FDA Hearing Draw Chronic Pain Community – So What Now?

FDA Hearing Draw Chronic Pain Community – So What Now?

By Ed Coghlan.

The FDA Public Meeting on Drug Development for Chronic Pain heard from an audience of chronic pain advocates and patients in Washington D.C. this week.

The FDA meeting was part of what the agency said is an effort to seek a balance on opioid access.

“While we work to ensure appropriate and rational prescribing of opioids, we won’t lose sight of the needs of Americans living with serious chronic pain or coping with pain at the end of life,” Dr. Scott Gottlieb, the FDA commissioner, said before the meeting. “They too face significant challenges.”

Here is Commissioner Gottlieb’s entire statement.

For chronic pain advocates, like Terri Lewis Ph.D. who shared the results of an extended survey that the National Pain Report promoted, the meeting Monday was a start.

“Now we find out if they listened,” she said. “The FDA heard from the people who have been caught in the federal government crackdown on opioids–the patients. It’s a voice not often heard, but it was today.

There is an unmet medical need experienced by patients with chronic pain.

“Collecting information from the patient’s experience provides an opportunity for the FDA to enhance regulatory decision-making”, she added.

For Cindy Steinberg of the US Pain Foundation—the nation’s largest pain patient advocacy group, the theme of what the FDA heard and what the agency will do now is also important.

“Anyone listening today heard a clear and resounding message from patients who traveled great distances to deliver it and will undoubtedly pay a cruel price in days of increased pain for doing so,” she said. “Their message was clear – we are sick with devastating pain conditions yet doctors will no longer treat us. We have been forced off opioid medications we have used appropriately that have helped us to function. We are suffering to the point that many of us are losing the will to live. Why don’t you hear our pleas and take action to stop this inhumane treatment?”

“My question now is what action the FDA will take to demonstrate that they care?” she told the National Pain Report.

Commissioner Gottlieb said the FDA is seeking a balance on opioid access and seemed to acknowledge the chronic pain patient has often been caught in the crossfire.

“As we consider new policy steps to address the opioid addiction crisis, the FDA remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines,” he said.

For Lauren Deluca, who is President and Founder of the Chronic Illness Awareness Advocacy Group, the hearing was a good opportunity for the chronic pain patients to make their case, but she also is wary about the focus of the government hearing.

“I am so proud of hearing so many passionate advocates speak out against these egregious human right abuses. But I have my reservations about the FDA’s focus on drug development rather than the delivery of essential medical services that are clearly need right now,” she told the National Pain Report. “Drug Development is fine and good for the future but our community needs immediate action. I am hopeful to see some steps from the FDA and other regulatory bodies to ensure access as this is a consumer rights issue as well.”

For more on what the survey of chronic pain patients revealed, click here.

Did you attend the FDA hearing? What did you think about the hearing?

Contact me @editor@nationalpainreport w/ your comments and contact information.

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Authored by: Ed Coghlan

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Tracy Cabanting

I really hope that all of these government agencies, doctors, lawmakers, and the like LISTEN to our plight as Chronic Pain Patients and start to fix the many, many mistakes and mistreatments that have been wrongly and blind fly bestowed upon all of and that have affected us so negatively.
I was cut back in January of this year, my pain is no longer controlled and each day is a struggle to function on the most basic of levels, pain management is my ONLY OPTION, and my doctor wants to cut me back even more because of an article he read that in JAMA saying that insurance companies made Opioids too easily available. Ok….how does that necessitate ME being cut back even more when I’m already barely functioning!!
We are PEOPLE, NOT statics or articles in black and white on paper!!
My pain, OUR pain matters, OUR stories matter!
Let’s all keep speaking up and speaking out so we are heard and can receive the proper pain meds that we so desperately NEED!!
God Bless ALL OF YOU!!

