Tell the FDA There is an Urgent Need for New Options for Pain

Tell the FDA There is an Urgent Need for New Options for Pain

At the U.S. Pain Foundation, we often send out notifications to the pain community about opportunities to take action on pain-related issues at the federal level. Most people, if they are anything like me before I became an advocate, assume weighing in on these opportunities doesn’t make a difference.

I want you to know that it does! Your voice really does matter. Federal agencies have rules for how they must handle responses to public comment periods. They are required to review and consider public comments in their final rulemaking. Typically, comments are read and then categorized according to key topics or concerns within the comments. If 1,000 people write in about a key topic or concern, it gets attention. At the very least, a large response to a comment period lets the agency know that many people are paying attention to what they are doing and will want to see their views reflected in the final product.

Cindy Steinberg, National Director of Policy & Advocacy, US Pain Foundation

With that in mind, I want to encourage all people with pain to submit their comments about the urgent need for new medication options for pain relief to the Food and Drug Administration (FDA) by this Monday, Nov. 18, at 11:59 pm EST. Specifically, the FDA would like the public’s views on two main issues:

  1. Should sponsors of new opioids be required to demonstrate comparative advantage relative to existing opioids?
  2. What incentives would better support and encourage the development of new treatments for pain?

This comment opportunity comes on the heels of a Sept. 17 public hearing at the FDA, called “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” At this hearing, many different views on these questions from various individuals and organizations were presented. For example, some people said that no new opioids should be approved and that existing opioids should be reconsidered for possible removal. Others said that there has been a drought of innovation in pain therapeutics and that FDA should do more to encourage innovation.

Sadly, it is true that there has long been a dearth of new safe, effective medications approved for pain. We encourage you to tell FDA what impact pain has had on your life and how speeding up the development of new drugs in the pipeline could make a difference to your life and the lives of so many others debilitated by chronic pain.

Electronic comments can be submitted here. Again, the deadline is Monday at 11:59 PM EST.

Your comment doesn’t have to be long to make a difference. What’s most important is that you submit one. This is one way that you can contribute to a better future for people with pain.

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Authored by: Cindy Steinberg

Cindy Steinberg is the National Director of Policy & Advocacy for US Pain Foundation

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James McCay

I’ve already contacted the FDA several times- the 1st time BY PHONE! I’m not wasting my time again!

SEVEN YEARS AGO- I called the FDA with my idea that they create an ID Card (similar to a Passport ID Card) for Chronic Intractable Pain Patients only. This ID card would be scannable by ALL doctors, pharmacies, and the FDA/CDC/DEA. It would have ALL your pain related medical records on this card, all criminal drug related convictions, all psychological diagnoses, all medications you are on & the patient gets to choose what the pharmacies get to see (HIPAA Laws), but by accepting this card you give ALL doctors & the agencies above full access to the info on your card.

This way ALL dumb doctors will NEVER AGAIN be able to “assume” you are a drug addict by the “way you act”, WHICH IS ABSURD!

All doctors will have all your pain diagnoses. So they’ll know how much pain you are in daily (in nearly all cases) by your diagnoses.

Pharmacies will NEVER AGAIN be able to stick their noses where IT DOES NOT BELONG (as long as you let them see all meds you are on, any drug conviction, any DOUBLE monthly fills, etc.). This will STOP pharmacies who MULTIPLE prescribe opioids by taking up to DAYS to submit what they fill to the BROKEN SYSTEM that’s supposed to STOP multiple monthly opioid very similar prescription fills. But what they see is YOUR CHOICE! If you DON’T let them see things & they refuse to fill an opioid; that’s ON YOU!

The FDA told me the1st time I suggested this “That is a WONDERFUL idea, but we’ll have to submit it at our monthly meeting. If it is accepted we will contact you. If not, it wasn’t accepted.”.

So since the FDA rejected my “WONDERFUL” idea SEVEN YEARS ago when getting opioids became a severe problem in NYC already, someone else needs to propose this idea again. It would be far more effective if several people propose this idea (adding ideas)!

I give full permission to anyone to submit this idea AS THEIR OWN.

Lee Green

Can someone put the DEA numbers for us to call. I can’t take much more pain, I always heard stories of people faking pain and getting meds. They should have test that show no pain or shows how bad shape a person is. DEA does good things. Why are they punishing the ones with real pain. I just wonder how many innocent disabled people are committing suicide because of our government. Send me message of a group to join. I will even travel to Washington to do the test they wont done. We are going to have to all go to Washington together.

