Practicing Adult Primary Care Requires Time

In September of 1979, the American Board of Internal Medicine awarded me “Board Certification in Internal Medicine” after I completed their training and testing requirements. In 2002, I took the board certification exam in the newly created specialty of Geriatrics and passed it. I answer to the titles of “Doctor,” “ Geriatrician,” “physician”. However, CMS and private health insurers instead lump me, and other medical doctors, into the broad category of “provider”. The term “ provider” is both insulting and demeaning since what I do in general internal medicine/ geriatrics is different than what a physician’s assistant or nurse practitioner does and involves several more years of schooling as well as observed and critiqued training.

Insurers added insult to injury by stripping me of my internal medicine designation and lumping me in with family practitioners, pediatricians and obstetricians. Those are all unique specialties with their own rigorous training requirements and post training testing. They too deserve to be recognized by name for their accomplishments. But how they practice medicine and how I practice medicine are not one in the same.

I bring this up as an introduction to a research paper published in the Journal of Internal Medicine that performed time/work studies and determined that to perform the preventive care, chronic issue care, acute problem care and administrative duties, when caring for 2,500 patients, a physician would have to work 26.7 hour per days. If you provided that physician with qualified support staff, and created a care team, you could reduce the required time to 9.7 hours a day.

Ten-hour workdays are long by anyone’s standards and the article didn’t specify whether the primary care provider was limited to outpatient office work or included caring for their hospitalized patients as well. At best, this team-based approach ensures that the patient spends less time face to face with their actual physician which, in my opinion, is not a positive step.

The paper cited the example of vaccinations and immunizations being something best handled by lesser trained team members and, providing patients access to educational reading material. Once again, I have no problem with trained staff administering vaccinations but as you have seen with the corona virus pandemic and monkey pox outbreak, patients have many questions about materials injected into their body and they want to speak to a physician.

As an alternative to teams seeing patients, the authors mentioned “direct pay practices” which keep their patient load to 1000 or less, charge a monthly administrative fee and only accept cash for services rendered. I propose even smaller panels of 500 patients with insurers and CMS covering the costs of membership.

Studies sponsored by a large concierge medicine franchise program, have shown that they reduce their patients’ hospitalizations, meet preventive guidelines and ultimately save CMS and private insurers money. As an independent concierge medicine physician for 18 years, I have seen similar results limiting the number of patients I care for to 400 and giving them time, availability and advocacy with a focus on prevention.

By practicing in the concierge medicine model, you retain your patients long term and develop strong relationships with them. Also, you learn quickly that taking care of fewer people, and the relationships you establish with them,  is extremely satisfying and rewarding – something which will attract future doctors to these types of practices.

The current system does not work. Independent internists found a solution 20-years ago called concierge medicine. It’s time to give that model a try. It would save private insurers and CMS hundreds of millions of dollars per year resulting from a focus on prevention and reducing costly ER visits and hospitalizations.  For employers, it would reduce absenteeism and presenteeism, improve productivity and serve as a terrific health benefit.

Flu Vaccination May Guard Against Alzheimer’s Dementia

While it is early summer here in North America, most primary care practices have already ordered their influenza vaccine for the fall of 2022. Our practice will be using the “senior” high dose quadrivalent vaccine for patients 65 years of age and older as recommended by the ACIP (American College of Immunization Practices), a division of the CDC.

While experts debate when to administer the vaccine, we prefer to do it between Halloween and Thanksgiving based on when influenza arrives in South Florida and the limited length of protection seniors get from the vaccine. Flu shots can protect against serious infection and hospitalization in most cases.

Avram Bukhbinder, MD, of the University of Texas Medical Center in Houston believes the vaccine also protects seniors against Alzheimer’s disease. His work was published in the Journal of Alzheimer’s Disease recently.

His group looked at almost one million influenza vaccinated adults and compared them over time with a similar sized unvaccinated group of senior citizens 65 years of age or older. The median age was 73.7 years and 57% were women. All were free of dementia over the six year “look back period”.

