norm j clement dds
“…racism wears many masks, it is called Jim Crow one decade…only to be disguised as voter ID in another century, preventing election fraud, when no fraud ever exists…when wisdom becomes a threat, the knowledgable are deem arrogant and those learned are imprisoned…in healthcare, we must lead the fight for justice by connecting the dots of injustice…uncovering the unique, cleverly designed barriers erected to inhibit people from seeking treatment and preventing those licensed professionally and whom are capable from delivering proper healthcare…requiring them to view humans as algorithms to be uncared, then only have systemic injustices wage war upon both their souls an affording neither of them dignity and respect…”
Joe Madison.
” The question is??? What are we going to do about it”
REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD., LEROY BAYLOR, ADRIENNE EDMUNDSON, NATASHA DUVALL PHARMD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
Cato Institute
My Statement for the Record
By
Senior Fellow in Health Policy Studies at the Cato Institute
Today the Subcommittee on Health of the House Energy and Commerce Committee is holding hearings entitled “An Epidemic Within a Pandemic: Understanding Substance Use and Misuse in America.” I was asked by the Subcommittee to submit a statement for the record.
In the statement I pointed out that despite a dramatic drop in the number of opioids prescribed to patients in pain, the overdose rate is soaring—in fact, preliminary reports are that it rose more than 27 percent in the past year. And the majority of the overdose deaths are due to illicit fentanyl created in clandestine labs. Also notable is the historic increase in deaths related to methamphetamine and other psycho‐stimulants.
I pointed to research showing no correlation between the number of opioids prescribed and the misuse rate or addiction rate for opioids. I argued that the overdose increase is a direct result of drug prohibition and the predictable tendency for prohibition to spur the creation of newer and more potent forms of drugs.
I exhorted the committee to discard policies that focus on health care practitioners treating their patients in pain—which only causes patients to suffer while driving non‐medical drug users to more dangerous drugs in the black market—and to avoid codifying the outdated and controversial 2016 Guideline for Prescribing Opioids for Chronic Pain released by the Centers for Disease Control and Prevention. Instead, I encouraged lawmakers to pivot to harm reduction policies, including reforming regulations of methadone and buprenorphine prescribing for Medication Assisted Treatment of addiction.
You can read my statement
“An Epidemic Within a Pandemic”
JEFFERY A SINGER MD
TESTIMONY BEFORE
April 14, 2021
Subcommittee on Health
Committee on Energy and Commerce U.S. House of Representatives Washington, D.C. 20515
The Honorable Anna Eshoo Chair, Subcommittee on Health
Committee on Energy and Commerce U.S. House of Representatives Washington, D.C. 20515
The Honorable Brett Guthrie Ranking Member Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives Washington, D.C. 20515
Dear Chairwoman Eshoo, Ranking Member Guthrie, and Members of the Subcommittee on Health:
My name is Jeffrey A. Singer. I am a Senior Fellow in Health Policy Studies at the Cato Institute. I am also a medical doctor specializing in general surgery and have been practicing that specialty in Phoenix, Arizona for over 35 years. I would like to thank the Subcommittee on Health for convening a hearing on Wednesday, April 14, 2021, on “An Epidemic Within a Pandemic: Understanding Substance Use and Misuse in America .” I appreciate this opportunity to provide my perspective, as a health care practitioner and policy analyst, to assist this committee with its assessment of the current state of substance use and misuse in the United States.
The COVID-19 pandemic has diverted the nation’s attention away from an overdose epidemic that was raging long before the appearance of the deadly virus and has accelerated during the viral pandemic. The Centers for Disease Control and Prevention reported last December that, after a brief pause in 2018, the overdose rate increased during 2019 by more than 5 percent to a total of 70,630. Overdose deaths due to opioids of any kind increased from roughly 47,000 to over 50,000, representing an increase of more than 6 percent.
