September 2023 Newsletter
Welcome to the next edition of the Direct Access Internal Medicine Newsletter for 2023. It has been an exciting and interesting summer. We have a lot to share including upcoming staffing changes, a modest price increase of our fees, new services coming in 2024 and DJ’s long-awaited return! On the clinical side, Blair has written an outstanding article on the use of bioidentical hormone replacement therapy for women. I will give an update on the RSV and Covid vaccines and the current state of Covid infections along with prevention and treatment.
COVID 19 Pandemic & Vaccine Updates
As many of you are likely reading and hearing in the news, the number of Covid cases is on the rise. The virus is rapidly changing, and new variants are constantly introduced into our environment. In fact, at the time of this article, there are seven variants circulating through the United States. Fortunately, none of the variants, since the Delta sequence, has proven to cause severe disease, hospitalizations, or deaths at anywhere near what we observed in 2020 and 2021. Regarding Covid vaccines, the current bivalent vaccines are designed to provide protection against the original strain andomicron variants, neither of which are circulating at this time. The updated vaccine, which may come out in the coming month, will add the XBB.1.5 strain which dominated the scene between January and June of this year but is rapidly declining in favor of newer variants and accounts for less than ten percent of current cases. The newest, and most likely predominant strain, over the next few months will likely be the EG.5 or Eris strain. It has so far been found to be as contagious as prior strains but is also producing generally mild upper respiratory infections without progression to severe lower respiratory infection. As we learned during the Omicron surge and henceforth, vaccines that are not specific for current variants are generally ineffective. Furthermore, after nearly three years of experience, the safety of recurrent injections has been far from guaranteed.
After assessing our current situation and having treated over 1000 Covid infections in the past three years, it remains my strong recommendation to defer further vaccination with currently available formulations. Instead, I recommend early testing, which is proving to maintain sensitivity, and treatment relying on tested and proven therapeutics with repurposed medications and vitamin formulations. We continue to use protocols that remain highly effective at treating these infections. Like any viral infection, one has a small chance of becoming severely ill, but this is simply not a concern for Covid currently, and vaccines do not safely decrease the risk of severe illness. Finally, while the news and government outlets are expressing concern that there are rising numbers, the actual number of cases and hospitalizations remains incredibly low and significantly lower than what we have seen the last two summers.
There has been talk about reintroducing masking and other interventions to slow the spread of Covid. We will continue to manage high risk scenarios as we have over the past two years, asking patients with suspected infections to wear masks in the office and we will do the same. We will not institute mandatory masking requirements for either our patients or staff.
RSV Vaccine
The CDC has recommended that adults over the age of 60 receive the newly released RSV vaccine. This is based on estimates of 6000-10,000 deaths per year in older adults from RSV infection and two New England Journal of Medicine articles published in February of this year detailing the risks and benefits of the two potential vaccines. The primary trial in the NEJM randomized 25,000 individuals. There were 40 infections (.32%) in the placebo group and 7 infections (.05%) in the vaccine group. There were no deaths or serious illnesses in either group and there were two hospitalizations in the placebo group. Meanwhile, 33% of the participants in the vaccine group experienced adverse events vs 18% in the vaccine group. Some of these were classified as severe. Three individuals died of unknown causes possibly attributed to “vaccine or placebo”. After careful analysis of both studies, it is my strong recommendation that this vaccine not be administered and its safety remains in question. This is further supported by the fact that in 30 years, I have never admitted a patient to the hospital with a known RSV infection. Therefore, I will not be offering or recommending either the updated Covid vaccine or the RSV vaccine. These vaccines are offered at local pharmacies and are available to anyone who feels strongly that they may benefit from additional vaccination. For any further questions regarding this recommendation, please reach out to me directly or we can discuss at our next visit.
Influenza Vaccine
Influenza infections tend to occur throughout the year but are generally more common in the fall and winter months, ranging from 3-11% in most years. This is a higher incidence than RSV, although less prevalent than the current rate of Covid infections. The likelihood of a more severe influenza infection is higher than other existing viruses and thus, vaccination may be beneficial since it has been shown to reduce the potential of an infection by about half. More importantly, versions of the influenza vaccine have existed for decades and have a tremendous safety record.
We will, therefore, offer the standard dose influenza vaccine again this year as it safely provides reasonable protection against the flu with very few, if any, side effects. To make an appointment, please email Roxanne at roxanne@directaccessinternalmedicine.com or text or call the office. Our vaccines have arrived and will be made available immediately and through the fall. The best time to get your vaccine is between late September and early November.
