Please Help, Your Comments Are Needed


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Andrew Kolodny, the Executive Director of PROP (physicians for responsible opioid prescribing) has filed a peitition on behalf of PROP, to the FDA.  He/they want to limit the amount of milligrams in certain herigher milligram opioid tablets.  Kolody/PROP continue to make very wrong, bad and unproven claims, in my opinion and in the opinion of many other health advocates, pain physicians, general physicians, pharmacisits and chronic pain patients. They are trying to get these higher doses banned altogether, which could make the chronic pain patients lives even more difficult and their ability to get prescriptions filled an even more arduous task.

The American Academy of Pain Medicine has written their comments regarding and opposing the afore mentioned petition by Kolodny and PROP. If you aren’t convinced that what’s happening to chronic pain patients is totally wrong and cruel, then please read the full comments written by this AAPM and the comments of all the other patients, physicians and more; already posted for the public to see. Here are a few of the points that the AAPM makes:

  1.  They state that there are false and misleading statements in this petition. That the writers of it have stated that the “CDC’s consensus was that increasing dosages to 50 or more MM#/day increases overdose risk without necessarily adding benefits for pain conrol or function”…..THE CDC made no such conclusion whatsoever. They just said that there wasn’t enough evidence base for the benefits of long term use.  The CDC guidelines were supposed to be for chronic opioid use in primary care settings and do not discuss at all, the use of opioid therapy in the pain management physicians setting.
  2. The AAPM shows us how Kolodny and his minions lied, just outright lied when they said the AAPM had explicitly endorsed the “notion that opioids should be prescribed without an upper limit”.  They never said that, it is a false statement.
  3.   They say Kolodny and co. seek the removal of “ultra-high doasage unit” opioid formulations.  But there is no definition of this at all and it is, according to the AAPM, just a “creation by the authors”. They also say how Kolodny & PROP limits their request and exludes the transdermal medicaions, and this demonstrates the “idosyncratic nature of their concept”.
  4. They prove how Kolodny and PROP literally lie about how children die from these higher doses but actually AAPM says children can die of respiratory distress even at the lower dosages.  They say that these guys are assuming that children are less likely to ingest several lower dose pills instead of a single higher dose pill and that is just a guess.
  5. The American Academy of Pain Management understands that there should be provider and patient education regarding opioid therapy.  There should also be interdisciplinary care for chronic pain patients.  But they also agree that there are times when Opioid therapy is indicated and there can and should be safety measures in place for inadvertent exposures. Things such as Naloxone can be used but not just arbitrary dose manipulations.

There’s more, but I think you get the idea.  The AAPM even states in their comments, that Kolodny & crew have set some dangerous ideas with their “cavalier assumption” that when higher dosages of opioids are required in some patients, that Kolodny thinks that reducing or taking the opioids away from these patients would be “unlikely to result in a significant inconvenience or hardship.” The AAPM says “this could not be farther from the truth”.  In Summary, the American Academy of Pain Management states that Kolodny’s and PROP’s petition, “if implemented, would cause great harm to our nation’s health.”

Please read the petition at the following link:  https://www.regulations.gov/document?D=FDA-2017-P-5396-0001

Please, I am asking everyone who sees this blog post, to pass it on to another person. Then to each person, I therefore ask you to please write your comments in right now. All comments must be in place before February 2018; when comments will close.  But I warn you that if you don’t do it now, today; you may forget and miss a chance to get your comments written and read.

