Disappointment in Decision-Making Regarding COVID-19

I received an email from the Chief Medical Officer at my main local hospital informing me that elective surgical and diagnostic procedures had been cancelled due to understaffing because of COVID-19 infections. He mentioned 136 employees testing positive yesterday and 36 nurses not reporting to work this morning for the day shift due to COVID. Nearby Holy Cross Medical Center has stopped delivering babies due to a shortage of staff.

I subscribe to numerous physician run newsletters that discuss expert opinions on many specialty topics. The physician writers are all at the stage of life where they and their children are young and they are grappling with in-person schooling and infection. They write about hosting large holiday gatherings and now learning that multiple attendees are ill and positive with COVID-19.

While there have been few hospitalizations so far in this young professional vaccinated group, they worry about infecting their young unvaccinated children and elderly parents with chronic illnesses. These are leaders in the health care public policy and influence pedaling industry today and their lack of discipline and ability to delay gratification has put us all in the unenviable position of having to face an absence of available medical services due to further spread of COVID-19

I have no more success with my own highly educated children who do not work in health care. My eldest child hosted a holiday gathering in Venice, California to celebrate their Christmas Canal Boat Parade and multiple attendees reported being sick four days later. She then boarded a plane to New Mexico with friends.  Upon their return, two of the three travelers are home with COVID-19

We are in a major surge of infection with a highly transmissible virus. Texas Children’s Hospital is full of children too young to be vaccinated and struggling to breathe and survive. Locally, Jack Nicklaus Children’s Hospital and Joe DiMaggio Children’s Hospital are facing similar problems.

I urge you to stay home. Wear a mask if you go out in public which is a N95 or KN95 mask or triple layer cloth surgical mask. Avoid eating out at restaurants even outside. Stay out of gyms. Stay out of country club dining rooms and card rooms. “The Board” can make those places clean but they can not make them safe from a respiratory virus with twice the transmissibility of smallpox and measles. The economy will suffer but can recover with intelligent leadership. Sadly, businesses will suffer too but they can recover. Lost children and seniors cannot be replaced.

Should I Measure My COVID Antibodies?

On a daily basis I get asked by patients to please add an antibody test to their necessary blood work monitoring chronic conditions and medications to see if they have immunity against COVID-19. Some want the information just to feel comfortable that they have responded to their vaccine administration. Some have had COVID-19 and want to see if their immunity is sufficient to avoid taking a COVID-19 vaccine or booster shot? Some who have not been vaccinated and have been ill recently but not tested just want to know if the illness was COVID-19.

The topic was just reviewed in the online journal MedPage Today. First of all, the test you order to determine if you developed immunity based on receiving the vaccine is different than the test you order to measure antibodies arising from a previous infection. Nathan Landau, PhD, a virologist with the NYU Grossman School of Medicine believes we do not yet have the data to determine if antibodies we develop from infection or vaccination are appropriate to provide immunity. “The real answer is we just don’t know. It takes time to gather that data, to know what titers people have and what their chance of getting infected is.”

To determine the level of antibody that is needed to prevent infection scientists must first perform neutralization assays or tests. These are not performed in the commercial labs that do antibody tests for COVID-19. The neutralization assay is the Gold Standard . The test is performed by taking the blood of an infected individual, isolating the blood serum and then diluting it into different strengths. The different strengths are then mixed with the live Sars2 Coronavirus in a set amount. They then observe if the virus is killed off.

 In order to kill the virus you must have neutralizing antibodies. The commercial labs only measure the total antibody not specifying how much of that is actually successful in neutralizing the live virus. The neutralization assay looks to see what dilution of the antibody kills off 50% of the virus.

For example a dilution of 1:100 means 1 milliliter of serum was mixed with 99 milliliter of saline. At this point we do not know what dilution is necessary to prevent infection. This data is known for diseases such as measles, German measles and different strains of hepatitis.

There has just not been enough time yet to make this determination but the research is ongoing and conclusions should be released soon. What is known is that the mRNA vaccines produce more immunity than the non mRNA vaccines. They also know that the antibody produced from a vaccine is superior to the immunity from infection against new variants and reinfection. The commercial tests are expensive, time consuming and use reagents affected by supply chain problems.