Melinda

I to suffer daily with Fibromyalgia. it’s real and the pain is unbearable.. I suffer from a nerve burning sensation all over my body. I can’t find a doctor that will write me anything for pain. All of the medications he has put me on doesn’t work. I can assure you I would not abuse any pain meds if I ever get them. I can honestly say there are days where you just don’t want to go on living this way. I’m praying for changes in our doctors and pharmacies.. I like so many others need pain meds to get through the day. It’s not right to punish the ones that need it. I have a doctors appointment in August and I’m going to ask if he will send me to a PAIN MANAGEMENT DOCTOR BECAUSE ITS JUST TO MUCH ON MY BODY MY MIND.. My family knows how much this has changed me. I’m very irritated and irritable all the time. When your living with this 24/7 you don’t even want to face tomorrow.

chris

I am sick and tired of this abise. I want to file Lawsuits against anyone my former Pain Doctor and ANYONE complicit with denying my human rights and endangered my life several times now. My Health is in decline and collapse. I am suseptable to everything.
Is there an Attorney that would give me a few hints. I’ve filed lawsuits before . Do I have to file 2 lawsuits meaning in Federal Court Too going after : DEA, CDC, Sessions , etc.?
I am mad . I have a new doctor and I am barely ok but I may have Prostate cancer along with several other ailments caused by weeknes and weight loss.
I would like a consultation at least. I am in 91306 area.

C Pridemore

i And a friend attended the meeting on July 9th. I was very hopeful for change. However, after taking a cue from my friend also in attendance, I watched the FDA officials as the pain patients spoke. The majority were not even engaged. One panelist couldn’t even bother to look up from his phone or computer most of the day. I believe the meeting was for show. So the FDA can say they “listened” to pain patients,advocates and etc.

Freda Lovell

I have issues now with taking prescription drugs. Waiting for new ones is not an answer for me. I am 65 years old on top of that and side effects with the memory, blood pressure and hearts are huge issues NOW! My vision is not doing well on two blood pressure medications, but if I don’t take them due to pain my back numbers are well over 100 all the time! Then what?? Heart attack and die?? Or stroke? I am allergic to Lyrica, Cymbalta, and Garlise is not working. I was told my Neurosurgeon that any more than 1800 mg. of Garlise is toxic! So, now what?? I have burning HELL fire nerve pain and Hydromorphone takes off an edge of pain. However, it gives me insomnia. But, TriCare will NOT let me have BRAND drug Belsomsra. I have had terrible reactions to other sleep medications, Restroil made me suicidal!! I live in Texas, CBD with THC is illegal!! What am I supposed to do?? Move?? Move Where?? On a fixed income with a husband who is losing his mind!! Who served his Country for 23 years as a Officer in the Air Force!! Where is my Country ‘s help now?? If I were rich and in the top 1%, I’d leave this country and move!! God only knows where as most Countries do not want the Elderly!! Maybe Canada!! When will MY COUNTRY turn on its BRAINS and take care of it’s CITIZENS!! ALL GOOD AND WELL TO CARE FOR THE REST OF THE WORLD’S PROBLEMS, AND MAKE US PAY FOR IT, BUT I AM SICK OF IT!!

GIVE US BACK OUR DOCTORS!! YOU WANT US TO WORK AND RUN THIS COUNTRY KEEP US WELL. AND, ADDRESS THE FOOD INDUSTRY AND ALL THE DRUG OF SUGAR GOING INTO OUR FOOD AND KEEP THE POISON ROUND UP OUT OUR INDUSTRY!!

Barbara Marstiller

Just another stall tactic by the FDA, CDC, DEA, AND TRUMP! AS A DISABLED FORMER RN, I can promise you big pharma will come up with “New drugs” alright…and f da will take the $$, look the other way, approve the single tested drug, and people will suffer and die…they’ve already been doing it with the abuse deterrent garbage that turns into an eraser in the gut, causing all kinds of adverse reactions and not working! And yes suboxone…then you are labeled an addict for life, and pay cash, and get addicted to it. The hedge funds popping up making millions for investors in ” pain clinics”…none of these people belong in the Drs office, but anyone of them will get whatever drug they need to FUNCTION! ITS always been this way…remember the stations? I personally watched many people die from those. Pain is subjective…and if the powers that be don’t think us health care providers can tell the difference in drug seeking vs. Pain…then the battle is lost…I have worked 30 yrs and have titanium, ceramic, ra, etc etc…now my life is over, at 55! It makes me vomit to think about how this country has turned it’s back on it’s people, many of which are baby boomers who’ve worked themselves half to death! They should all feel nothing but shame! Yet throw the baby out with the bathwater every chance they get!

