scholarly journals Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Allan Tran ◽  
Natasha Y. Sheikhan ◽  
Tania Sheikhan ◽  
Dominik A. Nowak ◽  
Theodore J. Witek
Keyword(s):  
Content Analysis ◽  
Drug Evaluation ◽  
Healthcare Providers ◽  
Product Category ◽  
Drug Approval ◽  
The United States ◽  
Therapeutic Benefit ◽  
Health Claims ◽  
Public Healthcare ◽  
Related Substances

Abstract Background The United States Food and Drug Administration (FDA) monitors, inspects, and enforces the promotion of products by companies that claim to mitigate, prevent, treat, diagnose, or cure COVID-19. The introduction of COVID-19-related diagnostics and therapeutics during the pandemic has highlighted the significance of rigorous clinical trials to ensure safety and efficacy of such interventions. The objective of this report is to provide a descriptive review of promotional violations of health products for COVID-19 infection. Methods Warning letters issued by the FDA’s Center for Drug Evaluation and Research were retrieved over an 18 month period (March 6, 2020, to August 30, 2021) to identify promotional violations. FDA violation letters categorized as “Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)” were reviewed. A content analysis was performed for each letter to identify categories for product type, promotional venue, violation type, and country of origin. For cannabidiol-related violations, a content analysis was repeated within its own product category. Results A total of 130 letters were reported. Across all letters, cannabidiol products were the most frequent subject of violation (15/130; 11.5%). Of the cannabidiol letters, all reported the promotion of unapproved products (15/15; 100%), misbranding (15/15; 100%), and/or had claims that lacked scientific substantiation (14/15; 93.3%). All promotional violations were linked to websites (15/15; 100%), along with other mainstream venues: Facebook, Instagram, YouTube, Twitter, LinkedIn, and email. Lastly, the cannabidiol products were described to provide therapeutic benefit to COVID-19, by acting as an anti-viral (5; 33.3%), pro-inflammatory (1; 6.7%), anti-inflammatory (7; 46.7%), immune-booster (5; 40%), immune-suppressor (2; 13.3%), and/or other (2; 13.3%). Conclusion Despite the urgent need for COVID-19 treatments, promotional material by companies must comply with standard regulatory requirements, namely substantiation of claims. As the pandemic persists, the FDA must continue their efforts to monitor, inspect, and enforce violative companies. Cannabidiol-related substances led the spectrum of products with unsubstantiated claims to treat COVID-19 infection. Improving awareness among the public, healthcare providers, and stakeholders highlights the value of drug approval process, while protecting public safety.

scholarly journals From Experimental Procedure to Clinical Practice: How Much Evidence Do We Need in Uterine Transplantation?

2018 ◽  
Author(s):  
Sabina Gainotti ◽  
Carlo Petrini
Keyword(s):  
Clinical Practice ◽  
Therapeutic Option ◽  
Clinical Care ◽  
Embryo Implantation ◽  
Healthcare Providers ◽  
The United States ◽  
Public Healthcare ◽  
Routine Practice ◽  
Functional Abnormality ◽  
Experimental Procedure

Background: Absolute uterine factor infertility (AUFI) is a kind of infertility that is completely attributable to uterine absence (surgical or congenital for women with Mayer-Rokitansky-Küster-Hauser syndrome: MRKH) or anatomic or functional abnormality that prevents embryo implantation or completion of pregnancy to term. Until recently, the only viable option to parenthood for couples with AUFI were adoption or surrogacy. Since a first attempt of uterus transplant (UTx) in 2000, nine babies were born from women with a transplanted uterus from 2014, eight of which in Sweden, and one in the United States. These promising results are raising immense hopes for the women with AUFI and there is optimism about the possibility for UTx to become part of clinical care even though, besides encouraging results, the procedure has also resulted in increased risks and harms for both the donors and recipients and increased risks of premature birth for the fetus. At present UTx is still considered as experimental and requiring more research and safety assessment before becoming a therapeutic option for AUFI. The transition from experimental procedure to therapeutic care would result in less strict ethical scrutiny for UTx and in the possibility for patients to get reimbursement for the procedure by the relevant healthcare insurance or public healthcare providers. In turn, an increase in the number of UTx performed yearly by specialized surgical teams would result in a general improvement of the “field strength”. However, at present it is difficult to establish the amount of evidence that we need in order to consider UTx as no longer experimental but routine clinical practice. The literature on UTx provides recommendations on the different outcomes that should be monitored in this experimental phase but no study is anticipating the number of subjects that should be followed and for how long. Conclusion: As for other transplants that have become routine practice, like renal transplant and heart transplant, it is likely that the decision on “routine practice readiness” will result from available cumulated evidences, from expert capacity to find a consensus on best practices and on political considerations as well, including pressures form patients and patient groups.

