People in Pain Petition the FDA:  Cease, Halt, and Refocus!

People in Pain Petition the FDA: Cease, Halt, and Refocus!

By Richard A Lawhern, Ph.D.

On May 25, 2016, National Pain Report ran an opinion article titled “Stop The War On Chronic Pain Patients” [Link: http://nationalpainreport.com/opinion-stop-the-war-on-chronic-pain-patients-8830555.html].  The CDC had just released its draconian and scientifically unsupported opioid prescription “guidelines”.  In the months since, controversies have widened over the CDC’s secretive and biased editorial process, the conflations of their research and the many omissions and errors in their conclusions.

Richard A Lawhern, Ph.D.

The NPR op ed  and the 76 comments it generated have proven to be prophetic.  Despite ample evidence that America’s so-called “opioid epidemic” is caused by street drugs (some of them diverted prescription drugs)  rather than by prescriptions made by doctors to chronic pain patients, CDC has continued to double-down on its errors.  They have thus far refused even to consider withdrawing the guidelines for a major and very needed rewrite.  The US Veterans Administration has compounded this mess by publishing practice standards which declare opioid analgesics don’t work for chronic pain and shouldn’t be prescribed —  ignoring the long record of effectiveness reported by patients, as well as hundreds of suicides which have already resulted from VA withdrawal of pain care from Veterans.

Among many other developments in this war on pain patients, the US Food and Drug Administration (FDA) has published a proposed “Risk Evaluation and Mitigation Strategy”, laying out proposals for FDA participation in combating addiction and the opioid crisis.  Comments on this REMS can be entered until March 16th, starting from [link:  https://www.federalregister.gov/documents/2017/12/13/2017-26785/opioid-policy-steering-committee-prescribing-intervention-exploring-a-strategy-for-implementation]

On Tuesday January 30, 2018,  the FDA will hold public hearings on eight questions related to their REMS.  I will speak second among a long list of contributors.   My presentation is titled “An Appeal to the FDA:  Cease, Halt and Refocus”.  The major take-away points are these:

* FDA is chasing the wrong opioid crisis

* The FDA REMS will harm many, help almost none

* FDA should stand down from further regulation

–  Take a breath before doing even more harm

–  Focus on recall and revision of the CDC opioid guidelines

**   Politically biased against opioid therapy

**   Weak evidence for most recommendations

**   Dangerously incomplete on opioid metabolism

The FDA hearings will be streamed in real time, beginning at 0830 Eastern time, Tuesday January 30.  For information see

Scroll down to “Webcast” and click on the  link to “webcast” in the description.
Watch the livestream here: https://collaboration.fda.gov/opsc

You’ll be hearing from me again after the hearings are concluded.  Wish me luck.

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Paul

I have been with chronic pain for 10 years now, and the only thing that I see from it is that I have been lied to. It is acceptable to hurt people to cause them to end their lives. Otherwise we would not have people dying in such great numbers since the medications have been cut back. Also if there were any real concern about the safety of the medications. People would be prescribed things that are longer acting so that there would be no addiction. That is they would feel that they are enough out of pain so that they do not need help, or just want to die because it is so bad.

I am not condoning it, but I can understand why some pain patients kill their doctor, they are taking their ability to be able to function away from them. This would not be happening if doctors that prescribe such medications were chronic pain patents themselves. They would know what to look for and know the difference between someone looking to check out of reality and someone that is suffering and needs help.

It is very said that we live in a world where it is acceptable to hurt and kill others, just as sociopaths so for fun. However, what I am saying is that we have too many that are sociopaths in positions of authority mainly because they want people to suffer. This is why we have a bunch of people that are more concerned about the possibility of addiction than suicide or homicide when they or a family member is suffering.

Chronic pain is not the only thing, but it is the large number of doctors that plainly refuse to look further when someone says that they are unable to work due to injuries because of TBI and they refuse to even do an MRI to see what is going on when they are seeing things that they know are not there, and it is not due to drugs. Or they are hearing things or not hearing normally, as the words do not form correctly in their mind.

I know about this because it has happened to me and I have read about the murder of doctors when the spouse is cut off of her meds and the husband kills the doctor, forgot what paper I read that one in. He is locked up now, but it was preventable. Some think that the FDA is there to help save lives, at one time that was true. However for a number of years now they have been approving new medications after they are paid their fees and get needed paperwork so they can make more billions off of another drug that has not been fully tested for safety.