But illicit fentanyl and its analogs comprised more than 36,000 of all opioid overdose deaths, an increase of nearly 16 percent over one year, while heroin was responsible for approximately 14,000 (a roughly 7 percent decrease) and prescription opioids were found in just under 12,000 overdose deaths, representing a decrease of more than 7 percent. Methadone was found in a little more than 2,700 overdoses, a decrease of more than 10 percent. Perhaps even more alarming was that deaths due to psychostimulants such as methamphetamine and cocaine increased to historically high levels of more than 16,000, representing a nearly 24 percent jump in just one year. 1
Now a study from the Commonwealth Fund suggests that overdose deaths may have increased by more than 27 percent in 2020, the year of the pandemic, to roughly 90,000 with opioids comprising 75 percent of overdose deaths and fentanyl and its analogs involved in 80 percent of opioid overdoses.2
All of this is occurring in the presence of a “war on drugs” that was declared by President Richard Nixon over 50 years ago and a “cold war” on prescription opioids that commenced over a decade ago.
Unfortunately, much of the nation’s current policy rests on the mistaken narrative that the overdose crisis is largely the result of doctors overprescribing pain medications to their patients, creating a population of opioid addicts.
However, data provided by the CDC and the National Survey on Drug Use and Health, and reported in the peer-reviewed literature, clearly show there is no correlation between the number of opioid prescriptions and the non-medical use of prescription opioids or opioid use disorder among persons age 12 and over. During a 12-year period when prescription volume doubled, non-medical use and opioid use disorder rates remained essentially unchanged.3
A study published in 2018 by public health researchers at Johns Hopkins and Harvard Universities reported on 568,000 “opioid naïve” patients prescribed prescription opioids for postoperative pain between 2008 and 2016 and found a total opioid misuse rate of 0.6 percent.4
A study reported in the November 2019 Annals of Emergency Medicine found that only 1 percent of emergency department patients prescribed opioids for pain had “persistent use” of opioids six months later, and 80 percent of those were still suffering from their painful condition at the time.5
And a study reported last month by researchers at Case Western Reserve University, the University of Alabama at Birmingham, and American University of Antigua College of Medicine found that opioid morphine equivalent doses “did not show a statistically significant relationship with injury-related mortality, including with any subgroups of unintentional deaths, suicides, and homicides” in trauma patients. 6
To be sure, the stress and isolation associated with the COVID -19 pandemic has increased substance use in general and has made overcoming addiction more difficult, as evidence suggests that connectedness is crucial in the treatment of substance use disorder. Furthermore, interruptions or disruptions in rehabilitation programs and access to Medication-Assisted Treatment for opioid use disorder have likely contributed to the rise in overdoses in 2020.
But in fact, as researchers at the University of Pittsburgh School of Public Health pointed out in 2018, the overdose crisis has been on a steady, exponential increase since at least the late 1970s, with different drugs dominating at any particular point in time.7 An NBC News reporter covering the study stated, “It [the overdose crisis] started before the availability of synthetic opioids and may have only a little to do with the prescribing habits of doctors or the pushy habits of drugmakers, the team at the University of Pittsburgh found.” 8
The researchers suggested that the overdose crisis may be driven by “an ongoing longer-term process” which may involve sociocultural dynamics. This suggestion helps explain why Cicero, et al of Washington University in St. Louis reported in November 2017 that more than 33 percent of heroin addicts entering rehab programs stated that their gateway drug—the drug with which they initiated drug use—was heroin, as opposed to just under 9 percent who initiated with heroin ten years earlier.9
Despite these findings, the bulk of public policy is aimed at reducing the number of opioids that physicians prescribe for their patients in pain. The CDC reports that total opioids prescribed per 100 persons peaked in the year 2012 and has decreased by 43 percent between 2012 and 2019 to a 14-year low.10 Reports of chronic pain patients being cut off abruptly from their prescription opioids and desperately turning to the black market for relief or, even worse, to suicide, abound in the press.11
Meanwhile, as the black market supply of diverted prescription opioids diminished starting around 2010, the proportion of overdose deaths attributable to diverted prescription opioids stabilized and then decreased while deaths due to, first, heroin, and later fentanyl began to rise as these drugs filled the void. And the overdose epidemic continues apace.