Alleviating Drug Shortages: The Role of Mandated Reporting Induced Operational Transparency

2021 ◽  
Author(s):  
Junghee Lee ◽  
Hyun Seok (Huck) Lee ◽  
Hyoduk Shin ◽  
Vish Krishnan
Keyword(s):  
Operations Management ◽  
Healthcare Providers ◽  
Product Category ◽  
The United States ◽  
Mandated Reporting ◽  
Pharmaceutical Drugs ◽  
Drug Shortage ◽  
Drug Shortages ◽  
Life Saving ◽  
The Impact

The ongoing shortage of pharmaceutical drugs critically threatens public health. With increasing industry consolidation, operational disruptions at a firm can lead to a nationwide shortage of life-saving drugs. In 2012, the U.S. Food and Drug Administration mandated all manufacturers to report any manufacturing interruption that can potentially cause shortages. The goal of the mandate was to mitigate drug shortages by enhancing operational transparency in the pharmaceutical industry. Subsequently, other countries such as Canada have also begun mandating reporting of interruptions to alleviate drug shortages. We leverage the policy changes in the United States and Canada to understand the impact of mandated reporting induced operational transparency on alleviating the extent of drug shortages. Using the data on time-to-recovery for individual drug-shortage incident and annual-days-of-shortage for each drug, we find that the new policy alleviates drug shortages, but its effectiveness is contingent upon the prevailing level of competition in the product category. Although the intervention is not as impactful under a monopoly, the mandate is most effective under a duopoly, and its impact wanes as competition intensifies. In the absence of the mandate-induced transparency, competition does not necessarily alleviate shortages, but with the regulation, competition can relieve drug shortages. Our results potentially offer healthcare providers and policymakers the impetus to alleviate drug shortages by mandating interruption reporting and improving operational transparency. This paper was accepted by Charles Corbett, operations management.

scholarly journals Discovering healthcare provider behavior patterns through the lens of Medicare excess charge

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sagnika Sen ◽  
Amit V. Deokar
Keyword(s):  
Healthcare Provider ◽  
Private Insurance ◽  
Healthcare Providers ◽  
The United States ◽  
Behavior Patterns ◽  
Public Healthcare ◽  
Medical Procedure ◽  
Excess Charge ◽  
Cost Shifting ◽  
Specific Patient

Abstract Background The phenomenon of excess charge, where a healthcare service provider bills Medicare beyond the limit allowed for a medical procedure, is quite common in the United States public healthcare system. For example, in 2014, healthcare providers charged an average of 3.27 times (and up to 528 times) the allowable limit for cataract surgery. Previous research contends that such excess charges may be indicative of the actual amount that providers bill to non-Medicare patients and subsequent cost-shifting behavior, where a healthcare provider tries to recoup underpayment by Medicare from privately insured, self-pay, out-of-network, and uninsured patients. Objectives The objective of this study is to examine the drivers of a provider’s excess charge patterns, especially the extent to which the degree of excess charges may be associated with physician characteristics, Medicare reimbursement policy, or socioeconomic status and demographics of a provider’s patient base. Methods Using data from the 2014 Medicare Provider Utilization files, we identify three procedures with the highest variation in Medicare reimbursements to study the excess charge phenomenon. We then employ a two-step cluster analysis within each procedure to identify distinct provider groups. Results Each procedure code yielded distinct healthcare provider segments with specific patient demographics and related behavior patterns. Cluster silhouette coefficients indicate that these segments are unique. Three random subsamples from each procedure establish the stability of the clusters. Conclusions For each of the three procedures investigated in this study, a sizeable number of healthcare providers serving poorer, riskier patients are often paid significantly lower than their peers, and subsequently have the highest excess charges. For some providers, excess charges reveal possible cost-shifting to private insurance. Patterns of excess charges also indicate an imbalance of market power, especially in areas with lower provider competition and access to health care, thus leading to urban-rural healthcare disparities. Our results reinforce the call for price transparency and an upper limit to overbilling.

