Yesterday marked an important milestone in the fight against COVID-19, as the FDA granted two COVID-19 oral antiviral treatments Emergency use Authorization: Paxlovid (Pfizer) and Molnupiravir (Merck). Both antiviral treatments work by interfering with the virus’ ability to reproduce and replicate within the body, but in slightly different ways. Paxlovid treats the virus by targeting its main component (protease), which restricts its ability to replicate. In contrast, Molnupiravir works by ‘sabotaging’ the coronavirus’ genetic code. Both Paxlovid and Molnupiravir are treatments for people who both recently test positive and show symptoms of COVID-19: they work to contain the severity of the illness and to reverse the spread of the virus. They are not authorized for use by people who haven’t tested positive because Paxlovid and Molnupiravir can only work when the virus is present in the body. Paxlovid is the preferred treatment: people who took it showed an 88% reduction in hospitalization and death, compared to 30% with Molnupiravir.
We are also learning more about which monoclonal antibody treatments are effective against the Omicron variant. So far, Sotromivab is the only monoclonal antibody treatment which has activity against Omicron. Its supply is extremely limited. Sotromivab treatment will be prioritized for moderately and severely immunocompromised people, regardless of age and vaccine status. It will also be prioritized for those 65 and up, who are not fully vaccinated and who also have an additional risk factor for severe illness (such as chronic kidney, heart, or lung disease, obesity, neurogenetic issues, and severe asthma, to name a few).
Marianne J. Legato, MD, Ph. D. (hon. c.), FACP is an internationally renowned academic, physician, author, lecturer, and pioneer in the field of gender-specific medicine. She is a Professor Emerita of Clinical Medicine at Columbia University College of Physicians & Surgeons and an Adjunct Professor of Medicine at Johns Hopkins Medical School. Dr. Legato is also the Director of the Foundation for Gender-Specific Medicine, which she founded in 2006 as a continuation of her work with The Partnership for Gender-Specific Medicine at Columbia University. She received an honorary PhD from the University of Panama in 2015 for her work on the differences between men and women.
At its core, gender-specific medicine is the science of how normal human biology differs between men and women and how the diagnosis and treatment of disease differs as a function of gender. Dr. Legato’s discoveries and those of her colleagues have led to a personalization of medicine that assists doctors worldwide in understanding the difference in normal function of men and women and in their sex-specific experiences of the same diseases.
She began her work in gender-specific medicine by authoring the first book on women and heart disease, The Female Heart: The Truth About Women and Coronary Artery Disease, which won the Blakeslee Award of the American Heart Association in 1992. Because of this research, the cardiovascular community began to include women in clinical trials affirming the fact that the risk factors, symptoms, and treatment of the same disease can be significantly different between the sexes. Convinced that the sex-specific differences in coronary artery disease were not unique, Dr. Legato began a wide-ranging survey of all medical specialties and in 2004, published the first textbook on gender-specific medicine, The Principles of Gender-Specific Medicine. The second edition appeared in 2010 and the third edition, dedicated to explaining how gender impacts biomedical investigation in the genomic era, won the PROSE Award in Clinical Medicine from the Association of American Publishers in 2018. A fourth edition is forthcoming.
She also founded the first scientific journals publishing new studies in the field, The Journal of Gender-Specific Medicine, and a newer version, Gender Medicine, both listed in the Index Medicus of the National Library of Medicine. She has founded a third peer-reviewed, open access journal, Gender and the Genome, which focuses on the impact of biological sex on technology and its effects on human life.
Dr. Legato is the author of multiple works, including: What Women Need to Know (Simon & Schuster, 1997), Eve’s Rib (Harmony Books, 2002), Why Men Never Remember and Women Never Forget (Rodale, 2005), Why Men Die First (Palgrave, 2008), The International Society for Gender Medicine: History and Highlights (Academic Press, 2017), and most recently, The Plasticity of Sex (Academic Press, 2020). Her books have been translated into 28 languages to date.
As an internationally respected authority on gender medicine, Dr. Legato has chaired symposia and made keynote addresses to world congresses in gender-specific medicine in Berlin, Israel, Italy, Japan, Panama, South Korea, Stockholm, and Vienna. In collaboration with the Menarini Foundation, she is co-chairing a symposium on epigenetics, Sex, Gender and Epigenetics: From Molecule to Bedside, to be held in Spring 2021 in Italy. She maintains one of the only gender-specific private practice in New York City, and she has earned recognition as one of the “Top Doctors in New York.”