Sample letter to Congress or legislators regarding the CDC Guidelines and the conflicts of interest of the co-author, Roger Chou
- This is the committee to write to regarding the CDC Guidelines: House Committee on Energy and Commerce Oversight and Investigations
- Please include this article about Roger Chou and the conflicts of interest
- Click here to find out who your local representative is.
- Research your state to see what the current prescribing laws are because you will need to create legislation based on what already exists.
- Ask if they will sponsor a bill to protect chronic pain patients and doctors
- Show them the legislation in: Oklahoma, New Hampshire, and Rhode Island to give them some ideas of what other states are doing.
Here are links to important helpful studies, articles, podcasts, interviews to help you when talking to legislators, media, doctors, etc. These are about the false narrative, the litigation narrative, PDMP, NarxCare, CDC Guidelines, PROP, Conflicts Of Interest, etc.
We will add new links as they come out.
Pain Med Prescriptions Did Not Cause The Opioid Epidemic, Courts Rule - Las Vegas news, George Knapp interviews Dr. Dan Laird
Against The Pain: The Opioid Crisis and Medication Access - NPR, radio show
Dosing Discrimination: Regulating PDMP Risk Scores - Law Journal
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: "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 USA is 5% of the world's population, but we consume 80% of the world's prescription opioids and 99% or 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:
- 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.
- 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 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.
- How People Obtain The Prescription Pain Relievers They Misuse by Rachel N. Lipari, Ph.D., and Arthur Hughes, M.S.
- The Myth of What's Driving The Opioid Crisis by Sally Satel
- Blaming Pharma Alone For The Opioid Crisis is Shortsighted by Brooke Feldman
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."
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 naïve to think it won’t have an impact. (The CDC Guidelines) In fact, it flies in the face of everything the NPS (National Pain Strategy) stands for."
- "There was no review of anybody doing well on opioids to understand whether there are any patient characteristics predictive of who might do well. So to me, that spoke to a kind of BIAS. So there we are.”
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.
- .A federal panel that has recently criticized efforts to cut back on painkiller prescriptions is studded with members who have financial ties to drug companies."
- :The revelation comes after the committee last month bashed a federal plan to recommend doctors scale back on prescribing painkillers for chronic pain. The guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to powerful but highly-addictive opioid drugs, including Percocet and Vicodin."
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:
- "While we have concerns about some of the content of the draft guideline that CDC has presented, the subject of this communication is the process that is being undertaken to develop that guideline. We are very concerned that this process is deeply flawed."
- "It will certainly have negative impacts on patients."
- “What was particularly striking to the panel was the realization that there is insufficient evidence for every clinical decision that a provider needs to make regarding the use of opioids for chronic pain, leaving the provider to rely on his or her own clinical experience.”
- "Although CDC has not been transparent about the members of the Core Expert Group that helped it develop the initial recommendations, the Stakeholder Review Group, or the three experts who will assist it in developing a final draft, we are privy to this information because we are one of the stakeholder groups invited to review the draft. We find the makeup of these groups both puzzling and concerning."
- "These groups, charged with developing a guideline on how best to use opioids to treat chronic pain, are overwhelmingly dominated by individuals with no apparent expertise in the subject, nearly devoid of groups representing and advocating for people with pain, and studded with a number of individuals who are publicly on record as opposing the use of opioids to treat most types of chronic pain."
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:
- Some groups have raised concern that the proposed guideline may be insufficient to treat those suffering from chronic pain."
- "We expect CDC's guideline drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain."
- "We have questions about why a 'Core Expert Group' established by CDC to assist with drafting these guidelines is not considered an advisory committee under the FACA (Federal Advisory Committee Act)."
The American Cancer Society wrote a letter (pdf) to Dr. Frieden and Dr. Houry on 10/1/15. The letter included the following comments:
- "We are concerned that the emphasis on how to reduce inappropriate use of opioids has paid very little attention to how these efforts may impede medically necessary access to these products."
- "We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines, and the transparency of the entire process. Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations."
