Why Have Guidelines, Rules & Regulations If No One Adheres to Them & There are NO Consequences?

I live and practice internal medicine and geriatrics in South Florida. We have a substantial elderly population living both independently and in senior facilities. The Sars2 Coronavirus Pandemic has been devastating to this patient population. There are many who became ill and passed away under the loneliest circumstances of in-hospital isolation. There are those who became ill and recovered but have lingering long-term effects. There are those who have avoided infection but are just beaten down by the daily monotony of staying safe, avoiding crowded public places and subsequently forsaking the company of friends and family.

The vaccine rollout in Florida was Helter Skelter and disorganized. It was every man and woman for themselves trying to obtain an appointment to be vaccinated. For the most, part the senior community managed to get the shots.

We were all grateful and buoyed as the summer of 2021 began by the news that we could venture out without masks and start resuming our pre-pandemic lives. The Delta variant and the recent surge in infectious cases, hospitalizations and now mortality put a quick and moribund end to that for most. The disparity between the message coming out of Washington and the CDC and the message delivered by our Governor and State Legislature has made decision making for individuals far more difficult than it should be. The latest conundrum is about the need for booster COVID vaccines or not.

The State of Israel, which exclusively used the Pfizer Vaccine, announced a third shot for those over 50 beginning a few weeks ago. Germany announced it would start such a program in September.

The CDC hinted at a booster program but until a NY Times article appeared on the evening of August 16th there was no official news on the subject beyond the recommendation that immunosuppressed individuals, especially organ transplant patients and cancer patients, under therapy get a third shot. Days before this announcement my patients had begun calling me, texting me, emailing me to tell me that their friends had walked into a Walgreens Pharmacy or Publix Pharmacy, showed them their Medicare ID card and their vaccine card and had been administered a third COVID vaccine shot with no questions asked. This was substantiated by multiple other patients including one couple spending the summer in the mountains of North Carolina.

Is there one set of rules for large chain pharmacies and another set for the rest of the world? What is the point of data and evidence-based recommendations if anyone can just do what they want when they want to?

At this point I will wait to hear the CDC’s recommendations on when to take a third shot and the data they used to explain why. I am thrilled that Pfizer has shown that a third shot is safe with few adverse effects. I am also buoyed by a research paper that showed that those groups who spaced their second shot at longer than the three- or four-week recommendations had a more robust immunologic response.

When my friends call me and ask me to join them on a trip to Publix or Walgreens to get the third shot now, I will hear my late mother’s voice in my brain asking that irritating question, “If all your friends decided to jump off the Empire State Building would you jump too?”

Delta Variant, Breakthrough Infections & What You Need to Consider

As a primary care physician treating older adults fifty years of age and older, I am starting to be involved in the treatment of “breakthrough” COVID-19 cases in vaccinated adults. At the end of June 2021, just prior to the July 4th holiday, we were told to enjoy the summer if we were vaccinated. Many in my patient population took this to mean book flight and cruise reservations and begin travelling. Others started meeting friends to shop again, exercise together in gyms or eat lunch socially indoors.  Experts at the CDC felt it was safe to take off our masks indoors.  Then came the Delta variant – a far more transmissible virus. 

I first read about breakthrough cases in a peer reviewed medical journal discussing the widespread outbreak of COVID-19 in Israeli citizens vaccinated with the Pfizer Vaccine. The message was clear, if vaccinated, you can still get the viral infection with the Delta variant, but you won’t require hospitalization and you have a minimal chance of dying. 

With that news many of my patients continued resuming their lives and normalizing to pre-pandemic routines without masking or distancing in public areas.  Three weeks ago, our local hospital had no breakthrough cases. Two weeks ago, there were five. All the breakthrough cases in individuals 65- years of age, or older, or with symptoms, are invited to receive the monoclonal antibody treatment which shortens the course of the illness and the severity.   Treatment should be within 10 days of first developing symptoms. The cases are so numerous this week that there is a wait of days to get treated.

In discussing the breakthrough cases with my ill patients, they all feel miserable.  They are exhausted, coughing, some febrile with high fevers and severe joint and muscle aches. Some have lost their sense of taste and smell. They say the monoclonal antibodies help, but a week later most of my patients are too weak and tired to do much beyond their necessary activities of daily living. They call daily asking how much longer this will last.  My answer is, “I just do not know.”

I also do not know If their viral load was high enough to transmit the disease to the unvaccinated, the immunosuppressed vulnerable vaccinated patients or even other vaccinated individuals.  The experts are not sure either. Will these vaccinated breakthrough patients become “long haulers” with chronic symptoms stretching to months post infection?  We don’t know – it’s too soon to tell. 

I am also getting calls from patients who were out socially unmasked with close friends and relatives and have now received a phone call that their friends have the COVID-19 infection, and they were exposed.  These patients need to be tested for the disease a few days after exposure but, with the closure of all the state-run testing sites locally, you are limited to going to your pharmacy or some walk-in clinics for COVID testing. Take my advice, get the nasal PCR test sent to the lab which takes longer than the quick test but produces fewer incorrect results.

What I do know is this is a disease well worth avoiding.  Get vaccinated if you haven’t already done so.  Wear a good N95 or KN95 mask if you must go out in public to an indoor facility, and you have no idea who is vaccinated, and who isn’t, and who might be spreading the disease prior to developing clear cut symptoms.  Yes, this is retreating and taking a step backwards into a bunker mentality.  If you don’t believe me, just ask my COVID-19 breakthrough patients. They will tell you this is more than just a “bad flu.”

Making Sense of the New CDC Guidelines Here in Florida

There were almost 6,000 new cases of Coronavirus illness in Florida yesterday with the positivity rate of those tested being well above 5%. Fewer and fewer people are showing up for testing or to receive vaccine here in the Sunshine State.

The Center for Disease Control (CDC) has issued new less restrictive activity guidelines last week which suggest outdoor activities in low population densities do not require a mask. This makes great sense and I am in complete agreement. They go further and say small indoor gatherings with vaccinated individuals do not require a mask. This makes great scientific sense as well. What they do not want is thousands of individuals, whose vaccination or immunity status is unknown to be packed into a venue indoors or out without being masked. They additionally don’t recommend large private gatherings indoors of individuals whose immune status is unknown. This makes sense to me as well in Florida where the infectious positivity rate remains greater than 5%.

We know vaccinated individuals have a low probability of catching COVID if exposed. If they are unlucky enough to catch it (about 6,000 breakthrough cases are known in the USA with about 150 million already receiving vaccine) there is an even smaller chance of getting sick enough to require hospitalization or dying. They still are not sure if those infected can transmit it to those unvaccinated or those frail, immunosuppressed and vulnerable.

The Governor of Florida and his Attorney General have sued the CDC, NIH and Federal government demanding that they allow cruise ships to begin sailing again from Florida ports. My daughter and grandchildren depend on cruise industry revenue to pay their mortgage, feed and clothe the family and live. The cruise industry has gone to great expense to vaccinate its crews and restrict passenger access to those who can prove they have been vaccinated or prove they are not COVID Positive. They wanted a “vaccine passport” for passengers.

Florida responds by having its Surgeon General, pediatrician friend and political ally of the Governor with zero public health or infectious disease background declare if you are vaccinated you are not required to wear a mask anywhere anytime. The legislature, composed primarily of members of the Governors party, passes legislation forbidding businesses from barring individuals from their business based on their vaccine status. This comes well after they supported the Governor with legislation forbidding local municipalities from enforcing local ordinances requiring masks.

I want the ships to sail so my son-in-law keeps his job! The last thing we need is for Florida politics to permit a ship to go out to sea and become a center of infection, illness and death because Florida elected officials watered down the sensible guidelines the cruise industry developed to begin sailing again safely.

Florida is a gateway state encouraging visitors from Latin and Central America as well as US tourists. Brazil is embroiled in a COVID surge of infection and death . The poverty in Central America and the islands prevent knowing exactly what their status is. I am more concerned about the disease entering and leaving Florida via visitors and no rules than I am concerned with illegal immigrants bringing it in at the Texas and Arizona borders as the media and certain elements of the U S seem to be.

Vaccines have brought us so close to controlling the Pandemic. Why can’t we mask up and be patient for a few weeks more?