Greg Pendry

I have been to 3 different doctors for pain meds since 2011 for my degenerative disc disease , spinal stenosis and a syrinx on my spinal cord .. I started recieving my meds from a doctor in Florida and i am now living in Tennessee. The doctor that took over my pain treatment in Tennessee told me that he could no longer treat my back pain due to FDA regulations. He said he could only write pain med prescriptions for his cancer patients. So , i was then refered to a pain clinic. I am still currently recieving 100% of my prescribed pain medications for my back problems which is 90 per month of hydrocodone 10/325 .. 3 x per day ( Its 06/21/2018 ). I predict this will end within the next few months though because the pain clinic keeps trying to push spinal injections on me which i keep turning down each month. I asked them if that was eventually going to be my only alternative and they said yes because they usually only prescribe pills as a last resort. Can that really be the only option they give me ? To stick needles in my spine ? I know there are many of you that are way worse off than i on the pain level and have had your meds cut tremendously or completely and i am so sorry .. I pray that somehow this gets better and the FDA reverses these regulations so we can all live pain free. Keep posting , keep petitioning , make your voices heard …. WHAT DO WE DO WHEN WE ARE IN PAIN ? WE SCREAM !!!!

Theresa

Help me my medications have been reduced because my doctored afraid the DEA will take his license away ! What can I do nothing !! I’m was hurt 10 years ago overcame 15 surgeries and no help can I file a lawsuit ? We all need our meds that are chronic pain sufferers !! Please tell me what to do and I’ll do it for everyone that’s suffering like me

K Baker

I went from having a productive, good life to bankrupt both financially and emotionally. Forced to chase therapies that have been inaffective and take handfuls of pills that have never worked and still don’t. I’ve been a responsible patient and have never broke the rules. I now get about 30% of the pain medication needed to keep me functioning physically. This is shameful and irresponsible of our government and only good for the illegal drug trade. Drug addicted people will not stop overdosing because chronic pain suffers are cut off medication.

Martha Arntson

Dr Lawhorn, I saw you today on the live feed from the HHS meeting on pain management and listened to you speak. You have been one of the few that has actually made a difference since I was involved in pain management from around 2013 to 2016 when I was abruptly fired for no reason from my P.M. clinic. I’ve posted an abundance of comments on this site and others. Finally the government it taking a new look at what the CDC and the government has done to pain management patients with their guidelines that are absolutely ridiculous. This was the Obama era when this started, I hope our President Mr. Donald Trump will take note of today’s meeting as well as try to redact what is now known to us as pain patients as “drug seekers”. We are not. We are regular people with pain that is now under managed or not managed at all anymore as physicians are reluctant to prescribe opioids for us. And, it is not just about opiates it is about the deprivation of carenin our country for people who need opiates to live somewhat of a normal life. Thank you for your input today. I will look forward to tomorrow’s live event! Thank you for speaking up for us! Martha arntson

Pam

I managed to reduce my pain levels with physical therapy, months and months of it. The PT is palliative as my spine, knee shoulder issues are degenerative and not fixable. So Medicare is paying thousands and thousands of dollars for PT rather than a prescription for generic hydrocodone which would have probably shortened the time I spend in PT and cost much much less.

Kris Aaron

Instead of turning on each other, pain patients and addicts need to stand together and DEMAND the government allow trained physicians to provide the opiates and help they desperately need. Allowing single-agenda special interest groups like PROP and the DEA to have a voice in the issue leads to endless suffering – and won’t save a single human life!

Kris Aaron

The current “opioid crisis/epidemic” was created by ignorant government agencies determined to do something… ANYTHING!!! to make it appear as if they were earning their funding.
Their kneejerk responses are echos of Harry Anslinger’s misguided assault on opioid users beginning back in the 1930s. Anslinger was a federal Prohibition agent who enjoyed feeding at the government trough and was horrified when the 21st Amendment put an end to his employment. He cooked up an anti-drug campaign with J. Edgar Hoover that secured his job and those of his drug warriors, denying opiates to not only addicts but pain patients, as well.
Thanks to PROP propaganda, the ghost of ol’ Harry is back again and wreaking havoc on sufferers with every known physical malady.
Portugal’s legalization of all narcotics use has proven that addicts and pain patients are NOT evil monsters looking for a “high” but people suffering with very real mental and physical pain who are turning to the only sure way they know of dealing with their agony.
Prohibition is not and has never been the answer. Once again, our country is succumbing to the mindset that insists Prohibition is the solution to the wrong question!
Shaming, degrading and prohibiting doesn’t work and never has. Legal prescriptions aren’t killing Americans; contaminated opiates and illegally used drugs are killing us! The fact that the CDC has to distort and misreport statistics to make their argument is proof that their “recommendations” are false.
The fact that Andrew Kolodny and PROP ignore the pleas of thousands of chronic pain patients who depend on opioids to control their suffering is clear indication that they do NOT have our best interests at heart.
Harry Anslinger was driven by racism, hatred and fear. He destroyed the lives of hundreds of thousands of people in his mindless quest to remove opiates from the earth. If we indulge in wrongly blaming addicts for the loss of our pain medication we’re falling into the same flawed mindset. Addicts (not casual recreational users) are trying to escape pain just like we are. Their minds are badly damaged, just like our bodies.
Legalizing just the use of narcotics would save America more than $41 billion annually. Taxing those same drugs would bring in another $46 billion. Why are we throwing those billions away on a useless quest begun by a misguided racist who was afraid of losing his job?

