MYSTERY WIRE — Up to 40 million Americans suffer with acute or chronic pain, and for most of them, opiates are the only medications that provide relief.
But over the past five years, doctors have been forced to reduce or eliminate opiate prescriptions leading to patients with crippling pain and no relief. Many continue to hurt, some even killing themselves.
At the same time, overdose deaths in the United States have skyrocketed. But according to data, many of these deaths are not from people suffering chronic pain. Nearly all of them are from people using illicit drugs like heroin and fentanyl.
Everyone is just one auto accident or cancer diagnosis away from becoming a chronic pain patient. The millions of Americans who already suffer with chronic pain are among the hardest-hit victims of an opioid crackdown that began in 2016 when the CDC issued voluntary guidelines for opioid prescriptions.
In the five years since then, legal prescriptions for chronic pain have plunged, while deaths from opioid overdoses have skyrocketed. The reason is that most of the people dying from overdoses are not pain patients. Nearly all of them are from using illicit drugs like heroin and fentanyl.
At the same time, legitimate patients in need of pain management who follow the rules have seen their lives destroyed because many doctors no longer provide pain management.
Richard “Red” Lawhern is a pain management patient advocate. A self-described non-physician expert in chronic pain and peer-to-peer online patient support groups. Lawhern has more than 70 published papers and articles in a mix of medical journals and popular media, some of which are co-authored with medical professionals.
“So, what we have here is that the US CDC has been using junk science as the fundamental logic for a guideline, quote, guideline, actual standard that impacts the lives of 40 million people in this country,” Lawhern said in a recent interview with Mystery Wire. “Because 40 million of us every year will be treated either short term or long term. on an opioid analgesic, an opioid pain reliever. Of that 40 million, 20 million are in intractable pain that affects the quality of their lives every day.”
Lawhern says the opioid crackdown has been engineered by unqualified CDC advisors, and millions of pain patients have suffered as a result, with many of them resorting to suicide.
From patients being told they are imagining the pain, to being cut-off with no plan for coming off the medication, to even having people in hospice die in pain, Lawhern says there are too many real-world examples of how the regulations are hurting the people who need the medication the most.
Currently, Stanford University is recruiting patients for a pain management study called EMPOWER (Effective Management of Pain and Opioid-Free Ways to Enhance Relief).
RELATED
- Richard Lawhern co-authored paper, “Opioids and Chronic Pain: An Analytic Review of the Clinical Evidence“
- US Pain Foundation
Connect with Richard “Red” Lawhern:
– The Lawhern Files
– Facebook
– Twitter
– eMail
In 2017, George Knapp and Vanessa Murphy reported on this opioid issue many times on air on KLAS-TV in Las Vegas, NV. Below is the special report they and the KLAS I-Team produced which also aired on KLAS-TV.
Below is the transcript of the interview seen at the top of this article. Richard “Red” Lawhern provided editing assistance on this transcript to ensure clarity.
Duncan Phenix
Mystery Wire interview recorded on September 15, 2021
Richard “Red” Lawhern, thank you for joining me. Tell our viewers a little bit about your background in being a patient advocate for pain management.
Richard “Red” Lawhern
About 25 years ago, my wife came down with something that we initially thought was a tooth root abscess problem. It turned out to be something very different. It took us six doctors and a year to find out what different it was. It was a variety of face pain that is a form of neuropathy, basically, generated by nerve damage. And it is one of the most painful conditions that we know in medical practice.
While we were sorting out with the doctors what she actually was dealing with and what to do about it, we went to a meeting of the US National Trigeminal Neuralgia Association, (now rebranded as the Face Pain Association). I talked with the founder of that group, a lady by the name of Claire Patterson, and asked a question. It was, what are you doing to raise your visibility with the developing communities in the internet?
This was 1996, roughly. Claire crooked a finger at me and she said, “I want to talk to you after the meeting.” A year later, I found myself on the board of directors of the TN Association and signed on as their webmaster and principal research writer. And from there, I got really very active in social media and in what was then called the USENET or users net, which is a predecessor to a lot of the bulletin boards and chat rooms that we see now.
I started translating medical literature for people who couldn’t understand it. And helping them to understand where the authoritative sources were for information that they could use in working with their doctors to find relief from agonizing pain.
