Joint Meeting of Two FDA Advisory Committees: Are The Blind Again Leading the Blind?

Joint Meeting of Two FDA Advisory Committees: Are The Blind Again Leading the Blind?

On June 11, 2019, two FDA advisory committees will meet outside Washington DC. One is focused on Drug Safety and Risk Management and the other on Anesthetic and Analgesic Drug Products. Their declared agenda begins as follows:

“FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.

“FDA frequently hears from patients and healthcare providers that higher dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. [Link ]

As a patient advocate I frequently interact with government agencies on the kinds of issues summarized above. I have offered the following (slightly edited) insights to the Committees, with references from medical journals. I beg pardon from readers who aren’t regularly exposed to “doctor speak”. Doctors and regulators were the original targeted audience.

  1. Published data demonstrate a very wide range of minimum effective dose levels in individual pain patients, due to genetic polymorphism in liver enzymes which govern opioid metabolism. There is no one size fits all patient or therapy plan. Literally millions of US citizens benefit from high-dose opioid therapy with no evidence of addiction or mortality risk. To further restrict availability of high dose opioids in an already profoundly hostile regulatory environment would be both misdirected and abusive of patients.
  2. Published CDC data demonstrate no consistent relationship between overall rates of opioid prescribing by doctors versus overdose-related mortality from all sources. The contribution of medically prescribed opioids to mortality is so small that it gets lost in the noise of illegal street drugs. To the limited extent that there are any trend lines in the mortality data, they suggest that since 2016, mortality is marginally lower in US States where rates of opioid prescribing have remained highest. Prior to 2016, trend lines were flat, with very low correlation. There is no observable cause and effect relationship between overall rates of prescribing versus rates of overdose death.
  3. Models employed by HHS/CMS to identify potentially at-risk “over-utilizers” of opioids have been shown to have limited predictive value. Over half of all high-dose Medicare patients identified as having elevated risk of substance abuse are not diagnosed within 18 months. More than half of all overdose-related deaths in one US State occurred in people who had no current prescription. Rates of overdose mortality in people over age 55 – many of them Medicare patients — are the lowest of any age group, while mortality in people under 25 is six times higher.
  4. Studies of the impact of high-dose opioid analgesics on overdose mortality reveal an average rate of overdose-related mortality at 0.25% per year (2.5 deaths per 1000). This is comparable to mortality observed in medications for atrial fibrillation following stroke. While mortality rates rise with dose, there is no distinct “upward knee” threshold in mortality versus dose.
  5. Also of concern is an historical but unsupported bias against co-prescription of opioids and benzodiazepine drugs. Under-treated anxiety and depression are factors in elevated risk of patient mortality. Yet there are no published observational trials in live patients, to demonstrate actual risk of respiratory depression; all evidence is inferential, drawn from cause of death assignments that are confounded by non-uniform standards among county medical examiners.

Under the principle of “first do no harm”, I urge the Advisory Committees to refrain from recommending further restrictive measures on prescribing. You are dealing with patient populations so small that direct safety improvements cannot be measured. But the indirect effect of such restrictions will reliably be to further poison the regulatory environment for all pain patients and to encourage the departure of medical professionals from pain management.

Cease, halt, and desist.

Patients who are managed on high dose opioid therapy may share their stories and concerns at [link ]

Author Note: Richard A Lawhern, PhD is a technically trained non-physician patient advocate and healthcare writer, with 22 years experience in moderating social media support groups and over 70 published papers and addresses. He is a frequent contributor at National Pain Report.

Richard A Lawhern, Ph.D., is a frequent contributor to National Pain Report. He has over 22 years experience as a technically trained non-physician patient advocate, with 70+ published papers and articles in the field. He is a co-founder and former Director of Research for the Alliance for the Treatment of Intractable Pain.

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Alan Edwards

Please take a look at Scott’s comment below. Is he insane? Absolutely not! He or myself and 500,000 others could take an entire dose of pain medication, in front of the entire world and more and no harm would occur.. tolerance, no. Except for the acetaminophen, his medication if codeine or hydrocodone or morphine is non toxic. Mobic or relafen if demonstrated in the same way, would be fatal in three ways. Norco is a weak medication. And so are the rest. Headache, yes. Death, yes when Scott nears 120 years of age. Intractable pain is killing many. I am fighting for my life when three years ago I could add to th GNP.
I was amazed Red had the knowledge and courage to address the benzodiazepine myth in paragraph 5. And there is no one effective dose or medication for CPP OR IPP PATIENTS.

peter jasz

Reading these replies has spawned the thought of a new (and VERY accurate) ‘Tag-line’:

* ‘ Opiate Deaths from Underdosing ‘,

^ SUICIDE: Pain Patients Horrific Agony ”

Additionally we hear/read a boat-load of (rightfully) angry folk who have been used/abused,
neglected, left-for-dead -abandoned.

I think it high-time to put our money where are mouths are and begin a (large) legal fund to locate, expose and charge all /any persons individually or collectively for the these Crimes
Against Humanity (Malfeasance, Patient Abandonment, Failing to Provide the Necessities of
Life, Assault, Torture, Attempted Murder/Second-Degree Murder … chose the legal semantics of choice … )

So many people suffering, so many people impacted. AND YET NOT ONE/organization or Fund-Raising campaign to fight (and win this) in a Court of Law ? WHY NOT ?

