Does New CARA Law Expand And Extend Opiate/Opioid Addiction?

Are We Expanding Rather Than Reducing the American Opiate Epidemic by Legally Increasing the Availability of Buprenorphine/Naloxone to Treat Opiate/Opioid Addiction?

Based on good intentions by Obama and lawmakers the United States has overwhelmingly approved an expanded increased availability of buprenorphine /naloxone (sold under the brand name Suboxone) from the previous 100 patient restriction to 275 per physician to assist in this treatment option. The law will come into effect on August 5th. While this could translate to a better chance for especially rural communities to expand its treatment to many people iatrogenic addicted to opiates/opioids, are we actually expanding rather than reducing the American opiate epidemic?
In this discussion we are cognizant that buprenorphine is a very potent highly addictive opioid with similar withdrawal to opiates like morphine and heroin. The combination with a very low dose of the narcotic antagonist Naloxone does not alter the addiction characteristics of Buprenorphine, however it does provide a barrier to diversion in the street.
HHS estimates between 10,000 and 90,000 new patients will be able to get buprenorphine in the first year as a result. Another 2,000 to 15,000 new patients should be able to get the treatment in subsequent years.  “If Congress would approve the budget request of $1.1 billion more, there would be more doctors trained in buprenorphine, particularly in rural areas where there is a shortage of physicians who can prescribe the drug, said White House drug policy director Michael Botticelli.”
Interestingly, on the heels of this new law a paper published on July 18, 2016 in the prestigious peer-reviewed journal Substance Use Misuse by a number of addiction medicine experts including Kenneth Blum, Westley Clark, Mark Gold and Rajendra Badgaiyan has called for an expansion of the combination of buprenorphine/ naloxone to at least 200 patient per physician option for treatment. In this article the authors suggested that attention must be focused on needed changes to the current United States law that restricts physicians who prescribe buprenorphine for the detoxification or treatment of Opioid Use Disorder, to accepting no more than 100 patients.
The current system does not provide comprehensive treatment as defined by the American Society of Addiction Medicine (ASAM) criteria.
Additionally, it suffers from both fragmentation and stigma and will require a significant change to comply with ASAM’s call for integrated delivery of comprehensive addiction treatment.  This commentary calls for the development and implementation of “best practice,” by recommending caution in lifting the 100 patient limit until substantial achievement of this goal occurs. The authors call for an increase to 200 in the patient limit to be restricted to those physicians who are Board Certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) or in Addiction Psychiatry by the American Board of Psychiatry and Neurology (ABPN), or other responsible medical organizations.
Any additional restriction lifting should follow a systemic evolution that rewards and documents competency in the integration of treatment, treatment systems, and recovery with the prescription medication and monitoring for emotional blunting and treatment progress and initiation of genetic addiction risk testing.
In terms of monitoring for emotional blunting, Blum’s group found and previously published in PLOSONE that long–term use of buprenorphine/naloxone (in the form of Suboxone) patients had less self-awareness of being happy, sad, and anxious, and a significantly flat affect (p<0.01), as compared to both general population and Alcoholic Anonymous (AA) samples.
In terms of genetic testing the authors suggest that each patient entering a pain clinic should be tested for genetic risk by utilizing a sophisticated researched panel of reward genes known as Genetic Addiction Risk Score (GARS). This genetic test could be very useful as the window to the brain and may help identify patients entering a pain clinic for potential future opiate/opioid risk. While some may argue against the initiation of genetic testing as a barrier to treatment, the authors point out that obtaining a genetic risk profile for each patient is beneficial because it provides critical information about particular genetic vulnerabilities and gauges treatment susceptibility with the possibility of reducing subsequent opioid addiction risk.
In fact Steve Magura the editor-in-chief of the journal Substance Use Misuse stated that – “While it is important to provide patients with this option, realizing that in spite of a potential for relapse if buprenorphine/naloxone is terminated, scientists should find even better ways to induce ‘dopamine homeostasis’ in the long-term and testing genetically for risk up front is a laudable goal.”
Understanding the need for expanded treatment options co-author Westley Clark, the former director of SAMSHA, stated – “While I applaud the vote to increase the availability of Buprenorphine/Naloxone especially for rural communities and HIV users, the government along with for example ASAM must cautiously develop a vetted plan that will eliminate expanded abuse which will translate to even an enhanced narcotic epidemic.”

Kenneth Blum the lead author had this to say – “It is well-known from the literature that discontinuation of opioid maintenance therapy with opioids results in high relapse rates and even death. However, we hereby propose that neuroscientists and clinicians alike should consider the development of either pharmaceutical or nutraceutical alternatives that induce dopamine homeostasis, rather than promote anti-dopaminergic activity.”

The take home message here is that while the recent Obama administration proposal and vote in congress (bipartisan) passing the expansion to 275 must be accompanied with guidance by knowledgeable professionals and organizations and some of these concerns above are required to prevent further abuse of the already broken system with the hope to improve treatment availability to those who otherwise would not have access.

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Joe Ullrich
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CREDENTIALS: Kenneth Blum, B.Sc. (Pharmacy), M.Sc., Ph.D. & DHL; received his Ph.D. in Neuropharmacology from New York Medical College and graduated from Columbia University and New Jersey College of Medicine. He also received a doctor of humane letters from Saint Martin’s University Lacey, WA. He has published more than 550 abstracts; peer-reviewed articles and 14-books. Dr. Blum has been the recipient of many NIH grants and numerous awards including the prestigious Life-Time Achievement in Addiction Medicine from The Holistic Institute of Addiction Studies and The Presidential Award for Scientific Excellence from National Council of Alcohol & Drug Abuse Councilors. Blum is the Editor in Chief of “Addiction Genetics.”  Currently, Dr. Blum is serving as Editor-In-Chief of “Journal of Reward Deficiency Syndrome” and co-Editor-In-Chief of “Journal of Neuroimaging in Psychiatry and Neurology” and is on 7 prestigious journal editorial boards. Prof. Blum is also a founder President of USG and founder President of USG Editors Association (USGEA). Dr. Blum is the recipient of Julius Axelrod (Nobel Laureate) Distinguished Speaker Award.

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