Relief From Migraine Headaches Erenumab (Aimovig) versus Topiramate

Patients with frequent migraine headaches, which disabling symptoms, were in the past treated with oral medications called beta blockers such as propranolol or metoprolol to prevent recurrences. Drugs such as amitriptyline (Elavil) and other antidepressants were used as well. Triptans, caffeine, acetaminophen, narcotics, and Ergot alkaloids rounded out the therapy. The headaches could be crippling and disabling for suffering patients. In recent years, physicians have added topiramate (Topamax) and injectable Aimovig (Erunumab) to the regimen.

Recently a double blinded controlled research project looked at 777 adults with at least four migraine headache days per month. To be in the study these individuals needed to have never been treated with migraine medications. Patients were randomly assigned to receive either Aimovig 70 mg, the 140 mg injection monthly or topiramate at a dosage of 50- 100 mg per day.

The study ran for twenty-four weeks. This was a phase 4 head-to-head study of the efficacy of one versus the other (Clinical Trials.gov Identifier: NCT03828539. The endpoints were at least a 50% reduction in monthly migraine days plus ability to remain in the study without leaving due to side effects from the medication.

The results and conclusion were that Aimovig injections resulted in fewer migraine headache days per month and less discontinuation due to side effects of the medication. Only about 11% of the Aimovig patients stopped the drug due to side effects (fatigue, nausea, disturbance in attention and dizziness) versus almost 40% in the Topiramate group (parasthesias, disturbance in attention, fatigue, and nausea).  The Aimovig group had a 55.4% of its participants achieve at least a 50% reduction in monthly migraine days compared with 31% in the topiramate group.

Patients with recurrent and severe headaches need a full neurological evaluation to determine the exact cause and type of headache they are experiencing. Once the cause and type of the headache are known, it is wonderful to have this calcitonin gene-related peptide receptor antagonist available to prevent migraines in sufferers of these severe headaches.

Omicron the new COVID Variant & the Pandemic

Last week my office staff and I met to discuss loosening some of our COVID-19 precautions due to the low positivity rate in the area and the vaccination status of the local population. We all enjoyed the return to normal this Thanksgiving inviting family to celebrate with us for the first time in two years. My children, their spouses and kids all flew home for a joyful few days. Then came news of a new variant out of South Africa, Omicron.

It is too soon for scientists to know very much other than structurally there are multiple mutations on the P-spike. It is felt that this makes the virus more transmissible than previous versions including the Delta strain.

We don’t yet know if the Omicron variant will produce more severe illness. It is too soon to know the incubation period and most significant period of disease transmission. We do not know if the COVID-19 vaccines will work against Omicron or if it will dodge our immune response. Nor do we know if it will bypass the immune response of those previously infected? I expect it will take at least three weeks to get some of the answers but probably three months to have a better idea.

The travel restrictions imposed by world leaders are too little and probably too late. Banning foreign nationals from entering your country while permitting citizens to return assumes the virus recognizes national flags and only infects foreign nationals. This decision is an outrage. Returning citizens need to be tested frequently while being quarantined for about 14-days. That is the type of travel restriction required. It is highly probable the new strain is already in the USA.

We need mass testing to start again so we can identify infection quickly and we need the lab capability to identify the infecting viral strain. In the meantime, while we learn about what we are dealing with, we need to once again wear masks, keep our social distance and avoid crowded indoor venues.

My practice will continue to screen patients over the phone and at the door. We will limit entry into our office and require masks to be worn. We will stagger patient visit times so that patients coming and going are not in close proximity. If necessary, we will return to telehealth visits only.

On the bright side, we are much more prepared for a new surge than before. More individuals are vaccinated and boosted. The COVID treatment pills work via a mechanism that is independent from the genetic mutations on the P-spike protein. Vaccine manufacturers have already begun preparing a vaccine against the Omicron strain that will take three months to reach the market. It is disheartening to face this crisis again, but we will, and hope the knowledge we need to acquire is learned quickly.

Vitamin D & Autoimmune Disease

Karen Costenbader, MD, of the Brigham and Women’s Hospital in Boston reported at a plenary session of the American College of Rheumatology that adults taking 2000 IU of Vitamin D and one gram of omega 3 fatty acids daily were less likely to develop autoimmune disease than adults taking a placebo. Costenbader’s research group reviewed data from the Vitamin D and Omega 3 Vital trial which included 2,000 men ages 50 and older and women 55 and older.

In her work, Dr. Costenbader looked at almost 17,000 participants who had blood tests for Vitamin D levels and Omega 3 fatty acids. The study groups were followed for over a five-year period. Those supplemented with Vitamin D and Omega 3 fatty acids reduced the incidence of autoimmune disease by 25- 30%.

