Omicron is the Grinch That Stole Christmas

The Center for Disease Control (CDC) is reporting that up to 90% of the infections with COVID-19 Sars 2 Coronavirus are the new Omicron strain. It replicates itself 70 times faster than the Delta strain and contact with an infected person within 12 feet for one or more seconds can result in infection. For those who have been vaccinated against COVID-19 with the Moderna or Pfizer Vaccine, and received a third shot or booster, the expectation is that if they become infected with Omicron, they will either have no symptoms or a mild case. By definition “mild COVID” means your respiratory system is not compromised enough to require hospitalization. Despite this, most of the current deaths in countries which are having a COVID surge are in people older than 65 years of age.

In the past, when patients in this area became infected with COVID-19, we arranged for them to go to the local hospitals to receive an infusion of a monoclonal antibody solution made either by Regeneron or by Eli Lilly. The infusion prevented the infection from becoming severe enough to progress to a severe state requiring inpatient hospital respiratory care. These monoclonal antibodies do not work against Omicron. For this reason, the FDA and CDC have removed the Emergency Use Authorization and ended the administration of these drugs nationwide.

There is a third monoclonal antibody made by Glaxo and Var called Sotrovimab which effectively throttles Omicron, but it is in limited supply. As of today, the State of Florida has received 1050 dosages. Production has been accelerated and hopefully the drug will be available in mid to late January for infusion. There are two new antiviral pills which should work as well. The Pfizer product received FDA approval today and, with production acceleration, some should be available by mid-January. Until these drugs are locally available the medical community has no medications to offer patients who contract the COVID-19 Delta or Omicron variant to limit the severity of the disease.

My advice to my patients and loved ones is to reintroduce distancing and masking. Wear a good N95 mask when you will be around others – especially indoors. If you must be indoors with others, make sure the windows and doors are open and the ventilation is excellent. If there is an air filtration system with HEPA Merv 13 level filters and ultraviolet light that adds protection. Distancing with the aggressive Omicron variant will require 12 feet not six feet.

This is a heartbreaking restrictive change in scheduling and behavior we are asking for at a time of the year when families and friends travel to gather to celebrate. Younger and leaner healthier individuals who are vaccinated will survive this. The real questions are who they will transmit this infection to unknowingly, who is too young to be vaccinated or too old to have a robust immune system?

Our office staff will be reassessing the risk to patients and staff daily. With the local testing positivity rate >10% in Palm Beach County, our contacts will be by phone and telehealth. When the Pfizer anti-viral pill Paxlovid is available, and or Sotrovimab for infusion, we will return to regular in-office patient visits.

I apologize for the inconvenience. Stay safe and call if you have questions.

COVID-19 & Public Health Departments

I received an email from the Florida Department of Public Health saying a Federal Judge from Missouri had struck down the necessity for health care workers to be vaccinated against COVID or risk losing their jobs. The suit was brought by several states and, while Florida was not part of this particular lawsuit, was part of other lawsuits which are ongoing.  My immediate thought is that the Florida Department of Public Health should have more important things to do such as providing public health! 

I contrast this with a story told to me by a reliable source – a 66-year-old New Yorker. He lives in the Upper West Side of Manhattan with his 63-year-old wife and spends winters at a home on the West Coast of Florida. 

They packed up their car and, for the first time, hired a professional driver to transport it plus some belongings down to their Florida winter home . They were scheduled to board a flight to Sarasota on December 2^nd until the husband received a text message from the NY City Department of Health.  The message said that using cell phone location tracking data they have discovered that the husband was within six feet of an individual who tested positive for COVID-19.  They provided contact information and requested he call the number to receive precautionary recommendations.

When he called, they advised that if he was vaccinated and had no symptoms of COVID he should be tested in four to seven days but remain masked and quarantined until then. The husband stays home most days, except for a daily morning bicycle ride along the Hudson River down to Battery Park where he rents out a gym for a private 90-minute workout with a vaccinated masked trainer who is the only other individual in the facility.  He then bikes home along the Hudson River stopping at a food truck on sunny days to purchase a cup of coffee which he drinks alone on a bench overlooking the river. He and his wife mask, maintain safe distances from others and avoid indoor facilities.

