A Light at the End of the Tunnel?

My cellphone emitted the shrill sound of the Emergency Broadcast System Saturday evening.  It repeatedly said, “This is an Emergency Message from the Baptist Health System. Please check your email immediately for an emergency message about COVID-19. Please press 1 to confirm receipt of this message.”  Since I was watching my favorite college football team on TV, and they were not doing well, I was in a particularly sour mood, so I ignored the message and sat down and watched the TV.

Almost immediately my home phone rang and when I picked it up, I heard the exact same message.  This time I pressed one and then ran to my iPad and went to my professional email address. There was a message from the Director of Baptist Health Systems and the Chief Medical Officer saying that they had the Pfizer COVID-19 vaccine and they wanted to vaccinate me. I am apparently in Group IA. They explained that the decision to vaccinate was voluntary but if I was interested I should “click here.”  

 I followed the directions and was directed to a calendar with times in fifteen-minute slots.  I selected a day and time that allowed me to drive down to Baptist Hospital on Kendall Drive in Dade County and I received a prompt reply that confirmed my date and time to receive the vaccine.  I was so amazed and surprised by the mechanism of delivering this information that I was sure it was a joke or a scam.  I have two neighbors down the block who are physicians and nurses at Baptist Boca Raton Regional Hospital, so I called them. They had received the same message.

The fact that in this dysfunctional state, run by a government that has maximized the interests of the tourism and business community while minimizing the dangers of the pandemic, could be delivering vaccine to health care workers astounded me.

My team lost the game I was watching Saturday night turning what should have been sheer joy into a mixed bag. Sunday was a glorious day – sunny, warm but not muggy. The local Fire Department sent around Santa Claus on a fire truck with Santa’s elves and helpers.

I walked around the community in complete disbelief watching young families and their children and older family members and friends all closely gathered without masks or social distancing having lawn Christmas parties in advance of Santa arriving.   It was as if there was no pandemic and no warning of the main mechanism of COVID-19 transmission being at family and informal at home gatherings. 

Santa arrived later that day and stayed on his fire truck smiling and waving from a distance while his elves handed out candy canes from a very safe distance from the lawn revelers.  I kept thinking and wondering if Santa would place these apparently carefree individuals on his annual “naughty” or “nice list”?

The vaccine will be a start towards providing some protection against the Sars2- COVID-19 virus. We do not know if it will completely prevent the disease or just modify its complexity and severity.

We do not know:

  1. How long the immune response antibodies to the shot will last and protect the recipient?  
  2. If the recipients can still pick up the virus and transmit it to those without antibodies?
  3. Which of the seven shots in development, and expected to be available by March 2021, are best for adults, seniors, adolescents, children, toddlers and pregnant women? 

We will still have to wear masks, maintain social distance and practice scrupulous handwashing hygiene until we have the answers.  There is, however, a vaccine being administered which is the first light at the end of the tunnel in a painful pandemic plagued year.

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.

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.

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.

Perspective on COVID-19 Testing

It’s November and Thanksgiving is on the horizon. Patients, friends and family hope to return home, quarantine safely from COVID-19, and then share the holiday in some safe manner with the people they love. They all have their individual plans for traveling home, quarantining and testing themselves for COVID-19 and, in most cases, the plans are well intentioned but unscientific.

After traveling home by plane, if you arrive with no symptoms of COVID-19, it will take about 4-5 days after you arrive home to produce enough viral load for the tests to detect the virus if you have been infected. Testing immediately before you board a flight only tells us if the virus is present before you left – specifically, did you have exposure 4-5 days prior to traveling?

Upon arriving home, rushing out for a “quick test” while you have no symptoms will not answer the question of whether you are a contagious asymptomatic carrier of COVID-19 or not. The “Quick Tests” being used were designed specifically to detect individuals who are sick with symptoms. They were not designed to screen for asymptomatic carriers despite them being used that way locally by walk- in clinics and testing sites. They detect a surface protein on the virus and are far less accurate when used for screening than the traditional PCR nasopharyngeal swab test sent out to the lab.

The incubation period once exposed to the disease should be 14 days or less but some documented cases have lasted a week longer. If you have no symptoms and are tested by PCR nasopharyngeal swab at five days post arrival, and again at 7-10 days, and are negative, you are probably not infected or contagious. That means you probably can see your loved ones at a safe social distance wearing masks and eating and drinking at a distance using separate utensils and plates without infecting each other. An outdoor setting is safer than an indoor venue.