Vitamin D supplements and Omega 3 Fatty Acid supplements are readily available, inexpensive and non- toxic when taken in appropriate dosages. Their use should be encouraged.

Prediabetes & Exercise

Prediabetes is a condition that identifies individuals who have an increased risk of becoming Type II diabetics. It is diagnosed with either a fasting blood glucose measurement of 100-125 or an elevated Hemoglobin A1C level. The Hemoglobin A1C level provides a look at the average blood sugar level over the previous 8-12 weeks and is fairly independent of the previous few meals.

Gone are the days of the physician saying to his patient, “your blood sugar was elevated at 120” and the patient responding, “Well it was my birthday this week and I had some cake and alcoholic drinks causing the elevation.” The hemoglobin A1C removes that reason.

When physicians diagnose patients with “prediabetes” we try and educate the patient and family encouraging dietary education on a healthy eating lifestyle, weight reduction if they are overweight and regular exercise. Fortunately, in the senior citizen age group, newly diagnosed prediabetics usually don’t end up developing full blown diabetes if they watch their weight and get active.

A recent study published in BMC Endocrine Disorders found that aerobic exercise was best at controlling Hemoglobin A1C levels but resistance training was not far behind. Those individuals who engaged in both aerobic training plus resistance training showed better weight control and fasting blood glucose levels than the control groups or aerobic training alone. When evaluating the data both aerobic training and resistance training helped. The message to me for my patients is, if you are a prediabetic, start exercising doing what you enjoy doing. Make it fun, not work. Couple that with a dietary education from a trained dietitian or diabetes peer educator and you will do well.

Zinc For Colds This Season?

Two weeks ago, my wife was doing her weekly childcare activity of love watching our two toddler grandchildren while our adult kids were on a business trip. The 3.5-year-old had brought home a viral respiratory infection the week before, gave it to his one-year-old brother and both kids were now in the tail stages of recovering from annoying but not serious illnesses.

In today’s world, coming home from school with a sore throat, runny nose and malaise means tea and honey, warm soup and a COVID-19 test. Both kids were negative but several days later my wife, then I, had similar symptoms. My wife’s symptoms settled in her sinuses and 10 days later her doctor put her on antibiotics and nasal spray. I was fortunately much less symptomatic but still have some nasal congestion and dry cough. We have a commercial preparation of a zinc product to prevent and reduce the symptoms of these infections but did not get around to taking them. In the past the literature wanted us to take these lozenges every two hours and I was not going to set an alarm at night to wake up to suck on a zinc tablet.

Jennifer-Hunter, PhD, from the Western Sydney University and associates studied the questions about zinc products’ effect on preventing and abating the common cold and published their findings in the online version of the BMJ Open on November 1, 2021. They looked at 28 randomized controlled studies with 5,456 patients. Their results showed that oral or intranasal zinc did prevent about 5 infections of those exposed per 100 persons when compared to a placebo. They found that if you challenged healthy individuals with a human rhinovirus inoculation the sublingual zinc did not prevent a clinical cold. Those who continued the zinc tended to have resolution of symptoms two days earlier than those who took placebo. For those who took the zinc prep there were more episodes of nausea and mouth and nose irritation.

I appreciate the science and think I will pass on the zinc for now and stick with avoidance of sick individuals plus chicken soup, tea and honey when I catch the virus anyway.

FDA Approves New Non-Verbal Computerized Test for Cognitive Impairment

Many of you are used to the Mini Mental Status Test or Montreal Cognitive Assessment Test during which an examiner asks you verbal questions and there are some pictures to interpret. This week the FDA approved a new test taken on an iPad or tablet using images of animals. The test asks you to classify the pictures as either an animal or nonanimal. The advantage of using the nonverbal picture test is it eliminates bias based on level of education and culture. In addition, it eliminates a successful score on subsequent tests due to a “learning the test” effect.

The test results can be incorporated into a patient’s electronic health medical record and become a part of the patient’s permanent chart. The test was given to 230 volunteers. There were eighty individuals with mild cognitive impairment, 55 with mild Alzheimer’s Disease and 95 healthy individuals. The results revealed the test was as sensitive as current verbal tests currently used to detect early dementia.

CognICA is the name of this new test and will be available for purchase in the next few months

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.