What is the Sound of One Hand Clapping?

What is the Sound of One Hand Clapping?

What Was Said or Missed in the FDA Opioid Policy Steering Committee Hearings?

By Richard A Lawhern, Ph.D.

Many years ago, a stand-up comic named Shelly Berman helped to immortalize a riddle told by Zen masters.  “What is the sound of one hand clapping?” can have many answers.  One might be that the sound of one hand clapping is silence… unless met by another hand.

Richard A Lawhern, Ph.D.

On January 30, 2018, I was one of ~40 speakers before an audience of over 200,  in public hearings of the US FDA Opioid Policy Steering Committee, at Silver Spring Md.  The Committee is composed of eight FDA senior department heads and Center directors.  For once, pain patients were allowed to participate, along with medical professional societies, healthcare technology corporations, and a few partisans intent on obstructing all access to opioid pain relievers.

The hearings were convened (we were told by the presiding officer) as a “listening session” to receive public input concerning eight questions.  [link: https://www.federalregister.gov/documents/2017/12/13/2017-26785/opioid-policy-steering-committee-prescribing-intervention-exploring-a-strategy-for-implementation]. FDA had previously announced eight questions relating to implementation of an FDA “Risk Evaluation and Mitigation Strategy (REMS)” responding to the so-called “opioid crisis” in America.  FDA is considering steps to more tightly regulate standards of physician and pharmacist practice in prescribing and reporting opioid analgesic use.

At times during the day, I found myself shaking my head.  Although the audience was discouraged from applause, some of the speakers also seemed not to connect hands – or ideas.  The Committee itself was carefully non-committal.

I heard four prevailing messages.

  • Professional associations want to be consulted and to participate in shaping the REMS.  Some speakers offered specific ideas concerning how FDA might better regulate medical access to opioids.
  • Corporate players clearly want a “piece of the pie” of government contracts for integrating patient treatment data that now resides in 50 separate State Prescription Drug Monitoring Programs (PDMPs).  One surprise was that a substantial amount of integration and data sharing has already occurred in multiple over-lapping programs funded under Federal grants.
  • Anti-opioid partisans implied that nobody should ever need an opioid pain reliever, and that those who are prescribed such medications are instantly at risk to opioid dependence and addiction.  These presentations were dominated by strong emotions – and regrettably few facts.
  • Patients and their advocates were unanimous in telling the FDA that policies of the US Center for Disease Control are already driving physicians out of practice in droves.   Patients are lapsing into agony and death by medical collapse and suicide.  The message was “don’t make a horrible situation worse by further over-regulating doctors.  Don’t deny treatment to patients for whom opioids are the only therapy that works.”

Despite disconnects between these narratives, several important insights emerged.  I was particularly pleased by professional responses to the first question posed by the Steering Committee:

  1. If a REMS were to specify threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity, what should the amounts be and how should they be determined for various clinical indications? What data are there to support such amounts? What additional data would be useful?”

My presentation responded with a “not only no but HELL no.”  The CDC and Veterans Administration have already killed hundreds of patients with their scientifically unsupported risk threshold .  Their 90 MMED nonsense has widely been interpreted as a statutory limit on opioid prescribing.  Above this threshold, doctors are at risk of being persecuted out of practice by DEA and State authorities.  The Veterans Administration is trying to get rid of opioids altogether.  Don’t make this mess worse!

In this context, the position of the American Academy of Pain Medicine was significant.  They also oppose risk thresholds, as well as expressing concern over documentation that would be routinely imposed upon doctors who choose to exceed any specified dose level on behalf of their patients.  A speaker from a different organization declared that if opioid prescription practice standards are to be updated, then the task should be left with professional Associations and Academies in each medical specialty, not with the FDA.

There is no one-size-fits-all pain patient.

— — —

Several questions on REMS implementation concerned requiring doctors to access and provide patient data to a unified National Prescription Drug Monitoring Program.  Doctors expressed concern that State PDMPs are time-inefficient and interrupt doctors’ work flow.  No one wants to have to upload real-time data  to any PDMP, unless burdens can be reduced on doctor workload.

However, there was another interesting example of the sound of one hand clapping.  Not once did any speaker identify how many cases of doctor shopping or drug diversion have so far been detected by existing State PMDPs.  No one talked about false alarms and how they might turn away desperate patients at pharmacies which deny them refills.   Failure to address these fundamental issues is already causing grievous harm.

Several questions on REMS implementation focused on diversion of opioid drugs from home medicine closets.  It was generally acknowledged that many people with addiction first begin with pills prescribed to others; they haven’t themselves seen a doctor.  Speakers suggested measures that might encourage patients to turn in unused medication and store essential medications safely.  But again, a basic patient concern was largely unheard.

Few seemed willing to speak the truth that medical exposure to opioids among patients treated for pain plays a relatively minor role in our ongoing “crisis”.  FDA is in danger of over-regulating 100% of pain management practice in order to reduce addiction and overdose risk among relatively few – possibly less than 2%.  It is also clear from CDC data that restriction of opioid prescriptions isn’t reducing overdose deaths.  In fact, deaths are rising.

As I outlined and others reinforced in the session, we now know that major assumptions  enshrined in the CDC opioid guidelines are unsupported by medical evidence.  In a landmark study published this month by the British Medical Journal, over 660,000 opioid-naïve patients were followed for an average of 2.6 years after being prescribed opioids for surgery pain.  [Link:  http://www.bmj.com/content/360/bmj.j5790.long].  Only 0.6% were later diagnosed with opioid abuse disorder or overdose.  Fewer than 1% continued renewing prescriptions 13 weeks after surgery.  Vulnerability to opioid abuse was much less sensitive to dose levels initially prescribed than was claimed in the CDC opioid prescription guidelines.