Knowledge and Communication of the National Core Standards Tool

2018 ◽  
Vol 20 (2) ◽  
Author(s):  
Winnie Thembisile Maphumulo ◽  
Busisiwe Bhengu
Keyword(s):  
Pearson Correlation ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
Sampling Technique ◽  
Quality Of Healthcare ◽  
Survey Study ◽  
Public Healthcare ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Professional Nurses

The National Department of Health in South Africa has introduced the National Core Standards (NCS) tool to improve the quality of healthcare delivery in all public healthcare institutions. Knowledge of the NCS tool is essential among healthcare providers. This study investigated the level of knowledge on NCS and how the NCS tool was communicated among professional nurses. This was a cross-sectional survey study. Purposive sampling technique was used to select hospitals that only offered tertiary services in KwaZulu-Natal. Six strata of departments were selected using simple stratified sampling. The population of professional nurses in the selected hospitals was 3 050. Systematic random sampling was used to recruit 543 participants. The collected data were analysed using SPSS version 25. The study showed that only 16 (3.7%) respondents had knowledge about NCS, using McDonald’s standard of learning outcome measured criteria regarding the NCS tool. The Pearson correlation coefficient between the communication and knowledge was r = 0.055. The results revealed that although the communication scores for the respondents were high their knowledge scores remained low. This study concluded that there is a lack of knowledge regarding the NCS tool and therefore healthcare institutions need to commit themselves to the training of professional nurses regarding the NCS tool. The findings suggest that healthcare institutions implement the allocation of incentives for nurses that attend the workshops for NCS.

New Drugs of 2012: A Concise Overview of the NMEs and Trends for Innovative Brand Market in the United States

2013 ◽  
Vol 6 (2) ◽  
pp. 2009-2013
Author(s):  
D Samba Reddy
Keyword(s):  
Drug Approval ◽  
The United States ◽  
New Drugs ◽  
New Combination ◽  
Drug Status ◽  
Combination Drug ◽  
Human Cord Blood ◽  
Life Saving ◽  
Genomics And Proteomics ◽  
The Face

Thirty-nine (39) new drugs have been approved by the U.S. FDA in 2012, a record highest number of approvals since 1996. The record is a sign that pharma companies are poised to tap recent advances from genomics and proteomics. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new products. Many life-saving drugs are approved for marketing. The list includes a total of 10 drugs for cancer treatment, and nearly a quarter of those approved in 2012 had orphan drug status.  Among the breakthrough drugs approved in 2012 were ivacaftor (cystic fibrosis), vasmodegib (skin cancer), HPC-C (human cord blood product), ruxolitinib (myelofibrosis) and a new combination drug to treat HIV. In addition,  several unique products were approved for the treatment of macular degeneration, chronic weight management, overactive bladder, actinic keratosis, erectile dysfunction, glaucoma, respiratory distress syndrome, and COPD. The approval of 39 drugs in 2012 underscores a robust success rate and confirms that innovation is once again beginning to pay off. In the existing climate of reduced revenues in the face of generic competitions, the future and survival of big companies rests heavily on their unique niche products. It is apparent that big Pharma and a growing number of emerging Biotechs alike have focused their attention on developing new NMEs for rare diseases. In 2012, the length of the FDA’s review is shorter than agencies in other countries. Innovative models adopted for R&D strategies, communications, and new regulatory changes appear to shorten development timelines. Despite record drug approvals, there is bleak scope for blockbusters because most of these drugs have a limited market. The pipeline for blockbusters appears very low. However, there is unmet medical need for new drugs in autism, Alzheimer’s disease and epilepsy. Overall, the new drug approval list unveils unique and reemerging trends indicating that the pharma companies are poised for big growth from new brands approved for marketing for narrow-spectrum indications.    

