Thursday, August 17, 2017

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An Open Letter To The President

obama

An Open Letter To The President, All Politicians, DEA, FDA And All Government Officials Involved In Drug/Addiction Treatment Policy

We Cannot Prescribe Our Way Out Of America’s Opiate/Opioid Epidemic

Dr. John Giordano and Dr. Kenneth Blum are internationally recognized experts and speakers on addiction and its treatment who provide a unique perspective with their rare combination of scientific research with applied science in the hands on treatment of addicts.

 

John Giordano DHL, MAC, CAP is a thirty-year veteran of clinical addiction treatment. Mr. Giordano is the founder and former owner of G & G Holistic Addiction Treatment Center, a 62 bed JCAHO accredited facility located in North Miami Beach, Fl.; and has contributed to sixty-five papers on addiction and its treatment published in peer-reviewed scientific and medical journals and is considered by Research Gate to be one of the top researchers in the country.

Dr. Kenneth Blum, a researcher on neuropsychopharmacology and genetics and the co-discoverer of the first confirmed Reward Gene; aka/the addiction gene, the alcoholic gene. He is one of the world’s foremost experts on addiction and its treatment. Dr. Blum retired as a full professor in the Department of Pharmacology, University of Texas, where he was also chief of the Division of Addictive Diseases, chief of the Division of Substance and Alcohol Misuse, and director of the Laboratory of Pharmacogenetics at the University of Texas Health Science Center (San Antonio, Texas) and has written over five-hundred papers on addiction and its treatment published in peer-reviewed scientific and medical journals.

We are appreciative of the politicians who have recognized that addiction is a biological and genetic based disorder and not a moral failing, that America is in a raging and deadly opioid epidemic and their efforts to turn this force around.  The purpose of this letter is to shine a light on critical facts that need to be considered in the planning and decision making process of any drug/addiction treatment policy. We believe that to have an open, honest and informed discussion on how to resolve America’s second opiate/opioid epidemic, it becomes imperative that we put all the facts on the table.

A Brief History On Both Of America’s Opiate/Opioid Epidemics – And The Policies That Successfully Ended The First   

America’s first opioid epidemic resulted from Chinese immigrants’ opium smoking habits that spread beyond their culture and the extensive use of morphine in the civil war. In 1898 the German drug company Bayer introduced Heroin in the United States as a non-habit-forming medicine that ‘could and would cure opium and morphine addiction.’[1]

Over 100 years ago America’s first drug czar, Dr. Hamilton Wright, was the subject of an op-ed for the New York Times with the shocking headline: “UNCLE SAM IS THE WORST DRUG FIEND IN THE WORLD” [2]. In this explosive exposé Dr Wright revealed that per capita, American’s were the biggest consumers of raw opium and opium based products such as morphine, heroin, laudanum, over the counter medicines and patented medicines, in the world. His efforts lead to as series of Federal laws that restricted the importation, distribution and prescription of opiates and opioids; effectively ending the first American opiate/opioid epidemic.

In the 60’s many solders returning from Viet Nam brought home with them their heroin addiction. The growing number of heroin addicts caused President Nixon to pass legislation (The Narcotic Addict Treatment Act of 1974) allowing Methadone Clinics to open across the country in an effort to combat heroin abuse.

The birth of America’s second opiate/opioid epidemic coincides with the aggressive marketing tactics of a pharmaceutical company’s launch of a powerful new and highly addictive painkiller in the late 90’s. Doctors were paid by pharmaceutical companies to prescribe narcotics – and they did; enough to keep every American adult high for a month. Opioid prescriptions nearly quadrupled in less than fifteen years. Responsible, hard working, non-drug abusing Americans became addicted to the Oxycodone they were prescribed by their doctors for pain resulting sports injuries and minor and major surgeries; giving rise to the infamous pill mills and pain clinics. Today we find ourselves in a full blown opiate/opioid epidemic that, if not addressed, promises to keep expanding.

America Has An Opiate/Opioid Epidemic – Not Just Heroin

If we are to have an honest discussion, it is consequential we frame the issue correctly. To say America has a heroin epidemic would be disingenuous and misleading. The facts below paint a clear and vivid picture of a country hooked on opiate/opioid painkillers – the most prescribed drugs in America today.

