THE OPIOID REFUGEE CRISIS: Caused by FEAR OF ADDICTION PHOBIA and RECOMMENDATIONS FOR MITIGATION

JATH EDUCATIONAL CONSORTIUM, LLC**

Erin O. LeBlanc, Thomas F. Kline

11–8–18

Beginning in the spring of 2016, unintended consequences of the CDC Guideline for Opioid Prescribing began — the Opioid Refugee Crisis, a crisis of failure to provide medical treatment for 6.5 million Americans with long term painful diseases.There are four principles in this catastrophe : The CDC, the DEA, Doctors themselves and the Pharmacies).

The driving force behind the four causal factors in the pain refugee crisis is the resurrection of the Fear of Addiction Phobia (FOA. A phobia defined as a persistent, irrational fear of a specific object, activity or situation that leads a compelling desire to avoid it”. Long standing irrational fears of dangerous, unpredictable, and crazy “dope fiends” now including anyone taking these “mind altering drugs”, for any reason, including medical need.

The Fear of Addiction (FOA) began at the turn of the century from fears of immigrants, enslaved African Americans, and especially Chinese Opium den operators being responsible for loosening the sexual morals of white woman visiting the dens.

Hamilton Wright MD, the first opioid commissioner said in 1910 “one of the most unfortunate phases of the habit of smoking opium in this country is the large number of women who have become involved and were living as common-law wives or cohabitating with Chinese.” In that same year, while testifying before Congress he said African Americans “would just as… rape a woman as anything else and a great many …cases have been traced to cocaine.” Dr. Wright also said The United States consumes most habit-forming drugs per capita. Opium, the most pernicious drug known to humanity has fewer safeguards than any other nation in Europe. As of physicians he says Our physicians use it recklessly and have become responsible for making numberless dope fiends. if opium were rightly safeguarded in the US 10% of all druggist would immediately be forced from business and many a complacent doctor willing to prescribe the drug would find his practice a mere detail of one of the worlds most vicious habits dwindling quickly into nothing. We are literally the world’s opium feeders.

We may have forgotten how FOA became woven into our cultural fabric but the glowing embers of the original fear remains and as irrational as ever. We have made rules, laws, and arrests for 100 years to destroy the beasts of this moral turpitude, the dope fiends and those who feed them — the dope prescribing doctors.

FOA suspending reason, critical thinking and science is currently destructive for two thirds of the ten million people identified by NIH as needing long term pain medicines for their rare and unusual painful diseases. These are all legitimate diseases without cures, only with palliative treatments available. 95% of the time the only effective relief they can find is from the only effective and systemically safe medicine successfully in use for 50 centuries — the opioids.

This FOA phobic person falsely reasons exposure to any opiate for any length of time will lead to the greatly feared addiction. The inconvenient medical facts show exposure to opioids will only addict 0.5% of the population and only if those people carrying the genetic propensity for opiate addiction. It is difficult to replace the theory of opiate exposure as the cause of addiction with scientific facts. These are currently being rejected out of FOA, “no, no, that’s bull, we know what causes this, doctors and “heroin pills” a term describing pain medicines quoted from the PROP (Physicians for Responsible Opioid Prescribing) and former CDC Director Thomas Frieden.

Opiate exposure as the cause of addiction is a good example of the irrational fear definition. Only a small fraction of people will ever become addicted (in spite of “way too much opioid prescribing” the per capita addiction rate is holding steady at 0.5% as it has for 100 years) We are punishing 99.5% of Americans with acute or chronic pain who will never become addicted. A much larger percentage of people can become addicted to marijuana, sedatives, amphetamines, and cocaine, but in a different way. It is still “addiction”, and the brain still is involved, but without the hard wired genetic mistakes in the mu opioid receptor where our own endorphins provide us with pleasure, an essential ingredient for survival. If women did not have a huge internal opioid, or endorphin surge following childbirth women would quit having babies.

We will call addiction to things like marijuana Addiction “A”. In the “A” type the addicted person can stop with treatment. People with Addiction B (opiate addiction) cannot stop. It is the nature of the disease so consistent it generates the types (Addiction A vs Addiction B). Actually with the 0.5% genetically driven rate of opiate receptor disease addiction (“junkies”) leaves 99.5% of the population safe from opiate addiction no matter the dose, type of medicine, or how long it is taken. Not understanding there are two type of addiction just like there are two types of diabetes will continue to lead to terrible mistakes like the pain refugee crisis we are currently seeing, with ruined lives and lives taken just to stop the pain. Ignoring medical science always leads to trouble, it already has for 6 million people unjustly harmed by forced tapering of medicines necessary for treating 30 or so rare diseases.