Capturing the surge of public interest towards Hydroxychloroquine, Azithromycin and BCG vaccine during COVID-19 Pandemic (Preprint)

2020 ◽  
Author(s):  
Shabbir Syed-Abdul ◽  
Shwetambara Malwade ◽  
Sim-Mei Choo
Keyword(s):  
Social Media ◽  
Preventive Measures ◽  
Healthcare Providers ◽  
Specific Treatment ◽  
Drug Effects ◽  
The United States ◽  
Bcg Vaccine ◽  
Public Interests ◽  
Treatment Regimes ◽  
Appropriate Treatment

UNSTRUCTURED The outbreak of COVID-19 that started in December 2019, was declared a pandemic in March 2020. Currently, there is no specific treatment recommended and healthcare providers are struggling to find appropriate treatment regimes. Medication misinformation spread through social media has caused panic situations and self-prescription leading to harmful drug effects. The situation worsened following false propaganda via social media, leading to shortage of some medications. Our study shows the frequency of search for the medications Hydroxychloroquine (HCQ), Azithromycin and Bacillus Calmette-Guérin (BCG) vaccine in Google Trends, across 6 countries. Public interests from the United States, Italy and Spain leaned towards HCQ, whereas those from Taiwan, Japan and South Korea were keen towards learning about the BCG vaccine. Our article aimed to inform the general public of the adverse drug reactions to avoid self-prescription or yield to the assumptions of leaders and unanimous social media posts. Proactive participation and preventive measures such as social distancing, use of face masks and hand sanitizers are recommended to help curb COVID-19 and other infections.

Capturing the Art of Public Service: The Government’s Perspective

Public Voices ◽  
2017 ◽  
Vol 14 (2) ◽  
pp. 55
Author(s):  
Tony Carrizales
Keyword(s):  
United States ◽  
Content Analysis ◽  
Popular Culture ◽  
Public Service ◽  
Public Art ◽  
The United States ◽  
Virtual Museum ◽  
Film And Television ◽  
Government Institutions ◽  
Art Forms

Public Service, in popular culture, can be viewed through many artistic lenses. Although there has been a consistent negative portrayal of government through art forms such as film and television, this research looks to review how government institutions in the United States have used art to provide a positive portrayal of public service. Eight forms of public service art are outlined through a content analysis of the holdings at the Virtual Museum of Public Service. The findings show that government and public entities have historically and continually engaged in promoting public service through art. Many of these public art examples are accessible year round, without limitations, such as buildings, statues, and public structures.

How Research Will Adapt to HIPAA: A View from Within the Healthcare Delivery System

2002 ◽  
Vol 28 (4) ◽  
pp. 491-502
Author(s):  
Mary L. Durham
Keyword(s):  
Health Information ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
The United States ◽  
Personal Health Information ◽  
Personal Health ◽  
Business Associations ◽  
Electronic Information ◽  
Healthcare Delivery System ◽  
Institutional Review

While the new Health Insurance Privacy and Accountability Act (HIPAA) research rules governing privacy, confidentiality and personal health information will challenge the research and medical communities, history teaches us that the difficulty of this challenge pales in comparison to the potential harms that such regulations are designed to avoid. Although revised following broad commentary from researchers and healthcare providers around the country, the HIPAA privacy requirements will dramatically change the way healthcare researchers do their jobs in the United States. Given our reluctance to change, we risk overlooking potentially valid reasons why access to personal health information is restricted and regulated. In an environment of electronic information, public concern, genetic information and decline of public trust, regulations are ever-changing. Six categories of HIPAA requirements stand out as transformative: disclosure accounting/tracking, business associations, institutional review board (IRB) changes, minimum necessary requirements, data de-identification, and criminal and civil penalties.

