Fda Taking Public Comments On Opioid Treatment Guidelines Through October 7, 2018

On August 6th, 2018 the FDA released an article drafting the endpoints for demonstrating the effectiveness of drugs for opioid-assisted treatment, more or less, as a form of guidance for the medical industry at large.

Ref: fda.gov/downloads/.../UCM615743.pdf

The letter begins by stating that it's being distributed for comment purposes only and that any comments or suggestions regarding this draft should be submitted within 60 days of publication in the Federal Register of the notice. The publication date is scheduled for 8/7/2018.

I share this information in a timely manner so that chronic pain patients and others facing related challenges can take action by voicing their thoughts, concerns and opinions before the end date (10/7/2018) - 60 days from 8/7/2018.

Federal Register: Guidance - Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment

The FDA says that we will have to submit any electronic comments to regulations.gov, & to submit written comments to the Dockets Management Staff (HFA-305) at:

Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

[Docket No. FDA-2018-D-2382]

All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. [For your convenience I went ahead and posted it above].

For questions regarding this draft document, the FDA suggests contacting Silvana Borges at 1-(301)-796-0963.

I encourage anyone who wishes to comment on their agenda to first have a look at the PDF link above where it outlines clinical endpoints for opioid treatment, adverse outcomes, changes in drug use patterns and more.

I hope this message finds you well as we all strive to make pain management a better option for all of us who may be requiring opioids for treatment.

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REPORT

Did you actually read this document? It is not about chronic pain patients at all. It is about “Opioid Use Disorder”. It is about treatment programs for those who abuse the opioids that chronic pain patients depend on to have any quality of life. The typical chronic pain patient is not an abuser. I guess this could apply if you want to be taken off opioids but until there is better options for pain control I can’t see anybody being interested in this.

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Re: Claude (# 1)

RE: "It is not about chronic pain patients at all. It is about “Opioid Use Disorder”. It is about treatment programs for those who abuse the opioids that chronic pain patients depend on to have any quality of life."

Hi Claude. Thank you for your feedback. The topic of "treatment programs for those who abuse the opioids that chronic pain patients depend on" is entirely relatable to "chronic pain patients and the false opioid epidemic". To me, this comment period is about voicing your opinion. It's about telling the FDA that you disagree with their perspective (narrative) on "Opioid Use Disorder" and the like. Let them know that the typical chronic pain patient is not an abuser (as you stated), for they don't seem to understand - hence why the mainstream media has such a miscued take on the so-called opioid epidemic. I think your message, including others, would be well-received by the FDA if you copied it in their comment section. Once again, this is more so about having the ability to voice your opinion to the FDA more than anything. Chronic pain patients want their voice to be heard, but when our options and timelines are limited due to our pain, I think it's very important to take advantage of these public comment periods that only come around a handful of a times a year, if that.

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Re: Claude (# 1)

Thanks David. I did not read it from that point of view.

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I would love to put my opinion in on the opioid crisis. So say I myself have chronic pain and with all the insurance I have cannot I repeat I cannot find a pain management doctor. They are few and far between. So with that said I thought they put me on Suboxone. Suboxone is for addictions. I will always be in chronic pain. To take my pain medicine from me you might as well shoot me. I am no good without it. I do not sell or trade my medication. Something has to be done. You mean to tell me the state would rather pay all that money for suboxone than just to give me my pain medication. The Suboxone is causing me to have triple problems. A drug addict will always find a way to be a drug addict. Count my medicine, call me in for a pill count. I am so sick of living in pain for all the drug addicts out there. I am in pain, I'm not an addict, nor do I give sell or trade my medication, so you need to find something else to come up with because I'm bedridden at 51 years old because I simply don't have my pain medication. I'm paying $200 a month out of my pocket to see a Suboxone doctor. It's unreal. All I make is 750 a month and $200 goes out of my pocket to a doctor. Seriously disgusted.

