April 2024 Newsletter

Welcome to the April 2024 Newsletter for

Santa Monica Primary Care

This month’s newsletter covers the COVID-19 Spring Booster answering the question “Do I Need One?” (spoiler alert: probably not). We also highlight the
expected seasonal lull in COVID cases we see in the Spring months before moving to the Change Healthcare hack and Blue Shield/Providence contract negotiations. By the end of the newsletter, readers will know the meaning of  “ACO”.

On Spring COVID Boosters: Do I Need One?

In late February, the CDC’s Advisory Committee on Immunization Practices (ACIP)  recommended that adults 65 years and older or those with an immunosuppressive condition receive an additional 2023-2024 COVID-19 vaccine dose. This recommendation is intended to “acknowledge” (CDC’s wording) the increased disease burden from COVID infection in this group and the efficacy of the vaccine. In their statement, the CDC references data that ‘show the importance of vaccination to protect those most at risk of severe outcomes of COVID-19. They also note that more than half of COVID-19 hospitalizations from October 2023 to December 2023 occurred amongst those over 65 years. The UK’s Advisory Committee recommended a Spring Booster for those over 75 years. So how do we proceed?

Let’s start with some perspective: the current booster is neither new nor bivalent. It contains only a single target, which last circulated in December of 2022. In discussion with patients, many have referred to the Spring 2024 Booster as a ‘new’ shot. The currently available vaccine targets the Omicron XBB.1.5 subvariant and was originally approved mid-September 2023. The Omicron KBB.1.5 variant itself emerged in late 2022 and rapidly spread in December of that year. So the currently available booster targets a variant that circulated in earnest about 16 months ago. To be fair, many of the subsequent variants share a relationship with KBB.1.5 making the booster still a reasonable choice.

Interestingly, in the UK the Spring 2024 booster is recommended for those aged 75 and older as well as those who may have immune compromise. The UK’s Joint Committee on Vaccination and Immunisation (JCVI) used a quantitative analysis to delineate when “reinforcing” immunization was likely to be most cost effective

A brief analysis from our own data at Santa Monica Primary Care was undertaken to look at the efficacy of Spring Boosters in preventing summer infections based on 2023 data. We had 31 COVID cases from May 1st of 2023 through August 31st. Of these we classified 16 as mild infections (congestion, runny nose, short duration illness) and 13 were moderate (fever/chills, prolonged illness). One was classified as severe (fever/chills, shortness of breath, nausea/vomiting and high heart rate) and one patient was hospitalized. Given that spring boosters are intended to prevent severe illness, we looked at the time between COVID infection and the last vaccine dose. When comparing those with mild illness to those with illness that was moderate, severe or required hospitalization there was essentially no difference in days from last vaccination.

Average Days from last vaccination

Mild Symptoms: = 391 days
Moderate/Severe Symptoms or Illness Requiring Hospitalization: 410 days

Now granted, this analysis is limited by small numbers, broad illness categories and an inability to meaningfully age adjust these results. Nevertheless, there is more information than has been provided by the CDC in terms of booster efficacy. The UK takes a different tack in terms of recommendations by looking at cost effectiveness in reducing hospitalization, ICU admission and death. It is for this reason that I’ve recommended in line with the UK’s advisory group that patient’s older than the age of 75 have the vaccine as well as those with underlying conditions that would predispose them to severe disease.

COVID-19: Spring Data from Santa Monica Primary Care

In the last two newsletters we have discussed the bimodal distribution of COVID cases that corresponds to two distinct seasonal peaks: one in summer and the second in November and December. Inversely, we have relative lulls in the Spring and Fall. So is that holding true for 2024 thus far? Most certainly it is. In 2024 we had 10 cases in January, 9 in February and only 2 in March. Thus far in April we have only had 1 case. This is a similar pattern which we have seen in prior years as well.

Total Cases of COVID-19 by Month: Santa Monica Primary Care

The Change Healthcare Cyber Attack: The Biggest Healthcare Story of 2024 (Which You Haven’t Heard About)

It would surprise me if any of our readers are familiar with Change Healthcare (a subsidiary of the UnitedHealthcare Group, yes the same company that provides insurance) cyberattack that occurred in late February and the massive impact it had on our healthcare infrastructure. There has been very little press on it (other than a Wall Street Journal here: https://www.wsj.com/articles/change-healthcare-hack-what-you-need-to-know-45efc28c) despite the fact that Change Healthcare accesses one third of all medical records in the US. Fortunately, our practice and patients were relatively spared although laboratory reporting and prescribing were impacted. Network outages began on February 21st for Change Healthcare which operates the largest clearinghouse of medical claims processing 15 billion claims a year.

In addition to Change Healthcare itself, the hack also caused disruptions in over 100 affiliate services giving some insight into how the centralization of medical records has led to significant vulnerability and downstream effects. We began to first notice difficulties with electronic prescriptions on February 21st and 22nd, particularly with Costco. Prescriptions needed to be rerouted and, in some cases, we returned to writing paper prescriptions for patients to bring into the pharmacy. We thereafter noted difficulty with our lab provider LabCorp which typically integrates directly into our Electronic Medical Record (EMR). As a workaround, I was able to access results directly through a physician portal and did so for the better part of a month. Patients, however, were not able to access their laboratory records for several weeks. Only this
week has our direct integration largely returned, but even still with some glitches.

Fortunately for our practice, Change Healthcare does not process our claims but other offices, clinics and hospitals were not as fortunate. The Department of Health and Human Services has had to step in and provide advance payments to keep funding available so these healthcare providers could continue to stay open. Change Healthcare completed a $7.8 billion merger (yes billion with a b) in 2022 with UnitedHealthcare. Antitrust experts have pointed to this data breach as an example of the risks of having one conglomerate at the center of healthcare services. While integrated medical records do provide a benefit to the coordination of patient care, they represent an attractive target for hackers.

The American Medical Association (AMA) recently released a survey of 1400 respondents, ranging from solo practitioners to groups of over 1000 physicians. Of these 80% reported lost revenue because of the cyberattack. A total of 55% of respondents used personal funds to cover practice expenses and 31% could not make payroll. This ransomware attack cost UnitedHealth $872 million in revenue during the first quarter of 2024 which presumably includes the $22 million paid to the hackers. Despite such, UnitedHealth exceeded earning expectations, reporting $99.8 billion (yes billion with a b) in the quarter, surpassing the $99.2 billion projected by analysts. Presented without additional comment that while healthcare providers and systems
could not make payroll, UnitedHealth’s valuation improved.

Santa Monica Primary Care: An Accountable Care Organization (ACO) / Open Payments

Healthcare can often be a lot of alphabet soup (HMO, PPO, IPA – not a beer – TQM, and CMS). Amongst those acronyms is ACO which stands for Accountable Care Organization, of which we are one. This is our second year participating in this type of organization, although we have now moved from participating at a regional level into a national level so many of our readers are likely familiar with the contours of such an organization. The goal of an ACO is to work as part of a larger group to improve the quality of healthcare provided. As a solo practitioner, this is an especially important process so that I might have some metrics against which I can evaluate the type of care we provide in the office.

Currently, our focus is on care transitions, such as following up with patients after Emergency Department visits as well as formal in-office visits after a hospitalization. The goal of these evaluations is to decrease admissions or re-admissions to the hospital. Hospital care accounts for about one third of all Medicare expenditures, totaling $1.4 trillion (yes, trillion with a t) so any opportunities to reduce these events could lead to significant cost savings. In some instances a hospital stay may be unavoidable but, in others, there may be steps that can be taken to reduce the chance of such occurring.

Another ACO effort is directed at having patient’s in for their Annual Wellness Examination (AWE). Currently our focus is on our Medicare-age patients but it is something we encourage of all our patients. Interestingly, a systematic review showed that routine health checks increased the number of new diagnoses and medications, but failed to reduce morbidity or mortality overall or from cardiovascular or cancer causes. On the other hand, in a study of over 8000 Medicare beneficiaries, AWEs were associated with a significant improvement in use of preventive care and a reduction in total healthcare costs compared with matched controls. The greatest cost  reductions were driven by decreases in hospital costs (but not hospital utilization implying that hospital stays were of lower severity) and subspecialist costs. Patients receiving and AWE were also more likely to experience improved glucose control and to receive other key preventive services, including breast and colorectal cancer screening.

Because data-sharing is a key component to ACO participation, it is important for patients to know that they can opt out of this program if they are not comfortable with their data being shared (securely). Patients who do not wish to participate can do so by calling 1-800-MEDICARE (1-800-633-4227). A similar notice is posted in our office, if you need additional information.

Lastly, you may have noticed a new link on DrBretsky.com called “Open Payments”
(https://openpaymentsdata.cms.gov/physician/70669). This is a Medicare program which seeks to highlight financial relationships that physicians have with private industry (pharmaceutical and device makers). The magnitude of our financial payments ($54.28) is far below the average US physician ($4195.00). Medicare has sought to make these data more accessible to patients, an effort with which I am in complete agreement.

Blue Shield and Providence Negotiations Reach An Agreemen

In some good news, Providence has ‘rescinded’ its contract termination with Blue Shield of California, having reached a tentative agreement this past Friday the 26th. Before the agreement, over 110,000 members would have been ‘out of network’ (i.e. not covered) for visits to Providence physicians, hospitals, clinics or Emergency Departments. Providence had been negotiating for a rate increase from Blue Shield. Normally these talks go on behind closed doors, but the contentious nature of them spilled over into the press (link:https://www.fiercehealthcare.com/payers/contract-negotiations-between-providence-blue-shield- california-go-publicly-south).

