Designation of Emerging Drug Threats in the United States 
2020-06-19 2020-06-19 2020-06-19 2020-06-30 2020-06-19 2020-06-29 2020-06-29
ONDCP-2020-0001-0014 ONDCP-2020-0001-0018 ONDCP-2020-0001-0020 ONDCP-2020-0001-0033 ONDCP-2020-0001-0015 ONDCP-2020-0001-0027 ONDCP-2020-0001-0026
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0014 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0018 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0020 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0033 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0015 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0027 https://api.regulations.gov/v4/comments/ONDCP-2020-0001-0026
Kenneth Kerry Brian Nicole Anonymous Anonymous Anonymous
Finn Anonymous Kerska Lieber Anonymous Anonymous Anonymous
The United States has failed to recognize or act upon marijuana as a drug threat, despite clear violation of international treaties.  The health harms are more apparent and societal and environmental harms will outstrip alcohol and tobacco.  Never before has there been such a public health and safety concern over a plant, which at one time, was fairly benign, but now, with rising potencies is associated with violence, driving fatalities, increased youth access, use, and addiction, and negative impacts to the unborn.  The United States must act accordingly and reign this in quickly before we lose generation of youth, destroy our environment, and to protect the public health and safety. Im  a 59 year old chronic pain patient with 4 autoimmune diseases. Ive bad 20 surgeries in 17 years. There are no cures for the diseases I have. Ive have tried multiple modalities to help ease my pain. I started with a pain management doctor 10 years ago. My pain had  been kept to a tolerable level when Im on pain medication. I have some quality of life now, but its not as good as it could be since the CDC guidelines came out. My medicines were changed and dosages lowered. I try to stay active visiting a gym. Im not expecting my pain medication to take away all my pain.I Just want to be able to do a few things. Ive had to give up so many things because of the pain I suffer everyday. Its Not just me and my Doctor in the exam room anymore. Now the government is telling my doctor what he can and cant prescribe. I do not have an addictive personality or do my pain meds make me high. I always pass my drug screenings and pill counts. I havent done anything wrong but Im being treated like a criminal. Please let doctors be doctors again and use the DEA to clean up our streets where the illegal  heroin and fentanyl are killing people. My heart breaks for all the chronic pain patients who are suffering to the point of wanting just to die so the pain will stop. I chose to do this anonymously because I dont want anymore restrictions put on my medical history. Im scared to death this has gone way too far with patients.  ONDCPs criteria that enables the country to be proactive in monitoring and identifying emerging drug threats to avoid public health crises has the potential to reverse destructive drug trends. The implementation of the sliding scale, both individually and holistically, allows for a more complete threat evaluation. There are three areas in which we can improve these criteria in order to prevent another crisis similar to the opioid epidemic. The first would be to prioritize or re-categorize these criteria to focus on the proactive measures, such as monitoring online discussions. Secondly, we must avoid the racial disparity experienced with the opioid crisis. Lastly, our outdated approach of smothering drug markets to force prohibition should be at the forefront when developing and implementing these criteria.It would benefit all to prioritize or re-categorize these criteria based on preventive measures versus compiling data of newly diagnosed substance use disorders or measuring morbidity or mortality, when the damage has been done. Through identifying these avenues of discussion or activity early, we can increase interventions to keep the emerging drug threat at bay.   We also want to avoid racial divide over potentially criminalizing by prioritizing based on racial characteristics. The narrative that todays heroin users are largely white and that heroin suppliers are largely black and Latino has contributed to the publics willingness to address opioid use less punitively (Werle and Zedillo, 2018, p. 326). This has created massive disparities in our prison system. We must not prioritize criteria or use language that unfairly highlights a particular racial or ethnic group more than another.    Lastly, we must eliminate our reaction to smother drug markets, which actually makes the problem worse. Look at the Volstead Act during prohibition. Werle and Zedillo (2018) state that it did far more to change what Americans drank than how much (p. 330). Just as with the opioid crisis, eliminating access just pushes production, transportation, sale, and use underground. In addition, overdoses are more common following cessation of naltrexone treatment than among either untreated heroin users or maintenance users (Werle and Zedillo, 2018, p. 328). This may slightly benefit Big Pharma by allowing continuation of production and supply of a potentially dangerous drug; however, as a public-health focus, it is more dangerous if we try to eliminate the drug completely. We would benefit by removing or revising criteria that encouraged suppression that lead to illicit products, such as heroin, fentanyl, or synthetic opioids.Some may object that this approach of rehabilitation versus criminalization by lowering access thresholds would risk providing a[n] acceptable means for people to initiate drug use (Werle and Zedillo, 2018, p. 338). However, this has not held true in countries, such as Switzerland, taking this public-health approach. With these aspects in mind, we should re-categorize and reword the criteria, basing