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Re: Claude (# 1)

That's the way I read it... They are trying to develop better ways to treat people with addictions to opioids and those with dependence that wish to come off of them. The thing I am concerned about is the panel that is making the decisions for rules for physicians prescribing opioids and pharmacists guidelines to fill those prescriptions. We need to let that panel know and hear our voice. I know that they have a chronic pain patient on the panel but can't tell u off the top of my head the names on the panel.

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Re: Marjorieson (# 5)

I completely agree with you and share the same concern about the panel that is making the decisions for rules for physicians prescribing opioids and pharmacists guidelines to fill them. I feel that we as patients & consumers don't get many opportunities to voice our concerns in so far as sending comments to those (unelected) decision-makers. We don't even get to vote for who makes these high level decisions within the FDA. It's almost like they only hire insiders on the panel who fit their agenda so they don't have to reprimand them or go against the orders of their "shadow government". Nevertheless, I just believe that there's a lot more of us than them and maybe someday our combined influence will have an impact.

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On a relevant/related note, I also started a petition concerning the corruption within the FDA & DEA organizations, their decision-makers and why they should be voted into position, not hired. We need full transparency from the top of their pyramid down to the civilian level where they hold public meetings.

If you stand in agreement, please take a moment to sign this petition and share it with others who are fed up with these unelected organizations who have more power than the integrity it takes to run them:

change.org/p/donald-trump-fda-dea-decision-makers-should-be-voted-into-position-not-hired

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Wow! Already stigmatized. What makes any of you people think that just because someone has SUD means they abuse drugs? That’s the whole problem. I’m dependent on a SUD drug (Suboxone), but that doesn’t mean I abuse them. Open your eyes people. Not one size fits all. Abusing a drug is simply taking more than what’s prescribed. Two of these comments above and the FDA mentions only abuse, not dependency. I haven’t abused drugs in God knows how long. I take them to keep from being sick. There’s a huge difference. I’ve known people who take less than half of what the damn doctors prescribe, and then when they tell them they wanna decrease their dose, they wanna act like they know everything and say you’re not ready. I wouldn’t let a doctor tell me what I need. I’ve been through this too many times and I know what I need. I listen to my body, and so are the people I know that have asked for such decreases. Tbh, I decrease when my body tells me so. Why? Because not every person needs 16 mgs of Suboxone. That’s overkill!!!! They just want your damn $ and that’s a sad fact. These doctors don’t care about us and neither does the FDA, and especially the DEA. DEA goes into these doctors and has their patients taken off life saving meds because the doctors fear punishment and threats. The DEA has only made things worse. Why you think the heroin epidemic is so bad? Didn’t y’all know this was gonna happen? And as for the person who got prescribed Suboxone and taken off your pain meds, I feel horrible for you. They put you on a med that’s 10x harder to come off of than any other opiate known to mankind, other than maybe Methadone. Good luck to those who are fighting the fight to remain sober. And even those that are in pain. It’s time we the people, do something about it.

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Re: David (# 6)

I think there is a way to still contact or send comments to the panel. I'm sure the people on the panel have Facebook pages also, not to harass them but to maybe message them and ask if there is a pathway to let our concerns be known??...

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Re: David (# 6)

Department of Health and Human Services (HHS)'s new Pain Management Best Practices Intra-Agency Task Force took comments thru the first week of June. That's where I sent my concerns.

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Re: Lisalandry (# 4)

That is probably one of the best messages I have read yet on this subject. The way you wrote it is heart touching. It is shameful that this country feels a need to punish innocent people this way, taking medication away from people in pain and/or making it next to impossible to reach out for some relief. I have said all along, the only thing they are doing is making the innocent people who are suffering-making them suffer even more; and as far as the addicts, they are going to find what they want and they will keep going. The government and their "big" ideas have never worked the way they want them to work. It is deplorable to think that they believe this is going to work in any way. Our lives are already horrible without some pencil pusher using us to make a statement or further their war against legal drugs. I don't let my meds out of my sight so the chances of anyone else getting one of my pills is next to impossible. Once I returned an entire bottle of opiates to my doctor because it was generic and it did not work for me. I took it to my doctor hoping they would be able to dispose of it in the proper manner since I could not take it back to the Pharmacy. Our government is totally stupid when it comes to this subject. They have not done their homework and they won't listen to the people they really need to be listening to. I hope you can make some progress in your need for help. I hope you comment on this paper that is being drafted. You need to tell your story and they need to listen. That is the very least they could do. My rambling is not very good, but I am hoping and praying you get some help.