The ascendancy of fentanyl and the resurgence of methamphetamine-related deaths 15 years after Congress passed the Combat Methamphetamine Epidemic Act of 2005 should come as no surprise to those familiar with what has come to be called “The Iron Law of Prohibition,” an application of what economists call the Alchian-Allen Effect.12 Put simply, as law enforcement increases, the potency of the drug increases. As the term’s author, Richard Cowan puts it, “the harder the enforcement, the harder the drugs.” 13
When drugs are prohibited, they will be produced in more concentrated forms because they offer better efficiency by taking up less room in storage, less weight in transportation, and can be subdivided into smaller portions to generate more money. During alcohol prohibition, whiskey and other potent liquors were smuggled rather than beer or wine. Likewise, when people “tailgate” at football games, they drink beer or wine—but when they enter the stadium where it is not permitted to bring in alcohol, they tend to sneak in the “hard stuff.”
The Iron Law of Prohibition explains the popularity that fentanyl and its analogs have with drug dealers: it is easily made in clandestine labs and mixed with heroin to increase its potency and reduce the size and weight needed to smuggle heroin across the border. Fentanyl is also smuggled across the border where it can be mixed with cocaine or methamphetamine (a preferred combination of people who like to “speedball”) or pressed into counterfeit prescription pain pills. Restrictions to movement and travel arising from the COVID-19 pandemic have disrupted the supply chain for heroin. This has increased the utility of fentanyl and may be contributing to its predominance among the drugs causing overdose deaths.14
The Iron Law of Prohibition also explains why drug cartels have found more efficient means of producing more concentrated forms of methamphetamine, using substrates such as phenyl-2-propanone (“P2P”) instead of relying on diverted over-the-counter Sudafed. Meanwhile, nasal congestion and allergy sufferers find it more difficult and inconvenient to obtain Sudafed, a very effective decongestant, which is behind-the-counter and controlled in most states, and prescription-only in Oregon and Mississippi.
I implore this Subcommittee to avoid attempts to “double down” on the policies that are clearly not reducing overdose deaths but are causing harm to innocent patients suffering from pain while making non-medical drug use even more dangerous and deadly.
Policy should avoid further attempts to codify the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.15 It must be stressed that the guidelines were never intended to be prescriptive, but rather suggestive. In fact, the authors of the guideline made clear that most of the recommendations were based on “Type 4 evidence,” which was defined as evidence “in which one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.”
The misinterpretation and misapplication of the 2016 CDC guidelines by lawmakers, insurance plans, pharmacies, and some practitioners caused the CDC to issue an advisory letter in 2019, urging against the guideline’s misinterpretation and misapplication.16 The guideline has come under criticism from multiple addiction and pain management specialists.17
June of 2020, Dr.JamesL.Madara of the American Medical Association wrote Dr. Deborah Dowell, the Chief Medical Officer of the CDC, stating that “patients experiencing pain should be treated as individuals, not according to one-size-fits-all algorithms and policies that do not take individual patient’s needs into account.” The letter went on: “Early on, the AMA feared that the arbitrary opioid analgesic dosage and quantity thresholds appearing in the CDC Guideline would cause unintended consequences when used to severely limit individual treatment decisions made by physicians…”18
The heavy reliance on Morphine Milligram Equivalent (MME) dosage to regulate prescribing has also come under heavy criticism from pharmacologists and pain specialists.19 This reliance ignores the substantial genetic differences in drug metabolism between individuals. For example, the levels of the two primary enzymes that metabolize opioids can differ by 100-fold from one person to another, so the same dose of an opioid can be too low for a 100-pound woman and too high for a 250-pound man.20
We have seen during this pandemic how quickly our state of knowledge changes as more information about transmission, replication, and how to protect against the COVID-19 virus evolves. This applies as well to the state of knowledge that existed about the overdose epidemic when the CDC published its guideline in 2016. It would be unwise to codify a guideline that, at the time was admittedly based largely on Type 4 evidence , and is now 5 years old.
