The Mad Hatter’s Tea Party

The Mad Hatter’s Tea Party

By Terri A. Lewis, PhD

It’s time to call a spade a spade.  Our government leaders have no idea what they are doing or why.  Healthcare policy has become a massive game of SWAG.  Science has slipped the bounds of earth. And it looks like it’s going to take a while to settle down.

Terri A. Lewis, PhD

The Center for Medicare Services (CMS) fully intends to implement CDC’s flawed opiate prescribing guidelines ( https://www.cdc.gov/drugoverdose/prescribing/guideline.html ) as policy. The citations for CMS’ Opiate Misuse Strategy 2016 is found on these link: https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf.  They propose to issue revisions to the retrospective drug utilization review criteria used to identify potential opioid over utilizers (>90 MED/day) to better align with the CDC guideline on opioid prescribing, reduce false positives, and maintain a policy that is still manageable for drug plan sponsors; and, propose to establish the expectation for sponsors to implement hard formulary-level safety edits based on a cumulative morphine equivalent dose (MED) approach to prospectively prevent opioid overuse at point of sale at the pharmacy.

This “Big Brother” approach to fighting opioid abuse reinforces the assumption that the root cause of the opiate overdose crisis is found in Grandma’s medicine cabinet, and adopts a strategy that encourages pharmacists to become clinical gatekeepers, to report doctors who they believe may be overprescribing opioids, and to report patients who they believe may be abusing them. Information about these “potential opioid over-utilizers” is to be shared with insurance companies, which will be empowered to “prevent opioid overuse at point of sale at the pharmacy.” Nothing in this policy affords the physician or the patient due process. Disclosure, or appeal rights.  They have issued an Advance Notice and Draft Call Letter for Medicare Advantage and Part D drug plans to implement the opiate prescribing policy.  CMS will accept comments through this AdvanceNotice2018@cms.hhs.gov on all proposals through March 3, 2017, before publishing final versions on April 3, 2017.   The link to this call letter is found here:

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-02-01.html.

At the same time, in a parallel universe, other sectors of government are pushing for reduction of opiates and pharmaceutical pricing by increasing the use of compounded drugs to support epidural injection and pain pump applications.  This theory of applied pain management suggests that as the distribution of opiates in pill form is reduced, the use of epidural steroid and joint injections and installation of pain pumps is expected to increase.  As we speak, the Veterans Administration has issued defective solicitations for the supply of ‘FDA approved’ compounded drugs to support epidural steroid injections and IV applications.  The logical problem here is that (1) FDA does not regulate or approve compounded drugs in any form, and (2) there is no such thing as a compounded drug whose sterility can be assured by any approval process associated with FDA oversight because (like the Bowling Green KY massacre) these regulatory oversight processes don’t exist within current standards.

Compounded drugs are produced in one of two types of facilities under the Drug Quality Safety Act (DQSA, 2014) – (a) a facility that produces for instate distribution purposes like a hospital or local pharmacy, or (b) a facility that is registered with FDA to produce compounded drugs in large quantities for distribution and sale across state lines in accordance with commercial rules of business practice.  The first type of facility is regulated by state pharmacy boards.  The second type of facility is inspected by state pharmacy boards with enforcement regulated by state pharmacy boards.  The problem herein lies with the fact that the majority of state Pharmacy Boards have so far failed to enact regulations to provide adequate oversight of producing facilities of either type under the DQSA.  A quick review of registered facilities and their associated deficiencies can be found here: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

We have emerging evidence through both FDA inspections as captured on Fm483s, patient injuries (you know who you are) and mass casualty events such as the New England Compounding Center (NECC) disaster of 2012 that tells us that our assumptions about the safety of compounding under USP 757 should be strongly questioned.  Barry Cadden, owner of NECC and investor in a sister company, Ameridose, is currently on trial for the distribution of contaminated compounded medications to 75 clinics in 21 states.  Here, at least 13,500 individuals were exposed to contaminated medications, 800 were sickened, and 76 deaths were documented.  Mr. Cadden, his Pharmacy Director, and 14 of his employees are charged with 25 counts of second degree murder and racketeering. Many, but not all, of the clinics involved have contributed to a nationwide bankruptcy settlement fund in order to avoid prosecution for their role in contributing to this catastrophe.

