FDA Drug Safety Committee to Meet Next Month – What Would You Tell Them?

FDA Drug Safety Committee to Meet Next Month – What Would You Tell Them?

When the Food and Drug Administration (FDA) public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee meets on June 11-12, it will be hearing from some chronic pain advocates.

Richard “Red” Lawhern Ph.D.—who heads the Alliance for the Treatment of Intractable Pain–has filed comments in advance of the meeting. The Committee is designed to provide advice and recommendations to FDA on regulatory issues. Dr. Lawhern warns the committee against doing anything else that can harm patients. Here’s his testimony:

I write and speak widely as a technically trained non-physician advocate for chronic pain communities, with over 60 published papers in both medical journals and mass media. Please place the attachment before all members of both Advisory Committees prior to their meeting.

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.

As noted in greater detail in the attachment, published data from the CDC demonstrate no consistent relationship between overall rates of 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 trend lines in mortality data, they suggest that since 2016, mortality is marginally lower in US States where rates of opioid prescribing are highest. Prior to 2016, trend lines were flat, with correlation coefficients less than 0.05.

Algorithms 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 do not present with such a diagnosis within 18 months. More than half of all overdose-related deaths in one US State occurred in people who had no current prescription.

Studies of the impact of high-dose opioid analgesics on overdose mortality reveal a gross rate of overdose-related mortality at 0.022% per year (22 deaths per 100K), 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 vs dose.

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 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 encourage the departure of medical professionals from pain management.

Cease, halt, and desist.

If you wish to add your comments, you can do so here.

Subscribe to our blog via email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Authored by: Ed Coghlan

34
Leave a Reply

2000
34 Comment threads
0 Thread replies
1 Followers
 
Most reacted comment
Hottest comment thread
31 Comment authors
  Subscribe  
newest oldest
Notify of
Terri T.

God bless Red Lawhern. As an elderly patient I have been (mis) treated as a drug seeker for wanting my pain relieved. For heavens sake if I lived 60 years without using drugs or liquor you think they’d believe me when I tell them I’m in pain.

This is just one more step in the American police state. Atty. John Whitehead talks about just this in his newsletter. His book: “Battlefield America: War on the American People” should be read by everyone. Unless we all stand up now you can look forward to more usurpations of our rights.

The Federal government has grown too strong. It’s no longer a government by the people. This should be a WARNING.

Walter Strickland

By the way, our duely elected politicians could care less about what we think ,how we feel , or how much pain we have to try to live with.Only thing that concerns these animals is that they look like they are accomplishing a good for the general public.And I will add they will do this at the cost of every life in the chronic pain community.Dont believe it , look around you and you should be able to see.If you can’t see it and you still believe in the good intentions of these animals it may be time for you to wake up.

Walter Strickland

My pain management doctor graciously prescibes to me even month the following— 1-30 mg morphine sulfate ER every 12 hours and 3- Percocet s 10-325 for break through pain.He tells me I am at the maximum I can take for my chronic cervical pain.This does not provide the relief I need and each month I as for an increase in the morphine sulfate er to 60 mg every 12 hours and the 3 Percocets for break through pain They don’t want to discuss it much the y just say if we raise the morphine sulfate ER to 60 mgs every 12 hrs they will have to cut back on one of the Percocets.They always make me feel uncomfortable and like I am begging and so I keep going on with my regular prescription.I live in Houston,Tx .Am I really at the maximum dosage of these medications?