An "opioid" is any synthetic narcotic not derived from opium. Opiates are analgesic alkaloid compounds found naturally in the opium poppy plant Papaver somniferum. One main source fueling America’s opiate/opioid epidemic that continues to expand its boundaries is the over-proscribing of addictive opiate/opioid painkillers. Admissions of babies addicted to opiates and opioids (prescription and illicit) at birth to U.S. neonatal intensive care units nearly quadrupled from 2004 through 2013 and continues to rise. [3] Everyday in America, 2,500 youth (12 to 17) abuse a prescription opioid painkiller for the first time. [4] Twice as many people die from prescription painkillers than from heroin. [5] A study conducted by Express Scripts found that nearly half of patients who took opiate/opioid painkillers for more than 30 days in the first year continued to use them for three years or longer. [6] Almost half of chronic opioid users took only short-acting medications – rather than longer-acting formulations – thus increasing their risk for addiction. [6] Anywhere from 45% to 75% of heroin addicts surveyed said they were first addicted to opiate/opioid painkillers then moved to heroin. [7,8] Quoting from Journal Of American Medical Association Psychiatry (JAMA Psychiatry July 2014) “Although the “high” produced by heroin was described as a significant factor in its selection, it was often used because it was more readily accessible and much less expensive than prescription opioids.” [7] More Facts:
–    Americans, constituting only 4.6% of the world’s population, have been consuming 80% of the global opioid supply and 99% of the global hydrocodone supply, as well as two-thirds of the world’s illegal drugs. [9]
–    Since 1999, the amount of prescription painkillers prescribed and sold in the U.S. has nearly quadrupled (272%) to nearly 207 million in 2013 [10]
–    Enough to medicate each American adult every four hours for an entire month [11]
–    The CDC reports that there has not been an overall change in the amount of pain that Americans report in the same time frame. [10]
–    Centers for Disease Control and Prevention (CDC): Many states report problems with for-profit, high-volume pain clinics (so-called "pill mills") that prescribe large quantities of painkillers to people who don't need them medically. [12]
–    CDC: Overprescribing leads to more abuse and more overdose deaths. [10]
–    CDC: The number of drug-poisoning deaths in 2013 was 43,982, the number of drug-poisoning deaths involving opioids (prescription painkillers) was 16,235 (45 people a day), and the number of drug-poisoning deaths involving heroin was 8,257 (23 people per day). 1,342 deaths involved both opioid analgesics and heroin. [13]

In summary, Americans, who have not reported any more pain in the 14 year period starting in 1999 and ending in 2013, were prescribed – by the doctors they trusted their health to – nearly 300% more prescription opiate/opioid painkillers in the same time period. Also in 2013, nearly twice as many people died from prescription opiate/opioid painkillers as compared to those who died from heroin overdoses. Moreover, studies clearly show a trend of addicts migrating from the opiate/opioid painkillers they started their addiction with, to the more accessible and less expensive heroin – a fact that in our opinion, clearly distinguishes prescription opiate/opioid painkillers as a gateway drug to heroin.

We cannot proscribe our way out of America’s Opiate/Opioid Epidemic

The kitchen sink is full. Water is gushing over the edges flooding the floor below. It would be simply incredulous to believe we could resolve this plumbing issue by adding more water; and equally as fantastical to believe we can end America’s opiate/opioid epidemic by prescribing more opioids specifically methadone, buprenorphine, Subutex  Suboxone and ZubSolv. It is our opinion, based on the mountains of unbiased empirical data, that all the policies related to addiction treatment will not end this epidemic if we don’t first shut off the tap. We believe that chipping away at key parts of the Harrison Narcotics Act of 1914 (HNA) – legislation resulting from Dr. Wrights efforts that played a significant role in ending America’s first opiate/opioid epidemic – as suggested by the drug/addiction treatment policy plans published by presidential candidates’ can have major negative consequences that simply cannot be ignored.

To be clear, we recognize the desperate situation we find ourselves currently in and accept that this opiate/opioid epidemic requires actions to bring it to its end that perhaps might seem counterintuitive under less precarious circumstances. We see value in the MAT program’s potential to reduce harm in the short-term of less than 12 months. However, we do not condone actions that satisfy the short-term while ignoring the serious and avoidable long-term consequences, no matter how well intended, as we strongly suspect can occur from what we’ve been able to glean about these proposed policy plans through media reporting. We also acknowledge that there are people who are experiencing chronic pain that require narcotics for relief. We also accept that some addictions are so extreme that narcotics are the only answer. It is our intention to make sure these people get all of the medications they need.