it on priority, equality, and a public-health approach instead of criminalized suppression. Through this proposed policy, we will see lives saved and decreased healthcare costs. This comment addresses the Office of National Drug Control Policy (ONDCP) specifically 21 CFR Part 1401 (RIN 3201-AA02) entitled Criteria for Designation of Emerging Drug Threats in the United States. To determine the emerging drug threats a committee was created and established 11 proposed criteria to identify emerging drug threats and I would like to propose an additional criteria to specifically address the vulnerable population of children aged 12-18, for whom drug abuse can be particularly debilitating, by examining federal, state, local and tribal data for the emergence of use of new or evolving drug, class of drugs, or other substances in this population. This new proposed criterion should exclude substance abuse disorder because waiting for children to develop a substance abuse disorder as written in criteria 7 will prove to be too late. This additional criterion is important because drug misuse has been shown to increase with age starting in early adolescence and peaking in early adulthood (McGorry et al., 2011). With this fact in mind, interventions that aim to stop or postpone the onset of drug use should be targeted to a specific population before or during adolescence (McGorry et al., 2011). In order to effectively decrease the burden of emerging drug trends and its effect on medical and public health, the ONDCP must be able to carefully consider the adolescence population and quickly determine patterns to avoid another opioid crisis. Many are aware of the health hazard that adult opioid abuse poses in the United States, however the effect of opioid abuse on children is often overlooked. Opioid abuse is a major public health issue for children in the United States and is clearly evident with the increasing number of emergency department visits by young children and adolescents for poisoning by prescription opioids (Allareddy  Rampa, 2017). Emerging drugs threats in adolescence must be identified and action must be taken early to prevent future public health hazards.References: Allareddy, V.,  Rampa, S. (2017). Opioid abuse in children: an emerging public health crisis in the United States. Pediatric Research, 82(4), 562-563.McGorry, P., Purcell, R., Goldstone, S., Amminger, G. (2011). Age of onset and timing of treatment for mental and substance use disorders: Implications for preventive intervention strategies and models of care. Current Opinion in Psychiatry, 24(4), 301-306.  Dear ONDCP,I wish to strongly oppose the legalization of cannabis across USA.This has major effects internationally and is a clear and present danger to the health of the population of the rest of the world as well by virtue of the major leadership role which USA plays in the international community.Cannabis is also a clear and present threat to the coming generations - at least four generations and probably more - by virtue of its well documented heavy epigenetic footprint.  Cannabis has been shown to act on both DNA methylation and histone modifications and even reduces histone synthesis.  Reduced synthesis of histone proteins necessarily implies that the controls over gene transcription are reduced, just as occurs in cancer, aging and in many congenital anomalies.A frightening and very detailed geotemporospatial consideration of the US epidemiology of four areas of:1)Mental Illness2)Autism3)Congenital Anomalies4)Pediatric Cancerhas been compiled by me in an as yet unpublished book entitled Cannabis Indictment: Heritable Cannabis Epidemiology: Neurotoxicity, Genotoxicity, Teratogenicity and Carcinogenicity and is available at this Dropbox linkhttps://www.dropbox.com/sh/9es9yzrqnfon7sn/AAAIjoHKOomx-7d38NRry5oNa?dl=0 On geospatial criteria 38 of the 62 congenital defects tracked by CDC are shown to be linked with cannabis exposure.  On risk ratio criteria (Prevalence ratios, the same as used by CDC epidemiologists) 44 of the 62 defects tracked by CDC are shown to be elevated in states with higher cannabis exposure.These are very concerning findings by any metric.Similarly many detailed documents addressing these issues are also available at this Dropbox link.https://www.dropbox.com/sh/pq64wseep2x7evu/AAA7cmAGg4qfUvJCOe6gsFyaa?dl=0 We presently have seven papers in Submission to various general and geospatial medical journals relating to the subjects of:1)Mental illness in USA2)Autism in USA3)Atrial Septal Defect in USA4)Downs Syndrome in USA5)Phocomelia in USA6)All Congenital Defects in the High Cannabis Area of Northern New South Wales in Australia7)Cannabis potentiation of Coronavirus infection rate across USA.When these seven papers were compiled I had mastered geospatial analysis in R from CRAN (using packages spdep and splm).  Now I have also mastered inverse probability weighting and eValue techniques which allow me to formally investigate CAUSAL relationships using well established methods.Work on CAUSAL RELATIONSHIPS is complete in the three domains of:1)Atrial septal defects2)Cannabis-coronavirus interaction and 3)Autism.IN EACH CASE THERE IS VERY STRONG EVIDENCE THAT CAUSAL RELATIONSHIPS EXIST BETWEEN CANNABIS EXPOSURE AND EACH OF THESE THREE METRICS.IN VIEW OF THE HIGH LEVEL OF STATISTICAL SIGNIFICANCE SHOWN AT GEOSPATIAL ANALYSES, WITH MANY P10 -16 I FULLY EXPECT THE CAUSAL ANALYSIS TO ALSO BE STRONGLY POSITIVE IN THE OTHER FOUR KEY DOMAINS EXAMINED.It will not be lost on ONDCP I am sure that Downs syndrome is a major genetic defect which has risen three times over the last forty years when one factors in the very high rates of abortion conducted for major genomic errors in most jurisdictions.  