The 2016 Guideline recognized that one size does not fit all, and that individual context matters—which is why it was offered for consideration as a “rule of thumb” as opposed to absolute instructions. Codifying guidelines has the effect of casting them in stone. I t makes nuance impossible. It incentivizes law enforcement agencies to view any deviation from the guidelines as a legal transgression and, as a result, frightens practitioners into abiding by guidelines at the expense of their best medical judgment.
I urge this Subcommittee to focus its efforts on harm reduction rather than on further punitive and restrictive measures.21 One measure to consider is to require the Food and Drug Administration to reclassify the opioid antidote naloxone as over-the-counter. 22 The FDA has expressed a willingness to do so but has been too deferential to the naloxone manufacturers, who may benefit financially by being able to charge higher prices to third-party payers because of naloxone’s prescription requirement. 23
Medication-Assisted Treatment (MAT) with methadone or buprenorphine has been shown to be the only form of addiction rehabilitation to be associated with reduced overdose and opioid-related morbidity, when compared to opioid antagonist therapy (naltrexone), inpatient treatment, and intensive outpatient behavioral therapies, according to recent research reported in the Journal of the American Medical Association.24
Yet because of the onerous requirement that practitioners get an “X-waiver” on their narcotics license from the Drug Enforcement Administration, only about 7 percent of practitioners are prescribing buprenorphine MAT. Furthermore, restrictions on the number of patients a practitioner may treat at any given time, along with restrictions on non-physicians engaging in buprenorphine MAT make matters worse. Congress should remove the X-waiver requirement. In the previous Congress, this idea had bipartisan support.25
In addition, Congress should consider legislation to deregulate methadone treatment programs in order to allow outpatient prescription by primary care providers in an ambulatory setting. Methadone has been prescribed by primary care providers to treat addiction in Canada since 1963, in the U.K. since 1968, and in Australia, since 1970.26 A pilot program was undertaken with success by researchers at Boston University in conjunction with the Massachusetts Department of Public Health and reported in the New England JournalofMedicine.27 AreportlastyearbytheNationalAcademyofSciences, Engineering, and Medicine also argued for allowing methadone treatment to be prescribed in primary care settings.28
Ordinarily, patients enrolled in methadone treatment programs must take the methadone—usually in liquid form—in the presence of treatment clinic staff. This implies distrust and reinforces the stigma attached to substance use disorder patients. It also makes compliance difficult. As an emergency measure to address the needs for isolation during the pandemic, the Substance Abuse and Mental Health Services Administration announced it will allow methadone clinics to dispense up to 28 days of take -home medication to patients.29 Codifying that temporary administrative decision would be a step in the right direction.30
Congress should repeal the so-called “Crack House Statute,” which stands in the way of cities that wish to establish Safe Consumption Sites, operating in over 120 locations in the developed world, including neighboring Canada, and proven since the early 1990s to be effective in reducing overdose deaths, blood-borne infectious diseases, and in bringing more people who suffer from substance use disorder into treatment.31
The previous administration encouraged the proliferation of syringe services programs, also known as “needle exchange programs,” and this should continue. Unfortunately, many states have drug paraphernalia laws that stand in the way of the development of this federally legal and highly effective means of harm reduction. These same laws prevent the distribution of fentanyl test strips to opioid and psychostimulant users as well as operation of anonymous drug testing drop-off sites by harm reduction organizations.32
Finally, Congress should de-schedule marijuana. Among other benefits, this will facilitate research into the potential benefits of cannabis as a substitute for opioids in the treatment of pain as well as a potential adjunct in Medication Assisted Treatment.33
If Congress wishes to prevent a gathering tsunami of drug overdose deaths, it should end its focus on the number of pain pills practitioners prescribe to their patients. Instead, Congress should pivot to measures aimed at reducing harm to non-medical users who access increasingly dangerous drugs on the black market fueled by drug prohibition.
