I Told My Daughter “Find Another Doctor!”

I have three adult daughters, all college graduates.  All are in long-term relationships with men,  children, dogs and careers.  I am “dad” and will always be dad.  I additionally happen to be a physician who cares for adult patients.  If they are ill or have a medical problem their first phone call is to my cell phone. If its not a phone call it’s a text message. I do not bring this up to give the impression that I am complaining about it. They are my children, I love them and always will.  Anything I can do to comfort or help them is always fine with me. 

I have stressed to them that they need to find a family physician or internist to handle their medical care  who is compassionate, available, caring, accessible and will advocate on their behalf. The older two are financially secure enough to find a concierge physician and I have encouraged that. My younger adult daughter lives about one hour south of my home and practice. She has a primary care physician under contract and on the panel of her Blue Cross Blue Shield PPO. That internist is an employee of the large medical health system that recently purchased my local community hospital. They have been purchasing doctors’ practices and putting in place hospital employed physicians with the speed and rapidity that a wildfire spreads in the dry California brush propelled by the Santa Anna winds.

My daughter called me this morning at 6:15 a.m. with a 102-degree fever, sudden onset of body aches, chills, sweats and “ a killer sore throat”   She is vaccinated against influenza but had a Flu Assay positive case in December 2022. She wondered if she could catch flu again.   

My toddler grandchildren attend daycare and pre-school and bring home febrile viral illnesses in abundance almost weekly.  Bacterial Streptococcal infections and Respiratory Syncytial Virus are epidemic locally along with flu and high risk of COVID, per the CDC and not our Florida Department of Public Health.  Her COVID home antigen test was negative so after taking some Tylenol and throat lozenges she called her family physician.  She was told to, “Go to Urgent Care.  We Don’t see sick people in the office.”

At the beginning of the Sars 2 Coronavirus pandemic most physicians were unvaccinated and unprotected against COVID-19 and we followed the advice of the CDC in referring patients to COVID-19  test sites for testing. We conducted phone calls with patients and telehealth visits. With five COVID vaccines, and an abundance of at-home quick tests available locally, most of us are now seeing sick patients in our offices again as long as we know their COVID test status. 

In my practice, pre-COVID and pre-Concierge Medicine, we always adjusted our schedules to include patients who had an acute febrile illness and were not in respiratory distress. I knew most of these illnesses were caused by viruses and required nothing more than fluids, Tylenol, cough syrup and tincture of time.  Most did have multiple medical and metabolic conditions as well which exacerbated with the infection. The purpose of the visit was to make sure the other conditions, exacerbated by the viral infection, didn’t exacerbate. To accommodate our sick patients, we started the day earlier, worked through lunch at times and stayed late if need be.

When my daughter called me from the urgent care center facing a 90-minute wait, she asked me what she should do.  I suggested she wait it out, see the physician and when she felt better find another doctor. I understand the reason for not bringing an acute COVID patient into the office. For everything else there is no excuse for only seeing “well” patients. Our job is to keep our patients healthy.  What value are we if we don’t see them when they are ill?

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Universal Flu Vaccine in Development

It’s been a more serious flu season than I have seen in the recent past. The flu season began much earlier than expected here in South Florida and was more severe even in young healthy individuals. We administered the quadrivalent flu shot to all our patients younger than 65 years old and the high dose vaccine to seniors far earlier in the season than in previous years due to the flu’s early arrival.

There has been a great deal of conjecture that in senior citizens the vaccines protection begins to decline at 90 days. With this in mind, and influenza still raging in the community, we are requesting information from the CDC on whether we should be administering a second flu shot to seniors in January 2023. The viral makeup of the flu shot is determined by research and surveillance done in Asia a year in advance of our flu season. There are 30 different subtypes and this year’s vaccine is directed against four of them. Ongoing surveillance is trying to determine the most likely strains to travel to the USA next season so they can prepare next year’s flu shots

Researchers at the University of Pennsylvania are trying to prevent the guessing game and develop a universal vaccine that protects against all 20 subtypes. They have developed a vaccine using the same mRNA technology used to develop the Pfizer and Moderna COVID vaccines. It was recently tested on ferrets and mice and was successful in preventing infection against all 20 of the possible variants. The results were published in Science as plans for human trials begin.

Dr. Ofer Levy, MD, PhD, director of the precision Vaccines Program at Boston’s Children’s Hospital, feels this new mRNA vaccine may be given to children to prime their T and B cells to react quickly and fight off a flu virus they are exposed to. The new vaccine will hopefully protect humans against any strain of vaccine.

The mRNA COVID-19 vaccines have been the source of much political backlash with “anti-vaccine advocates”, some politicians and their health care appointees using opposition to the vaccine to appeal to certain voter populations. Is it possible that a miraculous new scientific advance will again be met by inappropriate resistance?