In my office we will continue to follow the CDC guidelines. We will wait to see if the relaxed mask recommendations of the CDC, plus the vaccine program, keep the infection rate down. Florida Surgeon General Scott Rivkes’ no mask for the vaccinated anywhere may be interpreted as no masks anywhere for everyone. It will take three to four weeks for the consequences of these announcements to make an impact. If the number of infected decreases, my physician associate and I will sit down and alter our approach based on the science. Until that time, we will require masks in our office!

Put on a Mask and Just Stay Home!

I listened to the Governor of my home state, Florida, declare our state the freedom state because all the businesses are open and running full tilt.  He cited his success in keeping deaths from coronavirus low while keeping the economy running and jobs available.

I bring this up because on my way to visit my fully vaccinated adult children last weekend I passed by at least 20 overhead electronic road signs proclaiming, “Miami Beach Curfew 8PM – 6 AM Causeways Closed!”  Yes, here it was springtime with Passover and Easter on the horizon and the famed Miami Beach was closing at night.  We are at a critical point in the fight against the Sars2 COVID-19 coronavirus. We are trying to vaccinate enough people quickly so that the virus does not enter a vulnerable host and mutate to a form that the vaccine is less effective against.   We are so close to controlling this pathogen but human nature and failure to be able to delay gratification, and put off travel and group activities, is leading to a potential fourth surge of COVID-19 related illness and death.

My cell phone rang twice with patient calls on the 60-minute trip southward. The first was from a patient whose adult children came to visit him. His unvaccinated eighteen-year-old grandson was with them. After spending four days together they received a phone call that the grandson’s girlfriend was sick and tested positive for COVID-9. The next two calls were from patients who had been to two different Passover seders. One was outdoors, the other indoors with 20 plus guests. Both had been exposed to a person who called the next day to say they were COVID-19 positive.

I watched the director of the Center for Disease Control and Prevention (CDC), an experienced infectious disease and critical care physician, beg Americans to wear a mask and social distance while she was brought to tears by the thought of another wave of illness, death and prolonged restrictions. I listened to the President of the United States plead with state governments to maintain mask restrictions a bit longer to save lives and control the disease. I listened to the Vatican public relations division discuss not holding an Easter Service in St. Peters Square this coming weekend and wondered what it will take to convince people that we just are not ready to resume full activities.

The Governor of Florida is correct. Deaths are down due to vaccinations and the elderly staying home. I suspect if he tracks the cell phones of the tourists and spring breakers to their home states and countries three weeks from now, he will see an increase in hospitalizations and deaths.  Florida’s economy may boom but we certainly are maintaining it at the cost of illness and death elsewhere.

Are My Symptoms Due to COVID-19 or the Vaccine?

The Pfizer COVID-19 mRNA vaccine received Emergency Utilization Authorization by the FDA and CDC last week and is being administered to health care workers and seniors in senior facilities as I write. The process began overseas in the United Kingdom last week.

Many of the recipients of the first of two vaccinations are experiencing symptoms as their immune system reacts to the vaccine and hopefully builds antibodies and immunity. They are experiencing fever, fatigue, headaches, chills, myalgias and arthralgias.  Many of these symptoms are identical to the symptom’s individuals infected with COVID-19 experience yet these healthcare workers are expected to take some Tylenol or aspirin and head back to work caring for patients.  How exactly are they expected to distinguish between being infected with “the Rona” virus or just experiencing mild side effects of the vaccine?    

David Kuhar, MD, of the CDC’s COVID-19 Response Healthcare Infection Control Team suggests health care workers need to use their clinical judgement.  They need to assess whether they believe they were exposed to the virus in the previous 14 days?  He emphasized that in clinical trials, these adverse symptoms resolved within 3 days of vaccination and 2 days of the onset of symptoms. If the symptoms last any longer, he believes the healthcare workers need to be evaluated for a COVID-19 infection.  He stressed that the vaccination will not produce a positive COVID-19 antigen test response. It additionally should not produce shortness of breath and loss of taste and smell sensations. 

If you experience those symptoms or have your symptoms for more than two days, then you need to go to a COVID-19 test site and be tested.  The CDC has set up a communication system for those vaccinated called V-safe.  It is an app for your smartphone or tablet that allows you to communicate your symptoms and concerns with the CDC after you receive the vaccine.  When you are vaccinated at a test site, you are provided the information you need to register and participate in this V-safe monitoring program.  The information gathered on this smartphone app will allow the CDC to continue to monitor the safety of the vaccines being administered.

