Bulletin Allegheny County Medical Society
November 2023
Medical Emergiencies In Non-Clinical Spaces Exercise As Medicine: The War On Senescence 2023 House of Delegates Wrap-Up
Surgical oncology options for patients. When your patients need specialty care, AHN has physicians with the right expertise — like our new surgical oncologist. Dr. Chalikonda uses the most advanced minimally invasive surgical techniques to remove cancer, and to ensure the fastest and best possible outcomes.
To refer your patient, call 412-359-3115 Most major insurance plans are accepted.
06/22 Z MX1625051 ACMS Chalikonda 7.5”w x 9.75”h
Sricharan Chalikonda, MD Surgical Oncology Location: AHN Allegheny General Specialties: Expertise in diagnosing and treating patients with cancerous conditions of the pancreas and stomach Performs minimally invasive surgical procedures and HIPEC cancer treatment
Allegheny County Medical Society
Bulletin November 2023 / Vol. 113 No. 11
Opinion
Departments
Editorial.....................................5 HOD Wrap-Up ..........................7 • Winter Nourishment Sara C. Hussey, MBA, CAE & Deval (Reshma) Paranjpe, MD, MBA, FACS
Richard B. Hoffmaster, MD (2023 ACMS HOD Chair)
Editorial ....................................8 ACMS Statement of • The “New Normal” Ownership..............................17 Richard H. Daffner, MD, FACR
Society News..........................22 Perspective.............................12 • The Pittsburgh Ophthalmology • Medical Emergencies in Non-Clinical Spaces Kristen Ann Ehrenberger, MD, PhD
Articles Reportable Diseases...........11 Materia Medica ......................18 • Mavacamten (Camzyos™) Drake Meaney, PharmD, Habibur Rahman, PharmD, BCPS
Renew Your Membership .....24
Society Updates Nadine Popovich
Foundation..............................21
Perspective.............................12 • 2024 Grant Awardees • Exercise As Medicine: The War on Senescence Anthony L. Kovatch , MD
On the Cover
Aspen Grove, Near Vail, Colorado Adam Tobias, MD Adam Tobias, MD specializes in Radiology, Breast Imaging
Bulletin Medical Editor Deval (Reshma) Paranjpe (reshma_paranjpe@hotmail.com) Associate Editors 2023 Executive Committee and Board of Directors President Matthew B. Straka, MD
PAMED DISTRICT TRUSTEE
Douglas F. Clough
G. Alan Yeasted
Richard H. Daffner (rhdaffner@netscape.net)
COMMITTEES
Kristen M. Ehrenberger (kricket_04@yahoo.com)
President-elect Raymond E. Pontzer, MD
Bylaws Keith .T. Kanel, MD
Secretary Keith T. Kanel, MD
Finance William Coppula, MD
Treasurer William Coppula, MD Board Chair Peter G. Ellis, MD
Nominating Raymond E. Pontzer, MD
DIRECTORS Term Expires 2023 Michael M. Aziz, MD Micah A. Jacobs, MD Bruce A. MacLeod, MD Amelia A. Paré, MD Adele L. Towers, MD Term Expires 2024 Douglas F. Clough, MD Kirsten D. Lin, MD Jan B. Madison, MD Raymond J. Pan, MD G. Alan Yeasted, MD Term Expires 2025 Anuradha Anand, MD Amber Elway, DO Mark Goodman, MD Elizabeth Ungerman, MD Alexander Yu, MD
Anthony L. Kovatch (kovatcha42@gmail.com) Joseph C. Paviglianiti (jcpmd@pedstrab.com) Andrea G. Witlin (agwmfm@gmail.com)
ADMINISTRATIVE STAFF Executive Director Sara Hussey (shussey@acms.org) Vice President - Member and Association Services Nadine M. Popovich (npopovich@acms.org)
Administrative & Marketing Assistant Melanie Mayer (mmayer@acms.org) Part-Time Controller Elizabeth Yurkovich (eyurkovich@acms.org)
Manager - Member and Association Services Eileen Taylor (etaylor@acms.org) ACMS ALLIANCE Co-Presidents
Corresponding Secretary
Patty Barnett
Doris Delserone
Barbara Wible Treasurer Recording Secretary
Sandra Da Costa
Justina Purpura Assistant Treasurer Liz Blume
Improving Healthcare through Education, Service, and Physician Well-Being.
EDITORIAL/ADVERTISING OFFICES: Bulletin of the Allegheny County Medical Society, 850 Ridge Avenue, Pittsburgh, PA 15212; (412) 321-5030; fax (412) 321-5323. USPS #072920. PUBLISHER: Allegheny County Medical Society at above address. The Bulletin of the Allegheny County Medical Society is presented as a report in accordance with ACMS Bylaws. The Bulletin of the Allegheny County Medical Society welcomes contributions from readers, physicians, medical students, members of allied professions, spouses, etc. Items may be letters, informal clinical reports, editorials, or articles. Contributions are received with the understanding that they are not under simultaneous consideration by another publication. Issued the third Saturday of each month. Deadline for submission of copy is the SECOND Monday preceding publication date. Periodical postage paid at Pittsburgh, PA. Bulletin of the Allegheny County Medical Society reserves the right to edit all reader contributions for brevity, clarity and length as well as to reject any subject material submitted. The opinions expressed in the Editorials and other opinion pieces are those of the writer and do not necessarily reflect the official policy of the Allegheny County Medical Society, the institution with which the author is affiliated, or the opinion of the Editorial Board. Advertisements do not imply sponsorship by or endorsement of the ACMS, except where noted. Publisher reserves the right to exclude any advertisement which in its opinion does not conform to the standards of the publication. The acceptance of advertising in this publication in no way constitutes approval or endorsement of products or services by the Allegheny County Medical Society of any company or its products. Annual subscriptions: $60 Advertising rates and information available by calling (412) 321-5030 or online at www.acms.org. COPYRIGHT 2023: ALLEGHENY COUNTY MEDICAL SOCIETY POSTMASTER—Send address changes to: Bulletin of the Allegheny County Medical Society, 850 Ridge Avenue, Pittsburgh, PA 15212. ISSN: 0098-3772
Editorial
Winter Nourishment Deval (Reshma) Paranjpe, MD, MBA, FACS
T
his food column, and every one henceforth, is dedicated to my friend, colleague and role model Dr. Russell Fuhrer. Russell is a prince among men and a jewel among physicians. Many of you may know him,or know of him. As a radiation oncologist, he has taken care of very ill patients at their most vulnerable moments, always with the utmost kindness and compassion and gentle care. As a friend and colleague, he has always been a steadying and gentle voice of reason and humor. When I started practice straight out of fellowship and felt like a freshman at the seniors’ table in the high school cafeteria, he was one of the kind mentors who made me feel at home at AGH and in my own skin as a physician. We shared countless lunches in the doctors’ dining room at AGH over the years, and he shared wisdom about people, medicine, and how to enjoy and navigate life. He once told me that one of the secrets to a calm and happy life is to set aside one’s ego, and the more I see the more I know him to be right. One of the simple but great pleasures of his life has been exploring new restaurants and sharing lovely meals out with his beautiful wife, Nancy; we bonded over this column. ACMS Bulletin / November 2023
This brilliant, kind, modest, hardworking and unassuming man, beloved by patients, colleagues and staff alike—in an unforeseeable and grim irony--has been stricken by terminal malignancy himself. There really are no sufficient words at a time like this. I, like so many of his AGH family am grateful to have had the honor and good fortune of having Russell as a friend and colleague and mentor all these years. His spirit will live on in all of our actions, and may his love for the simple pleasures live on through this humble offering. Restaurants that will warm your soul on a cold night:
together perfectly. The ambiance is eclectic and welcoming and the focus on making guests feel warm and welcome in a pre-pandemic dining experience with attentive service. This is somewhere you can go to warm your heart and soul. Ethereal arancini, sublime empanadas, an out-of-thisworld lemongrass dulce de leche, and hearty pastas served on whimsical dinnerware make for a magical experience. Imagine that you have two very cool free spirited sisters who are professional chefs, and they invite you for dinner in their house. You relax, enjoy and forget your worries. This is that place.