Anon

U.S. Code › Title 42 › Chapter 7 › Subchapter XVIII › § 1395
42 U.S. Code § 1395 – Prohibition against any Federal interference
US Code
Notes
Authorities (CFR)
prev | next
Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.
(Aug. 14, 1935, ch. 531, title XVIII, § 1801, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 291.)
Congress DEA,CDC,and FDA are breaking the law Period

I sent my comment and this is what I sent

Jeanette French

well said !!

dave

I have made comment s already to them. I have made it clear that their process is unfair, undemocratice, lacks social value lacks vision, lacks episstemic soundness and will not lead to social moral and political progress. The fda plays the same old games of dominating so many vulnerable people by falsely legitmting their beliefs and practices on the thinnest of epistemic values and even thinner moral social and poltical values. When will Americans stop playing their game and call for real reform in the FDA and tell them to serve the public better and for their staff to have real education in epistemology, axiology, morals and intellectual values.
Lets no longer tolerate their quick and dirty self serving top down managerialism- it is obvious a terrible failure for society and causes too much suffering. See what is happening with Xarelto and roundup- its not just about opioids or pain meds The FDa is unfir to serve the American public. Let them debate yours truly in public- theyre smart enough to duck and dodge when i raise these issues for they are unprepared to deal with them- they dont care enough about the public good to be truly prepared.

sarah yerxa

The history of the last couple of years is an insane one and some should be held accountable for starting this string of lies and deaths. I’m not going on about my health problems, let’s talk about what we all need to do (we know our problems). First write your legislators. Tell them they need to make law on the HHS Pain Management report. Second we need to tell them they need to take prescription medications out of the DEA controlled Substance Act. Make another part that deals with prescription drugs under the FDA. They handle medications oh and btw not sure how the CDC got away with doing the guidelines for prescribing it does not fall under them. Tell your state and federal legislators they have to make things right. The report covers medication and non medication treatment. Challenge them to make things right. Don’t forget the people running for office state, federal or president, they need to know what is needed by the people they are asking to represent. There’s copies of the final report everywhere by now if not go to https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html . You will also find in the posts going out there 2 different pages to send to your representatives that are and are not on the panel. Remember we all know the problem let’s take the same time you would write a letter and do it to the people that can make change happen. Good luck to us all. Reminder spell check before sending letters/emails out.

Plus,

We are being marched to our graves.
Most seem to just complain about it.
I don’t want to go.
It’s time to ” Act Up”, just as the HIV/AIDS patients were forced to do in the 80s. @ 90s.
They ended up saving some of their lives.
We need to get louder. Do not consider suicide for yourself.
Can we organize? What’s the best site? Most secure for us?

Ree luc

Hi I want to leave a reply To the FDA to please retract all of the CDC’s recommendations that have caused Enormous great harm too many chronic pain patients and Drs alike
Chronic pain patients like myself can no longer receive treatment for our agony daily pain n diseases we can’t get scrips !!!
Or get filled because the pharmacys are not filling them
the doctors are running away from practice in droves
they will not treat because of the fear instilled in them not only by the CDC but mostly from the Dea Who like vultures are seeking out legitimate doctors and charging them with even trumped up crimes
this is the majority of doctors are legitimate

some are pill mill doctors but the majority are not !
point being this is science this is a medicine like insulin to a diabetic and now people cannot receive their medicine so are committing suicide
to many!

and that’s not being reported
it shows how the government doesn’t care about us ,
I want to thank the Fda for trying to get involved but please you have to undo this
They have to cease and desist immediately and then letters have to go out to the doctors that they can treat
with out interference by Dea
DEA must be dismantled because they went n are going way too far and politicians
it’s not gonna stop Infact got worse
I don’t know what is going on but this is insanity alcohol and cigarettes kill more people yearly then prescription pills and we know that heroin n fentynal are the real crisis 99% it’s cause of ODs and deaths
and yet the lies being spread bla is astronomical it’s ridiculous it’s in humane and it’s corrupt please undo this please help us we are dying we already have agonizing short lives please let us live out What little We have left w Dignity
to hold Our grandchildren or cook a meal and some can even go to work , To
give us back some quality of life
We are in pain!! Daily
it’s barbaric to make us suffer in pain
we are comitting suicide
Help us