The couple decided to follow the advice of the Health Department. They separated within their home staying masked indoors. They rescheduled their flights for the following week. They have appointments to have nasal PCR tests on day 7 after exposure.

Wouldn’t it be lovely if we had a public health department in Florida that actually practiced public health along with citizens who respected the health of others by following recommendations to prevent transmission of the disease?

Medicare Part D Annual Enrollment

As of October 15, 2021 traditional Medicare enrollees are encouraged to compare available prescription drug plans under the Medicare Part D program for the 2022 year. Private insurance companies administer these programs for Medicare. The drugs they cover and the amount they cover change from year to year. What was covered this month through December 31, 2021 may not be covered at all on January 1, 2022. The result may be sticker shock when you attempt to refill your normal prescription medications and are presented with a huge bill when you go to pick them up because your insurer no longer carries that medication or covers it through their formulary of medications. The open enrollment period ends December 15, 2021. A Kaiser Foundation poll and research study found that 70% of Medicare beneficiaries do not even compare plans during the October 15 – December 7th enrollment period.

If you have a computer log onto www.Medicare.gov. You will be given a choice to look at Medicare plans as an existing beneficiary or a new one. It will then ask if you wish to sign in with an account or as a guest. Either path will take you through.

You need to then choose Medicare Part D Prescription plans. It will ask for identifying information including your date of birth, initial date as a Medicare recipient and your zip code. It will request that you choose a participating pharmacy. If you use a chain pharmacy such as CVS or Walgreens, choosing any branch will do. It will then ask you to list your medications including dosage and how many you take daily and monthly. Once this task is completed it will allow you to select a plan.

Plans available in Palm Beach County, Florida are different than plans available in Dade County, Florida or even Nassau County, New York. If you wish to have a plan with no deductible the monthly premium will be more costly.

The computer program lists your current plan at the top with anticipated costs to you for 2022 if you keep your current plan. Underneath they list the best plans for you and the member ratings of those plans’ performance in previous years.

The process takes about twenty minutes but can save you hundreds of dollars and much aggravation. In my medical practice, we print out the data for our elderly patients who don’t have access to a computer or lack the skills to use the website.

Aspirin & Heart Disease Prevention Recommendations

In the 1950’s a research paper based on work done at a Veterans Administration Hospital found that men 45 years of age who took a daily aspirin tended to have fewer heart attacks and strokes. The VA patients were mostly male WWII and Korean War Veterans. That was the basis for most of the men in my Baby Boomer generation to take a daily aspirin.

Yes, we knew that aspirin gives us an increased risk of bleeding from our stomach and intestine. And we knew that if we hit our head while on aspirin the amount of bleeding on the brain would be much greater. It was a tradeoff – benefits versus risks.

Over the years the science has advanced to now distinguish those taking aspirin to prevent developing heart disease, cerebrovascular disease or primary prevention and those seeking to prevent an additional health event such as a second heart attack or stroke. To my knowledge there are no studies that examine what happens to someone in their 60a or 70s who has been taking an aspirin for 40 plus years daily and suddenly stops. It’s a question that should be answered before electively stopping daily aspirin.

Over the last few years researchers have hinted that the daily aspirin may protect against developing colorectal cancer and certain aggressive skin cancers. The downside to taking the aspirin has always been the bleeding risk. This data is now being questioned by the USPTF looking for more “evidence.”

The US Preventive Services Task Force was formed in 1984 with the encouragement of employers, private insurers selling managed health care plans and members of Congress to try and save money in healthcare. It is comprised of volunteer physicians and researchers who are supposed to match evidence with medical procedures to ensure that we are receiving high value procedures only.

In 1998 Congress mandated that they convene annually. Under their direction, recommendations were made to stop taking routine chest x rays on adult smokers because it didn’t save or prolong life and it took $200,000 of X Rays to save one life. They reversed their opinion decades later deciding that the math on that study wasn’t quite right and now recommend CT scans on smokers of a certain age and duration of tobacco use. I point this out to emphasize why I am not quite as excited today about their change in aspirin guidelines as the newspaper and media outlet stations seem to be.