The many errors in the CDC document would justify a major rewrite, even if the record of death and destruction visited upon pain patients did not.  Let us hope that the Steering Committee , the CDC, and the DEA will listen to the sound of two hands clapping among patients and their advocates.

Readers may contribute to this result before March 16, by commenting through the Federal docket page at https://www.federalregister.gov/documents/2017/12/13/2017-26785/opioid-policy-steering-committee-prescribing-intervention-exploring-a-strategy-for-implementation.  Tell the FDA about your own experience in being coerced to taper down medications, or refused medication renewal by pharmacists.

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There are 30 comments for this article
  1. Juliette at 6:39 am

    Thank you for your exacting and correct summation of the currently abusive use of ‘ RECOMMENDATIONS’ suggested by the CDC OVER THE PAST 2 YEARS.
    You are directly accurate.
    There must be accountability and lawful treatment utilized for CPP.
    I stand with you 100%.

  2. Betty A. White at 9:38 am

    Pain management: is a fundamental human right. By Betty A. White
    A decade ago the United Nations (U.N.) issued a declaration outlining its 10-year global strategy to “eliminate or significantly reduce” all illicit coca, marijuana, and opium plants from the earth under the motto, “A drug free world – we can do it!” THIS DID NOT WORK
    The ACLU seeks an end to punitive drug policies that cause widespread constitutional and human rights violations, as well as unprecedented levels of incarceration. U.S. government insistence on incarceration as a catch-all solution to the misuse of illicit drugs has failed to reduce drug-related harm both at home and abroad, while defying the basic tenets of the U.N.’s Charter and Universal Declaration of Human Rights.
    Sadly, where the international drug control regime has conflicted with human rights, systematic discrimination, abusive law enforcement practices, mass incarceration and easily avoidable health epidemics have prevailed.
    The U.N., and specifically the Commission on Narcotic Drugs (CND), have the power to take a step in the right direction by adopting resolutions acknowledging the Universal Declaration on Human Rights’ centrality to all of the U.N.’s work, and mandating that the U.N.’s drug control bodies adopt a human rights-based approach in accordance with U.N. human rights law. For this step to be effective, however, member states must also make specific resolutions mandating that U.N. drug control policy be conducted in accordance with human rights law.
    Meanwhile, the International Narcotics Control Board (INCB), the monitoring body for the U.N. drug control conventions, has openly stated that it will not address human rights.
    Application of international human rights laws can address many of the flaws and inequalities of the current drug control system. As mandated in the U.N.’s Charter, the Universal Declaration of Human Rights and several other treaties, human rights standards hold a greater position of legal authority than drug control treaties. For the U.N.’s drug control system to be consistent with the requirements of its own Charter, human rights must be the starting point, not an after-thought.
    A human rights-based approach to global drug policy would principally (1) prioritize prevention and treatment of negative health consequences of drug misuse over criminal justice responses and supply-side reduction measures, and (2) require that U.N. bodies measure effectiveness by assessing indicators of drug-related harm, rather than relying solely on drug use and interdiction statistics. Drug-related “harm” includes overdose rates, disease transmission rates, negative drug enforcement consequences as well as individual and communal criminal justice system-related consequences. To succeed, U.N. drug policy bodies must work closely with the World Health Organization and UNAIDS, a joint program of the U.N., to adopt effective strategies for reducing the spread of HIV/AIDS and other diseases.
    Given the unprecedented nature of the opioid crisis and the role of prescription opioids in the crisis, the Steering Committee is considering novel ways to reduce the number of new cases of addiction while continuing to ensure the benefits of opioid products outweigh their risks. YOU CANNOT ELIMINATE OPIOIDS FROM THE PLANET EARTH! It is exceedingly incorrect to label every person who has taken a prescribed opioid, as a patient with an OUD, opioid use disorder. Chronic pain patients are under direct care of a physician, in a pain management program and are never counted in the number of overdose cases resulting in death.
    It is quite evident to me and the public that given the over exaggeration of the unprecedented nature of the opioid crisis and the role of prescription opioids in the crisis, is nothing but a smoke screen to divert the public eye away from the work that the DEA should be doing to keep Heroin and Fentanyl off the streets of the United States. All of these regulations and limitations to adequate pain medication sufficient for alleviating pain, whether acute or chronic is creating excessive regulatory scrutiny causing interference of physicians adequately treating and managing pain of their patients. A terrorist attack on the elderly, the sick and the dying

    It is certainly unprecedented to create a new diagnosis of “OUD”, which has caused physicians to abandon and neglect all patients that are victims of diseases and disorders which have left them with the problem of chronic pain that needs treatment with opioids, which is the only method that can give them any quality of life.

    Your desire to seek an evidence-based approach to prescribing PAIN MEDICATION, has already been established by laws and regulations in the past, which has been followed by all physicians. By not trusting a physician’s judgment, that is filled with years of education, guiding careful administration of any medication, whether it is for pain for an upset stomach, is ridiculous and is an infringement on patients privacy and the right to be free of pain.

    The Controlled Substances Act, was amended by The Pain Relief Promotion Act of 2000, 106th Congress, H.R. 2260, 106-299 C.Rpt. 566: Congress finds that–
    (1) in the first decade of the new millennium there should be
    a new emphasis on pain management and palliative care;
    (2) the use of certain narcotics and other drugs or
    substances with a potential for abuse is strictly regulated
    under the Controlled Substances Act;
    (3) the dispensing and distribution of certain controlled
    substances by properly registered practitioners for legitimate
    medical purposes are permitted under the Controlled Substances
    Act and implementing regulations;
    (4) the dispensing or distribution of certain controlled
    substances for the purpose of relieving pain and discomfort
    even if it increases the risk of death is a legitimate medical
    purpose and is permissible under the Controlled Substances Act;
    (5) inadequate treatment of pain, especially for chronic
    diseases and conditions, irreversible diseases such as cancer,
    and end-of-life care, is a serious public health problem
    affecting hundreds of thousands of patients every year;
    physicians should not hesitate to dispense or distribute
    controlled substances when medically indicated for these
    conditions; and

    Anesthesia and Analgesia 2007 Jul; 105(1):205-21. Pain management: a fundamental human right.
    Brennan F1, Carr DB, Cousins M. In this article they state that: Strategies currently applied for improvement include framing pain management as an ethical issue; promoting pain management as a legal right, providing constitutional guarantees and statutory regulations that span negligence law, criminal law, and elder abuse; defining pain management as a fundamental human right, categorizing failure to provide pain management as professional misconduct, and issuing guidelines and standards of practice by professional bodies. The role of the World Health Organization is discussed, particularly with respect to opioid availability for pain management. We conclude that, because pain management is the subject of many initiatives within the disciplines of medicine, ethics and law, we are at an “inflection point” in which unreasonable failure to treat pain is viewed worldwide as poor medicine, unethical practice, and an abrogation of a fundamental human right.

    Opioids and the Treatment of Chronic Pain: Controversies, Current Status, and Future Directions
    Andrew Rosenblum,1,* Lisa A. Marsch,1 Herman Joseph,1 and Russell K. Portenoy2
    In this Introduction they state that: Opioids play a unique role in society. They are widely feared compounds, which are associated with abuse, addiction and the dire consequences of diversion; they are also essential medications, the most effective drugs for the relief of pain and suffering (Portenoy et al, 2004). Historically, concerns about addiction have apparently contributed to the under treatment of disorders widely considered to be appropriate for opioid therapy, including cancer pain, pain at the end-of-life, and acute pain (Field and Cassel, 1997; Schnoll & Weaver, 2003; Portenoy & Lesage, 1999; Breitbart et al. 1998; Smith et al., 2008). The use of opioids for chronic non-malignant pain (CNMP) remains controversial (Manchikanti, 2008; McQuay, 1999). Following publication of reports on the safety and efficacy of opioids prescribed to small numbers of patients with CNMP (e.g., Portenoy and Foley, 1986; Nyswander and Dole, 1986) and the publication of a seminal article entitled “The Tragedy of Needless Pain”, (Melzack, 1990), the use of opioids to treat CNMP began to be more widely practiced and incorporated into clinical guidelines. Nevertheless, despite the advances in pain medicine and the wider use of opioids for various chronic pain conditions, there is still considerable controversy surrounding the type of conditions that should be treated, whether the treatment can be generally safe and effective in selected patients, and what the clinical goals should be.

    (Ballantyne & Forge, 2007; Streltzer & Johansen, 2006; Stretzler & Kosten 2003). Their Brief Overview of Opioids: Neurobiology and Mechanism of Action. The “pattern of suffering” or the pain-related disability that often occurs in concert with persistent pain commonly touches on all domains of function. Patients with chronic pain may demonstrate pain-related interference with ability to perform usual activities at home, work, or school; maladaptive or dysfunctional behaviors, social isolation, and poor sleep patterns; and frequent health care utilization.

    (Dworkin & Sherman, 2001). The recognition that acute pain can compromise health has led major medical associations and accreditation committees to designate pain severity as a “fifth vital sign”, along with blood pressure, temperature, heart rate, and respiration (Fishman, 2005). Further recognition of the increased interest in the assessment and management of pain is underscored by the U.S. Federal Law (Pain Relief Promotion Act of 2000) that declared the first decade of the 21st century as the Decade of Pain Control and Research (Gatchel et al., 2007). Chronic pain is a major public health problem, which is associated with devastating consequences to patients and families, a high rate of health care utilization, and huge society costs related to lost work productivity. The existing treatments for chronic pain are unable to address the problem and better therapies are urgently needed. The need for these therapies is the backdrop for the expanding use of opioid drugs. An extensive clinical experience indicates that long-term opioid therapy is able to help selected patients have a better quality of life, less use of health care and improved productivity. The medical community is no longer debating the reality of these outcomes, but rather, is now focused on a more fruitful debate about patient selection and the benefits and burdens of these drugs in varied subpopulations. Whether the frame of reference is the individual patient and family, or society-at-large, the issue is about balancing the potential benefits of these drugs in the large and diverse population with chronic pain with its potential risks.

    Nothing should encourage electronic prescribing as a mechanism for the prescriber to provide documentation of a safe-use condition. To elude that the quantity prescribed is possibly not medically necessary for the patient, is insinuating that the prescribing physician does not have the intelligence to know how much pain the patient is in to adequately prescribe the proper amount of pills to alleviate the patients pain. For anyone to consider limiting the amount of relief a person in pain should be allowed to achieve is barbaric and abusive and should not be allowed to be recommended in any case. The only humane solution to guarantee that every patient suffering from chronic pain receives adequate medication, could be to assign an adequate amount of medication prescribed according to the diagnosis, to be distributed by the documented amount of suffering presently current in the stage of disease progression, equal to stage I, II, III, IV, or V.

    As each of the articles above clearly state that prescribing pain medication for patients having chronic pain, is on an individual case basis. There is already in place a specific amount of medication that is generally prescribed by physicians and that will be approved by the patient’s insurance company. All, patients and conditions are imminently guarded in the patient/physician relationship and should never become subject to a cold hearted, unjustified limitation of the amount of pills that will be adequate, without clearly justifying the patients diagnosis and conditions causing their pain, whether it is acute or has become chronic.

    The H.R.2260 – Pain Relief Promotion Act of 2000, 106th Congress (1999-2000), was written for purposes of this Act and any regulations to implement this Act, alleviating pain or discomfort in the usual course of professional practice is a legitimate medical purpose for the dispensing, distributing, or administering of a controlled substance that is consistent with public health and safety, even if the use of such a substance may increase the risk of death. Nothing in this section authorizes intentionally dispensing, distributing, or administering a controlled substance for the purpose of causing death or assisting another person in causing death. The probability of the use of an opioid causing addiction, administers more harm to the patient mentally, emotionally, physically and socially. This attitude of prohibition of opioids, totally excludes a patients right to quality of life to be free of pain, especially when that pain can be alleviated by administering medication that is effective to eliminate that pain.

    How do you have the right to think that you should increase pain and suffering in millions of citizens of the United States, simply because you think that they might get addicted from taking prescribed medication? Might I remind you that in the past, Americans were faced with the prospect of a suicide drug being administered to them, at their request or by a physician that thought death would alleviate their painful life circumstance, howbeit, the Pain Relief Promotion Act of 2000, 106th Congress was enforced, but limited to not deliberately be administered to cause a person’s death. This law, as far as I know, is still in place and all of these recommendations by the CDC, FDA, DEA and CMS are in violation of this law. This law allows physicians to prescribe opioids to patients even if the use of such a substance may increase the risk of death, i.e. addiction. It is more beneficial to alleviate pain and suffering, than to withhold medication because certain persons are more concerned about creating addiction in the elderly, the sick and the dying. This false presentation of preventing people from becoming addicted to their pain medication is merely an act of torture, with the intention of forcing people to find an alternate form of pain medication outside the boundaries of safety of their trusted physician.

    More attention needs to be directed towards removing Heroin off the streets and preventing Fentanyl from entering the drug dealer’s hands. Millions of people are afflicted with disorders which cause chronic pain and they have the human right to have access to whatever amount of pills is necessary to alleviate that pain without needing to see the doctor every week and filling a prescription again and again. Sick people suffer enough with pain and the small amount of relief that pain medication may provide. They now have become stigmatized by being given an incorrect diagnosis of OUD. This diagnosis is insulting and now has caused me to refuse surgeries that I desperately need, but do not trust that I will receive adequate pain relief after the surgery.

    Because of these new recommendations to not use opioids for pain, I have been abandoned by my physician and abused immediately after he performed a c6-c7 injection and abruptly refusing to refill pain medication or muscle relaxers. He referred me to a drug rehab facility and treated me like I was a street junky. I was terrified and had no one to turn to for help. I had fallen and have 2 complete off the bone rotator cuff tares, a slipped vertebra between L4-L5; hip injury; internal fracture of my elbow, and an unexamined injury to my C6-C7 nerve. Even I began to believe that maybe I WAS addicted to Percocet and I did not want to go through withdrawal as predicted by all of these reports of OUD. Because of this incident, I found a drug rehab hospital that would accept Medicare. I had not taken Percocet for 3 days and the urine drug screen did not reveal any opioids in my system. I was admitted in Fort Lauderdale Hospital for 3 days to a program called HOPE. This was a psychiatric hospital offering inpatient 3-5 day detox for persons 55 or older or younger in wheelchairs who were being treated for withdrawing from alcohol, heroin, opioids or whatever they needed. These people were serious addicts, with serious physical and mental and emotional problems. I was in pain and could not sleep on my left hip or on my right shoulder. They gave me robaxin 750 mg for muscle spasms and pain and Benzyl 10 mg to control the abdominal spasms for withdrawal from Xanax. I have not had any withdrawal symptoms from Percocet. I am treating my pain by drinking Wild Lettuce Tea and taking aspirin. I am afraid to go see a doctor for any of these injuries. I have sharp pain where I received this injection that I did not have prior to it. I had pain going down my am to my hand and a spasm over the clavicle. I refused the surgery on my shoulder because now, you get 2 days of #10 Percocet, go back to doctor in 2 days and get #5 Percocet for 5 days. In 6 weeks you are expected to go to physical therapy for 3 months that is excruciatingly painful, without any pain medication. In all of your regulations, how would you classify my pain? Is it acute? I have been in pain from all this for 3 ½ months, without any treatment. I am limping and walk with a cane and presently undiagnosed. My hip in now coming out of socket and I need an MRI or CT scan to determine what is wrong with my cervical spine and hip. I AM AFRAID TO GO TO THE DOCTOR BECAUSE COMPLAINTS OF PAIN ARE CONSIDERED BY YOU TO BE OUD BEHAVIOR.

    I do not have OUD, as you have classified all persons who have used or will use opioids to already have acquired. What are you trying to achieve by creating this diagnosis of OUD? What purpose are you trying to accomplish by not wanting to treat 70 million people who have chronic severe pain?

    Your association and agreement with the CDC, DEA and the CMS have caused this catastrophe that has spread across this nation and you should all be ashamed.

    STOP THIS MADDNESS!