Ali

The government agencies should consider there collateral damage of suicide’s stop the guidelines.
New studies done on COMPLIANT intractable chronic pain patients and Veteran’s by using duediligence in “first do no harm”. COMPLIANT Intracable Chronic Pain patients have been profiled with drug addicts, labeled, demeaned, bullied, lost physician care, medical care, support system, felt soiled by drugs, profound depression, ignored, degraded, subjected to harrassment, called derogatory names, classified as drug seekers, forced to take many multiple drug test paid by patients, profiled and forced to signed consents for regulating there drugs and urine test, physician’s have walked out on them, subjected them to degrading lectures at clinic visits, and now with no where to turn for help called it quits committed suicide by government agencies negligence of duediligence to “first do no harm”. When other Compliant irretractable chronic pain patients and Veteran’s see the blatenly ignoring of there please to listen and help there intracable chronic pain can not continue so suicides are there only option. These suicides are collateral damage of profiled negligent guidelines put in place by our government agencies with disregard to protect American citizens from destructive harm.
I have debilitating chronic pancreatitis, fibromyalgia, debilitating migraines, and I have signed consents to drug monitoring even as a septagenerian who has been Compliant for 20 plus years.
This is a travisty of injustice to our citizens and strips them of there constitution rights for there country to protect them. Our government agencies are attacking there own citizens with guidelines that causes harm to the point of suicide in the patient population of intracable chronic pain patients and Veteran’s. We compliant intracable chronic pain patients and Veteran’s are lost citizens with no government or country to come to our aide.

Michael E Springer

Request for a Waiver to the Prescribing Opioids for Chronic Pain Protocol

My name is Michael Springer. I am 70 years old. Some of my diagnosis have specific genetic markers others do not. My pain is caused by the combination of MS, an immune deficiency, Ehlers-Danlos, peripheral neuropathies and the impingement of my nerves at C6/C7. The pain is severe and unrelenting, keeps me from falling asleep before 2am and prevents me from sleeping more than two to three hours at a time.
I had been taking high doses of aspirin and Advil for 30+ years but they have damaged my kidneys. Over the past six years I discovered that I am “non-responsive” to opiates. My physicians have been empathetic and have made a genuine attempted to manage my pain with palliative strategies, physical therapy, gabapentin, opiates but, other than Nucynta, none have been effective (Lyrica) or have side effects that are intolerable (Cymbalta, gabapentin).
I am now at Stage II renal failure and can no longer take any kind of NSAIDs. With the exception of large doses of NSAIDs, Nucynta has been the only medication I can take to reduce the pain I have lived with for decades. Nucynta is a new medication that is used to treat pain in patients who need an alternative to NSAIDs and opiates. What sets it apart is Nucynta has no extra pyramidal effects (the drug will not get anyone “high”). Yet I am treated like a street junkie when I have to request a refill.
I am putting “Guidelines” in quotes because they are being administered as a rigid protocol. I am requesting the entity composed of the CDC/FDA/DEA develop a Waiver program which will allow those of us who have been living with chronic pain to obtain the medications we need in an amount and frequency we need to control our pain.

ElizabethR

Just a few more thoughts for my (already-lengthy) earlier comment. It comes as no surprise to people living with ongoing, incurable pain that it saps one’s energy and hits the “delete” key on much of life’s joy. I used to be a high-energy person. I was involved in my career and activities including volunteer work, gardening and decorating. I retired involuntarily 4 years ago at 78, when my nonprofit lost funding. (BTW, this comment isn’t intended as “Debbie Downer speaks”. I fully recognize that there are many people far worse off at a younger age.)

That said, I can no longer do major housework or even light yard work for more than a short period of time. I once covered shifts at the cat adoption center where I volunteer when others couldn’t come in; now I question if I can continue even a 1X/week shift. Lifting kitties in and out of upper level cages hurts. Without the mild opiate I currently take (usually 4 tabs of Tylenol #3/day), I would be unable to do it at all–or much else.

I find today’s “healthcare” environment humiliating and totally intimidating. I am NOT a criminal, but I’m afraid even to broach a medication adjustment with my new 30-something physician, who has been in practice for all of 2 years. She could decide arbitrarily that I’m a “drug addict”! Thus, I cannot look forward to improving my situation anytime soon–if ever. It takes all I have just to keep the basics going for myself and my 89 Y/O spouse: groceries in the kitchen, our 2 senior kitties fed and cared for (they’re family and this is their forever home), laundry done, the house kept reasonably clean (with periodic professional help) and other tasks I need to perform.