Lilith 238 Spahr Street, Shadyside Dinner Wed-Sat, Sunday Brunch. Reservations on Resy. A worthy successor to Toni Pais’ Café Zinho which occupied the same space for decades, this restaurant is the loving endeavor of Pittsburgh chefs Jamilka Borges and Dianne DeStefano. The menu is delicious and celebrates their respective Puerto Rican and Sicilian backgrounds while working Continued on Page 6
5
Editorial From Page 5
Balvanera 1660 Smallman Street, Strip District Dinner Tues-Sat. Reservations on Resy and by website/phone. At last, the long awaited Pittsburgh outpost of this New York Argentinian restaurant has opened. This is a breezy and beautiful space, with tasty food and excellent cocktails. As you can imagine, this is a steak-heavy establishment which does not disappoint, but the really delightful jewels are the small plates and sides. Gildas, arancini, boquerones, empanadas, jamon iberico are just for starters; sides include rotisseried beet, mushroom and cabbage dishes, octopus, beef tongue and crispy sweetbreads. Chicken Milanese and
Sea Bass are also on the menu, as are an assortment of sausages and chorizo. Check out the decadent classic desserts including flan, and the lovely cocktails including a riff on the Pisco Sour and French 75 entitled the Pisco 75. Zuppa’s Delicatessen Wexford and Cranberry locations www.zuppasdeli.com Doordash delivery available; eat in or take out. For many of you, this may be an oldie but goodie. I have somehow just discovered this marvel of an establishment. If you are in the mood for good soup, under the weather, or in need of a healthy and hearty meal, this is the place. I don’t think there’s a better place for soup in all of Pittsburgh. Wedding soup, pasta fagioli, pumpkinapple-bacon, chicken, and every other manner of soup, each better than the last, and served with heavenly toasted bread on demand. Check out the spicy corn and shrimp chowder and the lobster bisque. I wanted to get all of them and nearly did. The salads are delicious—check out the spinach orzo and chopped chicken. The paninis and sandwiches feature freshly made bread and quality ingredients that will satisfy your taste buds and your wallet. The corn spoonbread is another delight you won’t find on another menu. The service is warm and kind, and the food will satisfy. Worth a trip to the Northland for the rest of you, and a jewel in your back yard for those of us in Siberia.
6
www.acms.org
2023 House of Delegates Wrap-Up
By: Sara C. Hussey, MBA, CAE & Richard B. Hoffmaster, MD (2023 ACMS HOD Chair) On October 27-28, the Pennsylvania Medical Society held its second hybrid House of Delegates (HOD) meeting, allowing attendees to participate both remotely and on-site at the Hershey Lodge. Allegheny County had a great showing, with 23 Delegates & Alternate Delegates attending in person. In addition to robust discussion and commentary online ahead of the HOD, delegates had a lively debate on many of the issues that face health care, patient care and the practice of medicine. The Allegheny County Delegation worked diligently with other counties to attempt to find a solution to the medical student delegation representation issue. Although, in the end, the medical student representation issue was deferred to an ad-hoc task force, the ACMS Chair of the Delegation felt this process has things moving in the right direction. 2023 ACMS Delegation Chair, Richard Hoffmaster, MD says: “Our ACMS Delegates, and our partners across the state, made our view clear: it is critical that our medical student and trainee colleagues be active in organized medicine. At the House of Delegates, we affirmed our commitment to these important members, who are the future of our county and state medical societies, as well as our profession as a whole. We have succeeded in calling for an ad-hoc committee at PAMED that includes all important stakeholders. Members from the Board, the MSS and RFS, and both rural and urban counties have pledged their good faith efforts to resolve this issue fairly. Our focus will be to add value to membership for student and trainee members (as well as all other members), while realigning representation at PAMED to more equitably reflect the ways in which student and trainee members contribute to PAMED, across county lines. I look forward to the hard work necessary to develop a lasting compromise.” Additionally, the House was able to affirm PAMED’s opposition to censorship in schools regarding sexual health and gender affirming care. Delegates voted to Adopt opposition to legislative efforts to criminalize or impose
ACMS Bulletin / November 2023
legal penalties against parents and guardians who allow minors to receive gender-affirming care, healthcare facilities, physicians and other healthcare providers, and patients seeking and receiving gender-affirming care. Delegates voted to reject further study, and rather Adopt a resolution instructing PAMED to ask schools across the state to develop age-appropriate comprehensive sexuality education. The resolution called for education on topics including, though not limited to, consent, gender identity, sexual orientation, abuse, STIs, and contraception. Such education has been shown to improve a multitude of important pediatric health outcomes, including teen pregnancy rates, bullying, reporting of sexual abuse, and adolescent HIV transmission. Below is a sampling of some of the resolutions that were tackled either ahead of the HOD or extracted at the event for debate. Proceedings and Actions of the 2023 HOD will soon be available online at www.pamedsoc.org/HOD. •B oard Certification: Delegates adopted the recommendation to support a model of board certification through training, exams, and continuing education. •F ood Deserts and Food Insecurity: Delegates adopted a resolution to address food insecurity and promote healthy food access, along with supporting food-related interventions for health conditions. • Advance Directive Conversations: Delegates adopted policies encouraging physicians to discuss advance directives with patients,
incorporate related education into medical schools, and enhance healthcare settings’ ability to talk with patients about advance directives. • Convergence Insufficiency Testing: Delegates chose not to adopt the addition of Near Point of Convergence screenings to school vision screening programs. • Supporting Kidney Transplants: Delegates adopted a resolution to support the safety of kidney donations. • Improving Blood Pressure Monitoring: Delegates referred the resolution for further study due to existing relevant programs and concerns. • Physician-Nurse Practitioner Prescriptive Authority: Delegates adopted support for requiring physician consent prior to nurse practitioners being assigned to them. • Equitable Mammographic Technology: Delegates adopted support for advocacy efforts to ensure full access to optimal mammographic technologies. • Surgical Attire Adaptations: Delegates adopted the removal of barriers for surgical attire adaptations, including wearing religious head coverings like hijabs. • Addressing Health Literacy: Delegates adopted recommendations to support state legislation for health literacy and promote clear communication in healthcare settings. The Resolutions Portal will be open for HOD 2024 Resolutions/Bylaws Amendments on Jan. 1, 2024.
7
Editorial
The “New Normal” Richard H. Daffner, MD, FACR
M
any years ago, a new resident of Pittsburgh made her initial visit to her new internist. While giving her medical history to her new doctor, the woman mentioned that she had frequent bruising. Her internist asked if she ever had any difficulties with bleeding. The woman related that when she was a child, she had excessive bleeding following a tonsillectomy. Further, she noted repeated heavy menstrual bleeding requiring several D and C’s, for which she ultimately underwent a hysterectomy. On hearing this, the internist sat straight up and asked his patient if she had ever been checked for a bleeding disorder. She hadn’t – not by the many physicians who had cared for her in the past. He ordered several tests for clotting factors and was not surprised when they revealed that his patient had Von Willebrand disease. The internist was “old school” and relied on a thorough medical history and physical exam as well as appropriate laboratory and imaging studies on his patients. That was the “Old Normal”, medical practice dating back to Hippocrates (c.460 – 370 BCE), who taught his followers to carefully listen to the patient’s symptoms, to examine the patient and observe the signs of disease, to make a diagnosis and then to treat the patient. 8
A few years ago, Dr Michael Lamb wrote a Perspective column for the Bulletin1 that highlighted what may be the “New Normal” in the practice of medicine. Dr. Lamb reported his observations while accompanying an elderly former patient of his to the Emergency Department (ED) at one of our local major medical centers. There, he noted that the ED physician never conducted a physical examination on the patient. To his credit, the ED physician ordered “routine” tests that included blood work, urinalysis, chest x-ray, and EKG. That same summer I had a similar, but slightly different experience while accompanying my wife on a visit with an endocrinologist who was evaluating her for osteoporosis. She had fractured her wrist in a fall and was unable to drive. After the initial pleasantries, our consultant began looking at the electronic medical record, in a manner that suggested to me that he was studying for his specialty board exam. At that point, I began noting the time on my watch. Twelve minutes later, he interrupted his fascination with the computer screen and briefly reviewed the results of my wife’s lab studies (which she and I had already discussed) with her. Then, he did a very cursory exam, all of which lasted a grand total of three minutes.
