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BULLETIN Allegheny County Medical Society

January 2024 / Vol. 114 No. 01

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BULLETIN Allegheny County Medical Society

January 2024 / Vol. 114 No. 01

Opinion

Society News

Editorial

ACMS News

Editorial

ACMS Foundation

• The Shoemaker's Children Deval (Reshma) Paranjpe, MD, MBA, FACS • Incidental Findings Richard H. Daffner, MD, FACR

Women’s Maternal Health

• Why We Need to Talk About the Risks of Childbirth Jocelyn Fitzgerald, MD, URPS

Women’s Maternal Health • Understanding Autonomy in Obstetrics Marta Kolthoff, MD

Editorial

• Safeguarding Infants from RSV Infection Raymond E. Pontzer, MD

• Looking Ahead to 2024 New Year, New Goals Raymond E. Pontzer, MD • MAYA Organization Catching Moms MAYA Staff Member

Articles Legal Update

• Assessing Impact of Venue Rule Change Philadelphia Medical Malpractice Cases Surge Curt Schroder — Executive Director at PCCJR

Materia Medica

ACMS News

• Embracing Maternal Health Awareness Day: A Call to Action for Physicians Sara Hussey, MBA, CAE

• Tofersen (Qalsody™) Madeline Dillen, PharmD; Abigal Reigh, PharmD, BCPS

ACMS News

• Specialty Group Updates Nadine Popovich — Vice President of Member & Association Services at ACMS; Eileen Taylor — Manager of Member & Association Services at ACMS; Melanie Mayer — Administrative & Marketing Assistant at ACMS

Cover Photo by Michael Lamb, MD Michael Lamb, MD specializes in Internal Medicine ACMS Bulletin / January 2024

Bulletin Managing Editor Sara C. Hussey, MBA, CAE ACMS Executive Director shussey@acms.org Medical Editor Deval (Reshma) Paranjpe, MD reshma_paranjpe@hotmail.com

2024 Executive Committee and Board of Directors

PAMED District Trustee

President Raymond E. Pontzer, MD

2024 Board Committees

President-elect Keith T. Kanel, MD

Bylaws Kirsten D. Lin, MD

Secretary Kirsten D. Lin, MD

Finance William Coppula, MD

Treasurer William F. Coppula, MD

Nominating Keith T. Kanel, MD

Board Chair Matthew B. Straka, MD

Women’s Committee Anu Anand, MD & Tiffany DuMont, DO

G. Alan Yeasted, MD, FACP

Bulletin Designer Victoria Gricks

victoria@thecorcorancollective.com

2024 Associate Editors will be approved at the Feb. 13th, 2024 Board Meeting.

Term Expires 2025 Anuradha Anand, MD Amber Elway, DO Mark A. Goodman, MD Elizabeth Ungerman, MD, MS Alexander Yu, MD Term Expires 2026 Michael M. Aziz, MD, MPH, FACOG Michael W. Best, MD Richard B. Hoffmaster, MD Micah A. Jacobs, MD, FIDSA Jody Leonardo, MD

Administrative Staff Executive Director Sara Hussey shussey@acms.org Vice President - Member and Association Services Nadine M. Popovich npopovich@acms.org Manager - Member and Association Services Eileen Taylor etaylor@acms.org

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.

Directors Term Expires 2024 Douglas F. Clough, MD David J. Deitrick, DO Jan B. Madison, MD Raymond J. Pan, MD G. Alan Yeasted, MD, FACP

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.

Administrative & Marketing Assistant Melanie Mayer mmayer@acms.org Part-Time Controller Elizabeth Yurkovich eyurkovich@acms.org Bulletin Designer Victoria Gricks victoria@thecorcorancollective.com

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.