  3. Jessica Tonner at 12:22 am

    Thank you once again Dr Lawhern for speaking up for us and for the doctors that still try to help us.

    I am definitely going to comment. I won’t put my whole story here – I probably have told you and others before. But it is pretty terrible.

    Currently I do not believe there should be any limit on opioid prescribing because one size does not fit all. What we need is doctors trained on how to prescribe them, how to look for, identify and treat addiction – and how to spread compassion. I was in excruciating, writhing, unbearable pain for years. I’ve been told by many professionals that the majority of people in My position would have died from pain long ago… I deserved opioids years before I received them – without a diagnosis (proof) years before I got a diagnosis…I was finally diagnosed with adhesive arachnoiditis, but I had it, and was in excruciating pain years before I was diagnosed. I believe it was wrong to withhold medical treatment for me just because the doctors I went to either did not know what was wrong with me were covered it up (mine is a medical injury).

    It’s possible that my disease Could’ve been prevented had I been diagnosed earlier. I was in that kind of pain without a diagnosis, is believe I still deserved to receive treatment for my pain. I believe what needs to be done is training for doctors, the regulations lifted, Punishment lifted, and Doctors Trained on how to prescribe, how to look for addiction, how to treat addiction….

    And to remember what the Hippocratic oath means “…to do no harm…” Allowing somebody in excruciating pain to continue in pain, or to be forced to reduce or end their opioids is a direct violation of that oath.

    Anyway I’m getting off on a tangent, but I appreciate the time and effort you put into speaking. There are so many of us that are too sick to fight, and I for one am grateful for your time and effort in fighting For Those of us that cannot fight back. Thank you. 🙏

  4. Susan Brown at 9:32 pm

    I take a low dose of hydrocodone and should be on a higher dose but I am afraid to ask because of all the bull S… going on. I have Adhesive Arachnoiditis which is the worst pain you will ever have. I have a scar on base root nerve coming from my spinal cord. To say it simply, I have a spinal cord injury that has caused my nerves to stick together and this condition will only get worse. They say that Arachnoiditis is like having stage 4 cancer pain. If my pain meds are taken away from I don’t know how long I will last. Is the government trying to clean house of the sick, and poor????

  5. Barbara Johnson at 2:38 pm

    I am currently in a battle with my insurance company to fill my opioid. This makes 2-3 months of struggling with them as we both try to make our way through the red tape…..for 1 medication. I am currently waiting on them, again, to fill the same prescription. I run out in a few days, so if they don’t figure it out I’ll end up in the ER. Stress trigures my pain levels and my pain is shooting upwards from all the discourse. I certainly hope the officials will help us that legitimately need our medication to live, a chance to live a somewhat dignified life. Without my medication I will be unable to leave my house. My R eye will feel like someone is pulling it out of its socket, interspersed with lightning-like stabbing pain in that eye, the pain travels down my face and into my mouth, where it feels like my teeth are being pulled without anesthesia. This pain is horrendous and excruciating! It’s accompanied by intense itching, it’s infernal and internal. It travels around the eye, into the back of my socket, then down my face and into my mouth. Then it feels like thousands of bees are stinging me in and around my eye and face. If my medication, which is the only way known to science to treat my condition, is taken away, I don’t know if I can bear the pain and itching. Right now on my medication, the edge of this pain is taken away. I live with, between a 5 and a 10 on the pain scale. Some days are better than the others. I certainly hope that this meager quality of life is not stripped from me by people that have no idea of what real pain is. I was told that my pain is the worst known to mankind. It’s worse than cancer pain.

  6. Patriot at 8:00 am

    You know I love grandma’s and grandpa’s,but the video of Sessions on his stance on RX meds and weed just make me glad these old fogies shouldn’t have much time left.Take a bufferen and go to bed,Right! I bet he has a Fentanyl patch on as he speaks.

  7. Lauri at 5:33 pm

    I had a bad experience (just not directly) with a rookie pharmacist in 2013. My husband had gone to pick up a new prescription at XXX, because I wasn’t allowed to drive yet. My lumbar fusion was in June of 2013, and my surgeon was carefully titrating me off my oxycontin after the surgical pain had passed. It was a Friday, and I was having my follow-up with my surgeon’s PA rather than with my surgeon. We decided to reduce the oxycontin from 80mg 2x daily to 60mg 2x daily. For some reason (it was the only time this ever happened to me), she took my bottle of pills (I don’t even know why I had them with me; it could be she called and requested that I do so, but cannot truly recall this detail), leaving me 1 or 2 tablets in case it took extra time for the pharmacy to fill the new script.

    The pharmacist refused to fill the script because it was “too early” for a refill, not acknowledging it was a NEW prescription of a LOWER-STRENGTH medication. My husband pointed this out to her, but she said it didn’t matter, it was too early. My husband explained that the PA had taken my pills away in preparation for the new script. When requested to call the doctor’ office (it was after hours, but they have an answering service), she complied, but when the doctor on call was not the PA who wrote the script, but actually MY DOCTOR, under whose license the PA wrote the script. She REFUSED to talk to him and told my husband she would not fill the script.

    When my husband asked if he could send her the bill if he had to take me to the ER for withdrawal complications, she said it didn’t matter, she wasn’t going to risk her license to do her job. That was that.

    Fortunately, I had just enough oxycontin of lower strengths to cobble together (along with the 1 or 2 tablets left to me by the PA) to get me through Sunday night. I called my doctor first thing Monday and he got the pharmacist straightened out QUICKLY, so I was blessed to have continuity in my medication until I could get help from my doctor, without having to suffer withdrawal, humiliation, and further torture in the ER.

