Making Sense of the New CDC Guidelines Here in Florida

There were almost 6,000 new cases of Coronavirus illness in Florida yesterday with the positivity rate of those tested being well above 5%. Fewer and fewer people are showing up for testing or to receive vaccine here in the Sunshine State.

The Center for Disease Control (CDC) has issued new less restrictive activity guidelines last week which suggest outdoor activities in low population densities do not require a mask. This makes great sense and I am in complete agreement. They go further and say small indoor gatherings with vaccinated individuals do not require a mask. This makes great scientific sense as well. What they do not want is thousands of individuals, whose vaccination or immunity status is unknown to be packed into a venue indoors or out without being masked. They additionally don’t recommend large private gatherings indoors of individuals whose immune status is unknown. This makes sense to me as well in Florida where the infectious positivity rate remains greater than 5%.

We know vaccinated individuals have a low probability of catching COVID if exposed. If they are unlucky enough to catch it (about 6,000 breakthrough cases are known in the USA with about 150 million already receiving vaccine) there is an even smaller chance of getting sick enough to require hospitalization or dying. They still are not sure if those infected can transmit it to those unvaccinated or those frail, immunosuppressed and vulnerable.

The Governor of Florida and his Attorney General have sued the CDC, NIH and Federal government demanding that they allow cruise ships to begin sailing again from Florida ports. My daughter and grandchildren depend on cruise industry revenue to pay their mortgage, feed and clothe the family and live. The cruise industry has gone to great expense to vaccinate its crews and restrict passenger access to those who can prove they have been vaccinated or prove they are not COVID Positive. They wanted a “vaccine passport” for passengers.

Florida responds by having its Surgeon General, pediatrician friend and political ally of the Governor with zero public health or infectious disease background declare if you are vaccinated you are not required to wear a mask anywhere anytime. The legislature, composed primarily of members of the Governors party, passes legislation forbidding businesses from barring individuals from their business based on their vaccine status. This comes well after they supported the Governor with legislation forbidding local municipalities from enforcing local ordinances requiring masks.

I want the ships to sail so my son-in-law keeps his job! The last thing we need is for Florida politics to permit a ship to go out to sea and become a center of infection, illness and death because Florida elected officials watered down the sensible guidelines the cruise industry developed to begin sailing again safely.

Florida is a gateway state encouraging visitors from Latin and Central America as well as US tourists. Brazil is embroiled in a COVID surge of infection and death . The poverty in Central America and the islands prevent knowing exactly what their status is. I am more concerned about the disease entering and leaving Florida via visitors and no rules than I am concerned with illegal immigrants bringing it in at the Texas and Arizona borders as the media and certain elements of the U S seem to be.

Vaccines have brought us so close to controlling the Pandemic. Why can’t we mask up and be patient for a few weeks more?

In my office we will continue to follow the CDC guidelines. We will wait to see if the relaxed mask recommendations of the CDC, plus the vaccine program, keep the infection rate down. Florida Surgeon General Scott Rivkes’ no mask for the vaccinated anywhere may be interpreted as no masks anywhere for everyone. It will take three to four weeks for the consequences of these announcements to make an impact. If the number of infected decreases, my physician associate and I will sit down and alter our approach based on the science. Until that time, we will require masks in our office!

I Was Wrong Regarding Athletes Post COVID-19 & Inflammatory Heart Disease

In a January 2021 blog post, I criticized college athletic departments for allowing their athletes who were infected with SARS-CoV-2  to resume training and competing in their sport without taking a cardiac MRI scan first. This was based on an article early in the pandemic from Italy citing the large number of inflammatory heart issues seen in 100 relatively mildly symptomatic COVID patients.  There was unexpected heart inflammation found in over 50% of these older nonathletic individuals.

The Big Ten Intercollegiate Athletic Conference published an article from the University of Wisconsin Department of Athletics a few months later. All their athletes recovering from COVID (182) received a cardiac MRI at the three-week mark and only two students had MRI evidence of myocarditis.  Based on this small study, other institutions decided that a history session, physical exam, electrocardiogram, echocardiogram and laboratory measurement of the athletes’ cardiac muscle troponin levels would be sufficient. Athletes with abnormalities on any of those tests were referred for a cardiac MRI which could cost $1500- $7500 per study.  I was extremely critical of that decision citing the large amount of income these athletes generated for their university and the potential cost in terms of long-term medical care, potential lawsuits and negative publicity from an athlete becoming seriously ill.  

Like most information regarding this pandemic over time, we learn more about the disease and how to diagnose and treat it. The more familiar we become with Sars2 coronavirus the more previous beliefs change.

This week researchers reported in the Journal of the American Medical Association Cardiology that very few elite athletes recovering from COVID-19 develop myocarditis.  They pooled medical data from May 2020 until October 2020 from Major League Baseball, Major League Soccer, the National Hockey League, the National Football League and the Men’s and Women’s National Basketball Association.