The CDC.

The CDC created this crisis when they, without regulatory authority, and for the first time in the history of medicine, attempted to limit dosage of all opioid (opiate, narcotic) pain medicine, disregarding medical textbooks and decades of clinical experience.

We have, yet again, ignited fears of addiction and overdose death, reminiscent of the great sweeping fears of the Eisenhower, Nixon, Reagan, and Bush Wars on Drugs. This war is different. Now we have significant non-addiction casualties with 6 million pain refugees as collateral damage from failed government programs and increasing, palpable Fear of Addiction (FOA) creating the worst health care crisis in American history. The unprecedented, forced loss of treatment for people with serious, lifelong, painful diseases is appalling, especially when measured in lost years of life. In my 40 years of practice I have never seen nor imagined anything this cruel — especially not for a “medical reason”, all out of fear of being possessed by opioids.

We are at the 100 year mark now in the ongoing War on Drugs and one trillion dollars in wasted taxpayer expenses, all while not preventing a single case of addiction. We see addiction disease as immoral, wrong choices, a characterological disorder worse than organized crime, murder or smuggling. We are talking about the “dope fiends”, the scary, worst of the immoral worst. These people must be stopped at all costs, no matter what it takes, ersatz lynchings, torture, and labeling of sick people as a danger to society.

The unreasonably intense fear is still alive, still shrouded by negative stereotypes, an easy button to push for frightened politicians trying to deal with what is in reality a medical disease, a disease we physicians are not allowed to treat unless sanctioned by the federal drug police. The federal government has become the doctor, and has done a poor job. No one believes the 5 Wars have been successful yet we are starting another one just the same. The same failed policies as though we all had historical amnesia. We would not have a “crisis” today if federal policies of interdiction and prohibition worked.

Fear of home invasions, murders and rapes by “crazed fiends” lives on. In fact, violent crime, home invasions and other like crimes are rare in people addicted to diamorphine (Heroin). No psychoses are induced with opioids, only cocaine and amphetamines, drugs we never hear about, only doctors being arrested for prescribing opiate pain medicine.

The fight has historically been lead by one or two moralists at each juncture in our history, highly effective in espousing their firmly entrenched beliefs of purity and control. Cotton Mather was first in 1692. The suicides over the past two years due to lack of pain treatment are no different than death by hangings in the early 1600’s. Both are 100% morally driven and 100% preventable. In the early 1900s a physician, Dr. Wright, led the crusade against immoral behavior of opium users and influenced the passage of the first “control” act, the Harrison Act of 1915, a racist act, not a medical act.

From 1930 to 1962 the War was led by Harry J. Anslinger, Chief of the Federal Bureau of Narcotics under five presidents. Anslinger became a disciple of demonizing drugs after a personal experience as a young man frightened him and turned him into a lifelong crusader and liar. Anslinger ran campaigns against drugs on radio and at major forums. His view was clear, ideological and judgmental: drugs are dangerous, they can only lead to insane asylums and crime, a falsehood he created. It worked, Fear of Addiction is a powerful force for doing the wrong thing. Anslinger was a marijuana narcotic crusader whose new racial and political enemies identified with particular drugs. Nixon later associated cocaine with activist African-Americans and marijuana with hippies and left wingers using the Anslinger model.

Anslinger got his way. FOA swept the nation, as it does today. Federal laws were passed, and states were pressured into passing similar legislation he recommended. His thirty years left an indelible stamp on our culture, popularized in 1936 with the movie Reefer Madness, funded by a church group expressing their moral outrage with drugs. Of course, Anslinger quietly produced the film for the United States Government without being mentioned in the credits.

We have a current moralist group carrying on the work of Wright and Anslinger: The Physicians for Responsible Opioid Prescribing (PROP), an oxymoronic name belying their actual function, the leaders of which are Jane Ballentyne, MD and Andrew Kolodny, MD. One of their co-conspirators is Thomas Frieden, MD the previous director of the CDC who lied as Anslinger lied, saying “Overprescribing opioids — largely for chronic pain — is a key driver of America’s drug-overdose epidemic.” This was his main lie. CDC already had undisclosed data that for 5 previous years the prescription rates were already dropping but the addict’s overdose death rates were climbing even faster. That disproved the central thesis of Frieden, Houry and PROP thus it was not discussed, a dishonest thing to do to prop up their extremist and dangerous medical viewpoints

PROP members were hired by the CDC and played a critical role in the disastrous CDC Guidelines for Opioid Prescribing in Chronic Pain of March 15, 2016, a job CDC was not entitled to do. PROP is “bordering on lunatic fringe” as one ex FDA Official put it, a man previously in charge of consulting scientists at the FDA.