It is important for my patients to know that although I have staff and admission privileges at Providence Saint John’s, I am not an employee of the Providence Health System and, as such, have an independent contract with Blue Shield. So there would have been no effect whatsoever on Blue Shield patients coming to the office as we remain in network with the insurer

This is not the first instance in which a major health network’s relationship with Blue Shield has gone crossways. For over one year beginning in 2011 and extending until September of 2012, UCLA did not have a contract with Blue Shield, forcing patients to seek care elsewhere or pay upfront for their care. This was especially burdensome for our patients who had subspecialty care (such as organ transplant) that is unique to an academic medical center like UCLA. In these instances, I was in the position of trying to manage their care and/or finding new subspecialists with whom they could establish a relationship. UCLA and Blue Shield had talk breakdowns in 2006 and 2008 as well.

Both Blue Shield and Providence are both non-profit corporations. As neither are publicly traded, there is no requirement that either file compensation disclosures so the financial implications behind these disputes are impossible to quantify. But, it is safe to say that patients do not benefit from them.

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February 2024 Newsletter

Welcome to the February 2024 Newsletter for

Santa Monica Primary Care

This month’s newsletter arrives just under the end of the month wire, but we will use that to our advantage as we dive into the latest COVID prevalence estimates from Los Angeles County’s data as well as those from our own practice. The seasonal patterns to COVID now seem to be better defined based on information collated from 2022 and 2023 and can inform our activities moving forward. But before COVID, we will cover Lp(a), the ‘horrible cholesterol’ along with new clinical trial opportunities in its treatment. We conclude with the slow demise of the CDC’s 5 day COVID isolation guidelines.

Lp(a): The “Horrible” Cholesterol

Some of you, particularly our Medicare patients, may have noticed over the past year or so that Lp(a) has been added to your annual cholesterol panel (Note: I have not generally included this measure for commercial PPO patients as insurance coverage of the test has been spotty but it makes it no less important). Lp(a) is a subtype of LDL cholesterol (‘bad’ cholesterol) and higher concentrations of Lp(a) have a strong association with the future development of coronary artery disease. Interestingly, most racial/ethnic groups tend to have low Lp(a) levels with the notable exception of African Americans, Africans and individuals from India amongst whom Lp(a) levels
trend higher

Statistical footnote here: for most ethnic groups, Lp(a) levels show a “right skewed” distribution towards lower values as represented in the first Figure. Among African Americans, Africans and individuals from India, Lp(a) values show a more “normal” or Gaussian distribution but centered at a higher mean value.

Both the European Society of Cardiology and the American Heart Association recommend that Lp(a) be measured once in the lifetime, in particular to identify those with very high levels (>430 nmol/L with an upper limit of population normal being 75 nmol/L using LabCorp’s reference values). The American Heart Association notes that Lp(a) levels over 125 nmol/L function as a ‘risk enhancing’ factor for cardiovascular disease. The molar concentration provided by LabCorp (amongst others but not all labs) is a better predictor of cardiovascular disease events than are mass units
(mg/dL).

The once a lifetime measurement may be appropriate as Lp(a) levels stay fairly steady although there are age-related increases related to sex steroid deficiency, inflammation and decline in renal function. And, at least currently, there is no intervention that can specifically target Lp(a) levels. Instead we emphasize more traditional cardiovascular risk reduction techniques including diet/exercise, statins, Zetia (Ezetimibe) and the more recently approved injectable PCSK9 inhibitors. Statins raise Lp(a), Zetia has no effect and PCSK9 inhibitors reduce Lp(a) and likely
represent the current best treatment for high risk patients with elevated Lp(a)

Through our Cardiology colleagues, we do now have the ability to refer qualified patients to one of three clinical trials opening this Spring testing Lepodisiran, which is a once yearly injectable agent that lowers Lp(a) levels by 90%. It is not anticipated that this agent will reach the market for another 3 years, and these sorts of outcome trials are critical in understanding the relationship between Lp(a), familial hypercholesterolemia and risk of cardiovascular and cerebrovascular disease.

COVID-19: 2022 and 2023 Data from Santa Monica Primary Care

In the last two newsletters we have discussed the bimodal distribution of COVID cases that corresponds to two distinct seasonal peaks: one in summer and the second in November and December (Figure below). Inversely, we have relative lulls in the Spring and Fall; the latter interesting because the return to school has always been implicated as a primary driver of respiratory viruses. This does not seem to be the case in our practice (which admittedly has very few school aged patients)

Total Cases of COVID-19 by Month: Santa Monica Primary Care

So how do we estimate the impact of COVID infection now that we have a couple of years of data? From the graph above it is clear that 2023 was a less impactful year than 2022 in terms of overall caseload with 116 total infections (19% of the practice) reported in 2022 as compared to 239 (40% of the practice) in 2022. Converting this into more conventional epidemiologic units, our 2023 rate corresponds to 39833 cases per 100,000 population. For comparison, infection rates for other communicable diseases are listed below:

COVID-19: A Seasonal Illness with Two Peaks - 2022 and 2023 Data from Los Angeles County

Turning now to incidence data provided by the Los Angeles County Health Department, we see a similar pattern with a May-August peak followed by a second November/December peak. Note in the Figures below that I removed the first weeks of January as there was a massive peak in January 2022 that renders the rest of the graph unreadable. Similar to what was seen in our practice, infection rates for the County were higher in 2022 than in 2023, although this may correspond to underreporting and an increase in home testing.

Smoothed Daily Incidence Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles County, California for 2022 (Blue) and 2023 (Red)

Given that Los Angeles County data relies on passive surveillance from laboratory testing and that they no longer accept home testing as a valid reporting tool, an estimate of prevalence rates are a better measure by which to estimate the county-wide impact of COVID-19 infections. The two seasonal peaks of COVID are even more clear when looking at prevalence data (again with 2022 having significantly higher rates than 2023).

Smoothed Daily Prevalnce Rate (Active Cases per 100 population) of SARS-CoV2: Los Angeles County, California for 2020 (Blue), 2021(Red), 2022(Yellow),and 2023(Green)

The cumulative prevalence of COVID-19 in 2023 for the County is actually higher than that of our practice in Santa Monica – an estimated 24% of County residents had a COVID infection in 2023 based on these data (19% for Santa Monica Primary Care).

COVID-19 Mortality Data: Los Angeles County

One of the unqualified wins regarding COVID infection is the significant improvement in mortality rates that we have seen throughout the pandemic. This is, no doubt, a conjoint effect of vaccination, early outpatient treatment with antivirals and improvement in protocols and supportive care for those hospitalized. The mortality rate from COVID peaked in the first half of January 2021 in Los Angeles County at 2.80 daily deaths per 100,00 population. The most recent rate is 0.007 daily deaths per 100,000 population (Figure below). That’s a 4000 fold improvement.

Log Transformed and Smothed Daily Mortality Rate (Per 100,000 population) of SARS-CoV2: Los Angeles County,

Unsurprisingly, mortality rates correlate strongly with case rates, reinforcing the adage “more cases, more deaths.” However, the trend lines are markedly different with greater separation between the two becoming apparent in mid-2022. While a number of factors have contributed to this observed improvement, it is important to note that Paxlovid came to market in December of 2021. Its more widespread use, particularly amongst those at highest risk, may be part of what is driving this effect (Figure below with cases in red and mortality in blue).

Smoothed Daily Mortality (Blue) and Incidence (Red) Rates (per 100,000 population) of SARS-CoV2: Los Angeles County,

No More 5 Day Isolation: New California and Upcoming CDC Guidelines

To very little fanfare, the CDC began discussions to loosen its COVID isolation
recommendations such that those who test positive for coronavirus no longer need to routinely stay home from work and school. This, ostensibly, is to align it with guidance for RSV, Influenza and other respiratory pathogens to reinforce our “showing up sick to work” approach. Interestingly, a recent study showed that 89% of Americans still show up to work when they feel unwell, with many (45%) doing so because they don’t want to use up sick days. Compounding the issue, two-thirds express “stress, guilt, fear or anxiety” when calling in sick and 80% of managers admit to being skeptical of such requests (link:
(link: https://www.bamboohr.com/resources/guides/sick-guilt-2023).

To summarize the absolute bind the CDC has gotten itself into, Dr. Osterholm, an Infectious Disease expert from the University of Minnesota, offers the following
spell-binding conclusion:

“Public health has to be realistic. In making recommendations to the public today,
we have to try to get the most out of what people are willing to do. […] You can be
absolutely right in the science and yet accomplish nothing because no one will
listen to you.”

[“Right in the science” is probably the most perplexing phrase in this very curious statement. But that can be a topic for another newsletter.]

Under the CDC’s new approach, people who test positive for COVID should now use clinical symptoms to determine when to end isolation – namely being fever free for 24 hours off of medication (fever is no longer a commonly reported manifestation of acute COVID infection but is one that can be quantified so often kept in guidelines) and having mild and improving symptoms. Fever, loss of taste/smell and difficulty breathing were more hallmarks of SARS-CoV-2 infection in an immunologically naive population. Now with widespread blended immunity (from community acquired infection and vaccination) we see mostly runny nose, cough and sore throat. For those living in California, any federal recommendations have little impact because on January 30th, the state already loosened isolation recommendations
(link: https://covid19.ca.gov/isolation/#guidelines)

Rather than being disingenuous about COVID isolation guidelines, the CDC and the California DHS would be more consistent by abandoning testing entirely. If a positive test won’t change your actions, then why test in the first place? Of course here I am being contrarian to illustrate a point, because there is inherent value in knowing what is making you ill and applying an appropriate treatment, particularly at high risk of severe disease. But, beyond such, the antigen test provides no formal public health benefit under current California guidelines.