789 professional athletes tested positive for SARS-CoV-2 and entered the return to play protocol (RTP). Athletes who tested positive had a cardiac screening 19 days after their positive test without cardiac MRI imaging. From this group, only 30 athletes had abnormal results and were sent for additional screening. Cardiac MRI was performed on 27 of the 30 and inflammatory heart disease was found in 5 of them. This represents 0.6% of the original screened group. Three of the athletes had confirmed myocarditis and two had pericarditis. These athletes were held out of training and competition. The other 25 returned to training and competition.  None of those athletes who returned to competition had a cardiac illness related event as of December 2020.

In my blog I  tried to provide the ultimate safety evaluation and recommendation for athletes. My patients are older – not elite and anxious to resume their grueling workouts with their local personal trainers.  Given the knowledge base at the time I would make the same choice leaning towards safety, but the data proved me wrong. 

As we learn more about this disease previously held beliefs will be disproved. We have learned that hydroxychloroquine does not work in the treatment of the disease even though initial expectations were that it would. We learned that the virus does not last exceptionally long on surfaces but in the beginning a published article about the cleansing process on the cruise ship Yokahama Princess showed the virus survived 17 days on the ship’s surfaces. We learned that convalescent plasma does not save lives in severely ill patients. This is what happens in the field of science. The CDC and Dr Fauci do not flip flop and are not wrong. As information becomes available, they review the data and try and explain it to the rest of us. As the data changes over time, and the picture changes over time, they adjust their recommendations to be consistent with the facts. They tend to err on the side of caution and safety, as will I, as we move through this tragic pandemic.

Safety & Efficacy of Lowering Lipids in the Elderly

I am bombarded regularly by older patients, their adult children and various elements of the media with complaints that elderly are taking too many medicines. Poly pharmacy is the word they use and the first prescription medications they want eliminated are their cholesterol lowering drugs – either a statin (Lipitor, Zocor, Pravachol, Crestor , Livalo or their generic form), Zetia ( Eztimebe) or the newer injectable PCSK9 inhibitors Repatha and Praluent. Is there an age that we should stop these medications? Is there benefit in the elderly to continue taking them? Should we start these medications in the elderly if we discover they have high cholesterol and vascular disease?

A recent study was published in the prestigious Lancet medical journal. The authors looked at 29 trials with 244,090 patients. From this pool there were 21,492 patients who were at least 75 years old. Half of them were on oral statin drugs and the others were on Eztimebe or PCSK9 inhibitors. They were followed from 2 – 6 years.

The results showed that for every reduction of LDL cholesterol of 1mmol/L there was a 26% reduction of in major adverse vascular events. These numbers were similar to those in younger patients. The data also pointed out that these patients had a significant reduction in cardiovascular deaths, myocardial infarction (heart attacks), strokes and the need for heart surgical revascularizations. It was extremely clear that if you are on a cholesterol lowering drug you should stay on that medication despite your age!

A study in JAMA internal medicine, authored by LC Yourman, answered the question of whether you are too old to start on a cholesterol lowering drug. They found that it took 2.5 years before the cholesterol lowering medicine reduced your risk of a major cardiovascular event. Their conclusion was that if you are 70 or older, and your lifespan appears to be greater than 2.5 years, you should start the medicine.

The Pandemic, Snail Mail & Credit Reporting

Not a day goes by that I do not receive an unsolicited email offer to run my credit report for free.  It never occurred to me that while the pandemic was raging, and millions of people were out of work without a true source of income, business as usual was occurring at the three major credit reporting firms.   I have been extremely fortunate in that my wife and I have been able to pay our bills on time.

The only negative issues we have run into is the dreadfully slow journey first-class mail takes today.  Bills and invoices for services rendered arrive late routinely if they arrive at all. I mail my payments when I receive a bill or invoice well in advance of the due dates.  Sometimes they arrive. Sometimes they disappear off the face of the earth. They all have my return address on them, but none have been returned. I mail them from the local post office these days putting on a mask and gloves and dropping them in the stamped mail slot inside the post office. 

Last month I ran out of first-class stamps, so I went to the nearby Post Office on Banyan Road and bought stamps directly from a postal employee inside because the automated machine was out of order. I stamped my three envelopes and handed them back to the postal worker behind the counter.  Those were payments to FPL, Florida Public Utilities (gas company) and to my homeowner’s insurer Tower Hill.  Those payments never arrived. Those checks never cleared.  USPS is so slow that several companies I purchase from refer to US mail as “snail mail.”

My children tell me to “… pay your bills online by setting up an automatic deduction from your bank account”.  This comes a few days after another major cyberattack and hack – this time to Facebook.  I used the email address and app Facebook provided to see if my credentials were part of the stolen data and yes, they were.  I subscribe to LifeLock for help in protecting my identity, so I know my data flows on the “Dark Web”. Last month someone tried to use that stolen data to obtain unemployment insurance in the state of Illinois.  I squashed that quickly.