They followed these groups for 46 months and found the risk of developing Alzheimer’s Disease was 40% lower in the vaccinated group. The paper did not determine why the flu vaccine lowered the risk of developing Alzheimer’s dementia. Dr. Bukhbinder hypothesized that the vaccine may have prevented severe inflammation seen with infection reducing the development of amyloid plaques and neurofibrillary tangles. An official with the Alzheimer’s Association was quick to point out that possibly those who took flu shots were more health conscious leading to less development of Alzheimer’s Disease.

Further research is warranted but this study provides an additional incentive to obtain your flu shot this fall.

COVID-19 Burnout

I was supposed to be visiting the NY Metropolitan area this week to celebrate a family high school graduation. Children and family were traveling from all over the country for this celebration when the parents of the graduate contracted COVID-19. The graduate stayed healthy and attended the ceremony and all post ceremony celebrations. Our family gathering was postponed, and my wife and I stayed home cancelling our flights and hotel reservations. The infected group were all vaccinated months ago and young, healthy and placed on Paxlovid . They are recovering. The fact that all will recover is what is important in a scene played out in homes across the globe all dealing with COVID and family gatherings.

At the same time this was occurring the FDA approved a Pfizer three-shot vaccine and Moderna two-shot vaccine protocol for COVID for children six months to five years old. It provided great joy in my south Miami daughter’s household since her four-year-old son has been attending pre-school and summer camp with no real protection other than a mask. My grandson has been the only child in his class and group wearing a mask indoors and the school psychologist asked my daughter if he could remove it because it was a barrier to playing with the other children.

The vaccine for young kids is not a foolproof shield but at least provided protection against serious illness. The FDA approval was a great comfort to parents hoping to have their kids vaccinated prior to the start of the next school semester in August. Then, the Governor and Florida Surgeon General announced Florida was not ordering the vaccine because they believed healthy kids did not need it despite all the infectious disease, public health and virology experts reviewing the data and approving the vaccine. Morale fell to a new low.

The very next day the Governor announced that doctors and pharmacies could order the vaccine through the Florida Shots website and had that option all along. That is not the way we ordered the vaccine earlier in the pandemic. We ordered it though the Florida Department of Health.

Supporters of the Governor blamed this ordering confusion on “big government bureaucracy”. If that is the case, then why not just announce from the beginning that pharmacies, doctors and health systems can order the vaccine through the Florida Shots website?

In the political gamesmanship of placing barriers in the way of our youngest and most vulnerable children being vaccinated, did the Governor forget that most physician offices do not have freezers capable of storing the vaccine at -90 degrees Centigrade? Also ignored was the plight of those who have relied on their county or city health department to provide the vaccines for their children for years and now those public health facilities will not have the vaccines.

My office was bombarded this week with calls from patient’s testing positive for COVID-19, all with mild symptoms of fatigue and upper respiratory viral symptoms. The current treatment options are to supply supportive care such as fluids, cough medicine, Tylenol and rest or prescribe the Pfizer pill Paxlovid. The Paxlovid must be started within five days of onset of symptoms.

So many patients walk around with cold symptoms for several days before home testing that it’s difficult to start the medicine within the five day window advised by the manufacturer. Paxlovid interacts with so many popular and common prescription medications for seniors which must be discontinued and washed out of your system prior to starting Paxlovid that they can’t start the medication on time.

The best option, in my opinion, remains receiving an infusion of the monoclonal antibody Bebtolivimab within seven days of onset of symptoms. Boca Raton Regional Hospital has a program that gets you in within a few days but several patients have been so anxious and worried that they would not wait for an appointment. Several called private services to come to their homes and treat them with monoclonal antibodies. These companies have popped up out of nowhere and their reputation and reliability are relatively unknown. Are they really administering Bebtolivimab? At least at the hospital I know the product is the real thing and the monitoring staff is well trained and experienced.

Also, several patients have insisted on Paxlovid and stopped their blood pressure, cholesterol and antidepressant medicines. Two of them took the Paxlovid and improved, then rebounded with a positive test and return of all symptoms several days later. They all recovered in a few days, but the potential rebound is another reason I prefer offering the monoclonal antibody infusion.

