Category: Ethics

Efficacy Of SARS–CoV-2 Specific Antiviral Therapy for Enteroviral Myalgic Encephalomyelitis/ChronicFatigue Syndrome

Abstract:

Background: Etiology remains elusive for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and no treatment exists. Antivirals had no efficacy in randomized clinical trials (RCT) for Epstein-Barr Virus and HHV-6. Enteroviruses (EV) have been implicated, but no antivirals are available. Many patients who received SARS–CoV-2-specific antiviral drugs for acute Covid-19 (COV19) infection experienced significant improvement of prior ME/CFS symptoms. This study summarizes their responses to antivirals for SARS-Cov-2.
Methods: Neutralizing Antibody (NA) for Coxsackievirus B (CVB)1-6 and Echovirus 6, 7, 9, 11, 30 were done by ARUP lab. Enterovirus Protein (EVP) of Peripheral Blood Leukocytes (PBL) was determined by Western Blot. ME/CFS patients fulfilled Canadian consensus criteria, and had either elevated NA for enteroviruses and/or positive EVP in PBL. ME/CFS patients hospitalized for acute COV19 infection and patients without COV19, were given 5-10 days of IV Remdesivir (Rem) +/- immune modulators. Controls: 20 ME/CFS patients seen concurrently without Remdesivir treatment. Other ME/CFS patients (non-COV19) were given Nirmaltrelvir/Ritonavir (PAX) daily for 10 days +/- one repeat. The energy index (EI) was monitored by the patients before, during and after treatment. Significant improvement was defined as > 30%.
Results: 15/20 (75%) ME/CFS patients – 10/12 hospitalized, 5/8 non-COV19 patients – responded to IV Rem 2-6 weeks after infusions; remission lasted 6-8 weeks to 6-9 months before relapse. Of Controls: 2/20 had mild improvement (< 0.001, X 2 ).

104/200 (52%) of PAX-treated ME/CFS patients improved, often within 2-3 days; all relapsed within days to weeks after treatment. 66%, 33% and 44% of CVB4+, CVB3+, non-CVB3,4+ patients responded to treatment, respectively. EVP decreased and increased with clinical response and relapse.

Conclusion: Rem and PAX demonstrated clinical efficacy in ME/CFS patients with chronic enterovirus infections. Placebo-controlled RCT will be needed to clarify the role of antivirals in ME/CFS.
Source: John K Chia, David Wang, P-2363. Efficacy Of SARS–CoV-2 Specific Antiviral Therapy for Enteroviral Myalgic Encephalomyelitis/ChronicFatigue Syndrome, Open Forum Infectious Diseases, Volume 12, Issue Supplement_1, February 2025, ofae631.2514, https://doi.org/10.1093/ofid/ofae631.2514 https://academic.oup.com/ofid/article/12/Supplement_1/ofae631.2514/7988721?login=false 

Questioning Biomedicine’s Privileging of Disease and Measurability

Abstract:

Within biomedicine, the diagnosis of disease is often privileged over a patient’s experience of illness. Yet up to 30% of primary care visits might be attributable to persistent illness without a diagnosed disease, including functional somatic syndromes like fibromyalgia and chronic fatigue syndrome. When clinicians are unable to diagnose disease or correlate symptoms with measurable changes in biomarkers, patients experiencing such an illness are at increased risk for suspicion, misplaced questioning, or having their motives misinterpreted through damaging social and cultural narratives about gender, race, ethnicity, socioeconomic status, or disability. Adhering strictly to a biomedical model of thinking about disease and diagnosis can prevent clinicians from empathically engaging with patients and helping them navigate their illness experiences.

Source: Kroll C. Questioning Biomedicine’s Privileging of Disease and Measurability. AMA J Ethics. 2021 Jul 1;23(7):E537-541. doi: 10.1001/amajethics.2021.537. PMID: 34351263. https://pubmed.ncbi.nlm.nih.gov/34351263/

A Womanist Approach to Caring for Patients With Empirically Unverifiable Symptoms

Abstract:

Some illnesses and diseases are not apparent to onlookers. Conditions like chronic fatigue syndrome, fibromyalgia, multiple sclerosis, postconcussive syndrome, endometriosis, and many psychiatric illnesses, for example, have symptoms that are not easily or at all measurable. Both clinicians and health care systems, however, tend to focus exclusively on measurability, which can result in evidentiary overreliance and undervaluation of experience narratives and can have clinically, ethically, and socially important consequences for patients with these conditions.

Source: Gatison AM. A Womanist Approach to Caring for Patients With Empirically Unverifiable Symptoms. AMA J Ethics. 2021 Jul 1;23(7):E519-523. doi: 10.1001/amajethics.2021.519. PMID: 34351260. https://pubmed.ncbi.nlm.nih.gov/34351260/

Ethical classification of ME/CFS in the United Kingdom

Abstract:

Few conditions have sparked as much controversy as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Professional consensus has long suggested that the condition should be classified as psychiatric, while patients and advocacy groups have insisted it is a serious biological disease that requires medical care and research to develop it. This longstanding debate shifted in 2015, when U.S. governmental health authorities fully embraced medical classification and management. Given that some globally respected health authorities now insist that ME/CFS is a serious biological disease, this paper asks whether it can be ethical for the U.K. practice guideline now in development to characterize the condition as a mental health disorder.

Following a brief history of ME/CFS controversy, I offer three arguments to show that it would be unethical for the U.K. to now characterize ME/CFS as a mental health condition, considering the relevance of that conclusion for ME/CFS guidelines elsewhere and for other contested conditions.

© 2019 John Wiley & Sons Ltd.

Source: O’Leary D. Ethical classification of ME/CFS in the United Kingdom. Bioethics. 2019 Feb 8. doi: 10.1111/bioe.12559. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/30734339

To Serve or Not to Serve: Ethical and Policy Implications

Abstract:

The Institute of Medicine (IOM) is one of the nation’s more influential health-related non-profit organizations. It plays a large role in shaping health policy by commissioning panels to develop “white papers” describing research and recommendations on a variety of health topics. These white paper publications are often used to help make policy decisions at the legislative and executive levels. Such a prominent institution might seem like a natural ally for policy-related collaborative efforts. As community psychologists, we strongly endorse efforts to positively influence public policy at the national level. However, while serving on influential panels and commissions like the IOM might seem to be very much part of the ethos of our discipline, there are occasions when such institutions are pursuing a mission that inadvertently has the potential to instigate divisive friction among community activists and organizations.

A case study is presented whereby I describe my decision not to accept an invitation to serve on a controversial IOM panel. I explore the ethical challenges regarding maintaining my independence from this institution and its attempt to redefine chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME), as well as the process of searching for alternative avenues for collaborating with community activists to influence policy related to these debilitating illnesses.

© Society for Community Research and Action 2017.

Source: Jason LA. To Serve or Not to Serve: Ethical and Policy Implications. Am J Community Psychol. 2017 Sep 18. doi: 10.1002/ajcp.12181. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28921637