Public Meeting for Patient-Focused Drug Development on Chronic Pain

Public Meeting for Patient-Focused Drug Development on Chronic Pain

By Ed Coghlan

Over 1,000 people—many of whom are National Pain Report readers—have filled out a survey designed to inform an FDA Patient Meeting on July 9, 2018. The official title of the event is a Public Meeting for Patient-Focused Drug Development on Chronic Pain.

For Dr. Terri Lewis, who is conducting the survey, the response has been both gratifying and disturbing, noting that she is capturing a lot of data that reflects the changing ways chronic pain is treated in the wake of the CDC Opioid Prescribing Guideline.

She (and we) are asking that if you haven’t yet filled it out—to please do so in the next couple of weeks. She will cut off responses by June 17 in order to tabulate the results to be ready for the meeting in July.

To take the survey, click here.

As Dr. Lewis wrote last month, “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.”

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. 

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. 

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.

Here is a story on the early results found in the survey. A more comprehensive report will be available before the July 9th meeting.

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Authored by: Ed Coghlan

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Steven

I forgot to say in my earlier comment that my current 187 mme is down from 352 mme at its peak. So that leaves me down 40% today and there going to take me down another 50%. I can’t get by with what I’m taking now let alone go down another 50%. I’ve told the provider at the last 5 visits as they reduced me that I can’t possibly live on that 90 m m e. They just look me in the eye and say tough I guess you need a second opinion. Seriously, it’s obvious that whoever’s left a year from now will be taking Tylenol, ibuprofen and aspirin. Thank you NPR for all you but what purpose will you have when all in pain have been eliminated? yoga, exercise, diet, acupuncture, massage and all the rest are no substitute pain medication. If they were we would all be cured. The public just will not accept that this is happening. I’ve tried to explain that the doctors are being forced by the government to do this to us. That it has led countless deaths and my immediate family a counselor and even my pastor just won’t believe it.

FormerPatriot

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Notasheep

P.S. What the hecks up with captcha? Have to type at least 2 for acceptance, even though they were all correct? Am I the only one having trouble?

Notasheep

Well. I just sent to the fda to see comments. Mine was gone. No where to be found. What the ####?? Emailed, will see what the reply is. I even had received the receipt same day I commented!!!

Mary S

Thank you Terri for your guidance and assistance!
I filled out the form. It’s a bit iinitating at first but once you get going your thinking I know all what to say. So I filled in the answers , questions that didn’t apply to me I left blank. Try it is is for us to regain our dr. Treating us, pharmacy too.
Thanks everyone! We have to bear this insane notion that we too need treatment.

Steven

I get treatment in California. my Dr has told me that he doesn’t want to do this but is being made to . His practice has gone from whatever the patient needed all the way down to a pitiful 90 m m e. I am currently at one eight seven and I know I can’t get by with less than 200. Does anyone know any state that will give 200 mme. I cannot last much longer. Thank you one patient to another.

Dear former Patriot,
You should not feel as though you need to apologize for posting what we all need to do and know. Perhaps someone missed a story the day before or the week before and has no idea about these other places we all need to respond to. It only takes a few moments of time. Literally no longer than 30 minutes if that. I for one think what you are doing is very admirable! Keep on posting and God bless you for caring so much! It’s people like you that make people like me smile! Still praying miracles for all!

carl s. dunn

I filled out the survey, but I have to comment on a Florida Republican Congressman Vern Buchanan who voted to give corporations a permanent tax cut, and his is a multi-millionaire, close to 100 million in wealth and he owns a bunch of car dealerships, funny how he is so rich now. However, here is the joke, and that is he has a re-election campaign using mothers who lost their children, actually adults in age, to overdoses. So his advertisement is telling us how he has fought the opioid crises for 9 years! And lost, apparently, but yes, vote him in again! Now you see how these slime-ball sleazy politicians will use emotions to sway the public to vote him in again! My point is he isn’t really concerned about doing something about overdose deaths but get re-elected. These creeps only care about their self-serving interests and are two faced about real issues. I haven’t heard this one do anything for people needing help to get their lives together again, or create a movement for compassionate care for CCP’s. Nothing but re-elect me and uses mothers of overdosed sons and daughters tell how wonderful he’s been doing for 9 years fighting the opioid crises! This so called crises hasn’t even been a crises for two years! The problem in Florida is it was a pill mill and has the highest number of heroin addicts! It became the highest of heroin addicts because of the pill mill shutdowns! What do addicts do when one supplier is shut down, but find another source! Duh! You would think they would have more methadone clinics or safe rooms to medically administer heroin safely or needle exchanges. Hell, if I can think of these things, why don’t we hear of what the government is doing for the people addicted to drugs, but no, we hear “just say no!”