Susan

The CHRONIC PAIN CRISIS is undeniably the most stupid, ignorant ascinine set of events which has happened in Medicine to date.

Addicts, illicit users, and CPPs have all been lumped into one. Frankly, I’m one of millions of intractable cpp’s sick of hearing about the groups who had EVERYTHING to do with creating the PAIN CRISIS.. Cpp’s need to have their pain managed by whatever is the best, legal, most appropriate method to manage THEIR pain. Cpp’s are, have been punished and scapegoated by other groups and we did not cause the problem. I pray daily the 8-12 m cpp’s who require opiates will not continue to be penalized, nor their pain pract. be penalized by Feds./Regs. This has been and is a travesty of epic proportions. Deplorable. Criminal. Abandon the CPP? Yep, that’s just the problem. Wrong. Wrong. Wrong.

Michael Blaisus

I have osteonecrosis, crps following surgery to replace r. Shoulder, collapsed lumbar spine, & FBSS (failed back surgery syndrome. One year ago I could easily walk 1 mile. Since then meds cut by 75% and more cuts threatened. Today I can’t walk more than 2 blocks. Is this how CDC and FDA are “helping” me??

Marty

Please go this link and sign the petition:

https://petitions.whitehouse.gov/petition/dont-punish-pain-victims-amend-cdc-90-mme-guidelines-reduce-dea-pressure-doctors-prosecute-illegal-drugs

We need 100,000 signatures before it will even be considered…..Once you sign it , you need to go to your email and confirm your signature!
Thanks ….we really need to stick together

H flock

I believe President Trump should look at this part of the swamp and lies fed by the DEA. Many of your supporters are older and pain patients and you are leaving them to the lions. Please read and look and the research by others than government. Have some pity on the ones that are hurt by these crazy laws and don’t abuse their medications. Many of us are on fixed incomes and can only afford one doctor a month, so we put aside regular checkups. These overly written and enforced laws are only hurting the ones in need and the ones abusing keep abusing.

Cindy J Colbert-Hock

Kris Aaron, thank you for the contact you made regarding a class action law suit. I have been trying to think on how to go about this possible avenue. I joined my State People in Pain Facebook page for Arizona. 50 states have these FB groups. In the group I joined they have different sub groups. One of which is looking into the legalities of what the FDA/CDC are doing in their misguided attempts that in the end harm Chronic Pain Patients. I have asked to be a part of that group. You all probably know about about the state Facebook groups. If you do not, they are not hard to find within the FB platform. You do ask permission to join then within a day or two you are accepted and can see what they are doing and what they need from all of us. I believe they were the ones who organized the 4/7/18 rallies at the different state capitals. I think the more organized we get the attendance at these rallies will increase.

In addition the many last minute comments to the Steering Committee include many from groups whose members number in the thousands, tens of thousands! I am hopeful these 502 comments even though they are not ten thousand still have the same effect as the comments from these companies/associations etc do number in the tens of thousands.

Marty

Kris. Good for you!!! This is what we have been looking for in hopes that it will make someone take notice that the government in playing with people’s lives!! Thanks, I’ll pray this pans out…..

Kris Aaron

I have a friend who was legal counsel for a mid-size non-profit organization until her retirement. I just sent her a summary of our issues; she may have some ideas about how we might find an attorney or legal firm to initiate a class action lawsuit against the government or government entities who have been involved in restricting opioid prescriptions to chronic pain patients. I’ll post her response on this site.