However, the home rapid antigen test has a dual value insofar as it identifies infection as well as infectiousness. As long as a positive line is visible, one is still capable of spreading the infection and it takes little mental effort to ask the question – “if a coworker has a positive test and comes to a large meeting in a poorly ventilated conference room, do I really want to be in that meeting?”

Isolation, defined as the public health practice used to protect the public by preventing exposure to those that have a contagious disease, separates those who are sick and contagious from those who are not. It is distinct from quarantine which restricts the movement of those who have been exposed to the disease but may not be contagious. With the widespread availability of rapid antigen tests, there is little need for quarantine as we can identify who is infectious, but isolation still has value when we consider COVID infection which occurred amongst 24% of County residents in 2023.

My general advice follows a University of Chicago study looking at healthcare workers returning to work in early 2022 after acute COVID infection. In that study 58% of healthcare workers returning to work on Day #5 were still positive, but only 26% were positive on Days #8 and #9. This fits with out general experience here where I call Day #5 a ‘coin flip’ and recommend it as the first day of retesting. Most antigen testing converts to negative between Days #7 and #10 with 90-95% of patients testing negative by Day #10. Some small proportion do, however, continue to test positive and the longest sequence of positive testing I have seen was 16 days! As long as there is a positive rapid antigen test, one still runs the risk of spreading the illness. The faintness of the line is an additional barometer of relative infectiousness, so the darker the

line the more likely one is to spread the infection. Spread is influenced by viral load, proximity and duration of exposure so all of those can be taken into account as well in determining the relative risk to others of leaving isolation.

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January 2024 Newsletter

Welcome to the January 2024 Newsletter for

Santa Monica Primary Care

We start the New Year with a recap of the biggest medical stories of 2023. The
top story will come as no surprise – Ozempic. We will cover its development,
mechanism of action and evidence for use both in diabetes and obesity. We
will also review the new Pneumonia vaccine, Prevnar-20, and try to
understand why it costs nearly $300 a dose. Did we see an expected COVID
surge in December? Oh yes we did – we will cover this as well with at least
one colorful graph.

The Biggest Medical Story of 2023 - Ozempic and Its Cousins

2023 was definitely the year of Ozempic (Semaglutide) and its counterparts – Wegovy, Rybelsus and Mounjaro (Tirzepatide). Obesity has become a global epidemic with its worldwide prevalence tripling since 1975. It has a strong association with cardiovascular disease, diabetes, several cancers and kidney disease. A body mass index exceeding 30 kg/m2 has been associated with an increase in annual healthcare costs of over 35%. Given the difficulty that patients have in regaining weight after achieving weight-loss goals, these newer medications have shown promise in both weight loss and maintenance.

COVID-19: A Seasonally Expected Rise in December

Unsurprisingly, December saw a significant uptick in COVID cases in our practice with a total of19 new cases reported; two of these led to hospitalization. It was the highest monthly total we had experienced in all of 2023, more than the 13 cases in August seen during our late summer surge (Figure 1 below). Many of these were repeat (second or third) infections.

Total COVID-19 Cases (Blue) and Repeat infections (Red) by Month in 2023: Santa Monica Primary Care.

A rise in COVID infection rates was also seen at the County level although was less pronounced than the increase we saw in our practice. Incidence rates doubled from 3.8 new daily cases per 100,000 population in the last week of November to 7.4 new daily cases per 100,000 the last week of December (Figure 2 below). This increase remained below the August peak however of 8.3 new daily cases per 100,000.

Smoothed Daily incident Case Rate (Per 100, 000 population) of SARS-CoV2: Los Angeles Country, California

Historically a post-Thanksgiving increase in COVID cases has been the norm, most particularly in 2020 (blue) and 2021 (red) when rates skyrocketed. This phenomenon was seen to a lesser degree in 2022 (yellow) where an uptick in cases occurred but peaked the week of December 8th before dropping down; prior years continued to spike upwards into January. Rates in 2023 are quite low in comparison to earlier years (green) to such a degree that the doubling in cases from November to December barely registers on the Year over Year graph (Figure 3 below).

Smoothed Daily incident Case Rate (Per 100, 000 population) of SARS-CoV2: Los Angeles Country, California for 2020 (blue), 2021 (Red), 2022 (Yellow) and 2023(Green)

Pneumonia and the New Prevnar-20 Vaccine

As we covered in previous newsletters, 2023 has been a boggling array of vaccines including (but not limited to) the new COVID booster, RSV, seasonal influenza, and a new Pneumonia vaccine. The landscape has become so crowded that upon logging onto the CDC website, there is a highlighted section at the very top that asks “Recommendations too complex? We agree!” That doesn’t exactly strike a tone of confidence. But, in truth, the Pneumonia vaccination process can be greatly simplified for most adults to Prevnar-20, and is to be given only once at the age of 65 or older.

But to backtrack, pneumonia or pneumococcal infections are a significant cause of morbidity and mortality among adults, particularly those over the age of 65. It is for this reason that pneumococcal vaccination is recommended for all adults 65 and older. But which vaccine do you give and when? Currently there are 5 difference pneumococcal vaccines available: PCV10 (Sunflorix), PCV13 (Prevnar 13), PCV15 (Vaxneuvance which is a great name), PCV 20 (Prevnar 20, lacks originality) and PPSV23 (Pneumovax 23 or Pnu-Immune).

Fortunately, and to greatly simplify the process, the CDC’s Prevention Advisory Committee of Immunization Practices (ACIP) now just recommends a single administration of PCV20 for all patients with an indication for pneumococcal vaccination. Patients can also have PVC15 followed by PPSV23 one year later, but that seems overly complex when one vaccination will do.

But what about revaccination? This is where topic experts and the CDC part ways. Whereas the CDC ACIP does not recommend revaccination at all, topic experts recommend revaccination for those receiving the PPSV23 (Pneumovax) every 5 to 10 years. There are no data as yet to support revaccination with PVC20 or PVC15 so the only revaccination recommendation is for PPSV23.

So this, then, leads us to the nearly $300 cost for PVC20 which is a ‘one and done’ vaccination protocol. This compares somewhat favorably to the other option wherein PVC15 costs $95 and is followed in one year by PPSV23 ($140) and the PPSV23 is repeated again every 5 to 10 years ($140 each time). Suddenly, $300 doesn’t seem like such a bad deal.

Another Big Medical Story of 2023: The Mediterranean Diet

Although Ozempic dominated the headlines of 2023, a study by Delgado-Lista et al. conducted a large, randomized controlled clinical trial to assess the efficacy of a Mediterranean diet in the secondary prevention of cardiovascular events. Secondary prevention is not a concept we have covered in previous newsletters but is one commonly employed among patients who have already had a health event, such as heart attack, stroke, or cancer. It is distinct from primary prevention which seeks to avoid an outcome entirely. But with secondary prevention, we are asking, “is there anything that can be done to prevent such from happening again?”

The Mediterranean diet – characterized by an emphasis on fruits, vegetables, legumes and nuts with white meat and fish as the primary sources of protein and olive oil as a primary source of fat – has been shown to be more effective in primary prevention of cardiovascular disease. But until the Delgado-Lista study, there was no evidence that the Mediterranean diet could work in prevention of a subsequent event.

A total of 1,002 patients with established heart disease were studied for 7 years randomized to a low fat diet or a Mediterranean-diet. One perk of the study is that participants received a Liter of extra-virgin olive oil at no charge, and the low fat group received a bag of healthy complex carbohydrate rich food also at no charge. By the end of 7 years, a total of 87 events occurred in the Mediterranean-diet group (17.3% of the group) and 111 in the low-fat-diet group (22.2%) which represented at 25% risk reduction. This is a resource for more detailed on a
Mediterranean diet: https://www.health.harvard.edu/blog/a-practical-guide-to-the-mediterranean-diet-201903211619
4

Paxlovid: Questions Abound and Rebound

We have covered Paxlovid for the treatment of acute COVID infection in prior newsletters. It has been well established that among high risk and unvaccinated individuals that Paxlovid reduces viral load and progression to severe disease. As yet, there are not randomized clinical trial data to support its use amongst vaccinated individuals although a September 2022 CDC study showed a 51% lower hospitalization rate within 30 days of infection amongst those who had received a primary mRNA vaccine series and at least one booster.

An additional reason I have been a proponent of Paxlovid was a 30% reduction in risk of Long COVID – which are symptoms that persist after the acute phase of infection – suggested by a VA study. Vaccination reduces but does not eliminate the risk of Long COVID. Higher viral load and/or prolonged viral shedding appear to act as risk factors for increased Long COVID risk.

