Public Meeting for Patient-Focused Drug Development on Chronic Pain – United States Food and Drug Administration, July 9, 2018 Patient Meeting

Public Meeting for Patient-Focused Drug Development on Chronic Pain – United States Food and Drug Administration, July 9, 2018 Patient Meeting

By Terri Lewis Ph.D.

For months now, chaos has reigned in the lives of persons with complex illnesses, chronic and intractable pain. It’s breathtaking – we hardly know where to turn in response to the advancing hordes of disinformation, misinformation, and downright false representations about the lives of Americans who rely on the healthcare system to live and meet family and community obligations. The effect of this chaos is palpable – outrage, fear, frustration, confusion, anger, feelings of just giving up because it is simply too much. And increasingly some are doing just that – saying ‘enough’ and ending their lives.

We asked you to organize and mobilize and you are rising to the occasion. Groups are forming, planning is occurring, and while it’s by no means perfect, sometimes messy, it is action and it will sort itself out. Leadership is emerging, folks are stepping forward to help and by taking action, rage is converted to discernment, activity.

Terri A Lewis, PHD

Why is it worth your time to complete this 31 question survey that was posted through National Pain Report and social media? Wouldn’t it just be simpler to send FDA a message or just respond to the questions they posed on their meeting link? Yes, absolutely it would. And you can. Or you can register to attend in person or watch this meeting from the comfort of your living room or bedroom.

But it is not just about you. And we have heard over and over again that nobody has asked you how you are affected by this crisis. So we are asking you to come forward from every state and territory to tell us how you are being affected by the most recent changes in your healthcare system.

While management of diseases and pain is very personal, the goal of this survey is to help us to understand the effect of the chaos that has been visited upon you and to communicate this to others in ways that it can be heard and cannot be ignored. By linking your comments to other data at the state level and the federal level, we can document harms and counter the misinformation and disinformation that is spread by the bots and trolls that manipulate and move regulators and policy makers who are making decisions that will negatively impact your lives.

The CDC Guidelines unleashed in March of 2016 served as the tail wagging the dog. While we believe that this was the beginning of profound changes, in fact they were the culmination of a quiet change management effort that began in 2012 in the state of Washington. States were quietly making exploratory changes to their pain regulations from 2012. The impact of this effort simply became visible to most of us in 2016 with the passage of the CDC’s Guidelines. And not one of these regulatory approaches to managing your health care looks like another. While the 2016 guidelines added yet another layer of complexity, chaos has been building for awhile and you have felt it in ways large and small.

Most of us would agree that we need consistency – but there is none to be found. Not at the state level and not at the federal level. The last federal election simply magnified the impact of the health care battles over rights to access and costs of care. Fifty states and seven territories have enabled various forms of legislation – but among them there are no consistent definitions or directives that make sense. And not one of these regulatory devices has built in ways to measure how affected persons are impact – good or bad. Where legislators believe the poison that prescriptions are the root cause of the street drug crisis, patients are turned into villains of the crisis. As prescriptions reduce, overdoses and deaths due to suicide are steadily increasing. So is the negative impact on you and your health care.

In this environment, physicians cannot properly care for patients – and so they are doing all they know to do – and that is to stop providing care until somebody figures this out. They will protect themselves from this chaos first because they must.

It takes about 30 minutes of your time to complete this survey (unless you write a book). All of FDA’s questions for the July 9 meeting are included into the survey tool. They are incorporated in a way that they can be compared to a variety of important questions about other pending changes to the system – the CMS2019 final rule that will take place in June of 2019, DEA’s proposal to downsize production caps (again), continuous changes to state regulations, and more.

Here’s a link to the survey.

I live in Tennessee – it’s a wasteland at the moment, but on a brighter note, patient groups are organizing and a palliative care law has been passed that we hope will finally help improve wider access. Conversation with our elected regulators is increasing.

