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.

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.

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.

Thoughts During Self-Quarantine

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

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

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

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

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

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

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

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

COVID-19, Phase III Reopening & Influenza Vaccine

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

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

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

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

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

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

My advice to my patients remains:

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

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

3. Stay out of hair salons and nail salons.

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

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

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