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.

An Oral Medication To Stop Coronavirus?

Researchers have produced a pill that, taken twice a day at the 800 mg dosage for five consecutive days, seems to stop SARS-CoV-2 virus from multiplying and causing clinical symptoms. The work is quite early and needs to proceed through stage 2 and 3 clinical trial phases before it can be presented to the FDA for emergency utilization authorization.

The drug is called molnupirvir. It could be taken in the first few days of infection to prevent advancement to severe disease much like Tamiflu is used with influenza. In initial human trials, the virus was eliminated from the nasopharynx of 49 infected individuals.

Wendy Painter, MD, of Ridgeback Biotherapeutics presented the data at the Conference on Retroviruses and Opportunistic Infections. The drug works by interfering with the virus’s mode of reproducing and mutating – overloading the virus with replication and mutation until the virus burns itself out and can no longer make effective viral copies.

Their method of testing the drug was to administer it, or a placebo, to humans who were infected and in the early stages of symptomatic disease. They used three different dosages and swabbed the participants’ nose and cultured for the virus at different times during the experiment.

At day 5, after the onset of symptoms, there was no detectable infectious virus in the nasopharynx of participants who were treated with molnupiravir. Dr. Painter reminded everyone that the next test will be given to patients who are actually sick with COVID-19 and see if it works. This preliminary data should encourage us that when scientists are given the time and resources, they solve problems. Imagine in the near future a vaccinated society that has at its disposal accurate and reliable quick tests for COVID-19 and the availability of a pill taken twice a day, for five days, to prevent the disease from becoming severe and requiring hospitalization.

Obstructive Sleep Apnea Surgery vs. CPAP? Daytime Anti-Snoring Device?

Obstructive sleep apnea is now epidemic in a population where it runs hand-in-hand with obesity, which is also an epidemic. The consequences of untreated sleep apnea include daytime somnolence, cardiovascular, neurological and endocrine complications.   One of the hallmark signs of obstructive sleep apnea (OSA) is snoring. 

The US Food and Drug Administration (FDA) recently approved an oral device to be worn during the daytime to reduce and/or eliminate snoring. The device is called eXciteOSA made by Signifier Medical Technologies.  The device is a prescription item which will be used by sleep specialists, dentists and ENT physicians.  It has four electrodes that deliver a series of electrical stimuli to the tongue with rest periods in between. The stimulation over time improves tongue function preventing the tongue from collapsing backward into the airway and obstructing it during sleep.  The device is used for 20-minutes once a day, while awake, for six weeks and then once a week thereafter. It is designed to be used in adults 18 years of age or older with snoring and mild OSA. Think of it as physical therapy for the tongue.

The device was tested on 115 patients, 48 of whom had mild obstructive sleep apnea plus snoring. The others were all snorers. The snoring was reduced in volume by more than 20% in 87 of the 115 patients. In the group of patients with the diagnosis of OSA and snoring, the apnea-hypopnea index score was reduced by 48%

It is recommended that a thorough dental exam be performed prior to trying this device. The major side effects noted from its use were excessive saliva production, tongue discomfort or tingling, metallic taste, jaw tightening, tooth filling sensitivity.  No mention of the cost was included in the printed review.

The online journal Practice Update reviewed a JAMA Otolaryngology publication on the use of surgery to treat Obstructive Sleep Apnea versus using a CPAP machine. There are many patients who just can not wear the CPAP mask which is the first-line “gold standard” for treating OSA.  Most patients who spend 90-days adjusting to the mask sleep far better and look forward to using the device to obtain a restful night’s sleep. The study looked at patients who were at high risk for not being able to adhere to a CPAP use regimen. Soft tissue surgery to the uvula was found to reduce the rates of cardiovascular, neurological and endocrine systemic complications compared with prescriptions for CPAP in patients less likely to adhere to or use the CPAP mask. 

The takeaway message is clear. When a patient is unlikely to adhere to CPAP mask use offering soft tissue oral surgery should be offered early while treating the disease.

Foreign Dependence on the Drug Supply Chain

I have written often about the problems we have as a nation being dependent on foreign nations for the raw materials and manufacturing of common everyday drugs and supplies. The COVID-19 pandemic has only amplified that problem as the U.S. compete for supplies against nation states for needed drugs to treat the infected and prevent transmission. I have addressed how many common drugs are manufactured in China, India and Israel and, due to financial cutbacks for FDA inspections, production plants have not been inspected for years.

I have also addressed how a hurricane that destroyed Puerto Rico left the only intravenous solution producing factory in North or South America unable to function – leaving hospitals and the military short of vital materials for health care. We witnessed the shortage of personal protective materials including masks, face shields, gloves, sanitizers, etc. as the coronavirus spread through the Americas with businesses and states bidding against nations for a limited supply of products, preferentially kept in the nation they were manufactured in.

This past Wednesday, President Biden issued and signed an Executive Order directing Federal agencies to study ways to secure the supply chain for pharmaceutical goods and manufactured goods. The Executive Order will direct 100-day reviews for supply chains for pharmaceutical goods, computer chips, large capacity batteries like those used in electrical cars to prevent dependence on foreign governments. The studies call for “consulting with experts in private industry, academia, workers and communities”.