Dr. Lamb and I are “old school” graduates (although I have a few more years seniority), where we learned the importance of carefully listening to the patient’s history and performing a thorough physical exam. We learned the value of using four of our five of our senses—visual, auditory, tactile, and smell. (Really “old school “doctors tasted the patient’s urine to detect sugar!) I have always had an extraordinary sense of smell. When I was in the Air Force, we would routinely obtain throat cultures on anybody presenting with a sore throat. Those patients whose cultures grew β-streptococcus, were called back, and given a prescription for penicillin. However, whenever my patients were called, the callers learned that the patients were already taking penicillin. Thinking that I was treating every patient with a sore throat with penicillin, “the Brass“ began auditing my patients and, to their surprise, they found out that I was only treating those who subsequently had a positive culture! The hospital commander called me in and asked me how I was able to make the diagnosis. “I smell it,” I replied. “And what does β-strep smell like?” “Like β-strep, a sickly-sweet odor, very distinctive.” www.acms.org
Editorial In the first aid courses I teach, I emphasize the necessity of first responders using the same four senses at an accident scene: visually assessing the victims for obvious bleeding, respiratory distress, limb deformities, skin color; listening for abnormal breath sounds (gurgling, wheezing); feeling for pulses, skin temperature and dampness, pain on touching; and using their nose to smell for gasoline, alcohol, cannabis, or vomit. All these observations will affect how they attend to the victim(s). Dr. Lamb noted that in the world of modern medicine, the patient’s physical exam often takes second place to laboratory tests or imaging studies. In the 1940’s the diagnosis of one patient in twelve depended on lab tests or x-rays. Today, all patients will have their diagnosis made based on lab tests or imaging. Of course the pitfalls of relying solely on tests are mentioned in two of my “Diagnostic Pearls” that I emphasized to medical students,: “If you perform enough tests, you will eventually find something you cannot explain,” and “If you perform enough tests, you will eventually find something you will wish you hadn’t found.”2 I can’t count the number of times I discovered an incidental finding on a physical exam that turned out to be significant. This fact validates another one of my “Diagnostic Pearls”, “Patients are entitled to, and often have more than one disease concurrently.”2 Dr. Lamb noted, “The laying on of hands … remains a crucial part of the medical examination, even if only for the reassuring value of the physical contact.”1 It is perhaps, for this reason that chiropractors remain popular with
their patients. In my 50-year career as a diagnostic radiologist, I gravitated to super specializing in musculoskeletal (MSK) imaging. A significant portion of my day was spent interpreting images in the ED. There were many times when I would see something on an x-ray that would prompt me to go to the patient and examine the limb in question to see if that was where s/ he was symptomatic. I found that this eliminated the necessity of obtaining more images (comparison views) and the subsequent increase in radiation exposure. When we began using our PACS (Picture Archiving and Communication System) in 2005, I had to rely on telephoning the referring physician to ask if their patient hurt at a specific place that I questioned from the x-ray, since I was no longer physically present in the ED. This was part of the “New Normal”. The “New Normal” in medical practice is also on display when we visit the book vendors at medical meetings. There has been a profound change in the content and organization of medical books, catering to the new generation of physicians, who grew up in the computer age. Most of the classic medical texts had long, detailed descriptions of the various diseases discussed within. Today, medical textbooks contain many more tables, and bulleted text highlighting the important topics. While this format is very useful for preparing for board examinations, the lack of depth and detail is frightening when one considers that their physician or surgeon may have read the “Reader’s Digest®” or “Classics Illustrated®” version on the subject.
Medical education has also changed. I used to give the medical students rotating through Radiology a final exam, oriented more toward my determining how effective our teaching methods were, as well as what they had learned. My format was to use fill-in-the-blanks format (Q: “What are three findings of congestive heart failure seen on a chest radiograph? A: Cardiomegaly, pleural effusion(s), Kerley lines”). One student who received a score of 30 (out of 100) complained that the test was unfair. Why? Because they are only given multiple-choice questions. I replied that I guessed the way the system worked was that the patient handed their physician a card with five diseases, and (s)he picked one! In 2015, the American Board of Radiology (ABR) phased out its previous certification format of an initial written exam followed by an oral exam with a new protocol consisting of a “Qualifying Exam” at the end of the third year of residency and a “Certifying Exam” 15 months after completion of the residency. Both exams were in written, multiple-choice format and were image rich. I remember the most common question I was asked by resident applicants who would be the first to take the new exams was, “How were we going to change our teaching to reflect the new exams?” I could see the shocked looks on their faces when I told them, “We’re not changing anything. We’re training you to become a radiologist, not how to pass an exam. If you do your work and read the textbooks and current literature, you’ll do fine, no matter what kind of Continued on Page 10
ACMS Bulletin / November 2023
9
Editorial Editorial From Page 9
adjacent lumbar vertebra, explaining her pain. My resident, from Georgia, test they give you.” Interestingly, the upon seeing findings said, inthat his ABR, in Junethe 2023, announced deepwere southern drawl,to“Fellahs, there’s they returning an oral exam a lesson here. Crocks daah (die), for certification. They realized that the too.” Unfortunately forformat the patient, CT existing written exam did not scanning and ultrasound examsskills, had test the candidates’ reasoning not been The important which an developed. oral exam does. I hadisathat large bookshelves lesson forarray most of patients with a that spanned one whole wallillness, in my the diagnosis of psychosomatic office. These held all my symptoms areshelves real, and in fact a small radiology orthopedic and have number ofbooks, these patients indeed osteopathology reference books, as real abnormalities accounting for their well as current journals, and the slide symptoms. carousels (remember those?) that I Sigmund Freud’s view of humor used in my lectures. Many a medical was that it was a conscious expression student asked I had read all the of thoughts thatif society usually books that were in my collection. suppressed or was forbidden.2 AsI told them that I hadinread most namecover long as theyes, humor, this case
calling, is meant in a benign fashion, it istoconsidered harmless. cover. Others were for reference However, today’s evidence politicallyof only, but alsoinshowed divisive atmosphere, it is best toresidents use having been well used. When humor onlyhow whenI knew you truly know would ask some obscure your audience. As a good example, radiologic fact, I told them I had readI remember it in a book.the not so “good old days,” when wasthese expected that a aberrations, speaker So,it are examples at conference or a refresher or aare they the “New Normal”?course To older would tell jokes. Many of the “old physicians such as myself and Dr. timers” very colorful characters. Lamb itwere is frightening to think that this Today, fortunately, speakers are younger generation of physicians will business-like andUsing jokes shortcuts are tacitlyand be caring for us. forbidden, since they are to not spending time talkingbound to, listening offend we puts should to, andsomeone. examiningFinally, a patient both always remember no matter how the patient and thethat physician at risk. unpleasant some of our patients are“Cut Another of my “Diagnostic Pearls”: to us, theytoday, are still human2. a corner payour forfellow it tomorrow” beings.
Dr. Daffner, associate editor of the ACMS Bulletin, is a retired radiologist References: who practiced at Allegheny General Hospital for more than 30 years. 1. Lisamb MG. “The doctor neverof He emeritus clinical professor examined me”. ACMS Bulletin, Radiology at Temple University School Dec 2021, ppis353 354. of nine of Medicine and the–author textbooks. He can be reached at 2. Daffner RH. Clinical Radiology: bulletin@acms.org. The Essentials, 3rd ed, p 527, Kluwer, 2007 ThePhiladelphia, opinion expressedWolters in this column is that of the
writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, Dr. Daffner is a retired radiologist, or the Allegheny County Medical Society. who
practiced at Allegheny General Hospital for over 30 years. He is Emeritus References 1. Shem S. The House of God. Richard Clinical Professor of Radiology at Marek Publishers 1978. Temple University School of Jokes Medicine. 2. Freud S, (Strachey J, Trans.). and their relation to the unconscious New York: W. W. Norton, 1960 (Original work published 1905).