Respectfully submitted, /s/
Jeffrey A. Singer, MD, FACS
Senior Fellow
Department of Health Policy Studies Cato Institute
FOR NOW, YOU
ARE WITHIN THE
NORMS
ENDNOTES
1 https://www.cdc.gov/nchs/products/databriefs/db394.htm
2 https://www.commonwealthfund.org/blog/2021/spike-drug-overdose-deaths-during-covid-19-pandemic-and- policy-options-move- forward?utm_campaign=wp_the_health_202&utm_medium=email&utm_source=newsletter&wpisrc=nl_health202 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6369835/
4 https://www.bmj.com/content/360/bmj.j5790
5 https://www.bmj.com/content/360/bmj.j5790
6 https://pubmed.ncbi.nlm.nih.gov/33814132/
7 http://science.sciencemag.org/content/361/6408/eaau1184
8 https://www.nbcnews.com/storyline/americas-heroin-epidemic/opioid-crisis-started-40-years-ago-report-argues- n911456
9 https://pubmed.ncbi.nlm.nih.gov/28582659/
10 https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html
11 https://www.cincinnati.com/story/news/2019/10/24/opioid-crisis-doctors-pain-pill-subscription- report/4012269002/ ; see also https://www.foxnews.com/health/as-opioids-become-taboo-doctors-taper-down-or- abandon-pain-patients-driving-many-to-suicide
12 https://web.archive.org/web/20131229232307/http://www.cato.org/pubs/pas/pa-157.html; see also https://journals.sagepub.com/doi/10.1177/002204269802800309
13 Cowan, Richard (December5, 1986). “How the Narcs Created Crack: A War Against Ourselves.” National Review. 38 (23): 26-34
14 https://www.unodc.org/documents/data-and-analysis/covid/Covid-19-and-drug-supply-chain-Mai2020.pdf
15 https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
16 https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html
17 https://www.cato.org/blog/multiple-distinguished-health-care-practitioners-speak-out-against-our-misguided- opioid-policy
18 https://searchlf.ama- assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2020 -6-16- Letter-to-Dowell-re-Opioid-Rx-Guideline.pdf
19 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5739114/
20 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3580761/
21 https://www.cato.org/policy-analysis/harm-reduction-shifting-war-drugs-war-drug-related-deaths
22 https://reason.com/2018/04/27/to-combat-opioid-abuse-the-surgeon-gener/
23 https://www.cato.org/blog/fda-bends-over-backwards-get-drug-makers-ask-them-make-naloxone- otc?queryID=5e8d90a53cd4146cbfeb21c6aa86396f
24 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032
25 https://www.cato.org/blog/will-congress-finally-x-out-x-waiver?queryID=862b69beb93afdd8be23b6799ddeb8ee 26 https://www.cato.org/blog/methadone-mixed-messages?queryID=37d266940cdf49bd3fc7293e474181e9
27 https://www.nejm.org/doi/full/10.1056/NEJMp1803982
28 https://www.cato.org/blog/nasem-makes-major-plea-harm-reduction-drug- policy?queryID=2d958d5b2aec6b124fa74f166c5de827 ; see also https://www.nap.edu/resource/25626/OUD- infectious-disease-services-recommendations.pdf
29 https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf
30 https://www.cato.org/blog/mat-regulations-relaxed-during-covid-19-pandemic-should-catalyze-further- reform?queryID=148915a5c7c82317219d83ce3d3c24e7
31 https://www.inquirer.com/opinion/commentary/philadelphia-safehouse-ruling-supervised-injection-site- department-of-justice-20191008.html
32 https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-020-00373-4
33 https://pubmed.ncbi.nlm.nih.gov/31109198/ ; see also https://www.cato.org/blog/yet-another-study-points- potential-cannabis-reducing-opioid-use?queryID=776a5aa470b889f0b8f2ffe884484f7c
34. A group of Black Pharmacy Owners found themselves under racist attack by the United States Drug Enforcement Administration (DEA). They organized together along with a diverse group of Black Scholars into a Think Tank called the North Star Pharmacy Group and began identifying and exposing systemic racial drug policies and injustices in healthcare delivery policies within both DEA/DOJ. They’ve further exposed racial targeting of black owned pharmacy businesses and physicians by DEA/DOJ; there is a demand for Congress to ACT, to investigate this agency.