Beginning in 2010 PROP physicians (without backgrounds in primary care medicine) began to spread the rumors that physician prescriptions were causing an “epidemic” rapidly sweeping though American society by way of “heroin pills” (pain medicine) causing rampant addiction and death for anyone taking them.

They falsely reasoned since no research was published (actually not true) showing opioids worked for long term pain, they must not work and need to be reduced or stopped. This is like saying we know penicillin treats strep throats so why bother to do a study. Using PROP logic: no study has been done to show penicillin works for strep throat and since some have allergic reactions, better ban it “to protect society” from allergic reactions and-use power of thought and gargling as first line treatment.

PROP, the group espousing the unproven dangers of routine physician prescribing of pain medicine, believes people should learn “to accept” pain and “move on with their lives”. This is not a position shared by other countries, by the United Nations’ policies of treatment of all pain, nor views of experienced primary care clinicians Denying pain exists and therefore does not need the centuries old opioids is a philosophy not held by any physician I have known, and certainly not by me.

The CDC is not in a position to try to write or even suggest new guidelines for opiate prescription, in spite of their weak protestations it was not their intent to force tapers and they were “voluntary” (mentioned once in the “Guideline”, pg 9). If this is true, then prosecuting under voluntary “suggestions” is outside legal reasoning.

You throw a match out the window and start a forest fire, you are responsible. The Bart Simpson defense of “I didn’t do it” won’t work. CDC knew what it was doing in usurping FDA’s role and knew the horrible outcomes (suicides as pain relief, loss of jobs and basic functions) in people who really do need this medication. The police weapon is the morning paper headline: “Dr. X under federal investigation for drugs.” This has caused more than half of doctors in the US to give up prescribing pain medicine for any reason, even though most of the physician rounded up are not crooks but regular office doctors accused of “prescribing too much”. All this pain despite there being no maximum dose of opioids by the FDA (The only agency mandated by Congress to make rules about opiate prescribing. Things have gone off the rails, with serious harm ensuing, including the ever-expanding suicide list (Google “medium suicides”).

The FDA is the only regulatory agency authorized by Congress to advise, change, and regulate all prescription drugs including opioids. The FDA is in charge. CDC is the interloper. CDC wants to limit all pain medicines out of FOA Phobia. The FDA has said all along opioids can be titrated or given slowly to the effective dose without dose limits, so CDC was trying to rewrite the FDA’s drug guidelines without Congressional authority to do so. No agency can do that without petitioning the FDA. PROP petitioned the FDA in 2012 and was turned down flat (FDA 2012-P-0818). These same scientifically discredited notions of limiting pain medicine dosage and use were carried forth into the CDC Guideline without blinking an eye.

Did CDC report more addicted “dope fiends”? CDC reported what sounded like an epidemic proportion of “prescription opioid overdose deaths but there was no mention of addiction increasing, because it was not increasing, but staying the same per capita as always. Ignoring the facts moralists like PROP and outspoken politicians ignited the old fears of addicted people on the increase confusing “increase” in overdose deaths from increase in addiction, two different things. The image of “fiends” ranging the streets, hiding behind dumpster and breaking into homes and doing God knows what can all start with “one doctor’s prescription”. True the rare genetic mu opioid receptor disease can be triggered by just a few opiate pills only in those with the genes.

In fact addiction is rare. CDC is reporting a overly generous figure of 2 million “addicted”people per year. If you divided the 2 million by the population over 16 years of age of 260 million one gets addiction prevalence rate of 8/1000. Ninety percent of addiction occurs in teenage years, (not from prescriptions but mostly from illicit supplies while “partying”). After subtracting out the 90% already addicted this leaves only one person out of 1000 beyond high school age left to addict. True, this opiate naive person can become addicted by triggering the genetically modified brain receptors. But, it is easy to prevent this addiction. Just ask if opiate naive, and if so be careful and report any excess “magic carpet ride” sensation. No more shooting up on the streets “junkies” and “dope fiends” if we add real education of the public.

What are the facts? Do we have a crisis? Do we have an “epidemic of prescription drugs” (by the way, all drugs on the street are “prescription” type except diamorphine or Heroin, and only 20% of the pills are from doctors prescription pads and usually for someone other than they who swallow the pills. CDC data is not categorized in a way that “increased prescription opioids” can be claimed. It is claimed however. Someone needs to look into this, as it set in motion the worse medical situation in my 44 year career, including a number of medical policy related suicides.

