PROP Calls FDA Ruling a ‘Small Victory’

PROP Calls FDA Ruling a ‘Small Victory’

The day after the Food and Drug Administration said it would change the prescription guidelines for some opioid painkillers, millions of chronic pain patients and their physicians are still trying figure out who “won” the often bitter debate over the safety and long term effects of the drugs.

“I would call it a small victory,” said Dr. Andrew Kolodny, one of the founders of Physicians for Responsible Opioid Prescribing (PROP), which filed a citizens’ petition with the FDA last year demanding major changes in the labeling guidelines for painkillers to stop doctors from over-prescribing them.

“I think the new labeling will hopefully lead to extended release opioids being used as a last resort when all other options fail.”

bigstock-Young-Blond-Woman-With-Medicin-12068330On the other end of spectrum is Dr. Jeffrey Fudin, a vocal critic of PROP and its petition, who says the agency’s decision was a victory for pain patients — including many who worried they would lose access to pain medication.

“I feel sorry for the many patients nationwide that anguished day after day and sent thousands of anxiety stricken e-mails to politicians, the FDA, and to me.  But they all owe this country and the FDA a debt of gratitude,” Fudin wrote in his blog.

So who won and who lost this contentious debate?

We may not know the answer for years – which may have been the FDA’s goal in crafting a carefully nuanced policy that seems to give a little to everyone.

One of PROP’s main goals was to have the guidelines for opioids changed so they are no longer routinely prescribed for “moderate” pain. That the FDA agreed to do, updating  the labeling so that extended release opioids are indicated for the management of severe pain only — “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

“When you read the full language on the label, it’s pretty darn good. I actually like the new indications,” says Kolodny.

But a major disappointment for PROP was that the FDA is only changing the labels for 20 extended release opioids, such as OxyContin and Opana. The labeling guidelines for short acting opioids like hydrocodone – which are much more widely prescribed – will remain unchanged.

“Everything they did was limited to extended release and I could see no rationale for that. That was a terrible mistake,” said Kolodny, who is Chairman of the Department of Psychiatry at Maimonides Medical Center in Brooklyn, NY.

“The FDA needs to go much further to prevent harm caused to pain patients by over-prescribing of opioids.”

PROP’s next course of action may be in court. Kolodny says he is considering legal action against the FDA to compel the agency to comply with the federal Food, Drug and Cosmetic Safety Act, which requires drug companies to prove their products are safe and effective before putting them on the market.

PROP’s petition states the long term safety and effectiveness of opioids in treating chronic pain has never been established. The FDA, in a sense, agreed with that point. The agency now wants drug makers to conduct more research and post-marketing studies on the safety of opioids.

“The idea that the FDA thinks they need to keep studying this when we have 16,000 people dying from opioid overdoses every year, 125,000 deaths in a decade, and they want to study this further? It’s hard for me to be happy about that,” Kolodny said.

“That’s why if we go to court, we are fairly certain the courts would require FDA to do its job properly.”

But a court battle could go on for years. What about the immediate effect on pain patients and their access to extended release opioids?

Kolodny says the label change, which is expected by December, is unlikely to affect patients already prescribed extended release opioids. But physicians may be more reluctant to prescribe long-acting opioids to new patients without trying other therapies first, such as over-the-counter pain relievers.

“Right now you’ve got prescribers who’ve been misled to believe that the compassionate way to treat someone with chronic pain is to put them on extended release opioids. They think it’s compassionate and its evidence based, but it’s neither,” said Kolodny, who insists PROP is not trying to take opioids away from anyone.

“All these patients who write in when you have a column on this who think my group wants to take their pain pills away from them. We don’t,” Kolodny told National Pain Report.

“I know very well that the majority of them are going to need to be on opioids for the rest of their lives, even if their pain problem went away. They’ve been made dependent on opioids and I know that many of them function okay. They take the pills the way they’re prescribed. I don’t think it’s really helping their pain, but they’re doing okay on long term opioids and I don’t want anyone to take away their pills from them.”

