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.

Phthalates and Early Death

Environmental Health is an online journal that printed the research of Leonardo Trasande, M.D. who practices and works at the NYU Grossman School of Medicine in New York City. His teams’ research found that the death toll and lost working time due to illness from phthalates were far higher than previously thought.

Their study examined middle aged adults between 55 and 64 years during the years 2013 and 2014. The analysis used the data of 5303 adults participating in the U.S. National Health and Nutrition Examination Survey who provided urine samples as part of the study. Phthalates can be measured in the urine and there are known reference ranges of normality. Their research, when extrapolated to the middle-aged population, estimates about 100,000 deaths and forty billion dollars or more lost in economic productivity among 55-64 year old Americans during 2013 and 2014.

Phthalates are a group of chemicals used to make plastics more durable. They are called “ plasticizers” and can be found in personal care products such as soaps, shampoos, hair sprays, fragrances. They are additionally seen in vinyl flooring , lubricating oils and in polyvinyl chloride plastics. These polyvinyl plastic products are seen in food wrappings, garden hoses, medical tubing ( IV tubing). Some of them get into our foods and we eat them and drink them. Some of them are aerosolized and we inhale them. In human beings we see damage to the lungs, liver, kidneys and reproductive organs from phthalate exposure.

Women apparently have a higher urinary phthalate content than men because there are so many of these chemicals in personal care products. There have even been reports of phthalates in infant diapers. Limiting exposure to these chemicals is important but learning where they are and what your risk is remains difficult. This is an area that requires far more timely research and far more transparency.

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.

Safety for Patients First

In the heat of the ongoing pandemic, my associate and I suspended in-person routine office visits for the safety of our patients. To get to our office, patients walk through a revolving glass door into a common lobby and then take a small elevator up to the second floor. There are stairs which are well hidden and not easily accessible. A sign is posted next to the elevator suggesting facial covering, but not requiring it, despite an executive order in Palm Beach County mandating their use.

This is a multiuse building with numerous offices. Many of the other tenants do not social distance or wear masks routinely. There have been multiple tenants who have tested positive for COVID. For this reason, we participated in telehealth visits exclusively to protect our older, chronically ill and vulnerable patient population. It was safer to keep them in their home than bring them into our practice. We were willing to forego practice revenue and income to do so. Our first priority is the safety of our patients.

The office has been open daily, answering calls, refilling prescriptions, filling out forms and scheduling telehealth visits. The criticism from patients for doing this has been scathing. The worst criticism has been from those requesting blood draws for visits to other doctors. We performed this as a courtesy in Pre- COVID days but believe the risks far outweigh the benefits for non-ill individuals at this time.

The COVID-19 hospitalization rate and percentage positive rate locally have declined to a level that is allowing us to begin safely seeing patients again in our office. The building management still will not enforce the Palm Beach County mask mandate so we urge you to social distance and wear your mask.

Do not enter the elevator unless it is empty. Wait for the next one to ensure safety. Hope to see you soon. Call with any questions.

Testing in Pharmacies, Another “Duh” Moment for Florida’s Governor DeSantis

At his coronavirus pandemic news conference, the Governor of Florida, who last week defined professional wrestling as an essential business, announced that testing for COVID-19 will be expanded by using pharmacies as test sites. He indicated the details still need to be worked out.

In the absence of a Federal plan for testing, states like Florida, which are desperately trying to reopen for tourism and business, are attempting to figure it out themselves. I just raise these simple questions:

  1. Who will be performing the testing? Will it be the same pharmacy techs that take 30 minutes to give a vaccination that can be administered in five minutes or less elsewhere? Will they hire nurses? Medical assistants? Moonlighting EMS personnel?
  2. Which test for COVID-19 will they be using? If it requires a nasopharyngeal swab will the personnel have adequate personal protective gear? Will it be sent to a lab? Will it be a quick on site test? If 100 people with COVID-19 took the test how many would test positive? If 100 people not infected with COVID-19 took the test, how many would falsely test positive?
  3. Who will train the pharmacy personnel on how to correctly take a deep nasal sample?
  4. Who will train the pharmacy personnel on how to dress in the personal protective gear and sanitize between test subjects so that they do not expose the non-infected, or next test subject in line, to COVID-19 or expose themselves?
  5. Where in the pharmacy will this be done? Will it be a drive thru in the parking lot? If it is in the pharmacy how will you protect healthy shoppers from potentially sick patients? How often will each store need to be disinfected and how will they do it?
  6. Who will pay for the cost of testing?
  7. For those who test positive, who will be responsible for reporting it to Public Health? Who will be available and responsible for tracking down contacts of infected patients?
  8. Will the testing only be done by appointment at specified times?
  9. Will the pharmacies have the same limited test supplies that has prevented appropriate recipients from being vaccinated for shingles with the Shingrix vaccine?