ELEVATED RATES OF DOWNS SYNDROME CONSEQUENT TO CANNABIS EXPOSURE NECESSARILY DOCUMENTS MAJOR HUNDRED MEGABASE SCALE CANNABIS-RELATED GENOTOXICITY.Atrial septal defect of course is one of the commonest of all the cardiovascular defects which itself is the commonest group of congenital anomalies, which are the leading cause of infant and child death under five years in USA and many other nations worldwide.Dropbox is used due to the size and number of the files concerned.Similar relationships were seen in Hawaii, Colorado and in our published geospatial analysis of all Canadian birth defects and or Canadian neural tube closure birth defects.This submission should be kept confidential as some of the documents quoted are still embargoed pending publication.However they are provided on this occasion for the benefit of the Government of USA, the health of the global population and in the developmental interests of many generations yet to be born.Thankyou for considering these weighty facts.Yours sincerely,Professor Dr Albert Stuart Reece,University of Western Australia,Edith Cowan University,Australia. Substance abuse in the United States is a widespread, costly and devasting situation. As a healthcare provider, I appreciate the effort of the Office of National Drug Control Policys (ONDCP) creation of 11 criteria for identifying and monitoring emerging drug trends in the United States. These criteria are broad but appropriate to identify emerging drug trends in hopes to prevent the development of another opioid like crises in the future.  As suggested in criteria 9, increasing online discussion of evolving drug threats is a great step to educating the public on emerging trends. Obviously, much of society spends a lot of time seeking out information online and having scientifically backed resources available to the public can eliminate gaps in knowledge. In addition, facilitating the communication with local healthcare providers in primary care, emergency departments and poison control centers can assist in identifying emerging drug trends. I know the ONDCP aims to open the dialogue online but I do believe opening up communication with healthcare providers in communities seeing spikes in misuse of these drugs would add to the data, surveillance and ultimate prevention of drug abuse. A focus on primary prevention will help mitigate issues of drug threats and proper dissemination of educational materials in waiting rooms, offices and lounges assists in getting the information out to the public in a safe and effective manner (Phillips et al., 2017). ReferencePhillips, J., Lim, F.,  Hsu, R. (2017). The emerging threat of synthetic cannabinoids. Nursing Management, 48(3), 22-30. https://doi.org/10.1097/01.NUMA.0000512504.16830.b6 To the ONDCPs Emerging Threats Committee,Regarding your request for public comments on issues specified in your Criteria for Designation of Emerging Drug Threats in the United States, Id like to provide my thoughts.  I am a registered nurse (RN) whose experience largely consists of urban emergency department (ED) practice, and am currently a Doctor of Nursing Practice (DNP) student in the Family Nurse Practitioner specialty.  I can certainly anecdotally corroborate the Committees statement that increases in ED visits are generally consistent with emerging drug trends; in particular, my experience of caring for patients believed to be under the influence of synthetic cannabinoids (e.g. K2) comes to mind.  With respect to the proposed criteria in general, I feel that the Committee has developed a comprehensive list that would reasonably facilitate designation of a substance as an emerging drug threat, and interpretation of findings based on a sliding scale is appropriate based on individual circumstances depending on the substance.  Related to criterion 4, I feel that comprehensive screening for what seem to be emerging drug threats during these visits, hospitalizations, or treatment admissions may play a particularly important role; patients may present seeking treatment for a substance use disorder unrelated to the emerging drug threat, however they may be using this novel drug in addition to the substance they are seeking treatment for (ONDCP, 2020, p. 29367, column 1, para. 3).  Although they are pursuing care for a different drug use disorder, a patient who endorses use of the emerging drug may still have pertinence in the interest of tracking its prevalence in a given region.  As a potential emerging threat, these substances may not yet be associated with any particular pathologies, overdoses, or patterns of presentation, which can make defining the substance difficult.  Despite the prevalence of patients presenting with these substance use disorders in ED settings, as described by Hawk and DOnofrio (2018), the EDs role in screening and facilitating intervention is still lacking.  If the Committee were to place greater emphasis on comprehensive screening for all substance use disorders in the ED and facilitating pursuit of treatment, theres potential for uncovering more information regarding these emerging drug threats and using these methodologies to inform interventions.  Potentially incorporating a reporting requirement in EDs for these new substances for measurement purposes, regardless of new or novel clinical illnesses that may develop in those users, may also be beneficial (ONDCP, 2020, p. 29367, column 1, para. 3).  By screening ED patients in particular for emerging drug threats (and all substance use, for that matter) irrespective of novel substance-related pathology, insight may be gained regarding trends and pertinent epidemiological information that can be used to guide future study and make recommendations for the public.ReferencesHawk, K.,  DOnofrio, G. (2018). Emergency department screening and interventions for substance use disorders. Addiction Science  Clinical Practice, 13(18), 1-6. https://doi.org/10.1186/s13722-018-0117-1 Office of National Drug Control Policy [ONDCP]. (2020). Criteria for designation of emerging drug threats in the United States. 85(95), 29366-29368. https://www.regulations.gov/document?D=ONDCP-2020-0001-0001 