I urgently stress anyone who may have some experience in Crowd-Funding to begin/build
a legal fund to charge any/all those responsible for creating/causing unnecessary suffering and misery, the agony of those battling/enduring vicious intractable pain, the PTSD that results and for remaining family members who’ve lost a loved one from suicide; for no other reason than for desperately needed PAIN RELIEF. (Yes, pain can be so visceral, nasty, unrelenting -and deadly.).

Let’s begin collecting cash/funding for this most noble of fights. I will send the first $100.

Who else is in ?

peter jasz

For all medical professionals who have commented below, I am circulating a 3-author article for endorsement by physicians and others in medical practice, to be published after June 14th and targeted on legislative markups in Congress. The article amounts to a “minority report” contradicting the remaining errors in the HHS Pain Management Task Force and advocating for the implementation of AMA House of Delegates Resolution 235 as mandatory interim policy for all US healthcare agencies, DEA and DoJ. The most important phrase is this:

RESOLVED, that our AMA advocate that no entity should use
MME (morphine milligram equivalents) thresholds as anything
more than guidance, and physicians should not be subject to
professional discipline, loss of board certification, loss of clinical
privileges, criminal prosecution, civil liability, or other penalties
or practice limitations solely for prescribing opioids at a
quantitative level above the MME thresholds found in the CDC
Guideline for Prescribing Opioids.”

I invite you to send a note to lawhern@hotmail.com to receive a copy. Please help us pressure a major medical journal into publishing this paper after expedited review, as an editorial advocating for outright repeal of the CDC guidelines.

Pancreatitis/Chronic pancreatitis is one of the most painful conditions. I have treated with opioids at a high dose successfully and without incident. I was able to work 2 part time jobs and volunteer. Since being forced to drop to the 90mg. dose a day I spend my days at home, alone .unable to enjoy my involvement with various art associations in my community., I’ve not been able to paint due to increased pain and haven’t touched a brush, something that used to help me with my pain since the regulations went into effect. The harassment I’ve received whether from the pharmacy, dentist, and even my doctors is also a factor in my constant thoughts of ending my life.There is nowhere to go for relief. Who would want to live like this? . I think about ending my life every day. My condition has worsened and now have many more related conditions some due to inactivity from pain, some from progression of my disease. I’ve recently had a colonoscopy where my GI doctor was afraid to order too much anesthetic and I was forced to suffer through while he removed polyps all the while being under medicated and begging for him to stop throughout the procedure. I also had dental surgery and was allowed nothing for pain as I am at maximum dose already. I do not believe there is any evidence that the maximum amount allowed can be applied to all pain patients. We are not the same in our suffering. Please let our doctors treat us without any regulations from a government agency Please take my comments into consideration while considering actions regarding opioid regulations and chronic pain. I want to live.

William Sanborn

I am a Chronic Pain Patient with multiple types and causes of pain. I was injured spring 2000. In the beginning of 2002, it was decided I required surgical intervention. During the surgery, I contracted a severe MRSA infection which required 4 additional surgeries over a 5 month period and the hardware had to be removed to stop the MRSA. This caused my fusions to heal improperly. I was found 100% disabled in 2003. In 2010 I had a car accident which nearly killed me. I broke all ribs, lost my spleen, an adrenal gland, gallbladder, broke my back, punctured a lung, died 3 times during the life flight, fractured my pelvic ring, developed blood clots and DVT and now have P.T.S. and lost 3″ section of left ureter which I now have a nephrostomy tube to this day. In 2014 my medication was cut from a stable dosage of 250MMED down to 180MMED. I was mostly homebound but stable and ok. 4 months ago I was forced to begin titration of my medication. My quality of life is severely diminished. I am down to 150MMED and they want to continue titration. I am miserable! My quality of life is gone. I can not cook for myself or clean up. I am no longer able to attend church services. I can not imagine how the next step down is going to go. Please, stop this! We are all different and require different dosages for different biology, injury, and severity. There is A LOT more to my story – I barely skimmed the surface. Please, reverse your guidelines! My injuries are not repairable. Only opioid medications allow me to live a semi-independant life and that is being taken away, all I can do is sit here and suffer with no hope or relief – please do not take away my hope or my relief.

Dennis

I have been on opiate treatment for nearly 30 years. I am well above the 90MMQ number and really have been on the current dose for at least 6 years. I feel like I am treated like a criminal for being in pain. I have new MRI evidence of the issues in my back with issues from C1 to S1. I have taken my medication as prescribed for the entire time I have been taking opiates yet I have to be urine tested every time I see the doctor. My prescriptions appear on the massive HIPPA violation of a drug registry.I have to take a fairly high dose of Lyrica that causes me to have horrible memory issues. I am unable to get any dosage change because I’m lucky I’m not tapered down (a quote from my doctor’s PA). All this because a group of politicians who don’t understand the medical treatment of pain decided to do something about an overdose problem they know nothing about. Frankly the war on drugs is a major failure and should be abandoned as a waste of money. It has been pushed by politicians who again have no real knowledge of how to fix the problem. If you want to cut overdose deaths legalize it all. Then tax it, control it like alcohol, and regulate the purity and doses. The would enable the addicted person to know what they are taking and will end the deaths of heroin users who don’t know they are getting dosed with fentenyl instead. The modern prohibition is a failure just like the prohibition of alcohol. Stop punishing me for being in pain. Stop making medical issues into law enforcement issues. Let doctors treat their patients like they were trained to.