Practice Updates
First, it is hard to believe BreAnne has been part of the Direct Access family for almost two years. Kacki and I are even more excited about her becoming our daughter-in-law when she and Hunter marry at the end of this month! Meanwhile, she will resume her fall class schedule this month and will transition to a part time position. We anticipate her leaving Direct Access permanently next spring when she enters her final year of nursing school. While obviously excited for her advancement, it will certainly leave a void. Additionally, Stacey will be moving into a slightly reduced four day per week position to spend more time with her grandchildren and enjoy some well-earned rest during the week. In anticipation of these changes, we have hired Beth Armistead. Beth is a Mathews native and has been serving the local community in long term elder care since 2007. She trained as a certified nurse’s assistant and has raised five boys preparing her well to deal with the challenges she may face at Direct Access! Beth started this Monday and is very excited about joining our amazing staff.
When it comes to our phlebotomy services, it has been a tough eight months to say the least. Bioreference has stood by us in DJ’s absence and provided us with consistent coverage. While it has been far from ideal, we have weathered the storm. More importantly, after two back surgeries, rehab and a few logistical challenges, DJ has returned to the office as our full-time phlebotomist. It is wonderful to have him back and healthy. As a quick note on phlebotomy, DJ asked to remind our patients to stay well hydrated when you are getting your blood drawn. A glass of water or two or a cup of black coffee is perfectly fine and suggested even when getting fasting labs drawn.
Many of you have asked me how the search for a new physician is coming along. As of now, that search is temporarily on hold while we manage higher interest rates and the climbing cost and increased complexity of day-to-day business decisions. Our mission is to continue to provide outstanding service delivered by our caring and compassionate staff. We are always working on ways to expand and improve care to current and new patients alike and there will be more on that front in the coming months.
Price Increase for 2024 and beyond
Over the past few years, we have seen a lot of changes in the medical landscape. We have experienced increased regulation and pressures from the government and insurance companies. We are dealing with more prior authorizations for routine care, testing and medications. We have seen the cost of supplies increase significantly as inflation take its toll. The cost of maintaining a consistent staff who feel valued and appreciated has risen appreciably as health systems and other employers have raised salaries to stay competitive. Meanwhile, Medicare and other insurance companies have reduced reimbursement in real dollars or maintained old reimbursement levels over recent years.
The need for more prompt test results while local facilities have reduced availability for stat testing has prompted us to add in house testing for basic labs. This new service will eliminate the difficulty of our patients having to go to the hospital and drop off blood or get their lab draw at the hospital for stat labs. We hope to have the new process up and running by mid- November. We will continue to provide on-site testing for influenza and Covid infections.
With the advancement of bedside ultrasound technology, we plan to gradually add this technology into our routine practice over the next year. This will allow us to more rapidly diagnose and screen for certain conditions as well as utilize this technology for certain joint injections.
With all these considerations and factors, we have made the difficult decision to raise our fee for non-covered services approximately $10 per month per patient in 2024. We have updated the fees on our website if you would like to see the exact numbers for individuals and couples for each age group. It has been difficult to come to this decision but with so many factors out of our control, we feel it is necessary at this time to make this adjustment as we prepare for the future. We appreciate this can be challenging for some but also hope that you continue to find the care and access we provide to be well worth the additional cost.
Clinical Insights
In our Clinical Corner this quarter, Nurse Practitioner Blair Nein has written an outstanding summary on the benefits of hormone replacement therapy in women.
Five Reasons Why Women Should Consider Bioidentical Hormone Replacement Therapy
This past March, I had an opportunity to attend a conference learning more about bioidentical hormone replacement therapy (BHRT) in women. Hormone replacement therapy has an interesting history which started in 1938 when researchers found a complex of estrogens that could be isolated from pregnant mare urine and the drug and Premarin was born. However, Premarin was not pure estrogen but instead contained a wide range of different estrogens, which were not bioidentical to human estrogen. Premarin became available for clinical use in 1941 and received Federal Drug Administration (FDA) approval in 1942 for the treatment of hot flashes in menopausal women, and then later Prempro (a combination of synthetic estrogen and progestin). In the 1980s-90s, Premarin/Prempro was the number one prescribed medication in the United States (Mok, 2017).