There are a few commonalities between the presidential candidates’ drug/addiction treatment policy proposals that we would like to comment on. Of the plans on record, presidential candidates are proposing federal financial assistance to states that provide a plan that meets certain criteria. We believe the criteria requires more detail and contains unintended consequences that are likely to minimize their desired effect. Below you’ll find the criteria with our observations and comments on how the standards can be upwardly adjusted so that the presidential candidates’ plans can meet the goal of ending America’s opiate/opioid epidemic.

Presidential candidates’ drug/addiction treatment policy proposals include the expansion of medically assisted treatment (MAT).

From our experience and observations, MAT, in practice, is the use of FDA approved medications – most of which are opioids – for the treatment of opiate/opioid addiction. The two primary opioids used to treat opiate/opioid addiction are methadone and buprenorphine which is up to 50 times more potent than morphine. Subutex is a name brand buprenorphine. Suboxone is a name brand opioid that consists of 4 parts buprenorphine and one part naloxone, a pure opioid antagonist often used as an antidote for opiate and opioid overdoses. Zubsolv a dissovable tablet which combines the drugs buprenorphine and naloxone and treats opioid dependency and addiction. It is our understanding through reports in the media that the published drug/addiction policy plans include a component allowing for greater availability and use of buprenorphine.naloxone combinations (Suboxone /Zubsolv) in addiction treatment.

Buprenorphine (Subutex) is a partial agonist, meaning that it partially blocks the brain’s opioid receptors. They also block Dopamine receptors. They work by tricking the opioid receptor into thinking it has been satisfied with opioids without producing strong feelings of euphoria, the effects are long acting and they eliminate the withdrawals associated with addiction. They also have a ‘high’ or ‘buzz’ ceiling, a characteristic not shared with methadone. Buprenorphine (Subutex) is thought to be safer than methadone and distributed to patients by prescription while methadone can only be dispensed daily at a clinic with few exceptions. These narcotics are reported to be safe when used as directed; but isn’t that the point? Addicts don’t take opiates and/or opioids as directed.

All of the narcotics mentioned above that have FDA approval for use in opiate/opioid addiction treatment are habit forming, addictive just like any other opiate or opioid, potentially just as deadly and subject to the same abuse as any other prescription or illicit narcotic. Quoting from the manufacturer’s own website: SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and death, SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. [14]
ZUBSOLV contains an opioid that can cause physical dependence. ZUBSOLV can cause serious and life-threatening breathing problems. It can cause death or harm. [21]

A study lead by Drs. Edward Hill and Charles Moehs along with Dr. Blum and Mr. Giordano and others from MIT  found that long-term Suboxone use lead to blunted emotional responses in its users. They had less self-awareness of being happy, sad, and anxious. In layman terms, over time Suboxone has a zombie like effect on its users. The paper titled ‘Long Term Suboxone™ Emotional Reactivity As Measured by Automatic Detection in Speech’ was published July 9, 2013 in the peer-reviewed journal PLOS one. [15]

Just because an addict is in a MAT program doesn’t mean that they have stopped abusing opiates, opioids and/or other dangerous drugs.

A Polydrug abuser will often mix two or more psychoactive drugs in combination to achieve a particular effect.
–    Joseph McMahon IV was prescribed a couple of thousand Suboxone pills over nearly three years. Still, he overdosed on other drugs at least five times and at 25 died of one final overdose in December 2011[]  http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?_r=0
–    Patients stopped and started their (MAT) medication so they could still use other opiates or mixed it dangerously with drugs http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?_r=0
There are countless stories in various media outlets easily accessible online describing how addicts stopped and started their MAT medication so they could still use other opiates and/or opioids or mixed it dangerously with other drugs.

Deaths Directly attributed To FDA Approved MAT Opioids

In 2004, USA Today reported: Methadone was cited in nearly 13% of all the overdose deaths reported in the USA in 2004, up from about 4% five years earlier. [16] According to the Centers for Disease Control and Prevention (CDC) as reported by CBS News in 2012: Methadone to blame for one-third of U.S. prescription painkiller deaths, CDC says – Methadone accounts for only 2 percent of painkiller prescriptions in the United States - but the drug is behind more than 30 percent of prescription painkiller overdose deaths. The report showed that deaths from the drug have been on the rise for years as more prescriptions have been filed. [17] According to the CDC, in 2012, there were 41,502 deaths due to drug poisoning (often referred to as drug-overdose deaths) in the United States, of which 16,007 involved opioids and 5,925 involved heroin. [18]

The numbers provided by the CDC indicate that in 2012; 5282 people died from an accidental overdose of methadone, while 5,925 died from heroin, a difference of 643 people. Yet in spite of the empirical data that clearly shows a pattern of increases deaths directly attributed to methadone and the slim margin between methadone deaths and heroin deaths – deaths we were told methadone would prevent – the FDA approved MAT narcotic is still prescribed, widely available and considered safe by the FDA and advocates for treating opiate/opioid addicts with opiates/opioids.