However, an early January 2024 paper from UCSF suggests that Paxlovid administration did not modify the risk of Long COVID symptoms among vaccinated individuals experiencing their first infection (link: https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.29333). An online cohort study of over 100,000 individuals identified 4684 eligible individuals of whom 21% were treated with Paxlovid and 79% went untreated. About 35% of eligible individuals responded to symptom survey requests and there was no difference in reported Long COVID symptoms between
treated and untreated. About 15% of all those surveyed did report Long COVID symptoms extending past 90 days of infection with the most common symptoms being fatigue, shortness of breath, confusion, headache and alterations in sense of taste and smell. Rates were 16.1% among those treated and 14.0% among those untreated.

Although there are limitations to this study (e.g. 35% response rate, online assessment of symptoms, those treated more often older, male, and with chronic conditions), one interesting aspect of the study was the 15% Long COVID rate among vaccinated patients. The UK Ofice for National Statistics has estimated that 22.1% of patients continue to experience post-acute COVID symptoms 5 weeks after infection and 9.9% at 12 weeks which are worrying numbers for patients and medical professionals alike. The UCSF group also reported a 19.7% Paxlovid rebound positivity rate (i.e. return of both symptoms and a positive test). This rate is remarkably close to the rebound frequency we have seen here at Santa Monica Primary Care; of 134 patients we have treated with Paxlovid, 24 (17.9%) reported a clinical rebound, typically about two weeks after treatment.

Follow us on social media

Dr. Bretsky is active on Twitter (or X) @santa_care as well as Facebook
(https://www.facebook.com/santamonicaprimarycare) and Instagram
(@santa_monica_primary_care).

Follow our blog posts on: www.drbretsky.com/blog

Archived issues of our newsletter can be found at: https://drbretsky.com/newsletters/

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June 2023 Newsletter

Welcome to the June 2023 Newsletter for

Santa Monica Primary Care.

In this issue we will cover the upcoming vaccination season.

Fall 2023 COVID Booster (Bivalent 2.0)

With very little fanfare, Los Angeles County’s COVID-19 Emergency ended on March 31st – with the major impact being the closure of County-run testing facilities. But beyond that, not much
changes. An indoor masking mandate was lifted 13 months ago and face covering recommendations for the general public ended two months ago. In healthcare settings, masks continue to be required for healthcare workers providing direct patient care or working in patient care cares. This, however, is a Los Angeles County only requirement as at other healthcare settings in California, no masks are required whatsoever

It was certainly reasonable for the County to close testing sites as weekly testing rates are the lowest they have been (at 148 tests per 100,000 population) since May of 2020 (Figure below). At their maximum, 2745 tests per 100,000 were performed the week ending 1/11/2022.

Smoothed SARS-CoV2 Daily Testing Rate (per 100.000 population): Los Angeles Country

Free testing remains available at LA County Public Health clinics

Seasonal COVID Incidence and Prevalence

The Los Angeles Times offered this outstanding turn of phrase when reflecting on the lifting ofthe COVID Emergency:

“But just as March 2020 is now indelibly etched in our collective consciousness
— a watershed moment when daily life screeched to a — March 2023 may be
remembered as when COVID-19 officially went from top of mind to back of mind.”

From my perspective, I was concerned that we would experience another January surge as we had in 2021 and 2022 but that never materialized (Figure below)

Smoothed Daily Incident Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020(Blue),

We are now in our current and expected Spring lull in cases, seen in all years of the pandemic -although 2020 should be interpreted cautiously given that we were under shelter-in-place orders.

Current prevalence rates (active cases per 100 population) are the lowest they have been at less than 0.1% – so fewer than 1 case per 1000 individuals – since October of 2022 (Figure below).

Estimated Prevalence Rate (per 100 individuals) of SARS-CoV2: Los Angeles Country, California

Seasonal Flu Shot for 2023/2024

One common mantra that has been repeated throughout the pandemic is that of “more cases, more hospitalizations, more deaths.” This is a pattern currently holding in the inverse with death rates also now at historic lows as case rates are at seasonal lows as well. However, in 2023 with early detection from accurate home testing and widespread availability of Paxlovid, mortality rates now stand at 0.02 deaths per day per 100,000 population (equivalent to 2 deaths per day in LA County, with 10 million people). The last time mortality was this low?

The week of March 17th, 2020.

The figure below is a log transformed graph which shows more clearly just how much mortality rates have dropped

Smoothed Daily Mortality Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California

RSV Vaccination for those over 65

Similar to the County’s experience, we too have seen a massive decline in cases since
November 2021 when we had 29 new cases (and 5 repeat infections). Thus far in April we have had only 3 cases (2 of which were repeat infections)

Total COVID-19 Cases and Repeat Infections by Month in 2022/2023: Santa Monica Primary Care

Timing of vaccinations

This past week, the FDA amended the terms of its Emergency Use Authorization (EUA) for the Moderna and Pfizer bivalent boosters, permitting individuals 65 and older and those with underlying immunocompromise to have an additional dose (providing that it has been 4 months from the last).

In conversations with patients about this new recommendation, I’ve found myself clarifying a few aspects of the FDA’s communication:

 

  1. This is not a “new” booster, it is a new recommendation. The booster is identical to that originally authorized at the end of August of 2022.
  2. The Bivalent booster contains mRNA components from the original strain of
    SARS-CoV-2 as well as from the BA.4/BA.5 omicron variants. The BA.4 and BA.5 variants have not circulated since the Fall of 2022
  3. This recommendation brings the US more in line with the UK and Canada. In the UK, they have referred to the second bivalent booster as a ‘top off’ for vulnerable populations.
  4. Fall 2022 bivalent booster uptake was far higher in the UK than the US. In the UK, 65% of those 50 and over received the bivalent booster, and >80% of those over 70 received the booster. In the US, only 42% of the population over 65 had a booster dose. So some of the rationale for recommending a second bivalent booster may, in fact, be to encourage people simply to get their first.
  5. The general expectation is that there will be a new booster available in the Fall of 2023 which would be updated for circulating variant(s) at that time and also coincide in timing with an annual flu shot
  6. For now there is little compelling reason if one is young and healthy to have another bivalent booster. Individuals that are older (65 and above) with comorbidities or any immunocompromise could think about one at this point, with the context that cases and deaths are currently at historic lows.

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December 2023 Newsletter

Welcome to the December 2023 Newsletter for

Santa Monica Primary Care.

In this issue, we will cover end-of-year tips and some of the things we see in a
GP practice around the Holidays. Winter is the season for respiratory viruses –
specifically Influenza, COVID and RSV. We will cover these as well with lots of
colorful graphs and even maps!

December: Not The Time to Schedule a Colonoscopy (or much else!)

Gastroenterologists of any subspecialty are busiest it seems during December. My best guess is that this phenomenon is due to patients hurrying to have screening colonoscopies before their insurance premiums reset in January. Interestingly, data from anesthesia practices (Piersa et al. 2021. Anesthesiology 135:804-812) show a 20% increase in daily caseloads during the month of December. In three years of data analysis (2017-2019), up to 24.5% more colonoscopies were performed per day in December than January through November

 

Gastroenterologists are not the only subspeciality that experiences this end of year rush and it does raise legitimate concerns about the availability of specialists for time sensitive and urgent cases – and not only at the end of the calendar year. It is part of a larger overall trend that I have observed with subspeciality wait times sometimes becoming unacceptably lengthy. Average wait times nationwide to see a Dermatologist average over 30 days, for Orthopedics over 2 weeks (55 days in San Diego!), and Cardiology 26 days (link: https://www.medicaleconomics.com/view/appointment-wait-times-drop-for-family-physicians-indi cating-shift-in-care).

One potential ‘fix’ to this phenomenon would be to have health insurance coverage run from July 1st until June 31st rather than from January 1st to December 31st. In this way, patients who have met their deductible would be scheduling procedures such as screening colonoscopies during the middle of the summer when sick visit rates are lower. The end of the calendar year is
always a busy time for medical practices as illnesses increase, hospitalizations increase and patients are left trying to fit in elective procedures.

COVID-19: Historically Low Rates Continue in Los Angeles (and Santa Monica)

While the Los Angeles Times recently raised concerns about a ‘tripledemic’ of COVID, flu and RSV (link: https://www.latimes.com/california/story/2023-12-05/covid-flu-rsv-on-the-rise-in-california-is-anot her-tripledemic-coming) objective data from Los Angeles County suggests that one part of that trio is not increasing. In fact, current COVID-19 rates are 65% lower than they were in the late summer and 80% lower than they were at the beginning of the year (Figure 1 below).

Smoothed Daily Incident Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California

One critique of these low rates is that most people are testing at home (if at all) so the numbers reported by the county really are not representative of the true case rate. However, using prevalence estimates (prevalence defined as the percentage of the population with an active COVID infection, calculated as a function of observed case rates, testing rates and positivity rates), we see a similar pattern with low current prevalence rates as well (Figure 2 below).

Estemated Prevalence Rate (per 100 individuals) of SARS-CoV2: Los Angeles Country, California

The most recent County-wide prevalence estimate for the week ending 11/28/2023 is 0.3% or, in other words, 3 discernable (not necessarily infectious) COVID cases per 1000 individuals.

Here at Santa Monica Primary Care, we are seeing far fewer cases than we did a year ago. Whereas in November 2022, we had 29 cases in the practice, this November we had only 6 (Figure 3 below). This extends a year-long trend wherein we have consistently seen, with the exception of September, fewer cases each month of 2023 as compared to 2022.

