September 2, 2020
IN THIS ISSUE / September 2, 2020
What role can dermatologists play in developing a COVID-19 vaccine?
DW Insights and Inquiries: Dermatopathology’s taste of honey
What role can dermatologists play in developing a COVID-19 vaccine?
Derm World talks to Adnan Nasir, MD, PhD, medical director of dermatology research at Wake Research Associates at UNC REX Hospital in Raleigh, North Carolina, about his involvement in COVID-19 vaccine clinical trials.
Derm World: Tell us a little about Wake Research Associates.
Dr. Nasir: Wake Research Associates is a multi-disciplinary clinical trial unit. For 20 years we have conducted inpatient and outpatient trials on treatments for a variety of skin conditions including skin cancer, atopic dermatitis, psoriasis, and alopecia areata. We have the capability of overseeing phase 1 through phase 4 trials.
Derm World: How did you get involved in the COVID-19 vaccine clinical trials?
Dr. Nasir: The Research Triangle of North Carolina is a hub of biomedical research despite its small size. Our state, as a coronavirus hot spot, has had a high number of cases of infection and hospitalization. We were asked to be one of 89 sites in the U.S. selected for phase 3 clinical trials on coronavirus vaccines. Our center is the first in the world, outside of the NIH, to administer an investigational mRNA Sars CoV-2 vaccine as part of a phase 3 clinical trial. The studies we are overseeing are a part of Operation Warp Speed. Vice President Mike Pence and FDA Commissioner Stephen Hahn, MD, came to the North Carolina Biotech Center to meet with us and some of our study patients. We have embarked on this study as well as additional studies as part of our response to the pandemic.
Derm World: Tell us about the vaccine for which you are currently conducting a phase 3 trial.
Dr. Nasir: We are part of the phase 3 trials for Moderna and the National Institutes of Health (NIH) vaccine. This is a nanoparticle-based vaccine and it’s an RNA-based lipid nanoparticle that encodes the spike protein of the coronavirus. In early phase 1 and 2 human studies, it has been shown to be safe and induce a cell-mediated immune response and an antibody response. It’s been shown in non-human primates, rhesus monkeys, to protect from the disease. In a recent article published in the New England Journal of Medicine (doi.10.1056/NEJMoa2024671) not only did investigators see that antibodies were produced, they challenged these animals with the live virus, and they were able to show protection.
Read more about Dr. Nasir’s involvement in developing a COVID-19 vaccine.
Visit the Academy’s COVID-19 Resource Center to help protect your patients and practice.
DW Insights and Inquiries: Dermatopathology’s taste of honey
Apparently, the answer is a resounding “yes!”
Despite the use of serological ELISA tests utilized for diagnosing autoimmune bullous disorders, DIF of perilesional skin remains the diagnostic gold standard, with sensitivities ranging from 82-91% and specificity of 98%. For transport, saline-soaked gauze may be utilized, but the specimen must be delivered to the laboratory within 48 hours. Given the vagaries of specimen pick-up schedules in my practice, I am not comfortable with that time frame.
The answer for this dilemma is sweet — as in honey. Honey has been utilized since antiquity as a binder vehicle, but also topically for medicinal and cosmetic purposes. Ancient Greeks and Egyptians used honey to treat skin wounds, burns, and infections. Persian traditional medicine documented the efficacy of honey for the treatment of eczema. It has also been utilized for tinea, seborrhea, dandruff, diaper dermatitis, psoriasis, hemorrhoids, and anal fissures. Honey is a bee‐derived, supersaturated solution composed mainly of fructose and glucose, and containing proteins and amino acids, vitamins, enzymes, minerals, and other minor components. Mechanisms of action include antioxidant activity, the induction of cytokines and matrix metalloproteinase expression, as well as epithelial‐mesenchymal transition in wounded epidermis. Keep reading!
Non-discrimination protections change under ACA
On June 12, 2020, the Department of Health and Human Services (HHS) published a final rule revising regulations in Section 1557 of the ACA, which address non-discrimination protections. The comprehensive health care reform law — the Patient Protection and Affordable Care Act, also known as the ACA — was enacted in March 2010, making affordable health insurance available to more Americans, expanding the Medicaid program, and encouraging innovative medical care delivery models that administer health care at a lower cost.
The law prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities. Effective Aug. 18, 2020, it is required that health care settings continue providing language access services for limited English proficiency (LEP) individuals, and interpretation and translation services for individuals who are deaf or hearing impaired under the Americans with Disabilities Act (ADA). It is no longer required, however, to display taglines in the top 15 languages in the respective state in the office, website, or on significant publications outlining language access services.
LEP Individuals
Section 1557 requires that covered entities must take reasonable steps to provide meaningful access to health care and language services including translation services, interpretation services, and translated documents free of cost to individuals with LEP encountered by the covered entity. The four-factor test will be used to assess if reasonable steps were taken. These include:
the number or proportion of LEP individuals the provider is likely to encounter;
the frequency with which LEP individuals receive services;
the nature and importance of the entity’s health program, activity or service; and
the resources available to the entity and costs of the services.
If it is deemed necessary using this four-factor test to provide language assistance services, the rule also maintains the specific qualifications for bilingual or multilingual staff, translators, and interpreters to assist and limits on the individual’s family to satisfy this responsibility. Additionally, HHS clarified that remote audio or video interpretation would be acceptable for LEP individuals or those with hearing impairment, respectively.
The Office of Civil Rights (OCR), under HHS, enforces Section 1557 and non-compliance may lead to enforcement actions.
Deaf or hard of hearing patients
Section 1557 requires that covered entities take appropriate steps to ensure that communication with individuals with disabilities are as effective as communications with individuals without disabilities, which includes the provision of auxiliary aids or services at no cost when necessary. Determining which aid will be most effective will require consideration of the nature, length, complexity, context of the communication, and usual means of communication of the individual. Practices must consult with the hearing-impaired patient to determine which service should be selected and can require reasonable advance notice to honor the selection. The exception to this requirement would be for those covered entities that can demonstrate “undue burden” in providing these services. To learn more read the complete 2020 Final Rule on Section 1557.
Skin of color dermatology content on Instagram
According to an article published in the Journal of Drugs in Dermatology, board-certified dermatologists are underrepresented among people generating skin of color dermatology-related content on Instagram. When researchers searched for 31 skin-of-color hashtag terms on Instagram, only 12% of the top posts were made by board-certified dermatologists, and about 40% of the top posts were promotional rather than educational. The study authors encourage board-certified dermatologists to establish a presence on social media platforms to educate their followers using reliable, evidence-based sources.
Want help getting started with social media or taking your online presence to the next level? Read more in Dermatology World.
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Submit nominations for 2021 Academy election
Nominations for Officers, Directors, and Nominating Committee Member Representatives (East Region) are now being accepted through Oct 1. To view reference materials and submit a nomination and letter of support, visit staging.aad.org/aadnominations or email callfornominations@aad.org.
