NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, WALTER L. SMITH BA., ADRIENNE EDMUNDSON, WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
THE MULTIDIMENSIONAL LEVELS OF CORRUPTED BEHAVIOR HAVE ALLOWED THE DEA TO VIEW THEMSELVES AS ENFORCERS OF JUSTICE
The multidimensional levels of corrupted behavior have allowed the DEA to view themselves as enforcers of justice within their own eyes, they see no wrong. Within their own eyes, they see no wrong. As this agency continues on its trajectory, it will soon develop into murderous acts to protect the agency or themselves from detection. This agency has subordinated the laws in exchange to justify their actions. Right or wrong they stand behind what they do and believe. This deliberate drive to be has shifted a once well-known and professional agency, to accept ‘deviant, dishonest, improper, unethical or criminal behavior. The men and women of this once well-known and respected agency would understand the impact of deception. Today the DEA does not and cannot accept errors of their ways.
According to research done by Dr. Richard Lawhern:
“The basic premises of the 2016 CDC guidelines on the prescription of opioid analgesics to adults with chronic non-cancer pain are wrong. And CDC KNOWS they are wrong!
Higher overdose mortality from 2010-2020 is a direct outgrowth of socioeconomic factors and the invasion of illegal Fentanyl into US street markets. We also know from State-level analysis of Prescription Drug Monitoring Programs data that when a prescription-type opioid is found in postmortem toxicity screens, it is likely to be only one substance among several, including illegal or diverted drugs and alcohol. Our “drug crisis” is driven by illegal drugs, not prescriptions.”
DOJ-DEA ISO’S AND INDICTMENTS ARE BASED ON A FOUNDATION OF JUNK SCIENCE
“FALSUS IN UNO, FALSUS IN OMNIBUS”
CATO INSTITUTE DR.JEFFEREY SINGER MD PODCAST, JUNE 1, 2021
JEFF SINGER MD________
” POLITICIANS AND POLICEMAN SHOULD LEAVE THE PRACTICE OF MEDICINE TO DOCTORS AND SCIENTIST”
Share with you, another of Dr. Jeff Singer’s podcasts on “Following the Science” is good advice for lawmakers”
COMMENTS TO THE FDA: OPIOID DOSING BASED ON MILLIGRAM MORPHINE EQUIVALENTS IS UNSCIENTIFIC
Opioid Policies Based On Morphine Milligram Equivalents Are Automatically Flawed MAY 24, 2021
JOSH BLOOM PH.D.____
Nearly three years ago I wrote how the science behind US opioid policies was deeply flawed, in particular, the use of Morphine Milligram Equivalents (MME) to quantify recommendations, policies, or laws. I argued that any use of MME was automatically flawed because it ignored even the most basic tenets of pharmacology, the absence of which made it impossible to rationally determine the relative strength of one drug to another. Unfortunately, this methodology, which became the foundation of the CDC’s catastrophic 2016 publication Prescribing Guideline for Prescribing Opioids, has metastasized ever since as one state after another has passed laws limiting the prescribing of opioid analgesic, often based on the Guideline’s erroneous conclusions.
In retrospect, it is not surprising that such a baseless document was created. First, the CDC lacks both the authority and expertise to regulate drugs; that is the function of the FDA. Second, the anti-opioid group Physicians for Responsible Opioid Prescribing (PROP), which also lacks expertise in drugs and pharmacology, has undue influence with the CDC – a relationship that remains nebulous to this day.
It was almost a foregone conclusion that the CDC “recommendations” would become law. Indeed, this is now the case in 36 states. Sadly, drug abusers, pain patients, and their physicians have paid a very steep price for this ill-conceived document.
Although it is years too late, it is nonetheless encouraging that the FDA is holding a workshop to examine the fundamental pharmacology of opioids. The deficiencies of the 2016 Guide need to be addressed. Here are my comments.
