WARNING TO THE FDA: BEWARE OF “SIMPLE” SOLUTIONS IN CHRONIC PAIN AND ADDICTION

WARNING TO THE FDA: BEWARE OF “SIMPLE” SOLUTIONS IN CHRONIC PAIN AND ADDICTION

The following article is reprinted with permission from its author, Richard A. Lawhern, Ph.D.  It was originally published here:  http://face-facts.org/lawhern/warning-fda/

By Richard A. Lawhern, Ph.D.

There is always a well-known solution to every human problem — neat, plausible, and wrong.”
– attributed to H.L. Mencken

On May 9-10, 2017, the US FDA held a workshop titled “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics—Exploring the Path Forward.” I attended that Workshop in person to offer public comment on behalf of chronic pain patients. This paper is an expansion on the same theme.

“… If you are truly concerned with the safety of patients who are prescribed opioid analgesics, then your first duty may be to adjourn this conference with a public acknowledgment that you aren’t ready to train doctors because you have no viable or safe standard of medical care in which to train them.  This is true because the March 2016 CDC Guidelines on prescription of opioids are fundamentally incomplete, desperately flawed, and actively dangerous to the lives and health of hundreds of thousands of people.” 1

When we survey the large body of contemporary popular and scholarly discourse concerning chronic pain and drug addiction, we ignore to our peril the idea famously offered by Mencken.  This is perhaps nowhere more true than in the March 2016 CDC Guidelines on prescription of opioid analgesics to adults with long-term non-cancer pain.  That document has prompted a hailstorm of sustained criticism from pain patients and medical professionals alike 2,3.  In my view, the criticism is fully deserved.

Primary criticisms of the CDC Guidelines can be summarized as follows:

  • Guidelines were developed by a core consultants working group which was hand-picked with an anti-opioid agenda in mind — and which met in secret until challenged by the Washington Legal Foundation 4 and Congress 5,6. The process of guideline development was dominated by addiction psychiatrists who had little training in pain management. None of the Board Certified pain management specialists in the group had practiced outside hospitals. Medical ethics consultants were never consulted.
  • Even after Congress forced CDC to schedule public input to the Guidelines 6, dissenting voices of pain patients and pain management specialists among more than 4,700 comments were largely ignored.
  • Writers of the guidelines drew strong conclusions from very weak medical evidence or unsupported opinion. Research referenced in support of the guidelines was manipulated to draw conclusions on opioid and non-opiod therapy that were unsupported by the medical evidence 1,7.  Pertinent research was omitted from consideration, possibly because it contradicted conclusions of the CDC consultants. 8
  • Although phrased as “voluntary” and directed to general practitioners, the guidelines became de facto restrictive standards even before the document was issued. A Congressional budget resolution bill in December 2015 made CDC guidelines mandatory for the US Department of Veterans Affairs. Multiple restrictive State laws have been modeled on the CDC conclusions.   US HHS Centers for Medicare and Medicaid have proposed mandatory “soft audits” of insurance claims, delaying the filling of prescriptions until a doctor can verify them, where opioid dose levels exceed the limits proposed in the guidelines.  The natural result of such audits will be to further restrict prescribing to people in agony.

To these generally understood weaknesses in the CDC guidelines, we must examine three additional observations which have not been as widely discussed in public sources.

  • The strong emphasis of the CDC guidelines was on reducing opioid addiction, not pain management. However, published evidence suggests that the most reliable risk factors in addiction are status as an adolescent, a history of family trauma, and/or prolonged unemployment.  None of these factors is addressed by restriction of opioid analgesics needed by pain patients. 9
  • While it may seem plausible that higher sustained doses of opioid analgesics might be associated with higher risk of addiction, the guidelines reference no literature supporting a particular threshold over others. The proposed maximum 90 Morphine Milligram Equivalent Daily Dose (MMED) is essentially arbitrary and is poorly supported by the limited evidence available 10. This maximum is being forced upon patients who have been stable on higher doses for years, despite the absence of any criteria for such action in the Guidelines. 11
  • The Guidelines are dangerously silent on a fundamental issue which should shape both prescription opioid practice standards and physician education. Opioid pain relievers do not create their effects directly in the brain.  Drugs must first be metabolized by enzymes into their component chemical parts.   However, there are substantial genetic variations in the ability of individuals to accomplish this metabolism.  Multiple gene alleles play a role. 12

Drawing from long-established medical literature, it is known that:

“Cytochrome P450 enzymes are essential for the metabolism of many medications. Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs, with the two most significant enzymes being CYP3A4 and CYP2D6. Genetic variability (polymorphism) in these enzymes may influence a patient’s response to commonly prescribed drug classes, including beta blockers and antidepressants. Cytochrome P450 enzymes can be inhibited or induced by drugs, resulting in clinically significant drug-drug interactions that may cause unanticipated adverse reactions or therapeutic failures…” 13

Some patients “hyper-metabolize” or ‘poorly metabolize’ one or more commonly used opioid analgesics.  For example, in patients with faults in the CYP2D6 allele who hyper-metabolize, the medication Codeine gets split rapidly by the enzymatic system into the prodrug morphine — at much higher levels than the original dose of codeine. Lethal blood levels can occur from doses that would be innocuous in a person with normal metabolism. This prompted the FDA to ban Codeine and Tramadol for children 14 — although genomic testing was ignored in favor of denying these alternatives to all children.

