified in the same case that she makes $500-$800/hour as an expert witness. The article states "Dr. Anna Lembke acknowledged that she has been paid hundreds of thousands of dollars appearing as an expert witness for plaintiffs suing opioid makers in recent years."
Yet, any pain patient advocate is accused of being "industry funded." Dr. Lembke is funded by both the opioid elimination industry and the litigation industry.
Quote from Chou when asked about The SPACE Trial: "I think this is going to shake things up,” Roger Chou, a professor at Oregon Health and Science University who was not involved in the research. “The belief has always been opioids are the most effective pain medicine, certainly for acute pain and even for chronic pain. This [study] turns that on the head.”
Here is a presentation by CHOU that includes the SPACE Trial
Quote from Krebs when asked about the misapplication of The SPACE TRIAL: "My experience with advocates criticizing SPACE is similar to what I experienced when I participated in the 2016 CDC opioid prescribing guideline development process. In both cases, social media and internet-based criticism focused on claims that the work was biased and therefore illegitimate. I suspect this type of criticism is fueled less by misleading media reports than by misleading industry-supported advocacy." It doesn't sound to me like she wanted to take that moment to express concern about the misapplication. Instead, she did just what Kolodny does, and instead of commenting on the actual issue, she accuses those with concerns of being industry funded.
Quote from Krebs when asked about the influence of the SPACE Trial: Although it's a bit too early for our study findings to be incorporated into guidelines, I have heard from many individual clinicians that this study has influenced their clinical practice and teaching of trainees. I expect our results to be interpreted as providing support for recent guideline recommendations. The 2016 Centers for Disease Control and Prevention opioid guideline advised that non-drug therapies and non-opioid medications are preferred for chronic pain, and the 2017 VA opioid guideline advised against starting long-term opioids for chronic pain. These recommendations were based on expert opinion and data about opioid-related harms. Our study contributes long-term evidence on the benefit side of the equation—we found no advantages to opioids that would outweigh their greater risk of serious harm. The results should reassure clinicians that following current guidelines is not likely to result in undertreatment of pain." Huh, interesting considering her study is cited as reasons to force taper, not treat acute post-op pain, and to deny opioids for all severe chronic pain conditions.
A newsletter put out by Health Professionals for Proper Opioid Prescribing (PROP) stated: "The best evidence now shows that prescription opioids are ineffective for long-term management of common chronic pain conditions, such as osteoarthritis and low back pain. Reducing opioid use for acute pain (after injuries, post-op) leads to fewer persons transitioning to chronic opioids, fewer then becoming opioid-dependent, fewer persons becoming addicted, and ultimately fewer opioid overdose deaths." Again, this is false. The study didn't show opioids are ineffective.
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.
The article contains the following information:
Do Forced Tapers of "High Dose Opioid" Patients Lower the Risk of Adverse Events or Death?
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 Korffshe's referring to. Von Korff is also a member of PROP
What Are Some Limitations of MME Conversions?
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:
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 Virginiaif 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."
As far as the tremendous emphasis put on MME as an overdose factor, Dr. Kertesz said "We have so many scientific papers to show us that the actual risk of an overdose event is driven by a web of risk factors, just like the risk of any other medical event. It's frankly bizarre to choose precisely one risk factor and make a fetish of it the way we have with morphine milligram equivalents. It violates everything we know about opioid overdose, and it is entirely at odds with how medical professionals conceptualize all other risks we ordinarily consider. I can only speculate as to why we should take such a bizarre approach in regard to opioids. But in all likelihood it reflects the poor quality of our own training in both pain and addiction, and the powerful desire of regulators to reduce opioid questions down to something they can digest quickly, preferably between appetizers and the first course of a 5 course meal."
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."
Will CDC's Updated/Expanded Guidelines Use MME Thresholds?
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:
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, andconveys 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.
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.
In summary, we've shown in this article that:
This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated January 10, 2022.
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.
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:
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:
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:
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.
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.
Do Opioids Induce Hyperalgesia in Humans? An Evidence-based Structured Review
Opioid-induced hyperalgesia (OIH): a real clinical problem or just an experimental phenomenon?
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).
"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 .
The Psychological and Physical Effects of Pain Medications
This article is written by Dr. Don Teater for the National Safety Council (NSC).
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.
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
A complaint filed against a doctor in NJ
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:
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."
Summary Of Main Points:
This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated January 17, 2022
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.
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:
"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."
"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."
Is There Stigma Involved With Cancer Pain And Opioids?
Are There Studies Showing Benefits Of Using Opioids In Terminal Cancer Patients?
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?
"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."
Summary of Main Points:
This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated February 7, 2022
Many of you have heard Kolodny or other anti-opioid zealots make comments like "pharma pays doctors to prescribe opioids." So first, let's address that. It is illegal for a pharmaceutical company to pay doctors specifically to prescribe their medication. What they can do, though, is pay them as "consultants" or for "speaking engagements." Do I think it's ethical? Probably not, but that's how it works. Medical device companies do the same thing. Well, actually, they often pay more than pharma, as seen in this article called "Medtechs top pharma in cash to doctors for consulting, travel.." If you ever want to look up a company and see how much they pay doctors, or look up doctors to see how much they've accepted, you can look up these two websites. Open Payments and Dollars For Docs. So, do opioid makers specifically "pay doctors to prescribe"? I would say no more than any other company does. For anyone to specifically state that companies that make opioids pay doctors to prescribe is incredibly misleading. But, that doesn't stop doctors from making that statement or from media repeating it. Why would people want to mislead the general public about opioids? It helps vilify these companies for the litigation narrative we're always talking about. This whole narrative was done in preparation for opioid litigation, which we see taking place across the country now. There are around 3,000 lawsuits that the Attorneys General have brought against pharma, pharmacies, and manufacturers.
What they don't mention is that doctors are now getting paid more money to NOT prescribe opioids? Yes, you read that correctly. BCBS of Michigan actually incentivizes doctors by paying them 35% more money if they don't prescribe opioids after certain procedures. Read all about it in this article called Fewer Opioids, More Pay: New Tack on How Doctors Prescribe Them . So, if you live in Michigan and have BCBS, this might be the reason why your surgeon isn't treating your post-op pain with opioids. I'll include the rest of the article below.
Listen to pain doctor and mal-practice attorney, Dr. Dan Laird discuss the false narrative and what the "opioid crisis" actually is. You won't want to miss him talking about the litigation narrative and how chronic pain patient advocates are helping to set the record straight. Click the following link: