Thomas F. Kline MD, PhD                                                    JATH                                                                    Carolyn M. Concia, NP

David John Williams                          EDUCATIONAL CONSORTIUM, LLC **                 Jaime James Sanchez

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                                                                                Pain Refugee Statistics

                                    DATA PERTAINING TO THE PAIN REFUGEE CRISIS

April 1, 2019

A crisis ten times the size of opioid epidemic has begun to occur and is worsening daily.  I am observing it with horror from my position as an independent chronic and rare disease specialist with more than 40 years experience and no ties to anything but my responsibilities to care for all of the patient, especially when suffering.

I have never seen a health care crisis develop of this magnitude without anyone seemingly knowing it is occurring.  I could never have imagined this happening within the United States of America.

The opioid crisis has nothing to do with office pain patients with one of many permanent, painful disease disorders.  Cardiac disease needs cardiac medication.  Painful disease needs pain medication.

On March 15, 2016 the CDC issued the “Guideline for Prescription of Opioids for Chronic pain” which started the cascade of disenfranchisement of potentially millions of legitimate innocent patients with very nasty painful rare diseases.

The “Guideline” has grossly interfered with the doctor-patient relationship by implying primary care doctors needed education in safe (read reduced) prescribing, as over prescribing by doctors was responsible for the opioid epidemic.  This is a terrible accusation and needs substantial establishment of validity before a federal agency would issue such serious statement.  To this date they have not provided the needed validity.  But regardless, the “Guideline” provided the accelerant for the wildfire that is actually getting worse each day as access to medical care for painful diseases is closing rapidly.

There are 10 million patients with painful diseases (Dr. Volkow)  such as:  Ehlers-Danlos, CRPS or Complex Regional Pain Syndrome, Adhesive Arachnoiditis from spinal injections, failed back surgery, Trigeminal Neuralgia, Chiari Syndrome of the brain being displaced, advanced inoperable multi-joint destructive disease, Central Pain Syndrome with Chronic Brain Inflammation (old title “fibromyalgia), pain syndromes following trauma, especially in Veterans with war wounds, Interstitial Cystitis, and about 25 more rare disorders.  None of these can be treated with Tylenol or with CDC “alternatives”.

No one has shown prescribing “too much” is the real reason behind the “overdose deaths” in street heroin addicts, a fact the CDC failed to disclose.  Of the 40,000 overdose deaths reported by the CDC 39,500 died from heroin addiction without medical care. None of the studies looked closely at Cause of Death, just association. Association may or may not be causal, which possibly could drop prescription overdose death rate in general population to near 0. Of 64 million people prescribed opiates 500 or less possibly died of OD.

In fact “opioid exposure” is like “demon exposure.”  It actually has nothing to do with genetically driven opiate addiction or Chemical Receptor Disease.  If it were true the $600 billion spent on substance control (CRS) would have worked by now.  The reason it has not worked and will not work is the pathophysiology of type 2 addiction or classical Heroin addiction is different from other addictions where exposure to substance is a factor.

Mass hysteria or Fear of Addiction Phobia has exploded pre-existing prejudices into a destructive mythology harming a large number of innocent bystanders – the pain refugees. This national fear is as bad or worse than previous fears of being possessed by the devil leading to hangings in 1692,  fears in the 1950’s communists in every walk of life,  fear in the 1980’s with “crack cocaine dope fiends” raiding communities in the 1980s, and the fear of catching HIV on every toilet seat.  

This mass hysteria is worse now, actual deaths are occurring from suicides to relieve pain caused by forcibly stopping effective, safe medicines.  Potentially millions of lives are being ruined people unable to function without proper treatment of the painful disease.  No one is counting these. No one really is seeking the truth.

CDC may say they didn’t really mean it that way, but they published a “Guideline” that looked much like a regulation when only the FDA has congressional authority to publish concerning any prescription drug.  I was and is taken with the zealousness of a real regulation – which it is not. Internally the “Guideline” does not discuss when to use opiates with the implication that they should never be used.

The “Guideline” is written as corrective actions for the wrongs of primary care doctors.  The doctors responded by stopping the opioid prescriptions as they did after federal narcotic police arrests in beginning in 1915 after the Harrison Act, a federal attempt to control pain medicines deemed by the police to be dangerous causing “highs’.  In the last three years two thirds of primary doctors have done the same thing – “send ‘em to pain management,” whatever that is.

CDC and their opioid avoidance consultants have tried to walk back the idea of forced tapering  in a futile and illogical attempt to reduce the heroin street deaths, a ludicrous, dangerous notion that cutting based on flawed thinking that back on substance exposure is what causes heroin addiction.  This is not true. It is doesn’t even make sense.  How can taking frightening sobbing people off medicines they know have saved their functional lives stop overdoses in street addicts.  There is something very wrong with logical thinking.  It sounds more polemic and it sounds policy based on fear of medicines for pain.

Whether the CDC regulations are valid is a moot point.  As a result of demonizing 50 centuries of the opiate pain medicine, and as a result of blaming primary care doctors, and as a result attempts to remove opiate pain medicine as the drug of choice, we have nearly annihilated the use of “God’s Medicine” in the words of Sir William Osler, father of Internal Medicine.

The following descriptive data is taken from my twitter following.  There are approximately 25,000 people in this group of chronic painful disease patients.  The data is sidewalk interview type data with those choosing to respond providing the data.  Each question had between 200 and 500 respondents.  This information is offered a beginning point.  We need to further define this serious and widespread injury to potentially millions of people.

The CDC was tasked by its Scientific Advisors to follow up to see if any unintended consequences were occurring. It has been three years.  No reports have been seen.  The unintended consequences of destruction of lives and suicide deaths remain unknown but until proven otherwise the estimate remains in the millions of American citizens, mainly women. These are people who did nothing to deserve being caught in the crossfire of opioid zealotry.  

Some facts:

1.  Ten million people in the US need to take daily opiate medication, of the 25.3 million with daily pain lasting longer than three months with 15 million already trying alternatives.

2.  Four different surveys, including my own Twitter poll indicate 60-70% of the ten million are being actively tapered off opiate pain regimens without medical reason.

3.  When asked why the doctors were tapering for no reason patients reported they were told it was due to the CDC and DEA.  (“I cannot lose my license over this, you will need to deal with your pain”)

4.  Fifty percent of the ten million with legitimate long term, incurable painful diseases are completely taken off medicines that should never have been taken away lacking a medical reason.

5.  Two thirds of primary care doctors have quit prescribing opiate pain medicine in the last three years

6.  Picking up the slack, pain specialists now bursting at the seams to help those denied access for their disease, are being raided by federal and state drug squads for “having too many patients”, and “prescribing more than any other doctor” – a crime I never heard of.  Punished for helping out.

7.  This data to follow is informal and should have been obtained by the CDC.  But, the obvious is not always an illusion>  Reading the stories of 28,000 pain patients makes me believe these these probes are more than likely portray the truth.

These statistics are from those patients who have been tapered down or off their pain medicines:

–After tapering 89% had more pain, 11% less pain or no change 302 12-27

–Sleep was worse in 92%  (sleep deprivation is a new secondary disease from tapering)

–70% were forced to taper against their will with their strong protestations and tears ignored

–Dependence or having withdrawl is pretty much the same as addiction. 18% yes 2-4 82% no

— 2/3 of patients require more than 90mg Mme per day (CDC never checked if 90mg would work)

      (FDA, the rulemaking agency for opiates has not recommended tapering and by law and regulations  has no maximum amount or dose)

–Those doing “fine” after the tapering  15%

–negative impact on parenting – 78%

–negative impact on sexuality – 88%  (78% stopped having sex altogether)

–negative impact on  social activities like PTA, church, civic activities:  57% stopped activities,  major reduction 36%, no change 3%

– -“big” problems with relationships – 92%

— weight gain 45%, weight loss 35%, no change 20%

–considered an addict for taking pain medicine- 50% said yes

–Flagged in computers as “drug seekers” – 43%

— agree or disagree with the statement made by opiate opposed doctors that long term opiate medicine is ineffective:  82% disagree

–Percentage of painful disease patients refused medication because they did not have cancer -69%

–Statement by CDC Director Thomas Frieden MD that “doctors are the cause of the opioid epidemic” – 82% disagreed

–Veterans: after two months off meds or tapered are you better for it? Yes better 13% worse 29% a lot worse 58% 112 1-17

–Antidepressant helped: quite a bit 9% maybe helped some 22% did not help 69%

Side effects of antidepressant: major 53% mild to moderatle 26% none 26%

–Do you know a vet: 12% no tapering 51% Stopped, 37% reduced 141 1-14

–Percentage receiving “adequate pain medicines”  17%

– suicide numbers – unknown.  CDC is reporting sharp rise in suicides especially in women.  About 70% of the population of chronic painful diseases are women, reflecting similar weighting in autoimmune disease.  CDC has not reported and data on why the increase in suicides.  It must be assumed to be related to pain so great as to make life  not a life until proved otherwise. One CDC person interviewed indicated the notion of medication tapering suicides said they were not studying this.  Google “medium suicides” for case reports.

–Problems filling their doctors’ prescriptions at the pharmacy -33%

–Major “life changes” – 68%

–Tapered off or down on pain medicines  but still doing “ok”    6%  94% worse

— Forced tapering without a say so-  76%

— tapering effects on employment- no change 3%, negative effect 36%, had to quit job 61%

–once tapering was found to increase pain and decrease functioning how many had their original doses restored- – 13%, 76% of practitioners refused to restore  to previous effective levels

— Percentage of “doctor shoppers” who are addicts – 40%, percentage who are pain patients -60%

— Percentage of patients currently looking for doctors but cannot find one— 65% (of ten million presumably)

CDC recommends using alternative, second line treatments first, not a standard medical practice I am familiar with..  Generally we physicians like to treat with the most effective first, back ups if the drug of choice fails.  As a result of the stampede to more expensive, higher risk and reduced effectiveness we asked several questions in each poll–

–Back surgery, was it “worth it”? – yes 23% , 77% no

–Neck surgery, was it worth it?  – 68% no, 32% yes

–Physical Therapy helped – 10%,  PT made it worse 43%

— Alternate medicines worked as well as the opiates:  5%  yes, 95% no

–Lyrica – effective in only 8%, noticeable side effects 72%

–Neurontin, side effects in more than half, worked in only 13% little or none 35% side effects bad 46% side effects minimal 6%

–Spinal Stimulators implanted by surgery, “was it worth it”? – no in 86% (40-50K dollars)

–ketamine infusions – effective in 50%  

–Morphine pumps “did it relieve pain”? – 50% yes, 50% no (30-50K dollars plus monthly fees, surgical risks)

–Injection treatments, “would you recommend to others with the same diseases?”  47% said no (high risk of addisonian adrenal suppression and adhesive arachnoiditis, a disastrous lifelong disease)

–Radiofrequency ablation, “was it worth doing?” – 79% said no, 21% said yes  (extremely painful and expensive procedure)

–of those without addiction how many felt euphoria when starting: 16%, euphoria later

–euphoria from gabepentin: heard of this? 24% yes 296 1-2

Most patients are referred to pain clinics.  The status of licensing requirements is unknown. People who no longer are treated for their pain by their regular doctors, traditionally the ones who treated pain prior to 2015, who now go to “Pain Clinics” are asked to respond on twitter polls.

Contracts, pill counts, urine-analyses were traditionally reserved for opiate addicts.  It is not clear why these methods are forced on the pain patients abandoned by their primary care practitioners.  They report the following:

–forced to sign addiction style pain contracts -80%  restricting what pharmacies to go to,  forced birth control, etc  one person committed suicide after an ER relief prescription was refused by the pharmacy due to restrictive pain control (google Medium Suicides)

–numbers reporting good care at the pain clinic- -25%, not so good in 25%, “terrible” care 50%

–Number of pain clinics not prescribing actual pain medication – 25-31%

–Number of pain clinics offering “injections only” – 41%

–Number of pain clinics refusing to prescribe pain medicines until patient agrees to injections first–34%

–Number of pain clinics prescribing pain medicine according to FDA guidelines- 18%

–Number of patients that were not sent to Pain clinics by their primary care and followed in the office for the pain treatment – 19%, with 63% were “referred out”

–50% have to pay $100-$300 for each pain clinic visit after insurance pays

–Forced to have addiction type urine tests  in spite of no one ever reported to addict already on pain medications with false positive and negative rates leading to discharge from pain clinic and labeling as drug seekers on EHR records damming the patient for ever in receiving pain medication for any reason.