I am a never smoker, frequently exercising adult with high blood pressure controlled with medication, high cholesterol controlled with medication and recently diagnosed non obstructive coronary artery disease. What does that mean? At age 45 my CT Scan of my coronary arteries showed almost no calcium in the walls. 26 years later there is enough Calcium seen to increase my risk of a cardiac event to > 10% over the next ten years. I took a nuclear stress test and ran at level 5 with no evidence of a blockage on EKG or films. The calcium in the walls of the arteries however indicates that cholesterol laden foam cells living in the walls of my coronary arteries and moving towards the lumen to rupture and cause a heart attack were thwarted and calcified preventing that heart attack or stroke. I am certainly not going to stop my aspirin.

My thin healthy friend who works out harder than I do told me he doesn’t have heart disease and is going to stop his baby aspirin. I asked him what about his three stents keeping several coronary arteries open? He told me he had heart disease before he got the stents but now he doesn’t. I suggested he talk to his internist or cardiologist prior to stopping the aspirin.

I may take a different path in starting adults on aspirin for cardiovascular and cerebrovascular event protection. I am certainly not going to withdraw aspirin from patients taking it for years unless they are high risk for falls and head trauma or bleeding. I suggest you ask your doctor before considering changing any of your medications.

Try an exercise by writing down all the prescription medicines and next to them list what condition you take them for. Once you have established that information, set up an appointment and talk about it with your physician. The decision-making is much more complicated than the USPTF and headline hungry media discussed and reported.

Concierge Medicine and the Pandemic

Twenty years ago I practiced internal medicine and geriatrics locally in a traditional medical practice. I cared for 2700 patients seen in 15-minute visits with an annual checkup being given a full 30 minutes. The majority of my patients were over 55 years old and many had already been patients for 10-20 years. The practice office revenue was enhanced by having an in house laboratory, chest x-ray machine, pulmonary function lab and flexible sigmoidoscopy colon cancer surveillance program. If patients needed more time, we allotted more time or, more likely, we just fell behind leaving patients stranded in the waiting room wondering when they would be seen. I had a robust hospital practice made easier by the fact that the hospital was a short walk across the street and most of my hospitalized patients came from being required to cover the emergency room periodically for patients requiring admission but not having a physician.

Much changed quickly in the early 1990’s as we approached the millennium. Insurers managed care programs kidnapped our younger patients by approaching employers and guaranteeing cost savings on health insurance by demanding we provide care at a 25% discount. In addition, mandatory ER call became a nightmare because insurers would only compensate contracted physicians to care for their hospital inpatients.

My very profitable chest x-ray machine became an albatross because that $28 x-ray reimbursement was now accompanied by a fee to dispose of the developing fluid by only a certified chemical disposal firm even though the EPA said there was not enough silver in the waste to require that you do anything other than dump it down the sink. The lab closed too. Congress enacted strict testing and over site rules which made the cost of doing business too expensive and not profitable. That flexible sigmoidoscopy went the way of the Model-T Ford when the medical community enlarged to accommodate board certified gastroenterologists certified to look at the entire colon under anesthesia not just the distal colon and sigmoid.

We tried to overcome increased costs and lost revenue by seeing more patients per day. We banded together as physician owned groups owning imaging centers and common labs but the Center for Medicare Services (CMS), which runs Medicare, and private insurers plus Congressional rules on conflict of interest thwarted those ideas. We attended seminars on becoming a member of an HMO and taking full risk for a patient’s health care and cost.

The message was clear, you could make a great deal of money if you put barriers in front of patients limiting access to care and especially in patient hospital care. The ethics of that model did not sit well with many. So, we started earlier, shortened each visit and worked later and harder. As time wore on, and our loyal patients aged, we realized that we needed to spend MORE TIME with them more frequently.  Not less time!

Spending less time with patients was the primary impetus which prompted my exploration of concierge medicine when I realized I was better off emotionally, ethically and morally caring well for fewer patients. Financially, seeing a smaller panel of patients who paid a membership fee generated similar income to maintaining a large panel of patients in a capitated system or fee for service seeing more people with shorter visits.

I discuss this now because I often wonder how I would be able to care for my large panel of patients today in the midst of this COVID-19 Pandemic.

For the most part I have been able to give my patients the time and availability they need to stay safe from Coronavirus and still keep up with the prevention and surveillance testing they need periodically. The 24/7 phone, email and text message access has allowed me to stay in touch with patients – something that would have been near impossible to do in a practice with 2700 adult patients.

