COVID-19 Burnout

I was supposed to be visiting the NY Metropolitan area this week to celebrate a family high school graduation. Children and family were traveling from all over the country for this celebration when the parents of the graduate contracted COVID-19. The graduate stayed healthy and attended the ceremony and all post ceremony celebrations. Our family gathering was postponed, and my wife and I stayed home cancelling our flights and hotel reservations. The infected group were all vaccinated months ago and young, healthy and placed on Paxlovid . They are recovering. The fact that all will recover is what is important in a scene played out in homes across the globe all dealing with COVID and family gatherings.

At the same time this was occurring the FDA approved a Pfizer three-shot vaccine and Moderna two-shot vaccine protocol for COVID for children six months to five years old. It provided great joy in my south Miami daughter’s household since her four-year-old son has been attending pre-school and summer camp with no real protection other than a mask. My grandson has been the only child in his class and group wearing a mask indoors and the school psychologist asked my daughter if he could remove it because it was a barrier to playing with the other children.

The vaccine for young kids is not a foolproof shield but at least provided protection against serious illness. The FDA approval was a great comfort to parents hoping to have their kids vaccinated prior to the start of the next school semester in August. Then, the Governor and Florida Surgeon General announced Florida was not ordering the vaccine because they believed healthy kids did not need it despite all the infectious disease, public health and virology experts reviewing the data and approving the vaccine. Morale fell to a new low.

The very next day the Governor announced that doctors and pharmacies could order the vaccine through the Florida Shots website and had that option all along. That is not the way we ordered the vaccine earlier in the pandemic. We ordered it though the Florida Department of Health.

Supporters of the Governor blamed this ordering confusion on “big government bureaucracy”. If that is the case, then why not just announce from the beginning that pharmacies, doctors and health systems can order the vaccine through the Florida Shots website?

In the political gamesmanship of placing barriers in the way of our youngest and most vulnerable children being vaccinated, did the Governor forget that most physician offices do not have freezers capable of storing the vaccine at -90 degrees Centigrade? Also ignored was the plight of those who have relied on their county or city health department to provide the vaccines for their children for years and now those public health facilities will not have the vaccines.

My office was bombarded this week with calls from patient’s testing positive for COVID-19, all with mild symptoms of fatigue and upper respiratory viral symptoms. The current treatment options are to supply supportive care such as fluids, cough medicine, Tylenol and rest or prescribe the Pfizer pill Paxlovid. The Paxlovid must be started within five days of onset of symptoms.

So many patients walk around with cold symptoms for several days before home testing that it’s difficult to start the medicine within the five day window advised by the manufacturer. Paxlovid interacts with so many popular and common prescription medications for seniors which must be discontinued and washed out of your system prior to starting Paxlovid that they can’t start the medication on time.

The best option, in my opinion, remains receiving an infusion of the monoclonal antibody Bebtolivimab within seven days of onset of symptoms. Boca Raton Regional Hospital has a program that gets you in within a few days but several patients have been so anxious and worried that they would not wait for an appointment. Several called private services to come to their homes and treat them with monoclonal antibodies. These companies have popped up out of nowhere and their reputation and reliability are relatively unknown. Are they really administering Bebtolivimab? At least at the hospital I know the product is the real thing and the monitoring staff is well trained and experienced.

Also, several patients have insisted on Paxlovid and stopped their blood pressure, cholesterol and antidepressant medicines. Two of them took the Paxlovid and improved, then rebounded with a positive test and return of all symptoms several days later. They all recovered in a few days, but the potential rebound is another reason I prefer offering the monoclonal antibody infusion.

I have not mentioned the Merck oral medication Lagevrio ( molnupravir) because it used new technology involving disrupting the genetics of the virus. I would like to see the adverse effects of this drug and its efficacy and safety profile after being on the market for twelve or more months prior to considering it.

COVID remains a “bummer”. We are in a much better place to prevent serious illness than we were three years ago but human behavior, the demonizing of science for political gain and the resilience of this virus continue to wreak havoc on my life and those around me.

Pfizer Pill “Paxlovid” & Post-Treatment Relapses

The introduction of the Pfizer antiviral pill Paxlovid to treat COVID-19 infected patients, within five days of contracting the disease, was supposed to be a “gamechanger.”  Reviewers compared it to Tamiflu, the antiviral pill used against influenza and taken twice a day for five days.