The evidence available for review by the Department of Justice offers us rare insight into the workings of compounding organizations under existing state and federal requirements. We can observe clearly the gaps in regulatory oversight.  From this evidence we are able to infer that current inspection systems under USP 797 (http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf)  are inadequate to protect the health and safety of individuals who rely on sterile compounded drugs produced in large quantities.  Products produced by these organizations rely on a process of self-certification as to their conformance with a standard of identity,  performance efficacy and safety.  FDA does not regulate or oversee compounded products produced for sterile applications and product verification is not part of the inspection protocol utilized under this standard.  As we see in the evidence submitted in the NECC trial, products sold into the commercial trade by this large supplier were frequently out of date (past their shelf life), subpotent (missing or not enough of the active ingredient),  super potent (too much of one or more of the active ingredients), or contaminated by bacteria and fungi.  The source of supplies incorporated into these medications can be derived from any domestic or foreign source without disclosure to the customer – their conditions of production and verification of their performance is neither assured or verified.  When physicians purchase compounded drugs, they frequently lack the business practices to protect patients from the purchase of impaired supplies or the knowledge about the performance of these supplies to properly counsel patients as to risks, benefits, safety or efficacy.  This makes informed consent nothing more than a farce.

So what’s a person to do when seated at the Mad Hatter’s Tea Party?

First, understand the context in which your medications are prescribed.  Under the proposed CMS rules, you’re going to have to do some homework with your insurance company.  Call them and find out how they plan to implement and how your medications will be affected.  Identify their procedures for appeal and provide them to your physician.  Begin now to document the needs that you have for continued care.  Make sure you have a dedicated pharmacy and that your needs are a matter of record.

Second, if you are pushed to accept the use of injections or pumps that rely on compounded drugs, and you and your physician together decide that this represents a reasonable alternative, make sure of the following:

(a) Know your source and do not accept any medications from a compounding pharmacy with open issues as documented by a Form483.

(b) Medications are developed for single use applications only – you should be provided with a label that contains your name, the product name, the lot code, the expiry date, the ingredients, and a certificate of analysis (COA) that provides assurance that finished drug is exactly what they claim it to be at the time it was sold.  You should be provided with a copy of this information and it should be entered into your medical records for recall purposes.

(c) Make an appoint with your physician to review their business practices – ask them to inform you about their ordering practices, their inspection and receipt verification (which should include production information placed into their order entry system), their inventory management and stock rotation to insure shelf life expiry dates are managed, and how they can assure you that you are receiving medication that is designed for your use.  Ask them to provide you with their procedures for patient followup in case of an adverse event, potential recall of medications and reporting of critical information to the manufacturer.  Compounded drugs are not regulated by FDA. Adverse events must be provided to the compounder, whose customer service complaint log is reviewed by regulators.  Regulators however cannot direct the compounder to take a specific action on behalf of customers unless there is a documented violation of USP.

Third, if you haven’t already started this process, know your role as a consumer, your rights, and the responsibilities of various parties to the health care transaction.  It’s getting more complicated by the day.  Enlist the help of your friends and family. Form a learning community with a method that works for you – meetings, social media, clubs. Put your key health care partners on speed dial.  Attend community meetings held by your elected representatives.  Above all, don’t be silent.

Many pain patients are losing their health care providers entirely within this climate of care or are threatened with the loss of their providers due to changes of regulation and insuror coverage.  That is also especially troubling as many consumers pay fees monthly for access to care. If this happens to you, file a complaint with your state Department of Health (http://www.apha.org/policies-and-advocacy/public-health-policy-statements/policy-database/2014/07/21/09/50/the-state-health-department ), the Center for Medicare Services r (https://www.medicare.gov/claims-and-appeals/file-a-complaint/complaint.html), and your insurer.  Ask for an investigation and remediation of this situation within 30 days.