Bradley Hannah

I dont have health insuance the VA has been my health care for 20+ years, the past 5 I cant get them to do anything. I have chronic pain knees ,back, my VA doctor got me exrays of my back and he calles me up and says “YOUR BACK IS REALLY MESSED UP” yes I know I told him, he did not one thing and continues to threaten to cut me off pain drugs, I became allergic to NSAIDS many years ago when they cause kidney failure. So opioides is it for me. I asked for one more pill a day he says I increase it by 1.5 pills a day. He absolutely lied he told me that to get me out of his office. Every morning is a struggle!

Susan

Big Pharm

Addiction is a 2 way street. The people who are taking the drugs are addicted to the drugs, and the people making the money are addicted to the money they are making from the sale of these drugs.

There should be no problem in funding"THIS"emergency.

Big Pharma should train 65% of graduating doctors in the art of prescribing pain medication.

It is my suggestion that the people who made the mess, clean it up. So get ready Big Pharma. Its time to invest all those profits in getting all the people you have addicted to all those drugs cleaned up and ready to be a contributing members of our society.

Oh yes, and all the Senators and Representatives who are taking Big Pharma money, its time for you to pay it forward.

You need to feel the pain of letting go of the one thing that has prevented you from being in the addicts position. You are the people who have forced the addicts into their addictive state.

Stop and think about what you would do to escape a life that no matter what you do, you can;t climb out of the cavern, that unemployment, a car wreck, and many other

 catastrophes have hit you dead on and landed you in the realm of "I just dont know what to do, and therefore I just don't care". The escape will be pill away, and it will be the easiest decision you will ever make. Then its down hill into that cavern you could not see you way out of it

So I am challenging Big Pharma, and those who delight in taking their money, ie investors dividends, lobbyist and those that take their money, TO CLEAN UP THEIR MESS!

Big Pharma profits have Caused this problem and will continuet to,until you STOP investing in death by legal drugs.

Rich Reifsnyder

Hello,Please don’t forget we Vote in New Jersey tomorrow June 5 th.Just remember Senator Menendez making St.Joseph Hospital,a model hospital for not giving pain medication in its emergency room and trama units.I wrote to Sen.Menendez numerous times about the CDC Opiod Guidelines and received no response.St.Josephs Hospital had real bad reviews but since it gave aspirin instead of pain meds to patients the Senator is making it a model for the rest of the country,how nice.I will be at the polls tomorrow and won’t vote For Menendez or Van Drew.Time to Clean Out The Swamp.

FormerPatriot

I apologize that I keep re-posting this. With now three opportunities to be heard, there is just too much chance for any one of them to dilute the other two.

As I write this, there are over 1500 comments on the HHS docket, but only 288 on the FDA docket.

If you have commented on just one of these two, YOU ARE NOT DONE!!. Every single comment on the HHS (https://www.regulations.gov/document?D=HHS-OS-2018-0009-0001) docket needs to be made as well on the FDA (https://www.regulations.gov/document?D=FDA-2018-N-1621-0001) docket, and vice versa.

(If you want to present your case in person at the FDA, note that the public hearing will be July 9th. Details are available on the FDA link above.)

If you have commented on both dockets, guess what? You are STILL NOT DONE!! This is a link to a survey tool (https://www.surveymonkey.com/r/Y8YXRJ9 or click on the link in the article) that will aggregate your responses for a presentation Dr. Teri Lewis is going to make to a meeting of the FDA.

Altogether, this may seem like a LOT of work, especially for someone in chronic pain, but since this nightmare began, we have NEVER HAD A BETTER CHANCE for someone in government to actually HEAR OUR VOICE!! If you need help, ask a family member or your caregiver.

All three of these are equally important. Please do not stop with just one.

There are over 60 anti-opioid bills in Congress right now. Chances are, not a single one even mentions patients in chronic pain.

Last day for comments HHS docket: June 15.
Last day for responding to survey in above article: June 17
Last day for written comments FDA docket: September 10th, 2018

(Looks like you have plenty of time on the FDA docket, doesn’t it? At least for me, that is exactly the situation that makes me forget about it altogether until it is too late. Even though the head of the FDA has a sympathetic ear and predicted this situation back in 2012, there are only 288 comments on the FDA docket. We need to push that number up hard and fast and NOW! )

Please do NOT let ANY of these chances to finally be heard pass you by!

Come on folks if you’ve not filled this survey out then please do so, that is if you are at all able to. It’s not hard at all. If you’re not up to it due to pain then we all know too well you’re not up to it and that’s okay. I also wish there was a way to get this test out to the millions of pain patients who have no idea that the national pain report even exists. One day I was looking for answers and happened to stumble upon the National Pain Reports website. We shouldn’t have to stumble upon anything, it should be in our local news among the national news; not just on a website. Perhaps doctor Lewis can get that accomplished as well. I have to wonder though just how serious we will be taken if only a few hundred write in when we know there are millions out there…..