Beth Wootton

Any study which evaluates increased risks with opioids must compare those risks to those of inadequately treated chronic pain which is an impressive list indeed! To do otherwise would be like saying we shouldn’t take out an infected gall bladder because of the number of people who get post-surgical complications without looking at the risks of leaving an infected gall bladder in the body. This is basic science but rarely seems to be addressed in these types of “studies” perhaps because they are not scientifically based but looking for evidence to support a conclusion they desire.

Scott

What i dont understand is why dont they bring a guy like me in. I am at half my stableizing dose. I would like to take my medication in front of them then doulbe it, then double that. I would take all the meds within 1 hr. This way they can see overdose is next to impossible. Death certainly isnt a worry. Im sure after an hour, i could repeat the total dose. The only thig that will happen is my pain will go away for about 4-6 hours.these idiots only believe what they read or witness. Most of the literature they get is outdated and false. If they can actually see, maybe they wouldnt be so ignorant when it comes to pain relievers

Guido

Actually our own government’s data shows the lowest % of O.D. deaths in patients prescribed opaites is in those above 200 mg MME group, as its been attributed to slow upwards titration in the dosage of opaites over a period of time therefore increasing the patients tolerance. Again more propaganda in the ficticuous national prescription opaite epedemic.

Ronda Bruse

Yeah! Harm not! Physically mentally socially harming is flat out a bad practice period! How would anyone of them like the shoe on the other foot.. I know from living it 18 years it’s tremendously difficult beyond Words.. Pain management Care is a Must in are Country after all u might be next.. Let’s make good judgment Everyone’s life Matter! I don’t care who they are they deserve quality Care.. The Hippocratic oath is one practice Everyone should be living by..

Sugah

Thank you for being our voice.

Lynne Hall

JAN.
I agree with you. Except there is just as many Republicans that are suffering too.
I was on a high dose of opoids and functioning. During that time I donated my liver to my Aunt. The doctors committed on how perfect my liver was, even going so far as to asj me if I ever drank
I didn’t back then, now I do for pain. With a loaded 38 at the foot of my bed.
I am trying to hold out for the laws to change and I can be with my Grandchildren again.

I can’t lay in this bed forever and dream of what I had before the government took my doctors from me and my quaility of life. I am a Republican. But one night the pain may be too much and I will put that gun in my mouth.

A note for those who have commented thus far or may do so in the coming days. I “get” where many of you are coming from. I chat with others just like you every day in social media. So I would offer a suggestion to go beyond talking to ourselves toward something more effective. Look up a contact phone in Washington for your Senators and Representative. Call their DC office and ask to speak to the legislator’s healthcare aide. Most often you will be routed to voicemail, and that’s okay. If you get lucky, the aide might talk with you briefly.

==============

State your name and “I am a constituent”.

I’ve been a chronic pain patient for __ years, and I’m having horrible problems because of restrictions on opioid prescribing.

I want your boss to be aware that two advisory committees of the FDA are meeting on June 11th to talk about further restrictions on prescribing for people who need higher doses.

Such restrictions are both scientifically baseless and actively dangerous to people like me. My doctor is already trying to force me to taper opioids, despite recent clarifications from the CDC that such steps were not intended when they published opioid guidelines in 2016.

Please have your boss read this article: http://nationalpainreport.com/joint-meeting-of-two-fda-advisory-committees-are-the-blind-again-leading-the-blind-8839897.html

Finish your call with your contact phone number.

Be polite but firm.

==============

I will continue working to change the public conversation on opioids and chronic pain. Many others are also working the project on your behalf.

Barbara

I’m one of the lucky few that is on ( high dose ) Morphine, Hydrocodone, Xanax and Soma. That is 4 controlled substances. Gabapentin as well. My doctor whom is my GP/internist commented on how pleased she is that this regimine has been working very well for me.
My 8-9 pain level before adding these scripts has brought me down to a average of 2-3. I am also lucky that Walgreens has been a very cooperative in filling these meds every month. On the other hand my insurance company has given me some problems covering them.

Sharon

“First do no harm”…. well that would be a nice change. But instead let’s wage war on the millions of people living with chronic (that means a reallllly long time!) pain (that means it hurts alllllllllot!)! There are so many variations of chronic pain inducing diseases. Arthritis, lupus, cancer, chrohns… just to name a few. Take your pick and they all come with chronic pain for which there is no cure. Yes there seems to be an epidemic on our hands, but it’s not where you are looking. It is ILLEGAL drugs causing the crisis, it is ILLEGAL use of narcotics, it is NOT due to a chronic pain patient who is reliant of their pain medication and who has been for a long time. By severely limiting and/or stopping someone’s pain medicine who truly depends on it, is the exact opposite of the oath you all swore to uphold. Fight for the chronic pain patients. Stop treating us as if we are just drug seekers looking for a fix. Treat us as human beings. Imagine if one of your closest loved ones was a chronic pain patient. Imagine the only medication that keeps them from succumbing to the pain inducing depression is ripped from their hands. Imagine it’s them crying to you and asking you why everyone keeps playing games with them or acts like they are a drug addict. Imagine their pain. Do you like it? No? Then fix the REAL problem. And if you don’t have someone who suffers because of this “crisis”, consider yourself lucky. Too many people would gladly trade places with you. Now do the right thing. Help.