I have not mentioned the Merck oral medication Lagevrio ( molnupravir) because it used new technology involving disrupting the genetics of the virus. I would like to see the adverse effects of this drug and its efficacy and safety profile after being on the market for twelve or more months prior to considering it.

COVID remains a “bummer”. We are in a much better place to prevent serious illness than we were three years ago but human behavior, the demonizing of science for political gain and the resilience of this virus continue to wreak havoc on my life and those around me.

Ashwagandha Improves Quality and Duration of Sleep

The American Academy of Sleep Medicine and the Sleep Research Society held their 2022 annual meeting earlier this month and researchers presented data on the use of the shrub Ashwagandha on sleep quality and duration.

The researchers found eight studies on the topic including one which showed that after 10 weeks of therapy it took less time to fall asleep than with a placebo. Another study demonstrated “significant improvement in both quality and duration of sleep with patients experiencing an improved mood upon awakening”.

The Ashwagandha plant is native to India but is now grown worldwide and used for “stress resilience”. It is revered in Ayurvedic medicine and felt to reduce stress. The product is used to treat arthritis and treat anemia since it is high in iron. Ashwagandha is also known as Indian Ginseng, winter cherry or poison gooseberry.

Like most alternative and complimentary products, there is limited data on the product in the English research literature. Ashwagandha can cause gastrointestinal upset, nausea, vomiting and diarrhea at higher doses. It should not be ingested by children or pregnant or nursing women. There is data that it interferes with normal thyroid blood tests and should not be taken with sedatives, blood thinners or thyroid medications.

One of the major criticisms of herbal medicines in general is that they are not inspected or regulated by the FDA for purity and safety. The label often does not reflect the contents of the bottle and there are often undesirable contaminants. For this reason, I only recommend products inspected by the independent USP lab.

Ashwagandha, inspected by the USP lab is available in the USA. With insomnia being such a large problem, this product is worth thinking about.

Antioxidants & Dementia Risk – A New Study in Neurology

May A. Beydoun, PhD, MPH of the National Institute on Aging of the NIH in Bethesda, Maryland and associates published a study on blood antioxidant levels, food consumed and the risk of developing dementia as you aged. The study hoped to determine which foods were best to eat to limit your chances of developing cognitive impairment in later years. The researchers discovered that those individuals with the highest serum levels of lutein+ zeaxanthin and beta-cryptoxanthin at baseline were less likely to develop dementia decades later than their peers with lower levels of these protective antioxidants.

Lutein and zeaxanthin are found in green leafy vegetables such as kale, spinach, broccoli, and peas. Beta -cryptoxanthin is found in fruits such as oranges, papaya, tangerines, and persimmons. “Antioxidants may help protect the brain form oxidative stress, which can cause cell damage,” said lead author Dr. Beydoun.

The study, published in the journal Neurology analyzed 7,283 participants in the 3rd National Health and Nutrition Examination Survey who were at least 45 years old at the start of the study and were then followed for 16-17 years. The data showed the higher the serum levels of beta-cryptoxanthin at baseline the lower the risk of developing dementia. No such protection was found for lycopene, alpha-carotene, beta carotene or Vitamins A, C, or E.

This was an observational study looking at data already collected. In critiquing the study, Dr B. Hooshmand, MD, PhD and Milia Kiviipelto, MD, PhD of the Karolinska Institute, Stockholm, Sweden commented on the research noting that this was an observational study and previous studies supplementing individuals with antioxidants were disappointing and did not prevent development of cognitive dysfunction. They believe there is a more complex relationship between the foods we eat, antioxidants, socioeconomic status and lifestyle which all contribute to the development of dementia.

While there is work to be done in this field, this study certainly supported my love for a fresh orange or tangerine to start off the day. The accompanying editorial made it clear that consuming my antioxidants and vitamins in fresh fruit and produce seems to be healthier than depending on store purchased supplements.