For anyone still following this thread, be aware that the Alliance for the Treatment of Intractable Pain has published a wide-ranging White Paper titled “Prescription Opioids and Chronic Pain”. The paper is carefully researched and referenced to over 45 sources in medical literature and popular media. It debunks the entire rationale underlying the CDC Guidelines on prescription of opioids in adult non-chronic pain.

The paper was downloaded nearly 4000 times in the first three days of its availability. Feel free to read it, print it out, and share it with your doctor and your legislators:

https://atipusa.org/2018/04/02/atip-white-paper-on-prescription-opioids-and-chronic-pain/

Jamie

I am a chronic pain patient. My pain has been successfully managed with hydrocodone for the last 5 years. I have never abused my medication and have always taken as prescribed. My doctor just told me that as of July 1st she cannot prescribe pain medication for her chronic pain patients due to the new law going in to effect. She said she can send me to a pain clinic after I get xrays/ Mri to reevaluate my condition. I feel like this is the beginning of an almost hopeless situation. What is this ? Communism, socialism ? What next ? Ban automobiles due to traffic deaths, cigarettes, skydiving, mountain climbing ? I think there definitely needs to be a class action lawsuit against the FDA and all who are involved in the new laws/ regulations. Now how do we get this going ? Ideas please….

Marty

I think Laurey is speaking the unfortunate truth!

Rhonda

I see a pain management doctor and I have for years. I am disable, I take my medication as should I never ask for refills o never ask for higher dose. I have already been lowered twice because of the government. I am not smoker or drinker, but I can not live on pain i can’t and I want. You guys as the government think by taking our meds away and lowering the amount what you think should help out pain. You will have more people dying by doing illegal drugs. Your not solving anything your making it worst. My pain meds is the only thing that helps me bare my pain to get through the Days. It’s America, we should have free will and your not stoping the the ones that abuse drugs that’s on them not on me or those that want to
Live a pain free life as best as they can to enjoy life as much as they can. I can’t take any more pain, and I am terrified of going through the pain I know that I will go through and I am afraid I want be able to handle it and end up on something worst to just live without pain you cant make someone be responable and you can stop those that want to do illegal drugs there’s no way. You are hurting ingeneral good people that take their meds as prescribed and should not be limited to what you think we should have. You should be thankful that your not one of the ones that live in pain daily and that’s disabled. Stop taking our rights away. Not all pain doctors are crooks not all pain doctors are heartless I know my pain doctor is not one that gives out medication to those that don’t Need it, leave m a lone before you end up with more deaths on your conscience because people cannot be in pain and they will not live in pain. you will help more people in pain turn to illegal drugs and alcohol on top of it if you keep taking our rights away as human beings. Until you walk a mile in someone shoes don’t judge don’t judge their pain And stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start by taking our doctors rights away and our rights away and what medicines we can have and how many pills we can take daily because y’all think y’all can control the illegal drugs on the street, I don’t know if you’ll even have a conscience or you wouldn’t be doing this. and stop thinking you know what’s best because I do not know what is best for us and you have no idea what you are about to start taking our pain management.

Laurey

Denying adequate pain control to legitimate pain patients is creating another population of street drug users. As a matter of fact, they tell me they are treated with more respect from the street drug dealer than by their own pharmacist.

Kris Aaron

Denying opiates to chronic pain patients because someone’s kid stole their relative’s oxy and overdosed on it is no different than taking away my car because the idiot neighbor stole his grandmother’s Ford, crashed it and died.
Yes, opiates CAN kill when used irresponsibly. So can alcohol, cigarettes, cars, motorcycles and guns. ESPECIALLY guns!!
Yet nobody is talking about taking those items (except for semi-auto military weapons) from responsible adults.
Recent opiate restrictions are so illogical that it’s become obvious there is significant profit to be made from it. Doesn’t take much imagination to figure out who is getting wealthy off our suffering: Start with the “rehab” clinics and their frequent flyer programs, consider investments in private prisons, take a look at the costly military toys handed over to local police…

Deborah Withrow RN

Stop this insanity, pain patients are being attacked wrongfully
This is not solving the opioid crisis. Every pain patient I took care of as an RN took their medications responsibly and kept them away from their children. The FDA needs to stop. We need to refocus what this is all about, why harm chronic pain patients and intractable pain patients quality of life. I my self took opioids for years for my back , and I stayed on the same dosage notco 10 mg every four hours. The reason I went off opioids after failed back surgery my primary dropped it to tramadol and this did not help my adhesive arachnoiditis. I started using a natural medicine that works for me. Please cease halt and refocus! If not I believe this will change people’s quality of life forever!

