CDC PRESCRIPTION PAIN MEDICINE LIMITS — did the Guidelines really say that? Did CDC have the authority? What has happened as a result?

(also see essay CDC 90 LIMIT NOT FOR CHRONIC PAIN PATIENTS in Medium)

note: {brackets} denotes terms you can web search to find the original documents. Bolding indicates quotes from the CDC Guideline of March 15, 2016.

From my viewpoint as a practicing physician the CDC is attempting to reverse centuries old standards of medical practice without asking practicing physicians. Since these guidelines were not generated from the broader physician community, they must be viewed with sharp questioning before we adopt a new ways of medical practice. The idea of limiting dosage for all pain medications comes soley from a very small group of physiians know as “Physicians for Responsible Opiate Prescribing” (PROP)and their associates at the CDC. Many members of PROP and CDC consultants and employees working on the “Guideline” project have anti-painmedicine postiions reflected in their previous writings and media contacts.

There is no other support for suddenly demonizing 50 centuries of pain relief from opium derivatives. No other physician group, the AMA, the Federation of State Medical Boards, State Medical Societies, American Academy of Family Practitioners, American Academy of Pediatrics, support the extreme and dangerous position tapering patients off “heroin pills” a polemic used to terrorize physicians and the general public — it has worked.

Pain medicine being the “same as heroin pills” is an inappropriate metaphor and is scary. One must ask why it was quoted by the director of the CDC, Thomas Frieden MD, and his consultant Andrew Kolodny MD founder of PROP. The effect seemed to be to frighten the country into following their tenants of the evils of the witch opioids. If we could just eliminate the opioids we can control the dope fiends. Hasn’t worked. Never has worked, and now we have put 5–7 million legimated painful disease patients out on the curb, returning to non-functioning humans just sitting trying to use “mindfulness”.

Mindfullness recommended by opiophobic officials is about as effective as it would be for cancer. These incancations allow the agenda to proceed by CDC and PROP of elimination of all opiate pain medications. This is nearing its goal. Only 20% of the ten million people who have to take around the cloci pain medicines for their rare and uncommon painful disease states are now in medically acceptable pain control. Suicides are being documented as the solution to returning to the painful states existing prior to the near mandated reduction and elimination of pain medications.

The result, robustly documented, is the same as it has always been: with restrictions in prescribed pain medicines the “overdose deaths” reported by the CDC increase. The program of pain nihilsm appears to have fatal consequences. CDC was required by its Scientific Advisors to follow up checking for unintended consequences of their polices. Three years has gone by. One half of those who have a medical indication for long term pain relief with opiate medicines are completely off their previously prescribed medicines. Another 20% or so are so far purposely under-treated their lives are wrecked, losing jobs, losing spouses, unable to grocery shop, unable to attend church, just “sitting on the couch, waiting for God”.

Heroin pills are actually illegal in the United States. Made so in 1925 being The real reason we have criminal distributors of opiates, like heroin, and the real reason we have an “opioid crisis”. The crisis has been there for 100 years. Looking carefully at other government data, outside the CDC one sees the “crisis” and “epidemic” have been there all along. The current alarms and terrorism have been there before. Read the New York Times in the 1950’s. NOthing has changed, especially the numbers. They have not changed in real terms, but seem so when data misuse by Leonard Paulozzi, MD and other an employees of the CDC and PROP member pushed the “epidemic” fear in CDC publication dating back more than ten years. Dr. Paulozzi is also a PROP member.

We await an outside congressionally appointed commission to look carefull at the data and how it was misued by the PROP/CDC alliance.

The primary change in traditional medical practice in place for centuries is the principle that we doctors always treat with the best medicine available. CDC an agency not congressionally tasked with making rules or recommendations for any prescription drug much less than opiate memdication XXXXSTOPhas decreed that they are so afraid of opiate medicines they have dangerously recommended real opiate pain medicines come second in line after alternatives, non of which work as well. This is not how we practice medicine. Would you like your cancer treated with alternative medicines first, before the effective medicine? What follows are quotations from the CDC “Guideline” and my analysis of CDC’s proposed changes to medical practice. Be advised that CDC is not congressionally mandated for prescription drug recommendations, only the FDA has that authority. CDC’s recommendation are at odds with the FDA.

from the “Guideline” of March 15, 2016:

“When opioids are started, clinicians should prescribe the lowest effective dose” Clinicians have always done this. This is unnecessary advice. Does the Director of the National Center for Injury Prevention and Control (NCIPC) at CDC believe practicing physicians start with the highest doses? There is no documentation provided in the document for such a characterization.