Sharon

I would like to thank each of you for your comments. Rebecca, I appreciate your posting of the real truths! I also commented on July 11th, today, the truths about addictions and omg what’s wrong with people. Alcohol, nicotine, marijuana and food can be addictive too and you can buy all of these things freely! I’m talking about this because I’m a recovering alcoholic and my pain is due to all the damages caused by it. Not then but over time omg! Two years after I stopped drinking I was at death’s door when a voice spoke to me and he gave me a choice; come home or stay with my family for a bit longer, and, well…..a 10 month hospital stay and I left with my family. That was 20 years ago and I am disabled with a bag of meds. Pills so I can eat (pancreas enzymes), etc, etc, etc. It’s hard work just to function and maintain. Opiates I use for maintenance of my pain along with breakthrough pain. Pain is what almost killed me 20years ago. I CANNOT go through that again!
Again I thank you all for hanging in and fighting for your rights. I believe this is also a question of Morals in so many. At the end of the day I wonder if people ever take the time to say to themselves, Did I help anyone today? Did I hurt anyone today? Did I??? It’s called your daily inventory. I ask this because come judgment day I believe your GOD will ask you for the answers!!
Sharon

Cheri Furr

How many people from the US Pain Foundation attended this meeting, because no one noticed anyone from your organization was there? I think you need to be front and center on this issue and in the faces of the FDA and every legislator you can reach before they vote on a bill already on the floor! I thought it was very brave of the CPPs who were able to attend this in person. Great testimony from first-hand sufferers for the FDA to hear!

Steven

No one can or will watch the DEA! That’s the whole idea. They’re running loose with an agenda and that is to rid the planet of opiates at all costs. The pain patient needs these medications so much the better let’s get rid of them. Enough said

Rebecca

Here’s the latest findings: Die Annually in USA

Obesity. 320,000 (CDC forced to remove stat)
Medication. 128,000. Did not specify type or kind
Alcohol. 100,000
Falls. 55,000
Suicide. 42,000
Vehicles. 40,000
PRESCRIPTION OPIATES. 13,000
2nd HAnd Smoke. 40,000
Inhaled Smoke 400,000
Police. 1,500

Allison

The problem…No one in the government is asking the cdc to set new guidelines, regardless of the fact that they used misleading data. The problem is being pushed back to the states, and physicians groups. Who’s watching the DEA?

So, where now? We’re running around in circles….thought the FDA might help, but it’s clear, they won’t, so who can?

Alan Edwards

Lauren Deluca is correct. I am wary of the FDA promises of ‘new drugs’. It’s a sham response to placate the simple-minded and disease- free elite. The FDA, CDC met illegally without due process in March of 2016 and made up guidelines worthy of a new standard of incompetence, led by Kolodny and his cohort from Washington. Suboxone is not angelic nor is Naloxone, touted as a lifesaver can be toxic and act as an agonist. The truth needs to get out. The government needs to stop interfering and either help or let real pain experts and patients take control…and the DEA stop kicking in doors, please. Trump was not told the true story much like a clueless Nixon and the disastrous controlled substances act of 1971 (signed in 1970 to accrue brownie points). There has to be an intractable pain patient advocate in the FDA, or one close to a pain patient, who will act rightly.
I wish Terri and the participants all the best and thank you.

Notasheep

Yeah, this is NOT the way several participants describe this publicity stunt. The ccps who spoke, spoke well with tears seen from some on committee during a few testimonies. Up until the very end all were hopeful. Some official sounding title woman came in, spoke on the horrors of opioid for far longer than the 2 min. limit enforced on cpp speakers and then left. Hmmmmmmmmmm
The closing speech leaves no doubt which class of people are more valued and it ain’t us.

Cindy Deim

I listened to the FDA webcast yesterday. It seems like movement to me. Why would they go through the expense and hassle of doing the webinar if they didn’t want to hear what people are going through? It gives me hope that something will change.

