Methylphenidate for ADHD rejected from the WHO Essential Medicines List due to uncertainties in benefit-harm profile

1. Ole Jakob Storebø1,2, 
2. Christian Gluud3

I felt a familiar sense of relief when I saw this repudiation of Ritalin and other medications as an effective treatment for attention related disorders. My training as a psychotherapist included the fundamental premise that medication was something to be used as a way to help to work effectiveliy in therapy. This perspective has been eclipsed by the promotion of medication as curative or the only thing that was needed for the remediation of neuropsychiatric disorders. I've spent the last 15 years working with children and adults having been given this diagnosic label and regularly finding that the side effects of these medications were signfiicantly more challenging than was indicated they should expect from their prescribers. I am aware that I'm writing this post the American presidential electtion has been decided in favor oif the candidate who promoted harm reduction with regard to COVID 19 and the climate crisis. The awful truth is that there are alternatives to amphetamines and related medications that have been assiduously avoided being given the funding and clinical attention they deserved. I hope the new administration will seize on this decision by the WHO and fund research to evolve a treatment service delivery system that will enhance cognition and behavior by promoting non-drug, noninvasive neurophysiologically-based methods of self-regulation, e.g., neurofeedback training. 

i think we are witnessing a powerful shift in perspective and hope the new administration in Washington can't act definitively to authorize the Department of Education to focus on recruiting competent, trauma-informed integrative health- oriented professionals to take up the challenge of improving public education. The FDA needs to rebuild its credibility and focus on supporting evidence-based treatment models predicated on doing the less invasive before more invasive interventions. Therapeutic methods that can be delivered remotely are now essential and we have shown that neurofeedback and other neurotherapeutic methods are precisely what's needed to promote improved levels emotional and behavioral regulation and academic perofrmance without risking exposure to COVID 19. 

Quietmind is promoting the use of near infrared light stimulation as a useful part of a broader CV!9 prevention strategy as well as to reduce the severity and likelihood of post-infection neurological symptoms. 

ebm.bmj.com/content/early/2020/04/24/bmjebm-2019-111328

This study supports our view that diagnosis of neuropsychiatric and neurodegenerative conditions require ruling out any presence of tick borne diseases including Lyme and all co-infections, heavy metal and mold toxicity. Anyone who works outdoors or participates in field related sport activity who then develops PTSD should be checked for the presence of these neuroinfalmmatory agents. Traumatic events may trigger the expression of symptoms in those who are sufficiently compromised to impair full recovery. QMF has long employed and advocated for the use of Quantitative EEG and heart rate variability (HRV) indices as neuromarkers that allow empirically validated injury assessment, thus leading to highly individualized treatment planning and efficacy assessment.  
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The prevalence of Lyme disease and associated co-infections in people with a chronic post-concussive syndrome
Azzolino S, Zaman R, Hankir A, Carrick FR.
Psychiatria Danubina. 2019 Sep;31(Suppl 3):299-307.
https://www.ncbi.nlm.nih.gov/pubmed/31488744

Abstract
Introduction
There is increasing awareness that Lyme borreliosis (LB) and traumatic brain injury (TBI) may cause mental health symptoms. TBI and Lyme disease compromise the health and activities of millions of patients per year. The chronic symptoms and disability of TBI and Lyme disease share a similar clinical presentation. We have identified an alarming number of individuals suffering from post-concussion syndrome (PCS) that are refractory to care and that have serologically tested positive for Lyme disease.

Subjects and Methods
A single-center retrospective review of patient charts that were symptomatic a minimum of one year after a TBI that were tested for Lyme disease to ascertain if there was a relationship.

Results
217 PCS patient records (93 females with a mean age of 34 years, 120 males with a mean age of 40 years and 4 individuals with unknown gender) were included in the review. 38% had a positive Western Blot Igenex IgM. There was a statistically significant relationship of a positive Western Blot Igenex IGM predicting chronic PCS Pearson χ2(1)=6.8866, P=0.009, Fisher's exact score p=0.015 and φ=0.2813 representing a moderate effect size.

Conclusions
Long term PCS over one year's duration is associated with undiagnosed Lyme disease. There was statistical and substantive significance between individuals with chronic PCS having a positive Western Blot Igenex IgM. Males were more likely to have a positive Western Blot Igenex IgM than females.

Free, full text (pdf file):
http://www.psychiatria-danubina.com/UserDocsImages/pdf/dnb_vol31_sup3/dnb_vol31_sup3_299.pdf

We can see now a growing body of evidence underscoring the relevance of photobiomodulation (PBM) and neurofeedback (NFB) as immediately applicable interventions for remediating the damage caused by COVID 19 infection. PBM has been shown to effectively reduce inflammatory markers throughout the brain, and promte improved cortical perfusion thereby improving tissue-level brain health and resistance to further injury. NFB can then be employed to repair the damage done to neural network connectivity allowing for a renormalization of overall brain activity.  