Coping with pain and the tasks of living take all of my energy and most of my spirit. Welcome to the “Golden Years”! Note to advisory committee members: I won’t be here 30-40 years from now when YOU are old, but the time will come. You can make it better–for your parents and yourselves.

Gail

PLEASE, PLEASE, stop this witch-hunt because instead of cutting off the addicts who OVERDOSE you are responsible for torturing patients, doctors and pharmacists who only want to care for the sick, injured and dying patients!!! MEANWHILE, the addicts are getting all the poison drugs they want from PUSHERS and CARTELS!!!
PLEASE understand the problem is illegal drugs and the people who consume them!!!
Due to ripping pharmaceuticals from patients under the care of licensed physicians and
then you count the suicides as OVERDOSING!!! Suicides are due directly to overwhelming
pain and suffering that has needlessly been brought on PATIENTS, DOCTORS and PHARMACISTS with no consideration for the irrevocable damage Your group, insurance companies and general stupidity have inflicted on innocent people!!!
Patients were given these drugs legally until someone thought gee we can really do damage!!! And damage is what you have done!!! This Kolodny person wants to take patients, doing well, on opioids and inflicted HEROINE on them!!! This is stupid!!!
PLEASE get rid of the Pushers and Cartels who are the real problem!!! They cut the stuff
they sell with animal tranquilizers and whatever else they can find and there is no exact dose to what they are pushing!!!
PLEASE, PLEASE think this through before more damage is perpetrated on innocent patients and the medical staff that is trying to care for them!!!
If there is no chance to resolve this problem amicably then the next move is to line up
all the patients and medical professionals and shoot us!!!

Loyal P Kuhn

I am a chronic pain patient. I am not a “druggie”, I do not exhibit “drug-seeking” behavior, and I use my prescription opioids responsibly like the overwhelming majority of chronic pain patients. Please consider what this ill thought-out “Opioid War” has done to chronic pain patients. Take this stupid crusade against responsible chronic pain patients out on the streets to combat illicit and illegal drugs where the war will have the effect it should have. Focus on illegal activity, not the few that need opiates to have a functional existence.

Excellently put, Red!!

btw, everybody else: I ran across someone trying to sell a toxic chemical to pain patients, dimethomorph. I assume because it contains “morph” in the chemical name, people will assume it’s morphine. It ain’t!! I looked it up; it is a fungicide, the limits of which the EPA puts at 0.90 ppm (EU puts limits at 30mg/kg). Beware!

Just when I think people can’t get any lower….

Larry E. Howard

My wife WAS a chronic pain patient for over 20 yrs. She lived a full life garden, landscape, keeping grandchildren and cooking and cleaning. But when the CDC came out with there guide line her doctor started tapering her off her meds. Her pain was so severe and it put stress on her heart she had 4 heart attacks in the 2 yrs after her tapering. The 3rd one was 7 hrs after she was forced to leave the hospital 2 days after hip surgery. She told them something didn’t feel right but they sent her home anyway. The 4th one killed her instantly all because of pain. On February 26,2019 I lost the woman of my dreams and my Best Friend for 27yrs.all because of the CDC Guide Lines. I would like for someone to explain why she is gone all because she was in pain. My name is Larry E. Howard and I am now a widower and I want answers because I think I deserve them!!