Enzyme faults, drug interactions, gastric bypass, Crohn’s disease, gastroparesis, late stage diabetes, etc. can also cause poor metabolism (p-glycoproteins, CYP3A4, CYP2B6, CYP2D6, OPMR, COMT, MTHFR)  and patients with these issues will often require significantly higher doses to generate therapeutic levels of analgesics.  12,13,14,15 Underlying disease progression also needs to be considered in dose increase over time.

There are potentially millions of pain patients in the US who both need and respond well to opioid doses exceeding 400 MMED.  There are case reports of patients doing well on megadoses exceeding 2500 MMED 15,16. Based on the preponderance of this evidence, it should be apparent that there can be no one-size-fits-all “maximum dose” or “addiction risk threshold” in the prescription of opioid analgesics.  Guidelines should not state such a maximum.  Dose must be tailored to each individual and informed by genomic testing when therapy fails. Prescription guidelines need to be explicit in directing that for patients who have been on stable doses and who have sustained improved function and quality of life over time, there is no scientific rationale for arbitrary withdrawal or tapering down from even “high” dose levels.  To the contrary, such tapering may contribute to iatrogenic suicide.


From postings by tens of thousands of chronic pain patients in social media, it is clear that the existing CDC opioid guidelines have directly resulted in an exodus of physicians out of pain management practice. Patients are being summarily discharged or unilaterally tapered down from opioid dose levels that have safely controlled pain and promoted function for many years.  Suicides have occurred and more should be anticipated as ever more patients are plunged into agony, disability, and depression by denial of care. 17,18

Given the substantial body of published medical and popular literature which contradicts the CDC de facto standard to which the FDA proposes to train doctors, the only ethically and scientifically sound direction for present FDA training efforts must be to publicly acknowledge that the CDC opioid guidelines must first be withdrawn and rewritten to correct their many errors and omissions. On the second time around, ethics consultants should be included in the writing group. Pain management specialists active in community practice should lead the effort. Pain patients or advocates must be voting members of the group.

This time, the CDC and FDA need to develop a practice guideline that is truly “patient centered,” rather than being a knee-jerk response to political pressure to “do something” even if that something is clearly the wrong thing. 19

About the Author:  Richard A (“Red”) Lawhern, Ph.D.  is a non-physician writer, research analyst, patient advocate, and website moderator for chronic pain patients, families, and physicians.  His wife and daughter are chronic pain patients.  His 20 years of experience has produced articles and critical commentaries at the US Trigeminal Neuralgia Association, Ben’s Friends online communities for patients with rare disorders, US National Institutes for Neurologic Disorder and Stroke, Wikipedia, WebMD, Mad in America, Pain News Network, National Pain Report, the American Council on Science and Health, the Global Summit for Diagnostic Alternatives of the Society for Humanistic Psychology, Psychiatric News and Psychology Today.

References:

1. Richard A. Lawhern, Ph.D., “Public Comment to ‘Training for Opioid Analgesic Prescribers – Exploring the Path Forward”. Workshop Proceedings pending as of May 26, 2017. Comment gateway.

2. Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM; and Andrew Lazris, MD, Neat, Plausible, and Generally Wrong: A Response to the CDC Recommendations for Chronic Opioid Use

3. Bob Tedeschi,  “A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fearSTAT News, January 17, 2017.

4. Pat Anson, “Law Firm Wants Transparency in Medicare Opioid Policy,” Pain News Network, May 24, 2017.

5. Rich Samp, “CDC Bows To Demands For Transparency And Public Input On Draft Opioid-Prescribing GuidelinesForbes, December 15, 2015. 

6. Congress of the United States, House of Representatives Committee on Government Reform, Letter to Thomas Frieden, MD, Director CDC, December 18, 2015

7. Baraa O. Tayeb, MD Ana E. Barreiro, MPH Ylisabyth S. Bradshaw, DO, MS Kenneth K. H. Chui, PhD, Daniel B. Carr, AM, MD, DABPM, FFPMANZCA (Hon)  “Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?”  Pain Med. 2016 Nov; 17(11):2036-2046

8. Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, Schoelles KM, Chou R, “Opioids for Long Term Treatment of Non-Cancer Pain”, Journal of Pain and Symptom Management, Vol 35, No. 2, February 2008, Updated December 2010. 

9. Maia Szlavavitz, “Opioid Addiction Is a Huge Problem, but Pain Prescriptions Are Not the Cause –  Cracking down on highly effective pain medications will make patients suffer for no good reason,” Scientific American, May 10, 2016

10. Richard A. Lawhern, Ph.D. “Tracking Down the ‘Research’ Behind the CDC’s Opioid Prescribing Guidelines, National Pain Report, August 10, 2016. 

11. Pat Anson, “Survey Finds CDC Opioid Guidelines Harming Patients,” Pain News Network, March 15,2017.

12. Steven H. Richeimer, MD and John J. Lee, MD “Genetic Testing in Pain Medicine—The Future Is Coming,” Practical Pain Management, October 17, 2016. 

13. Tom Lynch, PharmD and Amy Price MD, “The Effect of Cytochrome P450 Metabolism on Drug Response, Interactions, and Adverse Events,” American Family Physician,  August 1, 2007.

