Search Our Site

  • Why Can't I Get Help Managing My Pain? Patient Denied Opioids Due To Being a Sexual Abuse Victim!

    Watch Claudia interview Bev Schechtman about her experience in the hospital when she was denied pain medication for kidney stones due to being a victim of sexual abuse.  

    "Everything is looked at as drug-seeking.  No matter we do, they think we're drug-seeking." ~ Bev Schechtman

  • Against the Pain: The Opioid Crisis and Medication Access (NPR show 1A)

    NPR's show, 1A, had our VP, Bev Schechtman on a panel on November 11, 2021. The name of the segment is "Against The Pain: The Opioid Crisis and Medication Access." NPR became interested in the show after reading Maia Szalavitz's article about NarxCare in Wired.  Listen to the recording of the show.  You don't want to miss this!  

    "We have these people who have been on these meds for 20-30 years and doctors are under extraordinary pressure to get their numbers down" ~Maia

    "In a criminalized environment where doctors are not only afraid of losing their license, but of going to prison, and where patients are being squeezed because they're being told 'you can only have x amount because otherwise my numbers are too high,' you end up with a lot of untreated pain." ~Maia

    "I'd like to see context added (to these algorithms), if someone moves 3 times in 2 years, it needs to not look like they're 'doctor shopping,' I'd like to see a return to individualized care and stop these arbitrary guidelines where people are having a hard stop on what they can and can't have and they're not looking at what's actually going on with the patient." ~Bev

    "I was treated like a criminal; I was mocked, laughed at, scolded, I was embarrassed...I felt revictimized." ~Bev

    "There are tremendous gender and racial bias in these algorithms and in this false narrative." ~Bev

    "No one should ever be denied care, that's just cruel and unusual punishment." ~Dr. Dombrowski

    "Electronic Health Records are just a billing system, not to make patient care better...if you hit something by accident like malingering, next thing you know it's in the chart permanently. It's dangerous." ~Dr. Dombrowski

    Dr. Mark Ibsen, who is a fierce advocate for the CPP community, recorded the show with running commentary.  

  • Arizona

    Please join Arizona's Don't Punish Pain Rally page to network with other CPP advocates from Arizona

    In April of 2022, Arizona passed a law, Bill SB1162,  protecting pain patients. 

    Dr. Jeffrey Singer testified if favor of the bill

    Governor Doug Ducey Signs SB1162 into Law Helping Arizonians with Chronic Intractable Pain Get the Treatment They Need

    Senator Nancy Barto introduced Arizona SB1162 in January 2022. This new law will give protections to chronic intractable pain patients in Arizona. This amendment to ARS Section 32-3248.01, will improve access to care, give physicians the ability to treat their patients as medically appropriate, and confirm that providers and their state governing boards have oversight on the proper treatment for these patients.

    Accessing proper healthcare should be individualized and made more accessible. When adequate and timely care is not given, we see a more significant burden on taxpayers, individuals, and the State of Arizona. The Arizona Amendment to Section 32-3248.01, Arizona Revised Statutes; Relating to Controlled Substances will help define our rights and improve access to life-sustaining medications for all Arizonans in need and ensure that our state’s government truly represents the people of Arizona so that we may all participate in society more fully.

  • Claudia's TikToks

    Please follow us on TikTok and YouTube to watch all of our videos!

  • Debunking Lies

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

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

    LIE/FALSE NARRATIVE"80% of heroin users started with a prescription from their doctor."

    LIE/FALSE NARRATIVE"The CDC Guidelines were created with transparency using a wide range of experts with unbiased views. They were based on strong scientific evidence, and the CDC was unaware that the Guidelines could have a negative impact on pain patient outcomes."

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

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

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

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


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

    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. This study shows that 5 billion out of 7.7 billion people don't have access to pain med. So this statistic is meant to shock and mislead.
    • Some opioids are over the counter (OTC) in other countries.
    • Germany is the 2nd highest per capita prescribing country, and they don't have an "opioid crisis," which proves the point that our "over-prescribing" is not what's causing this overdose crisis in the USA.

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


    LIE/FALSE NARRATIVE: "80% of heroin users started with a prescription from their doctor"

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

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

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

    • When this statistic is repeated, it’s often implied or even sometimes stated that 80% of those starting heroin were given prescriptions from their doctors. The problem with this is that’s not at all what the source is stating. In the SAMHSA study, they took data from a ten-year period from the National Survey on Drug use and Health and found that around 80% of those who started heroin previously used nonmedical use of prescription opioids. I'm going to repeat the second part of that statement. Those using heroin previously used NONMEDICAL USE of prescription opioids. So, these weren't people who got a prescription from their doctor, took the medication as prescribed, and then turned to heroin. Again, what it actually states is that 4 out of 5 heroin initiates first started with nonmedical use of prescription opioids. That’s a huge difference from what they claim when stating this "statistic."  An excellent source on this topic is an article called "Today's nonmedical opioid users are not yesterday's patients..."  This article states that "The National Survey on Drug Use and Health (NSDUH) has repeatedly found that less than 25% of nonmedical prescription opioid users obtain these drugs from a prescriber." This means that at least 75% or more of heroin users who started by misusing prescription opioids obtained these pills illicitly. This directly contradicts their lie.
    • This lie implies that the statistic is uniform throughout the USA. This is false. The statistic is not consistent in every area of the country. In the article in Pain News Network, Roger Chriss states "The abuse of opioid medication by heroin users also varies considerably by time, region, and demographics...prior nonmedical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively." So making a blanket statement implying consistency throughout the USA is wrong.
    • One thing this statistic makes people believe is that most people who misuse prescription opioids turn to heroin eventually. In reality, it's only a very small amount. According to this article by National Institute of Drug Abuse (NIDA), less than 4% of those who abuse prescription opioids end up using heroin within 5 years. That is a fact you'll never hear anti-opioid zealots discuss.  For the sake of their litigation narrative, they need people to think the vast majority of everyone who not only abuses but even uses prescription opioids will most likely develop an addiction to it and turn to heroin.
    • When they repeat this lie, they love to imply or even state that the vast majority of heroin users of today were pain patients at first. That's blatantly false. In fact, if this were true, then when prescribing doubled in the USA form 2002-2014, heroin use would have likewise increased. Yet, it didn't. As stated in this article I mentioned earlier, “Doubling the amount of opioids prescribed does not seem to have had a discernible effect on the rate of nonmedical use or the rate of pain reliever use disorder.” Blaming OxyContin for the increased drug deaths is misguided. The truth is drug deaths have been increasing since 1979, well before OxyContin ever hit the market. But, yet again, they desperately need to keep people believing that the huge spike in overdose deaths is due to Purdue/OxyContin.
    • One last point is that the 80% statistic, even if properly used and applied, isn't even accurate anymore.  As shown by Dr. Bob Twillman in this tweet, 32% of people with OUD actually started with heroin. So the statistic isn't accurate anymore that 80% of those who use heroin started with misusing prescription opioids. This statistic can be found in this article.