A follow-up note for all who have subscribed to this article: the FDA Opioid Policy Steering Group docket for exploring implementation of the FDA REMS will close on March 16. So far, 316 comments have been received as of March 9.

I am hopeful that we can generate another thousand comments in the remaining week, in much the manner that occurred with the Centers for Medicare and Medicaid Services. Particularly gratifying in the CMS docket was a joint comment by nearly 200 medical professionals in clinical practice. These professionals, led by Stefan Kertesz, utterly destroyed the fraudulent and arbitrary reasoning behind the CMS rule change proposal. If CMS chooses to proceed with their rule changes, it can only be because decision makers have been bribed by Insurance company money

The federal docket for REMS comments is provided above. Please “push” this article to friends who care about your welfare and medical professionals willing to overcome their own cowardice and speak out publicly.

Susan Bahr

02/24/18 and unfortunately this is the first time I am seeing this.Thank you Dr. Lawhern for speaking out. I have been addressing this with my representatives, from the President on down, for about a year and have not received even one reply. The facts of the matter are never in the main stream media. What will it take, very frustrating and scary.

David Washburn

There are currently 236 comments submitted. I just submitted my comment, which was too long to add here for some reason. Everyone should submit a comment, as well as, write to their state/federal legislators, governors, etc. if you are wanting to see them make a change. Certainly there will be no change if very few voices are heard!

And…THANK YOU Dr. Lawhern for all you have done!!!

Cindy Colbert-Hock

As of today the link Red provided for us to make comments to the FDC/DEA REMS has 212 comments. If anyone here has not commented please do. Just follow that particular link Red provided. The link is the second one down in his article here.

Marla Mitchell

People with chronic pain need their pain medicine so they can function through every day life! Thank you for fighting for us! God bless you with your fight!

Cindy J Colbert-Hock

Your Comment Submitted on Regulations.gov (ID: DEA-2016-0003-0003)
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Your comment may be viewable on Regulations.gov once the agency has reviewed it. This process is dependent on agency public submission policies/procedures and processing times. Use your tracking number to find out the status of your comment.

Agency: Drug Enforcement Administration (DEA)
Document Type: Nonrulemaking
Title: Schedules of Controlled Substances: Placement of MAB-CHMINACA into Schedule I
Document ID: DEA-2016-0003-0003

Red Lawhern, please see above receipt I received regarding my comment to the DEA. I have a feeling I may have posted to the wrong area. Can anyone tell me if I did it right or wrong. This appears to be specifically pertaining to this MAB-CHMINACA which I believe has to due with the scheduling of bath salts and the like to sch.1. please advise. I do not want to miss the 3/16/18 cutoff date. Thank you in advance for your help.
Cindy

Dijon Evans

You have the facts. YOU HAVE HONEST TESTIMONIES, BACKED BY THOUSANDS OF YEARS, AND GENERATION AFTER GENERATION AFTER GENERATIONS OF PEOPLE WITH NO DEATHS OF ANY KIND, DUE ONLY ☆☆☆ ONLY ☆☆☆ DUE TO THIS DIETARY SUPPLEMENT. A product from nature. Meant to be used as a dietary supplement and at no monetary cost to the people using it as such. Given to us by nature. A natural product not meant for monetary gain, not meant to be kept from the poor or ill. Not to be synthesized and kept from the people who choose to live their lives through nature, by natural herbs, vegetables, or animals. It is our body. Owned by us. We are a free society, correct!? Isn’t that Why so many have paid the ultimate price for, or continue to pay on a daily basis? Paying with their bodies to protect OUR FREEDOM. OR is it just the opium fields.. the opioid products that you ” are protecting ” for the health, welfare any imminent threat of danger. Preventing opioid addiction. I understand now, what I never wanted to believe before. But you’ve shoved it down my throat in the last 7 months … We are at WAR, MILLIONS OF DEATHS .. to protect the OPIUM FIELDS, the OIL FIELDS the profit is NOT for our freedom. Not our Protection. Not our liberties and surely NOT OUR FREE WAY OF LIFE!! BECAUSE, if that were true, we would be able to pick a leaf off of a tree and have some tea! Pick a root off a plant to use as a spice for our food. SOME PEOPLE CAN: Pick and sell beans with their logo on it for something we call COFFEE. CAN pick several herbs, MIX them together and let them ferment… drink Alcohol and btw ( kill and mame millions… and become addicted) that’s ok though CAN pick the leaves off of plants and wrap it up, package it/ them and call them cigarettes/ cigars/ chewing tobacco…. hmmm btw, ( kill & mames MILLIONS…) you don’t even have to light it. Not even put it in your mouth… just breathe… it’s ok. It has a logo… just causes cancer. Sounds like a definite imminent danger to all!! OR With Alcohol you can drive and kill others. You can even ‘tax the society, unfairly” How would we use OPIUM, NATURALLY? FDA? DEA? CDC? President Trump? Anyone? Can you please explain to this simpleton why there’s so much heroin, meth, crack, illegal transported ( from China I believe you said Dr (Lol, doctor….pffff). Yet you want to waste all this money, all these resources to ban a leaf, after your guidelines state,” try other supplements before opiates,” ” don’t take opiates, don’t become addicted,…” Okay, we won’t. We resorted to nature, for our health, trying other products then opioids” We aren’t breaking laws We aren’t changing the leaf into anything else. We aren’t committing crimes We aren’t using illicit drugs We aren’t breaking into anyone’s… Read more »