Deaths attributed to Buprenorphine/Subutex/Suboxone/Zubsolv are harder to track. According to a New York Time report in 2013: the Centers for Disease Control and Prevention does not track buprenorphine deaths, most medical examiners do not routinely test for it, and neither do most emergency rooms, prisons, jails and drug courts. The addiction drug was a “primary suspect” in 420 deaths in the United States reported to the Food and Drug Administration since it reached the market in 2003, according to a Times analysis of federal data. [19]  

Two lives gone another ruined.

Courtney Howell, a 27 year old, was sentenced to 30 years in prison on 08/26/2015 after pleading guilty to manslaughter and exposing a child to a controlled substance, both felonies. Howell, who had a prescription for FDA approved methadone, put the narcotic in her 17-month-old daughter's bottle so that she would fall asleep. Howell was offered little sympathy from most or her family who said she know how powerful methadone is. The baby’s father died of an accidental methadone overdose a few months before the baby was born. [20]

All of the MAT drugs have found their way onto the black market and are abused.

Charlie Cichon, executive director of the National Association of Drug Diversion Investigators, said “But the abusers found out that this (Suboxone) was another drug that they liked. It’s not a drug that gets them on that high plain like the other drugs that they abuse. But if they can’t get that drug that they like, Suboxone is readily available and it keeps them at this mellow stage until they can get the next drug.” [] http://nationalpainreport.com/suboxone-new-drug-epidemic-8821747.html

Laura Ungar of the Courier-Journal Louisville, Kentucky – and area struck particularly hard by opiate/opioid addiction – reports that: Kenny Stearns III dissolved Suboxone strips in water and shooting the mixture into his veins. "The first few times I used it, I could get really high from it. Then I just felt normal ... I wasn't high, but I wasn't sick either," said the 25-year-old from New Castle, Ind. "To me, it's just trading one addiction for another." Stearns said he stayed off other drugs for a little while but soon returned to meth, using Suboxone as a "backup." Van Ingram, executive director of the Kentucky Office of Drug Control Policy, said this is common. "Some people are using it to treat their drug addiction, and some use it when they can't get their drug of choice. Suboxone can diminish the physical need for (opioid) drugs. But you have to have the behavioral aspect as well," said Murphy, who prescribes the drug to a small number of addicts. "A patient has to go to an aftercare program" providing ongoing support. []
http://www.courier-journal.com/story/news/local/2014/07/03/addiction-medicine-suboxone-now-abused/12153725/

–    National Center for Biotechnology Information (NCBI): The most common drugs diverted from the health care facility setting are opioids. [] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538481/
–    A report published in the Journal of Addictive Diseases, the Center for Substance Abuse Research (CESAR) at the University of Maryland warned “there may be an epidemic of buprenorphine misuse emerging across the U.S.” Researchers said addicts were smuggling buprenorphine into jails and the drug’s street value was growing because it doesn’t show up in drug tests. [] http://nationalpainreport.com/sharp-rise-in-suboxone-emergency-room-visits-8818470.html
–    “The true magnitude and scope of buprenorphine diversion, misuse, and adverse consequences is unknown because current epidemiologic measures do not systematically monitor buprenorphine,” [] http://www.cesar.umd.edu/cesar/pubs/20121214%20Buprenorphine%20CESAR%20FAX.pdf

For more information please see:
Systematic evaluation of "compliance" to prescribed treatment medications and "abstinence" from psychoactive drug abuse in chemical dependence programs: data from the comprehensive analysis of reported drugs.
Blum K, Han D, Femino J, Smith DE, Saunders S, Simpatico T, Schoenthaler SJ, Oscar-Berman M, Gold MS. Published in PLoS One. 2014 Sep 23;9(9):e104275. doi: 10.1371/journal.pone.0104275. eCollection 2014. PMID:25247439 [22]

 These are just a mere few of the thousands of heartbreaking stories of how FDA approved MAT opioids are tearing apart the moral and social fabric of America. Just because an addict is in a MAT program doesn’t mean that they have stopped abusing opiates, opioids and/or other dangerous drugs. We encourage you to search online and see for yourself just how vast and devastating America’s opiate/opioid epidemic has become.