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

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

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


     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 Groupsaying  "CDC sought the input of experts to assist in reviewing the evidence and providing perspective on how CDC used the evidence to develop the draft recommendations. These experts, referred to as the “Core Expert Group” (CEG) included subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline development methodology. CDC identified subject matter experts with high scientific standing; appropriate academic and clinical training and relevant clinical experience; and proven scientific excellence in opioid prescribing, substance use disorder treatment, and pain management. CDC identified representatives from leading primary care professional organizations to represent the audience for this guideline. Finally, CDC identified state agency officials and representatives based on their experience with state guidelines for opioid prescribing that were developed with multiple agency stakeholders and informed by scientific literature and existing evidence-based guidelines."  

    Interestingly, Andrew Kolodny has been quite outspoken about things he refers to as myths or conspiracy theories. He gave a presentation about this on Marcy 29, 2021., which was sponsored by Pharmed-Out, a group started by Adriane Fugh-Berman-also a PROP member. One of these myths, Kolodny claimed was that "CDC Opioid Guidelines was secretly written by PROP." Kolodny called this idea a conspiracy theory in a Justice article about our protest we sponsored at Brandeis, where he works. His said "One conspiracy theory Kolodny rejected is that he and PROP secretly wrote the CDC guideline calling for more cautious prescription of opioids."

    Now that you have the facts, you can decide for yourself. Did PROP secretly assist with the 2016 Opioid Guidelines? We've given you evidence and explanations from experts who claim they did. Kolodny claims that's a conspiracy. What is your conclusion?

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


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

    This article contains the following information:

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

    The Study was done based on the following assumptions: 

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

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

    Basic facts:

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

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

    Image

    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

    Image

    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.”

    Here is a presentation by CHOU that includes the SPACE Trial

    Quote from Krebs when asked about the misapplication of  The SPACE TRIAL: "My experience with advocates criticizing SPACE is similar to what I experienced when I participated in the 2016 CDC opioid prescribing guideline development process. In both cases, social media and internet-based criticism focused on claims that the work was biased and therefore illegitimate. I suspect this type of criticism is fueled less by misleading media reports than by misleading industry-supported advocacy." It doesn't sound to me like she wanted to take that moment to express concern about the misapplication. Instead, she did just what Kolodny does, and instead of commenting on the actual issue, she accuses those with concerns of being industry funded.

    Quote from Krebs when asked about the influence of the SPACE Trial:   Although it's a bit too early for our study findings to be incorporated into guidelines, I have heard from many individual clinicians that this study has influenced their clinical practice and teaching of trainees. I expect our results to be interpreted as providing support for recent guideline recommendations. The 2016 Centers for Disease Control and Prevention opioid guideline advised that non-drug therapies and non-opioid medications are preferred for chronic pain, and the 2017 VA opioid guideline advised against starting long-term opioids for chronic pain. These recommendations were based on expert opinion and data about opioid-related harms. Our study contributes long-term evidence on the benefit side of the equation—we found no advantages to opioids that would outweigh their greater risk of serious harm. The results should reassure clinicians that following current guidelines is not likely to result in undertreatment of pain."  Huh, interesting considering her study is cited as reasons to force taper, not treat acute post-op pain, and to deny opioids for all severe chronic pain conditions.

    A newsletter put out by Health Professionals for Proper Opioid Prescribing (PROP)  stated"The best evidence now shows that prescription opioids are ineffective for long-term management of common chronic pain conditions, such as osteoarthritis and low back pain. Reducing opioid use for acute pain (after injuries, post-op) leads to fewer persons transitioning to chronic opioids, fewer then becoming opioid-dependent, fewer persons becoming addicted, and ultimately fewer opioid overdose deaths." Again, this is false. The study didn't show opioids are ineffective.

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

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

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

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

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

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

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

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

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


    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."

    The article contains the following information:


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

    What is MME?

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

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

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

    What is the Purpose of MME Conversions?

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

    Where Did the MME Conversions Originate?

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

    What Are Some Limitations of MME Conversions?

    Calculations

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

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

    Pharmacogenetic variability, drug interactions and other limitations of MME

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

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

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

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

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

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

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

    Do the CDC Guidelines Use MME thresholds?

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

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

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

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

    Do Data Analytics Use MME thresholds?

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

    download 1 MME 90 NarxCare edit

    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.

    Couch transcript image updated

    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."

    "To prioritize a single number when you know the other factors matter as much, or even more, not only distorts the evidence but it can lead to bad health care decisions for patients as the dose focused guidance ultimately did. There are more than just scientific reasons the dose guidance played out as poorly as it did - and that was on of the points I tried to make before the CDC guideline was finalized!"

    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, andconveys similar risk as the other conditions. The dose threshold is arbitrary and inconsistent with other sections of the guideline (50 vs. 90 MME). As noted in overarching themes, many members recommended that these specific conditions be removed from the recommendation.

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

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

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

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

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

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

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

    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

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


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

    This article contains the following information:

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

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

    Defining Terms

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

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

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

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

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

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

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

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

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

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

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

    OIH In Acute Pain Patients

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

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

    Opioid Induced Hyperalgesia In Rats

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

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

    Mao rat study

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

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

    OIH In Patients On Methadone or Suboxone:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Misuse of Hyperalgesia to Limit Care

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

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

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

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

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

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

    Do Doctors Claim That OIH is a Proven Common Condition?

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

    New Opioid Guidelines - How Colorado Can Revolutionize Pain Management

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

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

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

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

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

    The Psychological and Physical Effects of Pain Medications

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

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

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

    Insurance companies want to save money

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

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

    Used as part of the litigation Narrative

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

    Colorado vs. Purdue and Sacklers

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

    A complaint filed against a doctor in NJ

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

    Doctors Are Afraid To Prescribe Opioids

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

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

    Accurate Diagnoses of OIH in CPP's

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

    Doctors' views of OIH

    Dr. Chad Kollasa 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." 

  • Dr. Wrenn, an 80 Year Old MD Who Has Treated Patients For 42 Years, Was Arrested and Put In Jail

    "Doctors can get wiped out in one fell swoop." ~ Claudia Merandi

    Listen to Dr. Wrenn describe what happened to him when his patient, who he was treating for addiction, died. "If you prescribe Suboxone, you're damned if you do and damned if you don't."

  • FAQs

    Where is the Abandoned Patient and Forced Opioid Taper Questionnaire?

    How can I sign up to receive The Doctor Patient Forum's free newsletters?

    How do I advocate for a loved one who is in the hospital?

    How do I file a complaint about a civil rights (ADA) violation?