CDC advises when starting the opioid at 50mg MME limit should be carefully reassessed and and if using 90mg MME should avoid increasing the dosage beyond 90mg MME. The key word is “starting”, nothing about later in the course of treatment.

This is type of specific medical advice is not appropriate for the communicable disease branch of government lacking regulatory and rule making authority to do so. Pretending this is not a “rule” comine clean just one time in the Guideline by mentioning the word “volunatry” belies the way the “Guideline’ was actyally I was received yb the press as a“warning” . Warnings are customary for the communicable disease agency. When CDC issues warnings people listen. If you do not, or you might die from the contagion. Takong advantage of their good offices CDC issued the same type warning for death from pain medicines. People listened Questions were not asked as fear of Addiction Phobia set it in and inquiry and critical thinking disappeared. Nearly 95% percent of the “overdose deaths” were serious addicted people dying in the streets, a fact revealed by the CDC, a serious violation of scientific rules by not disclosing relevant facts. No one does a description study without definining the population.

“Clinicians should use caution when prescribing opioids at any dosage (this has always been standard of practice) and should carefully reassess evidence of individual benefits and risk when increasing dosage to 50mg or more morphine milligram equivalents or MME. This is odd, since FDA already ruled there are as many deaths below the 90mg level as above. It would seem, unless CDC is presenting new evidence, that the FDA analysis should stand. It appears to have been ignored, inappropriate since FDA is the Congressionally mandated agency for all drug.

No references or justification is given to support this new 50mg number. It ws just stated as fact, which it is not until validated using scientific methodology. It appears to have been created by the “core experts” a group with strong bias against the use of pain medications writing the Guideline in secrecy for reasons that are not clear. Nor is it clear why they intended to avoid public hearings beforfe such a major change in the way people have their pain relieved as outined by the FDA.

The secrecy and non disclosure of who the architects of the new guidelines was alarming enough for Congress to ask for an explanation {12–18–15 letter to cdc Friedan}. The “Guideline” was quickly published three months later after being forced to do a proforma comment period, and after the adoption of the CDC Guideline for the Veterans Administration hidden in the omibus funding measure of December 2015. Forced tapering is now considered law in the VA. Suicides are rising at an unexpected rate. No outside authority is investigating how many are due to released pain from discontinuation of the opiate treatment plan to “prevent overdoses and addictions”. “We have to do this for you own good” one soldier was told with multiple painful war injuries. Its the law”

FDA rejected dose limits in 2013 remained alive and well incorporated in the CDC “Guideline” under discussion here. The idea of dose limits is moot since once some one is taking an opiate pain medicine and has not shown signs of addiction, addiction will not occur in the future. Overdoses are occurring in the street addict population only but yet the fear was effectively transmitted along with limit the opiate pain medicine and the overdoses will stop. This is not true, they are rising more rapidly than ever with a 20% reduction in prescribing of pain medicne. Even without evidence limiting the opiates will solve the problem, since the government can see no other solution, dose limitation of 50,90, 200 or whatever remains the solution de jure. CDC did say for the first time in history attempts to limit dose of pain medicine was based on “low scientific evidence”. There is no category below “low”. Imagine a stray federal agency recommending reducing medicine in patients they do not care for, nor have jurisdiction over, and causing 6–7 million people to lie awake at night with their painful diseases out of control.

— -and should avoid increasing dosage to 90mg or more MME per day , for first time users (now widely inappropriately interpreted as applying to those not first time uses) This is failure of government to recognize when writing medical guidelines language is critical. Is the first time use defined first time ever or is it first time because one is not taking opioids at present? Is the what is behind the false reasoning for denying post operative and emergency room patients pain medicine? First time means this time? The confusion has lead to doctors crossing ethical boundariesrefusing care to those in pain. I would imagine most of the ER and post-op patients had an opiate at one time or another, so is the the “first time”? The CDC doctors do not explain. This is like “don’t use nuclear bombs unless it is the first time”. This type of unclear wording with its attendant human tragedy is an example of why there is statutory prohibition against the federal government interfering in the practice of medicine {42 USC 1395}.

These new guidelines apply to every man, woman and child in the USA today and forever, irrespective of their body chemistry, irrespective of their disease state facts known to all practicing physicans, incidently absent from the CDC guideline process.