Cindy J. Colbert-Hock

These are my comments posted to the Federal Register, I hope everyone will post their story. Maybe the Federal Gov’t will begin to see they are mistaken in their approach to the War on Opioids. People in Pain Petition You are doing us harm by restricting our Doctors from treating us with the most effective methods available. I am a person who is extremely sensitive to most medications. I have terrible side effects that sometimes last months. I would have to write a novel here if I were to accurately describe here all the medicines I have tried and the terrible side effects they produce. Always have been willing to try what the doctor orders, until the side effects caused harm to my body, also the stress it put on my family. I was a very successful insurance agency owner with multiple employees for 25 years. During that time I basically was used a guinea pig for different meds many, many times. One cannot imagine what my business days/family life were like during these trial and error efforts. Finally after about 20 years my doctors and I found a combination of medications that allow me to function, and even participate in life. I had a right hip replacement in 2011, everything went great. I was the model patient, I breezed through physical therapy….then about 7-8 months later things began to go awry. In the end my Rheumtlgst diagnosed me with osteo arthritis, and Fibromyalgia. The Fibro was likely brought on by the trauma to my body of the hip surgery. I went for over a year just sitting because every medication they threw at me caused terrible side effects. It just hurt too much I could not bring myself to do much of any thing. Then my pain mgmt doctor prescribed oxy, small dose of 5-325 4 times a day. The difference this made in my life waslife saving. I had been growing weaker and weaker…..THEN the oxy took enough of the pain away I actually started moving again after many months of just sitting.. Doing housework, some yard work, going out to see friends and relatives etc. I was able to begin aquatic therapy and graduated to using resistance tools in the water which has made me stronger, allows me to participate in life. A God send. I have never abused my meds, I am like the poster child for following the pain med. agreement my doctor had me sign. If ever I had a question about certain meds being prescribed to me by another doctor I always called pain mgmt. and either got permission or didn’t to fill the script, and I followed the instructions from the pain mgmt doctor. I recently had a routine 6 mos. appt. with my primary care. I had hurt my neck/shoulder area and he prescribed Soma for a muscle spasm that was very painful and had not gone away with traditional treatments of ice and heat, and Nsaids over a period of… Read more »

Alan Edwards

Thanks for speaking for us Dr. Lawhern! The CDC and FDA have become increasingly empowered and are making mistakes. We are suffering for it. Patients in pain are now not being treated and have few effective options. Thanks again.

Alan Edwards

Thank you kind sir for all you have done for us. Why can’t others be so kind? Because without a Godly character it is not possible for the cdc, fda, bad doctors, reprehensible pharmacists and many others to act with compassion or even intelligence. I have been verbally attacked by pharmacists recently because of my chronic pain and illness. We are easy targets if we use opioids and benzodiazepines and they love to abuse me for sure. I have Cerebral Palsy, severe spondylitis etc. which causes suicidal pain. The cdc should live with my pain for only a day. Opioids if banned will kill many. Absolutely. It is already happening with United States Veterans and CPPs.
Again, thank you for speaking for us. You annihilated them all.