    How do I request my Electronic Health Records and what do I do if there are errors in them?

    What is NarxCare?

    What do all of the abbreviations and acronyms mean?

    What is the PDMP?

    Is there a list of up-to-date statistics, research, and studies that I can use to show to media, my legislator, or my doctor?

    Did the CDC know their Guidelines could potentially harm patients? Were they warned?

    Do studies show that prescription opioids don't work for long-term chronic non cancer pain?

    What is the SPACE Trial and does it prove that prescription opioids don't work for chronic long-term non cancer pain?

    What is MME? Are the concepts of MME (Morphine Milligram Equivalent) and MME limits such as 90 MME, based on solid scientific evidence?

    What are the 2016 CDC Guidelines? Will the updated CDC Guidelines make things better or worse?

    Did The Doctor Patient Forum submit comments to the docket for the updated/expanded CDC Guidelines?

    What is ORRP (Opioid Rapid Response Program) and do they actually help abandoned patients find doctors?

    What is the FDA warning about Suboxone/Subutex/Belbuca and dental injuries? Is there a lawsuit about it?

    What number do I call if I have had dental issues while on Suboxone/Bupe? 

    What is the VALUE Study?


    How can I sign up to receive The Doctor Patient Forum's free newsletters?

    Click here to sign up!

    Catch up on all of our past newsletters 


    How do I advocate for a loved one who is in the hospital?

    Some basic facts:

    • If the patient is currently a chronic pain patient and takes daily prescription opioids, the patient is less likely to receive opioids while in the hospital.
    • Chances are the hospitalist is already biased against the patient.

    Step by step instructions: 

    1. Have the patient ask for the charge nurse.
    2. If you’re on the phone, ask the patient to put you on speaker so you can start a conversation with the charge nurse.
    3. Introduce yourself saying:
      1. “Hello, my name is (insert your name here). I am a patient advocate based out of (insert your location). First, thank you for your hard work during the pandemic.  I know you’re terribly busy but I imagine we both have the same goal of controlling this patient’s pain.”
      2. “Can you please tell me whose care this patient is under? Is the hospitalist a resident? A fellow? Would you kindly provide me with their name, please?”
      3. Would you please contact the hospitalist, tell them the patient’s pain is unmanaged and he needs adequate pain relief?”
      4. “If the doctor is unwilling to put in an order for adequate pain medication, would you please tell me why?”
    4. If the doctor still doesn’t put an order in, the next step is the have risk management, the charge nurse, the hospitalist and the surgeon all come to the patient’s room at the same time so you all can have a conversation together.
    5. This is a time-consuming but necessary process.
    6. Once discharged, if the patient’s health was made worse by the treatment received at the hospital, then the next step would be to contact a medical malpractice attorney.

    Some more tips:

    • Documentation is key. Write down the names of every person you speak with and exactly what they say to you. This will be very important if you choose to file a complaint with the medical board.
    • Hospitals have protection from the feds, so there is no reason pain shouldn’t be treated while inpatient.
    • Remember, hospitals do have patient advocates, but they work for the hospital, not for the patient.
    • If the patient is under a pain management contract, the patient should not accept an opioid prescription upon discharge unless already agreed upon by the pain management doctor. Even accepting a prescription for 5 pills can cause a patient to be discharged from pain management if it hasn’t been discussed in advance.
    • If the patient’s pain management doctor has agreed to allow the patient to accept a prescription from the hospitalist or surgeon, it’s always best to take it to the patient’s pharmacy instead of filling it at the hospital’s pharmacy.

    PDF version of these instructions


    What is NarxCare?

    NarxCare, a product of a company called Bamboo Health, is a proprietary data analytics program. It uses up to 70 data points (that only Bamboo Health knows) and mixes them with your PDMP (prescription history) to assign four 3-digit scores letting your doctor or pharmacy know if you have a high risk of abuse or overdose. There is a Narcotic Score, a Stimulant Score, and a Sedative Score, and an Overdose Risk Score (ORS). According to Bamboo Health, "NarxCare aids care teams in clinical decision making, provides support to help prevent or manage substance use disorder, and empowers states with the comprehensive platform they need to take the next step in the battle against prescription drug addiction." Essentially, NarxCare pulls data from multiple state registries looking for red flags of drug seeking behavior. 

    The three categories of prescription medication it looks at are narcotics (opioids), stimulants (ADHD meds) and sedatives (benzos, sleeping meds, etc.). "The NarxCare report identifies risk factors with interactive visualizations, as well as an Rx Graph, and a set of scores that numerically correspond to the patient’s PDMP data." Although Appriss states on their website that their product shouldn't be used by itself to make medical decisions, that's not what's actually happening. As shown in this NarxCare article, patients are being denied medication or even being dismissed from a medical practice based on a NarxCare score alone.

    Some of the risk factors used in the proprietary algorithm are:

    1. The number of prescribers a patient has had in a two-year period.
    2. The number of pharmacies a patient used in a two-year period. 
    3. The dosage (MME-Milligram Morphine Equivalent).
    4. Amount of other medications that may increase potency of other medications.
    5. Number of times prescriptions overlap with prescriptions from other providers
    6. Any Mental Health Diagnosis
    7. Distance from patient to doctor

    Nobody knows (except Bamboo health) exactly what goes into the ORS (Overdose Risk Score).  Some of the factors we've found listed are criminal history, diagnoses in your EHR (Electronic Health Record) including mental health diagnosis (such as depression or PTSD), distance patient drives to the doctor, and diagnosis of sleep apnea.  

    What are some of the problems with NarxCare?  Why isn't it a good thing?

    1. There is no room for context. What does this mean? As mentioned above, if someone has more than one prescriber within a two-year period, that will increase the ORS.  But, there isn't a way to include an explanation such as if a patient moves, if a patient has multiple surgeries within that time period, or if a patient's doctor retires causing the need for a new physician.
    2. A patient's pet's prescription history is included. This means if a patient has surgery and if her pet has surgery, it appears as though the patient is getting prescriptions from more than one doctor.  
    3. The NarxCare algorithm has never been externally validated.  What does this mean? Essentially, it means the results of the study the algorithm is based on haven't been proven to apply to people outside of the study.  Yet, that's exactly what they are doing.  They are calling it evidence-based even though it is not.  
    4. If someone is prescribed 90 MME (Morphine Milligram Equivalent) or more, the NarxCare score is automatically at the to 1% of all Overdose Risk Scores.  Why is this bad?  Well, the whole concept of MME and arbitrary thresholds such as 90 MME are flawed and not based in science.
    5. The NarxCare algorithm has inherent gender and racial bias. How? Since they use criminal history, it is racially biased. Since more it women tend to have mental health diagnoses such as PTSD due to trauma, it automatically is biased against women. We have heard stories of women who have been denied prescription opioids due to having been a survivor of sexual abuse.