Authored by: Pat Anson, Editor

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I don’t know what bothers me more about dr. kolodny, the fact that he has absolutely no compassion for his fellow human, or the fact that he does not seem to understand how the human body works! Is he really a medical doc or is he a phd like dr. phil w/ a lot less common sense? How many years of specialized training in chronic pain management has he had? How many different chronic pain patients has he successfully treated? How much research has he done on chronic pain conditions and treatments for those conditions? How much proof of success in treating these conditions with all other treatments can he show? He claims to be an expert on pain to the point that he should be able to tell all other docs how to treat their patients. If he is going to put himself in this very powerful position, then he damn well better be qualified to play that role!

The only way ANYONE feels pain is by having a signal sent by your cns to the pain receptors in the brain. Yes it is true that signals are sometimes sent when there is no injury or damage; but the pain is the same no matter the reason. For example: you fall and break your arm which sends a signal to your brain’s pain receptors. Without that pain signal, how would you know that you are injured? Now take someone w/ fibromyalgia. Even though they do not have an injury to their arm, their cns sends the exact same signal to the brain’s pain receptors as if they did break their arm. So how is one judged as real pain and the other not? The only difference between the 2 is the fact that the one that actually broke their arm will heal and the pain signal will stop. However, there is nothing that will stop the pain signals of a fibro. patient. Not only will it not stop, in most cases, it will continue growing in intensity and will not just be one spot; but several body wide! For fibro patients somedays will be much worse than others; but will hurt to some degree everyday 24/7. Pain pills work by blocking the pain receptors, which will dull the full impact of the signal. However that does not mean that it will be able to stop all the signals or in anyway decrease the amount of signals sent. You will still very much feel pain; but if you are on the right med at the right amount, then you will get relief as the med will dull the intensity and take the edge off, which in turn will make the pain more bearable. There are also many chronic pain condition that cause a lot of damage to the body and have no cure, nor even a good management treatment plan. In addition to fibro. I also have arthritis both RA (diagnosed at only 14)& OS(diagnosed at 27) DDD(age 36) Fibro(age 25) So I do not even know what it feels like not to have pain. I am now only 42 and have been put through “treatments” and had docs do things to me that the general public would not believe. I am so tired of jumping through hoops,being cut, poked, and prodded, judged, treated like a junkie, talked to like a dog, humiliated, emotionally ripped appart, accused, looked down upon, lied to, and punished for something I did not choose or have any control over!! All I want is to be able to choose what is done to my own body and not be tortured and made to suffer needlessly just to get some relief that would allow me to have some quality of life!!! Yes I believe that docs as well as patients need education on chronic pain and meds used for it, yes I believe that their needs to be caution,& yes, my heart breaks to see parents… Read more »

This “snake oil” Kolodney us selling is BS! How dare someone who is not even qualified to speak for pain patients tell us what we need and don’t need, I suppose he is for “smaller government” too! What a joke. I can only hope that someday he will learn firsthand that what he is doing is helping NO ONE, only to self promote his name. If he doesn’t want to take away patients meds that gives them some quality of life then please jump on another bandwagon and leave this alone. Everyone is different and if you have chronic pain & take opoids responsibly these drugs can be the difference between living and existing. To say that 90 days is all we need is a careless cruel thing to say unless he has a miracle “cure all” he should move on & save someone that actually requests his help!

If you parse Dr. Kolodny’s words and follow his career with PROP, one can only come to the conclusion that, contrary to his protestations, PROP’s ultimate goal is if not to end pain patients access to opioids he wants it so limited that it would effectively be unavailable to those of us who need these medicines simply to live. Pain patients should be wary of Kolodny’s statement that the FDA’s decisions on PROP’s petition “a small victory.” Organizations that lose a large part of their agenda rarely recede from the scene, but step back, analyze their failure and map out new strategies to accomplish original goals. The fact that so many of you rose up to the occasion by organizing and flooding the FDA’s docket concerning this petition should be considered a victory. But make no mistake, PROP will come back more organized and more with more financial resources to try to remove opioids from our pain care. We have to keep our organizations together and focused on following any and all developments in this struggle. PROP is not to be belived.

“Kolodny says the label change… is unlikely to affect patients already prescribed extended release opioids… [Kolodny] insists PROP is not trying to take opioids away from anyone.”

These statements are *demonstrably* false.

My spinal cord was crushed 12 years ago, and I am practically the poster-boy for “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” I spent 8 agonizing years trying every therapy possible, every OTC remedy, surgeries, physical therapy, hypnosis, acupuncture, tai chi, TENS… nothing worked, and my quality of life was nil – my weeks consisted of doctors and therapies and then recuperating in bed.