14. US Food and Drug Administration, “Information for Healthcare Professionals: Use of Codeine Products in Nursing Mothers,” August 14, 2013.

15. Jennifer Schneider, MD; Alfred Anderson, MD; and Forest Tennant MD, Dr PH, “Patients Who Require Ultra-High Opioid Doses,” Practical Pain Management,  September 2009.

16. Forrest Tennant, MD, Dr PH, “Ultra-High Dose Opioid Therapy; Uncommon and Declining, but Still Needed.Practical Pain Management, October 28, 2014,

17. Observations of the author from postings to over 30 Facebook groups among aggregate memberships exceeding 20,000 pain patients, family members, and medical professionals.

18. Stefan G. Kurtesz, MD, MSc, “Turning the Tide or Riptide? The Changing Opioid Epidemic,Journal of Substance Abuse, Vol 38, Issue 1,

19. Editors, PAiNWeek, “What if Prescribing Guidelines Were Patient Centered? – Rethinking Public Policy for Better Patient Outcomes and Expanding CDC Guidelines*,” April 11, 2017,

* The introduction by PAINWeek is linked to an article by the author on National Pain Report titled “How Would Opioid Prescription Guidelines Read if Pain Patients Wrote Them?”  The same article was re-published in The Journal of Medicine of the National College of Physicians, titled “The CDC’s Fictitious Opioid Epidemic, Part II.”

There are 42 comments for this article
  1. Gillian at 5:40 pm

    I thank you for your tireless work on behalf of the chronic pain community! I’ve been negatively affected by the recent CDC guidelines, and each month my board certified pain management anesthesiologist physician is cutting my meds back. It does not seem to matter that I’ve been taking these medicines continuously for the past 7 years, passed drug tests, pill counts, and have taken the epidurals, trigger point injection, RFA’s cervical and thoracic, done some physical therapy, use a tens device, biofreeze, ice, heat, and an expensive compound cream. I need my medicine to continue functioning properly. I feel like we’re in the dark ages right now. It’s scary that they used a bunch of addiction specialist to write these guidelines for chronic pain patients, and the fallout from the opioid hysteria is scaring good doctors from effectively treating their patients. I believe it’s ridiculous that prescription for opioids have declined since 2010, or 2012, can’t remember the exact year, but these “overdoses and deaths” have supposedly continued to rise. The overdoses must be from illegal heroin and fentenoyl. And they must effectively separate the two categories, because chronic pain patients shouldn’t be suffering because they’re trying to save people from themselves (those suffering from addiction). It’s not right to take away our quality of life, and don’t even get me started on our rouge DEA that are attacking legitimate pain management doctors. Doctors of Courage website explains how our doctors are being threatened and shut down, having their assets taken, and their lives ruined.
    Just wanted to thank everyone that’s trying to help return things back to common sense and sanity.

  2. Incredulous at 11:21 pm

    I don’t understand why our government is allowed to get away with torturing and mass murdering of the disabled in such a way. Even if the government is for some reason unable to be sued, then why aren’t the physicians who refuse to treat pain, who abandon patients ILLEGALLY, who cause PTSD in their patients with their horriffic treatment (lack thereof) and all of the other autrocities, held accountable and taken to court? Surely there must be some attorneys who are willing to start making examples out of these doctors who have no ethics?? I didn’t have the energy to continue to beat down the paths in search of an attorney to help me fight, but there must be attorneys among us patients who also have advocates who might be on their side?

  3. Linda Godowsky-Bilka at 8:31 am

    Interesting note – on the President’s 2018 State Department Budget Request Hearing with the Senate Foreign Relations Committee this morning, Senator Markey made the comment “could lead to people losing their opiod coverage for their illnesses and their own families and it’s just absolutely wrong”. He was giving his opinion on the proposed Health Care Bill, stating that it’s “just absolutely wrong and we’re going to have to continue to elevate that issue”.

    So, for what it’s worth, a completely odd and out of place comment for a hearing on the State Departments budget. But you know how they all use their chance to talk on the issue at hand, to bring up something totally unrelated.

    Typically it’s a partisan rant but on this occasion it hit home for me. I was glad to hear ONE OF THEM, regardless of Party, bring it up at all!

  4. Jean Price at 3:36 pm

    Praying daily that someone will actually care about all of this…and be the catalyst within our government and the health care system to start a change back to sanity!! This is on target and certainly clear enough to understand…if they want to! Therein lies the real problem I think!

  5. Dorothy Morris at 2:35 pm

    HJ it took me 10 year to get diagnoised with chronic Fibro. By then my body had deterated a bunch, but worked til 36 years old till couldn’t work any more! Some 20 years from first back pain and worksman coop till disablity. So I know how you and others fell.Recently Doctor cut medicine down from 180 mgs to 75 mgs. Because of new FDA guidelines! Thanks for lissening.

  6. Pingback: What Matters to You – The MD, PhD Is In
  7. Maureen at 8:50 pm

    Dr. Aranda, Thank you very much for your post and for your understanding. It means the world to us and shows that more doctors know what we are wrongfully experiencing in our care. Maureen

  8. Maureen at 8:47 pm

    HJ, I feel for you, I for one was on a similar journey in my earlier days of chronic pain. Hugs to you.
    As I’ve said before, all of our stories are different yet so very similar and we could write many books! Keep strong everyone… This has to break through for us at some point!