Improving Healthcare through Education, Service, and Physician Well-Being 4

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Society News

Looking Ahead to 2024 New Year, New Goals

By: Raymond E. Pontzer, MD – 2024 ACMS President The Allegheny County Medical Society (ACMS) is now entering its 159th year, poised to be better than ever supporting our members in order to improve healthcare in our county, region and state. During the past couple of years, ACMS has experienced a transformation in leadership and staff, focused on supporting the everchanging needs of our members. Our executive director, Sara Albert-Hussey, and her staff have made great strides in stabilizing and modernizing the infrastructure of the administration as well as adding a fresh approach to our many outreach efforts, including our multiple social media platforms. Additionally, ACMS has also derived great benefit from our executive leadership and involved board of directors. I have had the opportunity and privilege to witness the energy and determination of both our departing board chair Peter Ellis and our past president and current board chair Matt Straka working together to lead ACMS forward. As we move into 2024, our focus will continue to be on the ACMS mission. That is to improve healthcare through education, advocacy, service, and physician well-being. Our society continues to be active in administration and educational activities with various specialty societies. This past year, ACMS added the Allegheny County Immunization Coalition (ACIC) to its association management umbrella. I was privileged to participate in their recent conference and was again impressed with the performance of the ACMS staff that managed this conference, as well as the

ACMS Bulletin / January 2024

smooth administration of other past conferences in which I have personally been involved. This past fall, Rick Hoffmaster worked diligently to lead our House of Delegates team in Hershey. The ACMS delegation worked together seamlessly to assist in advancing resolutions that will hopefully result in bettering physician well-being and overall improving healthcare in our state. However, I believe that we have the potential to further amplify and expand our advocacy impact through publicizing important ongoing issues in the legislature and keeping our members informed to further influence your legislators in real time. With this in mind, we are planning to closely liaison with key health care stakeholders in the legislature, as well as PAMED, to stay focused on ongoing proposed health care bills in Harrisburg and Washington. Relaying this information to our members in a timely fashion may allow you to have personal input with the legislator in your district. This personal input can make a significant difference in the outcome of legislation having a direct impact on healthcare. Another important issue for ACMS is physician well-being. During my 40 years in clinical practice, there have been ever increasing work burdens added to the physicians, including administrative, EHR documentation and insurance (i.e. prior auth) taking out much of the joy of our profession. At ACMS, in partnership with PAMED, we are launching a program to assist our members dealing with “burn out”. Here in Allegheny County, we have also initiated contacts with leaders

from UPMC and AHN to work together to better address this major issue. Additionally, we have been in touch with a nationally-recognized company, Abridge, to facilitate the use of artificial intelligence to assist in EHR documentation. There are reports that utilizing their program has resulted in a significant reduction in the time spent performing EHR documentation. ACMS is presently working with Abridge to make their product available to our members. We at ACMS are excited regarding the rapid growth of the recently formed Women in Medicine committee. Networking together, this group is exploring and addressing the special concerns and needs of our women members. Our staff and leadership view this committee as a very worthwhile endeavor and will continue to give it strong backing. As we have just finished a rewarding growing and transformative year, we are stronger than ever and looking forward to continuing to fulfill our mission: improving healthcare through education, advocacy, service and physician well-being. The ACMS staff and leadership welcome any comments or contributions from our members and wish you a healthy fulfilling 2024.

Opinion

The Shoemaker’s Children By: Deval (Reshma) Paranjpe, MD, MBA, FACS I’d like to start this year out talking about something I’ve never heard discussed. This past year, I’ve had multiple experiences with fellow physicians coming to me as patients. All of them share a tough, unemotional, nonnonsense approach at the outset. They concisely present their own history, grit their teeth and want to know what exactly is wrong, how the symptoms correlate, and how to fix the problems quickly and efficiently. It’s somewhat stunning because you can sense that they are wearing emotional armor, as though they expect to be belittled, not taken seriously, not given a proper workup, and labeled as hypochondriacs. The common emotion that I see underneath that armor as they sit in the exam chair is, to my horror and great sadness as their colleague and physician, fear. This is a special kind of fear. It is more than the standard fear of having a medical problem, or a generic fear of the medical establishment, or the fear of having to battle an insurance company to get the care you need. This is fear of the treatment and insensitivity one might receive at the hands of one’s own colleagues, which is heartbreaking. Imagine being in that chair and donning the same armor, terrified that your colleagues will think less of you or blow you off or let you down or miss something, terrified of a careerending or career-derailing malady, terrified that confidentiality won’t be respected and the entire medical staff and administration will know and gossip about your issues, terrified that you won’t be able to take care of people