Importantly, many of you qualify for palliative care (not the same as hospice or end of life care) for your multiple chronic comorbid conditions. Palliative care, used properly, will stabilize the ability of physicians to treat you through a supportive care delivery model. Tracking this across the states is one of the strategic objectives for this survey – documenting the fact that you are first, people (not villains or #$%&), who experienced a traumatic event, an illness, or a medical harm, and second, that these injuries left you dealing with lifelong diseases processes that must be managed. And one of the features is pain – in a variety of forms, chronicity, and unique expressions. This pain requires integrated care supports that is not uniformly available to you because your needs are not uniformly described or understood (chaos). And you have become the least important person in the room – and you know it.

This survey will close June 17. After that date the submissions will be analyzed into a summary of your experience across the nation, a state summary that compares your experiences to the operations of state laws, and a summary that will be readied for the Federal Register and Congressional Committees and their health care staffers. News releases will be readied for journalists who write about these issues. Human Rights Watch will be provided with copies so that they can continue to build their analysis of conditions of care in the USA. You will be provided with a copy of results for your personal advocacy efforts.

Estimates of persons with chronic and intractable pain range from 25 – 55 million depending on the source and definitions in play (there’s that chaos thing again). Medicare (2015) reflects that roughly 55 million people meet the definition of multiple complex chronic illnesses defined as two or more life-long disruptive progressive diseases. But we still have 17 states without consistent access to health care and in many states, hospitals and primary care and pain clinics are closing. Our experts are being harassed by DEA, because they framed the chronically ill as persons who are abusing the system.

We can continue to accept whatever is thrown at us. Or we can work toward making sure that services are provided appropriate for our use. It will not happen without evidence of your experience.
Either way, it is your choice.

Dr. Terri Lewis is the mother and the daughter of chronic pain sufferers. She is a critic of the nation’s health care system and is a frequent contributor to the National Pain Report.

Authored by: Terri A Lewis, PhD.

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Cathy Adams

I’m a 3 time cancer survivor and, while I’m deeply grateful to still be alive, I am suffering the well documented and well known long term effects of cancer treatment – severe heart damage ( widowmaker hearty attack, triple bypass, congestive heart failure, TWO aortic valve replacements ), secondary cancer of breast with more chemo and double mastectomy, and severe degenerative damage to the discs, cartilage, facet joints and joints of the spine along with both hips. I have had intermittent pain treatment for several years consisting of temporary pain meds and injections.
At this point, my conditions require constant pain meds and spinal and hip injections for flare ups.
What happens when my pain meds dosage inevitably increase to 90 MME and above? Do I then go on palliative care for the long term effects of cancer? Why is my pain doctor, who has given me such a great quality of life for so many years, suddenly forced to work within narrow limits of pain meds and dosage options to offer me?
Will I have to leave my wonderful long term specialist physician to start all over with a palliative care doctor who doesn’t know me?
I want to stay with my doctor and I want him to be able to offer me the most effective medications that have been created and approved specifically for pain relief. Why is that so unreasonable??

I live in Knoxville Tennessee. Most of the pain clinics have been shut down there’s only three now. And they have all gone to Chiropractic / acupuncture / Physical Therapy / yoga and the urine test they do are very expensive and insurance will only pay for so many and then it’s out of your own pocket. It’s like they’re Reinventing the wheel because chronic pain people have already done all these things to find relief but unfortunately it did not work. So why are we forced to pay for these things again just to prove that the Physicians are not doing anything wrong so the DEA will stay off their back. I did call Lamar Alexander and Bob Corker and only was able to speak to a secretary. I let her know how difficult this has been on me as a chronic pain person. I explained to her that they need to create newer drugs and not take people off opiates until the FDA approves new drugs to replace opiates. And that the pendulum has swung too far and they are hurting me as well as other people and some are even committing suicide because their pain is unrelieved and or they can not afford just like me to pay out-of-pocket for all these Hoops that a pain physician want you to go through . and then we have already tried all these above treatments and why should we be forced to pay for this again. And a physician has already sent us to do all these things prior to sending us to a pain specialist. Also I mentioned as a taxpayer and a voter why are my concerns about wanting pain relief ignored. I was very polite and all the secretaries would say, I understand and I will give this message to Alexander/ Corker. I gave them my name ,address and they already had my phone number because it shows up on their phone. I also brought up how the controlled substance database they need to extend the time so the pharmacies can make Corrections when they get it wrong and put someone else’s name on pain medication. And if the pharmacist makes mistakes that makes me look bad and especially when they cannot correct it at any point in time. That I am not an addict, that I do not like being sandwiched in between the physician and the pharmacy. I don’t smoke or drink. And that they are pushing people to go to the streets. The CDC does not include all the people that have committed suicide because of uncontrolled pain / or able to afford pain management in their studies that say suicide is now higher. And its less than 1% of people who have urine screens that they may find illicit drugs.