The hope is we will create manufacturing diversity and redundancy bringing some manufacturing home but insuring that one nation or one site will not be responsible for the total production of any vital product. In my view, this is a long overdue step in the right direction based on what has transpired in the recent past.

Blood pressure measurement, its importance in reducing vascular disease & remote patient monitoring

An article published in the prestigious journal Hypertension looked at following blood pressure over a decade and the reduction in heart attacks, strokes and deaths if you were able to keep blood pressure under control. It talked about extending your life by over four years and the preventing vascular disease from developing for at least five years.

The authors looked at multiple blood pressure trials and noted the difficulty in relying on one office visit measurement periodically. They too noticed that certain patients were always higher in the office than at home and noted the problems with home blood pressure monitors including trying to decide if they were accurate and being recorded correctly. The result was that whatever reading they obtained at your visit, when looked at over a 10-year period, influenced your survival and cardiac events.

We too have struggled with this issue in our office. We ask patients to bring in their home blood pressure equipment so we can correlate the readings they get in our office on our equipment and their equipment. Just last night a patient with no symptoms and feeling well took his blood pressure and found it elevated. Rather than contact me or his cardiologist he ran to the Emergency Room. He waited hours, had multiple tests and by that time his blood pressure lowered they referred him to his doctors without intervening at all.

When needed, we have a patient use a 24-hour ambulatory blood pressure monitor. They wear it on their arm like a blood pressure cuff and it inflates six times per hour during daytime and four times per hour during sleep while measuring their pressure. There is a small recording device worn on their belt. After 24 hours, it is returned to our office and we print out the readings and obtain averages to help us determine just what your blood pressure really is. The equipment has a diary so the patient can note when stressful events occur and we can correlate it with the readings. The minor drawbacks to the equipment are its bulkiness, the need to keep it dry and the disturbance to sleep it causes as the cuff inflates and deflates.

To improve measurements, as well as capture other health metrics, we are introducing a remote monitoring smart wristband. We have identified a vendor who will supply you with the high-tech wrist band at no out-of-pocket expense to you. The wristband interacts with your iPhone or android phone.

The device measures and captures pulse, heart rhythm, blood pressure, blood oxygen level, and steps.  It even has built-in fall detection. The 2021 model, which will be introduced in a few months, has an EKG component to help us follow patients who get dizzy, faint or have documented heart issues. It will also capture body temperature. There is an optional blood glucose sensor monitoring device. The wristband is water resistant so you may shower with it.

Due to the Pandemic, and development of tele-health, Medicare pays for the monitoring if you wear the device a minimum of 16 days each month. Patients are asked to identify emergency contacts so that if you fall or if you have an arrhythmia, abnormal blood pressure, abnormal blood sugar, the monitoring call center contacts your emergency contact on record.

Your physician can view all the data on our computers. Certain private insurances pay for these services as well as Medicare. I will start wearing one and my wife will as well.

I will personally discuss this with each of you whom I feel will benefit from wearing the wristband as remote monitoring is proven to reduce hospital admissions and ER visits. If you have a chronic condition, disease or certain risk factors; it’s likely I will encourage you to wear the band.

Some patients have asked if the band has a panic button for you to push if you feel you need to such as after a fall. The technology senses if you fell and have not gotten up or if you are ill and calls your emergency contacts but it does not have a unique panic button to push.

We look forward to introducing this new remote high technology to improve your health, safety and peace of mind.

New Oral Testosterone Replacement Treatment is on the Horizon

We see a many men who develop testosterone deficiency. Testosterone is a hormone produced in both men and women which plays a tremendous part in our lean muscle mass, our sexuality and our energy levels. It is secreted into the blood and peaks between 8:00 – 10:00 each morning.

To determine whether you have a testosterone deficiency, your blood must be drawn during those hours for accuracy. If two tests show your level below 280 you may benefit from replacement therapy.

To replace testosterone we currently have had only three options. One option is by placing a gel preparation on your skin and allowing it to be absorbed each day. One preparation comes in a gel in a tube and you measure out a particular dosage and administer it to your skin. Another preparation comes in pre-measured transdermal patches which you apply to your skin.

Both skin applications are easy to use and are less likely to cause the adverse effects testosterone is sometimes associated with such as an increased blood thickness or secondary polycythemia. The drawback to these preparations is they cost anywhere from $500 to $1,000 per month. The only less expensive alternative has been the injectable testosterone cypionate which costs about $80 per month and requires an injection into your muscle every two weeks.

The injectable form, while far more affordable, results in more adverse events than the transdermal form. We usually prescribe the lowest dosage possible and then, seven days after your shot, measure your testosterone level with a blood test at any time of the day. Based on the results, we adjust the future dosage.

Marius Pharmaceutical submitted a new drug application to the Food and Drug Administration for an oral form of testosterone undeanoate taken in a gel capsule twice per day. It will be marketed under the name Kyzatrex.

In their initial studies, looking at six months of data, they were able to achieve average expected testosterone levels in 96% of the men who completed the 90-day treatment study. High blood pressure was the only true adverse effect reported. No mention was made of what a month’s supply will cost if the FDA approves the drug for use in primary and secondary testosterone deficiency.

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.

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.