Too bad that there are som many pushing Suboxone and other drugs rather than deal with the crisis they have developed with their false narratives about “Opioid Epidemic” which is more of an Illicit drug trade featuring Heroin…cheap heroin and other drugs being smuggled into the US. The crisis is a lack of the US gov being able to stop any of it?????I guess we are the easier, more expendable option????

Holly

Cindy…in my area there are so many OD’s it’s pathectic. it’s all heroin laced with Fentanyl. They are mostly young….in there late teens and 20’s. They are brought back to life all the time. None of it is pain meds. CDC, DEA FDA etc etc. they all know this.

Bill Halper

I too, like every other chronic pain syndrome patient, hope that the FDA and their ilk have actually listened AND understood what our lives have been like since the initial suggestions/ruling took place. I also hope that these officials still have the ability of empathy, sympathy and care that other divisions of the government somehow lost. Since our doctors must be licensed to prescribe the opiates, and after quickly developing a new code of ethics pertaining to our medications, that we can go back to the amounts needed to keep our lives viable with the quality of life that seems to have been taken away from us.

Rachel

I am totally sympathetic to the chronic pain community and what is happening to you in the US. It is a removal of your Human Rights. However can we please recognise that addicts are human beings in severe emotional pain who have had massive trauma, often relentless,trauma and abuse over years and their emotional pain is as bad as our physical pain. Please talk about them with respect. Scapegoating another group instead of ourselves is immature and unhelpful. I have severe chronic pain myself and I don’t know how I would survive without my meds but I won’t campaign at the expense of another group of persons with a painful disability.

Very sick

Ed You don’t have to post any of my comments. My wife and I are selling our home and moving to Europe where we both can get proper treatment.

Ken Atwood

I have given up hope of the government doing right for people with chronic pain. Especially since trump and the republicans have control. I might as well give up and die today, the government doesn’t care about people

Joanna Pinne"Cra

I am really getting sick and tired of the “I am not an addict” coming from pain patients. By saying this we are setting ourselves up as judge and jury as to who an addict is, and we proclaim what should be ‘done’ with ‘them’…so we’re really doing to true addicts what anti opioid zealots are doing to us. Then we go on to say “crack down on the addicts and illegal drugs” – well, the US has been ‘cracking down’ on ‘illegal drugs’ for at least the past century. Frankly we need all drugs to be legal and sold OTC, as is marijuana in many places in the US and Canada.

Lori T.

I want to personally thank everyone who spoke up for the chronic pain patients. I was not able to attend the meeting in person as it was booked full, as was the webinar. However, I did give my story on the DEA website. I was really looking forward to today in hearing, (in detail), what happened at the meeting. I got some of the message from the NPR but the continued reading link is not working.
From what I have read so far, it sounds like the message was delivered loud and clear that we pain patients are suffering because of the continued crackdown on opioids. I question that anyone who can do anything about this problem, was or wanted to listen. Personally, I feel deflated and depressed. If anyone that has the power to change things at the government level regarding our segment of the population, I hope they heard the urgency part. We CPPs don’t have the TIME to wait out long, hashed out proposals. Many of us will have chosen to end our lives by then.
Let’s just see what happens in the near term….and hope.

William Dorn

These people at the CDC and the FDA will have to face the LORD at judgment day. If they don’t change these cruel guidelines I would not want to be them.

Deborah M Babcock

I think they should start a crackdown on illegal drugs such as methamphetimine and heroin etc. Those are the real addicts. Take there methodone away etc.its sick that a drug addict can get out of theyre pain while true chronic pain sufferers are suffering and being treated worse than an animal. Heck,a dog gets better treatment !! I cry myself to sleep what little sleep i get due to untreated chronic debilitating issues i have. My dr wont listen to me and im treated like a drug seeker any time ive mentioned my pain..restless leg syndrome through my whole body,chronic migraine headaches very debilitating burcittis in both hips buldging dics in my back due to an injury,diabetic nerve pains,muscles that wont stop aching,pain throughout my whole body,i literally have pain from my head to my toes,,IBS is very painful and embarrassing, severe anxiety and panic attacks also untreated…the opioid crisis needs to stop and NOW before more people COMMIT suicide from people who are trying to play GOD with peoples lives..we should have a say as to what we do or dont put in our body…

Kelli Davidson

I am very hopeful!