Sandi

Link to the survey says “This survey is currently closed. Please contact the author of this survey for further assistance.”

Will the survey be back up? I was ready to share until I received the error message.

We chronic pain patients desperately need help and to have our voices heard! I can’t have my medicine cut down any more, especially when I don’t really have the option to go to just any doctor. I was on a three medicine combination that worked quite well. Then the guidelines came in and I had to choose two and the amount and dosage went down.
I’m not a drug abuser, I just want some kind of life!

concernedpharmacist

This mess that we are in now is the fault of the DEA and each State’s Board of Medicine. The “pill” mills where allowed to run for far too long. No one in their right mind can really believe that going to the doctor month after month for 5 minutes and paying $100 cash and walking out with a script for 180 Oxycodone 30mg, or “max” quantity of whatever short acting opioid was good/legitimate patient care. The DEA knew this was going on for decades. The State boards knew this was going on for decades. They have caused legitimate patients to be looked down upon as criminals/junkies. While the real junkies are just going back to heroin. PBMs don’t want to cover narcs, pharmacist don’t want to fill them, and legitimate doctors are wary about writing for them all because the DEA is now on the war path in their “WAR ON OPIATES”. As a pharmacist, I’m scared (or perhaps terrified) of losing my license for something stupid. Mess up and don’t check PMP because I’m too busy and let someone that was dr shopping through? One day the DEA or Board of Pharmacy could come a knockin and “bust” me on that. Fill prescriptions from a Dr that I thought was being legitimate but DEA ends up investigating him?Whelp there goes my license. Could I fight it? Yes. Can I afford to be out of work for several months or years? No. Want to see how far the DEA will go? Just look up what they pulled on Morris & Dickson just a few weeks ago. This distributor that supplies thousands of pharmacies, hospital and nursing homes was unable to supply narcotics. Folks, that’s not just Norco. That includes seizure meds and surgery meds too, and many many others besides opiates. All because of some supposed paper work that was failed to be filed over a few “suspect pharmacies” in Louisiana a year ago. The DEA doesn’t care about your mom or grandma in the nursing home that may have to suffer. That’s just collateral damage in this “war”. Are there rx abusers? sure, but they are the vast minority who have now swayed policy over the majority of legitimate patients. I could go on and on.

Very sick

Please, all chronic pain people need to do this and also tell their stories to the FDA open comments that runs through Sept. 2018. It’s our only chance. 180 comments isn’t going to work. Let’s put it to the FDA like we did to the DEA open comments in May.

Jennifer Reed

I have registered to be a panelist for PA as a long term chronic pain patient that has been severely damaged in every possible way, simply for being sick with diseases that have no cure, are as painful as cancer pain (yes I’m saying this)& despite being a so very careful with medication, I have been treated as a drug addict for so long, no Dr could be bothered giving me basic health care; ignoring labs that clearly showed I was diabetic for 5 YEARS; being refused pain relief for kidney stones/obstructions that clearly showed on X-ray; having my prescriptions withheld by the (former) PCP to put me into withdrawal every month for 6 mos… I can’t possibly tell everything that’s been done to me, for no reason at all other than physicians automatic judgement when my medications were given, especially in the ER. Last year I became septic 3 times because my pain wasn’t believed. My medical records have multiple notes with zero truth in them. I want to be HEARD. I want my face to be seen. I write on the dockets & fight for my right for pain relief even when doctors tell me I DON’T have the right to receive pain relief even as an inpatient in the hospital. This is our chance to make an impact for everyone; I pray that my health will allow me to be there as I’ve planned to. Nothing is more important than this.

