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.

Do Cipro and Levaquin Cause Abdominal Aortic Aneurysms?

Melina Kibbe, MD, of the University of North Carolina Medical Center at Chapel Hill published an article in JAMA Surgery reviewing any possible relationship between taking fluoroquinolones antibiotics such as Cipro or Levaquin and the subsequent development of an abdominal aortic aneurysm.  An aneurysm is a weakening in the wall of a blood vessel that balloons out like the defect on a damaged tire or basketball and has the potential to rupture causing exsanguination and sudden death. Dr Kibbe is also the editor of JAMA Surgery.

The study looked at health insurance company data on antibiotics and aneurysm diagnosis and repair.  They found that 7.5 aneurysms formed per 10,000 fluoroquinolone prescriptions filled at 90 days. This was significantly higher than the 4.6. per 10,000 aneurysms formed after patients took non-fluroquinolone antibiotics.  Patients filling fluroquinolone prescriptions were more likely to undergo repair of aneurysms than those who took other types.

The study used data from IBM MarketScan health insurance claims from 2005 to 2017 in adults aged 18-64.  The study included data on 27,827,254 individuals. The data did not include smoking or hypertensive history or family history of vascular disease. The authors were hoping the FDA would require a warning or caution to high-risk individuals for developing an aneurysm.

We already see an increase in ruptured tendons in patients taking fluroquinolones – especially women who have taken corticosteroids. They are also associated with C difficile colitis, nerve damage, emotional health issues and low blood sugar events. 

Despite these known draw backs to these medications, patients continually demand to have Cipro or Levaquin on hand in case they develop a urine infection or upper respiratory infection or are travelling and concerned about traveler’s diarrhea. 

More research is needed to determine the exact risk of prescribing these medications. Should we be doing scans on patients with hypertension and or smoking history who frequently use these drugs to screen for an abdominal aortic aneurysm?  This is a question that will be addressed by a study soon.  While the research is in process, we need to make sure that our prescribing of these antibiotics is the safest choice for our patients.

The COVID-19 Vaccine Is Becoming More Available. Exercise Patience.

COVID-19 vaccine preparations are arriving in South Florida with several hospital systems opening appointments for men and women 65 and older to receive their first injection. Some will receive the Pfizer product, others the Moderna product. If you wish to travel to Dade County go to https://jacksonhealth.org/keeping-you-safe/  and sign up for the vaccine. They are taking appointments.  West Boca Medical Center and Boca Regional Hospital have opened appointments for non-employed medical staff members and their office staffs to receive vaccine with the hint that the week of January 11, 2021 they will start vaccinating community members.  

There is a sense of urgency and panic in the community about not having access to the vaccines. That is unnecessary and raising the stress level inappropriately.

After you receive your first vaccine dose you will still need to avoid crowds, social distance, wear masks and practice impeccable hand washing hygiene because you will not be immune. Twenty-one to 28 days later you will receive your booster shot and it will take about two weeks before we can detect antibodies to COVID-19 if you develop immunity.  You will have peace of mind, but won’t know if the vaccine prevents individuals from catching COVID-19 when exposed completely?  Will they get COVID-19  and have a very mild case because of the vaccine prevention?  Will these people be contagious to others? We do not know the answers to these questions yet.

If you get the vaccine, develop immunity and are exposed to someone with COVID-19, will you possibly transmit the virus to others without you yourself becoming ill?  No one knows the answer to that question yet either.  If everything goes perfectly well, and you develop a protective shield of immunity like a comic book superhero shield or cape, how long will that last?  Nobody knows that answer either.

The point is the vaccine is coming.  Once vaccinated we will still have to behave the same as before until the answers to these questions are known!  Please be patient.

COVID-19 Vaccine Availability

Update January 4, 2021

Last week the Florida Department of Health discussed providing the Moderna vaccine to our office for staff members who wished to receive the vaccine. Our office manager, Judi Stanich, requested enough vaccine to cover the entire practice. We were told we would have a confirmation this morning.

This morning we learned the vaccine isn’t available yet. The vaccine comes in vials of 10 shots. The vials are kept frozen and can remain active in that state or in a refrigerator for 30 days. Once a vaccine vial is opened the entire vial must be used in under six hours or it degrades.

Moderna and the Florida Department of Health require patients to complete legal release forms for the vaccine. They must then be registered into the Florida Shots data bank and a national data bank. That is one of the reasons patients are asked to bring their driver’s license with them.

If you have had a severe allergic reaction to any medication the Pfizer and Moderna mRNA vaccines may not be best for you. If you have ever had to use an Epi Pen or have been treated for anaphylaxis these shots are not for you. The Astra Zeneca Oxford vaccine and the Johnson and Johnson vaccine are thought to be more suitable for those individuals

After receiving your shot, you will need to be observed by medical staff for 15 minutes to look for adverse reactions. You will be given an instructional sheet on how to register with V-SAFE which is a CDC vaccine monitoring app. Every day, at about 2:00 p.m., you will receive a text message with questions about how you feel related to the vaccine.

Medical malpractice insurance companies have not yet formally announced whether physician insurance policies will cover administration of this vaccine in their offices because none have been FDA approved. The Pfizer and Moderna vaccines have received FDA Emergency Utilization Authorization (EUA) which is not the same as approval.

Currently the only avenue to obtaining the vaccine in Palm Beach County is to try and get through on the 561.625.5180 phone number or leave your demographics on an email at CHD50Feedback@Flhealth.gov. Baptist Health System is planning on opening reservations for seniors 65 years of age and older the week of January 11 working with Boca Regional Hospital, Bethesda Hospital and the FAU Schools of Medicine, Nursing and their EMT program. They have not announced how to make a reservation or if they will be using the data from the Palm Beach County Department of Health through the phone number and email address provided above.