    As summarized in this Wired article, the entire concept of NarxCare is flawed and is flagging patients who shouldn't be flagged.  "According to one study, 20 percent of the patients who are most likely to be flagged as doctor-shoppers actually have cancer, which often requires seeing multiple specialists. And many of the official red flags that increase a person's risk scores are simply attributes of the most vulnerable and medically complex patients, sometimes causing those groups to be denied opioid pain treatment."

    Many people are fighting against the use of NarxCare. Almost every state uses Aprriss' PDMP platform and roughly 25 states in USA use NarxCare. Contact your local Department of Health to find out if your state uses it. For more information about Narxcare, we've included links to a few articles.

    PDMP and NarxCare

    Dosing discrimination 

    What Every Patient Should Know About NarxCare

    PDMP and NarxCare

    The flawed study NarxCare is based on


    What do all of the abbreviations and acronyms mean?

    • BSC - Board of Scientific Counselors
    • CDC - Center for Disease Control and Prevention
    • CDC GL - CDC Guidelines (usually referring to the 2016 or 2022 guidelines for opioid prescribing).
    • CNCP - Chronic non-cancer pain
    • CPP - Chronic Pain Patient
    • DPP - Don't Punish Pain
    • EHR - Electronic Health Record
    • HHS - Health and Human Services
    • HR - Harm Reduction
    • LTOT - Long-term opioid therapy
    • MME - Morphine Milligram Equivalent
    • OIH/OIHA - Opioid-induced hyperalgesia
    • ORRP - Opioid Rapid Response Program
    • ORT - Opioid Risk Tool
    • PDMP/PMP - Prescription Drug Monitoring Program
    • PROP - Health Professionals for Responsible Opioid Prescribing

    What is the PDMP?

    PDMP (Prescription Drug Monitoring Program) is a data base that records all controlled substance prescriptions including opioids, sleeping pills, ADHD medication, muscle relaxers, among some others. The first PDMP was developed in New York in 1918. It is now in all 50 states (as of 2021).  These data bases have been funded by the Department of Justice (to the tune of hundreds of millions of dollars).

    We've seen several goals listed for the PDMP, but the most common is to give healthcare professionals real-time access to your prescription history so they can make sure you're not "doctor shopping," or otherwise abusing your medication.  Each state runs its own PDMP, usually by the HHS (Dept. of Health and Human Services). Thanks to a company called Appriss, PDMP's are now interconnected between states.

    Some common questions answered:

    1. Who enters your information into the PDMP?  The pharmacist/pharmacy technician.
    2. Do you have real-time access to your PDMP report?  No.  Each state has different rules. Contact your HHS and ask how you can see your PDMP history and how to fix any errors.
    3. Who has access to your PDMP? Pharmacies, doctors, hospitals, and in some states veterinarians and law enforcement.
    4. What's a risk score in the PDMP?  This brings us to Narxcare.  PDMP pulls from many different data bases (criminal history, financial history, school grades, Electronic Health Records, etc.) and mixes it all with your prescription history to spit out a risk score as to whether your doctor should prescribe to you or not.  See the FAQ "What is Narxcare?" for a more detailed explanation. 

    Still interested in reading more about PDMP? Here are a couple of articles we recommend:

    This study finds that Prescription Drug Monitoring Programs fail to reduce opioid overdoses and increase the use of black market opioids

    Dosing Discrimination: Regulating PDMP Risk Scores


    Is there a list of up-to-date statistics, research, and studies that I can use to show to media, my legislator, or my doctor?

    Yes!  We have a printable document (both Word and PDF) listed here under Advocacy Tools


    Did the CDC know their Guidelines could potentially harm patients? Were they warned?

    Yes to both! They were warned by many organizations. They knew these Guidelines were dangerous. We gave all the details in our Debunking Lies section. It includes links to all the warnings and an explanation of what happened and how the CDC responded. Read our answer here.


    Do studies show that prescription opioids don't work for long-term chronic non cancer pain?

    No, they don't! But, that doesn't stop anti-opioid zealots from making this claim. Read all about it and how to counteract this false narrative here, in our Debunking Lies section.


    What is the SPACE Trial and does it prove that prescription opioids don't work for long-term chronic non cancer pain?

    It is a study funded by the VA and done by Dr. Erin Krebs. No, it doesn't prove that prescription opioids don't work for long-term chronic non cancer pain. Yet, it is cited as a reason to not prescribe opioids and to force taper. We broke down this study for you with all the links and information you need to counteract this false statement.


    What is MME? Are the concepts of MME (Morphine Milligram Equivalent) and MME limits such as 90 MME, based on solid scientific evidence?

    We answered this question in detail in our Debunking Lies section. Read all about it here.


    What are the 2016 CDC Guidelines? Will the updated CDC Guidelines make things better or worse? How can I comment on them?

    In March 2016, the CDC published opioid prescribing guidelines. There was a lot of controversy surrounding the lack of transparency and secrecy of the CDC Guidelines

    As many of you know, the 2016 CDC Opioid Guidelines have caused harm to many. Whether the guidelines themselves are the problem or if they have just been misapplied has been widely discussed by experts. In July 2021, the CDC released their draft of the updated opioid guidelines. We explained it all in detail in our newsletter. If you haven't had a chance to read it, please do. It helps put all of this in context. The new draft of the guidelines was published last week. Here are two very important links:

    Chart of the 2016 Guidelines vs 2022 Guidelines  

    The 229 page document of updated guidelines

    CDC is accepting comments here on the updated draft of the guidelines until April 11.  

    We have some suggestions for commenting on the CDC Guidelines.

    Many media outlets covered this story. Our favorite is from Josh Bloom "Panic in PROPville."

    Here is the story from Pain News Network called "Why CDC Dropped One-Size-Fits-All Approach to Pain Care":

    By Pat Anson, PNN Editor

    The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.  

    Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.

    “Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”

    People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.

    In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.

    “It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”

    Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.  

    “I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”

    Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.

    “This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”

    “States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.

    “The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

    Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less.  Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”

    “We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.  

    He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.

    “The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”   

    The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.


    Did The Doctor Patient Forum Submit Comments on the Docket for the Updated/Expanded CDC Guidelines?

    Yes, we did!  Feel free to use any of the information included in our comment.

    Word  pdf


    What is ORRP (Opioid Rapid Response Program) and Do They Actually Help Abandoned Patients Find Doctors?

    We have all of the details here including e-mails we received from the director along with quotes from the intimidating phone call. They called us demanding we remove social media content that didn't exist.


    What Number Do I call If I've Had Dental Issues While on Suboxone/Bupe?

    410-442-6648

  • Hank's Protein Plus

  • Illicit Fentanyl Testing Strips

    This article contains the following information:

    Why Would CPP's Want This Information?