Constipation Treatment with a Vibrating Pill

Constipation is a major quality of life problem. When confronted with it, physicians advise more hydration, more exercise and activity and more fiber in your diet. If that doesn’t work, we try medications.  We start with medications to increase the bulk and fiber in your gut and to soften the stools. Next, we move to different strength laxatives. The problem with laxatives is that often the timing and consistency of the next bowel movement are unpredictable. Getting phone calls about new onset of diarrhea in patients taking a laxative for constipation is common. Chronic use of laxatives can adversely impact the muscles of the colon rendering them less, or completely, ineffective.

Satish Rao, MD, PhD, professor of Medicine at the Medical College of Georgia, presented a paper at the Digestive Disease Week meeting and reported by Medscape about a vibrating pill that reduced constipation. The pill is swallowed at 9:00 p.m. and then is activated remotely to vibrate for three seconds and then rest for 16 seconds. This process continues for two hours twice a day. There were virtually no side effects although some participants said they felt the vibrations. Spontaneous bowel movements per week increased in the treated group. Less straining was required to have a bowel movement and stool consistency was considered improved. Quality of life was felt to be improved. The timing of the vibration cycles enabled participants to have bowel movements at the time of the day they were accustomed  to having bowel movements.

The vibrating pill is now being reviewed by the FDA for approval sometime in 2022.

FDA Approves New Diagnostic Test for Early Alzheimer’s Disease

The Lumipulse G Beta Amyloid Ratio test, made by Fujirebio Diagnostics, detects amyloid plaques found in Alzheimer’s disease in adults 55 and older under investigation for cognitive disorders. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said, ”The availability of an invitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis. With the Lumipuls test, there is a new option that can typically be completed the same day and can give doctors the same information regarding amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.”

Currently the PET scan is used to visualize amyloid plaques to diagnose Alzheimer’s disease. The FDA says this test may eliminate the need for a PET scan, “…. a potentially costly and cumbersome option.”

As a physician, I appreciate the innovation and technical expertise required to develop a test that compares the ratio of Beta amyloid 1-42 and Beta amyloid 1-40. To do this, you first must perform a lumbar puncture or spinal tap to access cerebrospinal fluid which is the specimen used in the test.  This requires injecting an anesthetic into one’s back and spine and then inserting a needle to enter the spinal canal and drain the fluid. The needle is then removed, and the patient is required to stay immobile on their back for several hours to prevent a post spinal tap headache. Putting a needle into someone’s spine raises the risk of bleeding, post procedure leak and infection being introduced. Then, add in the cost of the procedure room and the post procedure observation costs and, suddenly, the non-invasive expensive PET scan seems reasonable.

I look forward to the day when a simple blood test based on drawing blood from your arm will be able to provide the information required to support a diagnosis of Alzheimer’s disease. I applaud the scientists and researchers who developed this product but the enthusiasm of the FDA in their statement is probably not shared by anyone who has had to undergo a spinal tap.

COVID-19 Ba2 Variant: My Medical Office

There has been an increase in patients infected and testing positive for COVID-19 in our area. For those who have been vaccinated, and received the boosters, if you get this new variant your symptoms will likely be similar to a cold and flu.   

Typically, most people will not get sick enough to require hospitalization or the intensive care unit. However, as with any serious illness, there are always exceptions.  Recently, we lost a patient who was vaccinated and had received the COVID-19 boosters. He was taking an immunosuppressive medication for a serious skin issue but still his loss is a horrible reminder of how fickle and deadly this illness can be.

At this time, we require our patients to be vaccinated and have received a booster. For those individuals over 50 years old, or immunosuppressed, who have taken the three shots, four or more months ago, we encourage you to take a fourth shot. Local CVS , Walgreens, Publix are administering the vaccines by walk in at some locations or by appointment. You can schedule an appointment online by accessing their websites or calling them. If you cannot use a computer, call my practice and we will try to set up your appointment for you if you are my patient.

We will continue to ask our list of questions as a screening process to determine if a  face-to-face office visit in needed. The questions come from the CDC, the University of Minnesota School of Medicine Department of Infectious Disease with M. Osterholm, MD as chairperson and from the cruise ship industry. With two staff persons over 65 years old, and two living in multigenerational households, we are entitled to know the risks to our staff in advance of a visit. We are taking these precautions for the safety of our staff and their loved ones.