- Unfortunately the guidelines drafted by CDC, by its own admission, are based on weak or nonexistent evidence."
- "In fact, the CDC imprimatur makes it more likely that these guidelines become de facto requirements through adoption by state health departments, professional licensing bodies or insurers. CDC even acknowledges that this is one of the goals of this process."
- "We are concerned that the draft document does not reflect the appropriate weighing of benefits and harms at the individual and population levels, a fundamental element of rigorous guideline development."
The Washington Legal Foundation wrote a letter (pdf) to Dr. Tom Frieden on 11/17/15. This letter included the following comments:
- The WLF is writing to express extreme concern with the flawed procedures being employed by the CDC in connection with its proposal to issue a Guideline from prescribing opioids for chronic pain."
- The overly secretive manner in which the CDC has been developing the Guideline serves the interest of neither the healthcare community nor consumers."
- Government standards for the prescription of opioids to treat chronic pain are highly controversial, as evidenced by the considerable number of protests that have been raised in connection with the CDC's draft Guidelines."
- WLF went on to express concern that the CDC was not abiding by the Federal Advisory Committee Act (FACA)
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?
The following letters were written by organizations commenting on the docket of the proposed CDC Guidelines:
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:
- "The AAFP certainly wants to promote safe and appropriate prescribing of opioids; however, we recommend that the CDC still adhere to the rigorous standards for reliable and trustworthy guidelines set forth by the Institute of Medicine (IOM). The AAFP believes that giving a strong recommendation derived from generalizations based on consensus expert opinion does not adhere to evidence-based standards for developing clinical guideline recommendations."
- "All of the recommendations are based on low or very low quality evidence."
- "The patient voice and preferences were not explicitly included in the guideline. This raises concerns about the patient-centeredness of the guideline."
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:
- "We are disappointed that despite our and others’ raising this fundamental concern, no substantive changes have been made in the methodology that remedies the biases of the current draft guideline."
- "In the current era of personalized, “precision” medicine, we should be mindful that some patients do well on chronic opioid therapy for noncancer pain, and conduct evidence reviews that seek to identify such subgroups."
- "We believe it is wrong to quote an arbitrary dose despite scientific evidence documenting individual genetic and environmental factors that produce variability of individual responses to opioid medications."
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:
- "ASA and ASRA support the federal government’s efforts to reduce opioid overdose deaths, and support the majority of recommendations in the CDC Guideline. However, we are concerned that the Guideline would curtail perioperative physicians’, which includes physician anesthesiologists, surgeons, and co-managing internists or hospitalists, ability to treat patients’ acute pain after surgery, and any recommendations made by CDC need to balance the overprescribing of opioids for acute pain with perioperative physicians’ imperative to treat post-surgical pain."
- "In the Guideline, CDC emphasizes that evidence on long-term opioid therapy for chronic pain is insufficient to determine long-term benefits. However, we would like to note that physicians can assess functional improvement when considering whether opioids are effective."
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:
- "The nonbinding Guideline is based on solid clinical evidence and contains recommendations that promote the effective treatment of pain and may prevent inappropriate prescribing of opioids, thus saving lives."
Letter written (pdf) by the Attorney General of Massachusetts regarding the Guidelines, written on 1/13/16. This letter included the following quotes:
- "While there have been various efforts from state officials and other organizations to memorialize best practices for opioid prescribing, the Guideline would provide prescribers with a single, nationwide, evidence-based standard."
- "Our national opioid-related overdose deaths are the result of years of overprescribing of prescription painkillers."
Letter written (pdf) by 36 Attorneys General regarding the Guidelines, written on 1/13/16.This letter included the following quote:
- By better informing and guiding prescribers, these Guidelines will not only provide a strong framework for providers, but they will also improve the access to opioids for patients for whom they are the best choice. For these reasons, we urge the CDC to promptly adopt these Guidelines.