Starting about 2010, I started getting reports from the relatively few people who treat face pain with a doctor’s help using opioid medications. And what they were telling me was, my doctor is getting really uncomfortable, because he’s seeing these actions by various federal and state authorities that seem to be oriented toward denying opioid treatment to people who need it. And what’s this all about?
So I started getting involved in the research of that. Rapidly, I found that even beginning as early as 2010, there were quite a number of initiatives being floated by anti opioid advocates, in an effort to deny opioids to anybody, and everybody. It went so far as to involve petitions by a group called Physicians for the Responsible Opioid Prescribing (PROP) to the FDA, in an effort to put a black box warning on all opioids, discouraging their use, and basically saying we shouldn’t use these more than a few days if you have to use them at all.
FDA kicked them out of court. Basically, the FDA group that’s charged with reviewing these matters, told PROP, you guys don’t know what you’re talking about. And PROP then started lobbying other organizations. It turns out there was a long standing relationship between key figures in that organization and the CDC. So they went to CDC and said, we have an opioid epidemic. You really ought to do something to regulate this more.
Starting about 2014 CDC started to gather its ammunition, if you will, for a very restrictive guideline that was later issued in 2016. And which almost didn’t get any public notice or public commentary because CDC tried to limit public review to just three days. It turned out that an outfit called the Washington Legal Foundation went to a congressional committee, specifically the Government Oversight and Reform Committee and said, “Hey, this isn’t right. This is a major guideline that’s going to be issued against medical practice in a very large field. And it’s had no public review.”
The Oversight Committee came back to CDC and said, open this up for real public review. I saw some of the public review and in fact, I commented even at that stage, which was late 2015. I can tell you from reading the details, that CDC deliberately and with knowledge of what they were doing, ignored every bit of input they got. They made no significant changes to a guideline that was flat out wrong, and that they knew was wrong. This is one of those nasty little government scandals that most of the time we don’t hear about, because it’s been buried in the paperwork long ago, basically eight years ago.
So I got involved in trying to find out what the truth of opioid practice was. And I found out that basically, they work pretty well. For most people, most of the time, they’re very safe. But CDC is saying, if you’re exposed to these more than a few days, you’ll be an addict. To which my candid comment is ‘horse feathers’. We knew better than that even in 2016. And we know and even more now, because there’s a great deal more research that’s been developed since.
I’m one of those who has been working in that research. I have a number of papers published in the field. And in this case, the number of papers is about 130, all of them since 2012. So that’s how I got into this. People basically said, Hey, help me understand what’s going on here. And because I’m a research type, and I’ve been doing this for years, I started finding out what’s going on. And it just appalled me and has ever since we got started into this mess.
Duncan Phenix
So if I’m just watching TV, casually reading a newspaper, getting some things online, which most people do these days, I might think that from what I’ve seen, that opioids are terrible, they’re bad. They’re evil. They’re the worst thing since the last worst thing. There’s lawsuits, Big Pharma is to blame. But, one, have I been misled? Has the public been misled? Two, is there blame? Or is it a, I don’t want to say a group effort. But, you know, patients, doctors, pharmaceuticals, government, have all had a hand in this.
Richard “Red” Lawhern
Okay. complicated question. So we’ll spend a little time on it.
First of all, I think you need to be aware that in the news, we’re hearing a lot about the settlement that was that occurred with Purdue Pharma. But that settlement was never based on merits. The settlement is completely bogus on science.
Purdue Pharma and others were urging more prescribing of opioids, we’re very well aware, in the 2000 to 2010 period. Pain is the most under treated condition in medical practice, but it’s also the most current or common problem that brings somebody to a doctor. So pain became “the fifth vital sign” — even though it was a kind of advertising meme –, and it was broadly used by the pharmaceutical companies.
Pain is the fifth vital sign is accurate. It’s true. And the lawsuits that were filed against big Pharma are again based on the assertions of anti opioid witnesses. I might add many of those witnesses have made a ton of money from US government reimbursement for their time. They’re basically financially self interested in persecuting and prosecuting big Pharma. And state attorney generals are financially interested in the same thing, because they’re running out of the money that the big tobacco settlement generated and they’re looking for a new cash cow.