Michael Springer

I retired when I was diagnosed with MS. I also have an immune deficiency, kidney disease from taking OTC pain medications and a genetic disorder that weakens all of my connective tissue. I cannot take any of the OTC pain meds and I am non responsive to opiates. There is only one medication I can take but it has been classed as a Class II drug. This means that I am treated like a street junkie every month. The drug is Nucynta and it it does not cause kidney disease. This political ploy makes no sense, stigmatizes us and has led to vague and nonsensical reasons to deny a perfectly safe medication for those of us who experience chronic, intractable pain. Stop and think about what you are doing and stop this war on those of us who have endured decades of unrelenting pain.

Jan

I have been on high dose Opioids for 20 years, the highest you can be on which is Fentanyl. NOT ONLY HAS IT NOT HURT ME, OR MADE ME AN ADDICT—- IT HAS SAVED MY LIFE AND ALLOWED ME TO FUNCTION AND TAKE CARE OF MY 92 YEAR OLD MOTHER WITH DEMENTIA!!!!!

I have COMPLEX REGIONAL PAIN SYNDROME—– THE HIGHEST RATED PAIN ON THE MCGILL PAIN SCALE ABOVE AMPUTATION, CANCER AND CHILDBIRTH! It feels like someone has poured burning acid on my legs and feet. THE COCHRANE REPORT STATES THAT LESS THAN ONE HALF OF 1 PERCENT OF PEOPLE WITH MODERATE TO SEVERE PAIN EVER BECOME ADDICTED TO OPIOIDS PERIOD!!! I can attest to that and so can every pain patient. I have never experienced a craving for Opioids unlike my craving for nicotine.
UNTIL WE GET GOVERNMENT (AND ALL OF IT’S AGENCIES) OUT OF HEALTHCARE, ESP. THE DEA, CDC, FDA, ETC., NOTHING WILL CHANGE. THE GOVERNMENT HAS RUINED THE DOCTOR/PATIENT RELATIONSHIP! Trump and the Republicans swore that THEY would repeal Obamacare! Somehow that because repeal and REPLACE. We, the people, never signed up for that! We wanted it to go back to the insurance companies competing with each other to keep prices down LIKE THE CAPITALIST SOCIETY WE USED TO BE!

But, no, Paul Ryan, Trump and the rest of the swampy Republicans wanted to control Healthcare like the Democrats did with Obamacare! SO NOW WE ARE HITLER’S GERMANY, AND TRUMP IS THE FASCIST DICTATOR CALLING THE SHOTS ON HEALTHCARE BECAUSE THE REPUBLICANS HAVE BECOME THE SOCIALIST PARTY, WHILE THE DEMOCRATS ARE THE COMMUNIST PARTY, AND THERE’S A FINE LINE BETWEEN THE TWO. Under socialism, eventually some fascist dictator rises to the top and socialism becomes communism!

The President and Congress took Opioids away from the veterans first, and then everyone else because of money and power. They want us to commit SUICIDE so they can SAVE 1 TRILLION A YEAR IN HEALTHCARE, and by “culling the herd” they prevent the largest voting Bloc (boomers) FROM VOTING THEM OUT OF POWER .

Natalie beeck

Perfectly written. Thank you for your support of cpp’s.
This should never have been allowed to reach this point. Hoping the damage can be undone.
Taking away meds for chronic pain is inhumane.

Rich Reifsnyder

Margie sad to say you are 100% correct! 50 + million Intractable Pain Patients So Severly Underprescribed Pain Medication And The FDA is worried we will OD.Its the other side of the Scale “Underdosed”is what is happening to me,us Pain Patients.The FDA doesn’t look at Underdosed complications,high blood pressure,strokes,heart attacks,anxiety,and Suicides.One question I would like to know,Since 2012 How many Wounded Veterans And Intractable Pain Patients Committed Suicide from being Forcibly Tapered and Severly Underprescribed Pain Medication?Yea Marge I feel the love Force Taper me from 160mg/day to 60mg/day and worried I will OD,Not Likely, more like complications of Underdosing are 50 million plus Intractable Pain Patients being neglected proper Pain Management and Flipping the story of this Genicide to fit the agenda for the moment that is convenient until it’s Flipped again!Its Truly Disgusting,Intractable Pain Patients managing their pain responsibly for decades on the same dosage and have it forcibly decreased 50%to80% for fear of OD and let us suffer torturous pain for being hurt and disabled from a disease,accident,or born with Disabilities.I didn’t realize the Americans with Disabilities Act would mark me in a databank,remove my rights,and let my medical records be on display for all to see and be in a secret study only known by politicians! God Bless All Our Brothers And Sisters.

peter jasz

Audrey: And all others who may read -or worse believe- this oft-stated [edit]:

“…THERE ARE NO STUDIES ON THE EFFECTS OR EFFICACY OF LONG TERM HIGH DOSE OPIOID USE.”