In America’s first MAT program, albeit it wasn’t called that in late 1800’s and early 1900’s, doctors prescribed heroin – promoted by it’s German manufacturer, Bayer, as a “cure for opium and morphine addictions” [1] – to opiate and opioid addicts from their office. And we all know how that turned out. We’ve learned through our own history that adding more opiates/opioids into an already over-served market with lax oversight mechanisms in place through the convenience of a doctor’s prescription – no matter how well intended – only adds more Americans to rolls of addiction with, in our opinion, the potential to extend America’s second opiate/opioid epidemic into perpetuity.

Dr Hamilton Wright’s efforts in the early 1900’s lead to the Harrison Narcotics Act of 1914 that proved to be an integral part in bring America’s first opiate/opioid epidemic to a close by restricting the flow of opiates/opioids. We agree with the Centers for Disease Control and Prevention (CDC) findings that overprescribing leads to more abuse and more overdose deaths. [10] and believe that the path charted by Dr. Wrights is the right course to end America’s second opiate/opioid epidemic.

Treatment Of The American Addict: Should We Embrace “Dopamine Homeostasis” Or Continue To Not Only Lose The War But Lose Our Next Generation!

Understanding that at our beginnings over 100,000 years or more ago, we homo sapiens evolved from apes in Africa and Asia might suggest that we are a violent species interested in the survival of the fittest. This unfortunate notion can easily be construed when we evaluate these early beginnings and even when we consider more modern 21st century humans. From the Christian Crusades to the Holocaust, to the atomic bomb and terrorism around the world. The beheadings of innocent people by ISIS and others, we as humans may have to accept this reality and face these atrocities every single day living with this stress on planet earth. Can we escape all of this by getting high?

Previously one of us (KB) published a paper concerning the molecular neurobiology of understanding the High-Mind and suggested that getting high may be an unresolved and little-understood age-old natural phenomenon. The concept of, for example, alcoholism being considered a disease from as far back as Benjamin Rush and was fortified by the work of Jellinek in his classic book on the disease concept of alcoholism (1951).

Certainly, the new definition of addiction by the American Society of Addiction Medicine (ASAM) accurately espouses that “addiction is a brain disorder”. Not everyone is in agreement with this important concept, others like G. Allan Marlatt favored  “control drinking”  an experiment that has failed and psychologist Stanton Peel, who’s books continually profess the non-disease concept seem unrealistic especially with the advent of research utilizing neuroimaging tools to help unravel the mysteries of brain function. Moreover, some cringe at the notion that addiction is indeed a disease because they believe that this concept gives the addict an out and an excuse to continue to abuse reducing their own responsibility. However, the user is told to take responsibility for their recovery.

In evolutionary terms, it seems that certain known genetic risk alleles – as an example, for reward deficiency or addiction such as the dopamine D4 7R variant or even the well-known Dopamine D2 A1 variant – are old variations found in our ancestors. One interpretation may consider these facts to mean that the risk for addiction even through genetic antecedents is nothing more than a molecular rearrangement of our DNA and our interaction with environmental elements. This interaction sets up an individual to be predisposed to drug or thrill seeking behavior and subsequent addiction. Possibly then we can settle this argument and suggest that high risk seeking behavior either substance related or non-substance-related is simply an alteration of our DNA (impacted by our environment) that has adapted for our survival and is nothing more than a molecular manifestation of humankind. So carriers of these older risk alleles (variants on the DNA) living in today’s stressful society may find themselves unable to “fit –in” and because of an inability to deal with or cope with everyday life especially when stressful find relief by getting high.

Recognizing that multi-million American Addicts have both DNA risk variants, as well as environmentally induced changes on their chromatin (a structure above the DNA) altering expression of particular genes, may be interesting, but does not solve the current opioid epidemic. However, testing for these genetic variants before prescribing powerful opiate-like substances (drugs) to reduce acute or even chronic pain, may assist the clinician in deciding how to treat these individuals potentially reducing unwanted iatrogenic induction of addiction to legal anti-pain drugs. The good news is that genetic testing for risk stratification will be available shortly.

With this stated -how can the scientific and clinical community begin to intervene and provide a new approach to treating our precious American Addict in a more sensible way to improved the quality of life in recovery? The answer may reside in what has been termed “Brain Dopamine Homeostasis”.  In due respect for those dedicated to pharmacological intervention, dopamine regulation is counter to the current FDA-approved Medication Assisted Treatment (MAT) which favors the opposite approach – “Brain Assisted Dopamine Dysregulation” (BADD).      

Can we obtain Dopamine Homeostasis?

