Keep Your Guard Up As The New Year Approaches

As we head into the last work week of the horrendous year 2020, my advice to my patient population is keep your guard up. Most of you have social distanced, worn masks, washed your hands until they are raw and avoided close contact in a social setting with friends and relatives to avoid contracting or transmitting the coronavirus to others.

I have been receiving phone calls for the last several weeks now from patients who have younger family traveling to Florida by commercial airlines or driving by car for the holidays and they ask me about how to stay safe. I applaud them for their common sense and decency after months in virtual isolation and advise them to continue their social distancing, hand hygiene and wearing masks.

If your family members do not have 14 days to self-quarantine from you upon their arrival, and prior to their visit, then there is a risk of contracting the disease from an unknowing asymptomatic carrier. Make sure the visit is outside in a well-ventilated area with at least 10 feet between individuals and you are all wearing up to date functioning face masks. If a meal is involved, make sure not to serve buffet style and don’t share food from each other’s plates.

If your visitors are feeling well and have no symptoms of illness and wish to try the short seven-day quarantine with testing for COVID, I suggest the standard nasopharyngeal or saliva PCR tests sent to a lab because they are more accurate in this situation than the quick tests. The test sites at FAU (they take walk-ins but are closed on Mondays) or the Town Center Parking Lot test site are professional.

In a few weeks, the Ellume home test kit should start to appear in pharmacies and its results even in asymptomatic individuals is remarkably accurate and quick. That test is a game changer.

Many of us have stayed out of restaurants and bars, avoided theaters and shows, postponed travel and worn masks now since late February. The vaccines are beginning to appear in the area and there will be an opportunity over the next few weeks to receive it. I will provide more details when they are made available to me.

Happy New Year to you all. May 2021 be sweet – filled with joy and health.  But please, until we have you vaccinated, stay strong and keep your guard up!

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.

The Tyranny of Drug Benefit Management & Chain Pharmacies

I received a call from a 35-year-old healthy strapping patient who was doing some yard work late in the afternoon, tried to straighten up and felt severe pain in his lower back radiating from his back to his buttocks and down his leg. It was after 5:00 p.m. and I was not in my office. After providing short-term instructions, I phoned his pharmacy and prescribed seven generic anti-inflammatory pills, a Medrol dose pack and a three-day supply of muscle relaxers.

When I made the initial phone call to this local branch of a pharmacy chain, I chose to speak to the pharmacist from the choices on their automated phone attendant. I held on for 10 minutes and no one answered so I hung up and called back choosing to leave a message for the pharmacist. I provided all the requested information requested, completed the order and then texted the patient.

One hour later his wife loaded their two young kids into their car seat and drove to the pharmacy. She drove into the drive through section and, when her turn came, was told no doctor had called in a prescription for her husband. She begged to differ and asked for the manager. Five minutes later she was told that they did have the order it was just not ready yet. They said it would take about one hour so she drove home.

As she pulled into her driveway, she received a text message that the medications were ready. She just put her kids back into their seats and drove back. Fifteen minutes later, at the drive through window, she was told that her drug benefit manager needed pre-authorization for the seven anti-inflammatory pills. Since it was now close to 7:00 p.m., and she knew I was not in the office, she asked if there was a phone number the doctor could call to obtain approval. She was told a note was faxed to the doctor’s office with instructions on who to contact and what information they were requesting.

The cost of seven generic anti-inflammatory pills was under $40. No one informed the patient’s wife that she could just pay for the medication and go home with it. The patient called me and explained the problem. He had the over-the-counter version of a similar medication at home so, I instructed him on how to take it until we worked it out. When I got into my office the next day, there were four separate fax sheets from the drugstore labeled first request through fourth for pre-authorization.

It should not be that hard to fill a generic non-controlled medication for a patient afterhours. No small private practice has the patient’s insurance information and their drug formulary with them and accessible all the time. I can probably access that information remotely from my tablet if I had my tablet with me but should I really have to carry it everywhere I go?

The insurer was not concerned about the insured’s pain. They knew if they denied it most individuals would foot the bill themselves and never ask the insurer to pay their fair portion. That, coupled with inappropriately high costs per pill, make the system a nightmare for patients and physicians alike.

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.