WHAT ??? Opiates (and opiate use/misuse) has been studied mercilessly over the past 100-years -and used for thousands more.

And yet, there are those out there who buy-into this complete and utter [edit] about ‘No Long Term Studies’ ? What a joke.
As is the US governments regulatory agencies CDC/DEA -and pathetic psychopathic lobbyists (not to name names “Dr.” Anni Kolodny -and bed-fellows) that spew complete lies about opiates when in fact it’s an exceedingly safe and a very, very effective analgesic -ABSOLUTELY ESSENTIAL for intractable pain patients.

(If you doubt it, consider opiates side-effects compared to that of, say, Gabapentin. Here’s a heads-up: Opiate adverse side effects will be over in a blink of an eye -Gabapentin (the “miracle” nerve pill will have you flipping page-after-page of adverse (in fact real nasty) side effects. In fact, that absolute toxic killer of a pill (that no doubt. Dr. Colonoscopy/dny endorses) has recently made it onto one of the highest found substances in OD Death’s ! )

Doctor’s (physician’s) out there who know of, and have living proof of pain patients on very- high dose opiates (prescribed 300-1,000 MMED -and up to 2,000 MMED) who are doing great and managing to live out a semblance of a life because of it; for the past 10, 20, and 30+ years !
In fact, what SHOULD REALLY BE studied (with far greater concern and precision) is ‘Gabapentin (Gaga-pen-poison). I’m willing to forecast that it WILL get yanked off shelves as a result of its brutal toxicity. Hopefully (mercilessly) it will come sooner -rather than escalating OD deaths from this brutal poison -that physician’s gleefully ( and naively ) ‘highly’ recommend.

If you wish/want some truths, follow the incredibly dedicated work by Dr. Lawhern (and colleagues) /ATIP, Dr. Kline ….

Dave

I had just spoken to my state representative in Pennsylvania as they have opioid legislation in the state Senate now. He has not heard from a person with chronic pain. He had no idea the CDC and FDA had sent advisories not to cut chronic pain patients back or in worst case off of opioid pain medications. I found that disturbing. Has anyone actually emailed or visited their State reps to voice their concerns? I know from reading how life changing it has been for States that used the CDC guidelines to shape state laws. Please let your State reps hear your voice. Like he said if they don’t hear from us they don’t know.
Thank You.

Donna Akers

I was stable and had finally gotten my life back on higher opiate medication doses after suffering for almost a year with ruptured discs that no doctor would take seriously because I was looked at as a seeker until I could no longer control my bladder and finally an MRI was done and I was immediately scheduled for surgery. I had four surgeries in total with placement of a titanium plate and bone grafts in my cervical spine and the last surgery was done with placement of titanium rods and screws in my lumbar spine. The pain was relieved but never totally went away because of the damage done by no one willing to help me. The last and fourth surgery was performed by an incompetent neurosurgeon that eventually lost her medical license for practicing while under the influence of alcohol but not before leaving me with CRPS/RSD. I did physical therapy, counseling etc. I had taken so many OTC nsaids that my stomach is ruined and can no longer tolerate them, years of steroids that my body began to reject them and landed me in the hospital. I was finally referred to a pain management specialist who after much trial and error found the medications and dosages that for the first time in years gave me hope and allowed me to function physically for myself and my family. I have now been force tapered to a dosage that meets the 90mme and lucky to still have that but my quality of life has deteriorated severely. I’m isolated from much of my family and no longer invited to get togethers etc because I have had to decline so many times because of the high pain levels. I no longer have a social life and my relationship with my fiance of 15 years has suffered badly with him only coming around to help me with a few of the things I can no longer do for myself. I have always been a strong, active and independent person but I have been reduced to almost nothingness through no fault of my own because there’s a chain of people that doesn’t even know me or others like me dictating what’s best!

Rhonda

My life improved immensely with a long term (25 years) higher opioid regimen. From 87 pounds and bedridden to a healthy weight and working, volunteering and enjoying my life.

Mgelang

It is sad that the uneducated and ignorant physicians involved with the torture of chronic pain patients, think they have knowledge. They do not. The science shows us just the opposite! The people have to suffer and die because of someone’s opinion, and not science! Medicine is going downhill. It seems that physicians were dumb-ed down in the past few decades, as well!

Neldine Ludwigson

A high dose of narcotic pain meds made all the difference. A year ago I was visiting family 80 miles away and taking care of everything I needed to. Now, cut off by a (hopefully) scared doctor, I have been trapped at home hoping to be able to just make one meal a day for my (also) disabled husband. This is not right!

Jon Robertson

Wow, he’s right, I’ve never seen it put so well. These are valuable points that mainstream media outlets are just now starting to realize, hopefully this will change the narrative. I wonder if anyone has figured out a statistic that looks like this:
“For every person dealing with opioid use disorder there are ______ people who need opioids for chronic pain in order to function.”