    • I want to be clear that we at The Doctor Patient Forum do not encourage anyone to obtain pills on the street, from a friend, or from anywhere other than your pharmacy.
    • We are aware that some chronic pain patients (CPP's) who have been medically abandoned have been so desperate for pain relief that they've either gone to the street or taken a pill from a friend.
    • Since up to 42% of all pills on the street contain illicit fentanyl, we want to provide Harm Reduction information so if you are getting medication from somewhere other than your pharmacy, you know what to do to try to keep yourself safe.
    • Please understand that when you take a pill that you obtained from someone other than your pharmacy, even if you use illicit fentanyl testing strips, there is no guarantee that the medication is safe for you to take. Even if you test your medication, we highly recommend you have Naloxone available (I will be adding content on this shortly, and I will link the information here) and that you don't ever take the medication when you're alone. In case you don't have anyone who can be there with you, there is a never use alone hotline 1-800-484-3731.  

    What is Illicit Fentanyl?

    Illicit Fentanyl is not the same as prescription fentanyl. It is often made in labs in China and then smuggled in the the USA through Mexico. Illicit fentanyl is the leading cause of all drug-related deaths in the USA. Many who end up taking illicit fentanyl don't even realize it's in the medication or drugs they ingest. Due to this fact, we prefer to call it a poisoning instead of an overdose. Those who sell it often use pill presses so it looks identical to prescription medication. It is made to look like hydrocodone, oxycodone, Xanax, and other prescription drugs. It has also been found in other illicit substances such as heroin, meth, or cocaine. One reason drug dealers are using illicit fentanyl is due to its potency. A tiny bit goes a long way, but that is also the reason it kills so many people. The last statistic I read was that 42% of all street pills tested has illicit fentanyl in them.

    What Are Some Myths About Illict Fentanyl?

    • A very common myth is that prescription grade fentanyl is what's killing so many people. This is absolutely false. Media and even addiction specialists often conflate prescription fentanyl with illicit fentanyl analogues. Illicit fentanyl, not prescription fentanyl, is what's killing so many people.
      • A recent toxicology study showed "Out of 18,393 deaths that were confirmed, probable, or suspected heroin deaths (including 2678 with morphine listed as cause of death on the DC) and 404 as probable pharmaceutical morphine deaths, among deaths with fentanyl detected, 89.3% were defined as probable or suspected IMF (illicitly manufactured) and 1.0% as probable pharmaceutical (prescription) fentanyl."
    • There is a false narrative that's widely spread in media and repeated often that just touching illicit fentanyl or being in the same room as it can cause an overdose/poisoning. You see images of police in hazmat suits. This doesn't happen. It's important to understand this fact because if you by a pill off the street and test it for illicit fentanyl, and it turns out your pill contains illicit fentanyl, merely touching the substance will not cause an overdose/poisoning.

    Ryan Marino MD often addresses the myths surrounding illicit fentanyl. He has shared the following image with permission to share it:

    Image

    What Are Illicit Fentanyl Testing Strips?

    Illicit fentanyl testing strips are part of Harm Reduction that assist in overdose prevention. They are actually FDA approved to detect fentanyl in urine, but are also increasingly being used as a Harm Reduction drug-checking strategy.

    Are They Legal?

    •  Please check hereTo find out if they're legal in your state.

    Where Can I Get Them?

    • For individual or small orders, you can get them at Dosetest. They cost about $1.00 each. 
    • For larger orders (like if you want to order in bulk for yourself or to hand out) you can get them at BTNX. For more information about how to order them in bulk, please e-mail Michael@btnx.com.They sometimes offer a discount for new customers.

    How Do I Use Them?

    • One important point to note is the results are opposite from other tests like pregnancy tests.
      • One tine = positive (+) result (meaning there is illicit fentanyl present).
      • Two Lines = negative (-) result (no illicit fentanyl detected).
      • The following graphic explains how to read results:

    Screenshot 31

    • Remember, a negative test result is not a guarantee that illicit fentanyl is not in your pill.

    • Most how to videos and information are geared toward PWID (people who inject drugs). We know that most CPP's who go to the streets won't inject the medication. When testing a pill that you are not intending to inject you have two options -both are explained in the following video:
      1. Dissolve the entire pill in water and test it (this is the most reliable method). Once it tests negative for illicit fentanyl, you can still swallow the liquid, or you can put it in a capsule to avoid tasting the dissolved pill.
        • Here are two websites to purchase gel caps which are specifically made for liquid such as essential oils: 
        • How to fill a gel cap with liquid according to these websites:
          • Pull apart the capsule. One side is larger than the other, allowing the smaller end to fit inside the larger one
          • Draw your liquid supplements into a medicine dropper. Place the end of the dropper over the smaller side of the gel capsule.
          • Carefully squeeze the dropper to fill the capsule. Slide the larger end on to enclose the liquid inside the capsule.
          • Store in an airtight container in a cool, dry place. 
      2. You can scrape off part of the pill as Amanda shows in the following video. Just know there is no guarantee that the composition of a counterfeit pill is uniform throughout. So, it's possible that the small sample you test will be negative for illicit fentanyl, but other parts of the pill will be positive.

    • If you bought more than one pill, testing one of the pills does not guarantee that the other pills will have the same composition.

    Here is a how to video by an amazing Harm Reduction advocate, Amanda Mazur. Check out her Tik Tok videos for more information about Harm Reduction. In addition to teaching about Harm Reduction, Amanda also fights for the rights of CPP's to have access to prescription opioids.

    As always, if you have any questions feel free to contact us through our contact page

    This content was written by Bev Schechtman and Carrie Judy for The Doctor Patient Forum. Updated March 3, 2022

  • Merchandise

    Click here to check out our new merchandise!!

    Merchandise       Merchandise 2    merchandise 5

    Merchandise 3      merchandise 4      merchandise 6

  • New Hampshire

    Please join New Hampshire's Don't Punish Pain Rally Facebook page to network with other advocates from NH.

    New Hampshire’s Bill, HB1639, was signed by Governor Sununu in August of 2020. It was originally created as a separate bill, SB 546, but was later added to Omnibus Bill HB1639. 

    The bill was created and passed with the amazing efforts of Bill Murphy, CPP advocate and original member of Don't Punish Pain Rally. When the bill was signed into law, Bill Murphy created this tweet

    "New Hampshire’s Bill, HB1639, has been signed by Governor Sununu. This Bill addresses the “Treatment of Chronic Pain”. Key sections of this legislation are attached"

  • Oklahoma's Bill SB57 and Hearing About Harms From Forced Tapers

    Please join Oklahoma's Don't Punish Pain Rally Facebook page to network with other CPP's in Oklahoma

    Oklahoma's Intractable Pain Bill

    In April 2021 Oklahoma's Bill SB57 unanimously passed the House and Senate.