The PCR tests are clearly the most accurate. They require sampling a specimen from high up in your nostrils using a special nasal swab. This is placed in a tube with transfer medium and shipped to a lab. Transferring the material from the tube it arrives in requires a specialized plastic pipette. Think of a pipette as a finely calibrated medicine dropper designed to fit perfectly inside the tube with your specimen and then seamlessly fit into the testing machine and deliver a calibrated sample for testing.

United States labs ran out of these pipettes early in the pandemic and, since they are produced overseas, supply chain shortages developed. With the current administration not instituting the War Powers Act to ramp up production of supplies needed to quell the pandemic, US firms did not tool up to manufacture pipettes or the chemicals required to perform the tests.

In many cases, hospitals and health care systems attempted to purchase the analytic machines required to perform PCR COVID-19 testing at their facility but machines ordered in December 2019 are now just being delivered without reagents 10 months later.

There are few, if any, peer reviewed clinical trials setting a gold standard for testing accuracy. In every case, the FDA issued an emergency use authorization to the product manufacturer of the test based on the data provided by a trained professional in the manufacturer’s lab. Contrast that with the personnel performing the tests at the many public test sites and you see why accuracy is an issue.

 “Quick tests” were designed to distinguish sick people with COVID-19 from sick people with symptoms of an upper respiratory tract infection other than COVID-19. They were not designed to test asymptomatic individuals who may be contagious early in the incubation period of the disease.

The Abbott Bianox test is the most well-known with the Federal government purchasing 150 million tests, making it virtually unavailable to any other health care systems. Tragically, it is being used locally at test sites for screening rather than its intended purpose of diagnosing symptomatic individuals.

I have sent patients with symptoms over to the FAU and Town Center Mall parking lot test sites for testing. Those sites advertised both the PCR test and quick test. When the patients reached the front of the line, they were told that the site was out of the quick tests and so they are still waiting for their results from the lab with the traditional PCR test.

Most were unhappy having to wait so they asked about the quick test I mentioned in a previous blog article with results available in hours. I called their medical director who told me that one of the machines was in repair and with chemical reagent shortages the four to eight-hour turnaround time for results is now 48 hours at best.

There will be new tests developed that are quick and reliable. It will take time. For now, we are left with distancing, wearing masks, practicing repetitive effective hand washing and avoiding crowded public places especially if they are indoors.

Drug Shortages Exacerbated by the COVID-19 Pandemic

Globalization and overseas outsourcing of manufacturing has resulted in periodic drug and medical supply shortages since 2001. This issue has been brought to the attention of US authorities multiple times with no action on the part of several administrations.

On this blog I have written about the defunding of the FDA so that many of the drug producing factories in China and India have not been inspected by FDA inspectors for quality in decades. Within the last five years the only major producer of intravenous fluids for the United States and Canada, located in Puerto Rico, was shut down after hurricane damage and electrical grid damage. The US Military was impacted by this factory shutdown and tried to purchase fluids from overseas producers, but they were at top capacity and could not meet the demand. There have been critical shortages of morphine for pain control.

The pandemic has further exacerbated this issue. CIDRAP, the Center for Infectious Disease Research and Policy at the University of Minnesota reported on its website that there is a shortage of 29 of 40 drugs crucial for treating COVID-19 patients. The shortage includes the short term anesthetic propofol, the bronchodilator albuterol, hydroxychloroquine (used for rheumatoid arthritis and certain lupus patients), fentanyl and morphine. The Food and Drug Administration has its own critical list of shortages and lists 18 of 40 on their drug shortage list. An additional 67 out of 165 critical acute drugs are listed as in short supply. This list includes acetaminophen (Tylenol), lidocaine, diazepam (valium) and phenobarbital among the most noteworthy.

As the election for President concludes, it is far overdue for whomever prevails to dedicate one department to evaluate, plan for and prevent critical drug and supply shortages. It is also long past due that the production and distribution of these key pharmaceuticals and medical supplies return to the United States so we are not subject to the whims of a foreign government or find ourselves trying to outbid our allies for supplies.