  9. Dr Margaret Aranda at 2:24 am

    This article brings up very pertinent points that are not generally known by physicians, ancillary healthcare workers, or the general public. So grateful to see it shared here on the National Pain Report; encouraging others to continue spreading the word. It really is true that what we aren’t being told is hurting many patients and physicians who do not want to see patients suffer.

  10. Donald at 9:25 pm

    Each day seems to bring more news of chronic pain patients being harmed by rapid tapering off opioid medications, and of formerly stable, functional, patients that are being deprived of their medication. The CDC Guideline, a “suggestion” has now become the de-facto document of the “standard of care” in America, and it is being used by the VA, CMS, Medicaid, State Medical Boards, Governors, Legislators and the media as the official “physician training” blueprint for pain care. Now the FDA is considering using these faulty guidelines that were based on faulty science and bad statistics. There is no mention of underlying disease conditions that often generate intractable pain. The presenters for CDC from the University of Washington do not represent the cutting edge of pain medicine, have a conflict of interest due to their involvement and membership in the activist organization Physicians for Responsible Opioid Prescribing – PROP, and its anti-opioid bias. The U of W has been the laboratory to create a model for the nation on pain care. It has a decidedly anti-opioid/addiction medicine bias, and is also heavily funded by medical device companies. Anesthesiologists are only offering risky, costly, and temporary interventions, that often cause intractable pain conditions such as arachnoiditis. U of W is so out of touch with the most current pain research and science, it is a public travesty that they were chosen to teach PCP physicians to treat chronic pain. What was presented would be good for 70% of patients with chronic pain, those outliers 30% of patients, with genetic differences in metabolizing, the latest science of genetics and medication metabolizing was left out. The CDC guidelines do not prevent high dosage or require taper if a physician deems it safe for the patient, yet this was a main focus of the trainings they offer. Physicians are now using the Guidelines as an excuse not to treat pain and abandon patients. Now we are witnessing the backflow carnage of these mis-guided policies in terms of patient suicides and deaths from too- rapid tapers. People are losing their quality of life that being on pain medications have helped them gain back, especially when other options have failed to help them. Too many lives are being lost, and no one hears us.

  11. Just Wrong on So Many Levels at 8:52 pm

    Thank you Red for being the voice of reason in this crazy position pain patients are in these days…! Ignoring the science of genetics when treating individuals in pain is the height of medical hubris.
    What the CDC has done to decent pain patients is despicable. I am sad to report that my husband who is a senior citizen, and is someone who has normal type metabolism, was just told by his primary care doctor who has taken care of his complex medical needs for 10 years, that he will have to go to a pain specialist because of the CDC Guidelines! We politely informed him that the CDC Guidelines are for primary care and he argued with us, oh no they are for pain management, and started to reduce his very low dose of Ativan he’s responsibly taken for last 10 years for anxiety and terrible spasms. That was O.K. with him, and he replaced it with a muscle relaxer-which from my point of view made him worse, hard time walking because his back was “going out” more. If the poor guy laughs too much he spasms from the kyphosis. Next visit he said, oh yes, I looked up the guidelines, and just completed a CME course, and the VA and the DOD are using the guidelines as law, and primary care doctors are being blamed for the over-dose crisis, so he’ll refer to the pain specialist and continue to lower his dose of Ativan, and start to wean him off opioids..He said it’s too bad because “you are one of the people these have really helped”, I can’t do this anymore because of the CDC and DOD and pain management will do a better job. In our state pain management means interventions, not medical management and my husband is a diabetic on blood thinners with heart disease and spinal kyphoisis/past broken neck from car crash, post-stroke, intractable pain and he is having his very low dose of opioids 15 milligrams per day for past 4 years cut by 2 pills per month or go to the interventionist. He is way under the CDC guidelines and the doctor is afraid of the DOD??? What is up with that?? (and he’s not a VA doctor! ) You would think the way palliative care is written he would be able to that, but no, he’s doesn’t have the right illnesses! We tried to explain the situation to him, but it’s I’m cutting or you’re going to PM..Now we are very well versed on all these policies, etc..but it’s like talking to a wall.I know his health is so bad that he won’t be able to live with the pain. It’s scary and I am furious! It feels really like someone putting the screws to you-do this or else. I guess it’s better situation than some as it’s a slow taper. He has been a model patient. So seniors are really being put in a bad place.
    Opioids are the safest option with his conditions and intractable pain, and we are going to continue to fight this and fight for others! Just plain wrong on so many levels.
    I have faith this will somehow work out, but what a terrible stress on both of us.

  12. Maureen at 7:20 pm

    Lisa, i believe you 100%. I am so very sorry to hear your story and all that you had to go through because of idiotic doctor’s decisions and malpractice treatment!
    And I know that that is just part of your story. I too have a similar story. We CP folks could truly write several books on how poorly we have been treated. It’s ludicrous! Be well, one day at a time. Maureen

  13. Dog lady at 5:55 pm

    Thank you so much for this article . Long time pain patient with Ra , fibro , chronic fatigue etc. Allergies to all biologics tried so far . When I was on the proper dose of pain meds I worked full time , lived a full life. Now very little pain relief . You are truly a hero for standing up for chronic pain patients. I pray it makes a difference

  14. HJ at 4:17 pm

    Oh, and I just had a friend say, “Those opiods are bad business.”