    Hearing About Harms From Forced Tapers

    On November 1, 2021 the Oklahoma, Alcohol, Tobacco, and Controlled Substances Committee held a hearing. The  purpose was to discuss an interim study that was done about rapid de-prescribing and the horrific effects it has had on patients.  This was requested and organized by Tamera Stewart-P3Alliance Policy Director, Julia Heath-P3Alliance Director of Medical Initiatives, along with their leadership team.

    Some of the speakers were Beth Darnall ,PhD from Stanford University, Dr. Vanila Singh, other doctors, a pharmacist, and chronic pain patients.

    Beth Darnall, Phd:
  • Our VP, Bev, Was a Guest On Pharmacy Podcast Network!

    "Where's the Patient's Voice in Evidence-based Treatment & Research?"

    Pharmacy podcast 2

    Part 4 in the series "Pharmacist and Physician Opioid Collaborative"on Pharmacy Podcast Network.

    Listen as Todd Eury, from Pharmacy Podcast Network, asks Bev a question that is long overdo..."What is the patient's perspective?"

    "No one ever asks the patient what we think, we are kind of shoved out of it." ~Bev Schechtman

    "But what they're missing, Bev, is they're missing the empathetic bedside manner to look you in the eye and give you a sincere little smile, showing they're there for me as a patient." ~Todd Eury

    "We feel like everyone around us is going to treat us as though everything we say is a lie, that we're going to try to get out of whatever it is they think they're trying to catch us in, and we can't trust any of them." ~Bev Schechtman

    "The way they set up the system patients can't be honest with our providers." ~Bev Schechtman 

      

    "

  • Rhode Island Bill 384

    On June 2, 2021, Rhode Island's Governor Dan McKee signed Bill 384 into law. A copy of the bill can also be found here. Greg Amore, Claudia Merandi's local Representative, fought hard for this bill to pass which protects intractable pain patients from the 2016 CDC Opioid Guidelines. Recently, in March 2022, Arizona also passed legislation that was based on this bill from Rhode Island. That has been Claudia's hope for years, that she could pass a bill in Rhode Island that would trickle down into other states. Practical Pain Management covered this story.

    Please join Rhode Island's Don't Punish Rally Facebook page to network with other CPP's in Rhode Island.

  • Supreme Court Case on March 1, 2022 Can Make All the Difference For Doctors and Patients

    On March 1, 2022, the Supreme Court will hear a case that could make or break the future for pain doctors and their patients. Pat Anson, from Pain News Network, summed it up perfectly in this article "Supreme Court Case May Decide Future of Opioid Prescribing."


    By Pat Anson, PNN Editor

    December 29, 2021

    "Over a dozen patient and physician advocacy groups have filed legal briefs with the U.S. Supreme Court in support of two doctors appealing their convictions for criminal violations of the Controlled Substances Act.

    The nation’s high court has consolidated the cases of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn, who practiced in Wyoming and Arizona. Both doctors were sentenced to lengthy prison terms after being convicted on a variety of charges – including the prescribing of high doses of opioid pain medication to patients “outside the usual course of professional practice.”

    Oral arguments will be heard by the Supreme Court on March 1, with a decision expected later in 2022. Monday was the deadline for interested parties to file “amicus curiae” briefs on the case, which could have a significant impact on opioid prescribing practices nationwide if the appeals are successful. Many doctors have stopped or reduced their prescribing of opioids because they fear being prosecuted under the Controlled Substances Act (CSA).

    “It is no exaggeration to say that CSA prosecutions of physicians have already impaired the treatment of chronic pain,” Ruan’s attorneys said in their appeal. “In response to the opioid crisis, fear of prosecution has increasingly prompted pain management doctors to avoid or reduce opioid prescriptions, even when those decisions leave chronic pain patients without recourse.”

    A successful appeal would mean Ruan and Kahn could ask for new trials, along with dozens of other doctors convicted of similar charges under the CSA.

    “It will also avoid what I see as the chilling effect that it’s had on lots of doctors who are not doing anything even remotely suspicious, but are afraid that they are going to get caught because they prescribe a higher dose, and so they’re dropping people from care or tapering them,” said Kate Nicholson.

    NPAC, along with other advocacy groups and the U.S. Chamber of Commerce, are asking the high court to clearly state how the practice of medicine should be regulated under the CSA. Some argued it is best left to state medical boards, not federal prosecutors or law enforcement.

    “Patients with pain, addiction, or both desperately need appropriate care and treatment. If practitioners are held strictly liable under (the CSA), patient abandonment will become ever more common as practitioners act to avoid scrutiny,” Jennifer Oliva and Kelly Dineen, professors of health law and policy, said in their brief. “Progress in medical care in these areas can only recover if the regulation of medical practice is returned to the province of the states except in narrow circumstances.”

  • The Pain Was Unbearable. So Why Did Doctors Turn Her Away?

    This article was published in Wired on August 11, 2021, written by Maia Szalavitz.

    Topic: NarxCare, Opioid Risk Tool, and discrimination against women sexual abuse/assault survivors

    Mentions our organization and quotes our VP, Bev Schechtman

    The Pain Was Unbearable. So Why Did Doctors Turn Her Away?

    "ONE EVENING IN July of 2020, a woman named Kathryn went to the hospital in excruciating pain.

    A 32-year-old psychology grad student in Michigan, Kathryn lived with endometriosis, an agonizing condition that causes uterine-like cells to abnormally develop in the wrong places. Menstruation prompts these growths to shed—and, often, painfully cramp and scar, sometimes leading internal organs to adhere to one another—before the whole cycle starts again.

    For years, Kathryn had been managing her condition in part by taking oral opioids like Percocet when she needed them for pain. But endometriosis is progressive: Having once been rushed into emergency surgery to remove a life-threatening growth on her ovary, Kathryn now feared something just as dangerous was happening, given how badly she hurt.

    In the hospital, doctors performed an ultrasound to rule out some worst-case scenarios, then admitted Kathryn for observation to monitor whether her ovary was starting to develop another cyst. In the meantime, they said, they would provide her with intravenous opioid medication until the crisis passed.

    n her fourth day in the hospital, however, something changed. A staffer brusquely informed Kathryn that she would no longer be receiving any kind of opioid. “I don’t think you are aware of how high some scores are in your chart,” the woman said. “Considering the prescriptions you’re on, it’s quite obvious that you need help that is not pain-related.”

    Kathryn, who spoke to WIRED on condition that we use only her middle name to protect her privacy, was bewildered. What kind of help was the woman referring to? Which prescriptions, exactly? Before she could grasp what was happening, she was summarily discharged from the hospital, still very much in pain.

    Back at home, about two weeks later, Kathryn received a letter from her gynecologist’s office stating that her doctor was “terminating” their relationship. Once again, she was mystified. But this message at least offered some explanation: It said she was being cut off because of “a report from the NarxCare database.”