The origins of DEA are alarming, according to John Ehrlichman Nixon’s domestic policy chief the “ WAR ON DRUGS” was specifically formed by Richard Nixon to attack, disrupt and arrest leadership within the black community. IT IS NOW TIME RID THIS COUNTRY OF ALL VESTIGES OF RICHARD NIXON’S RACIST INSTITUTIONS OF GOVERNMENT OPPRESSION FORMED TO SUPPRESS BLACK PEOPLE:
The story of How the War on Drugs is being used to target the Black family own pharmacies. And how a small group of pharmacist-owners, grads of FLORIDA A&M UNIVERSITY, WHO FOUND THEMSELVES TARGETS BY THE RACIST DEA ARE FIGHTING BACK. Black pharmacist lives do;
The origins of DEA are alarming, according to John Ehrlichman Nixon’s domestic policy chief the “ WAR ON DRUGS” was specifically formed by Richard Nixon to attack, disrupt and arrest leadership within the black community. IT IS NOW TIME RID THIS COUNTRY OF ALL VESTIGES OF RICHARD NIXON’S RACIST INSTITUTIONS OF GOVERNMENT OPPRESSION FORMED TO SUPPRESS BLACK PEOPLE: read: NIXON’S WAR ON BLACK PEOPLE read:
This matter must stop! The DEA knows they are wrong. Just like a bank robber knows he is wrong. What he hoping for is that he won’t get caught. This same processes functions within the DEA.
The agents know they are wrong. What they are confident is they will not get caught. The act of the agents falls under the aspects of the differential association theory. In this theory the officers are influence by the culture within the organization. This closeness form groups and role models and informal leadership. This groupthink aspect is the DEA’s criminal performance act. This act creates a negative and hostile antisocial set of behaviors. This closeness formulated the Blue Wall of silence where the DEA agents know it is wrong but they choose to remain silent and not ‘snitch’ on each another because the ‘price is too high to pay.’
The practice of the DEA and it wall of silence is evident when the agents claim that pharmacist have a corresponding responsibility with the doctor. No pharmacist has the authority, training and expertise to review x-rays and make a diagnosis. No pharmacist has the authority, training and expertise to medically challenge a doctor over a diagnosis. The DEA agents know this. However, the agents choose to remain silent and allow and participate in creating copy and paste warrants to raiding medical facilities. In essence, the DEA as transformed to become gang like by creating lawless scenarios to attack and achieve objectives.
We have documented and proven their lies and deceptions. Yet, nothing happens. This group of law enforcement officers have become law less and as they gain more confidence more heinous criminality will occur.
The DEA main expert of pharmaceuticals testified that he, Dr. Sullivan, never review the seized prescriptions records. This clearly shows the DEA agents has formulate and developed a wall of silence. In a critical state of evidence these officers used information to bring multiple practicing pharmacist to court. At no time has any DEA agent stepped forward to report this misconduct.
As the DEA become more impowered they will act far beyond the scope of service and create a constitutional crisis when they lend these tactics to the ATF and they enter homes, gun ranges and manufacturing and claim they create an imamate danger to the community. Guns will be confiscated if this process is continued to be allowed until the DEA and AFT has control.
What is wrong in one governmental agency will occur in another.
35. https://www.facebook.com/ red.lawhern