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Thank you so very much for posting this. I’m all over it!

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Re: Lisalandry (# 4)

When will the 'powers that be' finally understand that it's not an opioid or opiate crisis, it's a fentanyl crisis. Drug gangs easily find eager pharmaceutical chemistry students to mix a 'bathtub gin' version of fentanyl. Of course, fentanyl is also mixed in the 'dope' that crosses our southern border. Unfortunately, fentanyl kills and as they say in the newspaper biz, 'if it bleeds, it leads'. Forty years ago I was in an auto accident in upstate NY and was put on 4 mg dilaudid PRN for a month and I've been requesting it ever since. I never had a problem referring to myself as an addict. Without my opiate or opioid (there is a difference) or it's analog I suffer diarrhea, cold sweats, restless legs, etc. If you suffer any of the aforementioned symptoms, then my friend, you too are a junkie.

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Thank you for sharing this! I am happy to see that finally someone is willing to hear from those that rely on opiates for pain and addiction treatment, it's about time.

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If The Federal Government is successful in ending opioid-related therapy to those of us who need it the most in order to try and end what they are calling an epidemic of unnecessary overdoses, then they will by proxy kill millions of Americans who need these painkillers just to make it through the day. If this happens, I will personally spearhead a class action lawsuit to insurance and the federal government. I will wait to see what happens, but I’m consulting with legal teams now.

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Re: Lisalandry (# 4)

You are the 2nd person i have heard this very same story from. Where do drs get off prescribing Sub for pain? I personally find this appalling because its wrong and its something you will never get off and financially will overwhelm you. I so feel for you as i do for this other person who is taking Sub. Take care.

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David,
Thank you for this information. I am going to submit my comments in the timeline given. I hope all the others that have been posting concerns will join us. I find the wording a bit difficult even though I am a highly educated professional. If anyone has access to free legal cousel it may be helpful to fully understand each point presented. Please feel free to share your interpretation of these documents because to me it seems to be a “doomsday warning” for legitimate chronic pain patients. Everyone should submit their own opinions and experiences because there is strength in numbers. We must remain somewhat optimistic. Even a reduction is better than complete withholding of the medication many of us have relied on for years.

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Re: Marjorieson (# 10)

I wonder if a mass letter writing and telephone call campaign to State Attorney General's, Gov and Lt Governors and State Legislators strongly suggesting law suits could be helpful? I have no doubt that an increase in medical expenses from the result of patients being denied medication that has, was, did work to help relieve pain has occurred since the war against opioids crack down. Patients are prescribed medication and appliances that don't work. Patients that being forced from the workplace. Emergency room visits have increased. The elected officials in our States are supposed to work for us. Seems the States should file against the Feds on our and their behalf. Then the class actions, if attorney firms could be persuaded, against the individual agencies, CDC has already admitted they provided false information. The media is also guilty for reporting false information, which has affected opinions in support of this crime against humanity. Torture is wrong.

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Re: Concerned handicaps of the US (# 15)

I think that the idea has some merit.. My states Attny General almost immediately filed a suit against (is it
Perdue?) that makes most of our opioids. And he admitted it is so that the state has more money to treat and deal with the addicts and the overdoses. He said "not against the legitimate people who need it for pain". Doesn't he realize it will trickle down to us! Of course he does! I have written to my state senator and representative. I am in Kiwanis with the state rep and believe me he seems to lend a kind ear. I think a uniform letter from groups will hold weight. However, in the time it took me to interact on this site I could also contact my legislators. They are slowly changing rules that make it more difficult for us to get our pain medication. Once it's done, it's done! Let's get cracking!