Maureen M.

I’m glad to hear that Dr. Lewis and our advocates were heard. May this be the beginning of a very strong movement on our behalf. I will continue to pray that the tides change soon.
Far too many lives have already been taken due to this inhumane abuse on our community.
God bless all involved. Keep strong WARRIORS!!!

CRPS patient.

I’ve lost all hope of ever being treated fairly. We are survivors of these awful diseases and now are being vilified because of drug addicts. This ridiculous notion is now common everywhere due to the media and Trump. If I could leave this country, I would.

MrMarty

I participated in yesterday’s meeting thru the internet. I found it a valuable tool to hear from the many who can’t travel. Hats off to all participants who were there in that room yesterday. Their stories were heart-wrenching. They are true warriors that will pay dearly with extra days of pain due to their dedication & inner strength to travel & speak for the rest of us, in person. Thank You!
The FDA must do something quickly or deaths are going to pile up. Hopefully They’ve been re-educated on what compassion is.
I understand the docket is still open for comments and personal stories into September. If that’s correct, there’s no excuse for All to tell their story. If, You’re unable to perform this task on-line yourself, please reach out and ask a friend or a family member to assist. As we know many of our lives can depend on the continued Input & pressure we place onto the barbaric CDC. May God Bless.

Kathleen

For some, like myself, the damage has been done. Medicare has dumped members/patients off to a private company that now dictates my care without even knowing me. Doctors medical insurance has gotten their greedy hands in this and they have the ultimate say or the doctor faces increases premiums. I don’t matter to anyone, no one cares. After living a life with my chronic pain controlled I now have nothing and suffer every day. The problem was and always has been heroin and fentanyl. Junkies have had absolutely NO problem getting their fix through all of this. Every day I lose more and more of the will to live in untreated pain, treated like an addict/drug seeker. Why did I follow the rules of my state and doctor? To be tossed aside like trash when I did nothing wrong but inherit a rotten spine? All branches of law enforcement and the distructive DEA should be doing the jobs you have been sworn in to do…STOP illegal drugs. The ripples from the insane guidelines originally made by the CDC is killing me.

David M Peck sr

This will probably be a wasted or prolonged effort. In the meantime thousands like myself are suffering because of hurried decisions. These organizations ( the FDA, CDC,and the DEA) all know we are suffering. Do they care? I doubt it.

Rochelle

To all who were able to attend and those who were able to communicate by phone to the committee, you deserve a hearty thank you! Like many I submitted my story to this docket and hope they feel our pain and desperation.

Gottlieb’s comment definitely removes any air in the sails. By stopping short of saying they, the gov, would not change the damaging 2016 opioid guidelines pretty much says at this time, nothing will change. They claim to “hear” us and actually effecting immediate or even long term changue probably won’t happen in this administration. Thousands of pain patients have commented on the FDA site, have written to Gottlieb so he is well aware of the wrongs those who suffer from intractable and unrelenting pain on an increasing basis have undergone, but won’t see any increased relief if any, anytime soon.

The current administration has invested too much time and money blaming opioid pain medication as the cause of the grossly over reported numbers by the CDC on a misnamed opioid epidemic. I would love nothing more than to have to eat my words. I am also a realist..

Being a pain advocate is tiring and often overwhelming but we must continue our fight for change, we cannot just give up to the negative rhetoric. We can’t, our lives depend on it.

Sky

Let’s all pray that the FDA has heard our cries and starts as the first of many regulatory systems to start changing their strict rules and “recommendations” to exclude chronic pain patients. Hopefully, all of our hard work will start to pay off.

Cindy

Has anyone posted the rates of overdose of people who are taking prescription medication as prescribed ( not illicit or drug seeking behavior))

Because it seems to me that part of the problem is regular patients are penalized due to for lack of a better term , the tragic , heroin or street seeking drug addicted people

I’m glad to see at least voices are heard for as much as that as is worth with the government right now