The carnage of substandard research during the COVID-19 pandemic: a call for quality

Bramstedt, Katrina A.

doi:10.1136/medethics-2020-106494

Cited by 124 publications

(124 citation statements)

References 34 publications

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“…7 Other researchers have attempted to show that COVID-19 ICU patients had a decreased trend of mortality if they had also received "Chinese herb therapy" during the course of their disease [20]. 8 Research ethics committees and journal peer reviewers need to ensure robust analysis in the setting of a flurry of COVID-19 submissions [21]. In the marketplace, aligning with FDA regulations, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance, have advised sellers of dietary supplements (e.g., vitamins, minerals, herbs) that these products must not claim to prevent, treat, or cure COVID-19 [22].…”

Section: Discussionmentioning

confidence: 99%

Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters

Bramstedt

2020

Ther Innov Regul Sci

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Background The COVID-19 pandemic has created a global setting of clinical crisis and human anxiety. Without available safe and effective vaccines and cures, an unscrupulous marketplace has emerged selling COVID-19 quackery (fraudulent misrepresentation of preventions and treatments). Methods US Food and Drug Administration (FDA) Warning Letters issued from March 2020 to July 2020 were analyzed for themes pertaining to unapproved, adulterated, and misbranded COVID-19 products. Results During this period, the FDA issued 3,139 Warning Letters of which 98 (3.14%) of these were focused on COVID-19-related drugs, devices, biologics, and dietary supplements (products and ingredients). Specifically, these Warning Letters revealed regulatory nonconformities involving 40 identified herbs, 22 minerals/compounds, 6 devices and biologicals, and 3 vitamins. Products included hand sanitizers; COVID-19 antibody test kits; herbal teas and tinctures; nasal gel; toothpaste; and 1 vaccine. Nine Warning Letters were issued for products being sold via the Amazon online shopping platform. Conclusion A small percentage of FDA Warning Letters recently have been focused on COVID-19. These Letters expose the blatant and potentially harmful quackery of vendors across the world who prioritize financial gain over clinical beneficence. Patient history-taking should include queries about non-traditional and unapproved products to identify, document, and report potentially harmful quackery. FDA Warning Letters are a component of meaningful corrective action; however, greater effort in spreading awareness of such misrepresented, unapproved, and adulterated products is needed to deter purchases of such products.

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Section: Discussionmentioning

confidence: 99%

Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters

Bramstedt

2020

Ther Innov Regul Sci

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“… 64 , 65 The rush to publication has now been documented in peer-reviewed journals, with articles being published at extraordinary speeds in the early phases of the pandemic 65 , and several notable instances of articles being later retracted, withdrawn, or having an expression of concern issued. 66 The situation is unlikely to change in the near future, as a review of ClinicalTrials.gov has identified a concerningly large proportion of studies with an expected low level of evidence. 67 Accordingly, a recent systematic review which examined 42 guidelines related to COVID-19 released in the spring/summer of 2020 found that the quality of all was poor, especially with respect to the rigour of their development.…”

Section: The Infodemicmentioning

confidence: 99%

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Lau

McAlister

2021

Canadian Journal of Cardiology

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COVID-19 and our public health responses to the pandemic may have far-reaching implications for cardiovascular risk affecting the general population and not just survivors of COVID-19. In this narrative review, we discuss how the pandemic may impact general cardiovascular risk for years to come, and explore the mitigating potential of telehealth interventions. From a health care perspective, the shift away from in-person office visits may have led many to defer routine risk factor management and may have had unforeseen effects on continuity of care and adherence. Fear of COVID-19 has led some patients to forego care for acute cardiovascular events. Curtailment of routine outpatient laboratory testing has likely delayed intensification of risk-factor modifying medical therapy, and drug shortages and mis-information may have negatively impacted adherence to antihypertensive, glucose-lowering, and lipid-lowering agents. From a societal perspective, the unprecedented curtailment of social and economic activities has led to income loss, unemployment, social isolation, decreased physical activity, and increased frequency of depression and anxiety, all of which are known to be associated with worse cardiovascular risk-factor control and outcomes. We must embrace and evaluate measures to mitigate these potential harms to avoid an epidemic of cardiovascular morbidity and mortality in the coming years that could dwarf the initial health impacts of COVID-19.

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“…An example of the last is the little consideration given to the known cardiotoxicity of the combination of hydroxychloroquine and azithromycin early on in the pandemic. Issues surrounding patients’ participation in clinical studies have also been observed: in her analysis of COVID-19 papers unsuitable for publication, Bramstedt identified issues surrounding informed consent as the second most common source of concerns [35]. In addition to the ethical problems this poses, it could also weaken the trust that patients and the broader community afford researchers, with detrimental consequences for public health in the long term.…”

Section: Stage 1: Data Collection and Interpretationmentioning

confidence: 99%

Open Science Saves Lives: Lessons from the COVID-19 Pandemic

Besançon

Peiffer-Smadja

Ségalas

et al. 2020

Preprint

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In the last decade Open Science principles, such as Open Access, study preregistration, use of preprints, making available data and code, and open peer review, have been successfully advocated for and are being slowly adopted in many different research communities. In response to the COVID-19 pandemic many publishers and researchers have sped up their adoption of some of these Open Science practices, sometimes embracing them fully and sometimes partially or in a sub-optimal manner. In this article, we express concerns about the violation of some of the Open Science principles and its potential impact on the quality of research output. We provide evidence of the misuses of these principles at different stages of the scientific process. We call for a wider adoption of Open Science practices in the hope that this work will encourage a broader endorsement of Open Science principles and serve as a reminder that science should always be a rigorous process, reliable and transparent, especially in the context of a pandemic where research findings are being translated into practice even more rapidly. We provide all data and scripts at https://osf.io/renxy/.

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The carnage of substandard research during the COVID-19 pandemic: a call for quality

Cited by 124 publications

References 34 publications

Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters

Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters

Implications of the COVID-19 Pandemic for Cardiovascular Disease and Risk-Factor Management

Open Science Saves Lives: Lessons from the COVID-19 Pandemic

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