The week my doc put me on oxycontin was the week I got my life back. I saw him on a Monday, and had already scheduled an appointment with my lawyer for Thursday – I was going to update my will because I simply could not go on. As it happened, I never made it to that appointment with my lawyer… Oxy enabled a level of physical activity and interaction that had been missing from my life for 8 years, and my quality of life was back to acceptable. My whole family was giddy with joy.

Until 2 months ago, when my doctors got spooked by this PROP thing (that they were certain w a done deal) and decided that EVERY chronic pain patient taking over 100mg (equivalent) MUST transition away from a small list of specific opiates, a list that happens to include the only pain meds that have enabled me to have a relatively normal life.

So I’m spending a few months tapering down – same pain, plus withdrawal symptoms, plus raging depression over the whole thing. I no longer can handle as much physical activity, but I’m having to go to various therapies 3 times a week, physical activity I can’t afford and pain I can’t stand just to try therapies that I ALREADY tried for 8 years. Therapies that didn’t help at all, to replace the medicines that did help but I can’t have anymore. Despite Kolodny’s misinformation.

And since I’m out and about anyway, I rescheduled that appointment with my
lawyer. I don’t even care anymore. If people like Kolodny can destroy my quality of life, if a decade of medical plans carefuly crafted by few dozen doctors who have access to my files can be tossed aside by someone like Kolodny – who knows nothing about me, but has access to an extensive vocabulary of FUD – then my next 8 years are going to as bad as the first 8 that followed my injury, only worse, because I know that the meds I’m no longer allowed to have worked fine. And, frankly, I can’t do it all over again.

IMHO, the safety of these medications has been proven when people follow the dosing instructions… The entire agenda of PROP seems to be to STOP the prescribing of ALL opiate pain killers…. Long or short acting. This is ridiculous! The suggestions being made thru PROP are ridiculous because those restrictions would NEVER have prevented any accidental or intentional overdoses. If someone wants to kill them selves, they will find a way. If someone wants to get high, they will find a way. No amount of label changes or restrictions in the world will save any of these people! And again, the only people affected will be US, the chronic pain patients

I think they are going about this in the wrong way. The people that are overdosing or taking them to get high are getting these opiates on the streets ilegally. The legitimit pain patients are taking them as prescribed. Taking away pain meds ( opiates) from Chronic Pain Patients will only cause more problems. I cannot function without mine. i would turn to street drugs I would be so desperate for pain relief. And bdcause street drugs afe not controlled and prescribed there would be a increase in accidental overdoses and suicides. It is getting more and more difficult to get pain meds lawfully, so I see the problem only getting worse. It also makes me livid that the people that are making these decisions are not Chronic Pain Sufferers!!!!

Dr. Kolodny writes, “I don’t think it’s really helping their pain, but they’re doing okay on long term opioids, and I don’t want anyone to take away their pills from them”.

I find this statement quite patronizing, belittlling, and naive. Also, people who take prescribed opioids for pain take “medication”, not “pills”. Does anyone use that language when talking about the medication for other chronic health conditions?

There have been so many statements made by Dr. Kolodny that show his complete lack of knowledge, respect, and compassion for people who suffer from debilitating pain conditions.

When pain has gotten so bad that you literally can’t catch your breath, and it is so searing and all consuming that NOTHING else exists….. And you can take the medication that was prescribed for it, and that pain goes from and “8” to a “4” within 20 minutes….. Does that mean it’s not HELPING the pain? That scenario is my life sometimes, and I can promise that if not for the relief that my medication brings, I would cease to function.

I have Ehlers-Danlos Syndrome (a genetic connective tissue disorder) caused by a collagen mutation. My joints, including my spine, shoulders, hips, SI joints, cuboid bones, pelvis, jaw, knees etc… have all spontaneously dislocated. That is just the effect EDS has had on my joints. It wreaks havoc everywhere there is collagen….the most abundant protein in the body. The GI system, eyes, heart, blood vessels can also have complications. ( Go to to learn more about this painful condition). There is no cure for EDS, and treatment is mostly supportive, and symptoms (pain being the hallmark symptom) is managed.