The rollout and distribution of Paxlovid have been a problem from day one. Pharmacies objected to their reimbursement for distributing the product and doing the labor-intensive paperwork required because it is an Emergency Utilization Authorization (EUA) product – not yet FDA approved. In addition, it interacted with so many commonly taken medications that use the CYP3A4 pathway, including common antihypertensive and antidepressant drugs. The result is that very few pharmacies agreed to stock it and distribute it. The Federal government established an online locator of pharmacies that distribute it but often the pharmacies listed do not have it in stock when you call them to prescribe it.

This week a new wrinkle and complication appears to have been discovered. Patients treated with Paxlovid within the first five days, and completing the twice a day course, are now relapsing on days 9 and 10 post-infection. Quick at home antigen tests are turning positive in some. Viral loads are being detected and mild symptoms are returning. These relapsed patients still may be able to spread the infection.  

Pfizer representatives are suggesting we treat these patients with a second five-day regimen. The FDA has not yet advised treating for a second round. At this time the issue of post Paxlovid relapses needs to be studied. Those projects are now under way.

For this reason, until more is known about Paxlovid treated COVID relapse, our first line treatment for high risk COVID infected patients will be referral to the Baptist Health Boca Raton Regional Hospital Monoclonal Antibody program. Their use of bebtelovimab within seven days of infection continues to prevent the disease from progressing to the serious form.

My patients with any questions about this, should call the office at 561.368.0191.

Cocoa Flavonoids & Avocados May Protect Against Cardiovascular Death

The COSMOS study, sponsored by Pfizer and Mars Candies, looked at the effect of Cocoa flavonoids on cardiovascular events such as a heart attack, cardiovascular deaths and consumption of cocoa flavonoids and green tea. There were 21,442 U.S. adults in the study followed for 3.6 years.

The experimental group received cocoa and green tea. While there were just as many cardiovascular events in the study group as in the control group, the number of deaths dropped by 27%. The study was published in the American Journal of Clinical Nutrition and was commented on by David Rakel, MD, FAAFP in the online medical journal Primary Care.

Flavonoids are found in dark colored grapes and berries, apples, pears, green tea and dark chocolate. If you eat 1/4 of a dark chocolate bar you are getting the same dosage the experimental group was given in this study.

Dr. Rakel suggested that Flavonoids maintain the flexibility of the blood vessels as we age. Recent related studies indicate a handful of blueberries or cranberries daily have similar effects. A glass of red wine with a square of dark chocolate and some dark berries suddenly sounds like a healthy snack!

Avocados apparently convey cardiovascular protection as well. In a study published in the March 30, 2022 Journal of the American Heart Association researchers followed 110,00 adults for 30 plus years and found that those who consumed two or more servings of avocado a week had a much lower risk of developing cardiovascular disease then non consumers.

Omicron is the Grinch That Stole Christmas

The Center for Disease Control (CDC) is reporting that up to 90% of the infections with COVID-19 Sars 2 Coronavirus are the new Omicron strain. It replicates itself 70 times faster than the Delta strain and contact with an infected person within 12 feet for one or more seconds can result in infection. For those who have been vaccinated against COVID-19 with the Moderna or Pfizer Vaccine, and received a third shot or booster, the expectation is that if they become infected with Omicron, they will either have no symptoms or a mild case. By definition “mild COVID” means your respiratory system is not compromised enough to require hospitalization. Despite this, most of the current deaths in countries which are having a COVID surge are in people older than 65 years of age.

In the past, when patients in this area became infected with COVID-19, we arranged for them to go to the local hospitals to receive an infusion of a monoclonal antibody solution made either by Regeneron or by Eli Lilly. The infusion prevented the infection from becoming severe enough to progress to a severe state requiring inpatient hospital respiratory care. These monoclonal antibodies do not work against Omicron. For this reason, the FDA and CDC have removed the Emergency Use Authorization and ended the administration of these drugs nationwide.

There is a third monoclonal antibody made by Glaxo and Var called Sotrovimab which effectively throttles Omicron, but it is in limited supply. As of today, the State of Florida has received 1050 dosages. Production has been accelerated and hopefully the drug will be available in mid to late January for infusion. There are two new antiviral pills which should work as well. The Pfizer product received FDA approval today and, with production acceleration, some should be available by mid-January. Until these drugs are locally available the medical community has no medications to offer patients who contract the COVID-19 Delta or Omicron variant to limit the severity of the disease.

