Fda Taking Public Comments On Opioid Treatment Guidelines Through October 7, 2018 (Page 2)
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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The letter begins by stating that it's being distributed for comment purposes only and that any comments or suggestions regarding this draft should be submitted within 60 days of publication in the Federal Register of the notice.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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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: 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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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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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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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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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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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)

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

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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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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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