Post-Thanksgiving Travel Quarantine Guidelines & Other Matters

I hope all in my practice had a safe and enjoyable Thanksgiving. For those of you who travelled out of the area and stayed elsewhere for Thanksgiving, the Center for Disease Control recommends a 14-day quarantine at home before resuming local activities while staying masked and keeping a safe social distance in the community. A seven-day quarantine with a negative PCR test at that point is a less acceptable option but one noted by them as well.

Quarantine means staying home. It doesn’t mean shopping with a mask. It doesn’t mean getting a haircut or hair coloring or nail treatment while wearing a mask.  It doesn’t mean working out with a trainer from a distance in your home with a mask on. It means staying home for 14 days! These are not my rules and recommendations.  They are the recommendations of the CDC.

I was one of the lucky individuals who did get to see most of my children and grandchildren from a distance on Thanksgiving. Thanksgiving is my wife’s favorite holiday. A crowd of 20 or more is the norm in our home.

This year she made a small turkey, baked some breads and we drove down to Palmetto Bay in Dade County for dinner. My California daughter had been there for several weeks helping with the two children and working remotely as have my youngest daughter and son-in-law.

We brought a folding table, chairs, paper plates and disposable forks, knives and cups. My children made stuffing, sweet potatoes, salad and dessert. Since I am the only person in the group going out daily and seeing patients in my office, I am the security risk in this COVID-free bubble. We all wore masks and sat outside at distance.

As much as I wanted to hug and kiss my grandsons, I kept my distance. I stayed outside except for a trip into a poolside cabana bathroom. As different and sterile as it was, I was one of the fortunate ones who got to see and break bread with family.

With vaccines on the horizon, hopefully this will never happen again.

Pediatricians Sending Flu & Upper Respiratory Patients to ERs and Urgent Care Centers

As we head into the post-Thanksgiving and pre-Christmas season with a huge surge in COVID-19 infections and the emergence of the flu , pediatricians, like most primary care physicians , are sending their respiratory patients to be screened at ERs and Urgent Care Centers rather than bringing them into their offices for evaluation. Citing a lack of sufficient personal protective equipment, lack of accurate on site COVID-19 testing ability and concern for healthy individuals being exposed to COVID-19; they are offering telehealth visits only.

The Kaiser Health Foundation Newsletter, in a scathing opinion piece, quoted many academic pediatricians calling this an abandonment of patients. It is easy for those who supervise from a distance and don’t generally see patients to criticize those who do. The truth is, pediatricians are following the initial CDC guidelines.

Those patients tested in an appropriate timeframe after exposure, with an appropriate and accurate test, are being seen by their pediatricians and not referred elsewhere.

The lack of a national program providing guidance and support is the reason this health care situation exists. There are no clear-cut guidelines from our major medical societies, specialty societies, public health departments and major health companies which provide patient care including hospital chains as well as state, local or federal governments. There is no leadership about when practices should stay open and when they should lockdown.

Restrictions of any kind are met by legal challenges from the business and religious sectors. Citizens do whatever they choose to with little thought about how their choices impact others. Within this mix of chaos, Kaiser Permanente has no right to criticize small mom and pop practices trying to provide care and advice to their patients without possessing the resources to keep themselves and their employees safe from COVID-19.

Thoughts During Self-Quarantine

The CDC produced a research study that documented individuals who tested positive for COVID-19 were out in restaurants and bars within two weeks of detection as compared to a control group who did not develop COVID-19 and stayed away from open bars and restaurants. It’s been a frustrating seven months trying to educate my patients to the fact that they are older, vulnerable and that restaurant workers, hair and nail salon staff, gym employees need a paycheck to survive. If they don’t work they don’t get paid.

They live in homes where others go to work too and spacing does not allow distancing. They are high risk to contract COVID-19 and, because many of these workers are young, they may fortunately be minimally symptomatic but are contagious. Taking their temperature is just a poor screening method for determining if they are asymptomatic and contagious with COVID-19.