Total Cases of COVID-19 by Month: Santa Monica Primery Care

This may be a function of widespread blended immunity from vaccination and
community-acquired infection. General seasonal trends remain wherein we experience a large Winter (December/January) surge followed by a quiet Spring and then a mid to late summer smaller surge in cases. Historically we have seen an uptick in COVID cases after the Thanksgiving and December Holidays, so I think we can reasonably expect that this will again occur although it has not, as yet, become obvious.

Influenza

The second virus of the aforementioned ‘tripledemic’, influenza, is increasing as would be expected for this time of year. Currently, 6.8% of viral cultures sent to clinical laboratories have been positive for influenza, and 4% of outpatient visits nationally have been for influenza or influenza-like respiratory illnesses. The Southeast and South-Central areas of the country are reporting the highest levels of activity (Figure 4 below).

Of the strains isolated, 74% were H1N1 and 26% were H3N2. For those that follow my monthly newsletter, we covered the selection process for seasonal influenza vaccine components in the October newsletter. Indeed, H1N1 as well as H3N2 subtypes are in the 2023/2024 formulation. So it is reassuring to see that the vaccine matches the predominant circulating subtypes. This bodes well for this season’s shot to be effective against infection entirely and more certainly in the reduction of severe disease.

RSV: Vaccination and National Trends of the Infection

Interestingly, most of the vaccination questions I have had this season have been about the RSV vaccine. To recap, there are two RSV vaccines approved for use in the United States for those 60 and older: RSVPreF3 (GSK / Arexvy) and RSVpreF (Pfizer / Abrysvo). In the UK only Arexvy has been approved for use for those over the age of 65 as the data presented by GSK are far clearer and a demonstrated 82% efficacy for Arevxy as compared to 67% for Abrysvo. Both vaccines work by stimulating an immune response against the Fusion protein (the F of the PreF and F3) that allows the virus to fuse to a host cell (yours!) and release genomic RNA into it. Blocking this protein prevents the virus from infecting cells. The vaccines themselves are expected to last over several seasons, although the observed efficacy of each declines over
time. For example, Arevxy dropped from 82% to 56% from Season 1 to Season 2.

Seasonal trends are not difficult to discern in this CDC graph beginning December 2021 and extending through in the last week of November 2023 (Figure 5 below).

Antigen Detections and PCR Detections: RVS, United States December 2021 through November 2023

RSV seasonality is typically November through March in the United States although in 2022 cases began an upward trend in September, before peaking in mid-November. Cases began trending upwards later in 2023 with the first rise occurring in October. Cases are far lower now than they were this time last year.

Paxlovid Rebound

I have been a proponent of Paxlovid administration for acute COVID since it first came on the market. There are a couple of reasons for this. Firstly, Pfizer trials have shown that Paxlovid administration within 5 days of symptoms reduced hospitalization and death by 86% amongst unvaccinated patients. Secondly, a September 2022 CDC study showed a 51% lower hospitalization rate within 30 days of infection amongst those who had received a primary mRNA vaccine series and at least one booster. Lastly, a VA study showed a nearly 30% risk reduction in long COVID for those patients who received Paxlovid as compared to those that did not (link: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2802878).

However, it had long been my experience that COVID rebound associated with Paxlovid treatment (defined as a recurrence of symptoms and receiving a positive test after having the disease and then testing negative) was far higher than initial manufacturer estimates. Whereas Pfizer estimated a rebound rate of 2.3% with Paxlovid, a recent study published November 13th, (link: https://www.acpjournals.org/doi/10.7326/M23-1756) found that 20.8% of patients treated with Paxlovid experienced a rebound as compared to 1.8% of those receiving placebo.

The 20.8% is remarkably close to the rebound frequency we have seen here at Santa Monica Primary Care. Of 121 patients we have treated with Paxlovid, 24 (19.8%) reported a clinical rebound, typically about two weeks after treatment, Interestingly, rebound phenomenon appeared to cluster in our experience (Figure 6 below).

Paxlovid Rebound  Percent (%) by Month: Santa Monica Perimary Care,  2022-2023

The highest rates of rebound were seen in the Spring and Summer of 2022. During this time BA.1, BA.1.1 and BA.2 followed by the KBB sublineages of Omicron emerged. As compared to its Delta predecessor, Omicron multiplied 70 times faster in lung tissue but led to less severe disease. Perhaps rebound frequency is related to the circulating variant. In 2023, we had generally good results with Paxlovid with no reported rebounds until recently we have seen them reoccur in the months of July and October.

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November-2023 Newsletter

Welcome to the November 2023 Newsletter for

Santa Monica Primary Care.

In this issue, we will cover our progress with seasonal vaccines, specifically
RSV, Influenza and COVID-19. We will also cover the expected seasonal rise in COVID cases along with their relative severity. Lastly, as we near the end
of the calendar year, we will review some of our progress with our clinical
quality partner, Aledade.

Seasonal Influenza Vaccine & Low Flu Illness Rates Worldwide

Nationally, almost 84 million doses of the 2023/2024 seasonal vaccine have been distributed with a very, very, very small percentage of those being delivered to our office. Generally manufacturers produce about 165-170 million doses for 330 million Americans. While we have had a pretty steady uptake of the flu vaccine, immunization rates nationally are essentially on par with those of last year. About 3.8 million doses have been given to adults 18 and older the week ending September 9th (pretty long data lag) as compared to 4.0 million in 2022.

Globally, the World Health Organization (WHO) is reporting low overall activity of influenza illness (“the flu”) itself. The same holds true for our experience here in Santa Monica.. Specifically, in the northern hemisphere, influenza activity is below expected seasonal thresholds. Predominant strains that have been seen are Influenza A subtypes H3N2 and H1N1 followed by Influenza B. For those that follow my monthly newsletter, we covered the selection process for seasonal influenza vaccine components last month. Indeed, H1N1 as well as H3N2 subtypes are in the 2023/2024 formulation. So it is reassuring to see that the vaccine matches the predominant circulating subtypes. This bodes well for this season’s shot to be effective against infection and in the reduction of severe disease.

COVID-19 Boosters & (Pleasantly) Surprising Uptake in Clinic in Contrast to Disappointing Vaccination Rates Worldwide

We have been administering both Moderna and Pfizer mRNA COVID Booster vaccines for Fall of 2023. Similar to the flu shot, we have had an enthusiastic response to us having such, perhaps because pharmacies have had more difficulty obtaining the vaccine leading to long appointment waiting times. So enthusiastic that we had to reorder!

What we are seeing in our office vis-a-vis COVID booster uptake is substantially different from what is occurring at the national level. Thus far only 12 million Americans (3.6% of the population, have gotten the 2023 booster. By comparison, 17% of the US population received the 2022 booster and it seems unlikely that we will reach that level by season end.

In addition to the well known Pfizer and Moderna mRNA vaccines, the FDA recently approved Novavax’s 2023-2024 formula both as a booster (one shot) and as a primary series (two shots three weeks apart for individuals who have not yet had any COVID vaccination). Unlike the newer mRNA technology which directs cells to create the spike protein seen on the surface of SARS-CoV-2, the Novavax vaccine is protein-based and a vaccine type that has been used for decades (HPV, Hepatitis B and Shingles). The vaccine itself contains a synthetic spike protein and an “adjuvant” ingredient that enhances the immune response. The Novavax vaccine is also stable in standard refrigeration, making storage and delivery easier.

We have had a lot of questions about co-administration of the flu and COVID boosters and have recommended that space them out by 2 weeks or so. We had discussed a study in last month’s newsletter data suggesting that systemic reactions among those who received a flu+COVID co-administration was more than twice as high as compared to those receiving flu only. The FDA commissioner Dr. Peter Marks apparently agreed, stating that he had spaced out his seasonal COVID and flu shots by about two weeks to “minimize the chance of interactions, and minimize confusing side effects from one with the other.” He noted that this could be a good option for people who did not mind multiple trips to the pharmacy or the doctor’s office (I mean who doesn’t, right?) but for those where this was not possible, co-administration was still OK.

On the New RSV Vaccine

The RSV vaccine has been recommended by the FDA for adults 60 years and older. There are no national data published on its uptake, but from informal surveys amongst our patients this seems to be less of a priority than COVID and influenza shots. Approved in May 2023, two RSV vaccines are available in the prevention of respiratory tract disease among older adults – Arevxy (82% effective) and Abrysvo (67% effective). The CDC also recommends the RSV vaccine amongst pregnant women between weeks 32 and 36 of gestation to protect babies from severe RSV disease. To this end, only Abrysvo has been approved, importantly only for pregnancies during September through January as RSV itself is a seasonal illness.

RSV is typically seen from October through March but peaks in January and February. While the COVID-19 pandemic, associated masking and travel restrictions disrupted the virus’ seasonality over the past two years, it does appear that the usual patterns have returned. RSV is a common respiratory illness that infects up to 90% of children in their first two years of life and frequently reinfects both older children and adults. In most cases, RSV infection is typically mild and involves the upper respiratory tract with cough, runny nose and sometimes sinus and ear involvement. Interestingly, infection severity tends to decline after the third infection. However, amongst older adults RSV can involve the lower respiratory tract leading to pneumonia, asthma exacerbation and bronchitis. Illness among older adults can be serious and is associated with
60,000-160,000 hospitalizations and 6,000-10,000 deaths annually in the US among adults aged 65 and older.

Transmission of RSV is primarily by direct contact making handwashing and contact precautions important in preventing spread of the virus, particularly in healthcare environments. RSV can survive for several hours on hands and surfaces. Within families, studies of transmission dynamics have shown that infection of infants often follows infection of older siblings. In our own clinic, infection of older adults can be associated with visiting grandchildren who display typical RSV symptoms.