Fourth, if you are a Medicare insurance program user, each state has an advocacy organization that helps locate the best plans for your use and investigates fraud, waste and consumer abuse by plan providers.  This link ( http://www.seniorsresourceguide.com/directories/National/SHIP/ ) will help you locate resources in your state.  Make an appointment with them to make sure you are in the right plan for your needs as changes develop in coverage.

Fifth, if you are dumped or are locked out of care, make a polite nuisance of yourself.  Know who is on your state legislative health committees and make an appointment with them. Identify your needs clearly and what you have done to secure the care your need. If necessary, invite them into your home or make an appointment with them and inform them of how you have been negatively affected – be prepared to elaborate exactly what you have done to act on your own behalf.

If you are a family member, friend or someone in an advocacy position who is available to act, steel yourself for this work. Use all your resources and prepare to go the distance. Don’t try to go it alone.

It is not the work of heroes.  It work of people like you and me.

Terri A. Lewis, PhD, is a regular contributor to National Pain Report and is involved with the Rally Against Pain meeting that is occurring this today in Washington D.C.  National Pain Report ran an article about this rally, to which she submitted the following update in the “comments” section, which we believe warrants its own article. 

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Authored by: Terri A Lewis, PhD.

There are 21 comments for this article
  1. Kristine (Krissy) Anderson at 8:42 pm

    Thanks, Terri, for all this information. It’s indeed scary. I want to bury my head a little further into the sand, but I will keep my eyes open and act.

    Until definitions are changed, i.e., the “opioid epidemic” is changed to a “pain epidemic,” (since an epidemic is not a “thing” but is a medical illness)

    AND

    there is clear and distinct separation between the definitions of addicts and patients, this genocide will continue.

    It’s necessary for us to be informed and take personal action. You’ve just helped many of us. (I’m 64, yikes.) A pain in the ass, it is, but we must continue to fight for the fair treatment of chronic disease and pain.

  2. dave at 10:58 am

    Red Queen Hypothesis- People in pain have to run as much as they can -just to have some of the meds they relied on. For pain care is no Wonderland- it is more of a dystopia and nightmare. And Huxley or Orwell could not have written a dystopia like pain care in America today. The level and degree of incompetence and uncaring is extraordinary- especially when coupled with all the strategic misrepresentations and cruel rationalizations.
    I can say for my part, I continue to fight back- today I am in the process of convincing Senators in NYS to introduce new legislation to call for better education of doctors and providers and will call for better preventive care and curative treatment for pain. I have opposed the legislature lets have the experts deal with it approach- and have convinced a few that the experts will not get pain care right.
    If we want pain care to improve we have to demand a place in all aspects of pain care- from policy making in AHRQ, NIH, departments of health, narcotics agencies, in universities, colleges, on legislative panels,etc. Without structural changes- without more opportunities to directly create, monitor and evaluate policies and practices in pain care- we will continue to be consigned to 3rd rate citizens- serfs without rights who must plead before their feudal masters to get any pain relief.
    Lets compel government to be on the run for us as we demand a place in all aspects of pain care.

  3. LV at 3:48 am

    I have just experienced this at a PM visit yesterday.The pump and the injections were pushed on me again. A suggestion to move West to a warmer dyer climate which I have and will do again. I was told that my new doctor is prescribing the amount that a terminal patient would take and that this doctor has old school mentality, and this is poly pharmacy and so on. I looked at him and I said do u realize that AA can be equivalent to cancer pain? I said to him it is horribly painful at times and sometimes nothing works not even opioids. He just looked at me , no words…not to mention my pharmacy can no longer fill my scripts because “corporate” just suddenly decided after reviewing my meds that they can no longer fill them. But I learned through other pharmacies in my area that the DEA is auditing and saying no more out of state scripts…but when u mention the CDC Guidlines to most doctors and pharmacist they just give u this blank stare…they will not speak about it…Btw, are there any doctors standing up for us on any kind of level? I do not want to sound negative either and I will keep writing letters and speaking out any way I can but I feel we all must start to seek other types of modalities, supplements, treatments, so that can’t pull us by the nose or control us. In my eyes they are disgraceful especially to our soldiers that are making money for the government! There are no words for my anger and I know all of u as well! Great article!