OUR SYSTEM or YOUR SYSTEM? It’s up to you. • Physician Billing Services for All Specialties We would use OUR billing system or YOUR billing system based on YOUR preference. • Credentialing Services for All Specialties • Accounts Receivable Follow-Up for Practice Support We would work your accounts on your system to maximize cash flow. NEW Billing Client Example: A new client (a 6-physician family medicine group) liked their EHR, so the group asked us to bill using their billing system. Besides the benefit of keeping their EHR, the group is now experiencing greater efficiency and stability in their office by eliminating problems caused by biller turnover, vacations, diversion, and other time off. Contact Ruby Marcocelli, Vice President at 412-788-8007 or rmarcocelli@fennercorp.com
Three Penn Center West Pittsburgh, PA 15276 fennercorp.com ACMS Bulletin / August 2021 10
www.acms.org 229
REPORTABLE DISEASES 2023: Q1-Q3
REPORTABLE DISEASES 2023: Q1-Q3 Allegheny County Health Department
Allegheny County Selected Health Department — Selected Reportable Diseases/Conditions Reportable Diseases/Conditions Selected Reportable Disease/Condition* AMEBIASIS ANAPLASMOSIS BABESIOSIS CAMPYLOBACTERIOSIS CANDIDA AURIS CLINICAL*** CANDIDA AURIS SCREENING*** CARBAPENEMASE-PRODUCING CARBAPENEM-RESISTANT ENTEROBACTERALES CLINICAL*** CARBAPENEMASE-PRODUCING CARBAPENEM-RESISTANT ENTEROBACTERALES SCREENING*** COVID-19 CRYPTOSPORIDIOSIS GIARDIASIS GUILLAIN-BARRE SYNDROME HAEMOPHILUS INFLUENZAE HEPATITIS A HEPATITIS B ACUTE HEPATITIS B CHRONIC HEPATITIS C PAST/PRESENT LEGIONELLOSIS LISTERIOSIS MALARIA MEASLES MPOX MUMPS NEISSERIA MENINGITIDIS PERTUSSIS SALMONELLOSIS SHIGELLOSIS SHIGATOXIN-PRODUCING E COLI STREPTOCOCCAL DISEASE INVASIVE, GROUP A STREPTOCOCCUS PNEUMONIAE INVASIVE TOXOPLASMOSIS TUBERCULOSIS TYPHOID FEVER VARICELLA WEST NILE VIRUS ZIKA VIRUS
January to September** 2021 2022 2023 3 3 3 17 32 79 2 0 2 84 84 89 0 2 1 0 5 2 10
18
23
0 67,730 16 44 3 3 0 0 50 730 51 5 5 0 0 0 0 3 81 9 24 14 8 1 13 1 4 1 0
0 139,095 21 39 1 8 1 1 38 565 34 1 3 0 68 0 1 1 90 17 13 30 26 0 3 0 10 2 0
8 17,371 20 62 6 20 1 1 21 537 31 1 2 0 2 0 0 2 103 17 15 92 40 1 14 4 16 0 0
Case definitions classifications reflect definitions utilized by CDC Morbidity and Mortality Weekly Report. * Case classifications *reflect utilized by CDC Morbidity and Mortality Weekly Report.
** These counts do not reflect official case counts, as current year numbers are not yet finalized. ** These counts do not reflect official case counts, as current year numbers are not yet finalized. Inaccuracies in working case counts may be due to reporting/investigation lag. Inaccuracies in working case counts may be due to reporting/investigation lag. ***Newly reportable in 2022.
***Newly reportable in 2022.
NOTE: Disease reports may be filed electronically via PA-NEDSS. To register for PA-NEDSS, go to https://www.nedss.state.pa.us/NEDSS. To report outbreaks or diseases reportable within 24 hours, please call the Health Department’s 24-hour telephone line at 412-687-2243. NOTE: Disease reports may be filed electronically via PA-NEDSS. To register for PA-NEDSS, go to
For more complete surveillance information, see ACHD’s 10-year summary of reportable diseases: https://www.alleghenycounty.us/Health-Departhttps://www.nedss.state.pa.us/NEDSS. To report outbreaks or diseases reportable within 24 hours, please call the Health Department’s 24-hour telephone line at 412-687-2243. ment/Resources/Data-and-Reporting/Infectious-Disease-Epidemiology/Epidemiology-Reports-and-Resources.aspx. For more complete surveillance information, see ACHD’s 10-year summary of reportable diseases: https://www.alleghenycounty.us/Health-Department/Resources/Data-andReporting/Infectious-Disease-Epidemiology/Epidemiology-Reports-and-Resources.aspx.
ACMS Bulletin / November 2023
11
Perspective
Medical Emergencies in Non-Clinical Spaces Kristen Ann Ehrenberger, MD, PhD “Kristen, someone’s having a medical emergency. Can you help?” The pastor’s wife had come up to me near the end of the worship service and was pointing in the direction of an elderly man, slumped onto his wife’s shoulder a few pews behind me. I nodded and went to kneel in front of him. He was pale but conscious enough to protest when we tried to get him to lie down on the bench: “I’m fine, I’m fine!” His pulse was regularly regular. Okay, that satisfied the ABC’s of resuscitation; he didn’t need CPR. But I didn’t like the way he looked. I signed “telephone” to the pastor’s wife. She nodded and went to call 911. While we waited for emergency medical services, I was confronted by how strange it felt to be performing patient-care tasks outside of my comfort zone in a hospital or clinic. I thought of all the equipment I didn’t have and all the tests I wanted to order. My nametag read “the organist’s wife,” for crying out loud. I hadn’t intended to be Dr. Ehrenberger that morning. And yet, I had used my hands to feel a pulse and his diaphoretic skin. That reminded me of the satisfaction of learning the neurological exam as a medical student: Follow my finger with your eyes. Can you hear my fingers rustle? Can you feel me touch? Is it the 12
same on both sides? Pull me toward you; push against me; squeeze my fingers. Sure, we have some fancy tools these days, but you don’t always need technology to do good medicine. In my mind, I reviewed a differential for syncope and sweating: acute coronary syndrome or cardiovascular accident, hypoglycemia, perhaps a heat-related illness on this warm summer day. The patient and his wife told me his only medical history was thoracic aortic aneurysm repair, and his only medication was diltiazem for atrial fibrillation. That morning he had done an intense workout designed for men 30 years younger than he was. Despite his relative health, and his chagrin at being the center of attention in public, he was clearly in extremis. So I drew on my clinical judgment and used my presence as a health care professional. Having decided he needed a higher level of care, the most I could do was sit with him, his wife, and his sister until EMS arrived with their gear. Remaining outwardly calm even though my heart was pounding from worry was the best thing I could do for them and the other congregants. Thankfully two emergency medical technicians showed up to get vital signs
(HR 50, BP 110/70, glucose 80). The man was still talking—in fact, he was delirious and having trouble following directions. He was also complaining of vision changes in his right eye. But EMTs don’t have the ability to do EKGs or IV fluids. We waited some more. Once the paramedics arrived with an ambulance, the patient was stabilized and transported to Allegheny General Hospital, where he stayed overnight for a thorough and reassuring workup. Someone remarked it was lucky that I had attended church that day, as I had been absent for several weeks due to inpatient duties and travel. However, the other current and retired doctors and nurses in the congregation would have done the same. But what if you’re surrounded by strangers who aren’t aware of your credentials? If you want to volunteer to be available when a medical emergency happens in a non-clinical space, you can download the free PulsePoint app on both Apple and Android devices. After a call comes into an emergency dispatch system such as Allegheny County EMS, the app alerts nearby users and can also locate the closest automated external defibrillator. Although modern CPR was developed here in Pittsburgh in 1960s, too few laypeople know or use it. The American www.acms.org
Perspective Heart Association estimates that more than 300,000 Americans experience an out-of-hospital cardiac arrest per year, but only 10% survive. PulsePoint.org reports that ~33% of victims of sudden cardiac arrest receive bystander CPR, although it doubles survival, and AEDs are used less than 3% of the time, even though they triple survival. When the patient and I reconnected by phone later in the week, he shared that the final diagnosis was a vasovagal response to dehydration, exacerbated by the calcium channel blocker. Finding store-bought exercise drinks too sweet for his taste, he had been hydrating with plain water, not realizing that his body would have a hard time holding onto it without electrolytes. He felt this was an important take-away point, and it occurred to me that in our healthconscious culture, electrolytes have been vilified, although salt and sugar (and fat!) are life-sustaining nutrients. In addition, the church staff discussed their emergency response preparedness and reviewed the location of the AED in the building. The Food & Drug Administration regulates the production and sale of AEDs and recommends a physician or surgeon “prescribe” the
ACMS Bulletin / November 2023
device and oversee its introduction into a non-clinical space such as a school or ballfield, because CPR and AED training improve bystanders’ willingness to intervene when needed and success when they do. The affected individual has read and approved the publication of this essay; some details may have been changed to protect their privacy.