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​https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(20)30495-1

This paper offers an opportunity to the neurotherapy community to build the bridge between functional MRI and QEEG analysis especially with the availability of swLORETA and DTI analytics. The findings from this study suggest that trauma decreases the robustness of internetwork communications, thereby lending support to what I've suggested regarding the CNS's response to trauma involving a 'regression' shift to a more primitive (lower glucose demand) organizational algorithm that predates the development of bilateral connectivity through the corpus collosum. These data would be helpful in organizing a treatment model to support the renormalization of internetwork connectivity and a corresponding reduction in dissociation which is a primitive (primary process) object-relational mechanism for discriminating similarities and differences.

AbstractObjective:Dissociative experiences commonly occur in response to trauma, and while their presence strongly affects treatment approaches in posttraumatic spectrum disorders, their etiology remains poorly understood and their phenomenology incompletely characterized. Methods to reliably assess the severity of dissociation symptoms, without relying solely on self-report, would have tremendous clinical utility. Brain-based measures have the potential to augment symptom reports, although it remains unclear whether brain-based measures of dissociation are sufficiently sensitive and robust to enable individual-level estimation of dissociation severity based on brain function. The authors sought to test the robustness and sensitivity of a brain-based measure of dissociation severity.
Methods:An intrinsic network connectivity analysis was applied to functional MRI scans obtained from 65 women with histories of childhood abuse and current posttraumatic stress disorder (PTSD). The authors tested for continuous measures of trauma-related dissociation using the Multidimensional Inventory of Dissociation. Connectivity estimates were derived with a novel machine learning technique using individually defined homologous functional regions for each participant.
Results:The models achieved moderate ability to estimate dissociation, after controlling for childhood trauma and PTSD severity. Connections that contributed the most to the estimation mainly involved the default mode and frontoparietal control networks. By contrast, all models performed at chance levels when using a conventional group-based network parcellation.
Conclusions:Trauma-related dissociative symptoms, distinct from PTSD and childhood trauma, can be estimated on the basis of network connectivity. Furthermore, between-network brain connectivity may provide an unbiased estimate of symptom severity, paving the way for more objective, clinically useful biomarkers of dissociation and advancing our understanding of its neural mechanism
ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2020.19060647

This is the latest publication showing the impact of safe, self-administered infrared light therapy as an effective treatment neurotrauma and related neurodegenerative conditions. The device used in this study was the Vielight Duo which provides both 10hz and 40hz stimulation to the brain as well as the body's blood supply through intranasal stimulation.  The study results suggest that the 8 weeks of stimulation resulted in increased brain volume in an number of regions and a decrease in hippocampal volume and overall network connectivity in relation to the anterior cingulate cortex (ACC). The assumption that the intranasal stimulation would stimulate hippocampal activity is not supported by this study's results as the power density of the intranasal applicator is lower than the transcranial diodes and the amount of photons that could reach the brain would be rather limited. The intranasal unit does provide an excellent vehicle for stimulating the entire body's blood supply as it passes through the facial region every 4 minutes and thereby can irradiate all the free floating mitochondria now found to be in the blood stream. 
                               "Along with other data, the results suggested that the free-floating mitochondria
                               in healthy blood were in fact functioning, respiring organelles. The team estimates
                               that there could be between 200,000 and 3.7 million cell-free, intact mitochondria
                               per milliliter of blood plasma." 
Z.A.A. Dache et al., “Blood contains circulating cell-free respiratory competent mitochondria,” The FASEB Journal, doi:10.1096/fj.201901917RR, 2020. 

Quietmind Fdn. has been a long time advocate of PBM treatment and has taken a leading role in the integration of Vielight and other forms of PBM with neurofeedback and functional medicine. This study further illustrates the need for careful titration of stimulation dosing in order to avoid negative reactions (headaches) which can result from overstimulation. QMF provides consultation to Vielight users to optimize clinical results while minimizing adverse response potential.

The documented lack of improvement in delayed recall after 8 weeks of treatment while free recall did improve suggests the lack of neural connectivity improvement. This is not surprising and has been discussed in previous publications and underscores the relevance for an integrative treatment approach that seeks to improve both tissue level pathology with PBM and neural connectivity using brainwave biofeedback or neurofeedback training. This therapeutic combination leverages the value of increased perfusion, oxygenation and ATP production while renormalizing neural connectivity.  