Michael Osterholm, MD, the director of CIDRAP, sees the coming increase of COVID-19 cases further challenging the existing supply of medications available to the American public.

COVID-19 & Local Disease

We receive periodic updates on the census and status of the COVID unit at Baptist Health Boca Raton Regional Hospital. There have been under 25 COVID-19 patients per day for several weeks now. As of Friday, October 23, there were no patients with COVID-19 in the ICU.

On the downside, they are still very short on chemical reagents and nasal swabs to perform quick accurate on site COVID tests limited to about 30 per day and are sending out most tests to BioReference Labs. BioReference has a 48 – 72-hour turnaround time and is dealing with unexpected false positive tests.

In discussion with an official of Holy Cross Medical Center, they are very pleased with the accuracy of their four hour in house COVID detection test and have sufficient chemical supplies so that they do not send out any COVID tests. I have no idea why Holy Cross is flush in supplies and Baptist Health system short.

Lately, the number of respiratory cases showing up at the Emergency Department is increasing. The number of diagnosed cases of COVID locally is increasing. The number of positive tests performed, regardless of which method is used, is increasing. Hospitalizations in Florida are increasing.

As a result, I suspect in 3 – 4 weeks we will be discussing hospital bed availability, bed capacity and elective surgery. I’m sure this will be discussed during our morning staff educational zoom meetings regarding our local COVID status.

At the current time, Boca Raton Regional is participating in studies with remdesevir, dexamethasone, mesenchymal stem cells, convalescent plasma, radiation to the lungs of COVID-19 pneumonia patients and Regeneron monoclonal antibodies. The high-tech treatments you read about are available locally if you qualify.

The ballyhooed Abbot $5, 15-minute, testing kits are reported to have been distributed to local state testing sites. If you find them, please let me know where.

In a major review of quick COVID-19 tests published in JAMA this week, it is made clear that this was never meant to be a screening test. It is meant to be used on patients who are ill with symptoms. There are far more false negative tests with this product than are acceptable for screening situations. The last thing you want is a contagious person to test negative and then behave in a social setting as if they are free and clear of disease.

Palm Beach County Commissioners extended their Executive Order mandating wearing of masks at all indoor facilities. Be considerate, save some lives, wear a mask please.

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.

It’s Hard to Believe

I referred my patient to a surgical specialty office last week for a problem that was out of my area of expertise. The doctor’s office is in a building run and managed by our local hospital.

Upon arrival at the office the patient wore an N95 respirator mask, face shield and gloves to protect himself and others from COVID-19. The multilevel parking lot is a short walk to the office from the garage.

The office door to the suite was open and the staff, sitting in a large open reception area, either had no facial covering or a mask around the neck not covering the mouth or nose. It is a multi-physician office, all in the same specialty, so there were several other patients randomly seated in the waiting room.

When the patient approached the desk to sign in the receptionist recognized him by name and said he did not have to sign in with the logbook. The patient asked the receptionist to please cover her face with her mask citing the Palm Beach County ordinance which mandated masks in indoor facilities. She said, “We believe this COVID-19 pandemic is overblown and its really not necessary at this distance.” When he asked to speak to the office supervisor, he was told the same thing.

The physician came into the waiting room to bring the patient back to an exam room wearing a N95 mask. She too said the response to COVID-19 was overblown. The physician practices an outpatient specialty that is highly reimbursed and does not require going to the hospital. I suspect her office sees no COVID-19 patients although in our area, with the high positivity rate, everyone is a potential contagious patient.

If health care providers do not buy into the science of wearing a mask during a pandemic to lessen the transmission of the coronavirus, what hope is there for getting the rest of the public to buy into the idea? We are getting a breather now. The number of patients presenting to ERs with respiratory symptoms are down. Hospital admissions for COVID-19 are down. ICU occupancy is down.

The onslaught of seasonal visitors will soon begin to arrive, bringing with them all the pathogens circulating through their home communities. With them come the tourists from Europe, Canada and Latin America. Our Governor is desperate to restore tourism and the economy.

These out-of-state visitors bring the flu and COVID-19 and; they want to go to the beaches, restaurants, bars, theaters and “party hearty” as vacationers should. With politicians politicizing COVID-19, and now physicians in the community feeling the same way, it looks like a long dark dangerous fall and winter season here in Florida.