Paxlovid for COVID is About to Get Very Expensive

Paxlovid is an antiviral medication in pill form developed by Pfizer pharmaceutical company to treat Sars2Coronavirus or COVID-19. It is designed to prevent severe disease from developing in high-risk patients. There is an alternative, but far less effective, product called molnupiravir (“Lagevrio”) by Merck. Both were developed with a funding package passed by Congress at the start of the COVID pandemic which produced the Pfizer and Moderna vaccines plus a host of monoclonal antibodies to be administered to high-risk patients as well. Those monoclonals can no longer be used because the COVID virus has found a new way to elude or resist them. There are no new monoclonal antibodies in production because the cost of development of each one is about $200 million dollars, and the Federal government has decided not to guarantee purchasing them.

The US government purchased 20 million dosages of Paxlovid from Pfizer for the bulk discount rate of $530 per treatment. Americans who became ill received it for no upfront cost. The funding for that program has run out. The Biden administration submitted a bill to the Senate in early November requesting funding for this project to continue and the Senate replied by voting to end the COVID-19 “Emergency” state. The drug Paxlovid is still being administered to adults infected with COVID and considered high-risk under an Emergency Utilization Authorization designation. Pfizer applied for full approval status to the FDA in June of 2022. So far, the FDA has not taken any action on this request. That process can take months to years.

It is expected that in January 2023 , when Federal funding runs out, pharmacies will be charging patients $2,300 for the five-day course of Paxlovid. It will not be covered by insurance. It will not be covered by Medicare Part D which by law can only cover products which have the full approval of the FDA.

The CEO of Pfizer pharmaceuticals has sent a note out to his shareholders and board anticipating huge profits in 2023 because Paxlovid will be sold at retail price. Public health officials are anticipating that the poor and seniors on fixed income will just not take the medication at that price.

As of last week, with the medication available, there were still almost 400 people in the U.S. dying daily from of COVID. Ninety percent of those deaths occurred in seniors 65 years or older who are already vaccinated.

I URGE YOU TO CONTACT YOUR CONGRESSIONAL REPRESENTATIVES and PROTEST THEIR LACK OF ACTION ON CONTINUING TO FUND THE DEVELOPMENT AND FUNDING FOR MEDICATIONS TO TREAT COVID.

The End of Monoclonal Antibody Treatment of COVID-19

National Public Radio (NPR) reviewed the end of the outpatient use of monoclonal antibodies to combat SARS 2 Coronavirus (COVID last week. These synthetically produced antibodies were infused into patients infected with COVID and were at high risk to develop severe disease requiring hospitalization or death. It cost about 200 million dollars to invent, develop and then use the drug in trials to gain FDA approval for human usage. Drug manufacturers were willing to take the risk developing these products because the US government financially guaranteed their purchase.

The antibodies were synthetic Y shaped molecules which bound to the viruses spike protein rendering it incapable of invading human cells and alerting our own immune system that the virus was present facilitating the virus’s destruction. Over time, the virus learned to mutate and evade a particular monoclonal antibody rendering it ineffective. When 30% or more of the new COVID variants in a region became able to resist the monoclonal antibody, the CDC and FDA withdrew the product. Drug manufacturers continued to develop new monoclonals due to the Federal guarantee of purchase.

Bebtelivimab was the last product that worked well against COVID and on Monday, November 21, 2022 it was withdrawn as well. The Federal government stopped guaranteeing purchase of these products so drug manufacturers have now discontinued their expensive development.

Let me explain how this impacts my patients locally. Baptist Health BOCA Raton Regional Hospital had a robust outpatient monoclonal antibody program. I phoned or text messaged Lisa, the nurse practitioner program director the patient name , demographics and reason for participation and she scheduled and her team administered the drug within the seven day window required. No one became ill from the infusions. No one had to stop their usual medications due to drug drug interactions. No one progressed to severe disease requiring hospitalization and no one died. I referred at least 100 high risk patients including myself in the last 2.5 years and now that weapon is gone. No one treated cleared the virus and then had a rebound recurrent period of sickness.

So we are now left with Paxlovid and Lagevrio oral pills. One has multiple drug interactions with so many of the common medications the high risk population takes daily for cardiac, renal , diabetic and mental health it requires cessation or a reduction in dosage. The other is just not that effective. Patients taking these drugs also at times clear the virus then several days later have a mild rebound of symptoms and are contagious for a few days more.

We head into winter with an aggressive flu bug, respiratory syncytial virus in epidemic proportions and one less successful weapon against COVID-19. As I reflect on this past Thanksgiving holiday, I am grateful for the BRRH monoclonal antibody team and everyone connected with its development. I wonder what our elected Congressional officials were thinking when they stopped funding the development of these effective and safe, but expensive, products?

Tidbits with Tropical Storm/Hurricane Nicole Rolling In

November tropical weather systems, either storms or hurricanes, are a rarity for south Floridians including this grizzled veteran who has spent 45 years in this area.