Mark

Ive suffered from chronic pain for 25 years , the past 2 years I’m not able to get prescribed any pain med in a dose high enough to do any good , it just makes things worse , then I had to sign some paper at the pharmacy talking about mixing diazepam with pain meds can stop my breathing. Such a joke Ive taken both for all these years and never had a problem. I finally tapered off of the pain med my doctor was prescribing all of 2 mgs of hydromorphone 3 times a day. Now I use kratom and it seems to do the job.

Bravo, Red. Keep doing what you’re doing – millions of lives may depend on it. No pressure, right?

As for them wanting to look at findings, that’s great. However, they will have to have their medicine thrown back in their faces:

THERE ARE NO STUDIES ON THE EFFECTS OR EFFICACY OF LONG TERM HIGH DOSE OPIOID USE.

That being said, we’re here, we’ve been waiting – we are the studies, if only someone would look at us.

We can no longer beg for help it’s been going on for years & It’s just political same old blah blah blah. We’ve been put in the group of addicts not disabled people w/intractable pain. We’ve been experimented on w/ multiple surgeries still in pain. I believe they want us to die. They are just killing us Slowly by not letting us have any proper relief. They just flip the story & say oh but we care & we don’t want them to overdose but will let them suffer till they decide to take themselves out. That’s the true story. We are no different then the babies that they’re willing to kill up till birth. Babies didn’t do anything but be created. We didn’t do anything except work hard, autoimmune diseases, accidents, injuries, veterans going to war come back injured, you name it. All that’s okay that happened to us except they don’t want us to overdose but you can go ahead suffer for the rest of your life until you can’t take it anymore & decide to end it. Sure they really care what happens to us. We feel the love. Lol

Corrupt Government

The FDA needs to worry about all the carconegenics being contaminated in things like our blood pressure meds! Getting up to date on their factory inspections! Asking why they allow what they do in our food that has been banned in food in other countries for years!? You know things that are their jobs! Instead of being consumed by opiate pills they have left people to suffer in pain ask why they don’t mention deaths from cigarettes or alcohol being much higher! While they all ignore meth, heroin w/China fentanyl, cocaine is on a steady climb after their yet another war waged toward a substance. I trust my ex spouse more than this Government and they lied & cheated!

Stephen Ray

I like the picture as well as the rebuttal here. Listen to this man (Red Lawhern) he is speaking for hundreds of thousands. His research is backed by unarguable statistics. Lift your head from the sand please, regulatory officials and bodies.

For what is worse than Human Suffering?.

I believe benzodiazapines & opioid go hand in hand. As in being prescribed bother 16 yrs.taking as prescribed ,I am fine. As my recent bloodwork shows. Pain causes me extreme anxiety. I personally get very ” mean”. Together they “help” my breathing.When you go into a anxiety panic you have no idea what its like not being able to breath!! Then comes the pain. Which for me gives me anxiety attacks.The pain gets excruciating I start crying, here comEs attack. I have been tapered?d down 1 pill. But how I need that 1 pill. CT set for next week back is so bad. Im not old. 60. Too young to feel like I want to die after standing 10minutes doing dishes!! I need my Pioids. I take exactly how Im told. My Diazepam also. Never even came close to an overdose or adverse reaction! Give us our meds. It didn’t start with us pain patients ,won’t end with us. Nixon started the war on drugs in 1971. I was 12. !! I kinda remember. Hows that going for you ,U.S. Government???

Rhea Bullock

County medical examiners quite often are funeral directors who have no medical expertise. Just like Kolodny. No medical expertise.

Susan

Finally, I hear reason for the combination of opioid and benzodiazepines. This pairing of drug has been used for years, because it stabilizes the emotions, enabling the opiods to work faster. If chronic pain patient’s can remain calm and relaxed the lower dose opioid will work. Placing a patient on higher doses of greater strength can lead to needing more stronger opioids sooner rather than later.

Alan Edwards

I have read what i think was the HHS task force report due on Wednesday. It was disheartening. Andrew Kolodny will be hapoy. SUBOXONE- his favorite and the disastrous 2016 CDC guideline were mentioned. The attack on Chronic and Intractable pain continues at the Federal level. I saw no concessions. Only popular politics aimed at the healthy portion of our population. Addicts fear not, you are taken care of with antagonists and Addiction centers. CPPs and IPPs get cryotherapy for arthritis and neuropathy. Cancer patients, palliative care patients, and hospice patients will receive care if in severe pain. Nothing new.

Thank you Red for your huge efforts and courage, giving we who can no longer stand or speak without faltering a VOICE. You have not failed. The federal government, unless a change of conscience happens soon, has thrown us under a train. Do not be deceived. I have read propaganda before. The HHS report was long. I did not see anything comparable to Terri Lewis’ data compilation or her recommendation. I read the link given by US Pain Report which directed to HHS.