Source: “Out-of-hospital cardiac arrest: NHLBI studies tackle deadly public health problem,” National Heart, Lung, and Blood Institute (10 February 2023). URL: https://www.nhlbi.nih.gov/news/2023/ out-hospital-cardiac-arrest-nhlbi-studiestackle-deadly-public-health-problem.
13
Perspective
Exercise As Medicine: The War on Senescence
Anthony L. Kovatch, MD “Those who love deeply never grow old, they may die of old age, but they die young.”--Benjamin Franklin Musical Accompaniment: “Autum Leaves” sung by Edith Piaf (1915-1963)--In spite of an abbreviated, trouble life, the French singer’s largely autobiographical songs about love, loss, and sorrow made her one of the most celebrated cabaret performers of the 20th century. https://www.youtube.com/ watch?v=tIFPIscO2gM Since you went away, the days grow long And soon, I’ll hear old winter’s song But I miss you most of all, my darling When autumn leaves start to fall
Although love of life starts in the cradle, I have learned that its endurance is particularly challenged in “the autumn 14
of the year” with the emergence of variables beyond our control: retirement, loss of loved ones and contemporaries, departure of grown children from the nest, social/political cynicism, existential dread, physical disabilities, such as sarcopenia, expanding abdominal obesity, and cognitive decline, etc. It was with these variables in mind that I ---admittedly with mixed emotions and some trepidation regarding what I would learn about my future---attended the second annual Fritzky Family Integrative Health Summit on September 21-22, 2023, hosted by the Duquesne University College of Osteopathic Medicine, poised to open its new medical school in 2024. The symposium featured speakers and researchers from “many walks of medicine” and was supported by our own ACMS. The agenda featured a two-pronged approach to advancing health equity and preventing chronic disease in the 21st century. The first prong focused on the social determinants of health--in particular, making the “invisible” public health infrastructure more visible, expanding the REACH (Racial and Ethnic Approaches to Community Health) Project, unique maternal-infant-child health issues, and advances in “digital health” tools. This quote by Cardinal Roger Mahoney, archbishop of Los Angeles from 1985 to 2011 and an outspoken leader for justice on behalf of farmworkers, immigrants and other victims of economic prejudice, remains as viable a mission statement today as it was at the turn of the century: “Any society, any nation, is judged on the basis of how it treats its weakest members: the last, the least, the littlest.”
I later realized that if Edith Piaf had been born a century later in the United States, she could be the embodiment of a member of society reflecting the social determinants of health. Piaf was called “The Litte Sparrow,” not only because of her iconic heart-rending voice, but because of her diminutive stature (4 feet 8 inches tall and 90 pounds) and her extreme nervousness. She had an overwhelming number of reasons to live a life fraught with anxiety. Piaf was abandoned at birth by her mother (a café singer), reared by her grandmother in a brothel, became blind at age 3 as a complication of keratitis (she recovered her sight four years later, somewhat mysteriously), and, while in the company of petty criminals, gave birth to an illegitimate daughter who died of meningitis at 2 years of age. Politically, Piaf was accused by the French government of being an accomplice to the murder of her stage manager and of collaborating with German-occupying forces in World War II. Socially, her true lover died in an airplane crash and her first marriage terminated in divorce. Medically, treatment of painful injuries resulted in drug dependence and alcohol abuse requiring detoxification. When she died of liver cancer at the age of only 47, “The Waif Sparrow” was regarded, and still is regarded, as one of the world’s greatest popular singers. At the Q and A session ending that first component of the symposium, I nervously proffered this comment to the audience: “When I started pediatric practice over 40 years ago, my major mental health efforts concentrated on managing toilet training refusal and deciding whether to treat children with ADHD with Ritalin or with an amphetamine; by the time www.acms.org
Perspective I retired, I felt it necessary to treat (or at least to start treatment on) every psychiatric condition in the DSM-5. I envisioned myself as a psychiatrist who just happened to be a pediatrician!” I then entreated all primary care providers to try to evolve in this way in the years to come! As a pediatrician, I found the second prong of the conference’s approach to integrative health-----healthy aging and longevity medicine---highly relevant and illuminating, for both my physical and spiritual well-being. The title of the inaugural lecture in the second prong served as a fitting metaphor for an anti-aging revolution: “Longevity: Aging Like a Fine Wine Instead of a Glass of Milk, and How Exercise Can Help.” The mental disciple of exacting regular exercise into one’s lifestyle is certainly no novelty and its physiologic benefits have been abundantly documented from the scientific perspective. However, it was cardiologist, accomplished runner, and bestselling author Dr George Sheehan who spearheaded the national running craze in the 1970’s-80’s, launched by the publication of his bellwether treatise on the “total experience” of running and exercise in 1975, entitled “Running and Being.” Embarking on what he termed “the blood sport of running” in middle age, Sheehan—a self-proclaimed introvert--championed the benefits of the “athletic life” beyond the physical: the value of running as “play,” the opportunities for self-discovery and personal growth, and, especially, the interfacing with our spirituality. After last place finishes in competitive races, I recruit the hope and strength to carry on by reciting internally one of Sheehan’s best-known quotes:
“It’s very hard, in the beginning, to understand that the whole idea is not to beat the other runners. Eventually, you learn that the competition is against the little voice inside you that wants you to quit.”
