March 12, 2025
Dear Mr. President,
As dedicated medical professionals we share HHS’s commitment to improving the health, safety, and well-being of Americans. Accordingly, we are compelled to call your attention to a long-standing failure in basic preventive services in the United States that poses a profound threat to Americans of every age and patient demographic. We refer, specifically, to the potentially injurious and fatal consequences of undiagnosed vitamin B12 (cobalamin) deficiency, a commonly overlooked condition that, left untreated, can cause irreversible damage to virtually any organ system in the human body.
For over 25 years, we’ve campaigned to raise widespread awareness among our colleagues as well as governmental officials at local, state, and national levels of the need for updated screening protocols to detect B12 deficiencies early. Incredibly, our call for simple, common-sense, data-driven updates to standards of care in the US have been largely ineffective. Thus, we appeal herein to you, Mr. President, and separately to HHS Secretary Robert F. Kennedy Jr., who has the authority and requisite resources we lack to improve outcomes in this setting and, in the process, save the health of millions of Americans.
With over 30 years’ experience as board-certified, front-line practitioners in emergency medicine and emergency nursing—supported by a wealth of data in the professional literature—we bring first-hand knowledge to the compelling argument in favor of improving screening criteria, testing, and treatment. Undiagnosed, thus untreated, B12 deficiency constitutes a public-health threat that costs state and federal agencies billions of dollars and imposes an avoidable burden on Americans in terms of morbidity and mortality, as well as financial hardship. When one compares the benefits and minimal cost of B12 replacement therapy versus the aggregate consequences of misdiagnosis and failure to treat—the current status quo—the analysis points to ongoing fiscal and medical malpractice.
The importance of this essential vitamin is widely underestimated. Indeed, it’s fair to say we are in the midst of a silent epidemic of ignorance—or, worse, indifference—among healthcare professionals when it comes to the detection and treatment of vitamin B12 deficiency. Consumers who view B12 as “optional” are likely unaware of the vital role it plays in sustaining life itself, which can be problematic.
Vitamin B12 deficiency causes weakness, fatigue, mental illness, dementia, neuropathy, anemia, balance and gait disorders, tremors, fall-related trauma, vascular occlusions, and developmental disabilities. Often times it’s diagnosed late, and the disease has progressed to a debilitating condition causing neurologic injury. Billions of health-care dollars are squandered by failing to screen symptomatic and at-risk patients and using other medications and treatments in its place. Repeated ER visits and hospital admissions result, contributing to overcrowded facilities.
Sources of B12 include liver, seafood, meat, dairy products, and eggs. Vitamin B12 deficiency can occur from poor dietary intake, impaired absorption, medications, maternal factors, or from an autoimmune condition known as pernicious anemia. A variety of gastrointestinal disorders such as Crohn’s or celiac disease, atrophic gastritis, and gastrointestinal surgeries (e.g., bariatric, ileectomy) can cause B12 deficiency. Vegan or vegetarian diet, eating disorders, alcohol abuse, liver disease, chemotherapy, radiation therapy, Helicobacter pylori, and genetic mutations are yet other causes. Certain medications (proton-pump inhibitors, metformin) as well as nitrous oxide (aka “laughing gas,” an anesthetic used in medical and dental procedures, and increasingly abused recreationally by teens and young adults) interfere with B12 metabolism.
The damage caused by vitamin B12 deficiency progresses in a slow, insidious manner. Early clinical studies recognized that B12 deficiency caused severe neuropathy leading to paralysis and death, while post-mortem analysis demonstrated spinal cord demyelination. The signs and symptoms are similar to other neurological disorders (e.g., dementia, Parkinson’s, multiple sclerosis, Guillain-Barré syndrome). It is a great mimic and seldom suspected when pursuing more “common” diagnoses. Thus, the opportunity to rule out a B12 deficiency early, when it is often reversible with supplementation, is lost. For example, signs of Alzheimer’s and other forms of dementia can mirror signs of B12 deficiency. Unlike Alzheimer’s, a B12 deficiency can be reversed—but only if caught in time. Yet, proper screening and treatment by all practitioners is not universal, despite how devastating a B12 deficiency can be. We wonder whether former President Joe Biden received proper testing.