I applaud my colleagues who continued in the traditional practice primary care setting despite the fact that most sold their practices to local hospital systems or large investment groups who placed administrators in the care decision-making process dictating time and number of daily visits, referral patterns and products used in the care of the patients.

As an independent physician, I have been able to continue to provide services and referrals that are the best in the area using doctors and equipment I would see as a patient and proudly refer my parents, my wife and children, beloved friends and family members. I am able to guide patients based on evidence and quality of measures not only what is most cost effective. I have no contract with a health system that requires me to see a certain number of patients per day, per week, per month or face a drop in salary or dismissal. I am proud and fulfilled at the end of the day because I can look in the mirror and know that I tried my best for the patients.

I additionally have the ability to say “no” to a potential new patient that I believe would not benefit from being in my practice for numerous reasons. Providing time to meet potential new patients gives both the patient and physician an opportunity to assess whether developing a professional relationship would be a good fit for both.

During the pandemic these meetings have become tele-health virtual meetings which are far more impersonal and less educational for both the potential patient and the doctor. It is still far better than having an administrator schedule a new patient, with no questions asked, on your schedule with the only criteria being can they pay the price?

Sadly, this horrible SARS 2 Coronavirus pandemic has made concierge internal medicine and family medicine more attractive than less. Having your physician available to discuss prevention, vaccines, testing methods and locations and treatments, if infected, is much easier in these membership practices than in a traditional practice where your phone calls are routed through an automated attendant phone system, reviewed by a non-physician provider and handled usually by a nurse practitioner or physician assistant with only the most serious and complicated situations reaching the physician’s desk.

I predict that more and more patients will seek concierge care in the next few years because patients are getting tired of fighting the bureaucracy and struggling to get the attention of their health care providers when they think they need it.  But don’t blame the providers.  It’s the dysfunctional, inefficient and profit driven corporate system that has created this situation.

Quadrapill for Blood Pressure Control

At the beginning of each patient visit I make it a habit to meticulously review with each patient their list of medications, supplements, vitamins, herbs etc. I compare their list with the lists on notes sent to me from consulting specialty physicians and then I access the pharmacy prescribing data base whenever it is available.

I am always amazed by how many chemicals we put into our body for the sake of maintaining health. How patients maintain accurate medication lists and administer daily medications is something I am in awe of. In the best interest of their care, I am always looking for a way to reduce the number of medications taken and to simplify the process if possible.

Clearly researchers in Australia feel the same way. They realize that to control blood pressure, most seniors are taking low doses of 2-3 medications. In previous years we physicians prescribed one medication and pushed its dosage to the limit before adding a second medication to gain control of blood pressure. We soon realized that at the higher dosages, patients experienced adverse effects and just stopped taking their blood pressure lowering medications.

In an intriguing study, Australian researchers created a poly pill consisting of one quarter of the starting dosage of four medications. Irbesartan 37.5 mg, (angiotensin receptor blocker), amlodipine 1.25 mg (a calcium channel blocker), indapamide 0.625 mg (a thiazide diuretic) and bisoprolol 2.5 mg (a beta blocker) were put into one pill. Five hundred ninety-one patients at ten medical centers participated in the study. Their average age was 59 years with a fair mix of men and women. They were randomly selected and blinded from knowing whether they were receiving the Quadrapill or increasing dosages of one pill. If BP stayed up amlodipine was added.

At the end of three months the poly pill group had lowered their BP by 6.9mm Hg more than the single pill group. At a year the figure stools at 7.7. millimeters mercury. There were no significant adverse effects in the poly pill group. The study clearly showed that taking a pill with multiple types of blood pressure medication, at low dosage, controlled blood pressure and was convenient and tolerable. That pill is now in development and should be presented to the FDA and European Union for review in the near future. It’s release to the public will certainly make taking medication simpler and more convenient.

Why Have Guidelines, Rules & Regulations If No One Adheres to Them & There are NO Consequences?

I live and practice internal medicine and geriatrics in South Florida. We have a substantial elderly population living both independently and in senior facilities. The Sars2 Coronavirus Pandemic has been devastating to this patient population. There are many who became ill and passed away under the loneliest circumstances of in-hospital isolation. There are those who became ill and recovered but have lingering long-term effects. There are those who have avoided infection but are just beaten down by the daily monotony of staying safe, avoiding crowded public places and subsequently forsaking the company of friends and family.