CDC reported an increase of 1/100,000 deaths per year, virtually all in addicted persons. This is not a large number. In fact it is minute number less than deaths falling or choking; certainly not an “epidemic numbers” coming from the official contagion epidemic declarers. They know better than this. What is going on?

The fallout in just 18 months since the CDC Guideline is leading to more expensive “injection treatments, more unnecessary ER visits, spinal stimulators at $40,000 a crack, people driven to more surgery in a desperate attempt to stop the pain. More expenses are occurring with more physical therapy as an alternative, potentially more nursing home placements with loss of functioning, more disability applications having lost functions and loss of employment. More expensive and often ineffective “injection treatments” by anesthesiologists several of whom worked on the CDC Guideline to eliminate pain medicines the other way to control pain. Expensive Implantable morphine pumps injecting morphine into the spinal nerves is driving up costs and are rarely as effective as than taking enough pain medicine by mouth. No one to my knowledge has performed a cost analysis of what the CDC “suggestions” have cost. Just from listening to the 25,000 pain disease patients on social media I would image the CDC’s suggestions to try everything else first (a very bad and dangerous medical principle that can leave people with chronic pain for life) so that is what the healthcare profiteers wanted to hear, the government recommends you do these things first to avoid demon opioids, as they call them (pain medicine is the proper term as things like fentanyl, tramadol are not technically opioids. They are opioids but not opioids).

The question never asked of the sole proponent of pain nihilism, PROP, is “exactly who can receive a properly titrated dose of opiate pain medicine for long term use”.

Two thirds of the 10 million people in the United States are now being tapered down or off their pain medicines following the opinions of the CDC consultants, many PROP zealots, and their admitted comment that the recommendations were not based on science, only opinion. No warnings were given, it was rushed to the presses while under a cloud of concern by Congress, the Washington Legal Foundation and the Cancer Society. This occurred while in the background the legally mandated FDA policy was to titrate to effective level remained the “law of the Land” for doctors.

The agency in charge of health policy, the NIH did not agree with CDC figures which can be seen by “googling” {NIH overdose deaths, 1–17}. The third chart reveals there as been no increases in “prescription opioid deaths in 6 years. Someone is fibbing.

The DEA

The newest round ups of physicians not measuring up to the DEA’s medical standards is no different that the ones in 1915 and the early 1930’s. These witch hunts have been consistently created by laws made to satisfy a frightened public and public representatives bent on saving the virtues of those attacked (or potentially attacked) by “dope fiends”, a new criminal class on a par with violent crime perpetrators.This myth is so frightening that no one asks questions when DOJ crows about rounding up 160 doctors. Keep in mind that previous statistics showed DEA revoking narcotic licenses of 35 doctors per year in the few egregious criminal doctors selling drugs for money.

A law enforcement agency should not set standards for the practice of medicine. America is the only place I am familiar with that does this. My daily practice is hogtied by police regulations limiting what, when, and where I can prescribe. The most amusing outcome of this is “doctors in the United States prescribe more than any country in the world”. This is actually due to an interfering DEA regulation stating I cannot write for refills on narcotic prescriptions for three months, I have to write three separate prescriptions! The director of the CDC during the disaster of the “Guideline” writing was Dr. Thomas Frieden who blamed the “opioid epidemic” on doctors writing too many prescriptions. Dr. Frieden was well aware of the DEA rule forcing doctors to write these prescriptions inflating the numbers but never mentioned it as a confounding factor to the crusade led by himself against practicing doctors in the U.S.

Federal drug police now have powers by the CSA (Controlled Substance Act) to arrest anyone who steps outside CDC recommendations in spite of the agency having no standing in the matters of prescriptions drugs. The DEA not only sets standards and protocols for raiding and prosecuting doctors, they have paid for the process of “red flagging”, a process that is based on questionable science at Brandeis University to ferret out doctors who are “feeding addicts” with more “dope”.

The fear doctors have is reinforced by the DEA, unwarranted raids for records and real criminal charges for “prescribing to an addict,” saying you “should have know they were dealers”, and “you caused the death of someone taking one of your prescriptions.” Sometimes the DEA even traps doctors with paid informants. Obtaining voluntary surrenders can lead to bonuses and can be used as metrics for funding. The DEA revokes 25 licenses per year from real criminals but “accepts” 600 surrenders, many without due process, e.g., no Miranda style informing of rights.