Ali

I am attempting to read this article with an open understanding of the writers explanation.
As a retired RN,CNN I find an understanding of pain medication is quantified by patients metabolic rate and many other variables. One size doesn’t fit all.
Pain Management is a multifacet decision designed by an MD.
Stopping Opoids from compliant intracable chronic pain patients requires a study to validate the stopping of Opoids and the side effects.
Long term use also needs study valadation before placed in guidelines with no proof on Compliant Intracable Chronic Pain Patient’s.
Small population is a misnomer in Compliant Intracable Chronic Pain Patient’s taking Opoids. This population has been minamalized by government agencies due to unreliable studies. This population has been placed in drug addiction studies. No where have I seen any MD surveyed as to intracable chronic pain patients. MD’s have been profiled, bullied, and ignored in this arena and the negligent duediligence guidelines failure placed on them.
1. Compliant Intracable Chronic Pain Patient’s stopping Opoids have side effects not withdrawl as drug addicts.
2. COMPLIANT Intractable Chronic Pain Patient’s long term Opoids use is a proactive measure to give them quality and quantity of a productive life.
3. COMPLIANT Intractable Chronic Pain Patient’s want to be proactive about their pain medication to appropriately continue low dosages increase not to stop the pain but at a threshold tolerable to focus on living life to there fullest.
COMPLIANT Intracable Chronic Pain patients MUST be removed from inclusion into drug addicts studies. This was a erroneous travisty of injustice to the COMPLIANT Intracable Chronic Pain patients. The vocabulary needs changed as a COMPLIANT Intracable Chronic Pain patient following guidelines appropriately per there physician MD is not a drug addict with withdrawl.

Lori A. Frushon

I’m a 59yo female,chronic pain patient who has been treated with opioids for degenerative spinal disease, scoliosis & osteoarthritis of the spine for close to 2 decades. I’ve had 7 surgeries on my spine & neck, so I’ve been administered varying degrees of narcotics for the treatment of these conditions. I also have depression due to the restricted nature of my health and suffer from severe IBS, due to high anxiety levels as a result from living with high levels of pain and overall poor quality of life.
Over a year ago my pain management facility required that I stop taking the only medicine that EVER helped with relief from IBS. It was a combo drug called Librax … a mix of an anti-spasmatic for the intestines and a small amount of Librium (a benzodiazepine). This taper was required due to new Federal regulations restricting benzos and opiates. I weaned myself off of this extremely helpful medication (it also help with my frequent panic attacks and asthmatic induced anxiety episodes). Also, just prior and again, sometime just after, my opiates were also cut back twice to new Federal levels requiring the pain management specialists to treat many of their patients in a one-size-fits-all manner of capping narcotic treatment regardless of their very individualized conditions. In the last 15months my quality of life has suffered tremendously. My Spinal, including Cervical and coupled with Digestive pain levels have contributed to almost Daily incidences of hopelessness and isolation. I have almost no quality of life. This has lead to a divorce from my husband of 14 years and loss of quality in all my relationships with family and friends who find it challenging, as well as I do in retaining these relationships due to the very poor quality of my life.
I was told that the suicide rate of patients similar to me, has been on the rise. I have no argument in believing this because there is little relief and even less emotional support.

Ellen

Well said Oddly while I am trying to get my Medadvantage plan to cover breakthrough pain meds in suppositories that I have gotten since 1999 and was only needing 2 a day now with chronic pain but through three appeals they denied and said Medicare will not cover suppositories basically waste of time part D law does not cover
Yet we told the outside appeal I have chronic nausea and vomiting due to Sinemet I take causing severe headaches always nausea and vomiting because the usual anti nausea meds cause my dystonia/Parkinsonism an atypical form Dopamine Responsive Dystonia to worsen because it blocks dopamine and Sinemet stimulates peripheral dopamine hence headaches and vomiting why take carbidopa with it to try get more central useful I just trying help understand why suppositories was
Very importance to my suffering Now I have to take more breakthrough daily because I do not absorb oral breakthrough medicines
Just a note I take Valium as a muscle
Medication to help with severe rigidity
Baclophen did not work I go in now back to twice week for iv infusions of medicines to help both freezing episodes and headaches and vomiting
Lastly what happened to the draft of pain guidelines where I believe in addition to professionals over 6000 chronic pain patients contributed now we have FDA and Oregan going backwards They were well written the draft esp page 29 talking opioid prescribing and damage lack pain control or two small opioid pain med dosing May cause.

Thomas Wayne Kidd

Thank you very much for your work on our behalf..

Janna Crickmore

Your last paragraph. My “pain” doc refuses to prescribe a minimal amount of Vicodin if I was taking clonazepam, which I need to sleep because of restless leg syndrome. I’ve taken it for more than 20 years and now all of a sudden it depresses respiration. I’m showing this to my PA at my next appt

Alice Carroll

This is in direct relationship to the 60 Minutes story of February 24, 2019, Did the FDA Ignite the Opioid Epidemic? On this show a former drug manufacturer sights a mid-1990’s rule change by the FDA allowing opioids to be prescribed for long-term chronic pain. Now the agenda of these lawsuit seekers is to show that opioids are NOT effective long term, that the FDA was manipulated by the pharmaceutical companies and that the FDA and drug companies should be sued. They want a massive payout to rival the Tobacco Settlement. That is what this is all about.

They say there were no studies done on opioids for long-term chronic pain. It’s hard because patients quit the studies when they get no pain relief! Remember Vioxx and Celebrex? Both approved by the FDA for long-term chronic pain. They ruined patients stomachs and livers and caused numerous deaths, my father was one. Opioids do not.