who depend on you—patients, family, friends. I fully see myself in these colleagues sitting in my exam chair, and treat them the way I would hope to be treated. The really heartbreaking thing is that this fear of unkind and uncollegial treatment is justified. I’ve heard horror stories from colleagues who have gone to other physicians who have sneered at their questions and told them: “I suppose because you are in X specialty, you think you know everything!”. At a recent conference, when asked if one might accept an after hours call from a colleague, one physician stood up and said sharply: “Absolutely not. My time is my own and I would resent any colleague who would try a back line to talk to me.” Afterwards, multiple fellow attendees privately said “I would never want to be her patient, or send her patients.” How did we get here? At a recent holiday party, a group of physicians in their 40s and 50s lamented that younger physicians no longer want to get to know other physicians and shut down efforts at friendly conversations and efforts to bond. The networking aspect of practicing medicine has been severely impacted by the amount of interactions we have with EMR vs with each other in person. The old days of stopping each other in the hallways or picking up the phone to discuss patient cases have given way to EMR messaging--and unless you already know and have a good working relationship with your colleague, impersonal messages are just that—impersonal, and also ripe for misunderstanding.

We seem to be in an era of “take this job and shove it” because the fun and the collegiality in medicine is waning in the face of corporate culture and restrictions. As a CRNA who went in for a medical procedure (and had an unsympathetic fellow CRNA) told me, “we have so few perks in this job—one of the only perks is being able to request colleagues you like if you yourself have surgery.” But where are we if being able to request a colleague you trust when you are vulnerable is a perk and not the norm? Reading each other’s facial expressions and body language and voice makes a difference. If you take the time to get to know each other as humans---if you know that your colleague will go the extra mile for her patient, or that he is running home to take kids to soccer practice, or has a sick spouse, or that she is in the OR all day but still made time to call you back in between cases about your patient--you bond, understand and respect each other. You see each other as humans and physicians just trying to do the right thing and get through life. You are less likely to treat each other poorly and more likely to work together for the common good of the patient. You are also more likely to take good care of each other. What else contributes to this fear? As physicians, we are expected to be strong emotionally and physically. We’ve been conditioned, like soldiers, to bury our emotions in order to keep going and do the job when the job is taking care of others. We’ve been conditioned to disregard our own physical pain and symptoms and to put off our own

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Opinion workups, sometimes forever. Most everyone I know has, at some point before the COVID pandemic, bit the bullet and gone to work with a 102 fever. Why would anyone do this? Because there’s no one to cover for you, you don’t want to inconvenience or anger anyone, you’d have to reschedule patients, and on some level you are afraid of being branded “weak” by your colleagues. I know physicians who have gone to work immediately after surgical procedures or after being in the ER themselves so as not to inconvenience colleagues and patients. I know physicians who will operate unless they themselves are half-dead. I know physicians who confess they’re afraid they are in cardiac failure and think they may need an echocardiogram but still go to work. How did we get this way? Our training did this to us much the way that military training turns soldiers into soldiers. It is necessary to have some measure of discipline and mental and physical toughness in order to survive a career in either field. However, there are limits. Hazing is not acceptable either as a trainee or as an attending. Many of us in our 40s and above, and those of all ages in surgical specialties witnessed or lived with the implicit or explicit instructions that what didn’t kill us would make us stronger. We had no workweek limits. Flashbacks in my own mind take me back to hearing colleagues even a few years ago make fun of each other for going in for an annual checkup. Fellow medical students and residents made a game of who was the toughest, who could stay up the longest or work the hardest. Working through pain was strong; anything else was weak. Nobody wanted to be the weakest link. That mindset endures. When you take a group of people raised with this mindset and then put them in the doubly vulnerable position of having a medical problem and then having to depend on the very colleagues who made fun of them for being weak