So I say, stay home and be safe until we have a treatment for COVID or an available vaccine that works. Having a quick and inexpensive, but accurate, on-location test might help too. The research just proved what we already knew. If you don’t have a mask on, and remain around others who don’t have a mask on to eat and drink, you are more likely to catch a respiratory virus.

I read an interview with the Surgeon General of the US claiming we are ready for a second surge of COVID-19 because we have an additional 119,000 ventilators now. We don’t want to use ventilators, if possible, because the mortality rate for patients requiring ventilators approaches 30 %. He boasted that the Federal government had purchased 150 million quick COVID tests from Abbott Labs and SalivaDirect and they will be distributed at nursing homes and senior facilities by state government.

When I ask my state public health department about the tests they have no idea what I am talking about. My state medical association is unaware of the plan as well. When I contact Abbott Labs, SalivaDirect and several medical supply companies they too have no idea when these tests will be available. They don’t even have a waiting list for those interested.

I would love to have some tests to ensure my staff is healthy and free of COVID and for my patients’ peace of mind as well as being able to closely screen all incoming patients who might need screening.

The Surgeon General mentioned that compiling a national stockpile of PPE, which he says is in abundant supply, may be wasteful because, after all, it may sit and expire. I thought that’s what happens with all stockpiles.

If we were organized those supplies would be distributed worldwide for use before they expired and replaced with up-to-date products. The last time I looked, hospital staff were still limited on how often they received and could replace used PPE. Working parents, with multiple kids, do this well all the time so why can’t the US government? We do it every year here in south Florida with food and water set aside for hurricane supplies.

COVID-19, Phase III Reopening & Influenza Vaccine

Watched the Presidential debate last evening which resembled a sequel to the movie Animal House with Chris Wallace of Fox News doing his best Dean Wermer impression. The moderator had the right and duty to allow each participant to answer the question in their allotted time and could have turned off the microphone of the offending participant but chose not to. The American Public was cheated by his ineffective leadership.

This occurred on the same day columnist Fabio Santiago, of the Miami Herald accused Florida Governor Ron DeSantis of threatening public safety by opening the state completely before the state has met any of the recommended safety benchmark goals of the CDC.

An article in the Jerusalem Times forwarded to me discussed a large series of Israeli COVID-19 survivors who developed antibodies to COVID-19 and then became ill with it within the three-month recovery period. Their presumed second round of COVID was far more serious and complicated than the first bout raising questions about whether they ever cleared the disease or not. It underscores the tremendous lack of knowledge we have about this pathogen.

I understand the frustration of small business owners, stay at home working parents who now have to supervise their kid’s education while working remotely and; the unemployed who cannot break through the inefficient computer systems to obtain the benefits they deserve and need to survive. In my mind these issues just highlight the need for a national program to fight the spread of COVID-19, protect the most vulnerable, support those out of work as well as the businesses who need to pay rent and salaries to survive while we wait for a vaccine or medication. To say that its fine to come to Florida, and safe for tourism purposes, is a lie exposing Floridians to the COVID-19 they bring from their homes and exposing their friends and neighbors to the COVID-19 of the Sunshine State.

Which brings me to the influenza vaccine. Do yourself a favor and get your influenza shot. No, the vaccine does not make you more susceptible to coronavirus as one Midwest couple read on a disinformation website. No, it is not 100% effective, but it will reduce the intensity and the severity of the disease if you are exposed to it.

We are currently experimenting with the safest way to immunize our patient population. The tenants in our building, with the support of building ownership and management, did not enforce the indoor mask mandate when we were in Stages I and II. Now the younger, more casual tenants, are even less likely to observe social distancing CDC guidelines. We are experimenting with three different ways of administering the vaccine on site, which I believe is still far safer than the exposure in a commercial pharmacy.

My advice to my patients remains:

1. Stay out of restaurants and country club dining rooms despite the efforts of management and the board to keep these places spotless. CDC studies show restaurant attendance is associated with catching the disease.

2. Stay out of gyms – both public gyms and gyms in your apartment complex. Take walks outside. Use a chlorine pool. Walk at the beach. Bicycle ride.

3. Stay out of hair salons and nail salons.

4. Cook and prepare your own food. Restaurant workers, who must come to work to get paid, are often asymptomatic spreaders of COVID.