David W Cole

Thank you Red
You are truly an inspiration to us all. There are no words to tell you how much I appreciate what you’ve done for the pain patient community.
May God bless you and your family.
Hopefully they read what I wrote, and can feel the pain.
Sincerely,
David W Cole

Steve Abbey

Thanks for all that you do to get others to listen. I am feeling less depressed and hopeful that pain management is going in the right direction to help all chronic patients to get the help back that is needed to have a better active lifestyle while at the same time to get there hearts pumping again as “we” can walk, shop, work, ect!. I know we have a little while to wait, while it has been a very difficult road to travel!!. Thanks for listening and forwarding our comments to where it was taken under positive consideration. we would be completely lost without your help!!. 🙄

ElizabethR

This is what I would tell the advisory committee. I am appreciative of any voice on behalf of individuals with long term, incurable pain caused by medical conditions. Overwhelmingly, we use medication responsibly to maintain as much functionality and quality of life as possible. We also have tried a long list of other approaches to pain control, such as physical therapy, chiropractic, massage, TENS and countless non-opiate medications. Speaking for myself, these have shown very limited effectiveness. In addition, insurance coverage for alternative therapies is limited, if they are covered at all.

As more pain patients and their advocates speak out–which needs to happen–I ask our representatives and government regulators to understand that misclassifying long term, incurable pain patients as “drug addicts” is not supported by current evidence and is inhumane. It is causing immeasurable and needless suffering among those who did not cause and are not part of the “opioid crisis”. However, we are serious collateral damage.

Drug addiction, by definition, is life destructive; overwhelmingly, it involves younger people who use drugs for non-medical reasons. I’m 82 Y/O and have several ongoing medical conditions that cannot be cured, including severe osteoarthritis in my back and neck, degenerative disc disease, scoliosis and residual damage from 3 earlier back surgeries. I have been stable on a low dose of a mild opiate for years. Responsible use of this medication as part of a physician-monitored pain management program, has been life preservative for me.

As a younger woman I was energetic, active and involved in life. I spent 57 years in the workforce, mostly full time. That person is gone now (and I miss her). Still, as an old person, my goal now is simple: to remain as independent as possible and not become a physical or financial burden to my family or society. Achieving that goal depends on my ability to remain functional.

Norm

It’s just so sad. How many more suicides from lack of pain relief need to happen. I was told yesterday at my pain clinic. The one I thought was really fighting for me that I will have to taper down to about half of what I am on right now. What I am on right now only works well when I have my epidurals and Radio frequency ablation appointments on time. About every 6 months. This is almost too little too late. Even if you change everybody’s mind, how hard do you think it’s going to be to get our doctors to up our meds down the road They will say you are surviving with no concept of how crappy our lives are. Sorry but I hope they all have the amount of pain I have soon. Again people without the experience of pain making rules for us who are in pain.

Cindy

I just commented to the FDA via the above link.

I’m so glad to have been notified by this NPR email about it.

I wrote a comment with the hi-lites of my 3 page comment memo that I sent to the HHS Task Force about its draft report, and I attached that memo.

Kelley Eubanks

I would tell them that not to clump everyone into the same category a lot of us who are chronic pain patients are in so much pain now since the federal government has decided how much pain we are in and we are not in and they have no clue what it’s like to not be able to function, not be able to cook dinner or clean your house or go to social outings grocery shop since they put a cap on our pain medicine. I am very compliant and always have been so don’t put me in the same category as those who abuse drugs. You are demoralizing our doctors who specialize in pain management and you are making we who are in pain to begin with in worse pain people have already killed them selves because they are in so much pain thanks to your stupid new law. And Joe Bidens rude comment about the fact that chronic pain patients need to toughen up, is rude. And very uncalled for he has no idea he’s clueless unless you Are in so much pain that you cannot function anymore because of their decision to put a cap on our pain medication you have no idea what quality of life we have now which is none . It’s terrible. I have no life anymore thanks to this new law.

Vincent Morraele

I’m hoping this Topic becomes mainstream understanding that 90% of people that take a opiate pain medication are enabled to work, have quality of life, those suffering in bed, Combat Soilders injured, spine disorders, athletes, people with disabilities that take an opiate medication in return they can help someone else. The elderly that are living their last days. Police officers that need this medication to work, we need all The good people we can get to vouch. The one thing no one can disagree is that opiate medication is a God Given plant, so for Americans to be told no they can not have a natural plant is a recipe for what we are experiencing, and that is complete confusion. I hope this meeting will start a trend of the facts as stated in the above article. Legalize the opium plant in America is answer.