Raids on offices sometimes with, flak jackets, multiple agents and local police, timed for early in the day to catch offices filled with patients presenting “administrative subpoenas” without judicial authorization, terrorizing staff, demanding to look at patient records, threatening doctors with long prison sentences and trials unless they “surrender” their DEA narcotics licenses. These raids are frequently just to obtain medical records, the right of any agency if you do business with the federal government. Other agencies send a letter of request. The DEA sends swat teams and TV cameras.

The unwarranted DEA raids to obtain medical records are contributing to doctors leaving their opiate prescription pads in the drawer telling patients to go elsewhere for their pain medication. This is occurring in about two thirds of the 9 million patients part of the 25.3 million member group with daily pain, but who cannot control their pain with exercise, Tylenol and tai chi as recommended by the infectious disease specialists at CDC. These 9 million people need medical treatment with opiate pain medicine and have been getting them without addiction or side effect for years. Not any more. The consequences are unimaginable to this physician

Doctors

Thirdly, the crisis has been created by physicians themselves abandoning tried and true pain medication methodology and abandoning the patients themselves. What suddenly changed? It was the CDC meddling in the practice of medicine (forbidden by federal law (42 USC 1395)).

The “opioid” crisis boils down to this: imagine the worst pain you have ever had and then imagine the relief pain you got with pain pills. Now imagine the same pain every day for a week, a month, or a year and the same relief afforded by the same pain killers. Now imagine your doctor calls you into the office and says you can no longer receive your long term pain medicine, even though safely prescribed for years, because the CDC/PROP guideline writers say you will become addicted or someone else will become addicted with these “heroin pills” floating around in medicine cabinets and purses.

Many doctors are saying: “I just can’t risk losing my license over this”. There is a growing list of people denied pain medicine for no medical reason other than the “CDC told me to do it”, or “the DEA will close my practice”. So you leave the office without hope of ever returning to a functional level and living with serious daily pain, day and night, unable to get up off the couch to make your kids lunch, have sex, or leave the house. These things have been replaced with hours in bed after trying to work in the garden. This is the worst thing about pain medicine nihilism — lose of daily function.

Everyday, normal medical patients,with pain not of their own doing, are hitting the streets in large numbers looking for doctors, which most will not find. The are panicked. The relief of pain is a strong driver. Imagine you are in the same boat. Eighty percent of patients with painful disease are women. They dress up, put on makeup, rehearse what to say or not to say on advice of friends and nervously get ready for the talk with the doctor, if they are lucky enough to get in the door. Ironically many physicians take the view “you look so good, how can you have this much pain”. If they came no make up, hair stuck out, back yard clothes the response would be “you look like an addict”. This is unvarnished ignorance at its best.

The dash to eliminate treatment of all pain is Kafkaesque. Emergency rooms won’t treat people with pain medicine. You can no longer expect pain medicine (“opioids’) after your surgery and no more renewals for your long term diseases. All of this to avoid addictions (less than 1 in 1000), and overdose deaths (only in heroin people). Does this make sense? As one granddaughter reported: taking away my Grandmother’s twice a day Vicodin for her arthritis, so now she can no longer get up out of her chair and make it to the bathroom. Is this to prevent some addict (addicted person) from dying on the street?” “The yoga exercise sheets they sent are not helping”

This happened to physician I know in Tennessee with a rare disabling arthritis, no longer able sit at his microscope in the pathology suite triggered by mandatory pain medication cut off by a Catholic hospital corporation owning and controlling the attached primary care physician group). He applied for and was granted a social security disability pension and rues the day he had to quit his profession that he loved.

Some practices and even hospitals are putting up signs saying they don’t treat pain disease or we don’t prescribe “opioids”. According to two independent social media poll 65% of patients with pain are abandoned and are looking and not finding new doctors. That’s 65% of 9 million patients with painful disease already on pain medicine, not to mention the millions that will be denied in the future.

For those being treated, 80% say they are not getting the proper dose that used to work just fine without side effects. This far more serious than being reported. Patients with pain who do not want the return of their pain are not outspoken for fear of losing any pain medicine that the doctor is reluctantly prescribing since it is “against the rules”. There are no rule, read CDC mea culpa following the publication of the “Guideline” March 15, 2016.

None of these 9 million on long term opiate medicine will become addicted. There are no case reports of someone already treated with opioid medicine becoming addicted. Once you have been on, even a small amount of opioids and not begun seeking more, you have passed the test, so the 9 million people with valid medical disease would be fine at any dose, with any medication weak or strong for any length of time, even years.