5. Suppress the urge to use commercial air travel to visit your relatives. Airport terminals and inconsiderate and uncaring passengers are your biggest threat. If you do go, you will need to quarantine for 14 days before you see your vulnerable loved ones or; wait at least four days after arriving before being tested for the COVID-19 antigen indicating an ongoing infection.

Stay home. Wear masks when in public. Wash your hands frequently and stay 12 feet or more away from others. That is our best option for staying healthy and alive until a treatment or vaccine is available. Get your flu shot. Listen to science not politicians.

A Perfect Storm Brewing: Flu Season Plus A COVID-19 Resurgence

I was asked by a colleague what I thought influenza seasonal infections coupled with a predicted second wave of COVID-19 would look like locally? Influenza A arrives locally around Thanksgiving and peaks the last two weeks in January and first two weeks in February. I suspect it is fueled by seasonal visitors coming to Florida bringing the disease from their home locales. We see a low level of influenza B year- round in our pediatric population.

A full-page ad appeared in all Florida newspapers today sponsored by every major health system in the state including Baptist, Tenet, HCA, Cleveland Clinic, Broward Health, Jackson, U M Health, Memorial Health and others. It stressed wearing masks, social distancing and frequent hand washing.

If you get sick with mild symptoms, they encourage remote telehealth care. If you have moderate symptoms, they suggest going to their urgent care facilities. For severe symptoms call 911 or go to the ER. At no time did they suggest calling one of their employed physician offices or visiting your private doctor which is all consistent with CDC recommendations. Private independent and employed physicians just don’t have the ventilation systems, sanitizing systems, personal protective equipment or trained staff to see potential COVID patients in their offices. If a patient is positive, or a staff member converts, what is their responsibility to the next patient or to the other tenants of their building? Is a 14-day quarantine in order?

Much depends on unknown factors. How effective will this year’s flu shot be? In my area, the chain pharmacies already received their supply of influenza vaccine and have shamelessly been pushing it on customers since July. Scientific research shows that in senior citizens the flu shot immunity begins to subside 90 days after you receive the shot. Given that, if your pharmacy tech gives you the flu shot in September, then how much immunity will you have by the time the flu arrives around Thanksgiving?

Quick, accurate and inexpensive testing availability for flu and COVID 19 is an important factor as well. We have had a quick influenza test for years requiring a nasopharyngeal swab. A similar test for COVID -19 has just been released by Abbott Labs and received Emergency Utilization Authorization from the FDA. That means Abbot Labs researchers say it works and the FDA takes them at their word. This test, called “a game changer” by many, will be available in October.

When $15 per hour medical assistants start performing the test rapidly, in volume, I hope the accuracy results are similar to Abbots claims. Our health and lives depend on that. At the same time a finger stick blood drop test is heading to market to quickly detect flu and COVID -19 on the same test card. Finnish scientists and Israeli researchers have quick breathalyzer tests coming soon as well. I hope they work and get here soon. I will test everyone at the door as will restaurants, theaters, sports arenas and most businesses.

All of this information really skirts the issue. With no treatment and vaccines available yet, I expect this flu COVID-19 season to be a human health disaster. With no national plan in place and no close coordination with state and local elected and public health officials, I see the fall and winter as a time of continued disease surges and deaths while the political influence on disease treatment supersedes scientific research and public health realities. Without a coordinated program of PPE and medication distribution, coordination of testing availability and results with contact tracing and specific shutdowns of hot spots without challenges related to loss of freedoms the outlook is grim.

Protecting senior facilities without a coordinated program and funding for it will not work for residents or employees. Opening schools and day care without similar precautions, training and funding for materials and tracing will lead to hotspots as well. There are members of the student population such as special needs children who need to return too, in person, learning safely and creatively. Others need to learn remotely or be given a chance to catch up later when safe return to in person learning is possible.

Without a plan to assist renters, homeowners, landlords, small business owners, farmers, restaurateurs, etc.; any shutdown for disease will be met with overwhelming resistance. I see a bleak and dangerous health picture developing in the fall/winter creating a perfect influenza/COVID storm.  I hope I am wrong but, if right, the disease surge will overwhelm ERs and hospitals.