Credit scores are used today to evaluate job applicants. They are used to determine if you qualify for all forms of insurance, and how much you need to pay, including life insurance, auto insurance, homeowner’s insurance and possibly health insurance.  I can see checking a credit report if you are trying to buy something and are trying to obtain financing or a loan to pay for it. Even in that arena, this summer I leased a car from Acura.  I have leased a car from Acura using their finance company for twenty-five years now.  Did they need to run a credit report to determine if I pay my auto lease?

I think there should be a moratorium on credit reporting just like there is a moratorium on home evictions.  It should start in May 2021 and run until at least April 15, 2022.  Millions of people will be trying to get back on their feet as the vaccines take hold and people return to the workforce. They deserve a chance to rebuild their lives and their credit rating without the discrimination against them caused by the pandemic’s effects on the economy.

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.

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.

Vitamin D & Cardiovascular Health

The online journal Practice Update reviewed a publication in the Journal of the American College of Cardiology which basically says excessive calcium supplementation may harm your healthy heart. It was published at a pertinent time because it came while I was trying to convince my post-menopausal wife that between her Vitamin D pearls, calcium, Vitamin D pills and her multivitamin she was taking too much Vitamin D. Her measured 25-hydroxy Vitamin D level came back at 63.

Vitamin D is a fat-soluble vitamin like vitamins A and K. Extra doses of fat-soluble vitamins are stored in the body’s cells and can reach harmful and toxic levels. The normal level of Vitamin D measured by a standard blood test is considered to be 20 or greater by the World Health Organization. In North America it was originally higher at 28 then raised to 30. The Covid-19 Pandemic has raised issues about low levels of Vitamin D being a risk for catching the disease, and developing complications, but no one has defined what levels are considered unsafe.

The National Academy of Medicine, after reviewing this data, has set these limits and levels:

  1. Deficiency is less than or equal to 12ng/ml
  2. Inadequacy is 12-20 ng/ml
  3. Adequate is 20-50 ng/ml
  4. Risk of Adverse Effects occurs at > 50ng/ml

The data suggest avoiding supplementation unless the 25-hydroxy Vitamin D level is <20 and probably best reserved for <12 ng/ml.

Calcium is best absorbed when accompanied by Vitamin D .  Taking smaller doses like 500 mg plus 1000 of Vitamin D3 works. For osteoporotic patients they suggest 600mg of Calcium plus 1000 IU of Vitamin D3 daily. They want you to eat a diet that supplies another 600 mg of calcium a day plus walk for weight bearing exercise and get 15 or more minutes of sunlight daily. Of interest was the statement that calcium supplements may harm your heart, but any calcium obtained naturally through foods does not.

The article was reviewed and commented on by David Rakel, MD, FAAFP with the take home message being, “Eat a high-fiber, plant-based diet with some fish and go outside and play.”

Can Smartphones & Fitbits Interfere with your Pacemaker or Defibrillator?

The February 8th edition of Medpage Today, an online magazine, published the concerns of cardiologist and electrophysiologist Joshua Greenberg, MD, about the magnet arrays in the new Apple iPhone 12 interfering with the function of pacemakers and defibrillators.

When a patient goes to their doctor, cardiologist, electrophysiologist, etc., and the physician wishes to turn off their pacemaker to look at the heart’s normal electrical activity, they normally place a magnet over the implanted device to deactivate it. The new iPhone 12 apparently uses an array of magnets around a wireless charging coil.

Dr Greenberg used the iPhone 12 to disable a Medtronic ICD. Once he brought the phone over the patients left chest the device deactivated. His findings were published in January in a letter to the editor of the journal Heart Rhythm. “This is a big deal because if the patient were to go into ventricular tachycardia or fibrillation during this time, they would just drop dead without receiving a life-saving shock from the ICD.”

Separately, electrophysiologist M. Eskander, MD tweeted a video showing an iPhone12 shutting off a pacemaker as well as if a magnet had been placed over it. Wristband magnets in Fitbit and Apple iWatches have been reported to deactivate Medtronic ICDs from 0.9” away due to their wristband magnets.

Phil Mar, MD , an electrophysiologist at Saint Louis University School of Medicine agrees that this is a previously unrecognized issue that needs to be dealt with. He suggests patients with implanted pacemakers and ICDs avoid purchasing an iPhone with magnets. He encourages their spouses or bed partners to follow the same advice to prevent deactivation when they roll over and get close. He emphasizes that this was not an issue with earlier model iPhones which didn’t have an array of magnets and was not seen in Apple iWatches without the magnetic wrist bands for charging. He is concerned that any cell phone, wrist band or watch using wireless charging may cause the same deactivation.

The author of the article, Anthony Pearson, MD made the suggestion that patients with pacemakers and ICDs should have their cardiologist or electrophysiologist routinely test their cell phones, Fitbits and iWatches’ effect on their devices at a planned routine visit and certainly immediately after implantation. He reminded us this does not occur in devices that do not have a magnet array which is most cell phones and watches.

There has always been a recommendation that if you have a pacemaker or AICD you use your cellphone in the ear opposite your pacemaker or device pocket and never bring it within six inches of the device.

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.