Below are my comments posted October 18, 2017:

Suzanne Stewart wrote:

It is wrong to do this as we are not a “one size fits all” society. Everyone is different and has different needs  I have many allergic reactions to other medications. I have long QT syndrome and so I am unable to take many many medications. Legacy patients should especially be exempt from this craziness.  Also exempt should be anyone for whom a licensed pain Management physician  feels should be exempt! Pain Dr’s went to school  for many years, a very long time, and they specifically learned about pain and how to treat it.  This man, Andrew Kolodny is not a pain Dr. and he did not go to school to learn anything about pain or how to treat it.  He should in no way be directing what is to be done with the chronic pain community.  The pain community is falling through the cracks in this “opioid crisis”.  This crisis is that pain patients are dying daily and committing suicide because of our lack of access to opioid pain medications.  The Cochrane report of 2010, states that “only 1% or one half of 1% of chronic pain patients ever become addicted!”  This man, A. Kolodny is also trying to state that cancer pain is different than non cancer pain. That cancer deserves pain alleviation but chronic pain does not.   But the FDA said that “theres no scientific evidence to this” and they disagreed with him!  So please realize that he is not doing this for any good or helpful reasons. He is not a “good Samaritan” looking out for all of mankind. He has his own best interests at heart and his own treatment centers to make money for him through this crisis for chronic pain patients.  Sometimes the oral transmucosal opiates or the higher dosage of opioids might be somethng that a legitimate schooled pain physician feels is the best for his/her patient(s).  I don’t think there are any pain management Doctors that would give those out lightly.  There would be a reason and they know the reasons why they would be using these medications or analgesics.  If a legal legitimate pain management Dr. feels this medication is appropriate, then allow him or her to be the Doctor! The Government of the United States of America needs to stay out of the Doctors office and out of the patients rooms and records!

The link to go to for making a comment is below. Please, I am begging each and every one of you to go to this link and make a comment against this petition by Andrew Kolodny and the PROP physicians.  All comments are Due by February 18, 2018.

LINK:

https://www.regulations.gov/document?D=FDA-2017-P-5396-0001

Thank you so much!

Suzanne Stewart,

Patient Health advocate, RSD/RPS patient mentor, US Pain Ambassador, WEGO patient Leader and member of ATIP (Alliance for Treatment of Intractable Pain)

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My Letter To The CDC


Hello Luvs,

I just wanted to post for you, my letter to the CDC. It is in an attempt to help change some newly, “almost adopted” guidelines for prescribing Opioid medications! Their guidelines, say pretty clearly that Opiods should not be used for non-malignant pain. They only want to rarely use it and over regulate it even for malignant pain.  Even if your pain consists of many chronic pain illnesses, and/or if it is CRPS-#43 on the National pain scale, the”McGill pain scale. They set up guidelines to grossly lower the amount that some people may have been on for several years or many many years! 

The results can be disasterous if this goes through. Our voices need to be heard! I can only hope and pray that enough pain patients, their loved ones, their Dr’s and friends helped by also writing in during this open period for comments until Jan 13,2016! There’s still time!! Please read my previous blog post to this one. It explains all about how to do the comment writing. Also all of the information that you’ll need is in that prior post here at “Tears of Truth”! Here is the letter or comments that I wrote! (Be careful because I thought I’d submitted comments awhile ago!! But then I realized I hadn’t gotten a receipt or a tracking #! Something went wrong, so please make sure you get a receipt from the CDC, for your comments, along with a tracking #…Here are my comments below . This is what I sent:

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Your comment was submitted successfully!

Agency: Centers for Disease Control and Prevention (CDC)

Document Type: Nonrulemaking

Title: Federal Register Notice: Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain

Document ID: CDC-2015-0112-0001

*******Here are the exact comments that I have sent to the CDC, re: the Opioid guidelines.***

Comment:

Docket ID: CDC-2015-0112

I was an Interpreter for the Deaf! I worked at a major hospital & schools. Now I’m a chronic pain sufferer! I was injured in a MVA, 2002! I suffer from the pain effects of : CRPS (#43 highest on the McGill pain scale). A horrible fire-like burning pain that starts with nerves but is progressively debilitating. It progresses to blood, bones, skin & more. Eventually loss of movement & continuous burning pain 24/7/365! I have Polyneuropathy in Vascular Collagen Disease, Autonomic Neuropathy, Arnold Chiari I, Degenerative Disc Disease, Right long thoracic nerve Neuropathy, L4/5 & S-1 Radiculopathy from multiple herniated & bulging discs & Prinzmetal Angina. I suffer the results of a CVA & 2 “mini strokes” with nerve pain & restricted movement, Dysautonomia/POTS with PAIN & other issues from a TBI s/p the MVA as well! I also have “Combined Immune Deficiency Disease”, which in lay terms means that I’m not eligible for an SCS nor a pain pump. The danger of infections and/or paralysis would be too great of a risk. This is one main reason that I must be able to continue the medications that manage my pain & have since 2002! Not many of “us” fit into a nice, neat little “box”. While bringing up the point of “not many”; “not many of us” ever become addicted to Opioids, in fact only about 5%! Our bodies may become physically dependent on these pain meds, but we do not get any kind of “high” from them! At best, they keep us just a little more comfortable. Don’t Diabetics need Insulin to survive? Don’t hypertensive persons have strokes without their meds? Those who suffer from Epilepsy need certain medications to live without seizures! I take what is called “Warfarin”. It’s truly a rat poison! In large doses it kills rats! But in a small dose just for me, it keeps me from having more CVA’s! Those meds are not good for the average persons bodies, but some groups of people need certain medicines in order to have some kind of life outside of their homes or a hospital! 

I’m a Chronic Pain patient and I would literally die without my Opioid pain medications! Chronic pain can kill people! There’s not only disease progression, but deaths by suicide will also increase as people lose hope of any relief or help for their pain! I can speak for myself and for many other pain sufferers, when I tell you that I’ve tried many other medications, PT/OT, Injections, epidurals, nerve blocks etc. Nothing dented my pain, until I was told by my pain Dr in 2003, to “try the pain meds”, and I did it! I will confess to you that the Opioids only help to take the “edge off”of this type pain. My pain Dr nor my GP can work miracles but they can try to keep me (*and others like me) as comfortable as possible….but only if you; the CDC, will allow them to continue?

I’ve been a health advocate since 2005! I am an administrator for 3 online support groups for Invisible Diseases/CRPS & Chronic Pain; as well as the organizer and administrator for “in person” support group “meet ups” in state of Michigan! I’ve been responsible for many successful fundraisers for Pain illnesses. I am a “Mentor” for newly diagnosed CRPS patients. I truly try to stay positive and use my life to help others because I felt so isolated in the beginning. I even do awareness events as I’m able! I used to make support & Awareness jewelry. These days as my illnesses progress, I’m unable to do much of the jewelry creating. But if someone asks, I still try my best to make a few support items. I live with RA & OA as well, making it even more difficult to make my jewelry! I’m also a Chemo-angel, card angel & special assignment angel for the “Chemo-Angels” program!

That is who I am today! These are my words and what I have to say about the new CDC Opioid guidelines and why they’re so wrong. I have had much pain in my life, it continues today as will again tomorrow and for every tomorrow after that! But if my Dr’s are allowed to keep me as comfortable as possible, then why are they being “bullied” from helping me? If an Opioid pill &/or a patch can help me to at least to be more comfortable, then why not?

Many groups of people were totally & blindly left out of the guidelines decision making process! Somehow those who were allowed input on these guidelines, were some physicians,”non”physicians & others who stand to gain monetarily (they are: treatment center owners, Massage therapy office owners, Acupuncture clinic owners & administrators…and others who stand to gain from our losses). Their gains would be my (our) loss of any kind of life outside of a hospital bed in my living room and/or a wheelchair. I’ve been on the same medication regimen for a very long time. I do not need nor want higher doses! I’ve never gotten a “high” from any if it! But being allowed to take my opioid pain meds, gives me the chance to be a grandmother, a mother and a wife for a few hours at a time, some days! Please “Do No Harm”!!

First Name: Suzanne

Last Name: Stewart

For further information about the Regulations.gov commenting process, please visit http://www.regulations.gov/#!faq.