The State of Florida, through decimation of its Public Health system due to inadequate funding under former Governor, now Senator Rick Scott, is reeling from an inability to respond, test and treat the poor and underinsured of Florida. They once again turn to an inexperienced and untrained private sector to assume their responsibility.

There is Still a Pandemic in Florida Folks!

I opened the local newspaper to headlines that the Palm Beach County Commission has opened county facilities but is not requiring visitors to wear masks, facial coverings or observe social distancing rules.  A county commissioner was quoted as believing that it was not within their authority to require facial coverings.  Strange opinion when they have closed businesses , facilities and services due to COVID-19 and then reopened them independent of Public Health, CDC or even White House guiding rules and regulations and published the conditions under which these facilities will open and operate.  I imagine, or hope, the County civil servants have union representation that will address the issue of their employees being called back to work with their health and safety being taken for granted.

Recently, I spoke to a patient who believes COVID-19 is overblown. They are closer to 80 years old than 70, continues to smoke tobacco regularly despite having documented coronary artery disease and is incensed that the free flow of patients has not restarted in our medical practice.

I keep coming back to the same question.  Despite our Governor opening the state up again, what has changed medically or scientifically?

  1. We still do not have an onsite quick accurate test to determine if a patient has COVID-19 and is a contagious asymptomatic carrier. Yes, testing sites have increased but most test results come from a lab with a 48-hour wait delay.  Our local medical center, Boca Raton Regional Hospital Baptist Health system has on the physician website a request to only perform quick in-house COVID-19 testing one time on admitted patients only because they do not have enough supplies on hand.  Patient’s presenting to the Emergency Department still receive a nasal swab which is sent to an outside reference lab and results take 48 hours.
  2. We don’t have enough personal protective equipment for hospital staff to change masks, capes, face shields and gloves according to their own guidelines for treating an infectious patient and preventing transmission of the pathogen to others, including you! In view of the shortage of equipment, the CDC and hospital infectious disease departments have relaxed their own guidelines several times to ensure their guidelines agree with the way equipment is being used.
  3. We still do not have a treatment other than supportive care. Yes, there is some evidence that remdesevir early in the course helps and that a triple drug regimen in more severe cases helps.
  4. We are still months away from having a vaccine.

In Palm Beach County, civic leaders admit they bowed to the pressure of struggling businesses, distressed parents out of work, and home with school age children, and political pressure from Washington and Tallahassee in deciding to open the economy back up.  With Palm Beach County opening May 11th and Dade and Broward County on May 18th, we should begin to see an increased infection rate over the next two weeks based on the incubation period of COVID-19 and its complication rate developing around Day 8 or 9.  

I sincerely hope I am wrong about this, but my infectious disease colleagues, critical care colleagues and Emergency Department colleagues have shared this professional opinion with me.  This disease infects and kills youngsters, young adults, teenagers as well as senior citizens.  Asymptomatic carriers of the COVID-19 bug infect 5.7 individuals before they discover they are sick. 

Despite this, we ask county employees and restaurant servers to spend time up close with no requirement to wear a facial covering.  Tell me, what has changed other than the level of patience of our elected officials and their overwhelming desire to gain public favor and get re-elected regardless of the health care costs and carnage from COVID-19?

Taking BP Medications at Night More Efficacious Than in the Morning

The European Heart Journal published the Hygia Chronotherapy Trial which followed hypertensive patients in Spain for a decade between 2008 and 2018. There were 19,000 participants of whom 10,600 were men, all older than 18 and all being treated for high blood pressure.  The group was randomly selected to either take their blood pressure medications at bedtime or in the morning.  They were followed with frequent blood pressure checkups plus 48-hour ambulatory blood pressure monitoring to assess their sleep time blood pressures.

The study was performed only on Caucasian participants who went to sleep on what would be considered a normal day/night schedule.  The results were significant and important.

Those who took their blood pressure medications at bedtime saw the risk of dying from a heart or blood vessel related problem drop by two-thirds compared to those who took their meds in the morning.  Night time administration of blood pressure medications resulted in a 44% drop in heart attack risk, a 40% drop in the need for coronary artery revascularization, a 42% drop in the risk for heart failure and a 49% drop in stroke risk.  The overall reduction in risk for cardiovascular death was 45%.

This is a significant study which must now be performed in patients of color who tend to have higher night time blood pressures.  While these studies are in progress, it appears that taking your blood pressure medication before bed is the correct choice.

Fever Blisters or Herpes Simplex Labialis Treatment with Honey versus Acyclovir

Herpes Simplex lesions cause mouth and gum ulcers and fever blisters. In order for the virus to be activated it requires exposure to sunlight. As these ulcerations appear they are painful, unsightly and the virus can be transmitted person to person.  Modern day treatment has consisted of taking an antiviral medicine such as Acyclovir in topical form applied four to six times per day for seven days. The medication reduces the healing time and pain in this infection.