    The pharmacist was completely out of order and negligent in her duty as a pharmacist. She refused to fill a completely legitimate prescription and refused to talk to the doctor who could verify it for me. She put my health at risk with her profiling behavior. One of my biggest regrets is not reporting her infraction right away. Unfortunately, this happens a lot with chronic pain patients; we are so exhausted from our daily battles, that the non-essential ones slip by without prompt action (especially when recovering from major spine surgery).

  8. Therese LeDantec-Boswell at 1:48 pm

    Respectfully, Dr. Lawhern, another perspective was ALSO presented at the OSC Meeting:
    WHY did the FDA allow another Federal Agency to USURP its LEGITIMATE Administrative Mandate to act as the ONLY legitimate source of governance over ALL Rx formularies approved for use in these United States?
    In so doing, the FDA breached its Fiduciary Duty to stand as SENTINEL over the Rx Health of WEthePEOPLE.
    In perpetrating its EGREGIOUS BREACH of Administrative Mandate, the CDC violated both Administrative Law and OVERreached its own Administrative Directive to provide STEWARDSHIP over Communicable Disease challenges.
    These breaches MUST be redressed at the HIGHEST levels of the USAmerican halls of governance.
    We have launched a CALL to the President of these United States to MANDATE the IMMEDIATE and unequivocal REPEAL/RETRACTION of all 12 of the CDC’s ‘DIRTY DOZEN’ Recommendations contained in their nefariously generated ‘Guideline on Prescribing Opioids for Chronic Pain.’
    ONLY this Presidential action will redress the UNLAWFUL usurpation of the FDA’s rightful position as the STEWARDS over the Rx Health of WEthePEOPLE.
    ANY comments directed to ANY of the DIRTY DOZEN Recommendations illicitly crafted by the CDC simply lends credence to the underpinnings of the UNLAWFUL ‘Guideline for Prescribing Opioids for Chronic Pain.’
    They are NEITHER lawful, nor meritorious of credence by otherwise PRESTIGIOUS Professionals such as yourself.
    Respectfully,
    TheButterflyProtocol™

  9. Richard A Lawhern PhD at 5:25 am

    Thanks to all who have commented so far, and welcome to those who may do so yet. I strongly encourage each of you to comment on the FDA Steering Committee docket before March 16th. It is particularly important that they hear from patients who have been harmed by coerced tapers of medications that were working, or by pharmacies rejecting or delaying renewals of your medications.

    Also be aware that the Alliance for the Treatment of Intractable Pain is recruiting for citizen lobbyists who are willing to schedule face-to-face interviews with the staffs of State and Federal legislators, to relate the damage being done to us by FDA over-regulation, and demand retraction and rewriting of the CDC opioid guidelines. Emails or arms-length anonymous petitions won’t win the day on this issue. We have to put a human face on pain and get into the faces of legislators in person, to demand redress. HUNDREDS of such in-person interviews are needed.

    Nobody can do this for you, regardless of good intentions. Not me or anybody else. You have to own it and live it as visible and noisy advocates. If you can’t physically do this, then find a relative or friend who can and have them look up “Alliance for the Treatment of Intractable Pain” on the net.

  10. Kel b at 1:00 am

    Dr Lawhern and Fred, thank you both for your attendance at this committee. I appreciate all you are doing. Its nice to hear about some of the things that were discussed.
    For those who haven’t left comments in the attached site of Dr Lawherns comments, please do, its rather simple to get into this and follow the page for info you need to enter. If it acts like it won’t go thru just hit submit a few times and it will.
    Thx again for all you do!!!

  11. Susan at 11:18 pm

    Skeeter,

    You are correct. The Govt has become our “Dr.s” as CPP’s. I cannot fathom a less qualified group at the helm which continues to do nothing more shipwreck the lives of CPPs and their qualified pain practitioners.

  12. Holly at 5:44 pm

    I do not know Steven!

    Why am I ( or so it seems) the only one in “pain management” being cut back?

  13. Susan at 1:21 pm

    Red, thank you for nicely summarizing your presentation to the FDA last week.

    I am awestruck by the issues you nicely outlined which were not addressed during this meeting.

    How can any problem be resolved until all components which have fed into creating the problem are openly laid out on the table and openly discussed one-by- one?.

  14. Leslie Meadows at 1:17 pm

    Hey red, as I was watching the committee meeting and then you came on I was very frustrated because it kept going on and off on and off but I was able to catch most of your presentation. And I also saw that you weren’t able to complete your presentation. Which made me mad because I was really looking forward to you giving it to them! We all know that the government is behind the fake numbers and not even separating them out correctly I wish you could have gotten through to more people the only thing I can think to do now is to hoard my little bit of medication to make sure that I never run out, which I’m sure most chronic pain patients are doing unfortunately this is not what we want but the only way that we can see to survive!

  15. Ellen at 12:29 pm

    Thank you Dr. Richard Lawhern Phd for describing this fiasco that is hurting legitimate patients and scary good pain doctors
    So many believe these guidelines that more professionals like yourself are explaining how incorrect information is they are using them as law now There is a pain clinic associated with a University that refuses ( so I am told) to give patients any opiates. It seems illegal and malpractice to refuse a treatment that helps a patient
    As a previous writer said so well we would not be on opiates if other things worked
    It is really infuriating that the CDC finally tells truth the people dying of opiates were not prescribed them why should an actual chronic intractable painnpatient be denied what has helped for years because someone breaks the law or takes illegal drugs. Now legitimate chronic pain patients are suffering to point some commit suicide. Sounds like wrongful death to me

  16. Sandy Auriene Sullivan at 11:11 am

    Sadly my family have 2 stories to tell the FDA. The current policy even prohibits my brother from receiving pain medication for end stage cancer [but not yet hospice and not enough oncologists in his area]. Why? His state insurance – like most state insurance doesn’t cover a pain specialist. If it does, the wait times are longer than his life expectancy. Which was 6-9 mos 13 mos ago; and have not improved only spread.