60 Minutes and others fail to mention that overdoses are NOT from long-term chronic pain patients who use their medication properly. They do NOT need increased dosages for pain relief. Will anyone ever publicize those who benefit from opioids for chronic pain?

What about long-term chronic pain patients being taken off opioids by doctors too scared to prescribe, dumping them with no referrals. Patients who aren’t able to find new doctors to prescribe pain medication are left to fend for themselves in horrible anxiety and pain. They are turning to black market drugs or committing suicide. Is that what the FDA wants?

Randy

This makes so much sense. It’s no wonder the idiots that push the opoid crisis is so screwed up. The older citizens must now live in constant pain while the addicts still overdose on ileagle drugs and get treatment for their addictions. What is the recidivism of treated addicts???? How many painfully deaths have been caused by not getting pain meds?

Laurie

They hit the wrong nail on this with too many hammers and now, we’re all paying the price.
I’m seeing my prescriber today and am anxious he’s going to pull something on my prescription.
He’s kinda sadistic. Maybe he doesn’t like me, I don’t know.
We’ll see…

Zookeeper

Thank you, Dr Lawhern,
for standing with intractable pain patients and the TRUTH. Profit driven entities that seek to make public policy from private greed is unacceptable.
I’m a 52-year old mother who has had her health and ability decimated by the inaccessibility of opioids, am being verbally abused and railroaded off my life giving pain medicines. I’ve maintained myself DOSE CONSTANT on methadone WITHOUT “multiple.modalities”. I have been harmed by being pressured into steroidal injections with zero data to suggest efficicacious outcomes. I was diagnosed with bilateral cataracts by the age of 40 and more than 1,600 joint replacements occur DAILY in the US due to joint destruction from steroids. Another procedure I was harmed by was “nerve ablation”; it was performed unnecessarily. The protocol called for at least 50% improvement in symptoms prior to moving forward with ablation. I did NOT improve at all, in fact, I considered the initial injection to have increased my symptoms. No matter, the Dr went ahead with the procedure falsifying the outcome as more than 50% improvement just so he could benefit financially from performing yet another procedure at the doctor owned and operated facility he co-owned.
Profit driven medicine results in increased patient harms, which is the entire reason PROP submitted its “2016 Guidelines” to the CDC.
It is time for the immediate expungement of the profit seeking patient killing 2016 CDC Guidelines before one more intractable pain patient dies opioid DISUSE from pain suicide.
It could be claimed that third-world countries “don’t know better” but the first-world country, that is the United States, is currently complicit in human torture, human medical experimentation and violation of basic human rights, under the UN Agreement, allowing 100% preventable,100% treatable pain to claim lives daily.
It cannot, will not continue.

Debbie Nickels Heck, MD

Excellent! I couldn’t add anything to it myself. It debunks the mythology the govt and those with personal private agendas have been spewing these past several years with facts. Whether anyone with clout will be intelligent enough to understand what is said is another story. The Governor of Ohio hasn’t proven to be one in that category given the latest resistive laws he recently put into effect. Oregon is only partially listening as their legislators are still practicing medicine without a license. BUT I’ll still have hope. The meeting’s on my birthday!

Gail Honadle

Not only are the Blind leading the Blind, they are Ignorant of facts, knowledge of rare Painful diseases. And are blinded by Pharma’s promotion of certain drugs that have nothing to offer a Intractable Pain Patient. They lack Basic Pharmaceutical training. They are being used Off Label to treat diseases they were not made for. Plaquenil is a Anti-Malaria drug that damages the Kidneys, but is being prescribed by Rheumatologist’s to treat Lupus which destroys Organs as it Progresses.

Never mind the patient is already in Lung, Liver and Kidney Failure and having Pain Seizures, BP hitting 200/110 sitting in the Lung Doctors office, said doctor sends patient down to the ER where all normal protocol in treating a Stage 4 Blood Pressure Crisis are totally ignore. But we do a “Medicare” 24 hr hold. Not once calling a Cardiologist or administering 1 round of BP meds to bring the Stage 4 BP Crisis down. This is the current state of Medical care, has set us back to the 1800’s where patients are DYING from lack of quality medical care. As of today patient is still waiting on a Cardio appointment that the Primary doctor set up. She could be dead before that appointment of a Heart Attack brought on by Uncontrolled Pain.

Keir Farnum

The only thing missing was the risks associated with lower dosages; i.e., the potential harms of under-treating a patient’s pain and the risks of depression and possibly suicide. These folks only ever think in terms of high dosages and the risk of overdose; they need to also start thinking of the ramifications of under treatment as well and understand that there are more than one side to a coin.

Thanks Red; you rock!

Karen C.

Done and done.

Gary Raymond

Too many cooks in the kitchen. The CDC is the least effective and most evasive group, so let’s abolish the CDC. We need meetings for that. To avoid the meetings, let’s invent guidelines.

Mike

On morphine starting w/ 100mg ER twice daily, then fentanyl patches 50 mcg per 3 days+ morphine 30mg IR. Now, 100 mcg fentanyl patches and 30 mg morphine IR. Not enough! I’m in mad pain!