David Becker

Protesting as Meaction has done and continues to do has gotten more results than believing in communication with the iron triangle of government industry and academia. No one in the iron triangle is required to be empathetic. They are not one of us. Theyre special of course. And beimgcspecial means you arent like nonspecial pwople and you disidentify and distance yourself from them. This is the separate spheres doctrine. The same doctrine that kept women subservient to men for so long. And now people in pain are subservient.
Protest and demand big brother end the separate spheres doctrine and stop treating people in pain like serfs whose only rights are determined at the whim of big brother.
They hell with conversation that is designed to contain people in pain and relegate them to pleading serfs and sheeple.

Maureen M.

Dr. Lewis, Thank you (once again) formal of your fine, excellent, and expert efforts and work on our behalf. I filled out the survey this morn with no problem. I will now register to be present…I’d give anything to be physically present though.
I have been lowered to just 37.5mg/d for the the past 3 yrs! It’s not easy to say the least.
God bless you and your family. Maureen

Christina

We need more therapy covered and physician officed accepting all insurance plans. Need to STOP all this CASH business on Doctors and PHARMACY. It sickens me that they thinks its ok to take advantage of the sick and injuryed. We shouldnt have to decided if we are going to buy food OR medicine!!!
Now that technology has advanced we should find what works for patient by the patient and their record history (records of the hell youve been threw) be put on a usb drive that patient carry with them at all times in case of emergency to fill in any nurse or physicians to explains the journey and trial and elimination and testing we endure. If they had that in front of them before they even spoke to you it could get back compassion and care like its suppose to be. I think it would be an effective tool for everyone and most importantly pain patient and put the care of this a patient whos life has been altered by no choices of their own but must except and learn to deal with it and live on and there are so many things that make this HAPPEN it could be from bombing, shootings, car accidents, work injuries, failed surgeries and our GENETICS. All these things above puts in motion conditions that we should be dealing with as we age not in twenty or thirties. NOBODY wants to be in PAIN!
I think that disability and social security should be separated. If we started paying a separate tax for it the burden of fund for treatment could come m that I think the people should get to have a vote on it. I think its were we can get treatments covered by insurance. And also support after patient stabilities and can retrain find another way to work and support themself if they can. We need real solutions thats in this time period. Change care all the down to financial support.

Sue

Ive been in palliative care for 6 months. I spoke to the Doctor this morning and they too are struggling to get patients their pain medications. He went to bat for me a few months ago and tried to get oxycontin er low dose approved for me; so that for a change, I could sleep through the night. OF COURSE, it was denied. I got a letter from the insurance company saying congratulation, we have approve Xtampza er for you. From ive heard, pharmacy dont even have it right now and the recent reviews on it are scary. Its a new drug and i refuse to be an experiment for Big Pharma another time. I will continue to deal with broken sleep. The percocet wears off and wakes me up and i cant get back to sleep for 2 hrs. What happened to comfort care?

debbie

chrioic pain no doctor will help.
.

Nancy Apa

Just read on Wikipedia in 2015 the drug Rivaroxaban accounted for the highest number of cases of serious injury among regularly monitored drugs to FDA’s Adverse Events Reporting System. Did the media focus or report on THAT?? Nope!!! As a long term pain patient, I’m being punished and vilified for something that I haven’t done, I haven’t abused my prescription. And now that my prescription has been cut by OVER 75%, I hoard and guard it with my life!! Once, I went to ER becuz I felt weird, light headed, fuzzy,I told them I shouldn’t feel like this. I swore and knew exactly how much medicine I was on(my normal dose) but becuz my blood oxygen was only 72(very low) ER doc decided I OD’d and he Narcan’d me [edit]. For someone who’s neurologically impaired, it was a HORRIFFYING PAINFUL experience. And I DIDN’T improve even after i was put on oxygen. Nope!! Monday morning my pulmonologist showed up, takes over with STEROIDS AND ANTIBIOTICS. I had a bad upper respiratory infection. I will NEVER FORGET THAT as long as I live.