Nutritional Marketing of Plant-Based Meat-Analogue Products: an exploratory study of front-of-pack and website claims in the USA

2021 ◽  
pp. 1-32
Author(s):  
Jennifer Lacy-Nichols ◽  
Libby Hattersley ◽  
Gyorgy Scrinis
Keyword(s):  
United States ◽  
The United States ◽  
Health Claims ◽  
Processed Foods ◽  
Nutrition And Health ◽  
Nutrition Claims ◽  
Health And Nutrition ◽  
Alternative Protein ◽  
Health Related ◽  
The Usa

Abstract Objective: To explore how some of the largest food companies involved in producing alternative proteins use health and nutrition claims to market their products. Design: We identified the largest food manufacturers, meat processors, and alternative protein companies selling plant-based alternative protein products in the United States. Using publicly available data, we analysed the voluntary health and nutrition claims made on front-of-pack labels and company webpages. We also analysed company websites for further nutrition and health-related statements about their products or alternative proteins more generally. Claim classification was guided by the INFORMAS (International Network for Food and Obesity/Non-Communicable Diseases Research, Monitoring, and Action Support) taxonomy for health-related food labelling. Setting: United States. Results: 1394 health and nutrition-related front-of-pack label (FOPL) claims were identified on 216 products, including 685 nutrition claims and 709 ´other health-related´ claims. No FOPL health claims were identified. Most nutrient claims were for nutrients associated with meat, with 94% of products carrying a protein claim and 30% carrying a cholesterol claim. 74% of products carried a GMO-free claim and 63% carried a plant-based claim. On their websites, some companies expanded on these claims or discussed the health benefits of specific ingredients. Conclusions: Companies involved in this category appear to be using nutritional marketing primarily to position their products in relation to meat. There is a focus on nutrient and ingredient claims, with discussion of processing largely avoided. The findings highlight the challenges companies face in positioning AP products as healthy against the backdrop of debates about ultra-processed foods.

scholarly journals Best Practices in Specialized Amyloidosis Centers in the United States: A Survey of Cardiologists, Nurses, Patients, and Patient Advocates

2021 ◽  
Vol 15 ◽  
pp. 117954682110152
Author(s):  
Jose Nativi-Nicolau ◽  
Nitasha Sarswat ◽  
Johana Fajardo ◽  
Muriel Finkel ◽  
Younos Abdulsattar ◽  
...  
Keyword(s):  
Best Practices ◽  
Patient Care ◽  
Nurse Practitioners ◽  
Healthcare Providers ◽  
Multidisciplinary Care ◽  
The United States ◽  
Comprehensive Care ◽  
Patient Support ◽  
Patient Support Group ◽  
Patient Advocates

Background: Because transthyretin amyloid cardiomyopathy (ATTR-CM) poses unique diagnostic and therapeutic challenges, referral of patients with known or suspected disease to specialized amyloidosis centers is recommended. These centers have developed strategic practices to provide multidisciplinary comprehensive care, but their best practices have not yet been well studied as a group. Methods: A qualitative survey was conducted by telephone/email from October 2019 to February 2020 among eligible healthcare providers with experience in the management of ATTR-CM at US amyloidosis centers, patients with ATTR-CM treated at amyloidosis centers, and patient advocates from amyloidosis patient support groups. Results: Fifteen cardiologists and 9 nurse practitioners/nurses from 15 selected amyloidosis centers participated in the survey, with 16 patients and 4 patient advocates. Among participating healthcare providers, the most frequently cited center best practices were diagnostic capability, multidisciplinary care, and time spent on patient care; the greatest challenges involved coordination of patient care. Patients described the “ideal” amyloidosis program as one that provides physicians with expertise in ATTR-CM, sufficient time with patients, comprehensive patient care, and opportunities to participate in research/clinical trials. The majority of centers host patient support group meetings, and patient advocacy groups provide support for centers with physician/patient education and research. Conclusions: Amyloidosis centers offer comprehensive care based on staff expertise in ATTR-CM, a multidisciplinary approach, advanced diagnostics, and time dedicated to patient care and education. Raising awareness of amyloidosis centers’ best practices among healthcare providers can reinforce the benefits of early referral and comprehensive care for patients with ATTR-CM.

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