State attorney general’s don’t care that they’re harming patients. They don’t care that they’re lying through their teeth about the role that big pharma has played. They just want to get the big boys in the settlement. A multi-billion dollar settlement from Purdue is one part of that. As I said it’s as bogus as a $3 bill on merit. Likewise, they have succeeded in driving Johnson & Johnson out of the opioid market. They’re going to stop making all opioids. And we’re going to see, in the near future, if somebody doesn’t say, “Stop this idiocy”, we’re going to see the denial of pain care, to literally 40 million patients. And it’s gonna be a blanket denial.
So, I’ve been working to understand what’s been going on in this field from both the standpoint of public policy and the standpoint of science. I can tell you that when you hear something on television or radio or something, it starts out talking about the “opioid epidemic”. As soon as that phrase comes up, you/ve got a clue that what you’re facing is not news. It’s propaganda. And it’s anti-opioid propaganda, that has no basis in science, whatever.
We know this now beyond any reasonable doubt. I can give you examples if we get a little deeper into our talk. So basically, the answer to your question is, Big Pharma, indeed, did some things that were sharp business practice when they started prescribing in the 2000 to 2010 period. But we now know from very good statistical analysis, that the driving factor on opioid overdose deaths and dependency in that period, was mostly pill mills.
Mostly it was a few medical doctors who were basically operating outside of the guidelines of reasonable medical practice, and handing out pills with no kind of real monitoring of outcomes and no real patient evaluation or assessment upfront.
Well, that particular influence went away, even though it only in a small way contributed to the increases in opioid deaths over that period. That influence went away when the DEA finally got the message and started going after pill mills. That was about 2010 to 2011. After that time, we find a very interesting statistic that I share with people — and this is something you can absolutely verify from published data. This is not an opinion, this is fact.
Opioids are prescribed most often to seniors, age 62 and up because seniors have more medical conditions that create pain. These conditions are progressive, they get worse over time. They develop as an outgrowth of a wide variety of conditions that are individually painful, acutely painful. And the acute pain often turns into chronic pain. And guess why it’s because it’s undertreated in many cases.
So seniors, who get the most opioid prescribing have the lowest rates of opioid overdose related deaths by a factor of three to one. Kids under the age of 19 have the lowest prescription rates for opioids. And they have a rate of opioid related overdose death, that is three times that of seniors.
So what I’ve been telling people for the last roughly four years is that you can’t explain this inversion of demographics, by any model that proposes that prescribing is the problem or the cause of addiction. It’s not there, it has never been there. So what we are seeing is, statistics of the CDC itself demonstrate that the logic behind the 2016 guidelines is bogus. It’s flat not supported by the data that CDC itself has reported. But CDC has chosen to ignore the data, and instead to enlist the opinions of people who were hand-picked as anti opioid advocates, who may even believe the nonsense that they talk. But they’re lying through their teeth.
Increasingly, the anti-opioid zealots are being challenged in the literature and in public and popular media, by people a little bit like me and different from me, some of them medical professionals, some of them patient advocates. And what we’re saying to the CDC is guys, you got it wrong. You got it desperately wrong. And you’re doing it again with a revision that you have underway right now. Because the five people that you have rewriting the guidelines after they were challenged, don’t happen to have a board certification in pain medicine between them. None of them are experts in pain management, none of them are board certified in the field. They’re basically public health hacks.
These are people who don’t have a right to have an opinion, much less to have it converted into national policy. Now, I realize I’m being a little strong here. This whole matrix of issues, really bugs me, because I talk to patients every week. I mean, literally every week, and it’s more than one every week, who have been cut off from medications that were effective for them, that they never once misused. But they’re being told by their doctors, “I’m sorry, but I can’t prescribe for you because my license may be at risk.”
The number one, if you will, “culprit” in this is a DEA that has gone after the low hanging fruit. DEA has not been successful in stopping the ingress of illegal opioids. At least not very successful. They do have published cases that come off now and then. But they know the doctors, especially those that are individual practice, can’t really defend themselves. Because if a doctor’s practice is challenged publicly, the practice goes dead. Because people are saying, Oh, no, no, no, no, I can’t possibly work with that doctor. He’s not prescribing properly, he won’t protect me properly. He’s over prescribing.
But the over prescribing part of this, the strategy is accuse them now, sort them out later, but get them out of practice, no matter what lies you have to tell. The DEA knows this just as well as you and I do. DEA is practicing extra legal persecution of doctors not for appropriate enforcement, of drug regulation. And this kind of nonsense needs to stop right freaking now.