When I went to the site, it says “Do not submit comments here,” yet below there’s a form on which to submit comments. I’m confused. I don’t want to waste my time yet I don’t want to miss an opportunity.

For my chronic pain from falling off a roof 20 years ago – I find it is never going to be one magic thing that helps; it is a combination of many things. I also found no single doctor is as vested in my well-being as much as I am. Be your own advocate and fight for what you need. I still have pain, but find ways to minimize it as much as possible.

I believe the govt wants us to have pain so that ppl will hurt so bad that ppl wth pain will take their own lives. This thins the population out. This is the only reason that makes sense. Why else wld a human being want another human being to hurt so badly.

Thomas Israel

I retired and moved, when I tried to get a new doctor I was turned down by several different doctors because I was taking pain medicine. I finally found a new doctor that would accept me and would resume prescribing me pain medicine. I have witnessed my wife loose her quality of life because her pain medication was cut because the doctors are afraid to prescribe her pain medications to the limit she was accustom . The disabled are being mistreated just because she needs help with her pain.

Vanessa Franklin

Vanessa Franklin
Spinal Fusion and hip replacements
After 10 major surgeries (3 of which were spinal fusions, 5 hip surgery’s and 6 hip dislocations) I began my relationship with chronic pain. It has taken 5 years of experimentation, finally finding my comfort zone while maintaining a some what normal life with 6 Percocet a day and 75 mcg of fentanyl every 72 hours. I was treated by the same specialist for 15+ years, when, because of the changed guidelines, she advised me I was a one-of-a-kind patient and that she could no longer treat me. My family practitioner referred me to a Pain Specialist in Neuromodulation. I now struggle daily, 4 Percocet and 12 mcg fentanyl, with constant pain that has diminished my activity level and caused depression. I do not feel there is an end in sight for me and that I am anything but another statistic. I feel I’m being punished because I’m in pain and now being clustered in with addicts. December 9 I will be exploring my last option and going to UCSF Spine Center for another evaluation. I am afraid they might want to operate or use a pain implant. I refuse to accept there are no other options for someone like me.
Santa Rosa, CA 95404

Stephen

Patients need legal rights to get the medical care we all deserve. Patients should have the final say on treatment options for pain without fear of retribution by doctors, insurance carriers, VA, Medicare, Medicaid, and our local state and federal governments. All of these individuals, and government agencies have forgotten that they work for us, not vice versa. Chronic pain patients are required to do a lot of work every month, such as; unnecessary drug screens ( that we pay for out of pocket), unneeded med checks appointments every 3 months, medication contracts, making numerous phone calls to office staff every month to make sure they are doing their jobs, having to make a trip to Dr. office to get written prescriptions, the trip to the pharmacy. I’m not sure it’s possible to make this process more frustrating and humiliating. I am not a criminal!

Brad B

One of the comments said cannabis…that does nothing to people with chronic pain other than alter the mind for a few minutes unless all you do is smoke weed all day. I believe in cannabis i take a couple hits to help me wind down and also helps me sleep better.
What we need is the freedom for our pain management doctors and trust for them to decide what they feel that will make us get some relief. I’ve had a total of 13 surgeries after a mountain bike accident. After a failed fusion surgery…my third the doctor nicked my L5 nerve with his scalpel it has been one surgery after another surgeons telling me this one will give me some relief from the failed fusion. So, long story short and 10 surgeries later, failed electric stimulator implant surgeries, fentanyl patch that gave me a stroke, here I am to say what we that suffer need to do our part and say something immediately if you feel it is not working properly. Doctors are human and most care a lot don’t and you as a patient need to speak up and ask for another doctor that you feel more comfortable with.

Linda

If the FDA approved ALL this pain medication, then why are they trying to take it away?
Leave our meds and dr.s alone allow them to do the job, they took an oath to do… “TO DO NO HARM” seems to me this is what they are actually doing because, we are suffering, somebody please, we ALL need to start a civil suit against the FDA, CDC,DEA. I’ve been disabled for years and live in pain daily, and now they wanna take our meds away,, that’s CRUEL AND INHUMANE, animals are treated better 😭
What about alcohol??? Isn’t it an epidemic? Addictive,, destroying lives marriages, and killing people..