    She doesn’t know I take them, myself. And she’s just parroting the popular news media.

    If she had knee surgery for the knee that’s making it hard for her to walk, would she even realize she’ll be given opiods?

    Even my friendships can only go so far. It’s all quite isolating.

  15. HJ at 4:13 pm

    Iatrogenic.

    I was once told I was “just depressed” when I was living with undiagnosed illnesses causing chronic pain and fatigue (osteoarthritis, possibly fibromyalgia and sleep apnea). It was “all in my head.”

    It affected me so badly that I feared I couldn’t continue to work. I was in my 20’s. I’d tried seeing a rheumatologist, three primary care doctors over the course of several years (with job changes & moves causing me to switch doctors).

    I was trying very hard to get help — to get a diagnosis. I was actually treated very poorly. Mocked for my “little list” and the door to the exam room closed while I was speaking when the doctor stood up while I was mid-sentence and talked over me as she exited the room.

    I was female. I was fat. I was “just depressed.” I was a non-person to the medical profession. I guess there’s such a thing as iatrogenic depression — because I lived it.

    I stood outside the office in the bitter cold, picturing me having to give up my job and become dependent upon my parents. I was having terrible cognitive difficulties to the point I thought maybe I had early-onset Alzheimer’s. You can’t walk into a room and forget what you’re there for 12 times in a row without a co-worker noticing, and that was just the tip of the iceberg.

    I felt like I’d exhausted all my options. Christmas was coming. I planned to visit my parents one last time. They wouldn’t know I was actually saying good-bye.

    We got into a car accident. My mother insisted I see her doctor because I had numbness in both arms instead of just the usual one arm (I also have cervical spondylosis – another illness that was “in my head” until someone listened.)

    My mother’s doctor asked me strange questions. I cried when I got my fibromyalgia diagnosis. I didn’t know what it meant, really. It was a strange word. My mother’s doctor checked me… because my mother was diagnosed. It was one of those long words that she probably mentioned in with spinal stenosis, spondylosis… Lots of terminology that meant she’d need multiple back surgeries for very aggressive osteoarthritis that was cutting her spinal cord and would leave her applying for disability in her early 50’s.

    I cried when I was diagnosed because I had a direction. I could learn what was happening and try to help myself, finally… and maybe doctors could help, too.

    I helped myself a lot. As for doctors, I had more fighting to do… because I was still a woman, and I was still fat. A doctor gave me a history lesson about “hysterical women” while he offered me more anti-depressants and insisted I see a therapist. The therapist told me to find a different doctor (not directly… but she did try to coordinate my care with him and ended up saying, “He loves to listen to himself talk.” because he talked over her rather than listened).

    I have fantastic doctors now. My pain is pretty well managed (wintertime is rough) and I don’t expect to be pain-free — but I’m so relieved to be able to work full-time and support myself. I don’t take it for granted. I know others who wish they could go back to work. I’m one h*** of a fighter. But the medical system almost knocked me down… for good.

    And now… we’re fighting again… and if I’m a victim of this opiod witch-hunt, I don’t know how I can manage knowing that the system has denied me care I legitimately need and absolutely deserve. I have quality of life right now. For the moment.

    I don’t think I could stand having the things that give my life meaning taken away meaninglessly. My job, my life-adaptive hobbies (more passive than most people my age would enjoy), my independence, my mobility.

  16. Crystal Murphy at 9:15 am

    Thanks once again, Dr. Lawhern. You are a shining example of patient advocacy at it’s finest.
    I do believe that your extensive knowledge and tireless activism has given chronic pain patients hope; something that was sorely absent before.
    God Bless You and your family.

  17. Lisa Osborne at 11:23 pm

    I echo all of the comments shared here. My pain began in 1983. I began taking opioids in 1998 after spending 15 years trying everything else. Last summer, as a result of becoming disabled, I lost my private insurance and went on Medicare and Medicaid. At almost the same time, the primary pain facility treating Medicare/Medicaid patients was shut down due to patient deaths and alleged Medicare fraud. My private pain doctor merged with a company who did not take Medicare, as did a few others. Across all 4 Medicaid options, there was no longer one single pain doctor available to treat 8,000 of us. We were told to talk to our primary care doctors and if we were upset, to call the Care Crisis Line. The Emergency Rooms were innundated and suicide rates spiked.

    My primary care doctor believed I was an addict and we spent my appointments discussing addiction and her fear of losing her license. She immediately switched me to a contraindicated medication and began an extreme taper. No matter how much I cried, she refused to even consider the information I presented. The way she recorded information in my chart was borderline legal.

    I went thru unsupervised withdrawal twice in 3 months and struggled with breathing problems from the medication she put me on. She knew both these things and minimized them completely. I was assigned a case manager through the healthcare exchange whose attitude was that since I wasn’t going to die, she wasn’t going to deal with me. Since my coverage comes through the healthcare exchange, I can only complain to them–not the insurance commissioner.

    It took me over 9 hours on the phone to find a new doctor who would take me. I brought my new doctor a 2″ packet of MRI reports, CT scans, doctor reports, etc, to prove I am legitimate. Thankfully, he believed me.