When running guru Dr George Sheehan was not participating in marathons or giving lectures, he could be found writing his influential books at his beachside home at the Jersey shore. I can think of no better slogan to define the second prong of the symposium than “The War on Senescence.” The medical profession is reversing its role in society from treating the complications of aging, like performing joint replacements and recommending drugs to ameliorate memory loss, from “prescribing” modalities that actually inhibit the breakdown of the body (and soul) due to the mitochondrial dysfunction germane to the aging process. Current research on the pathophysiology of damage caused by senescent cells dominated the graphs of the presentations. Cellular senescence is a phenomenon characterized by the cessation of cell
division. Bench research has shown that human stem cells in culture reach a maximum of approximately 50 cell population doublings before becoming senescent. This process is known as “replicative senescence;” the discovery that human cells are mortal paved the path for the understanding of cellular aging molecular pathways. Cellular senescence can be initiated by a wide variety of stress-inducing events, both environmental and internally-damaging (primarily oxidative stress). These senescent cells are at the forefront of the aging phenotype; most importantly, senescent astrocytes and microglia contribute to neurodegeneration, having profound effects on memory and sleep. I must confess that, as a pediatrician, I had no prior knowledge of the term “senolytic.” Senolytic agents actually eliminate senescent cells, whereas senomorphics modulate their properties without eliminating them, suppressing phenotypes of senescence. Natural flavonoids, such as Fisetin and Reversatrol have been found to possess potent antioxidant activity—similar to the supplement endorsed by many of integrative medicine persuasion, Coenzyme Q10. Fisetin, a compound of polyphenols found in many plants, fruits, and vegetables, such as strawberries, apples, persimmons, onions, and cucumbers, has been found in studies on mice to have senolytic effects that destroy the senescence cells that accelerate aging and diseases, such as cancer. Not only naturally-occurring compounds are being researched. The popular angiotensin II receptor agonist losartan (Cozaar) has demonstrated antifibrotic properties in preliminary studies and may serve as a boon to preserve the overstressed joints of the avid runner (like myself). Continued on Page 16
ACMS Bulletin / November 2023
15
Perspective From Page 15
Prevention may be the key to a longer, happier life. As president John Fitzgerald Kennedy argued: The time to repair the roof is when the sun is shining.” It logically follows that preventative measures like running should commence in early childhood. After he won the Pittsburgh Great Race last month, I interviewed recordsetting elite runner and coach Nick Wolk and posed to an expert the question: How should one approach long-distance running in middle age? Wolk, who started running at the age of 6 and ran his first Great Race at the age of 10 (but is wise and practical well beyond his age of 25 years), urged taking up the initiative with moderate goals and not dive into running too aggressively to avoid injury. I asked him the hackneyed
question regarding the optimal pre-race diet, and we agreed the correct answer is “anything that does not upset your stomach!---if the furnace is hot enough, anything will burn.” His simple paradigm for running in older age: just practice, avoid crazes (like super beets), deny comfort, and keep the blood flowing--especially to the area of the abdominal fat. Wolk and his cross-country charges consummated the practice he was conducting with a prayer-like quote from college basketball icon John Wooden: “Talent is God-given. Be humble; Fame is man-given. Be grateful; Conceit is self-given. Be careful. Overall, I learned from the conference that humility, dedication, empathy, and subjugation of the ego are the pillars of overcoming defeat and despair in
the autumn of the year---along with an appreciation of humor! I found this engaging little poem in a magazine on “aging happily” while waiting for a “trim” of my almost completely grey hair in a barber shop last week---in preparation for Halloween. Staying in the Race in Spite of Obstacles “When your crinkles turn to wrinkles And your wrinkles turn to seams, When your nicely rounded bottom Is a widely flattened beam, When you see your outsides changing while your insides stay the same--so old age won’t overtake you, KEEP ON RUNNING! That’s the game! ---from “What’s So Funny About Getting Old?”
Strategic Planning When joining or leaving a health system.
For information contact John Fenner Cell: 412-638-1846 Email: fenner@fennercorp.com
Three Penn Center West Pittsburgh, PA 15276 fennercorp.com Specializing in Hospital and Physician Consulting and Billing Since 1991 16
“Runner’s Facies”: love of running keeps us young at heart!
www.acms.org
Perspective
ACMS Bulletin / November 2023
17
Materia Medica
Mavacamten (Camzyos™) Lauren Maurer, Doctor of Pharmacy Candidate, University of Pittsburgh School of Pharmacy, Pittsburgh, PA Background: Mavacamten (Camzyos™) is a novel cardiac myosin inhibitor indicated to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms, and was FDA approved in April 2022.1 Hypertrophic cardiomyopathy (HCM) is a myocardial disorder characterized by primary left ventricular hypertrophy. HCM can be broadly defined by excess myosin actin crossbridge formation, with core pathophysiological features that include hypercontractility, diastolic abnormalities, impaired rate of relaxation of the sarcomere, and dynamic left ventricular outflow tract (LVOT) obstruction.2-3 oHCM, defined as HCM with LVOT obstruction, is observed in approximately 70% of patients with HCM.4,5 Patients with oHCM are often symptomatic and can have atrial fibrillation, heart failure, and malignant ventricular arrhythmias. As an allosteric and reversible inhibitor selective for cardiac myosin, mavacamten reduces actin-myosin cross-bridge interaction, leads to attenuated contractility, improves energetics, causes less LVOT obstruction, causes more effective myocardial relaxation, and increased left ventricular compliance.3 Prior to mavacamten, oHCM patients were limited to treatment with beta blockers, nondihydropyridine calcium channel blockers, and disopyramide. These non-specific agents are often poorly tolerated and do not address or modify the underlying molecular mechanisms of hypertrophic cardiomyopathy.3 Invasive septal reduction therapy can effectively help oHCM
18
patients with drug refractory symptoms, but carries risks inherent to invasive procedures and requires expertise that is not universally available.2 A supplemental new drug application was submitted in October 2022 for mavacamten in symptomatic oHCM to reduce the need for septal reduction therapy (SRT) which is still pending FDA review. Mavacamten is formulated as an oral capsule to be taken once daily, and is available in 2.5 mg, 5 mg, 10 mg, and 15 mg strengths.1 Safety: In a 2020 phase 3 trial (EXPLORER-HCM) conducted in patients with oHCM, the incidence of transient decrease in LVEF to less than 50% associated with mavacamten was greater than placebo.3 The incidence of other drug-related adverse events associated with mavacamten was similar to placebo. In this randomized, double-blind, placebo-controlled, parallel-group trial, patients with oHCM and NYHA class II–III symptoms were assigned (1:1) to receive mavacamten (starting at 5 mg) (n=123) or placebo (n=128) for 30 weeks. Prespecified safety endpoints included frequency and severity of treatment-emergent adverse events (TEAEs) and serious adverse events. TEAEs were generally mild in this study, and patients with one or more TEAE were more commonly from the treatment group as opposed to the placebo group (108 [88%] in mavacamten, 101 [79%] in placebo). There were 11 serious adverse events reported by 10 (8%) patients on mavacamten versus 20 events reported by 11 (9%) on placebo. There were 7 (6%) mavacamten patients and 2 (2%) placebo patients that had a transient decrease in LVEF to less than 50%. Five patients (3 on
mavacamten, 2 on placebo) had protocoldriven temporary treatment discontinuation for LVEF less than 50% during the 30-week treatment period (median LVEF 48%, range 35–49). LVEF normalized in all patients, and they resumed treatment and completed the study. Four additional patients on mavacamten had LVEF less than 50% (range 48–49) at week 30 (end-of-treatment visit). LVEF was confirmed to recover to baseline after the 8-week washout period in 3 patients, and partially recovered to LVEF 50% in the fourth patient. This study demonstrated the relative safety of mavacamten, despite a higher association with decrease in LVEF than placebo. In a 2022 phase 3 trial (VALOR-HCM) conducted in patients with oHCM who met guideline criteria for septal reduction therapy (SRT), patients were randomized (1:1) to mavacamten (n=56), 5 mg daily, or placebo (n=56), titrated up to 15 mg based on LVOT gradient and LV ejection fraction.2 Safety endpoints included incidence of LV ejection fraction < 50%, permanent discontinuation for LVEF < 30%, and death/myocardial infarction/ or stroke. The only subjects meeting a safety endpoint were 2 (3.6%) subjects in the mavacamten group that had transient LVEF decrease to < 50% resulting in temporary drug discontinuation. These 2 patients resumed treatment without further adverse effects. Serious TEAEs occurred in 3 patients (5.4%) in the mavacamten group, with atrial fibrillation in 2 patients (3.6%), and COVID-19 infection in 1 patient (1.8%). There was 1 patient in the placebo group (1.8%) who developed a serious on-treatment adverse event (alcohol poisoning).