Since no one on long term pain medicine can become addicted or “overdose” (another fear myth) why are they being taken off their previously prescribed and previously effective pain suppression? If you take pain suppression away and allow the pain to be recreated, you are in the same position as the methods used for detainees in military prisons with pain creation. There is no difference in pain, whether it be cancer pain, pain from 30 or so uncommon diseases. Science does not support the theory of denying pain medicine to those with long term disease “because they don’t have cancer”, yet another myth to get everybody off opioids even “if forced” say the PROP zealots.

These medicines were working fine and without side effects. The reported abuse, name calling, and humiliations on the part of doctors, emergency room personnel, nurses, and pharmacists is shameful. Doctors are reporting 40% of their pain medicine prescriptions are being unilaterally denied at the pharmacy counters. People are ejected from emergency rooms. Patients who dare kvetch about having no pain medicine after surgery are told “you can manage your pain yourself.” The Attorney General (who is not a physician) suggested aspirin. FOA is so intense that the thought of relieving someone’s pain after a car accident or after surgery is tantamount to potentially setting loose millions of dope fiends into communities. This is a carbon copy of the fear of setting loose millions of communists about to take over the government and enslave everyone in the 1950’s.

Forced tapering by doctors is the disease, not the taking of pain medicine. The CDC used the word “tapering” 43 times in its “Guideline”, and proper use of opioids or “indications” only once. The word “overdose deaths” was used 142 times without the very important disclaimer that the overdoses were occurring in the addiction community not in the general population.

Very few physicians will take more patients discharged from other practices fearing the label and increased scrutiny of being a “pill mill”, so the problem escalates. The real criminal pill mills in Florida went on for years. Where was law enforcement? Pills were handed out by the box. Everybody in the opiate culture knew what was going on. Drivers with out of state license plates took hordes of pills to rural areas in NC, KY, and TN for resale.

After closure of the criminal storefronts, pills in the rural areas dried up, the addicted people found heroin, as they always do when a more suitable opiate is gone. The “rural crisis” was born. Facts have not been presented as to whether more addicted people were involved or just the expected increase in deaths for those already addicted but now resorting to unmarked, impure “bags” — always a setting for accidental overdose deaths. Addicted people do not want to die, they make pharmacological mistakes, which we do not help them with, “they deserve it”. When using pills for the addiction, the milligram dose is known, not so for diamorphine/Heroin.

Extra federal prosecutors have been added to find doctors that prescribe “a lot” of opioids since doctors prescribing opioid in general are the newly discovered cause of the 100 year old “drug epidemic” starting in 1923 when diamorphine (Heroin) an important pain medicine was made illegal by the US Government for moralist’s reasons. Now the doctor prescribing to many patients with pain automatically becomes a “pill mill”and soon see lights flashing outside the practice.

To reverse this epidemic of ignorance and fear four areas need to be addressed to stop to the Opioid Refugee Crisis:

We need low cost, aggressive, grown up educational programs with real facts in high schools and communities. If we catch the triggered addictions in 4 students in a 1000 student high school, we should be able to control addiction completely, cheaply, and without injuring 6 million people and causing suicides by trying to take away the substance.