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:
- "In this regard, he urged CDC to disregard all comments made by individuals with financial conflicts of interest and to issue as quickly as humanly possible the guideline that has been prepared for months" "apart and “shattered” as his was. Those who have died cannot be present to testify. CDC can wait for years for further research, but if it does, tens of thousands of people will die" ~Gary Mendell
- "Contrary to what some have claimed, the recommendations provide sufficient scientific support to justify their strength and the derivation of “strong” recommendations is entirely consistent with best practices in guideline development" ~Dr. Caleb Alexander
- "Much of the opposition to the guideline has been based on a faulty premise; namely, that the recommendations will somehow jeopardize the care of those living with pain." ~Dr. Caleb Alexander
- "The guideline was created using the best available evidence, expert review, and input from a broad and balanced group of stakeholders." ~Dr. Jane Ballantyne
- "Appropriate pain care is not jeopardized by the guideline: it demands it." ~Dr. Andrew Kolodny
- "FED UP! applauds CDC for creating this draft guideline which will lead to more cautious opioid prescribing and reverse the trend of ever-increasing overdose deaths." ~Judy Rummler
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:
- "One member of the Workgroup strongly opposes Guideline Recommendation #5 ( which discusses limits of 50 and 90mme) 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." Since changes weren't made, it appears that this warning was not taken seriously.
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 Group saying "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?
LIE/FALSE NARRATIVE: "Studies show that opioids don't work for long-term chronic non cancer pain."
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.
- 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.
- 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:
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.Lembke said in an interview : “What I think is really important to remind people is that if opioids worked long-term, I would have no problem with patients taking them,” she said. “The fundamental issue is that they stop working and then you have an additional problem.” So, I guess she wouldn't have a problem with low back pain, OA of hip and knee patients taking opioids because the SPACE Trial shows they both decrease pain and increase function.
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.”
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?
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."
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?
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.
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."
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."
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."
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:
- 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.
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:
- The method to determine MME isn't standard
- There are other limitations of MME calculations
- The origin of MME thresholds isn't based on evidence.
- The CDC tracked implementation of the arbitrary MME thresholds
- Risk Scores used on doctors and patients use arbitrary MME thresholds
- The updated CDC Guidelines plan to use more arbitrary MME thresholds
- Forcing tapers of patients on "high MME" causes more harm than good
LIE/FALSE NARRATIVE: "Studies show that opioids make pain worse in a common condition called Opioid Induced Hyperalgesia (OIH)."
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:
- Healthy volunteers following acute opioid exposure
- Acute postoperative pain
- Chronic nonmalignant pain
- Cancer pain-end of life
- 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:
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."
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.”
- 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."
- "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:
This 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's giving a lecture on the danger of prescription opioids while drinking a beer.
"Here is the mind bending thing. Opioids cause chronic pain is what we're discovering." ~ Dr. Don Stader
- "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."
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:
- 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."
- 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."
Summary Of Main Points:
- True Opioid Induced Hyperalgesia (OIH) is often conflated with other diagnoses such as tolerance and withdrawal.
- The idea of opioids causing pain was written about as early of 1870.
- The idea of OIH has been studied in the following groups:
- Healthy volunteers following acute opioid exposure
- Acute postoperative pain
- Chronic nonmalignant pain
- End of life pain
- People addicted to opioids
- The following criteria are needed for a true diagnosis of OIH:
- Increased pain intensity during ongoing opioid treatment
- No evidence of underlying disease progression
- No evidence of clinical or pharmacological opioid withdrawal
- No evidence of opioid tolerance
- Decrease pain intensity with opioid reduction
- No evidence of addictive behavior
- OIH has been proven in studies of rats, not people
- CPP's seem to have hyperalgesia that is unrelated to opioids.
- Many zealots say OIH is common and proven in studies.
- Insurance companies use OIH as a reason to deny coverage of opioids.
- OIH is cited in litigation.
- A diagnosis of OIH is often given to patients as a reason to not prescribe opioids.
- If OIH exists, it is exceedingly rare.
- More studies are needed to see if OIH is an actual phenomenon in people.