Vol 1 No.1

First Start, Fresh Start

Solving a Crushing Dilemma from New Perspective

You cannot be a practicing primary care or psychiatric provider without being keenly aware of the current, growing, and overwhelming demand for medications such as Adderall and Ritalin coupled with a continuing lack of reliable availability. A PBS News Hour report on July 18, 2023, provided explanations for what has led to this “perfect storm” of need and unmet demand.

They list several reasons:

  • The large number of children diagnosed with ADHD. Based on CDC statistics, 6 million children in ages 3-17 in the U.S. have been diagnosed with ADHD. 60% of them were being treated with medication, primarily stimulants.
  • The large and growing number of adults with ADHD. The CDC reports that 4.4% of adults above age 18 have been diagnosed with ADHD and that 93% of them are being treated with medication. The demand for ADHD medications has been increasing for over a decade, but based on insurance claims data, the demand exploded during the pandemic. From 2020-2021, the number of stimulant prescriptions filled rose by more than 10% among females ages 15-44 and males ages 25-44. Among women ages 20-24, there was a nearly 20% increase.

As schedule  controlled medications, the amount that manufacturers are allowed to produce is tightly regulated. In addition, prescriptions can only be filled with 30-day supplies and those are closely monitored by DEA units across the U.S. in an attempt to prevent illegal diversion.

Because of widely recognized severe shortages, desperate patients and parents have unleashed a torrent of phone calls to pharmacies seeking these drugs. Pharmacists are not allowed to transfer these controlled prescriptions to different pharmacies, and phone calls have swamped pharmacies already stretched beyond capacity.

So, what solutions might help you, your patients, and over-stretched pharmacists at this critical time of crisis? Here is a three-part possible solution that you should consider.

  1. View the diagnosis and treatment of this condition from a new neurobiological framework.
  2. Consider a potential solution from this new neurobiological framework.
  3. Apply this solution and its amazingly simple application from the perspective of “First Start, Fresh Start”.

The new neurobiological framework:

In 2022, Dr. Christopher Palmer, a highly regarded Harvard psychiatrist, published a book which is touted as a “Revolutionary Breakthrough in Understanding Mental Health”. The book, Brain Energy, explains why there is so much overlap and co-morbidity between psychiatric diagnoses, and why current treatments are often disappointing. The book states in the introductory overview (which is extensively explained and documented in the rest of the book), “mental disorders are metabolic disorders of the brain”, and “tiny things called mitochondria are the key”. This changes everything and should change the way we approach neurodevelopmental disorders including attentional ones like ADHD.

A potential solution considering this new framework.

Dr. Palmer’s book explains the necessity of improving mitochondrial function.  He fails to discuss potential treatments for dysfunctional mitochondria.

I think a very safe and simple option that can enhance and boost mitochondrial function for long-term use is a medicine known for almost 125 years. It is generic, inexpensive, and available without prescription. It is listed by the World Health Organization as one of its 100 “Essential Medicines”. An extensive scientific literature establishes that MB is protective and therapeutic for dysfunctional brain- cell mitochondria.

It is methylene blue (MB), an amazing agent that simultaneously increases energy (ATP) production and reduces reactive oxygen species and inflammation. While it is not FDA approved for ADHD, there is a substantial scientific literature that documents that attentional problems such as ADHD are often a result of dysregulated mitochondria in the brain and that MB enhances and stabilizes mitochondrial function. Because most chronic medical conditions also have known mitochondrial dysfunction. Instead of increasing medical risks, it simultaneously has significant potential to reduce them. While it has some MAOl inhibition (and there are warnings regarding use with serotonergic antidepressants), those warnings are based on high dose usage via IV at doses above 4 mg/kg body weight. The low oral doses used daily for psychiatric concerns are well below the NIH statement that it is safe below 2 mg/kg. I am using it and recommending it at doses around 0.25 mg/kg (equal to 15-30 mg of NeuroPro Plus) or even less. At these doses there are essentially no side effects except blue urine, and that serves as proof of adherence!

From now on, consider MB for the first treatment. Start first and start smart by treating the precious mitochondria.

If a patient is already diagnosed and treated with stimulants but is unhappy with results or inaccessibility, think fresh start by treating those precious mitochondria with MB. I think your patients, your staff, and your pharmacist will thank you!

Morella l. et. al., 2022. Emerging roles of brain metabolism in cognitive impairment and neuropsychiatric disorders. Neuroscience and Biobehavorial Reviews.  https//doi.org./10.1016.neurobiorev.2022.104892. Verma P.et al. 2016. Attention-deficit hyperactivity disorder suffers from mitochondria dysfunction. BBA Clinical 6. (2016)153-158.

Noel Gardner M.D, M.Div.

BRIEF BIO-SKETCH

Dr. Gardner Is an Adjunct Professor of Psychiatry at the University or Utah School of Medicine in Salt Lake City where for 15 years he was the Chief or Consultation-Liaison Psychiatry. During this time, he recelved many awaras tor nhs extensive teaching in the medical school curriculum, the psychiatry and family medicine residency programs, and in the Division of Medical Ethics and Medical Humanities. During this time, he also developed a forensic practice, serving as an expert consultant and witness that ultimately involved over 200 cases. He has consulted and/or testified in many high-profile criminal cases (including that of Brian Mitchell, Ronnie Lee Gardner, Ron Lafferty, Mark Hacking, and Roberto Arguelles) as well as a broad range of civil cases at local, regional, and national levels.