Duncan Phenix
So one argument, one might hear is that these rules, these regulations that have been put into place, they’re helping more than they’re hurting. I take it you just totally disagree with that.
Richard “Red” Lawhern
Absolutely.
Duncan Phenix
So right now, you mentioned the CDC is in theory, reworking their recommendations, correct?
Richard “Red” Lawhern
That’s correct. In a joint meeting July 16 of this year covered an outline of what they’ve done so far. The meeting also provided a report by an appointed advisory and oversight group. The group involved in this was the Opioid Workgroup, and they report to the Board of Scientific Counselors of the National Center for Injury Prevention and Control.
Duncan Phenix
Is there an opportunity with this process? Or was there an opportunity for people like yourself or the general public to get involved?
Richard “Red” Lawhern
The July meeting provided not only the reports of progress so far, but also a two-hour session for the public. People registered to comment in a meeting very much like the one you and I are having now, basically a zoom session. The interesting little wrinkle here is that there were so many people who wanted to comment that they were restricted to two minutes each. And two minutes each has to be a pretty well prepared speech.
Fortunately, NCIPC also invited people to submit separate comments. I listened in on the comment session, and I would say that something on the order of let’s say 50 to 60, people commented. Four of them were advocates from PROP. And almost all of the rest said something to the effect of “you’re killing us, you idiots. Because you’re pursuing a fantasy instead of real science.”
Now, obviously, that’s toned, a little tough. But it was a real tough love session, and you can believe that the public deeply disagrees with the positions that the CDC is is taking — at least the public that are chronic pain patients, that basically means about 20 million, maybe 20 to 40 million. That’s the number of pain patients in this country. And 20 million of those who are pain patients have unrelenting pain at a level that is sufficient to compromise the quality of their lives every day. And those are the people that were commenting on July 16.
Duncan Phenix
When the CDC makes these recommendations is that a done deal? You know, we’ve learned a lot about the CDC this past couple of years with the pandemic and how it works. Does that become law, whether they change or don’t change anything, do you know the process there?
Richard “Red” Lawhern
Interestingly enough, the CDC guidelines that were published in 2016, at least some part of the guidelines became law in 36 states that chose them as a basis for specifying what appropriate practice was in the prescription of opioids. That’s not all states, but just about all state medical boards, which review the qualifications and practices of doctors to resolve complaints took on the CDC limitations have drunk this Koolaide.
The limitations were in what is called morphine milligram equivalent daily dose. It’s MMED. State Boards took those on and basically said, if you go more than 90 MMED, your really should send this patient to a specialist in pain medicine, you know. If you’re a general practitioner, you shouldn’t be handling people at that dose. But various state legislators went further than that, and basically said, you shouldn’t be prescribing more than 90 MMED ever to anybody.
So CDC worked a really neat little handshake, without ever actually putting all of these limitations in the law. They used their influence to encourage state legislators who don’t know from squat about this issue, except for what CDC says, to take the guidelines into their hands and turn them into law.
Now, there’s another interesting wrinkle in that regard, too. There was a letter published June of last year, June 2020, by the President of the American Medical Association. They don’t have all doctors in their stable, but they have a substantial number of doctors. In that letter to the person who headed up the CDC guideline writing group in 2016, what they said was that the idea that limiting opioid prescriptions is going to solve our opioid crisis is a myth. It’s a mythology. It’s not true. And moreover, you should be encouraging every state legislature to repeal any law that applies a hard limit on either opioid dose, or duration.
That was AMA. Five other nationally recognized professional organizations, headed up by the American Academy of Family Practitioners, or maybe family physicians, I forget which. AAFP and among others, the American Psychiatric Association, which writes the diagnostic and statistical manual for disease, by the way. They came online and basically said in (I think it was March or April of 2019), it is time to end political interference in evidence based medicine and to remove law enforcement from doctors offices.
The aggregate group here represents over half of all practicing physicians and medical students in the US. When they take a public position of this type, it is not a trivial exercise. So both the AMA and the AAFP and several other medical associations have come on public record. This was such a major kind of confrontation. It wasn’t the only one. In March of 2019, CDC was forced to make an announcement that basically amounted to ‘oops, we think our guidelines are being misused.’
