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.

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!

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.