If PROP got its way, I could have a lowered dose of medication, and for about 90 days. Hmmmm….. I wonder which three months of my life I’d like to have pain relief? EDS is just one of MANY conditions that require opioid medication for disabling pain that hasn’t responded to other treatments.

So PLEASE, stop the patronizing language, the arrogance, and the pseudo-science. Addiction is a serious disease that requires lifelong treatment. Chronic pain, and the conditions that cause it, are serious diseases that require lifelong treament. These two things are VERY often mutually exclusive. Not always…. but usually. For many of us, the PROP petition’s recommendations would have been a death sentence. Thankfully, the FDA agreed more with professionals like Dr. jeffrey Fudin, that formed PROMPT. Health professionals who have knowledge, expertise, compassion, respect for pain sufferers, and SCIENCE in mind. Our lives are hard enough, and it’s not “PILLS” we want…it is the relief from torture that they provide us. It’s THAT simple….

I have read a lot of the research on pain, and I guess I sort of understand why Kolodny thinks the way he does. The latest medical research pretty much says that pain is an illusion. Especially long term pain. Basically, pain is caused by the brain sending a signal to nerve endings wherever to let you know that something is wrong. It’s the body’s way of telling you not to move an injured part and damage it further. It’s also the body’s way of telling you to stop what you’re doing and do something about the damage. It won’t let you think of anything else. With chronic pain, there is often no more damage going on…or nothing that can be fixed, but the brain is still sending out the signal. This is where these doctors are getting the idea that you don’t need pain medicine. I am probably not explaining it well, but if anyone wants to learn more, they can google Ted Talk Chronic Pain and have it explained better. There are supposed to be ways of re-training the brain to feel less pain, but as far as I can tell, they haven’t really settled on exactly how…they just know what causes pain and that there must be some way to fix it without drugs. BUT all of this being said, NONE of it makes the pain any less real to the person feeling it. It’s not even that they’re dependent on opioid pain relievers. The pain feels real to them. The arrogant and condescending tone Kolodny takes in his comments is just irritating. He might as well say, “I’m not trying to take your pills, you clueless junkies. I know the only reason you really want them is because you’re dependent. It can’t be because you’re in pain.” I also have issue with the fact that he says doctors are more likely to try prescribing OTC pain relievers first. Isn’t that the point of OTC pain relievers? Not having to go to the doctor to get them? If they’re actually working, why would you need to see a doctor for pain in the first place? I am not even a pain patient. I don’t take any opioid drugs. I do however, know the difference between someone who is actually suffering and a junkie. I have been in close contact with both kinds of people, and there are some people who are suffering needlessly because of a war that didn’t need starting in the first place. The people who abuse drugs like this will find ways get high, and unfortunately, many will still OD no matter what restrictions you place on legal medicines. That’s why we’re seeing such a huge resurgence in heroin abuse. The relief that real pain patients get from these pain medicines is just as real as the pain they’re suffering. It doesn’t really matter whether the pain is an illusion their brain is sending to their body. They still feel it and they can’t… Read more »
Julie Anna Bloodworth

I have been a Chronic Pain patient with Failed Back Surgery Syndrome, Radicular Neuropathy, Fibromyalgia, and Rheumatoid Arthritis for over a decade now. Believe me, I have tried ALL other therapies available from Physical Therapy, Acupuncture, TENS unit, Meditation, Yoga, Therapeutic Massage, Visual Imaging, OTC pain relievers, Non-Narcotic Pain Relievers, Short Term Narcotic Pain Relievers, over 20 Nerve Block and 5 Facet Blocks, Microdiscectomy, and Spinal Fusion with Instrumentation. If I had not been placed on Extended Release Opoids I would not be here today.
The suffering and mental anguish associated with these practically non-treatable disorders is unfathomable to someone that hasn’t actually experienced this type of pain – a pain that is not only excruciating but also eternal. However, if Mr. Kolodny truly believes that these very drugs do not work – well, I wish all my pain upon him and then I believe he would reverse his “witch hunt” against Extended Release Opoids.
ALL medications should be prescribed and taken appropriately and I believe that TRUE Chronic Pain Patients do follow the directions as they should. There are always people that try to manipulate the system and medications but WE shouldn’t be punished for people that are junkies and if Kolodny had his way, the death toll of suicide by Chronic Pain Patients may well exceed the deaths caused by people who have abused the drug.
I hope that wiser minds will prevail on this matter.