Dr. Gardner has been extensively involved in both education and research in psychopharmacology, serving as a site investigator or clinical director on Phase I-IV clinical trials. He has served on numerous national advisory boards involving medications for depression and bipolar disorder and has served on many national speaker’s bureaus.

Dr. Gardner has also had extensive experience in a private practice specializing in complex mood disorders including both bipolar and treatment-resistant depression. Most recently he has been the founder and medical director of a non-profit training clinic that provides completely free care to individuals who are very poor, have serious mental illnesses, and have no insurance. In 2020 the clinic was given an award as The Innovative Mental Health Charity of the Year” by a national organization, and in 2022 Dr. Gardner was named “The Humanitarian of the Year” by the Utah Medical Association.

Vol 1 No.2

Focus on the “How to” of Methylene Blue (MB) for use by
patients, (and family, friends, yourself, etc.) who want
better attention, concentration, and memory

So, you now know (from Vol 1 No. 1 of the Doctor’s Corner) that many cognitive disorders like ADHD are cellular metabolic disorders based on mitochondrial dysfunction. (If you missed it, get that first issue, and read it now). You are probably eager to find a better solution for the many people who need treatment for ADHD and are unhappy with the well-known crises of use, misuse, and unavailability of current treatments.

NOW, what do you and your patients need to know as you explore with them a “First Start” or a “Fresh Start” using MB? Here are the questions and answers you and they need.

HOW DOES MB WORK?
MB is a Mitochondrial Booster! Mitochondria are well known as the “power plants of the cell” (every cell except red blood cells). They do this by converting the energy stored in the food we eat into ATP that the body uses
for all its energy needs. When mitochondria are not functioning well, MB provides an alternative pathway by which mitochondria can continue to generate ATP in a more efficient way. In addition, MB is an important antioxidant that neutralizes reactive oxygen species and reduces inflammation which are primary toxic contributors to mitochondrial and cellular dysfunction. If untreated, mitochondrial dysfunction may continue to further impair cells and contribute to chronic mental and medical diseases. ADHD has clearly documented evidence of mitochondrial dysfunction, so it is not surprising that MB should improve attention, concentration, learning, and memory. In addition, it promotes wellness not only in brain cells but also in bodily cells at the same time. MB is truly a wellness agent for Mind and Body!

IS IT SAFE?
MB is remarkably safe at the oral doses used to treat mitochondrial dysfunction. MB has been used medically for over 100 years. This has generally been at much higher doses when given by IV with peak concentrations 10 to 50 times higher than the oral doses I recommend. The NIH states that MB is safe under 2 mg./kg of body weight. However, its use for neuropsychiatric conditions shows significant benefit at 0.25 mg/kg-0.5 mg/kg. At these doses, there are rarely noticeable side effects except those related to its staining properties. Remind them that it turns their urine blue which is not toxic in any way, and may actually suppress UTIs without causing antibiotic resistance.

IMPORTANT THINGS TO KNOW AND SHARE.
No prescription is needed. It is inexpensive and available online. Some clinics and health stores have it available for purchase.

  • Don’t use in pregnancy or lactation/breastfeeding.
  • Concerns were the result of high doses given by IV, but there is insufficient safety information to comfortably recommend it on the low oral doses I recommend.
  • Use in children under 4 is not recommended.
  • It has no clinically significant drug-drug interactions. It is not an inducer
    or inhibitor of CYP enzymes and is metabolized by multiple CYP enzymes.
  • It is primarily metabolized via conjugation via multiple UGT pathways. 40% is excreted unchanged in urine.
  • It is a reversible monoamine oxidase A inhibitor and has known
    antidepressant and anti-anxiety properties.
  • The warning regarding use
    with SSRIs or SNRIs was from much higher doses via IV uses. However, I generally encourage patients to reduce and consider either a low dose or stopping the SSRI. The lowest dose that caused a serious serotonin
    syndrome was given IV at 5 mg/kg, far above the oral use I recommend.
  • It has a 24-hour half-life so once daily dosing in the morning is recommended. Interestingly, it does not cause anxiety, agitation, or
    mental rigidity seen with stimulants, and does not impair sleep even
    when given late in the day and an additional dose can be safely given.

Finally, it is not habit-forming and has NO potential for abuse. It is available without a prescription online. I recommend ADHD 365 (tablets contain 2.5 mg each and can be dosed progressively higher adjusted to optimal results, or Neuropro Plus which has 15 mg in each tablet. Because of its mitochondrial protective properties, it would be good if people DID develop a habit of taking MB every day along with lifestyle activities that also support cellular/mitochondrial health (nutrition, exercise, mindfulness, social connection, and quality sleep). Until next time, this is Dr. Noel Gardner MD, wishing you many successful First Starts and Fresh Starts with MB, and encouraging you and those you care about and for to live in the “Blue Zone”!