Adults with certain medical conditions including pulmonary disease, asthma, heart failure, heart disease, diabetes and kidney disease are at particular risk. The risk of RSV-associated hospitalization increases among those 75 and older and severe complications can occur amongst those with compromised immunity – either due to medication or underlying conditions.

The decision to vaccinate against RSV employs ‘shared decision making’ between the patient and physician. One advantage of the RSV vaccine is that it is expected to last multiple seasons – currently at least two – so it would not be something that would need to be given annually, unlike influenza and seemingly COVID boosters. The current RSV vaccine is recommended only as a single dose for individuals 60 years and older in the United States but should be considered in the context of the need for flu and COVID boosters. Those most likely to benefit would be those with pulmonary disease (such as COPD or asthma), cardiovascular disease, moderate to severe immune compromise, and diabetes.

COVID-19 in Our Clinic

COVID cases have typically been low during the Spring followed by a mid-summer surge. Interestingly, this year our clinic saw a late summer surge in cases which has persisted through the fall (Figure 1 below).

Total COVID-19 Cases (Blue) and Repeat Infections (Red) by Month in 2022/2023: Santa Monica Primary Care

The majority of the cases we have seen in August, September and October have been first time infections. Symptoms have generally been mild (7 of 12 cases – congestion, cough, malaise) or moderate (4 of 12 cases – fever, shortness of breath). One patient required hospitalization.

Paxlovid has continued to provide significant symptomatic relief when initiated early (within 5 days) of the start of symptoms. Rebound infection, which is always a risk of Paxlovid administration, has occurred 20% of the time. We have prescribed Paxlovid 121 times and had 24 documented rebound infections.

Quality of Care Measures

As part of our ongoing commitment to maintaining our quality of care, we have continued our partnership with Aledade (https://www.aledade.com/) as an Accountable Care Organization (ACO). Several steps are involved as we focus on performance and quality measures. Primary among such is an emphasis on the Annual Wellness Examination and, as such, you have likely received a phone call from our office reminding you of this important yearly evaluation. Similarly, we have also been focused on transitions of care, following up on Emergency Department visits
and scheduling in-office follow-up after hospitalization.

Additional quality of care measures include breast cancer screening and appropriate evaluation of kidney health. For our Medicare patients, we have continued our monthly outreach that we started during the first months of the COVID pandemic. This regular outreach has been helpful both for patients and for our office as we manage routine preventive care as well as chronic medical conditions.

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26 September 2023 Blog: On Whole Body MRI Scans

26 September 2023 Blog:  On Whole Body MRI Scans

 

A patient asked me my thoughts on a recent New York Times post on Prenuvo, a whole body MRI.  Here is the post:

For $2,499, Prenuvo will try to predict your future. The celebrity-endorsed company offers a roughly hour-long session of magnetic resonance imaging, or MRI, that scans your entire body, searching for early signs of cancer, aneurysms, liver diseases and even multiple sclerosis. It’s part of a crop of companies that claim they can revolutionize preventive health care with full-body scans — but experts warn this might not be the right approach.

In recent months, images of celebrities and influencers posing in branded scrubs in front of a glossy, cylindrical MRI machine have popped up on social media. Kim Kardashian wrote in the caption of a post she shared last month that Prenuvo “has really saved some of my friends’ lives.” In May, the television host Maria Menounos said that a Prenuvo scan had alerted her to a mass that turned out to be Stage 2 pancreatic cancer.

Many celebrities talk about their health on social media. But the ones that are documenting their body scans — complete with nearly identical photo ops — have taken the celebrity health endorsement to new heights in terms of cost. And considerable harm can come from screening, experts said.

What do experts say about the scans? Read more at the link in our bio.”

 

INTRODUCTION and GENERAL CONCEPTS of SCREENING

There is so much to unpack here that it is hard to know where to begin. But let’s start at the beginning “Prenuvo will try to predict your future.” It’s never a good sign when the first sentence is factually incorrect. What a whole body MRI is trying to do is illustrate your present. There have been no studies showing that whole body scanning can materially impact one’s health. In fact, MRI and CT scanning were developed for diagnostic purposes for patients with either known disease, serious complaints or trauma (the so-called ‘pan-scan’ is a mainstay of Emergency Medicine and Trauma Surgery). Only low-dose CT scans for lung cancer screening among at risk patients (i.e. prior or current smokers with at least 20 pack years of smoking – or 1 pack per day for 20 years) have undergone careful evaluation and study with two large randomized controlled trials showing that CT screening reduces lung cancer mortality rates in these at risk patients.

Moving along, the suggestion that the Prenuvo MRI will detect early signs of cancer, aneurysms, liver disease and even multiple sclerosis is a curious constellation of outcomes. Multiple sclerosis has typical clinical signs but is best confirmed using an MRI protocol both with and without contrast.  Prenuvo does not use contrast stating ‘we believe the combination of sequences that we take performs as well as contrast-enhanced MRI for tumor detection’ but no mention of MS detection. Similarly, aneurysms are best detected with magnetic resonance angiography (MRA) which is similar to an MRI but focuses on vessels, rather than organs. So oddly, 4 of the conditions they choose to highlight as detectable are not best identified using Prenuvo.

Pancreatic cancer (to which I would add ovarian cancer and kidney cancer) is really an outcome where Prenuvo could make a difference. Typically diagnosed at later stages, the annual incidence rate of pancreatic cancer is 12.9 cases per 100,000 person-years with a death rate of 11.0 per 100,000 person-years. Compare that to colon cancer which has an annual incidence rate of 36.6 cases per 100,000 person-years and a death rate of 13.1 per 100,000 person-years.  I did find it odd that they used the experience of “television host Maria Menounos” to highlight early detection at Stage 2 of disease. Diagnosing pancreatic cancer at Stage 2 only has a 5 year survival rate ranging from 13-39% as opposed to 84% for Stage 1A. A far better example would have been finding localized pancreatic cancer at Stage 1. Once again, an MRI is not the imaging modality of choice for pancreatic cancer detection in a high risk population – endoscopic ultrasound or a magnetic resonance cholangiopancreatography is preferred. 

 

LEAD TIME BIAS

Those who follow my posts know that I won’t let a chance to introduce an epidemiologic concept go to waste – and this blog post is no different. One critique of Prenuvo comes from  lead time bias. Lead time is the period of time between the detection of a medical condition by screening and when it ordinarily would have been diagnosed because a patient experiences symptoms and seeks medical care. A disease for which early treatment is no more effective than late treatment can make early detection look more ‘effective’, when in fact all the patient experiences is more disease time.  This is illustrated in the figure below:


Specific screening for breast (mammography), lung (low dose CT scan among appropriate risk patients, detailed above) and colorectal cancers (colonoscopy) are known to be effective because randomized controlled trials have shown that the mortality rates of those screened are lower than a comparable group of unscreened individuals.

 

LENGTH TIME BIAS

A second epidemiologic Achilles heel of Prenuvo comes from  length time bias. Screening works best when a medical condition develops slowly (this is part of the reason that colonoscopy is such a good screening tool and can be done once every 10 years for an average risk patient with no polyps).  Screening tests like Prenuvo are more likely to find slow-growing tumors because they are present for a longer period of time before they cause symptoms.  This is illustrated in the figure below:

Because screening tends to find tumors with an inherently better prognosis, mortality rates may appear to be better but this has nothing to do with the screening process itself. It simply reflects what the Prenuvo is good at detecting.

 

FALSE POSITIVE RATE

One of the critiques I have specifically left out (until now) are concerns about false positive results arising from the Prenuvo screening. This actually may be one aspect where Prenuvo performs fairly well as it is an expected cost of any screening test.  In short, a false-positive screening test results in an abnormal result in a person without disease. These can then lead to the inconvenience, expense and potential risks associated with obtaining follow-up procedures. About 10% of mammograms lead to a false positive result, and in a study of ovarian cancer screening (CA-125 lab testing and ultrasound) returned an 8.4% false positive rate and one third of those cases underwent surgery. In that study, five times more women without ovarian cancer underwent surgery than did women with ovarian cancer.

My assumption would be that the Prenuvo screening would have a similar false positive rate of between 8-10%. But where clinicians get into trouble with higher false positive rates is when multiple tests are run (the so-called ‘covering all the bases’ phenomenon) occur at once wherein among several dozen tests, it is not unusual to have one or more return as ‘abnormal.’ So having the Prenuvo testing by itself could be a reasonable approach to reduce a cumulative false positive rate.  It is important to note, however, that practice variation can contribute to the false-positive rate.  This is a phenomenon we see with mammography wherein similar large screening programs in the US returned false positive rates nearly twice as high as in the UK – but with similar cancer detection rates. I would not imagine that the true false positive rate of Prenuvo screening will ever be known or publicized but an 8-10% rate remains a fair assumption.

 

SUMMARY: IS IT WORTH IT?

I suppose that the real question is for $2499, is it worth it? I’m not really sure how to answer that, because there are no guidelines on how often the Prenuvo should be performed. Is it annual?  Every five years?  Every ten? But to provide some framework, we know that colonoscopies ($1500, done every 5 to 10 years), mammograms ($200 performed annually), and Low Dose CTs of the Lungs among smokers ($500, done annually) do reduce mortality rate. Prenuvo has placed itself strategically with newer detection technologies such a Galleri which is a blood-based test seeking to detect early stage cancers ($1000, recommended annually). A vigorous evaluation of its efficacy would be reasonable, but as a cash-pay service there is little likelihood that Prenuvo will invest in research when they can put those dollars into marketing and endorsements.