Thanks to all who have validated my presentation to the FDA. For others who may not yet have seen the webcast, it has been divided up in four segments, available from https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm583543.htm. I should also credit the work of Kristen Ogden, Fred Brown, Meg Wilson, and Al Knowles (who spoke last and very effectively). I followed up my presentation with an email to the administrators of the hearings, as follows. Feel free to use this information in your own publications and lobbying work: ================== This note follows my presentation on January 30, 2018 before the Opioid Policy Steering Committee. During that presentation, I spoke of a recent large-cohort study published this month in the British Medical Journal. The study addresses opioid-naive patients prescribed opioids for control of pain following surgery. The study was not explicitly noted in my presentation materials, but I believe is deeply worthy of consideration in the deliberations of the Committee. Please disseminate this note to Committee members and to Dr Scott Gottlieb as Commissioner. The reference I made was to the following publication: http://www.bmj.com/content/360/bmj.j5790.long My personal reading of the results of this work is as follows: ~568,000 opioid-naive patients who were prescribed opiods for the first time after surgery, were followed for an average of 2.6 years during 2008-2016, to detect down-stream diagnoses of opioid abuse disorder or overdose. Among this group, the long term incidence of opioid abuse-related diagnoses was 0.6%. 99.4 out of a hundred post-surgical patients were not later diagnosed by a doctor with abuse-related issues or concerns. The study did not and conceivably could not address all policy issues pertaining to this patient cohort. ICD diagnostic codes for opioid “dependency” were not reported. Likewise, we have no way of inferring the number of surgical patients who may have falsely reported their otherwise-undetected history of opioid use. Equally, we cannot assess the impact of an increasing tendency of doctors to render abuse diagnoses out of concern for possible censure by regulatory authorities. Among this patient group, initial post-surgery prescriptions varied from 3 days to two weeks. Prescription renewals were tracked up to 13 weeks. At the end of 13 weeks, the number of post-surgical patients still renewing prescriptions was less than 1% of the original group. Among this much-reduced group, the number who presented with an opioid-abuse-related diagnosis in the follow-up period was about 6%. Incidence of opioid abuse diagnoses was also tracked as a function of initial dose level. Deeply contrary to research cherry-picked by the US CDC consultants’ group which wrote the 2016 prescription guidelines, incidence of opioid abuse diagnoses merely doubled between initial doses below 20 morphine milligram equivalent daily dose (MMEDD) and those over 150 MMEDD. These statistics directly contradict CDC estimates of 4 to 7 times greater abuse risk for high dose therapy in a heterogeneous population that may have included large numbers of patients who were already opioid-dependent. In concise form, I assess the significance of these findings as follows: (1) In properly medically profiled surgical patients,… Read more »

Barbara W

This is a repeat article but this is so out of control !!! We need to go on the Media I want to know if the Patients whom have been cut drastically with there meds & the families whom had suicides & deaths from heart attach strokes directly related to inadequate pain treatment be willing to go on a dvd or have #s shared with other CP patients for all of us to show on every media, CNN, David Muir International news & National News fastest way to fight this insane government lies Opiod Propaganda & for our doctors whom r disappearing NOW. If drug addicts are really down to getting high on I’m opium they are deliberate Pond Scum & I don’t care what happens to them. If it is just more BS then more than ever we have to United exposure just like the constant hammering of Opiod overdose! My e mail is barbara.woolston@Gmail.com. fire Jeff Sessions lift prohibition & everything that is on doctorsofcourage.org website show the entire world & public!!! This is pure corruption about the money & total dictatorship! Democracy is dead here Nazi germany reigns. “LEAP” law enforcment against prohibition are excellent whistle blowers of the entire criminal justice system 200k members all over the world active & retired!

SUSAN&MARTY: Actually the doctors that failed to treat patients for no known reasons should be the first to be sued for mal-practice,pain&suffering,failing to follow the “Do no harm” oath.Then we might get somewhere.The thing is that the FDA,DEA only sets guidelines there are no laws in all of the states.In those states there can be “Class action suetes”But in my state there are no new laws that doctors have to follow!It is up to each doctor to follow or not follow the guidelines.We need to stand up to our individual state legislators about each law that has CAUSED HARM ! Then if those courts fail to rescend those laws the Supreme Court is next in line! Stay strong people we will win in the end,good overcomes evil in the end!

I thoroughly enjoyed the speakers when it wasn’t fading in and out it was really hard to keep it going the whole time but I did manage to hear the second speaker the doctor he was great Unfortunately they shut him down I guess they only had 7 minutes a piece to speak , they should have been able to have more time for each speaker because at the end they did away with the public speaking which I thought was terrible I guess they didn’t want the public to be able to speak their mind! The doctor was very good spoke his mind and stood up for us Bravo to him! 🤗

Tim Mason

The “take home message” from the last speaker was that doctors were more concerned about their license than their pain and this should not be.
The ball was thrown back into the FDA court for them to act.