www.acms.org
Materia Medica Due to the attenuating effect of mavacamten on contractility and resultant systolic dysfunction, this medication can cause heart failure, as shown with transient LVEF decreases in aforementioned studies.1-3 This is a boxed warning, and as a result, mavacamten is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Echocardiogram assessments of LVEF are required prior to initiation, 4 weeks after each dose titration, and every 12 weeks during maintenance treatment with mavacamten. Initiation of mavacamten in patients with LVEF < 55% is not recommended. Mavacamten should be interrupted if LVEF is < 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.1 Another important consideration with this medication is that due to extensive CYP450 metabolism (primarily through CYP2C19 (74%), CYP3A4 (18%), and CYP2C9 (8%)), the use of mavacamten is contraindicated with moderate to strong inducers and inhibitors of CYP2C19 and CYP3A4.1 No renal dose adjustments are listed, as mild or moderate renal impairment had no clinically significant effect on mavacamten pharmacokinetics with the caveat that this drug was not studied in subjects with eGFR < 30 mL/min. No hepatic dose adjustments are listed, but exposure increased up to 220% in Child-Pugh class A or B patients (class C not studied) compared to patients with normal hepatic function.1 This being stated, no additional dose adjustment is required besides the recommended dose titration algorithm and monitoring plan. With pregnancy considerations, in utero exposure to mavacamten may cause fetal harm. Tolerability: Appreciating the risk of LVEF reduction, mavacamten has been otherwise shown to be well-tolerated by patients in clinical trials. The most common drug-related TEAEs were dizziness and syncope.2,3 In the EXPLORERHCM trial, the total number of TEAEs of any grade were similar between groups (419,
ACMS Bulletin / November 2023
425).3 Adverse reactions occurring in >5% of patients and more commonly on mavacamten than on placebo were dizziness (27%, 18%) and syncope (6%, 2%). There were two patients (1.6%) that discontinued mavacamten treatment prematurely due to adverse events (atrial fibrillation and syncope). In the VALOR-HCM trial, patients with investigator-reported TEAEs were more commonly from the mavacamten group than the placebo group (73.2%, 61.8%).2 However, no patient had a TEAE severe enough to result in withdrawing from the trial. Adverse events of interest included fatigue (8.9%, 3.6%), headache (3.6%, 9.1%), dyspnea (7.1%, 5.5%), dizziness (7.1%, 5.5%), nausea (7.1%, 1.8%), rash (7.1%, 0%), and COVID-19 infection (1.8%, 3.6%). Efficacy: Mavacamten has now been subject to 2 separate studies, EXPLORER-HCM and VALOR-HCM, evaluating efficacy for 2 separate indications. Efficacy of mavacamten in adults with symptomatic NYHA class II-III oHCM to improve exercise capacity and symptoms was studied in EXPLORER-HCM, a randomized, double-blind, placebo-controlled trial.3 Patients were allowed to continue standard hypertrophic cardiomyopathy medical therapy except disopyramide (for safety reasons). This included monotherapy with a beta blocker or calcium channel blocker if dosing remained stable for at least 2 weeks before screening and no changes were anticipated during the study. Of patients included in the study, background hypertrophic cardiomyopathy therapies continued were beta blockers (76%, 74%) and calcium channel blockers (20%, 13%). The primary endpoint was a composite to assess clinical response at week 30 compared with baseline, defined as a 1.5 mL/kg per min or greater increase in mixed venous oxygen tension (pVO2) and at least one NYHA class reduction; or a 3.0 mL/kg per min or greater improvement in pVO2 and
no worsening of NYHA class.3 Given this, 45 (37%) of 123 patients on mavacamten versus 22 (17%) of 128 on placebo met the primary endpoint (difference +19.4%, 95% CI 8.7 to 30.1; p=0.0005). Patients on mavacamten had greater reductions than those on placebo in post-exercise LVOT gradient (–36 mm Hg, 95% CI –43.2 to –28.1; P<0.0001), and greater increase in pVO2 (+1.4 mL/kg per min, 0.6 to 2.1; p=0.0006). Patients on mavacamten also had improved symptom scores than those on placebo.3 Based upon these results, the authors concluded that treatment with mavacamten improved exercise capacity, LVOT obstruction, NYHA functional class, and health status in patients with oHCM.3 Efficacy of mavacamten in adults with symptomatic New York Heart Association (NYHA) class III-IV oHCM to reduce the need for septal reduction therapy was studied in VALOR-HCM, a randomized, double-blind, placebo-controlled trial.2 The trial enrolled patients treated with maximally tolerated medical therapy. For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications < 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study was an exclusion criterion. Of patients included in the study, the most common background hypertrophic cardiomyopathy therapies continued were beta blocker monotherapy (46.4%, 44.6%), and nondihydropyridine calcium-channel blocker monotherapy (12.5%, 17.9%). One hundred and twelve oHCM patients were enrolled, mean age 60 ± 12 years, 51% men, 93% New York Heart Association (NYHA) functional class III/IV, with a mean postexercise LVOT gradient of 84 ± 35.8 mm Hg.2 After 16 weeks, 10 mavacamten patients (17.9%) and 43 placebo patients (76.8%) met guideline criteria or underwent SRT, difference (58.9%; 95% CI: 44.0%-73.9%; P < 0.001).2 Hierarchical testing of secondary outcomes Continued on Page 20
19
Materia Medica From Page 19
showed significant differences (P < 0.001) favoring mavacamten, mean differences in post-exercise peak LVOT gradient −37.2 mm Hg; ≥1 NYHA functional class improvement 41.1%; and an improvement in patientreported outcome. Based upon these results, the authors concluded that in oHCM patients with intractable symptoms, mavacamten significantly reduced the fraction of patients meeting guideline criteria for SRT after 16 weeks.2 It should be noted that while the results of the 2020 EXPLORE-TCM trial led to mavacamten being approved to improve exercise capacity and symptoms in oHCM, the FDA is currently reviewing (not yet approved) this medication for symptomatic oHCM to reduce the need for septal reduction therapy, as demonstrated in the 2022 VALOR-HCM trial. Price: The average wholesale price for one capsule of mavacamten is $294.25 and is the same for all doses (2.5 mg, 5 mg, 10 mg, 15 mg). The drug is dispensed in bottles containing 30 capsules per bottle. As this medication is taken once daily, cost per 30 days is $8,828, and cost per year is $107,401.1 The manufacturer, Bristol Myers Squibb, does offer a patient assistance program for patients to help with medication costs. Simplicity: Mavacamten is available in 4 different capsule strengths (2.5 mg, 5 mg, 10 mg, 15 mg), and should be taken daily.1 There are several elements of mavacamten therapy that complicate use. The existence of the mavacamten REMS program, as well as the requirement for LVEF assessment at initiation and 4 weeks after each dose titration, necessitates a considerable amount of follow up. In addition to this, contraindications stemming from considerable drug interactions with CYP450 inhibitors and inducers
20
necessitates reviewing patient medications each time a medication is initiated or discontinued.1 This includes nondihydropyridine calcium channel blockers, another class of hypertrophic cardiomyopathy medications, which are moderate CYP3A4 inhibitors and may increase mavacamten serum concentrations. Other non-specific agents for HCM (beta blockers, nondihydropyridine calcium channel blockers, and disopyramide), all available as cost-effective generics, may be simpler to manage than mavacamten given less monitoring and interactions, albeit at the expense of the added benefits that mavacamten may provide in oHCM patients. Bottom line: Mavacamten (Camzyos™) is an effective agent and is approved for improving exercise capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III oHCM. It is also an effective medication for symptomatic oHCM to reduce the need for septal reduction therapy, however, has yet to be approved for this indication. Mavacamten is a first-in-class cardiac myosin inhibitor that addresses the underlying molecular mechanisms of hypertrophic cardiomyopathy and modifies its natural history, whereas the previous stalwarts of oHCM management (beta blockers, nondihydropyridine calcium channel blockers, and disopyramide) just target the symptoms of oHCM. The most notable adverse effects seen with mavacamten use in clinical trials were dizziness, syncope, and reversible reductions in LVEF to <50%. The potential for CYP450 drug contraindications, REMS program requirement, and high cost may preclude use in some patients, despite the potential of mavacamten to be a disease-altering medication for oHCM.
