Romano Law Nurse Corner COVID-19 #33
Is there any positive news?
COVID-19 numbers still rising. As of Sunday night, 5 members of Vice President Pence’s staff have tested positive for COVID-19. The Vice President thus far has tested negative and is continuing with campaigning around the country.
As a country, in the last weeks, we have seen a daily increase in COVID-19. Some non–scientists argue that the increase is related to increase testing-we think not. Some more non–scientists argue that the death toll is also inaccurate also - again, we think not. Nineteen states set records for new COVID-19 cases last week. The United States and the world is far from done with the devastation and loss of life that is COVID-19. We are not “rounding the corner” toward the end of this pandemic despite what you may hear. Ignoring this disease is not working. Masks are still a point of contention and a political issue rather than a safety issue. We are all experiencing COVID fatigue, however it is not time to get complacent.
The White House Chief of Staff, Mark Meadows said on Sunday "We are not going to control the pandemic. We are going to control the fact that we get vaccines, therapeutics and other mitigation areas. Mr. Meadows further stated that we need to do is make sure we have the proper mitigation factors, whether its therapies or vaccines or treatments to make sure people don’t die from this. We agree with Mr. Meadows, a safe vaccine and treatment therapies are all important to fight COVID-19, however the ultimate mitigation effort in our current time, according to scientists is mask wearing in public and social distancing.
As we have often said, finding a safe and effective vaccine for COVID-19 is essential. While there are many scientists around the world working on finding one, most scientists agree that it will not be approved and available until well into next year. We need a vaccine that is properly tested and as safe as possible. Let us also remember that once it is available, there will be some time before it is widely available to all. Pushing through a vaccine without proper safety protocols and testing would be very dangerous. Avoiding spread as much as possible, by mask wearing, is the best thing we can do until one is available. Yet, wearing a mask is still a point of contention in our society, sometimes a source of shaming and violent interactions in stores and other public places.
A new study out of The University of Washington School of Medicine entitled Modeling COVID-10 scenarios for the United States came out last week in the peer-reviewed journal Nature [https://www.nature.com/articles/s41591-020-1132-9].
This study predicted that with both inconsistent mandates and inconsistent use of masks to prevent the spread of COVID-19, the cumulative loss of American lives could be more than half million by the end of February. Many of these deaths are preventable.
The Study also stated that if at least 95% of the public wore masks it could save almost 130,000 lives and that if 85% of the population wore them, almost 96,000 lives. Simply wearing a mask in public seems like a very small inconvenience to potentially save that many lives from now until the end of February. It really is that simple. The science does not lie. We care about those lives and choose to wear masks in public.
Given that we are heading into an expected very substantial fall-winter surge, Christopher Murray, director for the Institutes for Health Metrics and Evaluation at the University of Washington, says we expect that surge to steadily grow throughout different states, and at the national level continue to increase as we head toward quite high levels of daily death in late December and January. We are seeing the numbers of cases rise in almost every state in the country and all over the world. Hospitals in many places are filling up with critically ill COVID-19 cases.
Professor of Medicine and Infectious Disease Expert from University of California-San Francisco, Dr. Monica Gandhi says it's unfortunate that in the U.S. wearing a face mask has become a political or emotional issue rather than a scientific principle. While she notes that this type of study likely won’t change the minds of people, it can be a useful tool until enough virologic, epidemiological and ecological evidence is amassed to elevate masking to a definitive intervention. Masks are a useful mitigation tool.
Assistant Professor of Global Health and Epidemiology at Emory University noted that this model is on track with other recently published data. He further notes that while pandemic fatigue is real…this model is a good reminder of what can happen if we let our guard down and how this can really come back at us really quickly and really forcefully and lead to a lot of death and suffering. No doubt, we all feel some level of pandemic fatigue, however letting our guard down can be deadly.
Some Positive News!
Last week, the FDA approved Remdesivir for use to treat hospitalized patients with COVID-19. This is the first drug that has been approved to treat COVID-19 here in the U.S. Until now, there was only an FDA Emergency Use Authorization (EUA) issued in May allowing it to be used with severe COVID-19 cases, ages 12 years and over, with low oxygen levels and needing oxygen therapy or mechanical ventilation. Then in August, it expanded treatment to include both hospitalized pediatric patients and adults regardless of severity of disease. This approval was based on three different clinical trials that had been ongoing.
Recent FDA Press Release (https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19) : The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients. The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus, said FDA Commissioner Stephen M. Hahn, M.D. We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.
The first of these trials upon which the EUA is based is one funded by the NIH’s National Institute of Allergy and Infectious Disease which was published earlier this month, called the ACTT-1 trial. Link to this published study: https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
This study showed that hospitalized patients who received Remdesivir had a shorter median recovery than those that received placebo - 10 days versus 15 days. The data also showed some evidence that the Remdesivir group had a lower proportion of serious adverse effects. While this study shows its usefulness in length of treatment, it showed no statistically significant difference in mortality rates between the two groups. Decrease in length of treatment and intensity of symptoms is a positive start in fighting COVID-19.
The other two trials that were used to obtain the Remdesivir EUA were phase 3 trials done by a maker of Veklury (Remdesivir), Gilead Sciences. These trials, named the SIMPLE studies, were conducted in sites all around the world with a high prevalence of COVID-19 cases including the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom. These studies added further data showing the benefit of Remdesivir treatment for hospitalized COVID-19 patients in improving overall clinical status.
Time has given us some good data upon which the FDA has relied in this latest decision. This disease continues to show itself. We need everything we can come up with to deal with this deadly disease including safe human behavior, safe/effective vaccine and useful medication treatments. While COVID-19 fighting efforts are occurring at a rapid rate, the current best practice safety includes mask wearing in public to protect each other and slow down the spread. The scientific community does not debate this fact.
We continue to wear our masks and socially distance to protect our fellow human beings and ourselves, we ask that everyone do the same.
We are Susan Ramsey and Amie Goldberg, both practicing attorneys and nurses here at the Romano Law Group. Here is a little more about each of us:
Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools. During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts. She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force. Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.
Amie Goldberg is both an attorney and a certified APRN. After completing a Bachelor of Arts Degree at Whittier College, Ms. Goldberg attended nursing school at Emory University. Ms. Goldberg’s professional experience started as a Registered Nurse at Egleston Children’s Hospital taking care of children with congenital heart disease. After a few years, she continued working in all areas of the hospital while attending Kennesaw State University on weekends in order to get her Master’s Degree in Nursing with a specialty of Primary Care Nurse Practitioner/Family Nurse Practitioner. During her time as an APRN, Ms. Goldberg decided to attend law school at St. Thomas University in Miami, Florida. Since graduating, she has mainly practiced in the areas of personal injury and worker’s compensation, fighting for the rights of injured people. Since joining the Romano Law Group, Ms. Goldberg has been the Director of the Opioid Litigation Project. Ms. Goldberg also practices in the area of medical malpractice and nursing home negligence, bringing an inside perspective and knowledge to help get justice for our clients.