Susan M

I am a 59 y.o. female who was born with a congenital birth defect to my arms and actually to my whole body as I get older more things continue to show up. I was diagnosed with arthritis when I was 19…I have used opioids over the years when needed. I am now on them full time, I have been dx’d with fibro – degenerative discs in my lower spine – a non -malignant cyst in my cervical spine at the base of my brain stem – I have no cartilage in my joints – and bone spurs throughout my legs. I try to do everything I can as far as a healthy diet and foods that help with the pain(i.e. – turmeric w/black pepper – ginger – pineapple for the bromelain etc) I am very leary about “new” meds and trying them due to the fact they come back and bite you in the butt in ten years with all the drastic side effects. I do not abuse my meds however without them I can barely walk from my bed to the bathroom when I first awaken. Oh yes, I also utilize all the topical gels, ointments, capsasin, lidocaine, cbd lotions and everything combined I do get some relief. I don’t currently have much of a life due to the extent of my pain, but I would like to continue to be able to slowly function and do things like a “normal” person in my apartment. I think all the “associations” trying to limit or take our meds away should remember – you also could be one illness, one accident away from needing some relief. Does the FDA, DEA and everyone else involved have signed statements that if something was to happen to them or a family member there should NOT be pain meds administered? The answer is most likely no, please try to think about how this “opioid epidemic” is making our lives almost intolerable. It’s a shame – it’s sad and it’s putting extreme limits on us who use our meds properly. Also treating us like the scum of the Earth isn’t helping at all by making us sign agreements and doing blood and/or urine testing. Let’s do this with the lawmakers who make us feel so low and worthless. I’m done.

Samantha R Layman

I’ve been in constant, debilitating pain for 3 years due to 2 failed back surgeries, and consequent Complex Regional Pain Syndrome. My doctors have offered me ZERO options in dealing with my pain, besides gabapentin and lyrica, which do not work for me. Neither does PT. I beg that doctors start giving us pain folks options. The government is killing people by taking away the quality of life that RESPONSIBLE prescription opioids can provide. To whomever it may concern: Please help us.

When I first read this article I thought to myself, why are we being given such a short amount of time to comment when they’ve known about it for so long? No wonder they only have around a hundred comments. Also as others have said below in the comment section we don’t want some new concocted medicine that’s going to give hideous side effects or not work at all. We want what works back in the picture! We’ve been poked, prodded, bent here and there by physical therapist, our minds have been probed by some very ridiculous psychologists (who need psychologists themselves) to tell us it’s all in our heads or to go out and buy a self-help book. We’ve been forced over the years to have useless not to mention dangerous epidurals in order to receive our pain medicine. That’s what sent me into cardiac arrest not once but twice. We’ve lost so much more than our life-saving medication. A lot of us have lost our family, so-called friends, and our mobility to do the things we once we’re able to do with our opioid medication. You know like work, clean house, take care of the yard, cook, grocery shop and go to church are just a few.
Now when we see our physicians, when it comes to pain it’s swept under the rug. You just can’t talk about it anymore because there’s nothing they can further do. It’s become taboo. “They know you have severe chronic pain” or they would not have had you on the amount of medication they had you on before the opioid Injustice reared its ugly head. “Now” the FDA wants our comments. As stated below, didn’t we already do this not that long ago?

Cynthia

Personally, I don’t think there IS a need for new pain relief medications. The ones we already have work very well. And they need to give them back to us. Period. …I wrote to them, told them what I think. Thank you Cindy Steinberg for all your great work…… This latest comment period looks like a delay tactic. It seems superfluous to me. I’ve done probably a dozen such comments since 2016. They don’t need anymore comments…they know what’s going on. They just don’t care. And they can’t stop DEA from harassing doctors, a central issue,

Thomas Wayne Kidd

After 30+ years there’s no new option for my pain. Methadone has no replacements. Just stop this evil wickedness and allow our doctors to again do their jobs. Asking the FDA for new options for pain isn’t going to help. There’s already been way to many snake oil cures offered. We need the one medicine that has worked and will continue to work. It is enough of this torture. We are human beings and deserve to be treated as such. Stop the BS. Stop the fake opioid crisis. Enough is enough.

Steven

Did we not do this?