PharmD, BCPS, BCGP, the director of Geriatric Pharmacotherapy and director of the PGY2 Geriatric Pharmacy Residency, served as editor and mentor for this work and can be reached at sakelyh@upmc.edu
References: 1. Camzyos (mavacamten) [prescribing information]. Brisbane, CA: MyoKardia Inc; May 2022. 2. Desai M, Owens A, Geske J, et al. Myosin Inhibition in Patients With Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy. J Am Coll Cardiol. 2022 Jul, 80 (2) 95–108. 3. Olivotto I, Oreziak A, Barriales-Villa R, et al.. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, doubleblind, placebo-controlled, phase 3 trial. The Lancet. 2020;396(10253):759-769. doi:10.1016/s0140-6736(20)31792-x. 4. Sneha S. Jain, Sophia S. Li, Jipan Xie, Megan B. Sutton, Jennifer T. Fine, Jay M. Edelberg, Wei Gao, John A. Spertus & David J. Cohen (2021) Clinical and economic burden of obstructive hypertrophic cardiomyopathy in the United States, Journal of Medical Economics, 24:1, 1115-1123, DOI: 10.1080/13696998.2021.1978242 5. Butzner M, Leslie DL, Cuffee Y, Hollenbeak CS, Sciamanna C, Abraham T. Stable Rates of Obstructive Hypertrophic Cardiomyopathy in a Contemporary Era. Front Cardiovasc Med. 2022;8:765876. Published 2022 Jan 6. doi:10.3389/fcvm.2021.765876
Dr. Meaney is a PGY1 Pharmacy resident at UPMC St. Margaret and can be reached at meaneydt@upmc.edu. Dr. Rahman is a PGY2 Ambulatory Care Pharmacy resident at UPMC St. Margaret and can be reached at rahmanh@upmc.edu. Heather Sakely,
www.acms.org
ACMS Foundation | 850 Ridge Avenue | Pittsburgh, PA 15212
The ACMS Foundation Board of Trustees is pleased to announce the 26 organizations that are receiving over $250,000 in grant funds for the 2024 year. These grant dollars will support local projects and initiatives that will help support families and work to create a healthier region.
Abiding Missions
Light of Life Ministries, Inc.
Anchorpoint Couneling Ministry
Mary and Alexander Laughlin Children’s Center
Angels’ Place, Inc.
MAYA Organization
Beverly’s Birthdays
New Sun Rising - Camp Lucy
Blind & Vision Rehabilitation Services of Pittsburgh
North Hills Affordable Housing (dba HEARTH)
Church Union
NurturePA
Community Human Services Corporation
Open Hand Ministries
Family House Inc.
Roots of Faith (ROF) - Faith United Methodist Church
Familylinks
Samaritan Counseling, Guidance, Consulting
Footbridge for Families, Inc.
Sojourner House
Global Links
South Hills Interfaith Movement
Homeless Children’s Education Fund
Strong Women, Strong Girls
Jeremiah’s Place
The Children’s Home of Pittsburgh
Looking to boost your year-end giving? The ACMS Foundation could use your support! Scan this QR Code to Donate viz Qgiv or visit acms.org/acms-foundation/donate/.
To learn more about the ACMS Foundation, visit: acms.org/acmsfoundation.
ACMS Bulletin / November 2023
21
Society News
The Pittsburgh Ophthalmology Society October Monthly Meeting - Featuring Guest Faculty Carol Shields, MD Nadine Popovich - ACMS Vice President—Membership and Association Services She has contributed extensively to the field of retinoblastoma with research regarding clinical features of retinoblastoma, treatment of retinoblastoma, and risks for retinoblastoma spread and has pioneered the use of intravenous chemo reduction, intra-arterial chemotherapy, subtenon’s chemotherapy, and intravitreal chemotherapy.
The Pittsburgh Ophthalmology Society hosted their monthly meeting on October 5. This meeting attracted a record attendance of 80 members who welcomed world-renowned ocular oncologist Carol Shields, MD, Director, Oncology Ocular Service, Wills Eye Hospital, Philadelphia, PA. Thank you to Pamela Rath, MD, President of the Society, for inviting Dr. Shields and to Johnson and Johnson Surgical Vision and Thea Pharma Inc., for support of the program. Colleagues and family members were in the audience to welcome Dr. Shields back to Pittsburgh and to reconnect. The program included a case presentation by Saloni Kapoor, MD, Second Year Resident at the UPMC Vision Institute. Dr. Shields is a recipient of the American Academy of Ophthalmology Honor Award and was the first female ophthalmologist in the world to receive the prestigious Donders Medal for excellence in ophthalmology from the Dutch Ophthalmologic Society in 2003.
22
Members and guests appreciated the opportunity to engage with and listen to remarks by State Representative Venkat, who is the first physician in the general assembly in over 60 years. Thank you to Sharon Taylor, MD, FACS who invited State Representative Venkat. Featured in the photo below middle is State Representative Arvind Venkat, MD (second from left with Sharon Taylor, MD, FACS (immediate past president, Pennsylvania Academy of Ophthalmology); Pamela Rath, MD (President, POS); Kenneth Cheng, MD (Legislative Chair, POS).
After the Business meeting, the Society welcomed State Representative Arvind Venkat, MD. He serves as State Representative for the 30th Legislative District, which includes part of Hampton Township, and all of McCandless, Franklin Park, Ohio Township, Emsworth, Ben Avon, Ben Avon Heights, and Kilbuck.
Sara Hussey, CAE, MBA, Executive Director of the Allegheny County Medical Society, attended the meeting to greet members of the POS. In her opening remarks, Pamela Rath, MD, President encouraged Society members to support and join the Allegheny County Medical Society. In the photo above, Pamela Rath, MD with Sara Hussey, CAE, MBA. There is no meeting in November as the American Academy of Ophthalmology’s national meeting takes place November 3-6, 2023.
www.acms.org
Society News
Pittsburgh Ophthalmology Society (POS) Reconvenes December 14 The POS returns to the PNC Champions Club Thursday, December 14. The group will welcome Natasha Nayak Kolomeyer, MD, Board-certified ophthalmologist and Fellowship-trained Glaucoma Specialist, Wills Eye Hospital; Assistant Professor of Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA. Thank you to Sharon Taylor, MD, FACS for inviting Dr. Kolomeyer and to Alcon for support of the December meeting.
Natasha Nayak Kolomeyer, MD
Dr. Kolomeyer has been the recipient of numerous awards and grants throughout her career. These include the Achievement Award from the American Academy of Ophthalmology; the Mentoring for the Advancement of Physician Scientists grant as well as the Healthcare Policy Leadership Development grant from the American Glaucoma Society; the Resident Excellence Award and Resident
Research grant from the American Society of Cataract and Refractive Surgery; and The Chairman’s Award for Academic Honors and Distinction from the New York Eye and Ear Infirmary. Dr. Kolomeyer is the author of numerous book chapters and 35+ peer-reviewed publications and serves on committees for the American Glaucoma Society, American Academy of Ophthalmology, Association for Research in Vision and Ophthalmology, and the Pennsylvania Academy of Ophthalmology. Contact Nadine Popovich, administrator, to confirm the status of your membership, registration, or to inquire about an upcoming program. She can be reached by email npopovich@acms.org or by phone 412.321.5030 x110.
SO NT AL RE R FO
Lumiere #1008 - Downtown $339,000
LE NG SA DI N PE
“A Great Negotiator”
“Incredibly Knowledgeable”
209 Third St - Aspinwall $525,000 !
R T DE AC UNNTR O C
LD
SO
Julie Rost | Top 1% of All BHHS Agents $50+ Million in 2022 Sales More than 700 Satisfied Past Clients
julierost.com 131 S Dallas - Point Breeze $799,900
ACMS Bulletin / November 2023
Office: (412) 521-5500 Cell Phone: (412) 370-3711
6680 Woodwell - Squirrel Hill $525,000
23
850 Ridge Avenue, Pittsburgh, PA 15212
RENEW YOUR ACMS MEMBERSHIP
TODAY
The Allegheny County Medical Society (ACMS) membership provides advocacy and local support for physicians. RENEW YOUR MEMBERSHIP
More Information : www.acms.org
SCAN QR CODE TO RENEW NOW