    I had to go on multiple rounds of Prednisone in order to stabilize my breathing. I suffered at least 2 opportunistic infections due to compromised immune system. Every aspect of my life except survival ceased to exist. All in 3 months. It took 6 months to stabilize and restart my life. I carry the post traumatic stress and trauma with me forever. That doctor did real harm. I have no recourse against her to find justice. Worse, I have no way to prevent this from happening again.

    Now, because my pain is being managed by a non-specialist, I have no way to monitor my deteriorating condition, deal adequately with pain if I have surgery, or explore non-drug options as my health changes–and it is changing, no question. But I am not going to say a word or complain because at least now I have a primary care doctor who is is my partner in care, and like me, he is doing the best he can.

  18. Raz Sey at 10:59 pm

    First, thank you ! Finally lucidity over i`sanity and madness! You need to raise your voice on as many media platforms along wiith others in your field, as ‘ just’ patients, who by circumstance not choice , are unable to fight this unarmed. There are just over 20 comments here! Where are those that this has affected? Are there only 20 some people with untreated or undertreated chronic pain ? Tsk tsk. Instead of having many groups , there should be very few so that these people are not scattered abou^ instead of being united forces. Second, as a ]atient with maladies too numerous and documented medical issues for 18 years , was formerly on over 500mg daily for 14 of them, with functionality, was dropped for no reaso`, fired, left to my own devices to suffer with life threatening withdrawals! In this journey ,i have found herbs that helped with PAWS and lingering withdrawal symptoms. Anyone that has been on opioids and pstopped, knows only too well that after initial wd’s lessen, are )eft in pain ;with mood disorders, as well as depression due to overwhelming pain. Prop in their infinite wisdom , and financial interests, have for lack of better word, “fudge” the stats to have drs, and gov, believe their motives are for the patients.. We know whats good for you and we made up the statistics to prove it! The cdc interests lie in financial ones of rehab centers, which they are connected to, plus big pharma making billions, touting suboxone type drugs which are costly, at minimum 600 a month. Add to that, once on them, prob will be a lifelong customer, as they are so difficult to stop! Much more so than heroin! Their interest is the one that counts, not the truth. Yes, granted, rx for painkillers were at one time easily accessable not only to help people in pain, but, for crafty addicts, who used the rx meds instead of heroin products, as they were also cheaper! With no worries of legality. So, now with the so called guidelines being forced upon drs, seems that deaths due to od now have )essened, but, theat are illegally

  19. Maureen at 8:51 pm

    Dr. Lawhern, Bravo, bravo, bravo!! So well written! I felt safe and hopeful as I read your post, and with tears in my eyes. You always give me hope. I commend you on going to the FDA meeting and for all of your hard work on our behalf.
    Thank you also for providing the link for the Tues online show…I will surely plan to tune in! Best of blessings with it and always. I can’t wait to hear more from you down the line. With heartfelt appreciation, Maureen
    @ Dr. Hennessey, Thank you also for understanding our lives and standing up for us also. Keep strong in your position as a physician who knows best and as a person in pain.
    @ all who made comments… Thank you also for commenting and always helping
    me feel that I am not alone in this difficult life we live. I pray for all.
    @ Dave, who is Lana Kirby?
    Keep strong and vigilant o’ wonderful warriors! Maureen

  20. Carole Docherty at 7:38 pm

    20 years of chronic pain from endometriosis and pelvic adhesions. Non stop pain. Lost my career I loved. Changed me mentally.
    Only tramadol prescribed. Can not get into a pain clinic.
    Treated like a druggie in ER. A burden to my family. Never abused drugs. I fact, hate the side effects. Each month I learn of another Endo sufferer taking their life.

    Why are we being penalized for the criminals? SMH

  21. Patricia Leary at 9:35 pm

    Thank you Dr. Lawhern. I appreciate all you are dong. I would like to see someone like J. Sekalow ( I am not sure how to spell his name) and his team take up this cause and help us fight it legally. To me, you are the perfect person to bring all of this to his attention and speak for us in asking for his help. God bless you. From a heartbroken mother of two who suffer chronic pain.

  22. DAVE at 4:35 pm

    Red has set an example for others in his tireless efforts to help so many in pain to be treated with respect and humanity. Its an uphill climb up Mt Everest to get big shots in government to recognize the errors of their way and Red has been steadfast in his determination to do just that.
    Lana Kirby also deserves recognition in this regard and there are others.
    each one of us who care about pain and those who suffer can make a difference and should make an effort. No effort is too small. The only effort that doesnt count is not trying.
    People in pain and those who care about them can change the governments and providers position on opioids. The sooner the better. As Margaret Mead once wrote- Never underestimate the power of a few dedicated people to change the world. In fact its the only thing that ever has.

  23. Richard A. Lawhern, Ph.D. at 12:28 pm

    Thanks to all who have commented thus far. Please feel free to share this article with others, particularly medical professionals. This is a needed conversation.

    As a follow-on to this article, I have been invited to interview on “The Buchanan Report Online” for 60 to 90 minutes beginning 9 PM on Tuesday June 6th. The format is that of a “whistle blower” interview, which this group has done in many other areas of public life. I have shared this paper with the hosts and they have put it up on their website. We will be reviewing the many errors and frauds in the CDC opioid guidelines which are harming patients and driving doctors out of pain management practice.