Vincent Morraele

This is an excellent and on point Topic

Jeff

I want my doctors to have control of my health based on needs not wants. I don’t know of one real pain patient that wants to be on these medications it is a matter of medical needs for us, our comfort and mental stability. We have enough to deal with without this added fear we all live with at all times when will we lose our medications these days it isn’t a matter of if only when one of my pain meds was changed and the dose lowered which has left me more times than not begging GOD to please free me and let me die, he finally has answered my prayers I am now terminal and I blame much of it on the facts that my doctors cannot increase my meds regardless of needs so they add other meds trying all they can to help me with little if any help only side effects as a non smoker I am now dying of a fatal lung disease Idiopathic pulmonary fibrosis and YES the stress of this pain I blame this horrible disease on and wouldn’t you know it now insurance is fighting like hell to refuse PAYING for the one and only medication to treat it at all the state of our insurance and medical community due to constant fear of oversight and prosecution its shameful at best. My insurance is more my doctor than my doctors that is criminal. I have my GP and five specialist they fight for me as hard as possible yet often I am left untreated because they refuse to pay, here is an example, I was actually going blind my insurance refused to pay for again the last drug that would help me the make stepped in and gives me the medication free and my eye doctor was right at my three month checkup to see if there was any improvement I thought she was going to do back flips she got so excited for the first time in twenty years I now have healthy corneas that’s how much this medication has helped me I went from being almost blind to healthy corneas I just three months while I have to use this medication the rest of my life it is the manufacturer that came to my aid not my insurance!

Rosalind Rivera

Dr Lawhern has brings to light what the CDC and other such agencies what should be observed and practice. Instead, these controlling agencies are flexing their muscles by denying or controlling pain medication to chronically affected individuals such as myself and there are many of us. These agencies are not helping us but instead are morphing our lives to the state of inertia. I myself can no longer venture out to do those mundane things that I was able to do in the past and what almost everyone should be able to do. I am instead now housebound 99% of the time and bedbound 99.99% of the time as I am in such intractable pain that were it not for my religious beliefs, I would have no ago sought alternate measures of relief including illegal sources and finally the ultimate cure to top all cures and just put an end to my chronic, paralyzing pain. We need to be evaluated on an individual basis. Such things as x- rays, sonograms and others should be the determining factor as well as doctor patient trust before pain medications are eliminated or as in my case grossly reduced. I’ve written on this topic many times as it is the one closest to home. Stop this gross abuse of people in pain!
I for one desperately need help for the very limited assistance that I am getting barely touches the excruciating levels of pain, not that I am living with, but merely existing with!

Mary

I’ve been a chronic pain sufferer for many years now. I too have been mistreated, and have had to suffer that added anguish. I often wonder “what exactly is the agenda”, when our effective medicines were taken away from us?? I have a friend who suffers chronic pain, and has been through what we’re going through. Since Dr’s refuse to treat her pain, she found out heroine was available on the streets. She has pleaded with several Dr’s to show mercy and prescribe effective pain medicine, so she could stop going to the street Dr’s.. only to be met with yet another denial. How many death’s have been caused by this? Is this part of “the agenda “? And what about the suicides? Why did my physician increase my antidepressants, that was already making me more depressed. Then increased the dosage for flexeril, which knowingly makes me more sad? EXACTLY! AND I’M NOT GOING OUT LIKE THAT! Stop the restrictions on our effective opiates. We don’t want to suffer further harm.