Well, they never did get around to saying we think our guidelines are wrong. But what they said was a Mea Culpa, intended not to solve the problem, but to get off the hook for being guilty of it. Because what they said to the public was, your state legislators ought to do something about this because you shouldn’t be using our guidelines as a hard and fast limit. And interestingly enough, the letter that prompted that action was published. I believe by the Journal of Pain Medicine. I’d have to go look it up to be sure.
But it was published over the sponsorship of 300 practicing physicians who put their own professional reputations behind what they said. And what they said was this is freaking madness, freely translated understand. That’s language that a doctor wouldn’t typically use because the doctor likes to be thought of as a professional, but there are some of them that are just as angry with his mess as I am.
Duncan Phenix
So what can a pain management doctor at this point, or pain management patient, what can they do? Is it just beating down the door of your state legislature?
Richard “Red” Lawhern
That’s a big part of it. Absolutely. One of the things I’ve been advising people to do — and I talk to a very large number of people every week — is you need to call your representative and your state and your senators, your federal senators and your assembly person or your state senators and your governor’s office and the state medical board. It’s a long list when you think about it. What you need to say to these people is restrictions that you have encouraged on the practice of medicine are destroying pain medicine, and killing 1000s of people by suicide. SO stop! Literally, with that kind of tone.
I’ve had this conversation with my own representatives. And the staffer that one talks to in these circumstances — because the representative or the senator never talks to you — the staff are very polite. They’re basically saying I will record your input for the legislator, and then you never hear from them again.
When you look carefully at what’s actually going on in Congress, they’re not doing anything. They’re not acting on the messages they’re getting from tens of 1000s of people. And I think it is that high by now.
We’ve got a couple of other statistics that I think your viewers and listeners may want to know. And I’ll offer these to you. For one thing, there is an article out on Washington Post in the last week or so. And a comment on that article in the American Council for Science and Health, in which we have legitimate medical investigators, people with appropriate qualifications who have looked at the statistics of overdose and death in veterans who are denied pain treatment, which by the way is VA policy right now. Veterans don’t get opioids ever. No matter what their problem is.
Policy is a result of a document that’s called “The opioid safety initiative.” And it has nothing to do with safety. When you study the Veteran population, and you see what’s happened to veterans, after a veteran is tapered off of opioids involuntarily, the risk of overdose death quadruples. It is four times higher, and this is very likely caused by the act of involuntarily removing their pain treatment.
We also know in a separate study of insurance records by non veterans, that in civilian populations where patients are tapered either voluntarily or involuntarily, the risk of a mental health crisis or overdose death is on the order of two and a half to three times the risk of those events in the general population that are being maintained on opioids.
There is now conclusive proof that denial of pain care kills people. And so far, the CDC has been vastly silent on that issue. It’s time for that silence to end. That’s been my message and it will be the message of many others. We are all of us working to try to get Congress to sit up and take notice.
The other thing that we basically have to realize is that doctors are gun shy for good reason. I mean, they’re between a rock and a hard place. They’re being told if you do the slightest slip, if any one of your patients comes back and says you gave me too much, or I didn’t get a good result from your treatment, but I think I’m an addict… If that happens regardless of the merits, you’re dead, your practice is gone, your livelihood is gone. And we will pursue you to the ends of the freakin’ earth to make that happen.
Now I might add, I’m quoting from a medical doctor who used very nearly those words from a conference that he went to, that was addressed by the chairman of their state medical board. The medical board basically said to these practicing doctors, an audience of over 100. “If you are prescribing opioids, we’re gonna’ put you out of practice. And we don’t care if you think it’s unfair…Stop and cut ’em cold.
People in the audience was thinking but not saying because of course, that makes him a target. Yeah. What about these patients? What do they do? And the fellow that was up there in front of this group, basically said, you have to look for non opioid pain treatments that are preferred, according to the CDC, over opioids.
Now, there’s a wrinkle in that and the doctor that I talked to knew about this wrinkle. In 2018 and 19, the Agency for Healthcare Research and Quality, AHRQ, did a major outcome study on non-invasive non-pharmaceutical treatments for pain. They surveyed over 5,000 studies and trials. And they filtered for quality. They filtered for relevancy to the issues. And they got down to about 1,800 studies that they read line for line.