    Then there’s my neurological illness that requires ongoing pain management treatment. Luckily enough for me, I do have a pain specialist who has been able to prescribe me pain medication until November last year. When state, local and fed agencies ‘raided’ him – they gave him everything back about 2 days later – he has been fortunate to stay open. But within a week of that ‘raid’ – he stated he would no longer write schedule 2 medications and encouraged his patients who are well documented pain patients to try suboxone or similar for pain. Because he said he can write a better dose of buprenorphine, an opiate used all over the world for pain management when coupled with naloxone. They think it is ‘safer’ – it’s not safer, it removes euphoria, which doesn’t bother me as I do not get euphoria from standard opiates either.

    What bothers me about suboxone and other naloxone coupled medications is their stigma in the US. They are not used commonly. Tarniq 12hr is under the listed medications targeted despite having naloxone in it because it has oxycodone as its primary opiate analgesia.

    When asked I let other doctors and specialists know; it’s my right to try it – off label. Shouldn’t be my only option. Tarniq would be a much better choice for me as oxycodone doesn’t make me feel sluggish. Out of my reach, out of my doctor’s reach to even prescribe it to me would be next to moving a mountain on faith alone. Insurance wouldn’t cover it and most pharmacies would need to order it.

  17. Kahty C at 10:59 am

    Thanks Red!

    I have been waiting 2 decades to see of reason and science would prevail. They way things are going, and they way the public has been almost brainwashed to believe any of this, gives me little hope. They are Gas Lighting all of us. Our Government has been taken over by corporate criminals, so corporate interests, the same ones that created the Opiate Epidemic, and then marketed their profitable solutions, are in charge. Science no longer matters, and facts are irrelevant.

  18. Paulette D. Wright at 10:55 am

    We have beaten every issue, truthfully said, and where is it getting us medical professionals who have worked in pain management for years! This was a very good commentary, Red. No different than what we all agree to. Yes, medical professionals who work in pain management, should be making the rules. Not politicians, or anyone who has not worked in that area.
    Example: Do you want a housekeeper at the hospital doing your open heart surgery? Just because the housekeeper works at a hospital, doesn’t make them a specialist in heart surgery! Keep to your specialty, to make the rules! Hands on experience makes the difference!

  19. Deborah babcock at 9:33 am

    I was abruptly taken off my pain medication a few years back and I’m in chronic pain..everyday..im not suppose to take Tylenol because of liver and ibuprophen because of my kidneys the only thing that ever works on migraines is pain medication. I have literally tr died everything..i have diabetic pains,my lower back has at least 2 building disks,i have burcitis in both my hips..muscle aches and pains,i have intestinal pains from IBS, i have a chronic liver disease,and then there are the normal aches and pains that people have..i never not once abused the medication in the 6 years I was prescribed …but they will sure push anti depressents at people. Hand it out like candy !! Im not depressed. I’m in pain everyday of my life. I went to the hospital while back for migraine. I was treated like a drug seeker so i never have went back..when your in a full blown migraine you don’t want to go to hospital and wait 3 or 4 hrs just to be treated awful !! I have had at least 3 UA “popped on me at mention of pain. They checked for everything under sun and still told me they cant prescribe anything for me. They said that they aren’t allowed to dispense pain meds at that office..well,my sister has a doctor through same insurance,same just different location. She is an x drug addict and not long clean time and she is prescribed Percocet and prednisone and nausea meds along with sphycotropes for depression..tell me how that is fair. I’ve never been an addict…it seems the worse people are the more they get like the drug addicts. They can go get out of pain on my tax dollar for free to them..it is not fair !!! WE sit in pain and junkies can get what they need/want..something needs to give soon…were being treated worse than a wild rabid animal…for things we didn’t ask for,,like chronic widespread pain…

  20. Juliette at 8:48 am

    Thanks again, Richard A. Lawhern, PhD. for your research and representation for those in pain b/c of inaccurate CDC and other Fed agencies statistics. The stats Do NOT represent majority of prescribed opiates from Drs. to their patients.

    Just like congress is doing with the budget…keep kicking the can and never address the real situation…opiate are a useful medication for chronic pain sufferers.

  21. Janice Snyder at 8:40 am

    Thank you for attending as an advocate for pain patients and reporting on the meeting.

    I would hope this means there is some light at the end of this horrible tunnel. However before any changes ate made, how many patient will be told to think through their pain or diverted to pain relief options not covered by their insurance therefore unrealistic. How many will choose a quick death over a long painful one. How many physicians will be driven out of practice by the pill Nazis. And how many times will I cringe at the term opiod addict when directed at me when I have never abused pain killers in my 65 years of life. My firdt experience was probably at 15 years of age when I was prescribed them for severe menstral cramps, decades beforr my endometriosis was diagnosed.