Mona L Mallory

I don’t want new options that don’t work or have creepy side-effects. We have a drug that works and comes from a natural plant. This should be the primary focus. All of these new drugs have side-effects and we become like guinea pigs for the pharmaceutical companies. The legislators have their retirement accounts tied up in these companies. We should focus on getting that conflict-of-interest removed, before we cry out for more of the same.

ElizabethR

I am conscientious about responding to requests for input since I think it is vitally important. I cannot do much else, but I can write and that is one way for our voices to be heard. I may have simply missed the earlier post.

I just submitted my comment. In doing so I was surprised and dismayed to find that only about 100 others have submitted input to date. In most cases, regulatory agencies, legislators and media will dismiss, NOT listen to, 100 people! IMO, at least 500-1,000 comments are needed; 5,000 would almost certainly get their attention.

Millions of Americans, many of whom are older, live with serious chronic pain every day. Perhaps, like me, many patients were unaware of the opportunity to comment. I hope they will read today’s post and enter a comment before the Monday deadline. If we won’t advocate for ourselves, who will?

Randy

A link to Gov. Beauocracie. Is a link lost in the shuffle. Looking to maje a simple statement is going to be hard. Yeah I know my spelling is off. But so am i. Off opoids and in constant pain. I’ll be 66 soon and I shouldn’t have anyone telling me I can’t have opoids when I’m not an addict and never abused drugs. I’ve been off opoids for almost 2 years. My overall health has suffered so much if not for my wife is be in a nursing home or assisted living home. Can’t walk can’t do house work can’t even cook meals. My feet. Knees. Hips and lower back hurt so bad. My sciatic nerver is so painful. Give me back my opoids that worked for years. Give me back my life….

I think we would all be better off if we could do commercials like the ASPCA does for animal cruelty showing pictures of animals that are being cruelly neglected. BC that’s what we are animals being cruelly neglected. Yet we’re supposed to be higher up on the food chain. The caretakers of all creation yet we don’t take care of each other. Matter of fact the big dollar takes care of those that are in charge of our Healthcare, yet we suffer even more. Do unto others as you would have them do to you doesn’t apply here. Watching wildlife documentary on bears, Bears got into a fight and one was injured in the face this goes along with an article written about don’t show grimacing faces yet this bear kept putting its paw on the injury multiple times. Yet it wasn’t doing that until it had the injury. So even Mother Nature show signs Agony/ pain. Yet we’re being treated like wildlife to deal with the pain on our own.

David Hickle

I won’t tell the fda anything except for I’m leaving the state of Ohio and USA and this nation in real life in the spring or summer next year because of the mistreatment I received for 34years of my life by the state of Ohio and USA and this nation

FDA back in the day they approved oxycodone, hydrocodone, morphine, ect.
There has been no government funding to create a new pain control product. & with the big legal fees & bashing of big Pharma who would want to go into this take on creating a new medication that has anything to do with pain? The battle has been won & the pain people have lost but they’re losing not just pain control but their lives. I don’t even know why y’all come up with things to encourage any hope that things would be different. Surgeon wanted me to take CBD oil something that’s not even regulated by the FDA & extremely costly. No guarantee of what’s in CBD oil . That’s where we’re at folks for pain control unknown substances, instead of CBD oil should just be called snake oil.

Linda Olds

I would welcome a safe, effective, non-opiate for pain. I would be overjoyed if they could find or develop something like that…but I’m not hopeful.
Heroin was developed and marketed as a non-addictive alternative to morphine–that didn’t work out very well.
Meanwhile, chronic pain patients and even surgical patients and cancer patients are denied opiates that are effective and relatively safe, as long as they are used responsibly.
Yes, most people develop a physical dependence on these medications, but that’s also true of many antidepressants and antihypertensives. Most people do NOT become psychologically addicted to them, and can use them safely.

LOU Doss

How about some help for people. Who really need it. Doctors are afraid to help us. Do something now. Now.

Michael Uphues

It’s called medical cannabis.

Jan

I went to the comment section and one was already closed out! It only received 133 comments.

2 things are happening:
1) You can’t comment anonymously, which is intimidating pain patients from responding, AND
2) We are being given 1and 1/2 days notice to respond.

If only 1,000 comments gets their attention, you will never achieve that goal unless more notice is given and this article should be on Facebook for a broader audience. I hate to see us defeat ourselves.