My office has been in the same location since 2003 but this is at least the third ownership group (landlord) we have worked with. The building and grounds are well maintained. For reasons unclear to me, when NOAA issued a hurricane warning for Boca Raton yesterday at 2 p.m., the building management insisted we vacate the building by 4 p.m. so they could prepare for the storm. I have gone through multiple hurricanes as a tenant in this building, so I know just how long it takes to prepare the building for a storm. There are no shutters to install. There is no impact glass in the office building. The storm was not projected to arrive until sometime the next day.

Nonetheless we rescheduled our last patients, sent some home early and sent our wonderful staff home at 3:45 to comply. The storm still has not fully arrived and, thankfully when it does, it will not bring hurricane force winds or tornados to the area. I now have all this extra time on my hands to catch up on reading journal articles. None of the topics truly warranted a full blog so I thought I would give you a quick smorgasbord synopsis.

1. A small study suggested that if you perform physical exercise 30-60 minutes prior to your flu shot or COVID-19 booster shot you get an enhanced immune system response.
2. Drinking 2-5 cups a day of coffee probably reduces cardiac arrhythmia, cardiac events and cerebrovascular events. Ground coffee with caffeine seems more effective than decaf and instant coffee.
3. The new guidelines for vaccinating adults against community acquired pneumonia are about as clear as mud. If you turned 65 and received Prevnar 13 followed a year later by Pneumovax 23 you are probably complete. If you only received Prevnar 13 please go to your pharmacy and get a PCV 20 vaccine to complete the series. There was much disagreement on giving boosters to seniors five years after completing the vaccine series. If this confuses you all well then welcome to the club.
4. Screening for colorectal cancer with an office based flexible sigmoidoscopy saves lives. Screening with a traditional colonoscopy is even better at getting a look at the left and right colon. Any controversy created by a recent colorectal cancer study needs to be ignored. If you are 45 you need a screening colonoscopy. If your study is normal, then you will be retested in 7-10 years. In the future, tests such as Cologuard and fecal immune globulin may permit other safe means of evaluation and screening in low-risk patients.
5. There are some new and safe treatments for acute migraine headaches and prevention of migraine headaches. These include injectable monoclonal antibodies and receptor site inhibitors. Avoiding triggers of these headaches. Tylenol, non-steroidal anti-inflammatory drugs and triptans remain the main options for treating migraines but new and better therapies are now available.
6. Bebtelovimab, the monoclonal antibody infused to prevent COVID-19 from progressing to severe disease requiring hospitalization may not cover some of the newer Omicron variants. It is currently still recommended by the CDC in all 50 states and is the product administered at our local hospital. That may change in the next few weeks.

Hope you enjoyed this poo-poo platter of medical knowledge. Call me if you have any questions.

Recent Findings on Vitamin D and What It All Means

JoAnn Manson, MD is a professor of medicine and epidemiology at the Harvard Medical School and Brigham and Women’s Hospital where she directed the Vitamin D and Omega 3 trial known as VITAL. She was interviewed about the pros and cons of vitamin D supplementation and what is science and fact.

The VITAL study is one of the first large, randomized studies to study vitamin D and its effect on health. Dr. Manson points out that previous observational studies which cannot prove cause and effect directly led to the belief that vitamin D is a panacea and cure all for many chronic conditions such as cancer, cardiovascular disease, diabetes, bone fractures, cognitive decline, and depression. She said that the randomized studies do not support this conclusion, but she feels vitamin D remains essential to good health. It is so essential that she says we need exceedingly small doses to achieve the health outcomes we desire.

Most of it can be obtained in your diet (read labels) and by exposing yourself to sunshine a few minutes each day. Therefore, the National Academy of Medicine and US Preventive Services Task Force and many other professional organizations have advised against widespread screening for vitamin D deficiency and blanket supplementation.

Her VITAL study did not show a reduction in major health issues with supplementation of vitamin D except in two instances. Vitamin D Supplementation resulted in a 22% reduction in autoimmune diseases (Rheumatoid Arthritis and Psoriasis) and a 17% in advanced metastatic cancers at doses of 400- 800 IUs daily. In the VITAL study they used 2000 IU daily. They believe the vitamin D reduced the inflammatory process and damage.

Some scientists have hypothesized that vitamin D supplementation can reduce the severity of COVID-19 infections. That randomized study called VIVID (vitamin D for Covid Trials) is near completion using 3000 IU per day. The data should be available in the next few weeks.

When asked what Dr. Manson suggests for her own clinical patients, she admitted she suggests ingesting one thousand – 2000 IU per day hopefully getting most of it in her diet. That dosage has been shown to be safe during the VITAL trial. She went on to note vitamin D is found in fresh fatty fish and wild mushrooms. Most cereals, dairy products and some beverages are fortified with vitamin D.

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.