My advice to my patients and loved ones is to reintroduce distancing and masking. Wear a good N95 mask when you will be around others – especially indoors. If you must be indoors with others, make sure the windows and doors are open and the ventilation is excellent. If there is an air filtration system with HEPA Merv 13 level filters and ultraviolet light that adds protection. Distancing with the aggressive Omicron variant will require 12 feet not six feet.

This is a heartbreaking restrictive change in scheduling and behavior we are asking for at a time of the year when families and friends travel to gather to celebrate. Younger and leaner healthier individuals who are vaccinated will survive this. The real questions are who they will transmit this infection to unknowingly, who is too young to be vaccinated or too old to have a robust immune system?

Our office staff will be reassessing the risk to patients and staff daily. With the local testing positivity rate >10% in Palm Beach County, our contacts will be by phone and telehealth. When the Pfizer anti-viral pill Paxlovid is available, and or Sotrovimab for infusion, we will return to regular in-office patient visits.

I apologize for the inconvenience. Stay safe and call if you have questions.

COVID-19: Bringing Back Precautions & Restrictions

We recently spoke with our Friday night Shabbat Dinner friends of 40 years and cancelled our dinner plans because of the aggressive resurgence of the COVID-19 Delta Pandemic. I remember our last dinner eating outside in early February 2020 on a beautiful evening wondering if we should all be together one last time before suspending our weekly meals together. We were joined by a physician friend and his wife visiting from Cleveland and they were poking fun at my concerns and over reaction to the “Wuhan Flu.” The proverbial “shit hit the fan” the next week and we went into lockdown.

One year later we were all excited lining up for the Pfizer and Moderna vaccine. We really thought that would be the solution. We really thought our leaders at the federal and state levels would stand up and promote vaccinations. We really expected community leaders, respected by people of color, including church leaders, community activists, respected community members would be out there championing the vaccine, helping at vaccination sites and getting the shot into the arms of the most vulnerable.

Several months ago, when things began to calm down, we started having dinner together again in our homes. The rate of positivity in the spring of 2021 was low and our friends masked and kept distance when indoors shopping for supplies. We felt comfortable enjoying our friends’ company once again outdoors at a few restaurants and in our homes. Then came the Delta surge and with it the relaxation of restrictions.

It reminds me of pictures of the start of the Oklahoma Land Rush. A gun was fired, and everyone rode off to stake their claim. In 2021 they made their plane flight reservations, bought their concert tickets, made their hotel reservations and resumed everything they did prior to the pandemic. They stopped tracking cases, and, in many states, they stopped looking for new genetic mutations and variants of the virus. They forgot to get the vaccine to poorer nations but left the air and ship travel paths open to anyone and everyone. They underestimated the ability of the virus to find a way to survive by changing once inside the bodies of the vaccinated and unvaccinated.

Yes, it’s true that if you are vaccinated and get infected with the virus you most likely will not require inpatient hospitalization and die but according to those who went through this you will feel miserable for quite awhile. Yes, it’s true that you probably can transmit it to others even though the data on that is still new and quite controversial including passing it to unvaccinated children and the immunosuppressed.

To make matters worse, our Governor thinks he’s Bob Barker screaming; “Come on Down” as he invites foreign and out of state residents to come visit our beautiful state, spend money, pick up the virus and bring it home to your locale. I bet Florida is the leading exporter of sickness, death and chronic illness in the world over the last 12 months and no one in our state capitol seems to care.

We are returning to a bunker mentality in our household. No more dinners out. No more social engagements with friends whose activities and travels we are unsure of. If our grandson is sent to his preschool my wife will stop being his nanny because she does not want to risk catching the virus.

As college and NFL football season approach, it is unlikely I will sit in a stadium with thousands of unmasked individuals to see my teams play. The same goes for the theater and for travel. It’s really disheartening and depressing but we will do what is necessary to stay healthy and we hope you will too.

The COVID-19 Pandemic Continues Due to Citizen Dysfunction

Last night on the national news coverage of the Sars 2 Coronavirus Pandemic a major story dealt with the large number of children infected with the Delta variant of the virus and the severity of their illness. These children are too young to receive the vaccine.