James Moulton

I live in bad chronic pain, this started 20 years ago with a bad carpal tunnel surgery, which was unnessary . I went to a hand specialist, I almost lost my job , fortunateliy, I got beter within 3 days. I got better within 3 days of my disability deadline. I have been taking me ever since. The generic piils I take get weaker all of the time. I have developed bad scoliosis since.
Jim

Terry

I want to plead with everyone who reads this. Take 5 minutes and fill out the comments in the link above!!! If we don’t tell our stories than nobody will have anything to listen to. We have to be our own advocates and SCREAM if necessary! Every part of my body is riddled with untractractable pain, 24 hrs a day. I have no life since they reduced my meds from 195 mgs daily to 60 mgs daily. I literally have no life, and I’m really trying to participate in life events but most of the time I just don’t feel like moving. I’m sure there are plenty of you who are in the same boat. Well here’s your chance to be heard, OFFICIALLY!!! Please take the time and fill out the form, if we keep on shouting someone HAS to hear us eventually. Stand up for your rights to live without pain and have a great life. Email your governor, congressmen and senators, they work for us!!! We need a well known, public advocate so we have to keep bugging them. I send out 3 emails every week to all of them. Help yourself, be strong and God bless.

Truly I don’t see why our comments would make a difference. Especially when we’re being told what to comment on.. If it ain’t broke don’t fix it. Why would we want a new opioid medication when the old one worked just fine? It was proven safe and effective for severe chronic pain patients, veterans, cancer patients, people who had surgery and end-of-life patients. Now we are to wait for a new and improved opioid medication, oh please get real!
The incentives, that’s simple! Billions of people have been affected losing their jobs, homes, family, you name it! Many having no choice but to take to their beds and hundreds of others taking their own lives. All simply due to the fact that they live 24/7 365 in severe chronic pain through no fault of their own!. One day it will be the very greedy and ignorant people that have done this to us who will experience the tragic mistakes they’ve purposely made.

Martha

Come on CPP Community. I just submitted my 2nd comment. When I was done, I clicked on to the docket # ….and to my great dismay, the FDA has only received 133 Comments in TOTAL.
We only have 2 more days. For those who feel well enough to type today – PLEASE COMMENT. My comment today was about the FDA side-lining promising new drugs, simply because Small Pharma can not bring their drugs to the Clinical Trial Phase due to $$$$$. It is simply too cost prohibitive.
Furthermore, I questioned why the FDA granted Purdue Pharma Patent Protection on Oxycontin until the year 2030….for extremely minor formula changes!
Please click on the link above and leave your comment. You can do this anonymously if you choose to.
133 comments is Pathetic with a capital P!
Thanks to those who made the link so user-friendly. Great job

Thai 7

Submitted, thanks for wtitng.

Michael Sena

Back in 2017 I was addicted to opioids, vicodin to be exact. 16 a day plus 20 Advil was my pain management routine for osteoarthritis. Until then there was no hope, then I read up on plant based solutions like “hemp”, CBD AND CBG to be exact. After trying 5 different products, I found 1 that was “miraculous” for me. I have not taken an opioid since and never experienced harsh withdrawal symptoms. Please allocate the neccessary resources and look into this “proven” natural solution!
Thank you
Michael Sena

Soldier

That will do nothing in this administration where we have acting Dignitaries instead of sworn in by the Senate . Which gives them no real power . This White House cares nothing for anyone unless it looks good for them. To many pain advocates are looked at as drug Addiction people looking to get narcotics! lol at the laws passed , how hard it is to get pain medication any type! The pharmacist can deny your pain medication and it goes on . Unless we get the right people in office that give a crap about us it will go to representatives who don’t care . We need to vote this administration out . To get someone whom cares about others not themselves or how it looks to them! This in the history of the United States has never happened to people that had cancer or illness that cause pain ! Never . The dr was the expert not the government or Pharmacist . So vote! It sounds like a election pitch but look at all the facts you will find I’m right . Just within the last three years have I had such problems! I have stage 4 cancer served my country in four deployments in Afghanistan two in Iraq. And not only will I not go to the VA but I don’t think our new government cares .

Jamie

We already have meds that work. We dont need any new and unlikely improved versions. We need our drs to be free to prescribe without fear of DEA investigations!

Bram Judy Cast

Comment sent!