The vaccine rollout in Florida was Helter Skelter and disorganized. It was every man and woman for themselves trying to obtain an appointment to be vaccinated. For the most, part the senior community managed to get the shots.

We were all grateful and buoyed as the summer of 2021 began by the news that we could venture out without masks and start resuming our pre-pandemic lives. The Delta variant and the recent surge in infectious cases, hospitalizations and now mortality put a quick and moribund end to that for most. The disparity between the message coming out of Washington and the CDC and the message delivered by our Governor and State Legislature has made decision making for individuals far more difficult than it should be. The latest conundrum is about the need for booster COVID vaccines or not.

The State of Israel, which exclusively used the Pfizer Vaccine, announced a third shot for those over 50 beginning a few weeks ago. Germany announced it would start such a program in September.

The CDC hinted at a booster program but until a NY Times article appeared on the evening of August 16^th there was no official news on the subject beyond the recommendation that immunosuppressed individuals, especially organ transplant patients and cancer patients, under therapy get a third shot. Days before this announcement my patients had begun calling me, texting me, emailing me to tell me that their friends had walked into a Walgreens Pharmacy or Publix Pharmacy, showed them their Medicare ID card and their vaccine card and had been administered a third COVID vaccine shot with no questions asked. This was substantiated by multiple other patients including one couple spending the summer in the mountains of North Carolina.

Is there one set of rules for large chain pharmacies and another set for the rest of the world? What is the point of data and evidence-based recommendations if anyone can just do what they want when they want to?

At this point I will wait to hear the CDC’s recommendations on when to take a third shot and the data they used to explain why. I am thrilled that Pfizer has shown that a third shot is safe with few adverse effects. I am also buoyed by a research paper that showed that those groups who spaced their second shot at longer than the three- or four-week recommendations had a more robust immunologic response.

When my friends call me and ask me to join them on a trip to Publix or Walgreens to get the third shot now, I will hear my late mother’s voice in my brain asking that irritating question, “If all your friends decided to jump off the Empire State Building would you jump too?”

COVID-19: Bringing Back Precautions & Restrictions

We recently spoke with our Friday night Shabbat Dinner friends of 40 years and cancelled our dinner plans because of the aggressive resurgence of the COVID-19 Delta Pandemic. I remember our last dinner eating outside in early February 2020 on a beautiful evening wondering if we should all be together one last time before suspending our weekly meals together. We were joined by a physician friend and his wife visiting from Cleveland and they were poking fun at my concerns and over reaction to the “Wuhan Flu.” The proverbial “shit hit the fan” the next week and we went into lockdown.

One year later we were all excited lining up for the Pfizer and Moderna vaccine. We really thought that would be the solution. We really thought our leaders at the federal and state levels would stand up and promote vaccinations. We really expected community leaders, respected by people of color, including church leaders, community activists, respected community members would be out there championing the vaccine, helping at vaccination sites and getting the shot into the arms of the most vulnerable.

Several months ago, when things began to calm down, we started having dinner together again in our homes. The rate of positivity in the spring of 2021 was low and our friends masked and kept distance when indoors shopping for supplies. We felt comfortable enjoying our friends’ company once again outdoors at a few restaurants and in our homes. Then came the Delta surge and with it the relaxation of restrictions.

It reminds me of pictures of the start of the Oklahoma Land Rush. A gun was fired, and everyone rode off to stake their claim. In 2021 they made their plane flight reservations, bought their concert tickets, made their hotel reservations and resumed everything they did prior to the pandemic. They stopped tracking cases, and, in many states, they stopped looking for new genetic mutations and variants of the virus. They forgot to get the vaccine to poorer nations but left the air and ship travel paths open to anyone and everyone. They underestimated the ability of the virus to find a way to survive by changing once inside the bodies of the vaccinated and unvaccinated.

Yes, it’s true that if you are vaccinated and get infected with the virus you most likely will not require inpatient hospitalization and die but according to those who went through this you will feel miserable for quite awhile. Yes, it’s true that you probably can transmit it to others even though the data on that is still new and quite controversial including passing it to unvaccinated children and the immunosuppressed.