  4. don at 7:21 am

    Correction, meant to say: This is an excellent article and I agree with Dave that item C, (not number 3 ) would cause most of these doctors heads to spin. Although step 3 is excellent ..

  5. don at 7:15 pm

    This is an excellent article and I agree with Dave that number 3 would cause most of these doctors heads to spin. What an excellent “direct action” for patients to take. Way to go Terri! (and the rest of your article is excellent, too! ) This university, hospital based and “shot-mill” “Pain Care” for profit has got to stop, the harms are growing daily from these non-FDA approved procedures and devices. It’s being hidden from the public. It is evident by now that most of this Guideline business of opioid reduction has been to maximize profits off the backs of patients with pain, no pun intended. (and the addiction industry) And if you are harmed there is no recourse. You will be dumped with no where to turn with the worst pain imaginable. It’s your body…you have a say in how you are treated… Don’t let them touch you! Just say no-(after you grill them with point C) !
    How did this business of injecting such a corrosive substance as cortisone into the sensitive spinal area? Common sense just says -nooooooo, not a good idea! There is huge pressure on the patients to do this type of treatment for pain now .. if they have no business it will stop being profitable..
    Loud, proud, and hands off my body! We won’t be your cash cow any longer!

  6. N ciancio at 5:41 pm

    Why are we not sending these comments to the new president ??

  7. dave at 8:03 am

    Well written article. And I like the c recommendation, in particular. But overall, this article is right for calling for direct action on these issues.
    There are numerous medical organizations and medical schools that support these recommendations- and letters refuting the evidentiary and moral basis for supporting Big Brother opioid policies and practices are needed. For they have vilified and invalidated people in pain- for their own selfish purposes without regard to how people in pain are affected.
    Presidents of Universities and insurance companies need to be confronted with their cruel orientation to people in pain. They are a proud and stubborn lot but because the basis for their orientation is so wrong- they can be overcome.
    The siege against people in pain is war by other means. People in pain are fighting back and I believe the reign of witches will end their spells dissolve and sanity and humanity will be restored to pain care.

  8. Matthew J. Smith at 3:02 am

    I am at a lost for words…… There are new articles, posts, blogs, and columns on websites, everyday , that I read about this problem, and yet the issue gains no traction within the National Media, and the millions and millions of chronic pain sufferers are resigned to the fact that no one else is listening….

  9. connie at 11:35 pm

    I agree with Charles. We need to present facts and leave politics out of it. Give the current administration time especially since they will be fighting an uphill battle without our political infighting! Make sure to tell your story every chance you get and try to educate people around you.It’s the only way we have any hope!

  10. connie at 11:21 pm

    Michael L sometimes parents try to teach personal responsibility and it just doesn’t work! I have two adult kids. One is extremely responsible the other I’s opposite and an addict. They were raised in a stable, loving home where personal responsibility was taught. The only difference is their genes because they were both adopted as infants. Some people just prefer the life of an addict. This has been repeatedly shown after MANY trips to rehab from short to long term inpatient treatment!

  11. Jean Price at 10:39 pm

    I have some tendency to believe if we could do better, we would do better! Advocating for ourselves is okay on days where we may have less pain and more energy…other days it’s next to impossible! Those other days seem to happen more often due to less pain medication for many! And this is part of the elephant in the room for all of us I believe! That’s why it would be great to have more support, yet we don’t seem to find it with the public, or in the media…places we have flooded with information, along with the various offices and agencies of the government. There are many groups dedicated to all areas of pain, yet no cohesive effort when we need one desperately to get the message heard…and then have action to improve pain care! Doing more of the same seems somehow futile, unless we can follow through and keep the heat turned up. Yet I have seen many gung ho people burn out from all their efforts and become ill or disillusioned with the process…before they could realize any productivity! I still believe ALL our groups must form a coalition for a power base, and sheer numbers and delegate areas of responsibility, by doubling those assigned TO ANY ONE JOB so things won’t fall through the cracks when someone has flare ups or more health issues come up! And we could sure use a nationally known spokesperson to carry our banner…and help us have the legitimacy we need to effect change! So much to consider…such a complex problem for all of us, And IM NOT AT ALL SURE WE CAN SIMPLIFY OR MAKE AN IMPACT BY OUR PERSONAL ACTIONS. IF IT HAS NOT WORKED SO FAR, WHY WOULD WE THINK MORE SPREAD OVER TIME WILL? Not trying to be negative, just realistic!