In 2002, all of that came to a sudden halt when the World Health Initiative (WHI) released a study claiming that Prempro was found to increase cancer risk in women taking it over long periods of time (Cagnacci and Venier, 2019). This caused most patients and their providers to stop using hormone replacement therapy because they believed it was unsafe. Unfortunately, the study had substantial flaws. Most importantly, there was no distinction between the synthetic and bioidentical forms of hormones (Mok, 2017). The original analysis said that women who took estrogen and synthetic progestin (which was the only combination tested) had a 26% increase in developing breast cancer over women who didn’t take hormones (Rossouw et al., 2002). However, a 26% relative increase in risk translates to less than one additional breast cancer case per 1,000 women, per year.Furthermore, the study showed that women who had hysterectomies and took estrogen alone had a decreased risk of breast cancer (Rossouw et al., 2002).
Current medical guidelines suggest the benefits of BHRT outweigh the risks. Bioidentical hormones used today are produced in a lab from yams, cactus, or soy, but the structures and function of these hormones are identical to that of the hormones made in the woman’s body. New studies have showed that use of BHRT has safe and beneficial effects on quality of life for women regarding symptom relief, prevention of osteoporosis, dementia risk reduction, and most importantly no increase in cancer risk.
Here are just some of the potential benefits of BHRT in women.
Symptom Relief: As many women approach menopause and the years leading up to menopause, they experience symptoms such as hot flashes, insomnia, mood changes, depression, vaginal dryness, low libido, night sweats, chills, hair loss, weight gain, irregular periods, and in some cases, joint aches. The severity and duration of symptoms vary greatly between women; some women do well with menopause and others find it debilitating. Hormone deficiency affects almost all women, but with the use of BHRT treatments, we can stabilize the levels of your hormones to help you live life to the fullest again.
Osteoporosis prevention: During menopause, hormones levels decrease, leading to bone loss since estrogen helps control bone resorption. Women who lose bone density are more likely to have osteoporosis or fractures. Estrogen, in particular, is important for bone health; studies have shown that BHRT can help reduce the risk of osteoporosis and osteopenia in postmenopausal women by increasing estrogen levels.
Brain Health: Studies are now showing a strong correlation between dementia and loss of estrogen in women. Alzheimer’s disease strikes women harder than men. Over two-thirds of patients diagnosed with Alzheimer’s disease are women which may be hormone-related. Researchers have found that BHRT is most effective for dementia prevention when given during perimenopause (the stage before menopause). BHRT use can be associated with better memory and larger brain volumes, especially women at risk for dementia or Alzheimer’s (Saleh et al.,2023).
Blood Clot Risk: Synthetic estrogens that were used in the previous therapies, Premarin/Prempro were known to increase the risk of blood clots, raise blood pressure, and increase stroke risk. Bioidentical estrogens, especially when given topically, have not shown any increased risk, nor have they increased cholesterol levels. Synthetic progestins can increase atherosclerosis (narrowing of arteries) and suppress the protective effect of estrogen (Reslan & Khalil, 2012). Two studies on BHRT with both estrogen and progesterone therapy showed they protected against cardiovascular disease and had no additional risk for blood clots.
Cancer Risk: New research shows BHRT has no effect on cancer risk, mainly because the hormones are identical to the hormones already being produced naturally in women’s bodies. Estrogen itself does not increase the risk of breast cancer (Abenhaim et al.,2022). But, if you have a uterus, you should take estrogen and progesterone, to eliminate the potential increased risk of uterine cancer. Synthetic progestins slightly increase the risk of breast cancer. Study after study has shown no increase in breast cancer in women who take bioidentical hormones, and all hormones used at DIAM are bioidentical, including progesterone. However, were commend that all women, including those who are using BHRT, stay current with routine mammograms.
At DAIM, we work alongside Williamsburg Drug to compound our bioidentical hormones to ensure various indications, preparations, benefits, and risks are all addressed to find your individualized dose. Williamsburg Drug prepares their products under strict FDA regulations, but using a compounding pharmacy allows us to tailor the dosages delivered to each patient. Please talk to us if you believe you could benefit from bioidentical hormone replacement therapy.