    To listen, use this link: http://www.blogtalkradio.com/buchananinvestigations

    To dial in for Q&A, phone is 347-857-1710. The more dial-ins we get, the longer the show may run. Anticipated audience is on the order of 15,000, and they are set up to handle more than that volume in streaming audio.

    Regards, Red Lawhern

  24. Katmary at 11:17 am

    As a chronic pain sufferer for 30 years who has been kicked to the curb and has many issues, I thank you for being a voice of reason!

  25. William Dorn at 10:47 am

    Dr Lawhern can you get on shows like Tucker Carlson and the other ones and get the truth out to the public.All the medical experts like yourself that are not afraid to speak out must be heard by the public now.How many must suffer and die before this ends If doctors would honor there oath and start speaking out the public would listen.Time is running out for so many in chronic pain.With GODS help people like you Dr Lawhern will save millions of lives.

  26. Dorothy Morris at 9:41 am

    I think we all are in this together one year ago I was on 3 times medicine then now.now have chronic pain too! Unknown what future will bring!

  27. Danny at 9:11 am

    We now have 3 great voices of experience and reason posting on this site: Dr. Lawhern,
    Dr. Hennessy and Pharmacist Steve Ariens. There are certainly many other doctors and pharmacists out there who agree with them. I appreciate Dr. Lawhern’s efforts so much! If these gentlemen are willing, the pain organizations should make them available for news organizations to interview so that their educated and informed opinions can be presented to the public. The ONLY voices being heard are from the CDC and FDA as well as supporters of these organizations’ public statements. If we don’t get our point-of-view out there soon, it’ll be too late. I am so grateful for the efforts that have been made by all of the pain organizations. But we need more – NOW.

  28. Dorothy Morris at 9:01 am

    Finally we are telling the truth about us chronic pain people’s solutions or not.We need some type of relieve.I too have fibromyalgia, with chronic pain around my middle area.

  29. scott michaels at 8:07 am

    WHAT CAN WE DO? THE PAIN IS SO BAD I CAN’T MOVE WITHOUT SCREAMING IN PAIN… IS THERE A COUNTRY THAT CARES ABOUT THEIR CITIZENS IN PAIN. I’LLOVE THERE TOMORROW.

  30. Terri at 4:34 am

    This is by far the most honest and true article I have read. Well written and factual for once. Will the CDC listen is the question. The CDC knows that the guidelines they have “suggested” has injured and brought harm to hundreds of thousands and is only getting worse. When will they act and withdraw the huge mistake that they have made? How do we as chronic pain sufferers make them understand and act now instead of later? I believe that the biggest problem is that most people are suffering in silence and can’t muster the energy it takes to shout “This is wrong!!!.” Pain can be all consuming and if everyone that has been effected finds their voice, these politicians will cringe at the next election time for not protecting their constituents and standing up to the CDC and others who have created this farce. Thank you for writing this, I hope you will continue to tell our truth and help win this struggle that is so damaging.

  31. Owl at 3:44 am

    THANK YOU!! I am one of those people who has been victimized by the CDC’s and our government’s current malpractice witch hunt. I have successfully taken opioids for most of the last 15 years. I have never, ever had a “hospital” event because of taking my meds inappropriately, nor have I ever violated my doctor’s trust. Suddenly I am a criminal! I need yet another surgery but am aware that my pain will not be controlled so I continue to try to function without it, further damaging the joints in question. Your report is spot on and this malpractice of our government is killing people and making many more wish they were dead! I guess that is what big brother wants. This is what betrayal feels like! Praise God, we will all have to give account for our actions in the end, I wonder how they will try to spin this debacle?!
    Please continue to speak out for those of us who cannot. May God bless you in all your endeavors but especially to right this wrong.

  32. Jessica Agee at 3:11 am

    My son who has Autism was tested for the MTHFR & was missing one gene or chromosome ( can’t remember fibro fog ) , his doctor told me that if he’s missing one that means one parent is missing 2. We’ll his biological father is healthy as can be & me I have everything from chronic pain from a spinal fusion that caused nerve damage and osteoarthritis , fibromyalgia , gut issues , sleep disorders etc .. so I’m wondering if that’s why I’ve always needed to go up on doses after so long & wake up during a procedure? What kind of test do I need to ask for? Thanks so much Red for this post & your advocating for the chronic pain community, someone name pharmacist Steve made me think about all those who go to battle for us. Thanks you!!!

  33. Patrick T. Hennessey, MD, MPH, FACP, CRC at 7:36 pm

    As a certified (ASAM) addiction specialist who has treated addicts, predominantly with co-occurring complex psychiatric and medical conditions including chronic pain, almost exclusively in independent office-based practice;

    As a board-certified (ABIM) Primary Care Internist who has treated thousands of patients with both acute and chronic pain, with only one case of apparent iatrogenic opioid addiction over 30 years;

    As a DATA-waivered Suboxone prescribing physician who has successfully employed buprenorphine in saving lives and supporting rehabilitation of hundreds of opioid-dependent patients, including stabilization of legitimate chronic pain patients abandoned by their doctors or pharmacies;

    As a partially-disabled Veteran w service-connected chronic pain, who sees and hears the horror stories of fellow Veterans shamefully and tragically being mistreated and essentially abandoned in pain by the health care delivery system entrusted w their care, contributing to the appalling rate of Veteran suicides approaching 1 per hour, around the clock and around the country;

    As the caregiver of family members, both young and old, with inadequately-treated acute, post-operative and chronic pain;

    As a certified geriatric specialist (ABIM), who sees the impact of inadequately- and inappropriately-treated pain in our burgeoning and vulnerable aged population;

    As an academician with extensive post-doctoral training and experience in evaluating study design, data analysis and manipulation, interpretation and misinterpretation, and advanced degrees in Public Health, including Health Policy;

    I have but one word to add to Dr. Lawhern’s essay:

    AMEN!