Terry

I have been a chronic pain patient for over ten years and have taken my meds religiously without incident. The statistics used in this article are nothing I haven’t heard before and the powers that be have also known how that chronic pain patients are not the problem. So then I ask the question, why continue to torture and punish the chronic pain community? I don’t have the answer. The only thing I can surmise is that the only concrete, measurable thing to do is create new CDC guidelines for prescribing opioids. Also they (government officials), can spin it by saying people start with pain pills and eventually turn to illicit drugs like heroin or fentanyl rather than address the REAL opioid epidemic which is heroin and/or fentanyl. See they have no way to control the use of those drugs in any measurable fashion. It’s a travesty and I hope they can live with the facts that suicide rates are up and people are suffering needlessly, all because they can say that they took action to combat this epidemic. You can get a “hit” of heroin for $10 so regardless of your income you can afford the heroin. These people aren’t getting addicted to heroin because they were prescribed opioids for pain, they just want to get high! End of story. It’s such a screwed up mess it will never get sorted out, but at least the government can say they’ve taken drastic steps to combat the opioid epidemic. If it wasn’t so serious it would be funny. Damn the politicians, the screwed us over one more time. God bless all my chronic pain brothers and sisters. Stay strong, fight back! Write your public officials.

Marie Gafney

Why is this not secure!!

LMC

Thank you. It is very refreshing and encouraging when facts, statistics and common sense can be articulated so effectively.

My chronic pain condition has no down time, therefore I don’t sleep. Ever. For 12 years sleep medication allowed me up to 3 hours consistant sleep. Now I get 15 to 20 minutes 2 or 3 times in a 24 hour period. It is affecting my memory, perception of time and interferes with my ability to communicate without losing my train of thought. With no sleep medication and reduced pain medication I am exhausted and in more pain than ever before, and, as bad as that is, others have no medication at all.

Thank you for all if your efforts to help others. You will probably never know how many lives you’ve touch, and while I am sure you don’t expect it:

Thank you for your seemingly tireless efforts. God bless.

Jud

I suppose it might take a personal medical problem before the decision-makers realize that pain hurts, chronic pain never stops hurting, and that prescribed pain management medicines help patients control pain and make their lives a little better. Perhaps it would also help in funding research to find cures and education the medical profession regarding these terrible conditions, CRPS, for example, and other such painful disabilities. I would certainly never wish a medical problem on anyone, but it might open up their thinking about judging and condemning others who do have these problems.

Jeannette

I have taken opioids safely for 9 years since an unfortunate incident. Due to the CDC and PROP and Kolodny I have faced numerous barriers. Post-surgery I was woefully under-treated for pain. I’ve faced discrimination from doctors who have acted in accordance with Milgrams Experiments. Most recently I’ve been put on various medications that have left me with permanent impairments rather than raise my opioid dose which I have tolerated well.

I ask these people who happened to find employment at the FDA to realize the harm you have inflicted on innocent people who did nothing wrong, yet due to an accident or other we have been reviled in the news and forced to jump through hoops. Realize that whatever goes around comes around and one day you may wind up the victim of your own policies.

Think wisely.

Stan Riedel

It is a nice change to hear a sane voice of reasoning for a change. The decision makers will be thanked by all of the drug cartels. Without anybody being able to go to a medical specialist for problems with pain. The only people that anybody can turn to is drug dealers and cartels. With no insurance companies to turn people down for help with help needs, the prices will probably be close to what people are paying now. No pharmacy police to give people dirty looks for using a prescription for pain relief medicine. No more government controlled doctors calling legitimate pain patients “drug addicts”. Legitimate pain patients only use what they need for relief. Most drug addicts use all they can get and will run out of the money it cost to buy what they are addicted to, so they will steal from the people who made it possible for drug dealers to thrive, like overpaid politicians, DEA and CDC agents. After years of bad decision making like keeping medical marijuana outlawed, approving cancer causing blood pressure medicine and to many others to list here. They have opened the doors to the illegal drug market. The other war they have lost after billions of dollars and filling up the prisons for everyone to pay for. They all should get paid for what they accomplish for the American people, not for what their title says that they are worth.

Bernice moeser

There are good people out there who don’t overdose meds, and are in terrible pain,they need pain meds. Don’t punish us, we don’t abuse drugs. Only the young who want to get high,and stop blaming the good doctors who help us with severe pain.