Terri Lewis

There seems to be some who are using tools that are ‘cranky.’ If you will send me an email to tal7291@yahoo.com, I will send you a paper survey which you can fill out by hand and email back to me as a pdf. If you don’t know how to do that, find a teenager 🙂
They live and breathe this stuff!

Notasheep

Nana,

I am talking to my np about palliative care next week. It will be in addition to my pain mis-management doc. Only protection from the coming Medicare narcotic changes. Just in case I find a real doctor, one who follows his sworn oath.

Notasheep

Dee,
Just happened to me yesterday. Only my doc will now only go 50meq and this is pain management specialist too, with certs out of the wazoo!!!!! The one I drive almost 8 hours to see, not a regular doc or chiro climbing on the pain mis- management money train, a real specialist. Just in time for osteoporosis rx and consequent must do weight bearing exercise. Christ……….

Notasheep

Very well put Terri!
TY!

Steven

Thank you so much Terri, I wish we could have gotten them to listen to us before they had gotten all the way down to 50 m m e maximum. That’s not enough to treat a head cold let alone an 18-year neuropathy. Many of us will just die in the next month before we even get to be heard. I guess my mistake was being honest and playing by rules. That cost me my life. We all could have gotten what we needed for a normal life time when pills were available. All my doctors say tough there’s nothing I can do. I should just make my pain my friend. The doctors are not just treating us to a lifetime of torture but sentencing many of us to death. What else can we do? Time is has run out.

c.c.

They keep erasing my answers and won’t let me file.!

Penny Elmore

The survey states you have to install a survey monkey and download Java to take on a smartphone. Conveniently my iPhone can’t download Java. I have to check to see if I can on my laptop, but I haven’t updated it in a while cuz I rarely use it. Maybe I’ve missed the info, but I didn’t see how we can do the survey if we’re unable to do it electronically. Anybody see info on that or contact info to find out?

Holly D.

Thank you Terri so much!

I have an appointment for palliative care coming up. I am at my wits end. I will fill out the survey and “attend” the meeting.

Bernadine

Just finished the survey. Thanks for providing this information so that we in the pain community can stand up and be heard.

Kelley

I worry that they will manipulate the results, to further gain support for their barbaric laws, (guidelines) I have 0 trust in the powers to be in this country , and I have no doubt that they would find a way to do tomi he spreading the lies and hate toward pain patients, like myself. I believe they won’t stop until we are all dead, and they can co tune to line their pockets with government funds

Victoria A.

CathyM: I completely agree with you! I just turned 30 in March, and had to have an urgent surgery on the 1st of May for Endometritis & Endometriosis.

The pain management post-op was just not there…they gave me two tablets of 5mg Norco and an injection of Ketolorac (Toradol), wh/ is just an NSAID I believe. I was honestly waiting for an injection of pain medicine through my IV, but it never came. At least I got a few tablets of one of the lowest doses of pain medication known to man!

Anyways, if someone came into MY post-op room & had said, “you aren’t getting an rx for pain relievers to take home, instead you get Motrin 800mg, and were going to briefly teach you meditation, breathing excersises & you’ll have a 30-min. session of Cognitive Behavioral Therapy before you leave the hospital (and, btw, none of this is covered by your TRICARE insurance)”…I would be beyond angry, I would probably rip my IV out and tell the people off, and I would absolutely refuse to pay the hospital for my surgery and their services! I hope it doesn’t come to that when I get my next surgery!