CDC

  1. Clarification on the population descriptions studied. It appears 95% of the data is coming from addicts who overdose and die.
  2. Discuss the science of applying conclusions from one population base (addicts) to a different population base (medical patients receiving legitimate prescriptions in controlled amounts).
  3. Present follow up data on “unintended consequences” of the Guidelines as mandated by the Scientific Counselors in their report of January 2016.
  4. Any and all medical education on the topic of pain medicine must come through the FDA REMS system (the Congressionally mandated agency for monitoring prescription drugs).
  5. Current medical education designed by CDC must be reviewed by outside Medical Education specialists to be sure the data from deaths among street addicts is not being applied to the general population (as was the case when I took a CDC Continuing Medical Education video — which due to inaccuracies I stopped and voided my CME certificate).
  6. Collate and publish in MMWR all CDC statements subsequent to March 15th, 2016 explaining what was actually meant by the “Guideline” intents.
  7. Explain FDA is the regulating agency for opiate pain medicine and practitioners may prescribe any amount opioid of any medication they deem medically necessary, watching for side effects.
  8. Explain the data CDC has collected on suicides listing how many were due to pain medication reductions.
  9. CDC needs to present the data from the FDA review of opiate prescribing limits (FDA 2012-P-0818) in which all the proposed restrictions on opiate prescribing were found unsupportable by the FDA reviews and why these findings were not honored in the the final draft of the “Guideline”.
  10. Explain whether CDC data indicates true opiate addiction is increasing and explain that Opioid Use Disorder is not classic opiate addiction.
  11. Explain the science behind the now infamous and harmful “90mg” cutoff.
  12. CDC needs to address the question of why the “Guideline” was designed for primary care practitioners, apparently excluding all others?
  13. CDC needs to explain why they regard their recommendations as of “low scientific validity” yet published them in the “Guideline” based only on the opinions of selected consultants many with histories of unusual and outside general medical practice.
  14. CDC needs to explain why meetings were held in secret and the plan was to publish the “Guideline” without public hearings.
  15. CDC needs to explain their position, as espoused by Thomas Frieden, then Director of the CDC, that “Overprescribing of opioids — largely for chronic pain- is a key driver of America’s drug overdose epidemic” is tenable given the number of prescriptions is (1) inflated by the DEA rule that three separate prescriptions must be written where other countries allow one prescription for three monthly refills and (2) the CDC already had data in their hands showing that prescriptions had been falling for 6 years prior to the “Guideline” and the deaths were accelerating — a serious inconsistency unpinning the mass forced reduction in treatment plans for 6 million painful disease patient — the pain refugees.
  16. The word voluntary is buried one time in the text of the “Guideline.” CDC must reinforce this and explain that voluntary implies non binding with binding regulations coming only from the FDA where no maximal dose exists.
  17. Deborah Houry, MD, head of the section producing the “Guideline” said “today we know that he serious and fatal risks of opioids (for chronic pain) far outweigh the uncertain benefits.” Dr. Houry needs to explain “uncertain benefits.”
  18. Until proper studies, (not unethical controlled trials which would not pass muster with ethics committees, the lack of which prop up the the main assumption of “uncertain benefits”) are performed such as descriptive studies by survey methods are completed no governmental medical policy should be released.
  19. A resumption of the House Committee on Oversight and Government Reform query into the activities of the CDC under Thomas Frieden MD, Director as to the authority for issuing medical guidelines on prescription drugs when the agency is not tasked to do so.

The DEA

  1. Suspend all administrative raids on doctors offices conducted without probable cause and substitute requests for needs to auditing medical records with certified letters (as does CMS when auditing medical files).
  2. DEA must provide Miranda type disclosure before attempting to have the practicing physician surrender their DEA license.
  3. Patient records removed from the practicing physician’s office disrupts medical care and the doctor-patient relationship. Doctors are not drug cartels who would shred the documents. Copies of the records except in probably cause arrests would suffice and protect the medical care for patients who suddenly have no medical records
  4. CDC, FDA, and DEA need to make it clear that there are no prescribing limits of opioids and investigations on this premise will cease for legitimate office doctors in legimated medical practices. If a physician is prescribing too “too much” it is a state matter of medical practice.
  5. DEA needs to make it clear practitioners will not lose their livelihoods capricious.
  6. Set up internet communication with all licensees to make it clear what will cause DEA police actions and as important what physician activities will not lead to police investigation, raids or prosecutions.
  7. Set a precise legal definitions of practicing medicine for outside “ legitimate purpose” that involves law not aspects of medical practice such as co-prescriptions, amounts of pills, amount of individual medicine dosage.
  8. Provide proof to Congress that restricting the manufacture of opiate pain medicine, 95% of which goes to the treatment of pain, does not harm the medical patients and show that the restrictions have led to a reduction in overdose deaths and addiction.
  9. No physician should be investigated by the federal drug policy for “prescribing too much” since there is no definition by FDA nor by legal precedent of “too much.”
  10. DEA and CDC need to issue a joint statement that the 90mg cutoff is for first time opiate use only and is a voluntary suggestion.
  11. DEA red flags originating with the Brandeis PDMP training center must be validated outside the DoJ contract.
  12. The principle of “should have known” to prosecute physicians for patients who sell their prescriptions is said to be based on DEA regulation 21 CFR 1301.72 to .76 needs review as it appears this does not actually apply to practicing physicians who do not have opiate dispensaries on premises, which is rare. Physicians are prosecuted for failing to do criminal investigations on their patients when the patients end up selling their prescriptions. Physicians are not law enforcement and the presumption they are would destroy the doctor patient relationship of trust. The principle of “should have known” requires the physician to detect future criminal behavior of their patients at a 100% rate, a rate not found in law enforcement itself.
  13. When a physician is accused of causing a death with his or her treatment then full autopsies must be performed, not just blood tests, along with a forensic investigation plus a “psychological autopsy” to prove “beyond a reasonable doubt”. Accusing a physician of manslaughter is a serious matter. Blood tests alone are not appropriate. This full investigation would be performed to support the premise doctors needs to be proven guilty like other defendants, to rule out death from other causes. A person dying with my prescriptions on board would be expected to have blood levels of opioids if they are following my instructions and then die from a heart attack.
  14. Work more closely with the addiction community with immunity for minor CSA infractions to identify sources of fentanyl.

