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.

New Drug Shows Weight Loss Promise – Just in Time for the Holidays

Thomas Walden, PhD of the Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania presented data on weight loss at a Bariatric Medicine meeting held remotely called ObesityWeek. It was reported this week on Medscape Medical News.

Using the diabetic drug semaglutide (Ozempic), they demonstrated that 75% of the 611 participants lost 10 % or more of their baseline body weight. When they used the higher diabetic dosage, 55% of the participants lost more than 15% of their initial body weight and 36% lost greater than 20%.

Diabetic drugs have been used off-label for years for weight loss. Byetta and Trulicity work to reduce weight as well. The real problem with these medications is cost – with a month of Ozempic costing $800 – $900 while the other two (Trulicity and Byetta) are more expensive than that.

We know weight loss helps diabetics and hypertensives improve their control and health but there are a limited number of drugs you can safely give a 55 year-old with these types of medical conditions. I was surprised and perplexed when a local bariatric specialist started my 64 year-old patient on an amphetamine for three weeks with their heart rate accelerating and blood pressure elevating characteristics.

In patients, 55 or older, I believe in nutritional counseling first. We have experienced dietitians locally both at our hospitals and private practice who will teach you how to eat correctly and work you to develop a personal weight loss plan.

The retail diets like Weight Watchers, Jenny Craig and NutriSystem work and are safe. However, not all retail diets provide behavioral coaching which is a crucial component for losing weight safely and maintaining the weight loss (not yo-yo dieting).

I have twice now experienced great success with OPTAVIA.  The program incorporates Healthy Habits which is an innovative and proven lifestyle approach which gets your mind and body working together.  A health coach provides you with personalized guidance for maximum effectiveness.

Their plan uses five of their “fueling meals” plus one “lean and green meal” you prepare per day.  Following their plan, I have lost more than 35 pounds, in just three months.

I have recently signed up to be an OPTAVIA coach for those patients interested in this program and requiring help and encouragement along the way. Losing the weight is always easier than keeping it off for a “foodaholic” like me but with their maintenance program, and hopefully some discipline, I will keep it off this time.

Happy Holidays to all my patients, colleagues and friends. If you would like to shed those extra pounds, and live healthier, just give me a call. We will discuss the program and how you would benefit from it.

Advances in Prostate Cancer

Should we get a routine PSA on men at risk for prostate cancer? This debate has been raging for the past few years with the United State Preventive Task Force coming out against screening men for prostate cancer because if the PSA is elevated the subsequent diagnostic testing is painful , expensive and comes with many complications.

The specialty societies representing urologists, especially amongst European physicians, show a drop in deaths from prostate cancer since they started annual screening using PSA blood tests in senior men. When we find an elevated PSA, ultimately, the gold standard was the ultrasound guided biopsy through the rectum performed by urologists in their offices, which was both uncomfortable and accompanied by a post procedure infection at times. That has changed with the introduction of the MRI of the prostate which can detect prostate cancer. If the MRI is negative, then, in most cases, even if there is microscopic prostate cancer present, it would be treated with watchful waiting not surgery or radiation. If something is seen, biopsy interventional radiologists are now able to biopsy the prostate through the perineum under local anesthesia which is less painful and carries fewer post procedure complications.

If prostate cancer is found and the pathology and grading of the specimen indicates a significant risk of spread of disease we now have the capability of using the PET scan with gallium 68 PSMA-11 which targets prostate specific membrane antigen and highlights metastatic disease. This agent was approved by the FDA recently after studies at UCLA Medical Center and University of California San Francisco were reviewed. It has a second use in detecting recurrent disease in men already treated for prostate cancer who now have a chemical increase of their PSA but no detectable mass or lesion on imaging studies.

Radiologists have been using F-18 fluciclovine and or C-11 Choline as imaging enhancers, but these were not as effective as the Ga-68-PSMA just approved. By identifying areas of recurrent disease, it may allow physicians to locally treat the recurrent areas directly. Trial investigator Jeremie Calais, MD, of UCLA feels “Because the PSMA PET scan has proven to be more effective in locating these tumors, it should be the new standard of care for men who have prostate cancer, for initial staging or localization of recurrence.” Peter Carrol , MD, of the University of California, San Francisco added, “I believe PSMA PET imaging in men with prostate cancer is a game changer because its use will lead to better, more efficient and precise care.”

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.

No “Ouch” Band Aids in Our Future

Last week, at the direction of my physician, I had my blood drawn by my staff to monitor some chronic medication issues. My medical assistant, per usual, placed a band aid over the puncture site before I could object.

I went to work and forgot about it. Nine hours later getting into the shower I saw it and painfully yanked it off and with some of my hair. The next morning, that area looked like it had been punched by Mohammed Ali in his prime.

Ironically, I just read a review from an Israeli magazine of a gel or spray-on transparent polymer bandage. It hardens after application and dissolves with an ice pack or cold water. It stays firm and flexible in warm water so you can shower or bathe with it on. You can examine the healing wound through the transparent bandage.

The development of this new bandage took five years and was the idea of Professor Daniel Cohn, an expert on polymers. With a private investor, they started Inteligels and are in the final stages of receiving FDA and European Union approval. The plan is to first market it for chronic conditions to institutions to treat diabetic ulcers, pressure ulcers and conditions where the injury to the wound surrounding tissue causes skin disruption and pain.

A home bandage version is still several years off but is in the development stages. This is promising.