Completing the discussion on initial dosing the discussion moves to long term dosing, same section 5

“What about when patients are already receiving high doses.” (high dose is relative term since FDA labeling has no high or maximum dose for any opioid pain medicine, a high milligram dose may have the same levels of medicine in the blood stream for one person as a low milligram dose in another person. “High dose” is a relative term and does not imply more problems than with low doses (see FDA 2012-P-0818, supra). Although the average person would panic after being told by a major federal agency that your medicine for your pain is so dangerous that you better stay away from it. This is not true.

“There is likely to be a different benefit to risk ratio than there is for not escalating — - escalating is a biased anti-opioid word not used in everyday medical practice — “increasing” is the word we use. All opiate pain medicine need tweeking and sometime increases as the body gets used to the opiate. This is not bad it is expected and does not lead to death and addiction. This is false information from the CDC.

The text goes on to suggest if you go to a new physician the new doctor should look at your “high dosages” -this suggests physicians are negligent in prescribing the “high dose” and the patients should: “be offered the opportunity to reduce the doses in light of recent evidence…of opioid dosage and overdose risk”. (this is the CDC, clearly stepping out of bounds from their core mission again based on the “high dose” mythology. There is no rationale for this statement beyond polemics reflecting the known biases of the “core experts” and the CDC director at the time Thomas Frieden who said,”

CDC has denied that they recommended tapering but yet the word “taper” appears 43 times in the document, compared with once for the word “voluntary> The scare word “overdose” deaths appears 140 times. No where in the “Guideline” is a discussion of whom opiate pain medicines are would benefit leaving the impression no one should receive these dangerous drugs that don’t work, premises that are invalid. Remember as you read this, the FDA reviewers disagreed with the notion of an overdose risk related to high dose and found it unsupportable. {fda 2012-P-0818}. FDA is the last word in prescription drugs not the CDC.

“For patients who AGREE to taper opioids to lower doses, clinicians should collaborate with the patient on a tapering plan(this recommendation found in paragraph 3 of recommendation 5 is being ignored - wholesale. The majority of taperings are without consent and are forced. We doctors only urge the discontinuation of medicine if FDA has issued a new warning. This heinous, unethical and perhaps criminal practice has become so widespread a new type of suicide has developed, suicide from the horrors of returning intractable pain after being flat out denial pain treatment that was working fine without side effects or addiction. Many patients offered no medical reason for the doctors’ actions feel it being done out of spite and lack of understanding of rare painful disease syndromes. It matter not people are killing themselves to end the pain and no one is studying the problem in spite of “rising suicide rates for “unknown reasons”. The reason is not unknown to the families of those dead for no reason other than government cabal. See on the Web: {Medium suicides}

Editors summary: the 90mg cutoff is clearly for opiate naive people, people who have not taken opioids for some time or ever and even that is questionable in trying the “one size fits all patients”. You cannot establish absolute limits for drugs like insulin, opiates, or coumadin. To do so restricts care for those with different body chemistries and ties the hands of those with the licenses to practice medicine. We have always been careful with narcotics and all medicines. CDC has no grip on what transpires in real medical practice or they would not have made the mistake of trying to “digitize” the vagracies know to all practicing physicians who believed “warnings”from the trusted CDC, the warnings people

CDC ‘s dangerous and harmful 90mg “cutoff” mentality to solve deaths in the addiction communities does not make sense, forget the lack of science and the opinions of a seriously biased “lunatic fringe” (in the words of an ex-FDA official) group of doctors known as PROP extremist in their views of the importance of pain and “pain pills being nothing more than Heroin pills” . The most extreme viewpoint I have seen in medical practice of four decades.

Policies are not generated in the federal government based on opinions. Federal meddling in medical practice is forbidden by law and precedent. See Supreme Court [268 US 5}, and statute [42 USC 1395]. Federal agencies do not issue potentially dangerous policies without providing post hoc analysis looking for “unintentional consequences” which has happened to an extreme degree with ruined lives and documented suicides to stop the physical pain released with cessation of medical treatment.

Thomas F. Kline MD PhD
Chronic Disease Specialist
Raleigh, North Carolina
thomasklinemd@gmail.com

Raleigh NC

919–561–0144

Twitter @thomasklinemd for list of suicides from forced government recommended tapering of long term pain medicine and for unsolicted short testimony from chronic pain pateints

m the houry was too long but saved here the misleading guidline

42 years varied primary care • former Chief, Hospital in Home Service @harvardmed • formerly: @UofMaryland, @StanfordDeptMed, @uoregon • thomasklinemd.com

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