  12. Bob Schubring at 9:33 pm

    Title 18 of the United States Code, at Section 1091 defines a crime called Genocide, to be the attempt to destroy a group of people because of their race, ethnicity, or religion, and makes that crime punishable by a fine of up to one million dollars or a prison term of up to twenty years or both, except that if someone dies as a result of attempted genocide, the penalty is increased either to life imprisonment or the death penalty may apply, within the discretion of the court. At Section 1093 of Title 18, in paragraph 6, the word “race”, for purposes of Section 1091, is defined as ” a set of individuals whose identity as such is distinctive in terms of physical characteristics or biological descent”.

    We pain patients share a distinctive identity in terms of a physical characteristic. That characteristic, is that if we are denied the medicines we need to relieve pain, we become unable to function normally. Our loss of function can cause grave harm, including death. Beyond the shadow of a doubt, members of our race have died of these governmental policies. Also beyond any doubt, the genocidal government policies are being enacted with the intention of causing us to die. The CDC has had ample notice, by the public comment process, that it’s policy of imposing restrictions on the legal use of legal opioid pain drugs for treating chronic pain, is causing great harm to our race, including death. The fact that CDC is continuing the genocidal policies, after being warned of the consequences, can have no other explanation, than that CDC’s policy is intended to cause us to die.

    Our racial identity manifests itself when we present ourselves for medical treatment. Physicians live in terror of losing their license to practice medicine, if they give us legal and necessary medical care.

    While it is politically incorrect nowadays, to criticize the Obama Adminstration’s officials who created the CDC policy for racism,. it is necessary that we take this step. Our lives are in danger.

  13. Terri Lewis at 7:30 pm

    The references to USP should read USP797. USP757 is a keying error or an autocorrect with word or who knows what…

  14. Anne Fuqua at 1:58 pm

    Great Job Terri!!

    Also there is no FEFDonna,
    Would you add this to you your posts?

    There is NO FEDERAL DOCKET THIS TIME TO ACCOUNT FOR COMMENTS. It will be way too easy for the government to “lose” them.

    I’m trying to create a central repository for comments.

    PLEASE EMAIL ME YOUR COMMENTS SO WE HAVE PROOF PEOPLE COMMENTED.
    FuquaAnne@gmail.com

    If you want to remain anonymous, create a new email address. Use Google, Yahoo, etc and it should take about 5 minutes:)

  15. connie at 10:58 am

    This is a very informative article but I don’t see any medical practice being willing to inform you of their business practices! It may be our right to have access to that information but I see them just refusing to take you as a patient! The second largest city in Alaska has so few doctors willing to see a cpp even for a sore throat that if you find a doctor willing to take you as a patient you pretty much have to accept whatever crap they hand you or do without medical care of any kind!
    I also don’t know too many cpp that have the ability either physically or mentally to advocate for themselves at this level. It’s a nice idea but not very likely to be put into practice.
    I do appreciate the time and energy you have spent to inform us as to the latest stupidity being perpetrated on the cpp community!

  16. Karen Emerton at 10:24 am

    I had not seen the SWAG method cited in a long time. It is, however, exactly how I feel my pain has treated in the last 14 years. I have an Orthopedist who believes in surgery. If he can’t find something to cut, he has no suggestions. One personal physician believed in increasing Opiod levels until I stopped crying in her office. She discontinued her practice. My current PCP reluctantly prescribes Tylenol #3. It is minimally helpful. So I adjust my activities and suffer along. SWAG it is!