The quality of those studies was so poor, that they could only select 218 of them to report. And out of those 218, not one of them was a head-to-head comparison of some kind of non opioid treatment with some kind of opioid treatment. None of those trials were documented sufficiently even to find out what usual and customary treatment was.
So the quality of the literature for non opioid treatment of chronic pain is so poor, that we don’t know if they work any better than placebos. And yet, the CDC labels them as preferred to opioids. Now who did that little mess?
So you can see that what we’re dealing with is some very heavy hitters who are protected by government insurance against being sued. They can’t be sued effectively, it’s the doctrine of sovereign immunity, even though they’re wrong, and even though they know they’re wrong, and even though everybody else knows they’re wrong, they won’t give an inch because if they do so their personal reputations might be harmed.
Realize, that’s not a quote. That’s a judgment on what’s really going on here. In my view, and I’ve said this publicly in an article I published not long ago, the entire writers group for the revision that’s underway should be fired for cause and denied ever being able to practice any form of medicine to any patient cohort. They’re that bad. They are public health hacks. And they are destroying lives in large numbers.
Duncan Phenix
You mentioned at the beginning, about your personal interaction with pain and how it affected you and your family. Personalize this for me, what are these people experiencing? And what is this doing to the quality of life that is supposed to be helped by modern medicine?
Richard “Red” Lawhern
Okay, well, there are dimensions to this. There’s more than one kind of patient outcome. I have about 5,000 followers on Facebook. And my stuff appears on platforms that typically generate something like 200,000 impressions every day. So I hear from a lot of people, and they know where to find me. So believe me, my inbox is full.
What I typically get from people Is “my doctor retired and he retired without giving the referral to anybody else. Nobody else within 100 miles of me will take me. And the one practice that I did talk to said we’re not taking new patients. And the patients we have are being tapered to less than 90 MMED without exception.”
And this was from a patient whose former doctor was treating her with 350 MMED every day. What she told me was, “I can’t get out of bed, I am typing on my laptop right now. Because if I get out of bed, my legs will hurt so much that I collapse.
Now, here’s another narrative. “My mother just died in hospice. And she was in hospice for six months, and the only pain reliever they would give her was Tylenol. She was in agony the entire time, screaming for help, and they would not help her. They closed the door on her room and left her alone.”
Now that is an almost word for word narrative from one of the people that contacted me. Patients are being deserted broadly. The doctors who are still practicing — and it’s probably less than 40% of the doctors who were six years ago — The doctors who are still practicing are extensively documenting. They’re having to go through all kinds of hoops with pre-approvals from insurance companies. Some pharmacists are refusing to act on pre-approvals and denying prescriptions that are legitimate to pain patients.
Some pharmacists go so far as to blacklist doctors with all of the pharmacies in the area so that they can’t get anybody to fulfill their opioid prescriptions. That’s also from a doctor. Dr Amy Chagnon can also tell you a little bit about that. When you go talk to her , she will confirm that patients are now with their doctors, between a rock and a hard place. We are on the hairy edge of a wave of patient suicides. There are already over hundreds that have just been documented.
There’s a very interesting legal case. As a matter of fact, in Kentucky, the family of a patient who committed suicide, successfully sued the practice that denied him pain care for $7 million dollars. If that settlement holds up under appeal, it’s going to put a whole bunch of pain practices on notice that you can’t tell these people they don’t hurt. Because if you do and you refuse treatment, then you are legally liable for abandoning them. That I think may have some serious impact out there.
What we really need probably is a class action suit against CDC, it will be a real bear to mount that. But there is a case that’s being pursued by the Chapman Law Firm — I believe they’re from Michigan and DC — where there is a writ before the US Supreme Court requesting that the Supreme Court direct Walgreen pharmacies to develop and publish a uniform standard for what comprises usual and accepted medical practice and the prescription of opioids, because there is no such document now.
There is no universal standard for what real normal practice is. And even the guidelines that are published by the National Association of State Medical Boards don’t declare an MMED threshold. That’s one of the good things about them. There’s a lot of stuff in there that aren’t so good. What we’ve got is that so called expert witnesses are voting their opinions about what comprises normal practices — and their opinions aren’t worth squat. Some of them aren’t even pain management specialists. They’re not backed by any science. They’re not backed by any data.