Quietmind offers clinical and technical consultation to anyone purchasing Vielight devices through our clinical trial programs. Please contact our office for details info@quietmindfdn.org or call 610-940-0488.
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www.frontiersin.org/articles/10.3389/fneur.2020.00952/full

The growing recognition of serious neurological damage happening to people who were infected with COVID 19 is now growing and scientific findings are struggling to answer the question as to its viral or inflammatory cause. Treatment choices will turn on the underlying causative factors but the need for a quick and safe treatment is considerable now. I can speak from my personal experience with having had CV19 starting in late March and being tested as free of virus in late April about the impact this illness can have on neurological functioning. I had several spike of fever to above 103F and severe chills and productive cough and fatigue. I thought originally I had pneumonia until the test proved it was CV19. My neurological symptoms included ataxia, impaired cognition and was occasionally unable to organize my communication adequately, particularly with word finding and auditory processing. 

I was fortunately had the Cognitolite 1068nm pulsed (10hz) transcranial infrared unit at home and used it 2-4x daily for well over a month and then tapered to 3-5x/week now. I also was taking 2G VitC q2hr and tapering by half when my urine turned bright yellow. I never had GI distress during this period of high dosing nor afterward. I also was taking 5-10K D3 and Zinc daily and flushing my system with filtered water and electrolytes.  

It would seem likely that my symptom severity was decreased by this regime and it would now seem reasonable from further investigation that the use of transcranial photobiomodulation could be used as an initial intervention with minimal side effect potential while patients are evaluated for viral or parasitic and other neuroinflammatory markers that would indicate the need for antiviral or anti-inflammatory treatment. 

Quietmind Fdn. is making the Cognitolite treatment is available for home use by rental of the device on a donation basis. Please call 610-940-0488 to discuss the protocol.  
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www.nature.com/articles/d41586-020-02599-5

With the publication of this study jamanetwork.com/journals/jamanetworkopen/fullarticle/2770551, we are now entering a new level of recognition for the use of light therapy for treating neurodegenerative diseases and neurotrauma rehabilitation. The use of transcranial light therapy in treating TBI is now showing to be safe, easily tolerated and effective in making measurable changes in brain physiology. These findings are welcome addition to the published research and clinical programs at Quietmind Fdn. over the past 13 years with the Cognitolite and for 6 years with Vielight's Neuro photobiomodulation devices. We are conducting ongoing trials with Vielight's devices and can offer participants substantial savings and free clinical assessments. 

Our hope is to advance further with these techniques and hope to collaborate with the team at Harvard and elsewhere on designing new integrated tools that will deliver the correct amount of light to produce the optimal cognitive and physical responses for people with head trauma and neurodegenerative disorders like Alzheimer's, Parkinson's and ALS. More information on our current clinical trials can be found at www.quietmindfdn.org/trials.html

Recent work done in clinics in the US have shown that exposure to green light in the prodromal (early) stages of migraines can significantly reduce their severity. This report provided by Kaiyam Medical. I think this would be good to combine with neurofeedback to rework the CNS' response to stimulation. 

www.kaiyanmedical.com/post/defeat-the-migraine-with-the-power-of-the-green-light

This article shows current findings related to cerebrovascular reactivity(CVR) as a marker for dementia onset and progression. We've been promoting photobiomodulation with both the Cognitolite, Vielight and other LLLT devices as a means of decreasing vascular reactivity which in our case we've referred to as 'vascular inflexibility'. Not unlike how the healthy flexibility of the cardiac rhythm is undermined by various factors that lead to infarcts and other problems, we see cerebral vasculature as being susceptible to similar challenges. Neurofeedback training will help sustain the improved level of functioning by optimizing cortical electrical functions that will help improve vascular responsiveness.

https://www.psychiatryadvisor.com/home/topics/neurocognitive-disorders/alzheimers-disease-and-dementia/cerebrovascular-reactivity-predicts-cognitive-impairment-independent-of-ad/?utm_source=newsletter&utm_medium=email&utm_campaign=pa-update-hay-20200824&cpn=&hmSubId=6Qh5EgxRQ0A1&hmEmail=VFLBRZ7KAOgTOytGd7O2WyfFDtHnYy33zUsxQGbtptc1&NID=&email_hash=24523e9d8526aea879f1cbe868535f18&mpweb=1323-102963-6650987

I tested positive for cv19 in early April and was tested as negative on 4/27 and donated plasma the next day. I was sick for 2+ weeks and managed to avoid hospital and lasting damage to my lungs and brain by adding two things to my treatment regimen, high dose Vitamin C and near infrared stimulation to my brain. I took 5 doses of clarithromycin and some promothiazine with codeine over 3 days. I spiked 103 several times and otherwise ran between 99-102 for 2 weeks. I'm quite sure the Vit C which I took about 6-10g/day saved me a lot of damage. 

Here's a further discussion of the value of Vitamin C from Medium -
​ https://link.medium.com/RmfCaNNG18