ACMS Bulletin / January 2024

for acknowledging a medical problem--what else could result but fear and mistrust? What can we do to combat this? 1. No one can take away our humanity if we refuse. Combat the isolation imposed on us by the new systems of practice. Be friendly and make friends. Make efforts to reach out to your fellow physicians whenever you see them—on the floors, in the staff lounge, while entering orders on adjacent computers. Go to medical staff meetings and sit with people you’ve never met. Go to ACMS events and socialize. Collect cell phone numbers and get to know each other as humans. In work situations, pick up the phone and text or call each other if you can, even if you’ve sent an EMR message, especially if it’s about something potentially contentious. 2. Treat your fellow physicians as you would want to be treated in their shoes. It takes a lot for a physician to admit a problem and even seek care. It takes a lot to find the time and then overcome the guilt of taking time off and rescheduling patients to get tests and procedures and office visits done. Be kind. If you find a colleague with their armor up, realize that they are scared, and the thing that they are scared of most is that you will be unkind and unfeeling to them in their hour of need. Reassure them, perhaps more than even a regular patient. Reassure them that you will take care of them, do an aggressive workup, and not let them slip through the cracks. Reassure them that they are doing the right thing and that they are not weak for seeking care. Reassure them that you understand their challenges and constraints as a fellow physician and that you will work with them. Reassure them that it’s ok to be scared but that they have a friend, ideally a network of friends to guide them through. The magic words are: “I give you permission to take care of yourself.“ Physician colleagues need as much

or more warm bedside manner as your most nervous civilian patient despite their mask of exterior toughness. They also need as much explanation as a civilian. They’re coming to you because you have specialty knowledge they may not—explain it to them thoroughly and don’t assume they’ve done all the research. They are relying on and trusting in you. They are also scared and vulnerable and may not be thinking clearly. Don’t let the shoemaker’s children go barefoot. 3. Create a network of good people that you can call to help each other. This next part will come as nothing new to those who have been in practice for many years, but may be helpful for those new in practice. Nothing is as reassuring to a patient who needs an urgent referral to another specialist as being able to arrange that quickly. This sends a clear message: my doctor cares about me, and my doctor has a network of trusted A-list colleagues. When you can’t get in with a subspecialist for 6 months, but your doctor can ask for a favor and get you in faster, it means the world to any patient. When you can do this for a patient who is also a physician, you ensure there’s no delay to diagnosis (physicians may put off their own testing for months because they can’t get a day off) and you broaden and strengthen this network via interdependence and care. You introduce good people to good people who will pay the favor forward and create more goodwill. In return, do favors for colleagues at every opportunity to the extent of your ability without hesitation. Spread these favors far and wide; the good will come back to you and your patients. Be kind to each other, and that kindness will come back to you. It’s up to us to improve the culture—let’s spread collegiality, kindness and fraternity.

Opinion

Incidental Findings By: Richard H. Daffner, MD, FACR “If you perform enough studies, you will eventually find something you cannot explain. If you perform enough studies, you will eventually find something you wish you hadn’t1.” Modern medical care places significant reliance on the use of laboratory and/or imaging tests to aid our abilities to properly diagnose what is ailing our patients. Frequently, those tests reveal an incidental finding that was not expected. Common examples are a lung mass on a “routine” chest x-ray, a soft tissue mass in the chest wall or a lung mass on a CT of the abdomen ordered for suspected appendicitis, or an abnormally high serum creatinine found on a “routine” screening metabolic study in a patent with chest pain. In all my years as a practicing radiologist, I frequently encountered so-called “incidentalomas”. Earlier this year I briefly discussed incidental findings in an editorial on medical malpractice2. Two recent articles explored these issues in depth3,4 and prompted me to write a more detailed editorial on the subject. Once you have found an incidental finding, the important question is, “What do you do about it?” The simple answer is that we are obligated both morally and legally to investigate the finding(s) further. This will entail further imaging, additional lab tests, and, in most cases, biopsy. Unfortunately, in many instances, the incidental finding is not reported either to the referring physician or to the patient, allowing a small, potentially curable malignancy to grow to the point where it is no longer treatable. In Pennsylvania, PA Act 112-