And worse yet, oh, by the way, the FDA had a workshop in early June of this year to examine the science behind the whole notion of morphine milligram equivalents, which would relate the dose of one opioid to the dose of another. And what they found out is there is no science. The entire field, and the entire specification of 50 and 90 MMEDD are what a scientist calls a data artifact.
CDC looked at data that was organized in patients who had been given 20 MMED or less, 20 to 50, 50 to 90, and over 90. Well, it turns out, those are simply reporting levels that are part of the case notes that hospitals generate when they admit somebody for opioid toxicity, if they have medicals prescriptions they are characterized in those terms. But there is no curve that shows that the probability of opioid toxicity goes up in any significant way other than a kind of a gradual, weak slope. There’s no knee in the slope that says, you know up to here, you’re okay at such-and-such a level. But when you go above there, there’s a much higher risk. There’s no such curve. There’s no data to support such a curve.
So MMED is what an old guy like me, who is a little bit intolerant, calls junk science. It’s not science at all. It’s an effort to help doctors to figure out if they switch between one opioid and another, how much of the next opioid that they’re going to use. Should they use? You know, what’s the equivalence and it turns out that it’s a very, very weak measure. There is at least a 15 to one range in minimum effective dose between individuals on the same medications. And that 15 to one range is established by a very extensive literature, that addresses genetic effects of opioid metabolism. That’s the breakdown of opioids in the body system in the liver.
So, what we have here is that the US CDC has been using junk science as the fundamental logic for a “guideline” ( actually a practice standard) that impacts the lives of 40 million people in this country. Because 40 million of us every year will be treated either short term or long term pain. On an opioid analgesic, an opioid pain reliever. Of that 40 million, about 20 million are in intractable pain that affects the quality of their lives every day. And about three and a half million of them are taking opioids for a period of longer than 60 days.
Duncan Phenix
Do you see the recent change in state laws regulating certain schedule one drugs or drugs that were schedule one, marijuana, mushrooms or shrooms? Is that helping in this case?
Richard “Red” Lawhern
The research still hasn’t caught up. There are some indications that in states where medical marijuana is dispensed from regulated dispensaries that have state oversight, the rates of opioid prescribing are at least marginally dropping. But we don’t know if that’s cause and effect.
Basically, the rates of prescribing are dropping all over the US. They’re being forced down by the regulatory environment and whether prescribing of medical marijuana is a positive force in that, we just don’t know. And as long as medical marijuana remains federally scheduled, we’re not going to find out.
My proposal is that it should be taken completely out of the federal schedule and left to doctors to decide. Other marijuana related products, notably CBD oil and THC, which is an active ingredient in marijuana seem to help some patients some of the time. And there are reports in social media of people who have had a significant pain reduction. But there’s been no systematic effort to actually go in and trial this issue, to get closure on just what exactly science can support.
Duncan Phenix
Bigger picture now. Are you hopeful that there’s an end to what you see is this issue? You know, we’ve got a huge baby boomer population that’s looking to have a good quality of life. This issue on that end is not going away.
Richard “Red” Lawhern
It isn’t going away, but as far as short term relief is concerned, what we saw on July 16 was an outline of recommendations, if you will, without a lot of supporting data — but an outline of recommendations by the CDC writers group that basically doubled down on the same nonsense they committed in 2016. In some cases, they use words very strongly similar, and those words were challenged directly by the appointed Opioid Workgroup charged with identifying issues. The report of the Opioid Workgroup is available on the CDC website, and it’s worth reading.
The minutes of the 2016 meeting, including the documents that are being submitted by people other than those who spoke, should be available by October. By the end of the year, we should see a revised guideline put out for public review on the Federal Register. My reading of the environment now is that when that guideline comes out, if it continues to commit the idiocy that we saw on July 16, there are going to be people who march on Washington, and on state capitals to say “guys, you not only got it wrong, you got it criminally wrong, because you failed to account for science that is well established, and you are negligently killing people.” And that’s a voice I think we’re going to hear more of.
Whether this will resolve before the new guideline is issued in the spring of next year. I cannot yet read. I do know there is a building sense of serious urgency in patient and doctor communities. Doctors are tired of being persecuted too and they want relief. And the AMA has given them a factual basis for challenging, practically speaking, any action against them. I think a lot of doctors haven’t realized that yet. They need to go read that the AMA letter published June of last year.