Researchers in New Zealand decided to test their home grown Kanuka Honey versus Acyclovir in the treatment of herpes labialis. They randomized 952 adults who presented to community pharmacies with herpes labialis over a two year period to two groups.  One group received a traditional acyclovir 5% cream, the other kanuka honey (90%), and glycerin cream (10%). They applied their medication five times daily.

They then observed how long it took for the infected and involved skin to return to normal and pain resolution.  It took 8-9 days for the acyclovir to work and 8-9 days for the kanuka honey to return skin to normal appearance. There were no differences in pain observations or time for the open wound to close.

A large jar of Kanuka honey costs $60 by ordering online. A 15-gram tube of 5% acyclovir topical ointment sells for $379.99 locally.

Does Curcumin Use Help with Cognitive Dysfunction?

Recently, more and more patients have been adding curcumin or turmeric to their cooking to help with their memory. Curcumin is a metabolite of Turmeric and has been available in health food stores for years.

A study a few years back on Alzheimer’s patients published by J. Ringman and Associates showed no benefit in slowing the development of symptoms and no improvement in symptoms when supplied with curcumin. When they looked closely at their study, and analyzed the participant’s blood, they found that curcumin was not absorbed and never really entered the bloodstream.

Last month a study was published in the American Journal of Geriatric Psychiatry by Dr. Gary Small and colleagues. They looked at 40 patients with mild memory complaints aged 50 – 90.  Some were administered a placebo and others were administered nanoparticles of curcumin in a product called “Theracumin”. The participants were randomized and blinded to the product they were testing. The study designers felt the nanoparticles would be absorbed better than other products and would actually test whether this substance was helpful or not. At 18 months, memory improved in patients taking the nanoparticles of curcumin and they had less amyloid deposition in areas it usually found relating to Alzheimers Disease.

Robert Isaacson MD, the director of the Alzheimer’s Prevention Clinic at Weil Cornell Medicine and New York- Presbyterian, has been suggesting his patients cook with curcumin for years. Until the development of the Theracumin nanoparticles, cooking with curcumin was the best way to have it absorbed after ingestion. There is now some evidence to suggest that curcumin, in this specific nanoparticle form, may play a role in both the risk reduction and potential therapeutic management of Alzheimers Disease.

How Tightly Should We Control Blood Pressure in the Elderly?

A recent publication in a fine peer reviewed medical journal of the SPRINT study proved that lowering our blood pressure to the old target of 120/80 or less led to fewer heart attacks, strokes and kidney failure.  There was no question on what to do with younger people but to lower their blood pressure more aggressively to these levels. Debates arose in the medical community about the ability to lower it that much and would we be able to add enough medication and convince the patients to take it religiously or not to meet these stringent recommendations?

There was less clarity in the baby boomer elderly growing population of men and women who were healthy and over 75 years of age. The thought was that maybe we need to keep their blood pressure a bit higher because we need to continue to perfuse the brain cells of these aging patients.

A study performed in the west coast of the United States using actual brain autopsy material hinted that with aggressive lowering of the blood pressure, patients were exhibiting signs and symptoms of dementia but their ultimate brain biopsies did not support that clinical diagnosis. In fact the brain autopsies suggested that we were not getting enough oxygen and nutrient rich blood to the brain because of aggressive lowering of blood pressure.  Maintain blood pressure higher we were told using a systolic BP of 150 or lower as a target.

A recent study of blood pressure control in the elderly noted that when medications for hypertension were introduced or increased a significant percentage of treated patients experienced a fall within 15 days of the adjustment in blood pressure treatment.  This all served as an introduction to a national meeting on hypertension last week during which the results of this same SPRINT (Systolic Blood Pressure Intervention Trial) strongly came out in favor of intensive lowering of blood pressure to 120/70 to reduce heart attacks, strokes and mortality in the elderly and claimed even in the intensive treated group there were few increased risks.   On further questioning however by reclassifying  adverse events in the SPRINT trial to “ possibly or definitely related to intensive treatment, the risk of injurious falls was higher in the intensive vs conventional treatment group.”

What does this mean in the big picture to all of us?  The big picture remains confusing.  It is clear that lowering your blood pressure aggressively and intensively will reduce the number of heart attacks and strokes and kidney disease of a serious nature.  It is clear as well that any initiation or enhancing of your blood pressure regimen puts you at risk for a fall. You will need to stay especially well hydrated and change positions slowly during this immediate post change in therapy time period if you hope to avoid a fall.  Will more intensive control of your blood pressure at lower levels lead to signs and symptoms of dementia due to poor perfusion of your brain cells?  With the SPRINT study only running for three or more years it is probably too early to tell if the intensive therapy will lead to more cognitive dysfunction.