Charles Lapp

Charles W. Lapp, MD, is an Internist and Medical Director at Hunter-Hopkins Center in Charlotte, NC with a practice specializing in ME/CFS, FM, and related conditions. Earlier in his career, he practiced family medicine and pediatrics in Raleigh, NC. He became interested in ME/CFS following an outbreak of three small epidemics of a chronic fatiguing illness in the Raleigh area. One of these outbreaks was among all the members of the N.C. Symphony Orchestra.

"Patients started coming to me with persistent flulike symptoms[...]They would work one day and have to sleep for two. Perfectly well-adjusted people became disabled almost overnight.”

From 1992 to 1995 Dr. Lapp acted as Medical Director of the Cheney Clinic in Charlotte, in collaboration with Dr. Paul Cheney. In August 1995, Dr. Lapp opened the Hunter-Hopkins Center. His center does testing for disability insurance such as the 2-day Cardiopulmonary exercise testing (CPET) and a Computer-assisted cognitive function test.

He is currently in practice with Dr. Laura Black.

Awards

• 2009, Nelson Gantz Outstanding Clinician Award awarded to a physician who emulates Nelson Gantz's clinical acumen, his passion for medicine, and his empathy for persons with CFS/FM awarded by IACFS/ME

Pediatric Case Definition

• 2006, "A Pediatric Case Definition for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome"

  "Summary: For a diagnosis of chronic fatigue syndrome (CFS), most researchers use criteria that were developed by Fukuda et al. (1994), with modifications suggested by Reeves et al. (2003). However, this case definition was established for adults rather than children. A Canadian Case Definition (ME/CFS; Myalgic Encephalomyelitis/CFS) has recently been developed, with more specific inclusion criteria (Carruthers et al., 2003). Again, the primary aim of this case definition is to diagnose adult CFS. A significant problem in the literature is the lack of both a pediatric definition of ME/CFS and a reliable instrument to assess it. These deficiencies can lead to criterion variance problems resulting in studies labeling children with a wide variety of symptoms as having ME/CFS. Subsequently, comparisons between articles become more difficult, decreasing the possibility of conducting a meta-analysis. This article presents recommendations developed by the International Association of Chronic Fatigue Syndrome Pediatric Case Definition Working group for a ME/CFS pediatric case definition. It is hoped that this pediatric case definition will lead to more appropriate identification of children and adolescents with ME/CFS."

Clinical Trials

The Hunter-Hopkins Center is currently one of two clinical sites participating in the Hemispherx Biopharma 511/open label Ampligen trials to gain FDA approval. Ampligen is an IV medication given twice weekly in the Hunter-Hopkins infusion room. For more information in this program please see this link: Ampligen study at Hunter-Hopkins.

Clinic location

• Hunter-Hopkins Center
• 7421 Carmel Executive Park Dr.
• Charlotte, North Carolina 28226
• Telephone: (704) 543-9692
• Email: drlapp@drlapp.net

Notable Studies

• 2016, CDC Grand Rounds: Chronic Fatigue Syndrome — Advancing Research and Clinical Education. Morbidity and Mortality Weekly Report
• 2012, A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome.

  Abstract: "A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET). Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36). Subjects receiving rintatolimod for 40 weeks improved intra-patient placebo-adjusted ET 21.3% (p = 0.047) from baseline in an intention-to-treat analysis. Correction for subjects with reduced dosing compliance increased placebo-adjusted ET improvement to 28% (p = 0.022). The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies. The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048). Placebo subjects crossed-over to receive rintatolimod demonstrated an intra-patient improvement in ET performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg twice weekly was generally well-tolerated.

• 1997, Management of Chronic Fatigue Syndrome in Children: A Practicing Clinician's Approach

Talks & interviews

• 16 Feb 2016, CDC Grand Rounds - Chronic Fatigue Syndrome: Advancing Research and Clinical Education with Charles Lapp, MD, Elizabeth Unger, PhD, MD, Anthony Komaroff, MD and Avindra Nath, MD

HHS/CFSAC Testimony

• Oct 29, 2009 Testimony (read by Cort Johnson)

Open Letter to The Lancet

Two open letters to the editor of The Lancet urged the editor to commission a fully independent review of the PACE trial, which the journal had published in 2011. In 2016, Dr. Lapp, along with 42 colleagues in the ME/CFS field, signed the second letter.

• 10 February 2016, An open letter to The Lancet, again - Virology blog

Online presence

• PubMed - Charles Lapp
• Hunter-Hopkins Center Facebook page
• Hunter-Hopkins Center website

Learn more

• 2012, What Are The Most Important Things To Remember About CFS/FM?
• Curriculum Vitae - Charles W. Lapp, MD

See also

• NIH Post-Infectious ME/CFS Study
• Ampligen
• 1984 Chapel Hill outbreak
• Dr. Laura Black

cognition Thought processes, including attention, reasoning, and memory.

myalgic encephalomyelitis (M.E.) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.

double blinded trial A clinical trial is double blinded if neither the participants nor the researchers know which treatment group they are allocated to until after the results are interpreted. This reduces bias. (Learn more: www.nottingham.ac.uk)

agonist A chemical that binds to the receptor and stimulates it's function, e.g., morphine is an opioid agonist that binds to the opioid receptor, reducing pain. The opposite of an antagonist.

phase three Last phase of clinical trials before a drug can be approved for public use. Whereas Phase one assesses basic safety, and Phase two assesses basic efficacy, Phase three uses many trial participants to fully assess both safety and efficacy, and overall benefit/risk.

Short Form 36-Item Health Survey (SF-36) - A 36-item patient-reported questionnaire, used to determine patient health status and quality of life.

Chronic Fatigue Syndrome Advisory Committee (CFSAC) - (sometimes pronounced SIF-SACK) A US government advisory council that met twice per year, covering current topics related to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Meetings usually lasted for two days and the results were presented to the Secretary of Health and Human Services (HHS). After 15 years, on September 5, 2018, CFSAC's charter was not renewed by the Department of HHS, effectively dissolving the committee without notice or warning.

Centers for Disease Control and Prevention (CDC) - The Centers for Disease Control and Prevention is a U.S. government agency dedicated to epidemiology and public health. It operates under the auspices of the Department of Health and Human Services.