CDC 90mg — it’s not actually in the Guideline

JATH EDUCATIONAL CONSORTIUM, LLC
Raleigh, North Carolina

This attempt to override the FDA’s federal prerogatives in the regulation of all prescription medications is not based on anything but the opinion of those who wrote the unauthorized CDC Guideline of 3–15–2016. The CDC staff working with the Physicians for Responsible Opioid Prescribing (PROP), a private medical group, together have limited the use of prescription opiate pain medications for all Americans. What’s happened as a result is the disenfranchisement of millions of chronic and rare painful disease patients. There are millions of permanently wrecked lives, and even suicides, from having pain medicines forcibly taken from them under the new “anti-opioid policy of the federal government in violation of 42 USC 1395.

We will look at the rationale, or lack thereof, behind the worst medical tragedy in American history, non existent before March, 2016.

Standard font: quotes directly from the CDC “Guideline”
Italicized font: editor’s comments

From CDC Guideline itself (google: cdc 3–15–16} the key “Recommendation 5:

“When opioids are started, clinicians should prescribe the lowest effective dose.” CDC then explains that when starting the opioid at 50mg MME, the limit should be carefully reassessed and if using 90mg MME, you “should avoid increasing the dosage beyond 90mg MME.” The FDA previously ruled these limits were not scientifically supportable {FDA 2012-P-0818} but aside from that, they were not intended for long-term pain care.

“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 (MME) —

(No references given to support this new number, nor references to the validity and reliability of the MME metric. Ninety mg MME is the dose for an 10 year old).

— “and should avoid increasing dosage to 90mg or more MME per day.” (FDA previously disagreed with these limits after a citizens petition to the FDA to limit the dose of opiate pain medications. The answer to the petition was a resounding “No.” {FDA 2012-P-0818} FDA scientists reject all claims to limit use, dose, or length of prescriptions since remarking problems can occur at lower MME as well.

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)

“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, it means “increasing”) to high doses in the first place.”

The text goes on to suggest that if you go to a new physician, they need to look at your “high dosages— suggesting physicians are negligent in the first place and 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, stepping out of bounds from their core mission, suggesting that if a patient comes from another doctor, the dose might be reduced. This is also the CDC’s denial that they did not recommend tapering. The word “Taper” appears 42 times in the “Guideline.” The idea of tapering people off their pain medicines, without medical reason and without their consent, is part of the radical PROP manifesto that chronic pain patients do not need opiates — which of course is far from the truth. Ask anyone forced off their pain medicines what has happened with their rare painful diseases as a result. FDA reviewers of PROP opiate reduction disagreed with the notion of an overdose risk related to high dose and found it unsupportable. {fda 2012-P-0818)}

This is surprising, as in medicine, most of all drugs have problems if the dose is increased over the FDA limits. Opiates are rare exceptions as high doses are allowed by the FDA. If there was a danger, FDA would have certainly limited the doses by now. People do as well on 1000 mg a day as they do on 30 mg a day — it just depends on the person.The ignorance of this fact and pushing an anti-opiate pain medicine agenda has resulted in the current disaster, yet unrealized as to is full impact.

“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 average painful disease patient is being forced to taper whether they want to or not. Two PROP members have publicly stated tapering should be done forcibly. This false premise is causing untold harm to at least 4–7 million people and is leading directly to a new category of suicide; suicide from being denied pain treatment. (google “medium suicides”)T

The 90mg cutoff is clearly for opiate naive people; people who have not taken opioids for some time. Even the FDA, who puts no dose limits on opiates, suggests lower first starting doses. No where, other than in the minds of the “lunatic fringe” at PROP (FDA retired official), is there a milligram cutoff. However, it has swept the nation with doctors, legislators, and the police striving for numbers. Numbers that do not exist.

The idea of cautious increases is standard medical practice for all medicines. This is nothing new. The idea is good, but the artificial and inaccurate 90mg number is not good. There are no further comments in this press briefing about long-term use for the 9 million people who are already taking opiate pain medicine (opioids) for their painful diseases.

CDC never intended the 90mg cutoff to be applied to anyone other than patients with newly prescribed opioid pain medicine, but then hinted that people on long-term opioids “transferring from other clinicians be offered the opportunity” to taper off their medicines, considering the “association of opioid dosage and overdose risk” a statement that cannot be supported (FDA 2012-P-0818). To suggest tapering “on transferring from another doctor” negates including the actual pain in the equation, assuming all should be “offered the opportunity.” This recommendation is incorrect and is an intrusion into the practice of medicine reserved for state regulation, not for federal government Supreme Court [268 US 5}, and statute [42 USC 1395].

Most importantly, the great scare tactic of increased “overdoses” (read addiction) has everyone fooled. Ninety five percent of “overdose deaths” are HEROIN overdose deaths, an important adjective left out by the “chief of opioid epidemic statistics” at CDC, Leonard Paulozzi, a PROP member.

In fact, reviewing the papers in the “Guideline” falsely claiming higher doses lead to more “overdose deaths,” they actually reveal only 500–1000 people die per year of “overdoses” in the United States while under the care of a doctor or practitioner. The other 39,500 you hear about are as mentioned, street addicts sadly dying from lack of health care and lack of understanding that they have a genetic disease, not of their doing.

The CDC section on unintentional harm, led by Deborah Houry, MD, commandeered the FDA and NIDA prerogatives by writing an unauthorized “Guideline” themselves that has suggested uses for opiates, tables of literature analysis without references, and claimed their own assumptions were base on “low” scientific evidence (which includes “no” evidence).

Astonishingly the the drum beating goes on in medial schools, doctor training programs, and in state legislatures. This dangerous manifesto of pain medication avoidance goes unabated after we have seen people violently take their own lives directly due to anti-opiate pain medicine policies of the CDC “opiates don’t work, worse cause death and addiction”.

This is not true. It is killing and maiming millions of our neighbors who have done nothing wrong except have chronic and rare painful diseases, which is not their fault. They are fully entitled to the same pain medical care we give our pets.

Thomas F. Kline MD PhD
Chronic and Rare Diseases
Raleigh North Carolina
for JATH Educational Consortium, LLD

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

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