    In my opinion, the CDC “Guidelines” are essentially “garbage-in/garbage-out” policy based more on weak junk science, misconceptions, misinterpretations, and ill-concealed political agendas, than on sound science backed by quality research.

    A manure pile, properly tended and composted, can contribute to the growth of strong, vital plants.

    But without proper supervision, it just draws flies to the garden, breeds maggots, fouls the air and grows, at best, a few mushrooms.

    That metaphor is not entirely inapplicable to the current state of our national policy war on pain patients, with respect to the CDC Guidelines, and the nascent FDA policy development.

    As it stands today, neither resemble a rich and fertile substrate for sound policy or education.

    Can any rational, discerning and informed citizen be faulted for sensing manure (and not the Garden of Eden touted by certain political interests) based on the stench and the buzzing that has surrounded these projects since their inception?

  34. Marty Wolfe at 6:48 pm

    Thank you Richard A. Lawhern on behalf of a chronic pain patient who has battled CRPS for more than twelve years. The misguided March 2016 CDC Opioid prescribing guidelines have hurt me and many other chronic pain patients and CRPS survivors. Dr. Lawhern has represented the chronic pain community very well with his common sense approach that one size does not fit all, and he points out the misguided agenda behind the CDC flawed prescribing guidelines. Thank you Richard A. Lawhern for your excellent work and selfless determination you have devoted to all chronic pain patients.

  35. Linda Godowsky-Bilka at 6:11 pm

    I have not the strength of neither body nor mind to do any more myself. Writing and responding has become almost too much of a challenge for me. With that said, the most sincere thank you that one can give another, I give to you for this article, and this work. Pure but simple and the most sincerely.

    I just finished watching the Tucker Carlton show. I am at the end of my rope with what I saw and heard. The Ohio AG is suing major drug companies for “the opiod epidemic”. The visual to go along with this piece was truly one of a kind. The Ohio AG picked the WORST picture I have seen thus far to represent his case. I fear the picture will have a devastating impact on the health and well being of people who suffer from chronic pain who are striving and swimming up stream for a way to keep living without being oppressed so hard and for so long onto their death bed.

    God willing one or more of you out here, will see this, be moved enough to watch his show later tonight, and have the strength that I cannot muster up anymore, and respond to Tucker. Please let him know the truth. Please let him know the truth.

    Thank you for your article, and thank you to anyone reading this comment. God bless all of you. I wish you peace.

  36. Dorothy Morris at 5:27 pm

    These medical Dr.that think let us keep these chronic pain patients in pain should rethink their practice.As one of the patient,I don’t take pain meds.because I want to it’s because I need some type of relieve.please think of that first!!@

  37. Frances Kramer at 5:13 pm

    Thank you, Dr.Lawhern, for being our voice of reason and advocate. We are ever grateful for your hard work on behalf of all chronic pain patients.

  38. Veronica at 5:01 pm

    I’ve been a chronic pain patient for around 20 years or more. At first, I refused any pain meds. Then, I couldn’t do my job, without creating a severe amount of pain. So, I was fired. First time in my life, and I was 41 then. One of my doctors said I shouldn’t allow myself to be in such pain, as it will control everything I do, or don’t do, because of it. She put me on oxycontin, and I was on that for years. Then she moved. The neurologist nearer to me continued the regimen. This was after acupuncture, physical therapy(which made all much worse), 4 different pain clinics (the last one was supposedly the ‘best’,- no, they made me in more pain and wanted me on meth, which I refused). Then, my primary doc retired. I believe he knew what was coming, and didn’t agree. (he retired early). So, I was stuck with a NP, who gave me tramadol. It didn’t help much, but I took it. Now, the entire clinic refuses to give pain meds. So, after around 20 years of pain meds, I have none. I’ve never thought of death more than I do now. I wonder why I’m on this earth – what is the point? I can’t do anything at all, without creating a never-ending round of pain. So, yes, the FDA is wrong in their assumption of chronic pain patients. It is without help, that makes one depressed and possibly suicidal. I can’t enjoy life one bit. (I have Sjogrens, Fibromyalgia, Degenerative Disc disease, and severe migraines) I used to have some good days. That has ended. And no, I don’t get ‘hooked’ on anything, nor ‘high’. I’m like my mom, and her mom too. I also have a heart condition, which limits what I can or cannot take. My life is a ball. Is that what the FDA wants to hear??

  39. Jenny at 3:18 pm

    When the guidelines were changed to the current ones; my life was changed to an unhealthy level of pain. My medication was cut in half, The original dosage allowed me some freedom of movement , my current dose leaves me in severe pain, constantly. I don’t know what Im going to do. I suffer major side effects from morphine based medicine, so I must take a synthetic morphine based medicine, which is much left effective.