    Like most people, Kathryn had never heard of NarxCare, so she looked it up—and discovered a set of databases and algorithms that have come to play an increasingly central role in the United States’ response to its overdose crisis.

  • The Pain Was Unbearable. So Why Did Doctors Turn Her Away? NarxCare is the reason.

    When our VP, Bev Schechtman, was denied adequate pain medication when hospitalized for kidney stones due to having been a victim of sexual abuse, she became obsessed with researching how this could happen. She learned about NarxCare and the Opioid Risk Tool. We, at The Doctor Patient Forum/Don't Punish Pain, have been researching these topics for the past four years. We've reached out to countless investigative journalists only to be shot down. Thankfully, Maia Szalavitz, an author and leader in harm reduction, was interested in telling the story of NarxCare and other risk tools. This was our first piece of national media, and we are so excited to share it with you. We suggest holding on to this article and sharing it with your local legislators.  About half of the states use NarxCare, and this article can help you fight against it. Read about how our country has tried to help the "opioid crisis" by using a risk score algorithm, yet it seems they're only making matters worse.

     

  • Updated/Expanded CDC Guideline Information

    As many of you know, the 2016 CDC Opioid Guidelines have caused harm to many. Whether the guidelines themselves are the problem or if they have just been misapplied has been widely discussed by experts. In July 2021, the CDC released their draft of the updated opioid guidelines. We explained it all in detail in our newsletter. If you haven't had a chance to read it, please do. It helps put all of this in context. The new draft of the guidelines was published last week. Here are two very important links:

    Word and pdf of this information


    Some CPP advocates created this Community Sign-On Letter for anyone who'd like to sign. Please sign this as well as submitting your own comment on the docket.


    BACKGROUND OF THE CDC GUIDELINES:
    On February 10, 2022 the CDC published a draft of their updated/expanded Opioid GuidelinesRead our July and February newsletters for an in depth explanation of the 2016 Guidelines, and the all-day meeting CDC held in July to discuss their original draft for the updated/expanded guidelines.

    WHO SHOULD COMMENT:
    • All Chronic Pain Patients (CPP's) should comment.
    • All loved ones (family and friends) of a CPP should comment. They should include the following information:
      • What it's like for them to watch you suffer needlessly.
      • If your pain is currently adequately treated, they should write what you're able to do and how you're able to function due to medication.
      • If your pain was adequately treated and has been tapered or stopped, they should write how your life has changed since the medication has been taken away. Emphasize function. What things were you able to participate in before your medication was stopped? What things are you unable to do now?

    WHERE TO COMMENT:
    • CDC is accepting comments here on the draft of the updated/expanded Guidelines until April 11, 2022. You can also read comments that are already posted.
    • ***IMPORTANT INFORMATION - The link for leaving comments about the draft of the guidelines has been broken off and on. If you find the link is broken when you're trying to leave a comment, please contact Arlene Greenspan at 770-488-4696 or e-mail her at opioids@cdc.gov

    WHY COMMENT:
    • We can't express strongly enough how important it is that you comment. Every single person who has been devastated by these Guidelines needs to post a comment.
    • We also suggest that you send a copy of your comments to your local legislators. They need to hear from their constituents about how devastating the 2016 Guidelines have been and how your lives have been harmed.
    • CDC will review ALL comments, and based on what they see will update the draft accordingly. The new draft will come out by the end of 2022 and will replace the 2016 Guidelines.

    RULES FOR COMMENTING:

    ****We list some suggestions for you, but please don't use these suggestions word for word. If you do, there is a good chance the CDC will remove your comments.****

    The CDC lists the "commenter's checklist." The checklist includes the following:

    "Tips for Submitting Effective Comments

    Overview

    A comment can express simple support or dissent for a regulatory action. However, a constructive, information-rich comment that clearly communicates and supports its claims is more likely to have an impact on regulatory decision making.

    These tips are meant to help the public submit comments that have an impact and help agency policy makers improve federal regulations.

    Summary

    • Read and understand the regulatory document you are commenting on
    • Feel free to reach out to the agency with questions
    • Be concise but support your claims
    • Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
    • Address trade-offs and opposing views in your comment
    • There is no minimum or maximum length for an effective comment
    • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters

    Detailed Recommendations

    1. Comment periods close at 11:59 eastern time on the date comments are due - begin work well before the deadline.
    2. Attempt to fully understand each issue; if you have questions or do not understand a part of the regulatory document, you may ask for help from the agency contact listed in the document.

      Note: Although the agency contact can answer your questions about the document's meaning, official comments must be submitted through the comment form.
    3. Clearly identify the issues within the regulatory action on which you are commenting. If you are commenting on a particular word, phrase or sentence, provide the page number, column, and paragraph citation from the federal register document.
    4. If a rule raises many issues, do not feel obligated to comment on every one – select those issues that concern and affect you the most and/or you understand the best.
    5. Agencies often ask specific questions or raise issues in rulemaking proposals on subjects where they are actively looking for more information. While the agency will still accept comments on any part of the proposed regulation, please keep these questions and issues in mind while formulating your comment.
    6. Although agencies receive and appreciate all comments, constructive comments (either positive or negative) are the most likely to have an influence.
    7. If you disagree with a proposed action, suggest an alternative (including not regulating at all) and include an explanation and/or analysis of how the alternative might meet the same objective or be more effective.
    8. The comment process is not a vote. The government is attempting to formulate the best policy, so when crafting a comment it is important that you adequately explain the reasoning behind your position.
    9. Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (i.e., scientist, attorney, fisherman, businessman, etc.) say so.
    10. Agency reviewers look for sound science and reasoning in the comments they receive. When possible, support your comment with substantive data, facts, and/or expert opinions. You may also provide personal experience in your comment, as may be appropriate. By supporting your arguments well you are more likely to influence the agency decision making.
    11. Consider including examples of how the proposed rule would impact you negatively or positively.
    12. Comments on the economic effects of rules that include quantitative and qualitative data are especially helpful.
    13. Include the pros and cons and trade-offs of your position and explain them. Your position could consider other points of view, and respond to them with facts and sound reasoning.
    14. If you are uploading more than one attachment to the comment web form, it is recommend that you use the following file titles:
      • Attachment1_<insert title of document>
      • Attachment2_<insert title of document>
      • Attachment3_<insert title of document>
      This standardized file naming convention will help agency reviewers distinguish your submitted attachments and aid in the comment review process.
    15. Keep a copy of your comment in a separate file – this practice helps ensure that you will not lose your comment if you have a problem submitting it using the Regulations.gov web form.