But the question you asked is do you see relief on the horizon? The answer I would give you is I see the possibility of relief. And I see it happening over the objections and the falsifications and the fraud that’s been published by the CDC. And if CDC doesn’t wake up and smell the coffee, they’re going to lose all credibility with people who need a credible source of other information in areas where they actually have a little expertise. They need to start realizing they’re in deep doo doo. Because so far, they haven’t.
Duncan Phenix
In an email that you had sent me you mentioned this Stanford pain management study. That at least according to this was still recruiting. Is that still happening?
Richard “Red” Lawhern
The recruiting is still underway. The study is headed by Sean Mackey. He is the director of the Department of pain management at Stanford.. There’s another doctor who’s quite prominent and quite well known, who is going to be processing a lot of the data. And what they’re going to try to do. Here is that they are going to look at ….
Duncan Phenix
Dr. Beth Darnell.
Richard “Red” Lawhern
Dr Beth Darnell. That’s right. I’ve heard her speak and she’s a pretty sharp cookie.
NOTE: When Lawhern spoke about this study with Duncan Phenix, he mistakenly referred to the earlier EMPOWER study, rather than the current VALUE study. The protocol for the VALUE study is somewhat different. It may be reviewed here:
https://painnews.stanford.edu/news/what-value-value-study-patients-chronic-pain-taking-long-term-opioids
The study team are going to make the attempt to actually go in and carefully document what the patient’s experience is with opioids. I’d have to look up the name of that study right now it’s not in my head. But I have basically told the people that I influenced that if they can take that time to do the surveys, I think that the study is worth doing.
Duncan Phenix
We will definitely link to it. And we’ll get that information out there. Along with the information on the doctors about involved in this. Anything else that you’d like to say, I know we’ve talked for quite a while.
Richard “Red” Lawhern
I want to be very clear that I am to some degree self interested in this. I’ve been working with a statistician and a very competent doctor who is in the Veterans Administration system. His name is Steve Nadeau. And the three of us recently had a paper published by Frontiers in Pain Research. The title of that paper is “Opioids and chronic pain, an analytic review of the clinical evidence.”
What Steve, Jeffrey and I have done is we’ve gone in and tracked what the medical literature has to say about a number of medical issues that surround the use of opioids in treating pain, and particularly long lasting chronic pain. This paper was published August 17. In the month, since, it has had more than 7,000 downloads from this source, which exceeds the activity for 85% of all papers published on this venue. An earlier version of this paper was published by the Journal of Medicine of the US College of Physicians. This is a lesser journal, but they got 11,900 downloads since March.
I think this paper should be required reading for anyone who prescribes or regulates the practice of pain medicine, because it is thoughtful and deeply referenced — and by this I mean 128 references in 6,000 words; this is not trivial reading. This paper knocks a hole in the CDC guidelines big enough to drive a six-deuce truck through. Because it reveals that the guidelines are not only wrong, they are desperately wrong concerning every piece of science in them. This was an incidental finding, not any previous agenda.
So this is “ Red with his hair on fire” talking, not phrased in the manner often used by medical professionals. This paper takes you all the way through the background of this issue and its various dimensions — and does it with the published literature of others. So this is not opinion, this is solidly grounded information. And I think this could be a paper that will wind up being one of the most widely cited in the literature of pain medicine — at least I hope it will be because we’re seeing the initial indicators now.
Duncan Phenix
How can people get a hold of you if they if they need to or want to share?
Richard “Red” Lawhern
To get a hold of me — and I grit my teeth as I say this — you can send me email at lawhern@hotmail.com. I get an awful lot of mail through there already. I have a horrible suspicion that’s going to get to be a lot more after you guys get on the air. But that’s one way to do it.
If you want to join the social media where I am active, you can read in facebook.com/red.lawhern. My page is public, even if there are already so many people subscribed to it that you might not become one of my “friends.” I generally allow the public access. You need to be one of my FB friends before you can respond to my postings there.
That’s just to protect myself from being overwhelmed. As it is I get mail every doggone day and I get comments through my Facebook page every day. I’m also active on a medium called Quora.com. I’m active in Twitter as @lawhern1. I’m active on LinkedIn and I have over 40 papers published on LinkedIn.
So do a Google search on my name, and you’re going to get probably over 4,000 hits. It’s not hard to find me.
Duncan Phenix
All right. Well, thank you again for taking the time.