  22. Mark Ibsen MD at 8:03 am

    Thank you Red.
    I would also bemoan the fact that there is poor evidence all around.
    May I re-suggest
    A moritorium on policy decisions until evidence IS developed?
    I believe this was the position of the fda in 2015,
    Before Prop/Kolodny/ Frieden did their end-run with the cdc,
    Which NEVER before had opined on prescribing.
    In order to obtain this data,
    I suggest a marker be placed on each and every pill made in America.
    If saidcpill is involved in a crime,
    The tracer would be present in
    Blood
    Body fluids
    Etc
    And tracked back to its source:
    Patient
    Pharmacy
    Pharmacist
    And
    Prescriber.
    Like fingerprints
    Or
    VIN on vehicles
    This data would be very informative,
    And my hypothesis states that will will
    Once again find
    Demonstrate
    And prove
    That most opiates are taken responsibly
    By
    Legitimate patients
    Prescribed a legitimate medicine
    By a prescriber who is using the controlled substances act in a responsible manner
    In the course of their professional practice.
    Then the chicken Little’s can shutup
    Or
    I can.
    And I will be happy to.
    Until that time,
    We must end this scourge on doctors.
    Send you this from Athens,
    Where our ragtag team of refugee healers
    Are treating refugees from > 35 countries.

  23. Fred Brown at 7:58 am

    I too was in attendance with Richard Lawhern Ph.D. at last week’s FDA Opioid Steering Committee meeting as a presenter. I felt Richard’s presentation was well organized and said to the committee exactly what was necessary.

    I am a member of The Alliance for the Treatment of Intractable Pain. My direction was from that of being a long-term chronic pain patient of twenty plus years. I tried to share the fact if I had some “typical” disease such as heart or diabetes, there would be no problem seeing a physician, and if medications were needed, they would be prescribed.

    If I present myself as a legitimate chronic, Intractable pain patient, I would be looked at by physicians, and pharmacist as someone who is seeking strong opioid medications for the “fun of it” and thinking I am an addict.

    Nothing could be further from the truth. There have been many surgeries which I have gone through, and yet the specific ones on my cervical, and thoracic region along with a full knee replacement which in simple, straightforward language, failed.

    I looked right at the Steering Committee, and said: “am I unusual, perhaps, but anyone of you could have the type of medical issues I’ve had and needed to use opioids.” With all respect to this Steering Committee, there were two people on the panel out of eight who I honestly felt heard what I was saying, and this comment I am making is a result of the eye and body language.

    I further stated why opioid medication, and not some other type was necessary? Many other drugs were tried but simply put, the opioids have been able to keep me stable, and pain patients only receive the benefit of reduction of symptoms from the severe pain we live with each day.

    Further stated to the Committee, “do you believe that I, along with thousands of other legitimate patients should NOT have the right to seek relief if the medications are there to help us? We are American citizens who are part of society in which we live. Is it not INHUMANE for me and thousands of other patients to suffer without the medications that can best help us?

    Towards the end of my presentation, I asked what is going to happen to the legitimate pain patient when both Federal and State agencies say NO to physicians; you are not allowed to write the prescriptions necessary to keep their patient stable. Where are these patients to go? Who is going to take responsibility for the further increase of street drugs? Who is going to take responsibility when the suicide rate continues to rise?

    Who will be giving the answers to the physicians and their patients?

  24. Jan at 7:53 am

    Skeeter summer it up perfectly! The government needs to get out of Healthcare. Substance abuse (ADDICTION) is a mental health issue! You will never solve the so-called oipioid epedemic (War on drugs). Addicts will always find a substance to abuse. That’s why Prohibition didn’t work and turned beer and wine drinkers to hard liquor addiction.

    Legal oipioid prescriptions are are rarely PRESCRIBED anymore, yet OD deaths are rising dramatically! Yet these bureaucrats keep perpetuating the same old lies. Skeeter is absolutely correct in saying that the illegal drugs (heroin, Chin white fentanyl) coming over the border and through the Post Office are the cause of the OD deaths, NOT LEGAL PRESCRIPTIONS!!! There is NO WAY TO STOP THIS because the drugs are in Special compartments in so many cars and trucks, the border patrol can’t search every one of them! You can even get Fentanyl over the internet.

    DEA will continue to sue Dr.’s (to get their assets), Big Pharma (because the tobacco settlement’s are running out), Distributors, etc. to keep their budgets and employees funded, and keep the prisons full and judges and lawyers busy collecting their money. But the day will come when Big Pharma will say ” OK, fine, we won’t make them anymore and we’ll be back in the dark ages with a shot of whiskey for all our ills!

  25. Barbara at 7:45 am

    These government officials are acting like god. No one seems to be able to stop them. Even the President is wrapped up their lies. I tried contacting him at the White House and only got automated replies. It’s like the witch-hunt craze.

  26. Barbara at 7:38 am

    I know if they cut my meds, I’m opting out. I’m just barely hanging on as it is. I’ll stop my Coumadin and let nature take its course.

  27. Skeeter Langley at 6:16 am

    It seems that the government is now our Doctors. I would like to thank Richard A Lawhern, Ph.D. for standing up for the chronic pain community. With the DEA treating our Doctors like drug dealers and patients like drug addicts is not doing anyone any good, they drive some chronic pain suffers to look elsewhere for pain meds, not because they are addicts, because they are in so much pain. They take this risk because the only other option is, well, death. Isn’t this what the opiate epidemic is all about?
    Like everything the bureaucrats in the government seem to do is destroy what it touches. Can they provide one doctor that prescribed heroin laced with Fintinal? Yet they condemn the entire chronic pain community for illegal drugs coming from China by way of the Mexican drug cartels.

  28. Steven Smith at 3:16 am

    I’m dumbfounded! Why do patients who have conditions that require more then 200 mme have to die?

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