At best, Pfizer and Moderna hope to have approval to start vaccinating young children by the end of September. These children are dependent on their parents, teachers and counselors keeping them masked, keeping them distanced and keeping them safe. This story dealt with an outbreak in Missouri and Mississippi with 10 youngsters currently on life support systems.

It is a dilemma for parents, especially working parents, about what activities to allow their children to engage in. With previous COVID-19 surges and outbreaks, experts have discussed how mild the illness is in children and how infrequently long-term and life-threatening complications occur. They stress the need for children this age to socialize and go to school and camp but that was prior to the Delta variant and other mutations and variants becoming the dominant source of infection in the USA. It is hard to tell whether the news coverage is sensationalized to promote viewership or is the Delta variant a threat to young unvaccinated children different and more severe than it was 90 days ago?

It’s time for our federal government to take a hard line with health care workers and health care facilities. All employees without a valid health reason for being vaccinated must be vaccinated or face termination. This would include hospitals, outpatient facilities, senior centers, childcare centers, etc. If the result is the facility is understaffed resulting in delays in elective profitable procedures, then so be it until the pandemic is controlled!

Commercial air traffic from regions of the country and world with low vaccination rates and vaccine hesitancy battling large outbreaks of COVID-19 should be halted until their outbreaks are under control. Vaccine passports should be encouraged – not legislated against. When an individual’s actions and decisions threaten others around them by increasing the likelihood of spread of a disease, and its accompanying economic devastation, then the issue is not about loss of freedom. It is about public health and the governments’ sworn duty to protect its citizens.

It’s time to end this Pandemic and the way to achieve that is through mandatory vaccination.

Will I Be Able to Choose My COVID-19 Vaccine?

There are currently four vaccines to prevent COVID-19 in the pipeline. I have been asked numerous times when am I going to have the vaccine in my office and which vaccine should individuals take? This question was addressed by MedPage Today, an online health care periodical on 11/27/2020. The same question was asked of National Institute of Health “chief” Francis Collins, MD, PhD last week at a press briefing. Dr Collins responded there will not be enough vaccine available in December for the whole country and “people who get offered one should feel quite happy about that.” Leana Wen, MD, of George Washington University responded to the same question saying, “Initially there won’t be nearly enough vaccines for hundreds of millions of Americans. We will probably take whatever we are able to get access to.”

If you are a healthcare worker, or in the more vulnerable groups, you are most likely to be offered one of the nRNA vaccines from Pfizer/BioNtech or Moderna because they are further along in completing the FDA required trials and application process for approval. Younger healthier individuals having less priority may get to choose.

Larry Corey, MD, a viral expert at Fred Hutchinson Cancer Institute in Seattle and a leader of the COVID-19 Prevention Network Vaccine Program broke down the numbers at a November 18, 2020 meeting of the American Public Health Association and National Academy of Medicine:

  1. The US Government has contracts for 100 million doses of the Pfizer/BioNTech and Moderna vaccines with production producing the 200 million doses by the spring of 2021. That should cover the highest risk groups including healthcare personnel, nursing home residents, essential workers and the medically vulnerable per the CDC Advisory Committee on Immunization Practices (ACIP) guidelines. The vaccine will be shipped to 50 states, the District of Columbia, 8 territories and five large urban health departments including NYC and Chicago. Who receives it first, and where they receive, it will be decided by the local jurisdictions. This process should take until the end of March 2021 leaving some 200 million Americans waiting for a vaccine. Dr. Corey was clear that “We need other vaccines for the rest of the population.”
  2. In addition to the Moderna and Pfizer/BioNTech mRNA vaccines, there are products from Oxford/AstraZeneca, Janssen/Johnson &Johnson, Merck, Sanofli/Glaxo SmithKline and Novavax. Jay Butler, MD, deputy director for infectious disease at the CDC expects there to be mass vaccinations run by public health agencies and possibly some vaccination programs at community pharmacies. No mention was made of supplying physician offices or clinics.
  3. If there are no major delays, seven different vaccines should be available by the spring of 2021. Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins University in Baltimore said it is too soon to compare the products because there are no studies comparing them head-to-head. He reminded us that different vaccines might be better suited for different patient populations with pediatric patients, the elderly, the immunocompromised likely to do better with some and not others.

Despite the lack of detail to date, Moncef Slaoui, MD, head of the federal Operation Warp Speed, told CNN that he expects 70% of the US population to be vaccinated by May 2021.