To make matters worse, our Governor thinks he’s Bob Barker screaming; “Come on Down” as he invites foreign and out of state residents to come visit our beautiful state, spend money, pick up the virus and bring it home to your locale. I bet Florida is the leading exporter of sickness, death and chronic illness in the world over the last 12 months and no one in our state capitol seems to care.

We are returning to a bunker mentality in our household. No more dinners out. No more social engagements with friends whose activities and travels we are unsure of. If our grandson is sent to his preschool my wife will stop being his nanny because she does not want to risk catching the virus.

As college and NFL football season approach, it is unlikely I will sit in a stadium with thousands of unmasked individuals to see my teams play. The same goes for the theater and for travel. It’s really disheartening and depressing but we will do what is necessary to stay healthy and we hope you will too.

Delta Variant, Breakthrough Infections & What You Need to Consider

As a primary care physician treating older adults fifty years of age and older, I am starting to be involved in the treatment of “breakthrough” COVID-19 cases in vaccinated adults. At the end of June 2021, just prior to the July 4^th holiday, we were told to enjoy the summer if we were vaccinated. Many in my patient population took this to mean book flight and cruise reservations and begin travelling. Others started meeting friends to shop again, exercise together in gyms or eat lunch socially indoors.  Experts at the CDC felt it was safe to take off our masks indoors.  Then came the Delta variant – a far more transmissible virus. 

I first read about breakthrough cases in a peer reviewed medical journal discussing the widespread outbreak of COVID-19 in Israeli citizens vaccinated with the Pfizer Vaccine. The message was clear, if vaccinated, you can still get the viral infection with the Delta variant, but you won’t require hospitalization and you have a minimal chance of dying. 

With that news many of my patients continued resuming their lives and normalizing to pre-pandemic routines without masking or distancing in public areas.  Three weeks ago, our local hospital had no breakthrough cases. Two weeks ago, there were five. All the breakthrough cases in individuals 65- years of age, or older, or with symptoms, are invited to receive the monoclonal antibody treatment which shortens the course of the illness and the severity.   Treatment should be within 10 days of first developing symptoms. The cases are so numerous this week that there is a wait of days to get treated.

In discussing the breakthrough cases with my ill patients, they all feel miserable.  They are exhausted, coughing, some febrile with high fevers and severe joint and muscle aches. Some have lost their sense of taste and smell. They say the monoclonal antibodies help, but a week later most of my patients are too weak and tired to do much beyond their necessary activities of daily living. They call daily asking how much longer this will last.  My answer is, “I just do not know.”

I also do not know If their viral load was high enough to transmit the disease to the unvaccinated, the immunosuppressed vulnerable vaccinated patients or even other vaccinated individuals.  The experts are not sure either. Will these vaccinated breakthrough patients become “long haulers” with chronic symptoms stretching to months post infection?  We don’t know – it’s too soon to tell. 

I am also getting calls from patients who were out socially unmasked with close friends and relatives and have now received a phone call that their friends have the COVID-19 infection, and they were exposed.  These patients need to be tested for the disease a few days after exposure but, with the closure of all the state-run testing sites locally, you are limited to going to your pharmacy or some walk-in clinics for COVID testing. Take my advice, get the nasal PCR test sent to the lab which takes longer than the quick test but produces fewer incorrect results.

What I do know is this is a disease well worth avoiding.  Get vaccinated if you haven’t already done so.  Wear a good N95 or KN95 mask if you must go out in public to an indoor facility, and you have no idea who is vaccinated, and who isn’t, and who might be spreading the disease prior to developing clear cut symptoms.  Yes, this is retreating and taking a step backwards into a bunker mentality.  If you don’t believe me, just ask my COVID-19 breakthrough patients. They will tell you this is more than just a “bad flu.”

New Device Helps Stroke Victims with Hand Function Difficulties

Stroke victims often lose function of a hand. The road back to recovery involves months of physical therapy and work.

Last month the FDA approved the Neurolutions IpsiHand Upper Extremity Rehabilitation System for survivors of stroke trying to regain hand, wrist or arm function.  The system uses EEG electrodes to record your brain activity and then uses these messages to move an electronic hand brace according to the intended muscle movement. It essentially delivers your brain’s intended electrical message to the brace to retrain your limb to work.

This is a sophisticated device which will need to be fitted by stroke rehab professionals and then tailored for individual patient needs so it can be successfully used.