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Re: Concerned handicaps of the US (# 15)


When you gather the information needed to proceed, I would like to help or do the same regarding my legislators. I live in NY. I cannot function with any quality of life without my medication. My dosage has remained same for 10+ years. I have never abused or added additional meds not prescribed by my pain mamagement doctor. Waiting to hear how to proceed.

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Re: Concerned handicaps of the US (# 15)

Oh thank God!! I'm behind you all the way!!! I was a dental asst for 12 years and pharmaceutical reps brought in huge bolts of drugs and gave them to us so we would promote them!! I am sure that's where a Big Leak is!!!

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Re: David (# 2)

That was so well put! I've been saying for years there is a Difference between an opioid and those that live with chronic pain!!

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On September 18th from 12:00-2:00p there is going to be a “do not punish pain” rally in almost every state. Go to “your state” dontpunishpainrally.com and the city or cities that are having a rally will be listed. Bring as many people as you can! For Ohio it is in Cleveland, Columbus and maybe Cincinnati. If they don’t SEE us we don’t exist!!!

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Re: Marjorieson (# 26)

I'm very interested and staying in touch with you about this subject! I've been very concerned about it for several years now. There are many of us that go to pain management and I actually need our pain medication without the abuse of it, however because of the wide abuse and distribution of the medication illegally it's making it very hard on those of us that truly need it and are not criminals! Have been extremely frustrated over this situation and also treated horribly by many doctors now when I discuss my pain and pain level after having six Orthopedic surgeries since 2013 and I'm about to turn 64. So I definitely want to stay in touch so that I can do my part in signing petitions writing to the powers-that-be that are making these decisions and signing off on them! I want our congressmen and legislators to know that there's many of us who have a voice an opinion about this opioid crisis and we want to be heard and definitely understood! Thank you so very much!

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Re: Hop63 (# 22)


uspainfoundation.org is one of the groups that u can join and they are really on the forefront of advocacy for the pain patient.

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Re: Hop63 (# 22)

I will research and see if we can go in with a registered group of pain patients and send in letters or comments.

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Re: Hop63 (# 22)


The group in the state of Alabama is working as a task force with the Attny General. I'm sure ur state has some form of this type group.

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Re: Hop63 (# 22)

Go online to your state governments website and look for your current legislatures. Some will have their own websites linked to which will have contact info. You can email them a letter. Also call them and let them know your feelings on the subject. Make sure you contact your senator and your house representative.

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Re: Marjorieson (# 19)

We need your guidance so we can present as a unified group regardless of what state we live in and who our legislators are. Proceeding as a group sounds like a good idea, strength in numbers, etc. I am more than willing to put in the time but need some assistance on best way to proceed. If my meds are taken away I won’t leave my house.

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I've been dealing with some autoimmune diseases, in addition to a pain condition for many years. I have never, EVER abused the medication I was given. When the crackdown began, I was no longer allowed any decent pain medication (I was on Roxicodone). Now I'm on Percocet that barely takes the pain away. Barely! And I need to take every single pill I'm allotted, whereas when I was on the Roxi, I ALWAYS had extras left over. Why? Because I'm responsible and ONLY take them for pain, not a "high". The gov't lumping all pill takers as "junkies" is unfair and cruel. Not to mention, Percocet can be very damaging to the liver. While you *think* you're helping us not become so-called "junkies", you're possibly allowing liver failure to become a new health crisis, even beyond what alcohol does. And speaking of alcohol ... why can *anyone* of legal age (or not) still get this *deadly drug*? Is that because the gov't actually LIKES to drink? We all know it's certainly not "needed".

This pain condition has COMPLETELY changed my life, and not in a good way. Anyone suffering like this needs understanding, not lectures or assumptions (like "get over it", "deal with it", or "it can't be THAT bad"). You can't get over it, we're trying to deal with it, and yes, it CAN BE that bad. Please stop this ridiculously cruel practice of not allowing us access to what works. Please!!

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