2018, the Patient Result Information Act, requires that when a significant abnormality is found on a diagnostic imaging exam, the individual providing that service shall directly notify the patient or the patient’s designee of the findings. Radiologists at Emory University in Atlanta began a program to address this issue for “noncritical”, but actionable incidental findings3.The same methods apply to “critical” incidental findings. To further investigate this topic, the American College of Radiology (ACR), collaborating with the American College of Emergency Physicians (ACEP) formed a multidisciplinary expert panel of three domains: radiology, emergency medicine, and a panel of experts in IT, systems, quality assurance, and patient issues to focus on report structure, communication of finding(s) to patients, communication of finding(s) to clinicians, and follow-up and tracking systems4. The goals of both studies were to ensure that incidental findings were appropriately communicated and followed up. The first step in the process is to ensure that the findings are expeditiously communicated to the referring physician and as required by law in most states, to the patient. The ACR addresses communication issues in two ways. The first is in their Practice Parameter on Communication5; the second is in a series of clinical examples listed in a drop-down menu on the ACR website (www.acr.org) under “Clinical Resources”, where one can scroll down to “Incidental Findings”. This information can be accessed by non-members of the ACR as well

as members. Other information is available on the same menu for the ACR Appropriateness Criteria6 and the ACR Practice Parameters themselves. Regarding laboratory studies, the onus on the pathologists reporting the studies is to assure that the referring physician gets the report. It is the responsibility of the ordering physician to make note of unexpected findings, to notify the patient of the overall results, and to obtain appropriate follow-up studies to explain the unexpected finding(s). The same principles are true for those who perform studies evaluating organs other than bodily fluids, such as cardiac studies. Radiologists are obliged to follow the recommendations in the ACR Practice Parameter on Communication5. For imaging studies, radiologists recognize three categories of incidental findings: Benign, Aggressive - Probably malignant, and Indeterminate. Benign lesions (Fig. 1) are also called “Leave

Fig. 1A. Benign fibroxanthoma in a teen-age patient who twisted his ankle. This common bubbly lesion has well-defined borders. In time, the lesion will completely ossify, becoming a large “bone island.”

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Opinion that crosses a joint space is either an infection or an arthropathy. Tumors respect cartilage of either joints or epiphyses and do not cross.

Fig. 3. Aggressive lesion in the mid femur in an older patient who fell. Diagnostic possibilities include metastases, lymphoma, or myeloma. Biopsy showed metastatic squamous cell lung carcinoma.

Fig. 1B. CT image shows mixed cystic, osteoblastic lesion in right occipital bone. There is thickening of calvarium with a “ground glass” appearance typical of fibrous dysplasia in patient who suffered head trauma.

me alone lesions”, meaning they are so characteristic they do not require biopsy to confirm the diagnosis. Old studied, if they are available should be reviewed as well. The recommended follow-up is to repeat the study in 6 months to 2 years. Aggressive lesions (Fig. 2) are of two varieties – malignant tumors and infections. In most instances they will require a biopsy to make a tissue diagnosis. Imaging characteristics of malignancy include a motheaten or permeative pattern of bone destruction and a spiculated margin, indicating invasion of surrounding tissue. Non-neoplastic lesions such as osteomyelitis may resemble aggressive malignancies. However, any lesion

Fig. 2B. Osteosarcoma in the distal femur of a boy who hurt his leg playing soccer. Note the extension into the surrounding soft tissues. The lesion does not cross the epiphysis, characteristic of tumors.

Indeterminate lesions (Fig. 3) are those which could be due to a variety of causes and require a biopsy for the diagnosis to be made. Incidental findings are commonly found on diagnostic studies. It is incumbent on the physicians performing and interpreting those studies to make recommendations for appropriate follow-up. Those physicians who order the studies are also obligated to notify their patients of those incidental findings and to obtain appropriate follow-up. Table 1 summarizes management of incidental findings.

References: 1. Daffier RH. Clinical Radiology: The Essentials, 3rd ed. Daffner’s Diagnostic Pearls, 17, 18. Baltimore, Lippincott Williams and Wilkins 2007, p 527. 2. Daffner RH. Medical Malpractice 101: A primer - Part V: Communications and incidental findings. ACMS Bulletin, May 2023, pp 12-14. 3. Kadom N, Venkatesh AK, Sugarman SA, et al. Novel quality measure set: Closing the completion loop on radiology follow-up recommendations for noncritical actionable incidental finding. J Am Coll Radiol. 2022; 19: 881-890. 4. Moore CL, Baskin A, Chang AM, et al. White paper: Best practices in the communication and management of actionable incidental findings in emergency department imaging. J Am Coll Radiol. 2023; 20 422 – 430. 5. ACR Practice Parameter for Communication of Diagnostic Imaging Findings. Reston, VA, American College of Radiology, 2020. 6. Daffner RH. Appropriateness. ACMS Bulletin, May 2022, pp 8-10.

