Label Changes for Opioids, FOR or AGAINST

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On July 25 2012, Physicians for Responsible Opioid Prescribing (PROP) submitted a petition to the U.S. Food & Drug Administration (FDA) requesting significant label changes for prescription opioids.  The full letter is available here,

…and, it has created quite an uproar!

WE NEED YOUR INPUT!” 

I have been barraged with e-mails by pharmacist and medical clinicians who are outraged by this letter.  Others feel it has some merit, but is far overreaching.  I decided to create a forum by which clinicians can duke it out [professionally] by commenting herein, for or against.  I am purposely withholding my personal feelings and position on the letter [for now] in an effort to remain an objective referee in case this blog gets out of hand.  Please note the blog policy when submitting comments.

-the Opening Bell has rung!

Here are the first two paragraphs of the letter:

“At present, the FDA-approved indication for nearly all instant-release opioid analgesics is “moderate to severe pain”. For extended-release opioids, the indication is for “moderate to severe pain when a continuous, around-the clock analgesic is needed for an extended period of time.” These overly broad indications imply a determination by FDA that they are safe and effective for long-term use. As outlined below, an increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses.

Unfortunately, many clinicians are under the false impression that chronic opioid therapy (COT) is an evidence-based treatment for chronic non-cancer pain (CNCP) and that dose-related toxicities can be avoided by slow upward titration. These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids. In addition, FDA will be able to reinforce adherence to dosing limits that have been recommended by the United States Centers for Disease Control1, the state of Washington2 and the New York City Department of Health and Mental Hygiene.”

If you are a pain patient and wish to comment, please go to this blog and comment where indicated.

44 thoughts on “Label Changes for Opioids, FOR or AGAINST

  1. I feel like a nobody, my pain mgmt. dr. says after July 1, I live in Louisiana. My neuroloogist,pain mgmt specialist,and also a psycopharmacologist and a few more degrees. I saw him first becase i had a seizure., then as that resolved ,went away,i am allergic to many medicines, saw him as a psycpharmacologist. Then i crushed 4 cervical vertabrae leaving me paralyzed neck down for approx.2 yrs. Since my dr. had run a rehab unit he took over my rehab and has seen me since..I now am dealing with all the side affects from my accident, lg.bruise on spinal cord,i suffer alot of continos headache, some turn into migrains,My right side was last to come back ,so arthritis is settelindg in, ive had 2 unsuceesful back surgeries,constant pinched nerves. I can recieve one more presciption for muscle spasms,1 more nauseau med,and 1 more pain med. i thought the FDA was in place to protect us,disabled peple in constant chronic pain. I don’t like taking meds so i have tried chiropractics,got backon meds thoght i was going to die, i was in so mch pain,a yr later i lowered my doses of meds constant pain and in bed crying, i had recieved spinal block shots,and acupuncture, again back on full doses. I have been on all my meds since then,nothing else will ever help.,im hoping for trials for spinal cord treatment. the damage i have w/damaging my spinal cors, along with cervical,and lmbard disks Dr.’s call me thier miracle patient. For years every month ive seen my pain mgmt. Dr.and have had forms of pain i expierenced that mo. what i was able and unable to do, urinaysis.and a full dr.visit I would have ver little quality of life if,my valuimn for musle spasms were taken away,without it i have to have assistanc walking holing a glass, its amazing how well this 1 drug works for spasms,tightness in joints,and my pain meds. these meds let me play w/ grandcildren i can sit and garden sometimes,and cook sometimes, im always hurting during and after these activities, but w/them i can live,maybe not as well as others ,but i’ve come to accept my life. Now my state has deemed me disabled, and the FDA want me in bed crying,is this fair? I’ve fought breast cancer, and cervical cancer,and i fought to walk 3yrs. in the hospital,and other small sureies.This is my reward for fighting, I never thoght drug addict,and people who wanted to drink w/thier meds, wold affect me.I have no more fight left, my body and brain wo’nt last a yr. w/out my meds.I hope the people pushing for prop get a smalll taste of what cronic pain is just for 6 mo’s so they can see how meds really help people who need it.and i hope thier children stay healthy ,as well as parents, i’d love to speak w/ the woman that started all of this,she isn’t even a physcian. . Sincerly. Lynnette D.Wyble

    1. Wow, life in itself can be cruel and unjust we don’t need some jerk dictating what meds we can and can’t take, they are NOT a doctor and they have NO idea what we deal with everyday. I know exactly what you’re dealing with. I’ve suffer from chronic for almost 2 decades now. My doctor just says deal with it, I have even thought about suicide but the only ones that would get hurt is my family and friends and I don’t want to do that so my only other choice is to deal with it. I’m just stuck and have ZERO quality of life. Hope your pain can be alleviated at some point.

  2. “I wanted to make some points to PROP’s Petition and lets see what we can make of it by comparing what it is they say to what we really know.” Mark S. Barletta.

    2. Prescribing of opioids increased over the past 15 years in response to a campaign that minimized risks of long-term use for CNCP and exaggerated benefits.

    “My thoughts,the population has also increased putting much more people at risk of becoming a chronic pain sufferer.”

    3. Long-term safety and effectiveness of managing CNCP with opioids has not been established.

    “Whom did you ask this question ,just anyone that’s never suffered from chronic pain, they cant establish any answer if they have never suffered on a daily basis.
    Only those that suffer from chronic and intractable pain have established relief from their paralyzing chronic pain by following doctors orders and safely taking opiates as prescribed. We that suffer from chronic pain have finally found a way out of the never ending suffering ,why would PROP deny us pain relief.”

    4. Recent surveys of CNCP patients receiving COT have shown that many continue to experience significant chronic pain and dysfunction.

    “Yes this is correct once a chronic pain sufferer always a chronic pain sufferer, if surgery took our pain away we would have it but this is not available for me or people like me. I was told by many Surgeons and Pain Experts ,you cervical spine cant be surgically repaired, you will suffer the rest of your life. Stay with Pain Management, its your only option.”

    5. Recent surveys using Diagnostic and Statistical Manual of Mental Disorders or DSM criteria found high rates of addiction in Chronic Non-Cancer Pain or CNCP patients receiving Chronic Opioid therapy or COT.

    “Chronic Opioid Therapy is used for Chronic – Non Cancer Pain patients so they don’t have to suffer and be paralyzed with chronic pain curled up in bed .
    Most all never become addicted to these life saving medications, just somewhat dependent upon the medications so we can return to a Active Member of Society instead of suffering every day. Addiction is the misuse of opiates despite harm. All chronic pain patients are already harmed by the never ending chronic pain that confines us to our homes. We need freedom from our pain ,after all America is Land of the Free Home of the Brave.”

    6. A large sample of medical and pharmacy claims records found that two-thirds of patients who took opioids on a daily basis for 90 days were still taking opioids five years later.

    “That’s why it called intractable and chronic ,its not going away,so this is a fine example of why we need COT, this helps us live a somewhat normal life.”

    7. Patients with mental health and substance abuse co-morbidities are more likely to receive COT than patients who lack these risk factors, a phenomenon referred to as adverse selection.

    “Adverse selection, anti-selection, or negative selection is a term used in economics, insurance, statistics, and risk management. It refers to a market process in which “bad” results occur when buyers and sellers have asymmetric information (i.e. access to different information): the “bad” products or services are more likely to be selected. A bank that sets one price for all its checking account customers runs the risk of being adversely selected against by its low-balance, high-activity (and hence least profitable) customers. Two ways to model adverse selection are with signaling games and screening games.
    How this equates to those that suffer from chronic pain, I don’t see the link. I thought we where talking about chronic – non cancer pain and the medications that give us a life worth living without suffering.
    Is this how PROP views all people that suffer from chronic pain as BAD PEOPLE.”

    8. Three large observational studies published in 2010 and 2011 found dose-related overdose risk in CNCP patients on COT.
    9. COT at high doses is associated with increased risk of overdose death, emergency room visits and fractures in the elderly.

    “ As with all medical treatments of any kind of medical disorder risk are involved, there is no guarantee’s in life ,we must live life to the fullest extent.
    Every day we get in our car there is a risk of a bad accident. If we can prevent the suffering of good people why not give them what they need to survive another day,life is just way to short to cut people off of medications that can give them a better quality of life.
    Limiting opioid medications is like saying your better off suffering, isn’t life cruel enough for those in never ending chronic pain.
    Putting dosage limits on opioids is like taking the caffeine out of coffee why drink it, why go on suffering yet another day in never ending chronic pain.
    This is cruel and unusual punishment for those that never asked to be in chronic pain in the first place. Can we all please stop the slander and get along.
    We gain nothing by arguing amongst ourselves, it just causes stress we all don’t need. That tightening you feel in your chest is stress getting worse each day that passes,why make it any worse.

    Its time everyone comes back to earth and think rational.
    PROP’s petition is preposterous, proposing such one sided proposals.
    Never giving any real thought to the people proceeding to suffer so.
    20 plus year of this chronic pain and it seems we are going backwards instead of forward.
    Please all of you get on the same page so we can move forward.

    Regards,
    Mark S. Barletta

    1. Well said Mark S. Barletta, I have been reading the PROP and I am so stressed. I have been suffering with Intractable pain for 16 years. I have not found a pain medication that worked for me until one doctor put me on Oxycontin now she’s scared to continue and has been weening me off for a year. I was down to an amount that she felt comfortable with until one day recieved a letter from my insurance saying that they are not covering certain meds and that was one of them. I was taken off of oxycontin just like that. You can imagine the pain and withdrawal I have felt ever since. I spend all day in bed or on the couch. It’s unfair and I am considering suing if I have a case.

  3. My letter to the FDA as a person with something at stake in this fight that doesnt prescribe or take opoids. Thank you to the doctors at this blog fight for us please.
    Hi am the average American and i love my wife. I own my own home have a good job love family and god. I am kind and easy going don’t bother anyone and don’t get bothered. My wife is 27. At the age of 15 she was diagnose with EDS type 3 this effects the collogen cartilage the most abundant protein in the body. She has had 16 corrective surgeries from this and it causes a significant amount of pain in her daily life. pain that has been managed by opoid pain medication at times. Last November 11/8/11 She woke up with a migraine or what we thought was a migraine. It took 6 months to get a correct diagnosis from one of the 5 dr. in the United States that understood what was wrong. Atlantoaxial hypermobility. During those six months she was seen by 3 neurologists 2 week long stays in the hospital 3 pain management Dr. and loads of other dr. who could not figure out what was wrong. To make a horrible chapter in her life worse some of them said nothing was wrong. Her life was almost unlivable from the pain in her neck and her migraines. One pain management Dr. on a Friday afternoon said he “couldn’t find anything wrong with her and she just needed to get off all these drugs” These drugs where the only thing between her and sanity. Thank god there are good Doctors who care her family Dr. took over her pain management the following Monday. I unloaded my gun that weekend she had been in constant pain from November to March and the only thing that helped was opioid medication. I believed she may use that gun to end it so I hid the bullets. It turned out ok family dr. stepped in and helped, we found a Dr. that knew what was wrong in May and emergency surgery was performed 3 weeks later to relieve the pressure of the dens of the c2 pressing against the BRAIN STEM. Imagine that a bone pressing against the brainstem for 6 months her head unstable on her neck causing the occipital nerve roots to be compressed between c2 and c1. During these 6 months I saw pain and suffering like you can’t imagine in someone I would do anything for. The surgery worked metal from c2 to the cranium to stabilize the area probably 1.5 years to full recovery. That will be 2 years on pain meds and she may need something low dose for the rest of her life. I am not violent. I am not a thief. I know for a fact if my wife had been pulled from all her opioid pain meds at 90 days I would had done what I had to. I am perfectly capable violence and theft if given no option. I think a jury of my pears given the above statement might swing in my favor and let’s face it when someone you love cries in agony you will do whatever it takes to get that person relief. There is also the ability to just make your own “papaver somniferum giganteum opium” though this does take time to grow its not hard and well you do what you have to. I am a law abiding citizen of the United States. “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness” Now could you imagine that Americans started growing their own pain medication at the trouble that could cause. I ask that you seriously think about limiting the length of time pain medication can be prescribed.

  4. I am not a doctor, or pharmacist, but am a person who suffers from extreme pain caused by adhesive arachnoiditis, therefor i have a stake in this issue.I have been in constant contact with other Patient advocate groups and have helped organize a patient response to this issue. While talking with Donna Ratliff from Fight For Florida Pain Care Action Network, we decided to reach out to all the professionals involved against PROP. We would propose that a broad coalition be formed for the propose of drafting a response letter coming from all the parties being drug into this mess. I am grateful to have all you professionals on our side, but letting FDA leaders know that we are the ones affected by this petition and that we have a voice is very important to us as patients. I have had the chance to speak to DR. Kolodny on many occasions, he has always stated that he is not out to take our meds away from us, that he is trying to preserve our access. I have to agree with many of the comments being made here and on other blogs that the damage this would cause would be comparable to the trickle down economics made popular by Ronald Reagan, and the long term outcome would be more doctors fear prescribing off label. There is a solution, but it is going to take the combined might of all parties involved to bring such a solution to light. i pledge the full support of AVA and its growing membership to help solve this problem, and i am certain Donna Ratliff can do the same. Thank you for all the help y’all give us.

    1. Can you please send me a link to a patient advocate group. I live in New Jersey not Florida but it may not matter a voice is a voice. My Doctor went from prescribing Oxycontin to a very small amount of Morphine sulf Er twice a day for my intractable pain caused by an autoimmune disease and fibromyalgia. She first tried to pass me off to another doctor but I would not hear of it, I don’t have the energy to seek out a new doctor in the condition so she gave me a small amount of a drug that doesn’t work and a pile of referrals to other doctors. I know she is not planning on writing anymore scripts for me.
      We are being wronged and we need to fight back. Thank you, you can reach me at Blaze36193@aol.com

  5. After reading the PROP petition, one of the first things I thought was that the petition doesn’t address or encourage education for prescribers on proper opioid follow-up and monitoring, both of which are logical first steps to mitigate against controlled substance abuse and diversion. Instead, it seems that the PROP petitioners answer is just to limit the doses of opioids prescribed for non-cancer chronic pain. In turn, that serves mostly to tie the prescribers’ hands by limiting the doses of opioids he/she can offer or for a fixed minimal timespan. Empowering clinicians to properly prescribe and monitor opioids seems like an essential part of the whole equation.

    In all honesty, how many health care professionals were properly taught in school how to prescribe opioids and monitor opioid use (to help prevent possible misuse) by employing urine drug screens or serum testing? I graduated in 2005 from pharmacy school and I can confirm that we learned the basic pharmacokinetics of opioids, but we were never taught about the appropriateness or lack thereof when considering urine drug screens and/or serum testing for opioids, much less how one might interpret them. And let’s face the fact that proper opioid follow-up and monitoring was not emphasized or bestowed to prescribers by those manufacturing them. I believe there is a national need to educate prescribers and health care providers (including pharmacists) on proper opioid prescribing, follow-up, and monitoring appropriate monitoring.

    Although the PROP petition attempts to address opioid abuse and diversion through label changes to opioids, I don’t believe it actually focuses on better methods of prescribing opioids for patients that do indeed have chronic pain (if it’s chronic pain, it won’t go away with just 90 days of opioid treatment, especially when one considers that 90 days by definition is the accepted time at which one is considered to have “chronic pain”) or finding ways to monitor patients for possible diversion. If these label changes are made, the people diverting or abusing opioids will likely other ways to get money or highs and people with chronic pain may find their pain no longer controlled because prescribers are hesitant to prescribe “off-label” opioid regimens. If we want to find a long term solution to opioid abuse while limiting access to abusers, let’s not just put a quick Band-Aid on the problem by limiting opioid doses; instead let’s work on a solution that educates prescribers and the healthcare community so that opioid prescribing can be done in a safe and reasonable environment.

  6. When it comes to the misuse of opioids, our biggest problem is not a lack of consensus that something should be done but, instead, the paucity of good ideas for what that something should be. Grousing about the need to treat pain is not a solution. Moreover, it perpetuates the false dichotomy that adequate pain treatment and the prevention of accidental opioid overdoses are mutually exclusive outcomes or, worse, a zero-sum game in which one can prosper only at the expense of the other. Repeating the inferences drawn from these false assumptions only weakens our ability to address the core problem.

    In many, surely not all, cases, accidental fatal drug overdoses are preventable occurrences. For this reason, they deserve to be treated with the same sense of urgency and concern that we show for any other serious life-threatening medical risk. Moreover, since passage of the FDA Amendments Act of 2007, the known risks of accidental or intentional drug overdose and abuse have been redefined as adverse drug experiences that by law must be weighed by FDA in its drug approval process.

    Having worked in the regulatory field, I remain skeptical that the interests of patients and overdose victims can best and only be served by more government regulations. It would be better for all, I think, if a “solution” were to emerge from within the profession. For this reason, I initially applauded the PROP petition. On closer inspection, though, the PROP formula may be lacking in some respects, as others here have pointed out. Rather than simply criticize the PROP proposal, as most have, wouldn’t it be preferable to offer some thoughtful alternatives that might reduce the number of preventable deaths from the misuse and abuse of opioids?

    If the profession is unable to come up with suggestions for self-improvement, it is certain the Congress will impose additional regulations that may make the PROP petition seem mild by comparison. The 2007 legislation intended to reduce the misuse and abuse of prescription drugs has not reduced the mortality attributed to opioids. This may provide the impetus for more extensive legislation in the upcoming Congress.

    1. John,

      Thank you for the comments today. Specifically, your question; “Rather than simply criticize the PROP proposal, as most have, wouldn’t it be preferable to offer some thoughtful alternatives that might reduce the number of preventable deaths from the misuse and abuse of opioids? ” hits the nail on the head. This is the intent. STAY TUNED!

      In fact, my second blog post ended as follows, and I meant every word…
      Understanding pain management and mitigating risks collaboratively are essential if we want to get it right! In the words of my esteemed colleagues, “Alterum Alterius Auxilio Eget (Each Needs the Help of the Other)”.

    2. I will propose two solutions. I am a chronic pain patient who has taken Oxycontin and Percocet successfully for several years. My pain management regiment also includes Lidoderm and Flector patches, daily meditation, well-researched supplements, a spinal cord stimulator, regular exercise, rest breaks, braces, heat/ice, pulsating magnetic therapy, and an anti-inflammatory focused diet. I could avoid the effort of these auxiliary methods if I wanted to take a higher dose of opiates, but I don’t. Why? Because higher doses flatten my personality, reduce my energy level, and cause severe constipation and other side effects. So, the first remedy I propose is that doctors educate people about other methods of pain control besides or in addition to opiates. My second recommendation is that every time a doctor prescribes an opiate, he explain to the patient that taking more than the recommended amount can suppress respiration leading to death. Also, it should be explained that opiate drugs containing acetaminophen can cause permanent liver damage. Perhaps doctors should devise a standard handout that explains the risks of the opiates. I think this might make a difference because people don’t take these risks seriously. Opiates are handed out so readily after every surgery, dental procedure, etc., that people get the impression that they aren’t dangerous. Or they think that only persons of low character can get addicted. They have no idea about opiate-induced hyperalgia, nor its role in addiction or dependency. So, if doctors took more seriously their role of educating people about these dangers, then people would start treating their opiate medications with healthy respect, as I do. I myself was an alcoholic in my teenage years, and have been sober 24 years. This background made me particularly cautious about opioid therapy when I became disabled 12 years ago. This cautiousness has served me well, and I credit it with why I haven’t fallen into the addiction trap to which I’ve seen others succumb. In short, education is the answer. Opiates are sometimes necessary but they carry risks, and there are other options for managing pain that should be taken very seriously. All that said, it is flat out wrong to punish those of us who are responsible with our opiates for the crimes of those who are not. My life will dramatically change for the worse if this aspect of my treatment is withdrawn, as will my daughter’s life. When my pain is inadequately controlled, I can’t be a fully involved mom. As is, by doing everything I mentioned above, I am right on the edge of being able to care for her in the way she deserves. If a group of short-sighted doctors (PROP) send me back to the drawing board for pain management, the decline in my young daughter’s life will be on their conscience, not to mention the decline in my quality of life and my husband’s. Please let me know what else I can do to help. Jennifer Baker Gal, Indianapolis, Indiana, age 41. (p.s. I have Ehlers-Danlos Syndrome Type II & Type III, and have undergone 18 surgeries directly related to the condition)

      1. Jennifer,

        Thank you for your thoughtful insight. I agree with many of your points. I believe that all chronic opioid patient should be educated about the benefits and risks (as should any patients on any chronic medications). Furthermore, all chronic opioid patients (cancer and non-cancer) should be required to sign an opioid treatment agreement that includes educational material, risk strategies, and monitoring requirements. All of this should be taught by the prescribers and taught and reinforced by the dispensing pharmacist. Best of luck to you!

      1. Renee, Thank you for your comment. I would expect no less from John. He’s a smart guy; all of his comments have been clear, well-written, and fair-balanced.

  7. What wonderful discussion!
    I am going to infer that the current PROP statement, although written to address advertisement for off label prescribing, is fueled by the desire and need to address the opioid abuse epidemic. Without a tempered and thoughtful approach to the problem, the pendulum will undoubtedly continue to swing for years to come. As healthcare providers in the pain arena, we have a responsibility to advocate for our patients dealing with chronic pain on a daily basis. We cannot allow the current societal problems to contribute to inadequately treated pain. Instead of focusing on what is being abused, our leaders and lawmakers should be focusing on boosting support and breaking barriers for patients with an opioid use disorder. As one of my patients so eloquently stated “when I stopped abusing (prescribed oxycodone) I switched to alcohol and just switched seats on the Titanic”. With the PROP statement as written, although intended to prohibit drug companies from promoting long term use of opioids, it does not deal with the problem of addiction and it inaccurately suggests that there is valid and substantial “evidence”, the likely result of which will be inappropriate discontinuations and/or dose reductions of opioid therapy, ultimately leading to an overall reduced quality of life for our patients.

    Thank you for creating this forum so we can continue to advocate for our patients.

  8. Interesting comments. I am a retail pharmacist and see more opiod prescriptions in a day than I can count! Without a doubt, there is diversion and abuse. But, as the pain specialists have already stated, what about the legitimate patients with unrelenting pain? What are they to do? I watched my father suffer in pain for 49 years. He was injured in a construction accident in 1962. He underwent 3 failed surgeries, including 2 fusions. He had cages and rods placed in his back in the last surgery. Six months later he was hit by a tractor trailer. As a result of that accident, he had a crack in his fusion, almost lost both legs and dislocated and fractured his hand. He spent 3 months inpatient and 3 months in rehab and a year in a hospital bed at home. After that, he was no longer a candidate for any further surgeries. He had more steroid injections than I can count. He had a trial implanted intrathecal morphine pump (failed). He went to pain management specialists, and two of those specialists stopped practicing due to the tough regulations in NYS. He was lucky enough to find a physician who would write scripts for his pain. At the time of his death, he was on 200mcg q3days of fentanyl and 40 to 60mg daily oxymorphone for breakthrough pain. Even with that, he was in constant pain, usually at least a 5, more frequently a 6 to 8. He was tough and lived like that.
    So, my question to all: how do we take care of people like my father? He never abused his meds, never filled early, never took more than prescribed. Under the suggested label changes, would he have been able to receive adequate pain control? Probably not. I hope I never am in the kind of pain he was in.

  9. I am a Pain Specialist in Kentucky, so I speak to you from the front line in this battle. Our “leaders” recently enacted our country’s most far-reaching and intrusive pain regulations to date (http://kbml.ky.gov/House+Bill+1+Emergency+Regulation) . These laws were passed in a politically expedient manner with the media gleefully trashing the Kentucky Medical Association and our KMA President (by name), going so far as to say he was turning his back on his Hippocratic Oath and harming people by not supporting the pain bill.

    I know of and am personally acquainted with many of the signees of the PROP petition. I respect them all. But I want to caution against any medical expert providing ammunition or “cover” to politicians hungry to emerge as a “champion” against drug abuse. It is a “siren’s song” that will lead to destruction on the rocky shore (i.e. Kentucky’s current situation). There are plenty of cheers (and votes) to be had when one can claim he or she has done something to stop drug abuse. But as the politicians are beating their chests, and saying “Look what I did” no one speaks for the silent sufferers, the downtrodden and shame-filled innocent people suffering with legitimate unrelenting pain.

    We must speak for them. If not us, then who? If not now, then when?

    I hope the PROP faction will reconsider their petition and be inclusive of the wide range of people who have a stake in this issue.

    1. Dr Murphy, I am a chronic pain patient of 15 yrs. I live at ground zero in this battle, SE Ky. I moved here 11 years ago with no knowledge of the drug problem. I was working and transferred here with my company. Within 6 months I was ordered by my Dr to apply for disability. I was treated like a criminal because I required pain management to function due to mva resulting in back surgery.
      Fast forward to HB1. I was referred to yet another pain clinic. I have Chiari 1 malformation which causes horrific symptoms including severe pain at base of skull, neck, and shoulders, disc buldge @ C6/7 and C3/4 with stenosis. There is a bulge @L1/2, L3/4 with annular tear, and post surgical changes at L5/S1 with what “appears” to be a synovial cyst that “appears to abut desending S1 nerve root. There is more, but this should give you an idea of my issues.
      I have had multiple rounds of PT, before and after surgery. Also surgery was not a choice. It had to be done. I had a free fragment lodged on a nerve root and was not able to care for myself. I could not walk or go the bathroom unassisted. I also had 2 epidurals before surgery. Of course that did not help with a free fragment. I have used ATENS unit, tried acupuncture, heat, and exercise when possible. I have had more injections in my spine than I can count.
      Oct 2 I was given another epidural. I felt I had no choice since it was required to be treated at Premier Pain Center. I was told that HB1 requires patients to have “procedures” for pain. “It is the law” This is not true, but doctors do not seem to like informed patients. I have read HB1 and listened to politicians say that “those who need care will be able to get it” Another lie. I did not read anything in HB1 that would prevent me receiving pain management with opiates that would enable me to function at some level. It is the doctors who refuse to treat legitimate patients. HB1 may have closed “pill mills”, but what it has grown is the “ESI MILLS”. Why is there no discussion about the risks of permanent damage from epidurals? Arachnoiditis for one.
      The day after my last injection my pain was as bad as it was before surgery. Then I heard about the meningitis outbreak from contaminated injections. 28 people have died. 368 infected. What about them? Does no one care that these people have been sickened and died because they were given an injection for pain. Injections at pain clinics are done in an assembly line fashion. It is their “Cash Cow”. As soon as I was able, I picked up my records from the clinic and will not go back. No contaminated medication was shipped to Ky. So, I guess I am safe there. However, The MRI I had on the 16th showed the cyst where the injection was given and there is no way to know whether it is a true synovial cyst, or if it is filled with blood from the injection, or a localized infection. Either way I am in increased pain with less pain medication and my L leg is barely functioning. I am seeing a neuro surgeon soon. It seems to be my only hope of living.
      I found it interesting that a “Pain Management Director” contributed to the political campaign of Robert Stivers who “Worked” to get HB1 passed. Shut down the small clinics and let the “ESI MILLS” bleed the system doing “procedures” that are risky and expensive. They all make money. The patients suffer.
      God bless all who are suffering in silence because we have no voice.

  10. All,

    Good conversations all around. I am fortunate to count many who have commented here as friends and have to put in my support for the comments of Steve Passik and Mike Brennan. John Coleman is a dear friend as well and as always makes sound regulatory points. However, we are talking about a major impact and stance about clinical management. While I might argue that prescription drug abuse is more appropriately a pandemic than epidemic, bottom line is it is a real problem.

    However, we tend to “throw the baby out with the bathwater” and forget that the majority of pain patients are genuine, do suffer, and their conditions do not remediate in 90 days. As I often explain to patients, the best analogy to chronic pain is diabetes. We don’t “fix it,” at best we can manage it and give people some quality of life. What we are arguing about here are Band-Aids, albeit very important ones that can have negative implications if given inappropriately and used incorrectly. I also agree with Mike that this petition would lead to more off-label prescribing by definition, and where does that actually get us?

    I, for one, am happy to join up on Jeff’s upcoming PROMPT letter. On a national level, and a state level (KY being particularly restrictive and misguided right now), we are seeing a surge of political posturing and self-serving rhetoric that may help individual political careers but will ultimately cause millions of chronic pain patients to suffer. I, for one, can’t support that.

  11. PROMPT (Professionals for Rational Opioid Monitoring & PharmacoTherapy)

    After exactly 2 weeks of heated debate and e-mail exchanges surrounding the recent petition to change FDA labeling for opioid therapy, we have had no input from 36 of the 37 signatories on the PROP petition. A single respondent has heretofore only agreed to provide indirect communication. It’s been exactly 2 weeks since the original letter was written.

    I propose that a large multidisciplinary group of dedicated professionals draft a response letter collaboratively to address each of the points in the PROP letter. Signatories on this response to the FDA (in alphabetical order) should include, but are not limited to nurse practitioners, pharmacists, physicians (primary care and/or specialists), physician assistants, psychologists, and others. A suggested name for this group is PROMPT (Professionals for Rational Opioid Monitoring & PharmacoTherapy). If you are interested in joining our group of dedicated professionals to clarify certain issues for FDA review in a timely manner, please e-mail Dr. Jeffrey Fudin ASAP at jeff@paindr.com. THANK YOU!

    FDA has posted the Petition at the U.S. government site and is accepting public commentary on the PROP petition. The link is: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

  12. KOLODY AND FUDIN COMMUNICATE!

    I’m happy to announce that after initial Twitter communications between Dr. Kolodny and Dr. Fudin (me), Dr. Kolodny graciously contacted me this morning. Although he declined to comment directly on this blog, he did agree to provide a press release link that he feels will help to clarify his and PROP’s petition for the FDA to make opioid label changes.

    Specifically, he wrote the following in an e-mail which he agreed for me to share…
    “I think the press release makes clear that the purpose of this effort is to prohibit drug companies from promoting long-term use of opioids for conditions where use has not been proven safe and effective. The petitioners are not making a statement that long-term use of opioids for chronic pain or high dose opioids is always inappropriate. Our petition should not be interpreted as a manifesto on the appropriateness of long-term opioid prescribing for chronic pain. Instead, it should be understood as a request to FDA to better regulate the claims that opioid manufacturers can make about their products.”

    We discussed a number of points in the petition, some of which we agreed upon, but many of which we did not. To some extent I believe that that all of us have similar concerns about chronic opioid use, but the approach to this problem is where fall short on agreement. Many points of the petition have already been bantered around in the blog comments by me and others. However, I do wish to clarify a few points, some of which Dr. Kolodny and I discussed today.

    According to the press release, “Although the proposed label changes would limit the way drug companies promote opioid analgesics, doctors would continue to be able to make prescribing decisions based on their clinical judgment, assessment of patient needs and response to treatment. “Off-label” prescribing is considered appropriate, even though “off-label” advertising is prohibited.” We both agree that “off-label” use has a high probability of increasing liability to prescribers by regulatory agencies and in private law suits.

    We did not agree on the 100mg morphine dose cut-off for opioids, but we did agree that if the FDA accepted this, an equivalency chart would need to be adopted by the FDA because significant disparities exist with currently available equivalency schematics. We also did not agree on the 12 week limit for chronic opioids. To be fair, Dr. Kolodny acknowledges that many patients are appropriate for such therapy, but he believes that drug companies should not be allowed to market them as such.

    The press release also acknowledges signatures “… by 37 prominent experts, including leaders in the fields of pain medicine, addiction and primary care; health commissioners; researchers; and program directors at public interest groups.” I am particularly vexed that not a single pharmacist was involved in developing the petition. Can you imagine if a group of pharmacists tried to change the paradigm for how intraspinal drugs could be used without including anesthesiologists or other suitable interventionalists?

    The bottom line at this point seems to be that we all agree there are dilemmas with chronic opioid use. Our approach to mitigating the problem seems to be worlds apart. Infighting among the medical community will not likely yield a reasonable outcome. Perhaps a meeting of the minds, including more disciplines, is in order to revise the current petition for the ultimate benefit to patients, providers, and overdose casualties.

  13. I agree with Steve Passik!

    Are Physicians the only ones concerned with opioid prescribing? The PROP title itself is insulting and discriminatory towards other healthcare professionals. The FDA has little to gain by doing what this petition asks, because many drugs that are FDA approved, are prescribed at higher doses and longer durations than approved (Ambien and Xanax come to mind). In addition, changing the labeling does nothing to stop those with bad intentions from carrying out their schemes (pill mills, pharmacists dispensing without a valid prescription, etc). I do think that this move looks to me like “grandstanding” and attempts to make a name for PROP, but in my opinion, does just the opposite. I think their efforts would be better served by working with all healthcare professionals to improve the safety of the existing system rather than creating additional roadblocks for patients.

  14. As an active part of the palliative care team at my hospital, restricting opioids to cancer pain only or for 90 days only is short-sighted and cruel. There are many reasons for chronic pain unrelated to cancer. Unfortunately, there will always be addicts; however, we cannot punish those who truly need these medications to function.

  15. Dr. Brennan: Thank you for the kind words that I truly appreciate. My criticism of aggressive marketing in no way was meant to criticize the valuable educational work performed by you and many others in this field. Over the years, I have had the pleasure of working with you, Dr. Fudin, and others in helping to bridge the gap between our respective fields. I believe (perhaps hope) that a good deal of progress has been made in this regard.
    I recently completed a study of the pharmaceutical “supply chain” with an emphasis on the largely behinds-the-scene system used to bring manufactured controlled substance to market. What I found, to begin with, was that major drug companies do not market their drugs directly to their retail customers, such as pharmacies, dispensing physicians, hospitals/clinics, etc., but, instead, they use wholesale distributors who purchase and take title to the drugs directly from the manufacturers. In doing so, the distributors pay the full price for the drugs. The distributor typically will have marketing agreements with certain manufacturers to distribute their products to retail customers with whom the manufacturers, in turn, have sales agreements.
    Customers negotiate prices directly with manufacturers but the actual delivery of product is made by a distributor who charges the customer the discounted price agreed upon by the customer and manufacturer. The distributor charges a modest markup fee, often a small percentage (circa 2%) of the total transaction. When the sale is completed, the distributor notifies the manufacturer who then reimburses the distributor for the difference between the full price the distributor paid for the drug and the discounted price paid to the distributor by the customer. This difference, called in the business a chargeback, is paid by the manufacturer to the distributor who also may earn additional fees from customers and manufacturers for providing other services.
    According to industry sources, distributors provide almost nine million prescription drugs and healthcare products each day to some 200,000 customers. The revenue generated by this commerce, as you might expect, is massive. Federal law requires manufacturers and distributors of controlled substances to be registered with DEA and to employ systems that disclose suspicious orders for controlled substances so that they can be reported to DEA. The regulation defines “suspicious orders” as “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” Whenever an order fitting these criteria is received by a distributor from a customer, it must be reported to the nearest DEA office.
    Since 2006, DEA has suspended the registrations of at least 17 drug distribution centers, including facilities operated by McKesson, AmeriSourceBergen, and Cardinal Health, known in the industry as the “big three.” These suspensions were based on charges of unlawfully filling suspicious orders and failing to report them to DEA. The volume of controlled substances allegedly diverted by these distributors was substantial. Court files and other public records showed that, collectively, suspicious orders were filled for more than 23.5 million dosage units of hydrocodone products and more than 64 million dosage units of oxycodone products. In most cases, the customers or recipients of these drugs were identified as rogue Internet pharmacies, retail pharmacies, and/or dispensing physicians operating “pill mills.”
    I wish I could report to you that the sanctions imposed by the government for these egregious law violations were significant but, sadly, much to my chagrin they were not. In virtually every case, after just a brief suspension, the DEA registrations were reinstated in return for an agreement by the errant distributor to pay a modest fine and sign a “memorandum of agreement” to obey the law in the future.
    In the Purdue criminal case that I mentioned in one of my earlier messages, the court was informed that the company’s use of generous sales bonuses for reps encouraged them to mislead doctors and patients about OxyContin’s risk of addiction and its potential to be abused. This raises a legitimate question, I think, as to whether a similar effect – in a macro-sense – may be caused by marketing arrangements elsewhere in the supply chain that encourage the filling of suspicious orders for controlled substances by distributors whose earnings are based on completed sales.
    This was what I meant the other day by my comments criticizing aggressive marketing in the pharma business. To my knowledge, I know of no one who has raised this issue before in the context of controlled substances being diverted in bulk from the supply chain and, just as importantly, the potential implications of this activity for the public health. With respect to the latter, it should be noted that the drug volumes that are stated above represent minimums charged in the official filings. Given the way litigation is pursued, the actual volume of diverted drugs could easily have been far in excess of what the government alleged and was prepared to prove.

  16. My first thought when I read the letter from certain physicians responsible for opioid prescribing was that here we go again, punishing people who follow the law for ones who abuse it. As a pharmacist, I thought of the changes in the purchase of pseudoephedrine in an attempt to prevent the production of methamphetamine. As someone who takes pseudoephedrine daily for allergies, all this law change has done is made me feel like the criminal when I purchase my medication. It doesn’t appear this change has done anything to curb methamphetamine product or abuse.
    I understand that addiction is an epidemic in this country. However, I do not believe preventing the use of long acting chronic opioid therapy for non-cancer pain indications is the correct answer. Physicians who prescribe long acting opioids for pain management should have specialized training. In addition, they should have a monitoring plan in place for all patients on this therapy. Alternative treatments should be pursed and utilized whenever possible. However, opioids should still be used in certain cases.
    I have a family member who was unable to work for greater than two years because of a chronic, debilitating pain condition. One of the last medications attempted was long acting morphine sulfate 30 mg administered every 12 hours, which was titrated to a final dose of 60 mg every 12 hours over several months. With the help of this medication he has been able to return to work for the last seven years. Yes, he has tried every new drug that has come on the market for pain indications, but has not had the same level of pain relief and function with these agents. Therefore, he is still on long term opioid therapy and doing well.
    The proposal in this letter would take this life-altering medication away from him, a productive member of our society who is working and paying federal taxes. Why should he be punished for individuals who have abusive personalities or who are willing to take anything they can get their hands on to get high? I know chronic opioid therapy is not the answer for all patients with chronic pain conditions, however please do not take this option away from those who are truly benefiting from the therapy.

    1. Theresa,

      Perhaps the most profound comments are from healthcare professionals that understand the therapeutic and personal side simultaneously. Thank you for your thoughtful comments!

  17. VERY IMPORTANT UPDATE FROM FDA! The FDA has posted the PROP Petition at the U.S. government site where they are accepting public commentary.
    Click here now to make your comments. You may want to copy your comments from here and paste them into the FDA website link.
    Document Name: Physicians for Responsible Opioid Prescribing – Citizen Petition
    Document ID: FDA-2012-P-0818-0001
    Docket ID: FDA-2012-P-0818

  18. Hello again! While awaiting some comments and feedback from my PharmD colleagues, I thought perhaps I’d add my two cents on the FDA PROP (physicians for responsible opioid prescribing) letter. In doing so, I’m going to assume that the FDA takes their requests seriously enough as to actually implement all or part of the PROP letter suggestions. This response is also available here.
    From the very beginning of their letter to the end, I have more questions than answers. Here’s how I see it…

    “PROP (physicians for responsible opioid prescribing)” Are there any law-abiding physicians out there that are particularly in favor of “irresponsible” prescribing? “The undersigned clinicians, researchers and health officials from fields that include Pain, Addiction, Primary Care, Internal Medicine, Anesthesiology, Psychiatry, Neurology, Emergency Medicine, Toxicology, Rheumatology, and Pubic Health submit this petition…” Would such a document be accepted for publication in a peer reviewed journal from a group that has a potential for publication bias? As Dr. Passik points out, 10 of the 37 signatories (27%) are from the state of Washington, obviously the mecca of pain management by which all other states should be measured against.

    “These overly broad indications imply a determination by FDA that they are safe and effective for long-term use.” According the Merriam-Webster Dictionary, the definition of “imply” is to “involve or indicate by inference, association, or necessary consequence rather than by direct statement”. Why doesn’t somebody that wrote the FDA letter simply ask the FDA to clarify what they mean? And, why are we singling out opioids? To use the same logic, does the FDA “imply” that NSAIDS “are safe and effective for long-term use?” Do they imply any of the following “are safe and effective for long-term use”, all of which can be found on Drug Watch? [Accutane® (Isotretinoin); Actos® (Pioglitazone); DePuy® (ASR Hip Implant); Zimmer® NexGen Knee; Yaz® & Yasmin® (ethinyl estradiol, drospirenone); Avandia® (Rosiglitazone); Prozac® (Fluoxetine) I will give you this; the use of opioids far exceeds any of the individual drugs listed immediately above, but certainly they do not exceed NSAID use. I’m pretty confident that all of the signatories on the FDA letter realize the ubiquity of NSAID-induced GI bleeds, kidney dysfunction and adverse cardiac events. Is there a group called PRNP (physicians for responsible NSAID prescribing)?

    “Unfortunately, many clinicians are under the false impression that chronic opioid therapy (COT) is an Evidence-based treatment for chronic non-cancer pain (CNCP)…” “These misperceptions lead to over-prescribing and high dose prescribing.” What if we substituted “opioid therapy (COT)” in the sentence above with any of the following? “or multiple surgical interventions”. Personally, I think all of these would fit quite nicely into the equation as long as the second sentence is adjusted. For example, “Unfortunately, many clinicians are under the false impression that multiple surgical interventions are evidence-based treatment for chronic non-cancer pain (CNCP). Furthermore, some anesthesiologists, neurologists, and physiatrists routinely employ interventional procedures containing FDA approved drugs almost all of which are used off-label. The evidence to support such interventions is lacking and the cost for these surgeries to the healthcare system is millions of dollars per year. “These misperceptions lead to millions of unnecessary medical expenses. Research suggests that of the 500,000-plus disk surgeries performed annually, as many as 90 percent are unnecessary and ineffective.” While mainstream media focuses on the millions of dollars spent on prescription pain-relievers, articles are sorely lacking on the cost of routine back procedures such as Anterior cervical fusion at $44,000; Cervical fusion at $19,850; Decompression back surgery at $24,000; Lumbar laminectomy at $18,000; and Lumbar spinal fusion at $34,500. In fact, according to Dr. David Spodick, professor of medicine at the University of Massachusetts, “Surgery is the sacred cow of our health-care system and surgeons are the sacred cowboys who milk it.”

    “By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids.” Where is the proof that this can or will happen? Many of the signatories on the FDA letter are renowned researchers that should know better than to make such a statement without legitimate outcomes data.
    “The Federal Food, Drug and Cosmetic Act established that a drug intended to treat a condition must be proven safe and effective for use as labeled. The current label on opioid analgesics does not comply with this law.” Does the current label for the following comply with this law, specifically “proven safe”? warfarin, ibuprofen, digoxin, metoclopramide, any number of cytotoxic chemotherapy regimens, etc.

    SPECIFIC ACTIONS REQUESTED FOR CHANGES TO OPIOID ANALGESIC LABELS:
    “Strike the term “moderate” from the indication for non-cancer pain.” What do we do for an 84 year old man with SEVERE low back pain and whole body DJD that has a head injury, CAD, PUD, a Crs of 1.6, and cannot tolerate or doesn’t respond to anticonvulsants? Surely we can’t use NSAIDs because potential end organ disease or worse yet, DEATH, and acetaminophen won’t be effective. The patient complains of severe pain, level 10/10. Do we tell the patient that opioids aren’t approved by the FDA? No you say…use the drug off label; well really, what’s the point then?
    “Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.” Really? Whose equivalency chart will you use? According to a recent presentation by Dr. Kathryn Shaw (presented at Eastern States Pharmacy Residents Conference, Hershey PA, 2012), a review of 6 online opioid conversion calculators (all of which were based off peer-reviewed opioid conversion tables) yielded a difference in opioid conversion from (-50%) to (+242%), and that excluded 2 of the calculators because their percent deviation was even more egregious. Talk about risk of harm!!!

    STATEMENTS OF SCIENTIFIC BASIS FOR PETITION:
    “Long-term safety and effectiveness of managing CNCP with opioids has not been established.” I beg to differ. Few drugs have been available for centuries like opioids. I personally have patients that have been on opioids for 30-40 years. Not a single one has had opioid-induced liver disease (excluding those on combination opioids containing APAP), kidney dysfunction, or has become crippled from multiple surgeries.

    “Recent surveys of CNCP patients receiving COT have shown that many continue to experience significant chronic pain and dysfunction.” I agree. How is this different from interventional procedures or surgery?

    “Recent surveys using DSM criteria found high rates of addiction in CNCP patients receiving COT.” True enough. Maybe we need to teach prescribers about risk assessment and careful monitoring, including how to interpret the urine screens they order and the potential usefulness of serum analysis. How many patients have severe depression or suicide risk per DSM criteria because they are non-functional without opioids?

    “A large sample of medical and pharmacy claims records found that two-thirds of patients who took opioids on a daily basis for 90 days were still taking opioids five years later.” That’s wonderful. Why does it matter; maybe they worked? What percentage of patients remain on statin therapy 90 days after they start them, assuming their LFT’s are normal? Geeeze folks, didn’t you know that chronic pain is a chronic disease like hypercholesterolemia?

    “Patients with mental health and substance abuse co-morbidities are more likely to receive COT than patients who lack these risk factors, a phenomenon referred to as adverse selection”. Which came first; the chicken or the egg?

    “Three large observational studies published in 2010 and 2011 found dose-related overdose risk in CNCP patients on COT. COT at high doses is associated with increased risk of overdose death 18, emergency room visits 19 and fractures in the elderly.” Really, how about this? In a NEJM published study of patients 80 years or older, “…researchers reported that 65.7 percent of hospitalizations were due to unintentional overdoses and four drug classes were the culprit of 67 percent of these hospitalizations: warfarin (33.3 percent), insulins (13.9 percent), oral antiplatelet agents (13.3 percent) and oral hypoglycemic agents (10.7 percent).” Hey what do you know; opioids aren’t listed!

    I’m not opposed to making prescribed opioids safer, and I don’t profess that they aren’t dangerous if not prescribed for the correct patient with risk stratification and ongoing monitoring. The PROP petition was perhaps an attempt to make a step in a positive direction. But it is misguided to say the least. I believe that treating all scheduled opioids as schedule II might be beneficial to monitor prescriptions. Also, perhaps significant headway would be made in mitigating diversion if all prescribers and all pharmacists had direct real time access to an online data base, which would need to include all DoD and VA facilities. This at least could help to prevent multiple prescribers and pharmacies from writing and dispensing opioids nationwide.

    Keep the comments coming!

    1. I have been a pain managed patient for 9 years. I have never been treated like this in my life(scum of the earth, addict, etc.) until the last 8 months or so, and I cant tell you how good it is reading all of these posts. Its so great to know you professionals are really thinking the way we the patients are thinking; we are not all the bad ones! Attack alcohol, that kills everyday and then some….. but you don’t need a prescription, go figure. I just wanted to say thank you to you all. God bless. Shannon

  19. I’m neither for nor against this petition because I do not believe that simple modifications to the label will cause a significant change, if any, in opioid prescribing patterns. We have changed the labeling on cigarettes so often that it is too often. We make the images more graphic and the warnings of illness and death more severe. The statistics show that this is not having a major impact. Changing the labeling does nothing to educate physicians on proper opioid prescription practices. We are basically enforcing a stricter opioid diet on practitioners but guess what, diets don’t work! Much like successful weight loss requires the effort of food management a large part of successful opioid therapy is prescription management. I’m sure patients can give us more severe pain if that is what it will take. It just means that as a patient I need to scream louder, walk a little slower and cry a little harder to convey “severe” pain. While we hope that changing a few words on the labels of opioids will change prescribing patterns we might as well wish for money trees.
    The truth is that managing patients on opioid therapy is complicated; it takes commitment from the physician to assess patients closely and courage to identify patterns of misuse and diversion and actually do something about it. It is a cop-out to get rid of an indication rather than make the effort to manage its use.

  20. I’ll be quite honest in saying this – You can label ALL YOU WANT that’s never going to be the answer. As any past or present frontline practitioner in the community setting can tell you people BARELY read the labeling on thier maintenance medications. The current practice paradigm is WHOLLY inadequate to address the degree of counseling and subsequent patient monitoring that is necessary in order to properly address the problem. Right now the system is NOT designed for pharmacists to function as the true and properly suited healthcare professionals who can address this matter. We are in the best position to do so and that can’t be denied by anyone with a true degree of patient safety/pharmacovigilance in mind.

    The other part of the equation is that as a class of professionals PHARMACISTS have to STEP UP. Way too many of my professional brothers and sisters talk a good game but are TRUTHFULLY oftentimes TOO CHICKEN to make the leap to being the full – fledged HEALTHCARE PROFESSIONALS that we are trained to be. I don’t understand it but it’s true. We lack confidence in what we know and are often all too willing to capitulate at the first sign of opposition despite the fact that the only other person in our industry with more training that us is the physician and most of the time we are on the phone in one setting or another trying to correct thier mistakes.

    Proper counseling and follow up monitoring on a regular scheduled basis by a pharmacist WILL DO WAY MORE than any amount of labeling could ever HOPE to accomplish. Way too many people both inside and outside the healthcare industry are under the mistaken impression that the practice of pharmacy is still on a do- it- yourself level and that’s no longer the case. The potential for untoward effects from even ‘simple’ non narcotic chronic/ acute pharmacotherapeutic regimens is greater today than it ever has been before and truthfully it DEMANDS a change in our practice paradigm to accomodate that level of what I see as our professional responsibility. Truthfully I foresee a great falling away of many among our ranks because that’s not what they signed on for but if we as a profession are going to remain relevant it is going to neccesitate a change. Like optometrists evolved from simply selling eyeglasses out of a suitcase to the level of sophistication we have come to expect now SO ARE WE. In less than 100 years we have gone from 3 year PhG’s to 6 year PharmD’s but we are still trying to use the same model of practice as we were back then. It is this time and these situations that create opportunites for the profession to capitalize on – what we are waiting for I fail to comprehend

  21. Thank you all for your constructive comments so far…KEEP THEM COMING! Many of you may know of Thomas Sachy MD MSc. His credentials include specialties in Neuropsychiatry, Forensic Psychiatry, and Pain Management. He is also a Diplomate of the American Board of Psychiatry and Neurology.

    Dr. Sachy has been quite vocal with regard to the “War on Drugs” and appropriate pain management. He sent me an e-mail today (redacted to protect the innocent). He has quite a lot to discuss on the matter in this blog post; he respectfully requested few days before commenting and/or posting. In the meantime, he asked that I share his e-mail to me.

    1. Jeff: Dr. Sachy’s redacted email reads like the response one gets from sending a Freedom of Information request to the CIA! Just kidding! In 1940, speaking before the 91st Annual Session of the AMA, Lyndon E. Lee, Jr., M.D., a noted surgeon and leader in the medical community, expressed a contemporary view of opioids that, regrettably, would persist and influence patient care for decades: “The use of narcotics in the terminal cancer patient is to be condemned if it can possibly be avoided. Morphine and terminal cancer are in no way synonymous. Morphine usage is an unpleasant experience to the majority of human subjects because of undesirable side effects. Dominant in the list of these unfortunate effects is addiction.” In attempting to be evidence-based, regulatory law often reflects the prevailing wisdom (and interests) of the regulated entity. To what extent Dr. Lee’s advice may still underpin our regulatory schema for opioids is a valid and provocative question. The “war on pain” if we can call it that had its beginning in the 1990s with the marketing of old wine in new long-acting bottles. It was well-supported by a robust pharmaceutical industry, a growing and vocal patient community, and a new ethos of treatment given the prestigious imprimatur of no less an authority than the Joint Commission. Today, as we begin to sort out the data from almost two decades of this metaphorical war on pain, it seems only reasonable to ask who is winning the war. With an estimated 15,000 casualties a year succumbing to fatal opioid overdoses, is our current approach justified or should we try something else for a change?

  22. Although the PROP petition appears to raise some hackles, let us all agree that we have an epidemic of prescription opioid misuse that is killing thousands of patients and non-patients each year. Errant physicians, pharmacists, and pill mill operators are being hauled off to prison in record numbers and yet the epidemic continues. According to the CDC, “Sales of OPR [opioid pain relievers] quadrupled between 1999 and 2010. Enough OPR were prescribed last year to medicate every American adult with a standard pain treatment dose of 5 mg of hydrocodone (Vicodin and others) taken every 4 hours for a month.” The response by Congress and the FDA has been an ineffectual risk management program (REMS). Indeed, the FDA’s own panel of experts in 2010 voted 25 to 10 against the FDA’s proposed risk plan for long-acting opioids, saying that it was inadequate and would not reduce the misuse of these drugs. So, here we have the law enforcement and regulatory communities doing what they perceive to be the best that they can do and having virtually no effect whatsoever in halting the death toll. Enter the PROP group with a different perspective that takes the focus off prescribers, dispensers, and pill mills and focuses it, instead, on the drugs themselves. The specific actions requested by the PROP petition seem reasonable: “1. Strike the term “moderate” from the indication for non-cancer pain. 2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain. 3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.” While docs could still prescribe these drugs off-label as they see fit, private insurance and government-backed payer systems might challenge or even refuse reimbursement. Under the circumstances, this may not be bad for improving the overall public health. Yes, inevitably we will see the usual parade of horribles of pain patients being denied access to needed drugs, etc., and, yes, the alarm bells of the well-heeled industry lobbyists will be rung loudly throughout the land, but in the end, there may just be some improvement. Perhaps the most important outcome if the FDA grants the PROP petition would be new marketing restrictions for long-acting prescription opioids. Sales reps would no longer be able to market their wares except for the approved and narrowed indications. Some may remember that in 2007, Purdue Pharma L.P., the sponsor of OxyContin, and three of the company’s top executives, pled guilty in federal court to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. The company paid a fine of $600 million and three of its executives, including the company’s president, chief medical officer and top attorney, were fined a total of $34.5 million. Marketing, it appears, plays a much larger role than heretofore believed in promoting the misuse of these potent medicines. If little else, the PROP petition, if granted, may change this dynamic for the better. As for the clinical grounds for what the PROP petition is seeking, I will leave that for my better informed colleagues in the appropriate sciences to assess. John J. Coleman, PhD, Assistant Administrator for Operations (retired), DEA

    1. Dear Dr .Coleman,

      I know and respect you, but I believe you are wrong in the so called PROP letter support.

      While I will agree that there is an epidemic of misuse of opioids, I do not agree that these are necessarily related to good clinical practice. I refer you to various media outlining illegal prescribing of these drugs by pill mills. (See MSNBC and Bloomberg News). These developed stories on brothers in Florida single highhandedly responsible for over 40 million doses of opioids being diverted into the country nation wide. In CT, a drug dealer flew to Florida 3 times per week, bringing cash and returning with 8,000 Roxicodones per trip. that is 1,000,000 million illegal doses per year entering a state with 3.5 million people. To conflate proper care with drug diversion is to compare all investing with Bernie Madoff, a failure of logic.

      Concerning the contention that PROP is reasonable: Per your quote, The specific actions requested by the PROP petition seem reasonable: “1. Strike the term “moderate” from the indication for non-cancer pain. 2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain. 3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.” is as far from unreasonable as is imaginable. Chronic pain does not fit most definitions unless it is 3-6 months duration. it is analogous to telling a diabetic to stop insulin after 3 months. Or a person on a cholesterol drug to stop and eat better.

      As for the dosing range: absurd. Absolutely absurd.

      Look, as a physican I will not be affected in so much as I will see patients. And if this goes into effect, I will have to tell patients they cannot get meds if this is passed. To suggest off label usage is also inappropriate as it will tell doc to go even further into the nebulous.

      I certainly hope that the FDA sees this perhaps well meaning letter (though many of the authors have a huge financial stake in changing the way we treat pain, by either detoxing or forcing more inappropriate injections and interventional therapy as so called pain treatment) as the mistake it is and relegate it to the trash heap. If it does not, God Forgive them, because patients and many physicians will not.

      1. Dear Dr. Brennan: I respect your view on this issue. I should have made it clearer that I was expressing my opinion on the regulatory aspects of the PROP petition, not on its clinical implications that you have explained so thoroughly and well. In my appraisal of the PROP petition I valued three things: 1) that it was a proposal from the medical community that acknowledged a serious problem and offered unique options for relief; 2) that the PROP petition takes the regulatory focus off practitioners and patients and places it on the drugs themselves; and 3) that the proposed labeling changes would curtail aggressive marketing strategies that have been shown to contribute to drug misuse and addiction. In your comment you make what I think is a solid case for why some of the grounds offered in the PROP petition are absurd, to use your word. You may consider putting them in a formal comment to the FDA when (and if) the PROP petition is docketed and published. Incidentally, 10 of the 37 signatories of the PROP petition practice in the state of Washington where a new law took effect last year mandating dosing criteria for treating non-cancer pain with opioids. Unlike the PROP petition, however, that proposes a maximum daily dose of 100 milligrams of morphine equivalent, the state statute sets the maximum daily dosing at 120 milligrams of morphine equivalent. The Washington statute also requires that when this maximum daily dosing level is reached, the practitioner must refer the patient for a consultation with a pain specialist unless the practitioner is a pain specialist meeting the criteria described in the statute. It seems to me that with such a heavy presence of Washington state practitioners, the PROP petition might have drawn upon the past year’s experience in Washington, assuming it was positive, to offer similar recommendations that might have addressed some of the clinical concerns that you raise. As for my comment, rest assured that I was not attempting to provide a scientific or medical evaluation of the PROP petition. My initial thoughts were in praise of seeing an initiative from the medical community for dealing with a serious and refractory public health issue, and secondly for anticipated marketing restrictions that might follow the petition’s proposed labeling changes. It was my fault that I did not make this clear from the outset.

        1. Dear Dr. Coleman,

          Keeping this going, I too would like to comment on your gracious comments and thoughtful position. I know you to be a highly competent professional and for those unaware, a true advocate for patients in pain as well as for pain practitioners.

          The issues at hand are so multifaceted and even more than multifaceted: multifaceted at multiple levels, like 3 dimensional chess. The interactions of patient to doctor; doctor to patient; all of us to insurers; families; local and federal law enforcement and federal regulatory bodies. Having worked with all the above, I sometimes think it is law enforcement who has the greater perspective.

          What I fear is for the outcomes of patients and families if this proposal or facsimiles are offered as the law of the land. One of your points about aggressive marketing is particularly interesting. As a member of the pharma speaking world, I view the aggressive marketing as a means to educate. And this is a good example of how well intentioned regulations can have a counter effect. Prior to new FDA supported pharma guidelines, a speaker for a drug company would be paid by a drug company to speak about a topic. I would do entire talks about pain. (I once so incensed a rep by not even mentioning her drug, she burst into tears). Now, in an effort to clean up these talks, they have gone from collegial discussions, to full blown commercials. The result: Less interesting, and a much greater focus on the drug and not the topic.

          Some of the signing practitioners need to recall that our approach is relatively new. When I finished my training, the majority of pain treatment was neither opioid nor interventionally based. Rather, multidisciplinary pain services with goal of drug reduction of discontinuation was identified as the sine qua non of outcome measures. I ran such a program in Colorado in 1989-1990. What we also collectively fail to recall is that recidivism was at least 50% over 2 years, and in some cases 100%. As such, the number of approved multidisciplinary pain programs went from the hundreds in the early 90′s to the tens now. And, let’s also remember, the options offered by my colleagues in Washington, Oregon and Cleveland have no real outcomes either. The goal it seems is to limit the negative and not improve pain outcomes.

          It was into a terrible void of inadequate pain relief the work of Dr. Portenoy and others aimed to address starting in the late 80′s and early 90′s and to the present. There will be those who respond that inadequate post discharge planning led to the high failure rate (which significantly contributed to insurers stopping funding these programs). But, we who believe there is a role for opioids can make the same claim: clinicians not doing it right and illicit diversion by criminals has confounded our outcomes.

          I know too many good clinicians, with difficult patients who can achieve appropriate and sound outcomes. The letter from PROP should have advised better approaches, not tossing the baby out with the bath water.

  23. I think this letter is a symbolic gesture and seeing as I know a lot of the MDs who signed it, I know they know it. Question is why and why now? Not one of them, I am willing to bet, really thinks that unless a paractitioner trained on Mars, practices medicine straight from the Merck Manual or writes for oxycodone every time someone stubs their toe (to quote Hal Rogers, R-KY, years ago at an FDA hearing) that this has real clinical meaning? I think it is a political statement and very much at the wrong time.
    The wrong time, why? The nature of people coming to pain experts has utterly changed. It used to be that I saw patients (because of my interest in pain and addiction) who were escalated to grams per day of opioids, not benefiting, overusing, and one wondered why they were escalated that high to begin with. Nowadays, I see salt of the earth people with terrible injuries- no one thought they were a kook when they had their 5th back surgery or their 20th epidural steroid injection. But they have been on the same 4 hydrocodone/apap for 5 years and no one is willing to give them anything resembling a real trial of sophisticated, tailored opioid therapy. Now is the time to advocate for patients again. They are already losing access to opioids. Many patients do not and I would argue have never had access to real, safe, individualized, sophisticated opioid therapy. 8.8 million people are on opioids for chronic pain in this country, 5.5 million are on hydrocodone. Never mind the fact that we have been teaching that short actings opioids are not necessarily right for every patient along the risk spectrum, but if we were really individualizing therapy would 63% of people be on the same drug? Limiting the indication will do nothing to help anyone learn sophisticated opioid therapy and will likely have them focused on the wrong variable anyway.

    Finally and this gets my goat, “PHYSICIANS” for safe opioid prescribing – how colleagial. Well I guess PHDs, NPs, PharmDs, and PAs dont get a vote. Very colleagial. I know more people in these disciplines who have done more to try to make opioid therapy safer and more individualized and tailored than many of the MDs in the world who are regular writers of these medications; so I guess you can discount my opionions above. Jeff, you and I, and Steve Butler, and Simon Budman, and David Brushwood, and John Coleman, and Ken Kirsh and Peggy Compton and on and on…..we dont get a vote.

  24. On August 2nd, we posted at Pain-Topics UPDATES [available here] a long article by Dr. Bob Twillman that discusses all 9 “statements of scientific basis” for the petition. Certainly, there can be many sides to this issue, and we have invited Dr. Andrew Kolodny to respond to Dr. Twillman’s perspectives and to further debate these issues in ongoing UPDATES. We’ll see what happens — it would be helpful to have an ongoing dialogue objectively considering all viewpoints.

  25. On July 26, 2012, Congresswoman Mary Bono Mack and 5 fellow members of the Congressional Caucus on Prescription Drug Abuse sent a public letter [PDF available here] to Margaret Hamburg, MD, FDA Commissioner, essentially endorsing the Petition and all of its recommended labeling changes. The letter concludes:

    “We believe that if a labeling change were made to opioid analgesics to reflect the uncertainty and lack of evidence surrounding safety and effectiveness of these drugs for treatment of chronic non-cancer pain, physicians would think twice before prescribing these highly addictive narcotics for ‘moderate’ pain such as a toothache or sore knee. While those who seek treatment for cancer pain and other diseases that cause ‘severe’ pain would not be affected, the number of individuals prescribed opiate painkillers without evidence of the long-term safety and effectiveness may decrease and limit those susceptible to developing opioid dependence.”

    This letter commands that the FDA pay serious attention to this issue, since the Caucus closes with, “we request an expedited review of the Citizen Petition submitted to FDA, and look forward to a timely response.”

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