 

September 2023 Newsletter

Welcome to the September 2023 Newsletter for

Santa Monica Primary Care.

In this issue, we cover seasonal vaccines coming due this Fall  (Flu, COVID booster and RSV) with some detail on how they are formulated and deemed effective. We borrow heavily from analysis performed by the UK’s Joint Committee on Vaccination and Immunization (or “Immunisation”).

Flu Shots are “IN”: On Seasonal Influenza Vaccine

Doses of the 2023/2024 seasonal flu shot are stocked in our office and can be given any time as the best time to receive the vaccine is during the months of September and October.

The rationale for such timing is that annual local epidemics follow a fairly predictable
seasonal pattern with outbreaks in North America occurring between November and March. These begin abruptly, peaking in 3 weeks, and then end about 8 weeks later. Viral spread during winter months is presumed to be favored by improved virus survival in lower temperature environments and, indoor crowding due to cold weather. These annual epidemics can affect 10% to 30% of the world population.

Each year in January, a review of circulating influenza viruses is undertaken by the World Health Organization (WHO) and the most likely epidemic strains from two main categories – Influenza A and Influenza B – are selected. For Influenza A this year’s shot contains the ‘swine flu’ familiar H1N1 as well as H3N2 subtypes (H and N are specific surface proteins termed hemagglutinin and neuraminidase). The Influenza B lineages generally cause less severe disease and are called Yamagata and Victoria. So there are 4 components which is why you will hear the shot referred to as ‘quadrivalent’.

The decision on which strains to include in the vaccine formulation is based on global
surveillance data but, in the end, it is a prediction and not always correct. As such, the
effectiveness of the seasonal flu shot can vary from year to year. Even if the vaccine doesn’t completely prevent the flu, it can still reduce the severity and complications of the illness should you become infected.

Vaccination is associated with a reduced incidence of influenza from 2.3% among adults who were unvaccinated as compared to 0.9% among vaccinated. This effect is even stronger among those 65 years and older, wherein vaccination reduced the incidence from 6% to 2.4%.

Side effects to the flu vaccine are generally mild, most common being local injection site reaction (soreness), headache, muscle aches or low grade fever – all resolving within a day or so. About 15% of flu vaccine recipients experience a side effect.

COVID-19 Boosters Will Be “IN”: On the 2023 Booster

For the first time ever, our office will be stocking a COVID vaccine, in this case the 2023
booster. We have been able to bypass the LA County Health Department who had been unwilling to supply us with vaccines and instead are receiving them directly frow the manufacturers. Unlike the influenza vaccine which has population-wide applicability, I am favoring a narrow scope of vaccine efforts for COVID-19. Some of this recommendation is based on bivalent booster experience of 2022 wherein only 17% of the total US population ever received a booster dose. That percentage was a bit better for those over the age of 65 years at 43.3%.

Similar to influenza, COVID historically (until 2023 that is) has had a strong Winter surge beginning right after Thanksgiving (not a big surprise why an airborne virus would spike after such). The Fall 2023 COVID booster, which should gained FDA approval this week, targets the XBB.1.5 a coronavirus subvariant that emerged in late 2022. While XBB.1.5 only makes up 3.1% of the currently circulating variants in the US, basic science data has indicated that its offshoots (EG.5, FL.1.5.1, KBB.1.16.1 and KBB.1.16) share a close relationship with KBB.1.5. As such, it is expected that the updated booster will provide protection against these related variants

The UK’s Joint Commission on Vaccination and Immunization (JCVI) has offered some of the most coherent advice on boosters, recommending them for those at high risk of serious disease and therefore most likely to benefit from vaccination. These include:

Similarly, we will advise patients over 65 and those in higher risk groups to strongly consider having the booster by the end of October in time for an expected late November to January surge in cases (this differs from the UK recommendation to have the booster by the end of December). The crux of the JCVI’s advice is based on a coherent analysis of the number needed to vaccinate to prevent a hospitalization or death due to COVID-19. Based on the 2022 booster experience, it would require giving a booster to 240 high risk >90 year olds to prevent one COVID death but over 2 million booster doses to prevent one death amongst healthy 15-19 year olds.

Vaccine efficacy of the 2022 booster dropped rapidly from 53% 2-4 weeks after vaccination to 28% at greater than 15 weeks. Protection against hospitalization after an mRNA booster increases in the two weeks after vaccination and then declines towards a stable plateau of around 50-60% by six months.

While you can have both the flu vaccine and COVID booster at the same time, it may be more prudent to separate the two. That way in the case of an unlikely, but possible, vaccine reaction -the cause will be apparent. A recent study from Sheba Medical Center in Israel showed that systemic reactions among those who received a flu+COVID co-administration was 27.6% as compared to 27.4% for COVID only and 12.7% in flu only. However, COVID spike protein antibody levels were 19% higher amongst those who received the COVID booster separately as compared to those who received COVID and flu vaccines together (link:https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809119

RSV Vaccine is OUT there: On the New RSV Vaccine

This Fall will be the first time that an RSV (Respiratory Syncytial Virus) vaccine becomes available but is not a vaccine we will stock in the office. It will be available, however, at local pharmacies. Approved in May 2023, two RSV vaccines are available in the prevention of respiratory tract disease – Arevxy (82% effective) and Abrysvo (67% effective)

RSV is a common respiratory illness that infects up to 90% of children in their first two years of life and frequently reinfects both older children and adults. In most cases, RSV infection is mild and may even go unnoticed – with infants under the age of one year and the elderly at greatest risk. For infants, RSV can cause such severe inflammation of the small airways in the lungs that significant breathing difficulties can occur. There is no pharmacotherapy other than supportive care with fluid and respiratory support. RSV is a leading cause of infant mortality globally and, in
some developing countries, is second only to malaria as a cause of death among infants.

The burden of RSV disease in adults is less well understood but undoubtedly
underestimated given that it is most typically (and correctly) associated with respiratory illness in infancy. The same JCVI grappled with a population-wide rollout of RSV vaccine in the UK where the annual number of deaths was estimated to be somewhere between 741 and 6472. The US has about 5 times the population of the UK so that would translate to between 3700 and 32000 deaths here. They also considered the burden of RSV on the health system in general and concluded that a programme for those 75 years and older would be the most ‘efficient’ but one directed at 65 years and older would provide the most benefit. Note: they only considered the Arevxy, noting that these data provided the most ‘comprehensive read out’ and is also more effective. The committee was hopeful that Arevxy would provide multi-year protection, as RSV does not have the same mutation frequency as COVID-19 and influenza. At $336 a dose, one would certainly hope for longer lasting protection.

Side effects seem to be generally mild but common. 34% of recipients reported fatigue, 29% muscle aches and 27% a headache. These typically resolved in 24 to 48 hours.The current RSV vaccine is recommended only as a single dose for individuals 60 years and older in the United States. I would revise that upwards to 65 years of age. Those most likely to benefit would be those with pulmonary disease (such as COPD or asthma), cardiovascular disease, moderate to severe immune compromise, and diabetes. The CDC does not recommend against co-administration with seasonal flu shot or other vaccines although antibody titers for both influenza and RSV were lower when given together. So my recommendation would be to separate RSV vaccination out from other shots by two weeks.

 

Vaccine Recap

Seasonal Flu: An unqualified, yes
COVID Booster: Everybody 65 and older, patients with an immunosuppressed household member, those under age 64 with a risk factor for severe disease
RSV Vaccine: Everybody over the age of 65, those 60-64 with asthma, COPD, diabetes or immune compromise

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What’s Happening with COVID?

In August, the Los Angeles County Health Department reported a “concerning increase” in reported COVID-19 cases and indeed cases in our clinic showed a notable uptick as compared to much of the Spring of 2023. We had a total of 13 cases, of which 10 were first time infections (Figure 1 below).

Total COVID-19 Cases(Blue) and Repeat Infections (Red) by Month in 2022/2023: Santa Monica Primary Care

Smoothed Daily incident Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California

While this did represent a significant increase, it is important to contextualize the magnitude of such against the historic low rates of this Spring. Historically, a mid to late summer surge has been seen in every year since the pandemic began, but rates this summer (Green Line in Figure 3 below) were the lowest we have ever seen, including the Summer of 2020 (Blue Line). We were all under shelter-in-place orders during the Summer of 2020 as well.

Smoothed Daily incident Case Rate (per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020(Blue), 2021(Red), 2022(Yellow), and 2023 (Green)

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10 August 2023 Blog Post: Surge, What Surge?

Surge, What Surge?

The growing consensus I have heard from patients is that we are having a COVID-19 surge in Los Angeles and, given such, they are wondering what additional precautions need to be taken. I was somewhat surprised to hear that we were experiencing an increase in cases in the County, as this has not been seen in our practice case numbers. Whereas November 2022 we say 29 cases, case rates here at Santa Monica Primary Care have been a slow drumbeat since March. 6 cases in March, 7 in April, 4 in May, 5 in June, 6 in June and only 2 thus far in the first 10 days of August.

