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.

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.

PreDiabetes in The Elderly – Not to Worry

As physicians and educated adults we realize that developing diabetes increases our risks of heart disease, narrowing of our arteries or vascular disease, injury to the retina of our eyes leading to poor low vision or blindness, peripheral neuropathy or burning pains in our feet and elsewhere. We additionally have been taught the correlation between controlling our blood sugars and trying to reduce the risk of developing these complications.

In my early years in practice if a patient came in for fasting bloodwork and their glucose level was elevated above 110 on two occasions they met the legal definition of diabetes. Patients always had an excuse. “It was my birthday so I had cupcakes at work, cake and mixed alcoholic drinks at home, etc.” There were always rational reasons for being a human being, enjoying life and not being a disciplined diabetic patient.

The development of the hemoglobin A1c eliminated those excuses. It recognized that the higher your daily average blood sugar the more sugar would bind with a hemoglobin molecule and increase your hemoglobin A1C. That has given us a measure of your average blood sugar over the previous 90-days. Normal values were established as well as values in the diabetic range. The intermediate values were labeled “pre-diabetes”.

The question became “How do you keep “pre-diabetics” from becoming diabetics and risking all those complications.” Did the same rules apply to middle aged adults as to the elderly?

For the most part I counseled pre-diabetics that they had an increased risk of developing diabetes but if they stayed active, kept their weight down and improved their dietary choices they would be fine.

A research paper in Journal of the American Medical Association (JAMA) online edition now supports that position. Mary Rooney, PhD of the Bloomberg School of Public Health at Johns Hopkins University, published her data looking at 3,142 individuals 70 -90 years old with 44% being diagnosed with prediabetes. They were followed for six years.

During that time-period, only 9% of them went on to become diabetic. Thirteen percent (13%) improved into the normal glycemic range. Nineteen percent (19%) died of other causes.

The message is clear. If you are 70 years of age or older, and your hemoglobin A1C moves into the 5.7 or greater range, you are considered pre-diabetic. Stay fit and active. Keep your weight down. Meet with a dietitian and learn how to eat well and healthy, stop smoking and go for regular checkups. Diabetes will not do you in!

The “Fat but Fit” Paradox

The Reznick family has always struggled with weight issues. We enjoy eating large portions, snacking and having our wine and spirits in moderation.

I remember accompanying my dad to his checkup in my teenage years. His internist was a highly respected chief of the internal medicine department at a large NY academic teaching facility as well as a long-time family friend. I remember the conversation well. Dr. Cohen would say, “Lou you are too heavy and I don’t want you to get sick from it!” Dad would respond with,” Ted I am not too fat I am just too short.! I am really fit working on the loading docks at my business and running around on my feet all day.”

Here we are 60 years later and the “fat but fit“ paradox has been examined in the journal Preventive Cardiology where researchers looked at 527,662 adults aged 18-64 years. This was performed by reviewing insurance information of patients who underwent regular health checkups through an occupational risk- prevention company.

They divided the group into normal weight, overweight and obese. They then separated them by activity levels with some being inactive (64%), insufficiently active (12%) and regularly active (24%). Of the study group, 30% had elevated cholesterol, 15% had high blood pressure and 3% had diabetes.

The study showed that those who were physically active reduced their cardiovascular risk. The overweight and obese individuals who were active were never ever able to reduce their cardiovascular risk to the level of a normal weight active individual of similar age. Overweight individuals are still more likely to develop hypertension, high cholesterol and diabetes due to insulin resistance in lipid rich cells.

The goal for physicians is to help you to live longer with a high-quality life. To accomplish this, we still need to emphasize achieving a normal body mass index or weight, maintaining a healthy active lifestyle and controlling those health issues that still develop in fit active adults.

Weight control and regular check-ups with your physician remain extremely important!

Cardiac MRI Imaging for Athletes Recovering From COVID-19?

Watching competitive sports is one of my entertainment diversions from the realities of a COVID-19 pandemic, economic hardships created by the pandemic and of course divisive political discourse in our nation. When I watch a sporting event, and I am rooting for one team, I have my protective emotional shield for sudden medical tragedy turned off. That was the case as I watched the University of Florida men’s basketball team play their rivals, Florida State University, earlier this year.

A close friend’s grandson was one of the managerial courtside support staff, so we watch the games as much to see him run out on the court during breaks in the action as we do the game.  It was early in the game, after the player voted most likely to be the conference MVP shot a ball that came nowhere close to the basket and the teams were leaving a timeout, when this star just dropped to the floor face first as if he had been shot.  It was shocking to me in this unexpected location to see a life-threatening tragedy evolve in a young fit athletic man entering the prime of his life. From the looks on the players and coaches and then medical staff it was apparent this was a catastrophe unfolding. CPR was begun courtside and rapidly he was moved by stretcher to an ambulance and a critical care unit. 

The team and school and physicians protected the players privacy closely. Interviews with friends indicated he was placed into a hypothermic medically induced coma to save his brain and internal organs.  It was not until several days later that it became apparent that this player would survive.

Three months earlier he had caught and survived the coronavirus, COVID-19.  He went through a complete physical before he was cleared to train and play again. It is unclear what that exam consisted of beyond an EKG, Stress test, echocardiogram and heart muscle enzymes but the medical staff at Shands Hospital in Gainesville, Florida treats many athletes and is as elite as the athletes that grace the school’s playing fields. The unofficial diagnosis is that he had post COVID-19 inflammation of the heart muscle known as myocarditis. No official diagnosis has been presented to the public due to privacy considerations and laws.

A research paper in the European cardiology literature looked at 100 plus COVID-19 patients with minimal symptoms not requiring hospitalization for the disease. A cardiac evaluation including an MRI of the heart revealed unexpected inflammation of the heart muscle in over 50%. These patients were older in average age and were not elite athletes.  The question then arises “Should all individuals recovering from COVID-19 undergo a cardiac MRI and see a cardiologist prior to resuming strenuous exercise workouts?”.  

The Big Ten Athletic Conference decided that all their athletes with COVID-19 would receive an MRI as part of a battery of tests prior to receiving permission to resume training and play. This was influenced by several professional athletes taking a sabbatical post COVID-19 due to the onset of myocarditis.

The University of Wisconsin Departments of Medicine and Radiology published a study in JAMA Cardiology presenting the results of Cardiac MRI’s in 182 athletes recovering from COVID-19 at the three-week mark. Only two student athletes had MRI evidence of myocarditis.  The cost of a cardiac MRI in the United States is listed from $1500 -$7500.  I have no idea if insurance companies will pay for a cardiac MRI or not. 

The conclusion of the study authors, from this small study, is that MRI screening for myocarditis is of questionable value.    I beg to differ.   Had these elite athletes been allowed to resume training and suffered a similar fate to the University of Florida basketball player the cost of the test, which provides no X irradiation exposure, seems inexpensive. If I had a teenage child recovering from COVID-19 and hoping to strenuously work out or try out for a sports team at the local high school I would certainly want that test performed as part of a cardiology evaluation before I gave my blessing to participate. 

More studies will be done on the long-term effects of COVID-19 on minimally symptomatic or asymptomatic survivors. I stress caution in resuming aggressive physical activity until our data base is more complete.

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.