The human brain is a vast, elaborate labyrinth of complex neural pathways with over 100 billion transmitting sites (neurons) sending messages (neurotransmitters) that control everything in our body and brain – literally shaping our everyday life. Researchers at the Stanford University School of Medicine reported in 2010 that: “A single human brain has more switches than all the computers and routers and Internet connections on Earth.” That being said, it becomes crystal clear just how easily a message could get lost in our vast neural pathways and not reach its final destination. Such is the case with addiction where dopamine, the primary neurotransmitter of reward, motivation, and pleasure, is off balance and unable to fully communicate its message of calm and ease.

Fortunately, in the last thirty years we’ve learned much about the subject of addiction. We now know that addiction is hardwired to our brain’s reward circuitry, which is influenced by genetics and environment. Addiction is a hiccup in the way the brain’s ‘happy chemical’ messenger, dopamine, communicates the ‘all is well in the world’ memo to the rest of the reward center in our brain. It’s really not all that different from emailing a group of people asking each of them to perform a particular task; only to have many of them never receiving the email and go about their business accordingly. The message in the email got lost in the vast internet network and – as a consequence – the collective action you were expecting, never happens. Ergo, the parts of the brain that do not receive dopamine’s ‘all is well in the world’ memo react appropriately. It’s natural for us to repeat behavior that gives us a pleasurable and/or rewarding response. Therefore, addicts who do not receive dopamine’s ‘all is well in the world’ memo, search out ways to stimulate dopamine pathways in the brain, whether it be drugs or risky behavior, that will improve their dopamine function so they can feel at ease.  

Understanding Resting State Functional Connectivity

Along these lines, our laboratory with world-renowned psychiatrists and scientists have revealed that in laboratory testing on rats – whose brains are strikingly similar to the human brain – the amino acid nutraceutical, KB220Z, demonstrated a significant improvement in resting state functional connectivity across the brain’s reward circuitry. It is now accepted that one important culprit in the cause of additive behaviors involves a reduced resting sate functional connectivity. Understanding this phenomenon whereby one –part of the brain talks with another part of the brain [e.g. the accumbens (craving) talks with the hippocampus (memory) talks with the Cingulate Gyrus (decision-making)] allows for a “normal” resting state functional connectivity. If there is a reduction in this functional connectivity at rest, the individual will be set-up for addictive –like behaviors (view picture of Swiss cheese see figure 1).

 
Figure 1- Functioning brain connections represented by cheese. Addictive Brain: lack of connectivity at rest represented by holes (no cross –talk) compared to Non-Addictive Brain. KB220z helps restore resting state functional connectivity.

However, under a normal physiological trait (genes) or environment (epigenetics), the brain at rest is entirely connected, which is a good thing. Certainly it is now known that drugs of abuse and other addictive behaviors, like gambling, compulsive sexual behavior, and overeating all reduce resting state functional connectivity. In unpublished non-addictive rat work, we show that KB220Z significantly activates, above placebo, seed regions of interest including the left nucleus accumbens, cingulate gyrus, anterior thalamic nuclei, hippocampus, prelimbic and infra-limbic loci. Moreover, we also found evidence for additional recruitment of neuron firing which is very important in restoring resting state functional connectivity (see figure 2). These are the regions involved in craving, memory, and decision-making.

KB220z and rsfMRI in N. Accumbens

‘Resting state functional connectivity” is the gold standard among scientists and researchers. KB220Z was shown to effectively restore dopaminergic functionality in the brain reward circuitry. This means that messengers like dopamine can communicate their message – in this case, calm and wellbeing – through neural pathways in the reward center with greater ease compared to previously difficulties – and perhaps for the first time reach its final destination.

Additionally, in rats it was also showed that KB220Z increased brain volume recruitment referred to as neuroplasticity. This is noteworthy because this amino acid nutraceutical causes greater activity in key regions of the brain that control relapse, cravings and cognition – all critical elements that support a healthy and enduring recovery.

The implications here are many and the potential benefits of KB220Z or any other substance that can induce “dopamine homeostasis” cannot be overstated. KB220Z is a non-addictive or habit-forming amino acid nutraceutical made from things found in nature and has little to no known undesirable side-effects. It has been tried, tested and perfected for over forty-years. Treatment facilities are using this nutraceutical to detoxify heroin addicts with great success. In other studies, some published and some not, KB220Z has been reported to reduce drug and alcohol withdrawal symptoms; decreased craving for alcohol, heroin, cocaine, nicotine; and has shown potential in accelerating the healing process of addicts’ brains which, as has been suggested, can take up to three years. KB220Z achieved these treatment outcomes by restoring the balance of dopamine function or “dopaminergic homeostasis” as it has become to be known. This nutraceutical is able to achieve these results by up-regulating dopamine function that reinforces reward mechanisms as opposed to down-regulating – or blocking – dopamine as do most FDA approved MAT synthetic drugs. In the author's opinion, these important results warrant additional basic research and clinical attention.