–How many have problems getting your pain meds at pharmacies: at chain pharmcies 55% at independent 1% 115 sample of 15k 12-16-17

— repeating the poll in a different way: now many in general have had problems filling your prescriptions at pharmacies- 33% have had a problem 31% at chains 2% at independent pharmacies 225 sample from 15k 12-17-17

— “honestly now, pulling no punches do you believe over prescribing by doctors is contributing to overdose deaths Yes 18% No 82% 284 votes of 15k 12-22-17

–the CDC and PROP Believes long term medication continues to be taken after three months just to hold off withdrawal Agree 18% Disagree 82% 273 votes of 15k 12-20-17

–of you looking for new doctors to prescribe pain meds how many docs/np’s/pa’s have you contacted 1-10 34% more than 10: 9% eventually successful 15% still looking 42% 122 votes

–are you getting proper and adequate treatment for your painful disease? yes getting good treatment 21% No not getting adequate treatment for your painful disease 79% 175 votes 12-23-17

–Reactions by doctors and practitioners when telling you are going to be tapered against your will: neutral 41% vindictive 29% nice or sad 24% gleeful 6% 228 1-22

–How many of you have been denied pain medicine because you don’t have cancer 69% 251 votes

–Medical society with plan for board protection 23 votes 17% yes

In general painful disease patients are also reporting:

–34% take both benzodiazepines and opiate with no problems reported in  87%, problems in 13%

–Two percent report benzodiazepines work best to relieve pain, opiates work best 52% and the combination of benzodiazepines and opiates work best in 36%, with neither working in  10%

–Outcomes with opiate pain medicine:  89% reporting “good”

–Numbers of patients in the universe of twitter followers officially disabled from their painful diseases: 53%

–requiring more than 90mg MME for pain control: 63%

These twitter polls were conducted by JATH over the last two years.  Many of the polls were validated by other polls outside of JATH.  The polls cannot be dismissed by saying they were not properly done.  The obvious is not always an illusion.  Are these randomly stratified samplings – no.    This information is provided to issue an alert.

Opiate drugs have an addiction rate of 0.5% – a major side effect but which can be managed easily if caught early.  If each prescriber would merely ask their patients if they have ever had an opiate we would stop new deaths from opiate addiction.   With this simple question no more teenagers will die due to ignorance of the pathophysiology of opiate addiction and the different types.  There is no such thing as “addiction” or “drug abuse”, but there are types of addiction  which are very different and need to be treated differently just as we do with the two types of diabetes.  

If the answer to the critical question “ever had a pain killer before” is YES the person will never opiate addict.  If the answer is NO they will have < 1% change for genetically determined opiate addiction.  The prescriber needs to warn “no” patients to report back if they have other than a sedative effect from the narcotic especially if they “go on a magic carpet ride”   If they do,  they have opiate addiction disease, type 2.   They need not seek out heroin and die.  No new cases of addiction need to die.  Ninety percent of opiate addiction occurs in teenage years.  Why? – First exposure.   Opiate addiction differs from other forms of addiction as it is triggered by the hidden propensity for immediate addiction.  This is why the news stories report the addiction from the doctors prescription – first exposure, not “substance exposure”.  

Thus identified, the patients can be medically treated in the office. Opiate addiction is serious side effect, but it is not fatal like many serious side effects of other prescription drugs.  We need to ask more about the facts of the two types of addiction and why they are different.  We cannot apply one solution for both.  This is where the mistakes have been made, and money wasted for 100 years.   We need medical facts, pathophysiological facts before we subject millions of people to the withdrawal of medical treatment without rhyme or reason.   It is their choice to take the risks or not take the risks, not the government, not doctors cowed into harming their patients, not the drug police.

Of any new idea,  Einstein said that some things are easy to understand but hard to believe.  This is offered in that light.  I have seen it.  Heads are in the sand. A nationwide tragedy  is really happening on a scale no one could ever imagine.  

Thomas F. Kline MD, Ph.D

Chronic and Rare Disease Specialist

Raleigh, North Carolina

Web: thomasklinemd.com

Email: thomasklinemd@gmail.com    Intelligent discussions are welcome

**JATH Educational Consortium LLC is a Raleigh based research group providing unrestricted data to the medical community and the general public for policy making and improvement of medical care