The same can be said about autism spectrum disorders. Unlike autism, pediatric B12 deficiency can be reversed—but only if diagnosed early. Lack of B12 during pregnancy, infancy, or early childhood can injure the brain causing lifelong disabilities. Pediatric B12 deficiency causes demyelination and atrophy of the brain and nerves. During the third trimester of pregnancy and during infancy the brain rapidly develops, forming neural connections and myelination which is critical for motor, language, and communication skills, as well as sensory processing. The signs and symptoms of autism are virtually identical to those of pediatric B12 deficiency. Therefore, infants and young children with developmental delay or ‘autistic-like’ symptoms must have B12 deficiency ruled out. In the 21st century, there is no excuse for a child to have a brain injury due to B12 deficiency and later have it labeled or misdiagnosed as “autism.” Just as in stroke, “time is brain,” the same applies to pediatric B12 deficiency.
It is well established that B12 deficiency causes psychiatric illness. It is surprising that most doctors fail to routinely consider low B12 as a cause of their psychiatric patients’ symptoms. Patients who present with mental illness symptoms (e.g., depression, suicidal or homicidal ideations, psychosis, hallucinations, mania, OCD), need proper B12 screening. This is not currently happening.
Ignoring B12 deficiency in America—unknowingly or by design—results in lucrative profits when misdiagnosis leads to inappropriate use of costly prescription drugs, treatments, therapies, hospitalizations, and avoidable long-term nursing care. The unnecessary costs associated with failure to screen contribute significantly to our rising national debt, which is entirely avoidable given an inexpensive treatment has been available for nearly 80 years. Its landmark discovery proved life-saving to countless patients. Moreover, it was, and remains, highly affordable. Imagine the financial savings that could be realized by treating B12 deficiency in mental illness alone.
I (S.P.) started the fight for this cause back in 1998. I am an ER nurse from Macomb County, Michigan and have been practicing for over 30 years. I currently work at the same hospital that gave me a gag order in 2000, prohibiting me from educating staff and patients about B12 deficiency or else I would be terminated. I would not, however, be silenced. Since then, I have published four books (one of which has been translated into several other languages*), created B12awareness.org, have lectured in the US and in Europe, and appeared in a documentary. Additionally, an 87-minute feature film was made about my life story. Sally Pacholok won best feature film at the 2015 D.C. Independent Film Festival. The film’s tagline was, “This nurse could save your life.” “Registered Nurse Sally Pacholok takes on the medical establishment’s epidemic of misdiagnosis and writes her influential book about vitamin B12 deficiency (based on true events).” It debuted at the US Naval Heritage Center’s Burke Theater, in Washington, DC, and actress Annet Mahendru, well-known for her role in The Americans, played me.
Recently you stated, “Something is wrong,” about the rising incidence of autism, and “We’re gonna figure something out.” Well, something is definitely wrong and we can help you decrease the numbers by educating you and your team about pediatric B12 deficiency and how it is being misdiagnosed as autism. We continue to “Fight, fight, fight!”, because this atrocity has been lurking behind closed doors in our healthcare system for decades and it must stop. Identifying and treating B12 deficiency in all ages is common sense and we’re confident you would agree!
Despite our minor accomplishments and dedicated work exposing this epidemic, our healthcare leaders and governmental officials have all turned a blind eye. Untreated B12 deficiency has turned into a chronic disease over the past four decades, injuring Americans, ruining lives and wasting billions of healthcare dollars. It would be our great honor to update, educate, and work with you and your team in any capacity. We believe we can help you Make America Healthy Again and end this silent epidemic. A comprehensive list of possibilities is well beyond the scope of this letter, but we would be pleased to provide additional information and assist in any way possible. Please do not hesitate to contact us for further information.
Sincerely,
Sally M. Pacholok, RN, BSN
Jeffrey J. Stuart, DO
Pacholok, SM, Stuart JJ. Could It Be B12? An Epidemic of Misdiagnoses. Quill Driver Books; 2005.
*Pacholok, SM, Stuart JJ. Could It Be B12? An Epidemic of Misdiagnoses, (2nd Ed.) Quill Driver Books; 2011.
Pacholok, SM, Stuart JJ. Could it Be B12? Pediatric Edition: What Every Parent Needs to Know About Vitamin B12 Deficiency. Quill Driver Books; 2016. Pacholok, SM. B-12 Sally! Ingram Sparks; 2024, Kindle Direct Publishing; 2024.