But turning to headlines, I can see why a surge is of concern.  Yesterday the Los Angeles Times headline blared “COVID-19 is heating up all around’ this summer. Should we be wearing masks again?” (link: https://www.latimes.com/california/story/2023-08-09/covid-19-is-heating-up-this-summer-should-we-wear-masks-again).  According to Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert, said transmission is increasing and “we haven’t seen the crest yet” of the wave.

Now I understand that my small slice of the medical universe is not necessarily generalizable, but generally with a communicative patient population I’m aware when case burdens increase – whether it be flu, RSV, or COVID.  

Reading further into the Los Angeles Time’s coverage, state Epidemiologist Dr. Erica Pan noted that California’s test positivity rates have gone up in the last two to three weeks, “and I’m sure many of you are anecdotally both hearing about friends and family and colleagues … about some more circulating COVID,” Pan said. “Thankfully, our hospitalizations are looking very reassuring so far.”

Those who have followed my blog posts in the past will remember that test positivity rates are an inaccurate and problematic metric as it depends on the denominator of who is being tested. Few go to public health labs or obtain reportable PCR tests any more; rather most COVID cases are identified through home testing which are not reportable to public health agencies.

When diving into Los Angeles County Data, Dr. Pan is indeed correct that test positivity rates have increased, but not just over the past 2 to 3 weeks but rather over the past 2 to 3 months. Test positivity rates were as low as 2.9% in early May and have climbed to 7.9% in the last week in July (Figure 1 below).

Left unmentioned by the Los Angeles Times and Dr. Pan is the sharp decrease in testing itself (the denominator of test positivity). Only 45 Daily tests per 100,000 population are currently being reported to the County (Figure 2 below). For reference, at the height of the January 2022 surge there were 2,744 reportable tests being performed daily per 100,000 population. As numbers become smaller, the accuracy of a reported metric becomes less accurate.

To account for this statistical noise, we turn to prevalence rate which is the estimated number of active (not necessarily infectious) cases per 100 individuals. Currently, the County’s prevalence rate stands at 0.22 or, expressed differently, 22 cases per 10000 individuals. While this is an uptick compared to the rate seen in early May (9 cases per 10000 individuals), it is far lower than the late February rate of 60 cases per 10000 individuals (Figure 3 below).

It is important to note that mid to late summer surges have been a feature of COVID-19 in years past, most notably in 2022 when prevalence rates indeed surged to an estimated 9.7% of the population having the infection.  Placing this summer in perspective – the green line in Figure 4 below suggests that we are having an unexpected lull in cases, certainly when compared to prior years.

This is not to suggest that cases will not increase moving forward. In 2021 (red line), cases increased significantly through late July and peaked mid-August. However, at this point in time, there does not seem to be evidence of increased community transmission nor a particularly significant population burden of disease, particularly when compared to prior years.

Aug 2023 Newsletter

Welcome to the August 2023 Newsletter for

Santa Monica Primary Care.

In this issue, “Vaccine-palooza” we are going to cover all the vaccines that have been recommended this Fall and the rationale for each. This season we will have a new RSV vaccine as well as reformulated seasonal Influenza and a COVID booster. With so many, planning is necessary!

Seasonal Influenza Vaccine

Doses of the 2023/2024 seasonal flu shot have already begun to ship and typically vaccination efforts begin in late August or early September each year. Influenza has a seasonal pattern with outbreaks occurring in the winter months primarily (in tropical regions, it may be more year round). But this is why vaccination efforts begin in the Fall, in preparation for such. This season’s vaccine will have either three components (trivalent) or four (quadrivalent) with the latter being recommended for those over the age of 65 or with chronic conditions.

The decision on which strains to include in the vaccine formulation is based on global
surveillance data but, in the end, is a prediction and not always correct. As such, the
effectiveness of the seasonal flu shot can vary from year to year. It is important to note that even if the vaccine doesn’t completely prevent the flu, it can still reduce the severity and complications of the illness should one become infected.

One of my favorite online resources for influenza is Columbia University’s Flu Forecasting System (link: https://cpid.iri.columbia.edu/) which provides geographic spread predictions by US city. Influenza travels east to west so we will see case spikes along the eastern seaboard before we have a surge of cases in Los Angeles. But, for those who travel for business or leisure, this web resource is helpful to see if you are heading into an area with either a high current case load or a predicted increase. Historically, the peak of influenza cases in Los Angeles has occurred in the last week of December and first week of January, coinciding with holiday travel. My general recommendation is that patients have the flu vaccine by Halloween, although those
who have travel to the east coast or Europe may want to have it sooner.

COVID-19 Booster

Last year at this time, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose at the end of August 2022. This updated booster was to be given at least 2 months after completion of a primary series or the most recent booster dose of a monovalent (original) COVID-19 vaccine.

Population uptake of the bivalent booster was abysmal – only 17% of the total US population received a booster dose. That percentage is a bit better for those over the age of 65 years at
43.3%.

Similar to influenza, COVID historically (until 2023 that is) has had a Winter surge although there has been historically a mid-summer increase in cases as well (Figure below).

Smoothed Daily Incidence Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California for 2020 (Blue), 2021 (Red), 2022(Yellow), and 2023(Green)

Both the CDC and vaccine manufacturers have indicated that COVID booster shots will move closer to an influenza like pattern with the goal to ‘keep up’ with COVID variants. But this isn’t really a true or fair parallel because the seasonal influenza shot is planned and predicted whereas the COVID booster is reactionary. For instance, the Fall 2023 COVID booster, which should gain FDA approval this month, targets XBB.1.5 a coronavirus subvariant that emerged in late 2022. Unfortunately, XBB.1.5 is no longer the primary circulating variant in the US. In fact, it isn’t the second most common, nor the third. It’s the fourth at 12.3%  (link:https://covid.cdc.gov/covid-data-tracker/#variant-summary). 

While the expectation is that the updated booster will provide protection against subsequent variants, I think this is going to be a difficult gap to bridge for the US public and uptake will again be low. The CDC would be better served by making a strong case for those over the age of 65 or those with chronic medical conditions to have the shot rather than an across the boards recommendation for everybody to have it.

Most likely, I will advise patients over 65 and those in higher risk groups to strongly consider having the booster by the end of October in time for an expected late November to January surge in cases (although this never fully materialized in 2022 -2023). I have not seen compelling data to support its use in those that are younger and without risk factors for developing severe disease.

While you can have both the flu vaccine and COVID booster at the same time, it may be more
prudent to separate the two. That way in the case of an unlikely, but possible, vaccine reaction -the cause will be apparent.

RSV Vaccine

This Fall will be the first time that an RSV (Respiratory Syncytial Virus) vaccine becomes available. Approved earlier this year, this vaccine has been recommended for adults 60 years and older based on clinical trial data showing that one dose of the vaccine was ‘moderately effective’ in preventing respiratory tract disease from RSV.

Epidemiologically, RSV affects children more severely than adults and also displays a seasonal pattern with outbreaks more common during the winter months. Infection in healthy adults typically results in mild cold-like symptoms but can lead to more severe respiratory infections inhigher risk groups (infants, young children, older adults and those with a weakened immune system).

Developing a vaccine has been complicated due to the complexity of the virus, the fact that prior infection does not protect against re-infection (even amongst those with high specific antibody titers), and the potential for vaccine-enhanced disease in certain populations. Vaccine-enhanced disease occurs when vaccinated individuals experience more severe symptoms upon subsequent exposure to the virus.

The current RSV vaccine is recommended only as a single dose for individuals 60 years and older. Those most likely to benefit would be those with pulmonary disease (such as COPD or asthma), cardiovascular disease, moderate to severe immune compromise, and diabetes. The CDC does not recommend against co-administration with seasonal flu shot or other vaccines although antibody titers for both influenza and RSV were lower when given together. So my recommendation would be to separate RSV vaccination out from other shots by two weeks

Vaccine-palooza Recap

The Fall of 2023 is shaping up to be a busy vaccination season with seasonal flu, the COVID booster and the new RSV vaccination. While the flu shot itself is generally well tolerated without significant side effects, my general recommendation would be to separate out the vaccine shots by about 2 weeks – particularly the RSV which is a completely new vaccine and has not been studied widely. The finding that antibody titers of both flu and RSV are lower when given together is yet another reason to separate them out.

Also – if you can’t remember what you’ve had when – we have good news for you! Our office recently has integrated the California Immunization Registry (CAIR, now version 2.0) directly into our Electronic Medical Record. Not only do we send vaccination data to the registry for those receiving shots in the office, we are able to query the state registry for vaccines our patients may have had previously at an outside location.

What’s Happening with COVID?

Recently, the Los Angeles County Health Department reported a “concerning increase” in reported COVID-19 cases, detailing a 32% rise in cases week over week. This is a very curious assertion given that the data published by the County do not show this rise. Week over week data are below:

Smoothed Daily Incidence Case Rate (Per 100,000 population) of SARS-CoV2: Los Angeles Country, California

Cases have been in a very narrow band of 2.2 to 2.6 new daily cases per 100,000 population since mid May. The largest week over week rise has been 16% when going from 2.2 to 2.4. Most recently we have seen a slow rise in the last three weeks of 2.2 to 2.4 to 2.6 but nowhere is there a 32% increase.

Cases have also been steady within our own practice with only 4 to 7 cases monthly since March of this year. So case rates remain at historic lows.

Total COVID-19 Cases and Repeat Infections by Month in 2022/2023: Santa Monica Primary Care

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