Fear and anxiety are rampant in both the physicians and patients,

You have to live intractable pain to understand it.
Patients are pain experts by training.

Good Job ALL,

Sam

I’m sick and tired of health regulatory bodies becoming my judge jury and executioner. Why don’t they let us make up our own minds and sign releases while taking opioids for chronic pain control. It’s mine and my doctors business. Quit lumping us in with the street addicts and leave us alone. You don’t know me. Leave me alone with my family doctor and pain doctor to make these decisions. Just stop this madness!!!!😠

If public safety was REALLY the issue, why not start with tobacco and alcohol? The fact that this isn’t happening should dispel the “public safety” hoax. Compare the death rates!

Lisa

I’m praying for you all who sincerely care about us CP suffers! I have Panic anxiety disorder plus chronic pain and every month I panic just worrying how much they’re going to lower my medication this month I can’t live like this, this is hell. I live with severe chronic pain everyday of my life and they are lowering my dose how am I supposed to even have a life if this is what it’s going to be like I can totally understand why people are committing suicide or going to the streets just for help so they don’t suffer every damn day I happy you’re going to kick butt thanks for helping us all! God bless!

Thank You for your kind heart and fighting for us ,I am doing what I can too just feel as though I am not being heard

Susan

Thank you Red! Your presentation to the FDA was spot on today!

Let’s hope some the in the room had their eyes, ears, and some common sense effectiveness.

Yes, a former poster above is correct…A class action law suit is needed against Regulatories for the violation of civil rights done to chronic pain patients–all those who have been and are being denied access to their required meds.

PRO BONO, SAVVY HEALTH CARE ATTORNEY CRITICALLY NEEDED! SOMEBODY, PLEASE HELP THE MILLIONS IN CHRONIC PAIN WHO ARE NOW SUFFERING IN AGONY–THANKS TO THE INCOMPETENCE OF REGULATORY AGENCIES!

Lisa Guerette

I live with ruthahoid arithis and lupus both cause chronic pain. I see doctors and follow everything that is said it’s not fair to take away meds from people who need them and don’t abuse them.

Thank you for going to speak. Suicide rates need to be logged and tracked starting now for chronic pain patients denied their meds.
The drug deaths in country from illegal drug use not prescription meds for pain patients.
Blood on their hands. This is what it will be. I”d say the devil will be waiting for them in the afterlife. What a shame.

Thank you, Thank you ,
So excited for you, I bet you did great and I cant thank you enough.

Marty

Is there an attorney out there willing to take on a class action lawsuit against the CDC, DEA, FDA? This situation has gotten out of hand. Although many good points were made today, the government typically doesn’t respond quickly and so many of us are suffering we need to light a fire under them and a lawsuit may be just the thing to let them know we mean business.
COMPASIONATE ATTORNEY NEEDED

Reba caldwell

I have been a chronic pain patient for at least 15 years. Please help.My old doctor retired & I had hell finding another doctor. After about a year of looking I finally found a careing doctor. And I thank God for him every day. But people in pain should not have to suffer it’s curl. I couldn’t get out of bed without my meds. let us live a happy life. thanks for helping the disabled people.

linda marie

This is so typical. They did/do nothing to help people addicted to drugs just lock them up in jails and prisons to punish them . Very few to no programs exist to help them but passing stupid laws that keep people that truly need these type medications and use them as prescribed, that they can pass draconian laws against. The only people you will keep from obtaining them is people who need them. Addicts will still get all the drugs they want.

GG

Dr. Lawhern, thank you. Your presentation was sheer strength and power. And I cried.

Thank you for standing up for peoples rights. When a chronic pain patient that has obeyed every rule but still has there medications either cut off or lowered so much then some of the law abiding pain patients may turn to the streets. This may cause deaths by people only trying to get some relief from there pain. When someone takes a chance by buying off the streets then that person has no idea what is actually in the medication that may be bought. Wouldn’t it be much safer to just go ahead and let the Pain Physicians prescribe the right amount of what is helping the person???? Of course, it would not only be safer but also the right thing to do… People don’t ask to be in Pain 24/7 its something that has happened causing severe pain that could be simply controlled by a persons Pain Physician. The government needs to stay out of peoples business bc it only makes things worse!!!!!