PATIENTS WHO TEST POSITIVE:

1. Patients who test positive, with no symptoms, will need to quarantine at home for five (5) days per CDC guidelines. If they have no further symptoms after five days, they may resume their lives but wear a mask around others for an additional  five (5) days.
2. Those who test positive and develop symptoms should quarantine for at least five (5) days and until symptoms are gone for at least 24 hours. They should be wearing a mask around others for 10 days from the start of symptoms.
3. Those who test positive with symptoms and consider themselves high risk patients need to call the office. Sotravimab monoclonal antibodies are still being administered in Florida until the number of COVID cases caused by the Ba2 mutant is > 50% of all cases in the state. Baptist Health Boca Raton Regional Hospital still has an active monoclonal antibody infusion program. When Sotravimab is removed from use due to ineffectiveness, we can prescribe the oral medications Paxlovid ( if you are not taking any of the medications contraindicated with it) or the Merck pill Molnupiravir. If you are ill and have questions please just call us.

Testing locations are a real issue. The state sites at FAU runway and South County Civic Center have apparently been shut down. If you have questions about where to test call the office please.

We are actively seeing patients in person in the office Monday through Friday in the safest environment we can provide. Just because people wish to pretend that the pandemic is over doesn’t make it so! We recommend that when indoors, in public places, you continue to wear an N95 or KN95 mask if you do not know the others around you. With the Ba2 variant being so much more infectious and transmissible than previous variants you need to consider whether going to your gym, indoor dining and indoor clubs and theater are in your best interests.

Recent peer reviewed published studies show that those infected with even mild COVID not requiring hospitalization or treatment carry an increased risk of heart attack or stroke for at least the next 12 months. Controlled diabetics lose control in 40 % of the infections and those with pre-Diabetes on the borderline convert to full blown type II Diabetes in 40% of the infections even if mild.

At the current time, we are only accepting vaccinated individuals for our complimentary meet and greet sessions and as new patients. Patients who are not vaccinated and have at least one booster (unless they have a documented medical condition preventing vaccination) will not be retained when their annual membership is due for renewal. If you have any questions, suggestions or comments please call the office and stay safe!

New Blood Test Aids in Lung Cancer Screening

The US Preventive Screening Task Force updated its recommendations in 2021 for screening patients with  increased risk for lung cancer. Current guidelines call for providing a low radiation dose CT scan of the lungs annually for patients 50- 80 years old who have a smoking history of twenty pack years (calculated number of packages smoked per day x number of years smoking) and are still smoking or have quit within the last 15 years. These expanded criteria reduced the age to 50 from 55 and pack years from 30 to 20 years.  The recommendation is based on research showing that these criteria reduce deaths due to lung cancer by 20% as seen in the National Lung Screening Trial.

Despite this recommendation, many smokers who meet these criteria never get tested. Access to CT scans is one problem along with financial costs. For this reason, a group of researchers at MD Anderson Medical Center, led by Sam Hanash, MD, PhD, professor of clinical cancer prevention, developed a 4-panel blood test to screen for lung cancer. Their four test blood panel results were published in the Journal of Clinical Oncology on January 7, 2022.

The researchers then combined the results of the blood test with low dose CT scans of the chest and found that the accuracy of this method was far more sensitive than performing lung CT scans alone in the groups recommended for the procedure by the USPTF guidelines. Using the blood test and the low dose CT scan of the lungs, they found 9.2% more lung cancer cases for screening and reduced referrals for further evaluation by almost 14%

The blood test is still in the research phase and not available commercially for screening just yet. It will have to go through the full Food and Drug Administration (FDA) approval and evaluation process first.

The panel included tests for surfactant protein B, cancer antigen 125, CEA and cytokeratin-19 fragment. Currently the Ca125 test and CEA are available through commercial labs but there were no comments or recommendations from the authors or reviewers about whether clinicians should be using those two tests now with low dose lung CT scanning for screening.

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.