    Posted Comments

    After submission, your comment will be processed by the agency and posted to Regulations.gov. At times, an agency may choose not to post a submitted comment. Reasons for not posting the comment can include:

    • The comment is part of a mass submission campaign or is a duplicate.
    • The comment is incomplete.
    • The comment is not related to the regulation.
    • The comment has been identified as spam.
    • The comment contains Personally Identifiable Information (PII) data.
    • The comment contains profanity or other inappropriate language.
    • The submitter requested the comment not be posted.

    Form Letters

    Organizations often encourage their members to submit form letters designed to address issues common to their membership. Organizations including industry associations, labor unions, and conservation groups sometimes use form letters to voice their opposition or support of a proposed rulemaking. Many in the public mistakenly believe that their submitted form letter constitutes a "vote" regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters.

    * Throughout this document, the term "Comment" is used in place of the more technically accurate term "Public Submission" in order to make the recommendations easier to read and understand.

    Disclaimer: This document is intended to serve as a guide; it is not intended and should not be considered as legal advice. Please seek counsel from a lawyer if you have legal questions or concerns."


    WHAT TO SAY IN COMMENT:

    Sometimes it's hard to know what to say. We created some basic comment ideas. 

    In case you would like some suggestions on what to say in your comments, here are some ideas:

    • Tell your story and how you've been affected by the 2016 CDC Guidelines.
      • You can use your name or remain anonymous.
      • Mention your state and if your state has laws based on the CDC Guidelines.
      • Briefly describe how you've been hurt by the Guidelines.
      • Be sure to emphasize not just pain relief but also address function. What were/are you able to do with adequate pain medication that you weren't/aren't able to do without it.

    • Remove ALL mention of MME (Milligrams of Morphine Equivalent)including in the supporting text.

    • Remove ALL mention of limit of days for prescription for acute pain including in the supporting text.
      • Although they removed mention of 3, 5, or 7 day limits in the actual Guidelines, the supporting text still has "a few days" and "7 days" mentioned. This needs to be removed.

    • Fund and execute a plan for how to de-implement the 2016 CDC Guidelines.
      • Although CDC claims these were "just guidelines" arbitrary limits such as MME limits and 3,5, or 7 day limits are an issue because:
        • Many state laws have been created based on them.
        • They are worked into EHR (Electronic Health Records).
        • Risk score algorithms such as NarxCare use them.
        • CDC funded an extensive implementation plan for them.
        • DEA also uses risk scores to flag doctors who "prescribe outside of the CDC Guidelines."

    • The Guidelines need to be redacted and redone due to bias and conflicts of interest (COI's).

    • Pain is not one condition and they need to mention there are MANY very painful conditions that might require opioids.
      • Exclusions didn't work in 2016 and won't work now.
      • They excluded "cancer pain" in 2016 Guidelines yet cancer patients have been affected.
      • They added Sickle Cell Disease as an exclusion in these Guidelines (which is good since SCD patients have been horribly affected by the 2016 Guideline), but they also need to mention there are many painful diseases and conditions. Just saying "palliative care" patients are exempt won't help anyone. It didn't help in the 2016 Guidelines.
      • There is no scientific basis for the distinction of cancer and non-cancer pain.
      • Mentioning some conditions and not others leads to a lack of individualized care.

    OTHER ARTICLES ABOUT  THE UPDATED/EXPANDED CDC GUIDELINES

    Many media outlets covered this story. Our favorite is from Josh Bloom "Panic in PROPville."

    Here is an article from Pain News Network called "Why CDC Dropped One-Size-Fits-All Approach to Pain Care":

    By Pat Anson, PNN Editor

    The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.  

    Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.

    “Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”

    People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.

    In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.

    “It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”

    Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.  

    “I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”

    Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.

    “This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”

    “States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.

    “The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

    Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less.  Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”

    “We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.  

    He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.

    “The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”   

    The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register. Comments must be received by April 11.

  • US could loosen some restrictions on prescribing opioids

    US could loosen some restrictions on prescribing opioids

    CDC considers rolling back limits on which doses can be prescribed and for how many days in cases of acute pain

    The US could see loosened guidance around prescribing opioids, as the US Centers for Disease Control and Prevention (CDC) considers relaxing some of its guidelines in a move that could signal a new direction for managing chronic pain.

    The CDC last Thursday released proposed changes to its guidance on prescribing opioids, rolling back limits on which doses can be prescribed and for how many days in cases of acute pain.

    The agency created rules in 2016 to reduce prescriptions that were fueling the opioid overdose epidemic. But as rules like these were put in place, opioid overdose deaths rose instead of falling.

    New laws in several states were drafted to codify the restrictions, and some insurers began basing their coverage of medications on the guidance.

    The sweeping actions cut off medications for some patients battling chronic pain and substance disorders, sometimes without the option of tapering down the medications or undergoing substance dependence treatment.

    As the sources of medications dried up, some patients turned to illicit substances like heroin and fentanyl.

    “You’re inadvertently driving people to an illicit supply if they’re being cut off,” said Kate Nicholson, executive director of the National Pain Advocacy Center. “The street supply is so tainted that you’re really pushing people to a very dangerous thing.”

    Fatal overdoses rose from 63,000 in 2016 to more than 100,000 last year, many of them driven by the powerful synthetic opioid fentanyl. Deaths from fentanyl have doubled in the US in the past two years – but teens in particular have been hit hard by fentanyl overdoses, with the death rate tripling in that time.

    Yet harm reduction groups have struggled to access affordable naloxone, the drug that reverses opioid overdoses. And only one state, Arizona, had enough naloxone in 2017 to prevent a majority of overdose deaths, according to a study published in the Lancet on Thursday.

    ‘It was being used against me’

  • Where's the Patient's Voice in Evidence-based Treatment & Research? Pharmacy Podcast Network

    "Where's the Patient's Voice in Evidence-based Treatment & Research?"

    Our VP, Bev Schechtman, was a guest on Pharmacy Podcast Network.

    Pharmacy podcast 2

    Part 4 in the series "Pharmacist and Physician Opioid Collaborative" on Pharmacy Podcast Network.

    Listen as Todd Eury, from Pharmacy Podcast Network, asks Bev a question that is long overdo..."What is the patient's perspective?"

    "No one ever asks the patient what we think, we are kind of shoved out of it." ~Bev Schechtman

    "But what they're missing, Bev, is they're missing the empathetic bedside manner to look you in the eye and give you a sincere little smile, showing they're there for me as a patient." ~Todd Eury

    "We feel like everyone around us is going to treat us as though everything we say is a lie, that we're going to try to get out of whatever it is they think they're trying to catch us in, and we can't trust any of them." ~Bev Schechtman

    "The way they set up the system patients can't be honest with our providers." ~Bev Schechtman 

The Doctor Patient Forum

Claudia A. Merandi 5 Chedell Avenue / East Providence, RI 02914 / USA 1.401.523.0426

Follow Us: FACEBOOK REDDIT YOU TUBE TIK TOK 2 TWITTER