M.Billeaudeaux

Survey done! Thank you for this. It takes a few minutes but it is well worth your time to try and change this current attitude and restrictions for pain medications for patients.
PLEASE COMPLETE THE SURVEY

Geri

I will fill out the survey but, although I hate to be the voice of doom, I am afraid it will do no good. Nobody cares. Our government intends to criminalize as many Americans as possible. This is only the beginning. If our doctors really cared they would have risen up and protested but instead they are hiding and throwing their patients under the bus. Pharmacists care even less. They should realize that this is only the beginning and their businesses will be controlled more and more by the government. Our lawmakers are very happy to criminalize Americans on the instructions of Wall Street which is profiting from the jails and “rehab centers” they will be building. The media has fixated on the “opioid crisis” which really does not exist. There are already plans to make these rehabs compulsory for anybody who is found to be an “addict”. Which is anybody who needs pain medication chronically. Which is us. The train has started up and we are all tied to the tracks.

David Becker

The fda hearings on pain are both tragic and farcical. They tragically reflect the failure of government to hear the voice and suffering of people in pain for such a long time. Theyre farcical because government for so long has been inured to the suffering of citizens in pain that theyre not capable of genuine empathy compassion or understanding.
The culture of government officials and experts is far different from the culture and experience of people in pain. There is clearly a continuation of a great empathy and cultural insensitivity to pain.
I am aware of no efforts on the part of government to change their culture their empathy their capacity to include people in pain as vital decisionmakers in their pain care. And whose pain is ot anyway. Does people pain belong to the fda or cdc to do with as they please. And so in our feudalistic and callous pain system government acts like feudal lords over people in pain. Frankly the fda cdc etc are not fot to serve the needs of people in pain they lack the representational capacity the caring the motivation the intelligence to do so. Theyre a burden to people in pain. Theyll remain unhumbled unreformed unregenerate and continue their guernica like inquisition on people in pain until civil society remembers the history of rights and the memory of freedom and throws off their tragic farce on people in pain

Alice Carrollł

If we would like to attend the meeting are there going to be any hotel deals where we can book at a reduced rate? Are there plans for chronic pain patients to meet before the meeting to discuss what to expect and how to relate to FDA? Please let us know hearing times, address etc. as we will need to arrange transportation.

CathyM

Thank you so much for this!! I intend to fill out the survey, though for the moment I’m luckier than some, both in my level of pain and in my access. But I live in fear, especially after reading the news, so I know we have to advocate for ourselves. This is a macabre “response” to a small number of people abusing prescription drugs. Hearing that some hospitals are trying to do “no opioids post surgery” frightens the hell out of me!! I use and appreciate acupuncture, but OMG! And if someone came to my hospital bed after an operation and told me they would teach me cognitive behavioral stress reducers,I’d probably call the police. This has GOT to stop.

nana

So, chronic pain that will nerve “be fixed” patients should go to palliative care management instead of a pain management doctor?

B. Gould

As difficult as this is we must do this! You know what’s sad about this whole thing is that there was no Alternative Care to replace our most effective form of treatment and instead they just took it away without any thought about how this would affect the Chronic Pain Patients and now everyday people who are in need of emergency or care on an as needed basis. Thank you Dr. Terri A. Lewis, PhD.

Rita KIMBEL

If the survey is going to help the CDC when it comes down to 2019 rewrite, we must get our butts in gear and answer these questions. Finally they want to hear from us, will it make a difference in the way pain patients are being treated at other levels, pharmacy, ER, new patient? We’ve been treated worse then animals in a Zoo, caged in with no chance of being released. Something has to change…

Noelle

Survey Done! Thank You!

Susan Brucks

Great article, thanks Terry!

David Cole

Just joined SurveyMonkey it’s easy to do, so if you don’t know how to do it just go to Google and say Survey Monkey and sign up and then fill out this survey.

Dee

Chaos is a good name for it. People all over our nation are being punished. One comment I just saw made me realize the 200mme is nothing. “Well folks, I hope you’re all ready for a shock at your next 28 days doctor visit. It’s happened. My doc says now he’s not a 200 mme Doctor any longer but a 90mme” People thought the 200mme would make a difference. It isn’t doctors still have to talk to pharmacists to persuade them to fill a prescription. They must go over treatment plans to reduce. Doctors who have no time now, are not going to prescribe over 90mme when they know it will result in many phone calls from pharmacists.