  17. Tracy Bryan at 9:44 am

    I’m sorry, The opioid addiction of choice is heroin , I give no credit to BHO who continued to allow the flow of heroin into this country, and changing prescribing regulations in 2014, even those in need for chronic pain turned to heroin for relief because of the inability to be treated legally.

  18. Angel at 8:57 am

    Just more government and business getting in between me and my doctor. Never is the patient the priority. Some of us suffer miserably ever single day because of these opioid guidelines. I wish long and painful disease to every single person who implemented the CDC opioid guidelines and subsequent denial of pain relief to the sick dying and disabled because only then will they grasp a fraction of the misery they’ve caused.

  19. MichaelL at 6:42 am

    The basic premise that seems to be guiding the present hoopla is that people, uneducated in medicine, can better decide how we chronic pain patients should be treated. Even worse, having been educated in treating acute pain, as a surgeon, I found it amazing that family doctors seemed to be ill trained to care for people in pain. Having been trained in chronic pain management, I find the great majority of physicians have been poorly prepared to care for those of us that suffer from, unrelenting,chronic pain.

    But, in this republic, we end up being represented by physicians in congress, who have little experience in pain management and those lawyers and politicians that think they know more than those of us trained in pain management. Sadly,the statistics, that show that 98% of people taking opiates for chronic pain never abuse our medication, are completely ignored.

    As you note, a large majority of the deaths from opiates occur in the heroin addict, those who abuse opiates laced with other drugs. The use of clandestine labs to produce the “Fentanyl” that is used in the black market heroin are responsible for the uptick in deaths related to heroin abuse. The black market is what is killing people. Make cheap opiates available for those dependent due to past abuse, and the death rate will crash. Add the increased availability of Naloxone to it, and the statistics will suddenly change!

    Lastly, why do people continue to abuse addictive substances. I learned 55 years ago, (as a ten year old!) that the abuse of the drugs can be deadly and addictive. Why are there idiots that continue to abuse. Sadly, the masses are blaming us chronic pain patient for the problem, when it is a lack of personal responsibility taught by parents! Make everything illegal and the deaths will continue. Try thinking outside of the box (something the politicians seem to unable to do) an the problem might be lessened. But, like the poor, the addicts will always be with us. We need to decide to practice harm reduction and develop a system that is attuned to helping the people with the medical problem of addiction. We do with alcoholics.

    But, the alcohol elitists would wish death to those addicted to something other than the alcoholics’ preferred poisons! I have a brother-in-law who is an alcoholic. He has “little use” for meth addicts. Hypocrisy is rampant, even among the addicts

  20. Virginia rzekonski at 6:09 am

    I found this article to be a bit of a joke. No one battling a disease or their families caring for them are going to have anything left to take the many exhaustive steps suggested by the author. Within the slightest chance one may be able to, the offices mentioned (such as the office for the aging here in NYS) are useless and merely more beuracracy. This author needs to put her pen down or be honest; death is inevitable now for those suffering with a chronic painful condition.

  21. Charles at 5:54 am

    I like what was said here but why “in a parallel universe” do people who have been on the job, that isn’t part of HHS have to do with the “guidelines or regulations that were created by people who were on the job for eight years! Taking pot shots at the current admin. that hasn’t been able to get it’s HHS Secretary put in place because of the thinking of the last admin. have anything to do with decisions that started before their admin. In office two weeks and lets attack them? That one part of this will do our cause more damage than could be done trying to work with them! I will support them until they, by action, do not fix a problem that was created by the last admin. It’s gonna take awhile! Just like the emails and info I have sent to The Governor of Texas about their Marijuana rule. I will hold them accountable if they do wrong. But I guess that “Bowling Green” should have happened! Then it could be the new admins fault too! Please give them time to do different. If they don’t, I will give them plenty of crap! Until then, please don’t kick the people we are trying to show now, how bad the decisions of the past have been!

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