Adaptation of Dopamine Homeostasis for American Addicts

We know that many people do well in recovery by lifting both their spirituality and fellowship by attending 12 step type programs (both AA and NA) and there is evidence for these positive results in understanding the molecular neurobiology of each step (available in Blum et al. Springer Neuroscience Brief book, 2014). However, for the first time, the federal agency responsible for most of the public funding of drug addiction treatment (Substance Abuse and Mental Health Services Administration [SAMHSA]) has added language to its grant applications designed to push the treatment industry away from the abstinence model. From the beginning days of Alcoholics Anonymous (AA) in 1935 to current thinking, there are those who subscribe to AA treatment for RDS in the United States that follows this abstinent model as the only acceptable route to recovery. The abstinent model promotes the abstaining from all drugs, including medications prescribed specifically for addiction.

SAMHSA now encourages all states in America to reject the status quo and to require the option of medication-assisted treatment (MAT) in clinical settings. This new initiative appears in SAMHSA's block grant application for fiscal years 2016-2017 (involving $1.8 billion awarded by this organization in the fiscal year 2015).

In spite of general agreement that FDA approved MAT drugs including buprenorphine/naloxone combinations for opioid addicts, may be useful at least for short-term treatment; the vast majority of rehabilitation facilities in the U.S. do not offer such care. This may be a consequence of 100 patient per MD restriction or abstinence models of treatment. In our opinion, long –term use of buprenorphine/naloxone combinations should be avoided because of dopamine blockade and the risk for suicide. The FDA has approved MAT for Alcoholism, Opioid Dependence, and even Nicotine Abuse, there are no such approvals for Cocaine and Marijuana abuse.  

America is in throws of a tremendous heroin and opioid epidemic targeting and killing our kids and future generations (try to see Deleon’s film “Kids Are Dying” and Greg Smith film “American Addict”). The Centers for Disease Control and Prevention reported that heroin-related overdose deaths almost quadrupled between 2002 and 2013. In fact, federal drug czar Michael Botticell stated that the U.S. government would make drug court funding conditional on states being guided by the science of treatment, rather than ideology. Indeed moving in this direction paves the way for even better long-term less harsh treatments, since all the current FDA approved drugs favor blocking dopamine. We do know that long-term use of, for example, buprenorphine/naloxone combinations can lead to typical withdrawal symptoms and in some cases even suicide. There is some evidence that comparative analysis of long-term treatment with buprenorphine/naloxone combinations with short-term utilization revealed no significant benefit in treatment (long-term vs. short-term) of resultant clinical outcomes for patients.

Over many decades, our associates and even Nora D. Volkow (Director of NIDA) have argued that “Dopamine Function” is an important cornerstone for a healthy and happy life. If we accept this tenant, it makes little sense to block dopamine’s activity in the long-term. In fact, we have shown that long-term utilization of buprenorphine/naloxone combinations -induce a reduction in one’s normal (affect) expression of emotional impact.

While there is no magic bullet, in the mid-80’s Mark Gold and associates were on the right track when they proposed the use of Bromocriptine, a potent D2 agonist, to treat cocaine addiction. However, this idea did not hold up because when Bromocriptine was used on a long-term basis it resulted in D2 receptor downregulation. More importantly, this concept along with earlier work from our laboratory suggested that “dopamine agonist therapy” and not “dopamine antagonist therapy” should be embraced in the long-term treatment of addicts. Individuals displaying RDS behaviors (addictive) have been shown to possess low dopaminergic function due to a number of risk gene variants called polymorphisms (e.g. DRD1-4; DAT1; COMT, MAO, etc.). As such victims of RDS or even so-called healthy people have varying degrees of the above-listed characteristics caused by genes.