I suspect that by the middle of February there will be plenty of vaccine available locally including the Astra Zeneca Oxford product and the Johnson and Johnson products. In the meantime, remain patient and continue to avoid crowds and continue to social distance, wear suitable face masks and keep up the hand hygiene. Please remember that after you complete your vaccinations (two shots for the Pfizer and Moderna Products) we will not know how much immunity the shots will provide and for how long.

We additionally do not know if successfully vaccinated individuals are completely immune or partially immune if they are exposed to the virus. Furthermore, we don’t yet know if you are vaccinated whether you can carry the virus and transmit it to someone else even if you don’t have any symptoms.

Getting the vaccine will not be a reason to resume activities at crowded gyms, crowded bars or go on that cruise ship just yet. The hope is that by the summer 2021 we will have the answers to the many unknowns.

Keep Your Guard Up As The New Year Approaches

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

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

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

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

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

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

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

A Light at the End of the Tunnel?

My cellphone emitted the shrill sound of the Emergency Broadcast System Saturday evening.  It repeatedly said, “This is an Emergency Message from the Baptist Health System. Please check your email immediately for an emergency message about COVID-19. Please press 1 to confirm receipt of this message.”  Since I was watching my favorite college football team on TV, and they were not doing well, I was in a particularly sour mood, so I ignored the message and sat down and watched the TV.

Almost immediately my home phone rang and when I picked it up, I heard the exact same message.  This time I pressed one and then ran to my iPad and went to my professional email address. There was a message from the Director of Baptist Health Systems and the Chief Medical Officer saying that they had the Pfizer COVID-19 vaccine and they wanted to vaccinate me. I am apparently in Group IA. They explained that the decision to vaccinate was voluntary but if I was interested I should “click here.”  

 I followed the directions and was directed to a calendar with times in fifteen-minute slots.  I selected a day and time that allowed me to drive down to Baptist Hospital on Kendall Drive in Dade County and I received a prompt reply that confirmed my date and time to receive the vaccine.  I was so amazed and surprised by the mechanism of delivering this information that I was sure it was a joke or a scam.  I have two neighbors down the block who are physicians and nurses at Baptist Boca Raton Regional Hospital, so I called them. They had received the same message.

The fact that in this dysfunctional state, run by a government that has maximized the interests of the tourism and business community while minimizing the dangers of the pandemic, could be delivering vaccine to health care workers astounded me.

My team lost the game I was watching Saturday night turning what should have been sheer joy into a mixed bag. Sunday was a glorious day – sunny, warm but not muggy. The local Fire Department sent around Santa Claus on a fire truck with Santa’s elves and helpers.

I walked around the community in complete disbelief watching young families and their children and older family members and friends all closely gathered without masks or social distancing having lawn Christmas parties in advance of Santa arriving.   It was as if there was no pandemic and no warning of the main mechanism of COVID-19 transmission being at family and informal at home gatherings. 

Santa arrived later that day and stayed on his fire truck smiling and waving from a distance while his elves handed out candy canes from a very safe distance from the lawn revelers.  I kept thinking and wondering if Santa would place these apparently carefree individuals on his annual “naughty” or “nice list”?

The vaccine will be a start towards providing some protection against the Sars2- COVID-19 virus. We do not know if it will completely prevent the disease or just modify its complexity and severity.

We do not know:

  1. How long the immune response antibodies to the shot will last and protect the recipient?  
  2. If the recipients can still pick up the virus and transmit it to those without antibodies?
  3. Which of the seven shots in development, and expected to be available by March 2021, are best for adults, seniors, adolescents, children, toddlers and pregnant women? 

We will still have to wear masks, maintain social distance and practice scrupulous handwashing hygiene until we have the answers.  There is, however, a vaccine being administered which is the first light at the end of the tunnel in a painful pandemic plagued year.

Are My Symptoms Due to COVID-19 or the Vaccine?

The Pfizer COVID-19 mRNA vaccine received Emergency Utilization Authorization by the FDA and CDC last week and is being administered to health care workers and seniors in senior facilities as I write. The process began overseas in the United Kingdom last week.

Many of the recipients of the first of two vaccinations are experiencing symptoms as their immune system reacts to the vaccine and hopefully builds antibodies and immunity. They are experiencing fever, fatigue, headaches, chills, myalgias and arthralgias.  Many of these symptoms are identical to the symptom’s individuals infected with COVID-19 experience yet these healthcare workers are expected to take some Tylenol or aspirin and head back to work caring for patients.  How exactly are they expected to distinguish between being infected with “the Rona” virus or just experiencing mild side effects of the vaccine?    

David Kuhar, MD, of the CDC’s COVID-19 Response Healthcare Infection Control Team suggests health care workers need to use their clinical judgement.  They need to assess whether they believe they were exposed to the virus in the previous 14 days?  He emphasized that in clinical trials, these adverse symptoms resolved within 3 days of vaccination and 2 days of the onset of symptoms. If the symptoms last any longer, he believes the healthcare workers need to be evaluated for a COVID-19 infection.  He stressed that the vaccination will not produce a positive COVID-19 antigen test response. It additionally should not produce shortness of breath and loss of taste and smell sensations. 

If you experience those symptoms or have your symptoms for more than two days, then you need to go to a COVID-19 test site and be tested.  The CDC has set up a communication system for those vaccinated called V-safe.  It is an app for your smartphone or tablet that allows you to communicate your symptoms and concerns with the CDC after you receive the vaccine.  When you are vaccinated at a test site, you are provided the information you need to register and participate in this V-safe monitoring program.  The information gathered on this smartphone app will allow the CDC to continue to monitor the safety of the vaccines being administered.