Doctors

  1. Physicians will not respond the new Opioid Refugee Crisis without new update information from the same sources that have caused the pain refugee crisis. (see above)
  2. Need to stop accusing people in pain of being doctor shoppers, addicts, and people using poor choice. This is cruel and legally risky.
  3. Forty three percent of doctors in North Carolina has stopped prescribing opiate pain medicine caught up in the “I will lose my license” and “be arrested by the DEA”. Nationally the figures are the same or higher. Incentives for recapturing displaced pain patients. . We suggest a temporary CMS allowance for maximum billing codes to create a new “Certificate of Medical Pain Disease” and a “Certificate of Palliative Care Status” This would be an hour long intensive history and physical to establish and justify the need for long term medical pain medication and why. Once done this certificate can be presented to other doctors, pharmacies (where refusal to fill valid prescriptions has already lead to suicides), insurance companies, benefit managers, hospital ER’s, hospital surgical services, Medicaid, and Medicare. This would protect innocent medical patients from the harmful policies intended for addicts and put a disclaimer on the principle of “too much” unless the FDA changes the guidelines for opiate administration.
  4. CounterCDC education needs to be produced by FDA or NIH as CDC “educational modules” are presenting things that will influence medical practice in an unsupported and negative manner.
  5. Physicians and patients need to met in moderated sessions for a “truth and reconciliation” educational forum.
  6. Physicians need CME activities not centered around when not to prescribe opiate pain medication but when these traditionally useful drugs should be used and tricks of the trade.
  7. Obtain Health and Human Services (HHS) funding for factual healthcare educational programs outside the CDC’s unsupported, self proclaimed unscientific and heavily biased government views of pain and pain medicines attempting to change centuries of medical care for the person in pain.
  8. HHS might develop a compendium of the various uncommon disease with painful components might be a worthwhile expenditure of funds. Manuals for primary care practitioners teaching the tricks of opiate prescribing with case histories and inputs from other physicians, not government officials could be published.

Pharmacies

Pharmacists need to stop public statements in front of patients and staff accusing people with pain medicine prescriptions of being doctor shoppers and addicts. Making derogatory remarks about the patient’s doctor “we are not going to fill Dr. X’s prescriptions anymore. A risky public statement unless true.

  1. CMS and NIH funding for factual healthcare educational programs outside the CDC/PROP teachings.
  2. Disband the Pharmacy Benefits Manager system and replace with the system used by Medicaid.
  3. Standard for pharmacist who deny prescriptions without due diligence.
  4. The Prescription Drug Monitoring Program (PDMP) systems need a cost and effectiveness analysis along with analysis of unintended consequences of secret “red flagging” and surveillance of practicing physicians using untested profiling parameters. The reason for the “unsolicited reports” on doctors from this pharmacy data needs to be explained.
  5. The PDMP appears to be a law enforcement tool and as such need to have probable cause provisions before any professional is subjected to investigation based on profiling criteria created from Brandeis University, Heller School DoJ grant money.

Public Health Recommendations:

  1. Begin public health education for families and high school students for early intervention into opiate addiction where 90% of them start, not by programs of abstinence but programs of facts of the difference between type 2 opiate addiction, a genetic mu receptor disease, and type 1 addictions of choice, behaviorally reinforced by not triggered by genetic variant in the brain. Although rare, 4/1000 each person snatched from the jaws of addiction can lead a normal life with this genetic disease, if compassionately and intelligently treated.
  2. Begin public health outreach to those with type 2 addiction disease: confidential medical and pharmacist “advice lines” without retribution; distribution of “ambu” bags and masks ($20) so with a buddy system one addict can keep another addict alive indefinitely treating their apnea from multiple drug accidental overdoses, decriminalize paraphernalia and small possessions.
  3. Invite active and recovered type 2 addicts to participate in policy making designed for them as target audience.
  4. License all “rehab” facilities, provide choice treatment, and MAT (medically assisted treatment) in all facilities and provision for MAT treatment once discharged for at least one year.

**JATH Educational Consortium is an enterprise with a mission to provide unbiased, researched medical information for patients and doctors based in North Carolina. Erin O. LeBlanc, Editor. Thomas F. Kline, MD, PhD.