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:
- 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.
- 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.
- 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”.
- 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.
- 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.
**IF THE LINK DOESN’T TAKE YOU DIRECTLY TO THE FDA DOCKET, THEN CLICK ON THE LITTLE INTERNET GLOBE ON BOTTON RIGHT OF NEXT SCREEN (where clicking takes you-& it will proceed to the page you need for placing your comments )
Thank you so much!
Patient Health advocate, RSD/CRPS patient mentor, US Pain Ambassador, WEGO patient Leader