 So while it is important to embrace short-term dopamine antagonist therapy as espoused by FDA approval of MAT drugs, it is not recommended for long-term use. Understandably, while many of the proponents of current MAT would argue against this premise, our scientific challenge would be to find ways to boost dopamine without at the same time downregulating dopamine receptors and function. Can you imagine if we could harness our brain to provide regulation or “normalization” of dopaminergic function leading to what has been termed “dopamine homeostasis.” In fact, only a very small percentage of treatment centers currently embrace this concept by offering dopamine boosting modalities such as Yoga Meditation, Yoga Exercise, Brain Spotting, Behavioral Cognitive Therapy, Trauma Therapy, Sound Therapy, Music Therapy and the serving up of “dopamine for dinner” cooking recipes to name a few.

The literature in some cases like, Yoga Mediation actually shows a 65% increase in neuronal dopamine. Moreover, certain healthy low glycemic foods (low-calorie diets coupled with low fat and carbohydrates) are known to boost dopamine function (like fish oils). However, as yet, little direct evidence for dopamine boost has been linked to other holistic approaches including hyperoxygenation.

In conjunction with some respected ASAM physicians and Dominion Diagnostics, we studied compliance to FDA-approved Medication Assisted Treatment(MAT) and abstinence from drugs of abuse during treatment using the Comprehensive Analysis of Reported Drugs (CARD)™. The first article to measure both compliance to FDA-approved drugs and abstinence from drugs of abuse in urine drug screening of thousands of addicted patients in 6 states on the east coast of America was published in the journal PLOSONE. The results showed that compliance was good utilizing MATS especially buprenorphine/naloxone and methadone. However, there was still significant drug abuse during treatment.

The take-home message is that while MAT could be important, it was found that both compliance and abstinence in these patients could be improved. Keeping this in mind that we the authors believe that enhancing dopamine function (not Dopamine blockade) in the long term is better for the recovering addict. There should be no surprise that we are faced with an opioid epidemic knowing that even one addiction risk variant of the Dopamine D2 receptor gene (A1 variant) is prevalent in approximately 100 million Americans. The goal of our most brilliant minds must continue to find ways to enhance the quality of life for RDS victims in recovery, by improving “dopamine Homeostasis.”      

 It is acknowledged that Dr. Blum is the owner of US and foreign patents related to KB220Z a nutraceutical shown to reduce drug and alcohol withdrawal, reduce stress response in patients in recovery, enhance focus in healthy volunteers, reduce craving for alcohol, heroin, cocaine, nicotine, reduce inappropriate sexual behavior, reduce post-traumatic stress (PTSD) symptoms such as lucid nightmares and significantly reduce relapse rates following administration.

Please see:
Deleon’s Film –The American Epidemic http://www.americanepidemicmovie.com/
Smith’s Film – American Addict http://www.americanaddictthemovie.com

References:

[1] http://www.druglibrary.org/schaffer/history/casey1.htm
[2] http://www.druglibrary.org/schaffer/history/e1910/worstfiend.htm
[3] http://www.usatoday.com/story/news/nation/2015/07/08/babies-born-dependent-on-drugs-continue-to-rise/29212565/
[4] http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf
[5] http://www.drugwarfacts.org/cms/Causes_of_Death#sthash.vgOvYlmw.dpuf
[6] http://lab.express-scripts.com/insights/drug-safety-and-abuse/americas-pain-points#sthash.MSTAfyQY.dpuf
[7] http://archpsyc.jamanetwork.com/article.aspx?articleid=1874575
[8] http://www.cdc.gov/vitalsigns/pdf/2015-07-vitalsigns.pdf
[9] http://www.asipp.org/documents/TESTIMONY-FROMEXECUTIVECOMMITTEE-RESPONDINGTOTHEPRESCRIPTIONDRUGEPIDEMIC-STRATEGIESFORREDUCI.pdf
[10] http://www.cdc.gov/drugoverdose/
[11] http://www.pbs.org/newshour/rundown/prescription-drug-abuse-top-10-things-cdc-says-you-should-know/
[12] http://www.cdc.gov/vitalsigns/opioid-prescribing/
[13] http://www.cdc.gov/nchs/data/databriefs/db190.htm
[14] http://www.suboxone.com/content/pdfs/SuboxoneISI.pdf
[15] http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0069043
[16] http://usatoday30.usatoday.com/news/nation/2007-02-12-methadone_x.htm
[17] http://www.cbsnews.com/news/methadone-to-blame-for-one-third-of-us-prescription-painkiller-deaths-cdc-says/
[18] http://www.cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning.htm
[19] http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?_r=0
[20] http://www.huffingtonpost.com/entry/courtney-howell-killed-baby-methadone_55e1ad75e4b0c818f6181780
[21] https://www.zubsolv.com/
[22] http://www.ncbi.nlm.nih.gov/pubmed/25247439

 

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