Flawed science yields meaningless results
Below is a chart published by the CDC, a “guide” (2) for physicians who prescribe pain drugs. Morphine is normalized to 1.0 and the conversion factor reflects the relative potency of other opioid drugs. So, if the daily MME – the maximum dose of drug allowed – is 90 mg (3) then a patient may receive no more than 90 mg of morphine, 90 mg of hydrocodone, 60 mg of oxycodone, or 30 mg of oxymorphone per day. Although the conversion table seems to be straightforward enough, it is based on an assumption that all opioids behave similarly in the body. But this assumption could not be less accurate. Once we see the profound differences in the properties of the drugs and the difference between individuals who take them it becomes clear that not only is the CDC chart flawed, but the MME is little more than a random number.
Table 1. MME equivalents. Source: CDC
Not all opioids are created equal, especially in the body
Anyone with even a passing knowledge of pharmacology would immediately be skeptical of data in the chart. Let’s take, for example, the two drugs at the bottom. Although Table 1 tells us that oxymorphone is twice as “strong” as oxycodone it does not take into account a number of critical properties that paint a more complete picture of the fate of the drug once swallowed. In other words, there is no information about pharmacokinetics – the effect of the body on the drug.
Fact Sheet on Prescription Opioid Pain Relievers in the “Opioid Crisis”
EXPOSING THE DOJ-DEA JUNK SCIENCE
Patient Advocate [Lawhern@hotmail.com]
Richard A Lawhern, Ph.D.,__
My name is Richard Lawhern PhD. I am a volunteer advocate for chronic pain patients, with 25 years experience and over 125 published papers in journals and mass media.
Today I draw your attention to a June 7-8, 2021 FDA Workshop on “Morphine Milligram Equivalents.” Although public comments remain open until August 9th, major conclusions are already clear. The central metric and rationale of the 2016 CDC opioid guidelines was Morphine Milligram Equivalent Daily Dose (MMED). We now know from multiple sources that this metric is junk science — scientifically invalid and deeply harmful as a criterion for limiting opioid dose or duration. The 2016 CDC Guidelines are consequently flawed beyond possibility of repair.
I also note that CDC has no charter for issuing guidelines on prescribing and dosing any number of other non-opioid medications used to treat infectious diseases, depression, diabetes, hypertension, or other health problems the agency tracks. Interjection of the Agency into opioid guidelines was highly inappropriate in the first place. This mission is normally addressed by FDA.
Over-prescribing by doctors to their patients did not cause the “Opioid Crisis”
“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing… Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities.”
* [*Nora Volkow MD, Director National Institute on Drug Abuse, and Thomas A McLellan Ph.D. — NEMJ, 2016]
“We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens… A CDC Guideline only focused on “opioid prescribing” will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.” [AMA letter to Director CDC – Press Release, June 17, 2020]
There is no cause-and-effect relationship between prescribing and overdose mortality – But millions of patients are being denied safe and effective pain care.
Seniors over age 62 are prescribed opioids for pain three times more often than youth under age 19. But youth have overdose rates three times higher than seniors. No medical model can explain these demographics.
The only scientifically and ethically sound action now open to the CDC is outright repudiation and withdrawal of its 2016 guidelines – without replacement. No amount of marginal tinkering will help. You royally messed up and you must repair the fully predictable damage that you did to millions of patients and thousands of medical practitioners.
As one element of guideline withdrawal, you should recommend that the US Department of Justice and State Attorneys General conduct a judicial review for at least the last 10 years, of actions to sanction, suspend or revoke licenses, or imprison physicians for fictitious “over-prescribing” based on MME thresholds. Judgments involving MME as a criterion must be vacated with a monetary award of damages to physicians whose practices and lives have been ruined by this bogus pseudoscience.
“FALSUS IN UNO, FALSUS IN OMNIBUS”
FOR NOW, YOU ARE WITHIN
YOUAREWITHINTHENORMS.COM , (WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)