Sources:
Abenhaim, H. A.,Suissa, S., Azoulay, L., Spence, A. R., Czuzoj-Shulman, N., & Tulandi, T.(2022). Menopausal hormone therapy formulation and breast cancer risk. Obstetrics & Gynecology, 139(6), 1103–1110. https://doi.org/10.1097/aog.0000000000004723
Cagnacci, A.,& Venier, M. (2019). The Controversial History of Hormone Replacement Therapy. Medicina (Kaunas, Lithuania), 55(9), 602. https://doi.org/10.3390/medicina55090602
Gartlehner,G., Patel, S. K., Reddy, S., Rains, C., Schwimmer, M., & Kahwati, L. C.(2022). Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons. JAMA, 328(17), 1747. https://doi.org/10.1001/jama.2022.18324
Mok, C. (2017).The Long And Misunderstood History Of Hormone Replacement Therapy. Forbes. https://www.forbes.com/sites/forbesbooksauthors/2017/04/16/the-long-and-misunderstood-history-of-hormone-replacement-therapy/?sh=33fd2c64667c
Reslan, O. M.,& Khalil, R. A. (2012). Vascular effects of estrogenic menopausal hormone therapy. Reviews on Recent Clinical Trials, 7(1), 47–70. https://doi.org/10.2174/157488712799363253
Rossouw, J. E.,Anderson, G. L., Prentice, R. L., LaCroix, A. Z., Kooperberg, C., Stefanick, M.L., Jackson, R. D., Beresford, S. A., Howard, B. V., Johnson, K. C., Kotchen,J. M., & Ockene, J. K. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA, 288(3), 321–333. https://doi.org/10.1001/jama.288.3.321
Saleh, R. M., Hornberger, M., Ritchie, C. W.,& Minihane, A. M. (2023). Hormone replacement therapy is associated with improved cognition and larger brain volumes in at-risk APOE4 women: results from the European Prevention of Alzheimer’s Disease (EPAD) cohort. Alzheimer’s Research & Therapy, 15(1). https://doi.org/10.1186/s13195-022-01121-5
Stay Tuned
In future quarterly newsletters, we will discuss the pros and cons of prostate cancer screening and the management of hypertension.
Final Thought From Dr. Haggerty
Trust
Recently, I’ve read several articles that have highlighted the loss of trust in our institutions. I found the ideas relevant to many of my own thoughts especially as it relates to how the practice of medicine has evolved in the last several years. As I wrap up the quarter’s newsletter, I’d like to elaborate on the concept of trust.
Throughout history, at least to some significant degree, we had come to implicitly trust our institutions, their data, reporting and sincerity. Unfortunately, what we have learned is that, more than ever, these institutions are ultimately ruled by people with self-centered motives. They are motivated by ego, the desire for popularity and recognition, fear of failure and of course, money. Their purpose is to serve the company and the individual rather than the customer or the public. They will do anything, including lie, to sell the product, often despite a lack of objective positive benefits. In the past three years, especially, my eyes have been opened to a level of corruption within these institutions not seen, or at least known, until now.
Specifically in medicine, we have been told that masks would not help, and then they would. We are told that more vaccines will continue to provide protection despite the fact they are outdated and ineffective and their safety has still yet to be proven. We are still told that repurposed drugs like azithromycin and ivermectin have no place in the treatment of viral infections despite excellent scientific logic and many studies showing ongoing effectiveness for three years and counting. Instead, we must use medications that are ten times the cost, have severe drug interactions and cause rebound illness. Why? Because the “experts” say so. The fact is that government agencies, like the CDC and FDA, and big Pharma, who is making literally billions of dollars off of these medications and vaccines, continue to tell us lies to support their narrative, the vaccines and the drugs. Mistruths about Covid is just the tip of the iceberg.
Millions are spent each year influencing major health care organizations and health systems and individuals to further promote their narrative and their products. These truths are only serving to further erode the trust Americans have in nearly all areas of our lives. In a recent poll,only two institutions of 16, the military and small business, enjoy the confidence and trust of the majority of Americans. While I’ve long suspected corruption in medicine, my trust of the so-called experts and their organizations and the companies that support them is now at an all-time low. Until public health officials and scientists stop portraying themselves as infallible authorities and convey the latest evidence and data with the humility that the scientific method demands, and funding is no longer provided by influencing organizations, we are unlikely to see a shift back to the trust we once had for these institutions.
Many of us have decided we don’t want to practice our craft in this environment of lies. At Direct Access, we have no outside influences or controlling interest. There is no bureaucracy. We remain an island amid employed practice models with patient visits defined as relative value units and perverse financial incentives driving care. We are a team with individual players whose priority is to provide caring, compassionate care to each patient. Our only incentive is our patient’s health and satisfaction. What we have done, and will continue to do, in this practice is try to provide unbiased, calm, studied analysis of medical and scientific data in everything we do. BHRT and vaccine efficacy and safety are perfect examples. In doing so, we hope that you find that we provide an objective, informative alternative to the confusing and deafening noise from the media, pharmaceutical companies, and the government, and, ultimately, we will remain a trusted resource for your healthcare for years to come.
Dr. Haggerty
January 2023 Newsletter