Table 1. Managing Incidental Lesions

Fig. 2A. Incidental lung carcinoma (arrow) in the right lung in a patient suspected of having a pulmonary embolus. Note the spiculated margin of the tumor.

ACMS Bulletin / January 2024

Finding

Recommendations

Benign (“Leave me alone”)

Follow-up 6 months to 2 years

Aggressive, (? malignant ?)

Biopsy for confirmation

Indeterminate

Biopsy for diagnosis

Legal Update

Assessing Impact of Venue Rule Change

Philadelphia Medical Malpractice Cases Surge By: Curt Schroder -- Executive Director at PCCJR The Pennsylvania Coalition for Civil Justice Reform (PCCJR) has been tracking the number of medical liability cases filed in the city of Philadelphia during 2023. In addition, we have analyzed where the cause of action arose by reading the complaints and reviewing docket entries for cases started by Writs of Summons. We wanted to determine the impact of the medical malpractice venue rule change which took effect on January 1 of 2023. Prior to the rule change, a plaintiff could only file a medical liability complaint in the county where the cause of action arose. In other words, where the alleged injury occurred. This rule never sat well with the plaintiffs’ bar as it eliminated their ability to forum shop for the county most likely to give them the best chance of winning the case, and with it, a windfall of damages from which they take home a hefty contingency fee. The venue of choice for the plaintiffs’ bar has always been the city of Philadelphia. When the Supreme Court yielded to the demands of the plaintiffs’ attorneys and allowed forum shopping to return, we knew it would result in an avalanche of cases being filed in Philadelphia despite claims to the contrary by the attorneys. The results for 2023 are in and as expected, the rule change has accomplished everything the plaintiffs’ bar wanted to the great detriment of health care providers and doctors. A grand total of 544 medical malpractice cases were filed in Philadelphia in 2023. This averages 45 cases a month. By comparison, 2017 saw 406 cases filed, 2018 saw 418 filed, 2019 saw 407 filed.

There was a sharp pandemic related downturn beginning in 2020 which had 348 cases filed, 2021 had 344 cases filed, and 2022 with only 275 filed. But the raw numbers do not tell the entire story. To determine the real impact of the venue rule change, the causes of action need to be analyzed for each case to see where the cause of action arose and therefore whether that case could have been filed in Philadelphia prior to 2023. A review of the causes of action in medical malpractice cases filed in Philadelphia in 2023 reveals that 281 cases had causes of action arising IN the city of Philadelphia. 197 cases had causes of action arising outside of the city and therefore could NOT have been filed in Philadelphia without the rule change. PCCJR could not determine the cause of action in roughly 67 cases. This is due to some cases starting with a writ of summons which gives the addresses of the parties, but not the factual details of where treatment was rendered, or the alleged injury occurred. From these statistics we can conclude that if the venue rule had not been changed to allow plaintiffs to venue shop, Philadelphia would have seen fewer medical malpractice cases filed than in the years leading up to the pandemic. Taking away the 197 cases with causes of action arising outside of Philadelphia, leaves only 347 cases that could have been filed under the old rule. Therefore, the change in the venue rule must be the sole reason for this record increase in case filings in Philadelphia! But that’s not all. Perhaps for the first time ever, the number of

plaintiffs winning their med mal cases in Philadelphia exceeded the number of verdicts favoring the defense. While that is disturbing enough, 2023 also saw an outrageously high verdict dollar amount awarded to plaintiffs: $278,281,342.00! That is nearly five times the next highest total yearly award from 2016. 2023 was a very good year for the plaintiffs’ bar as their contingency fees ballooned at the expense of health care. PCCJR expects the 2024 filings to be similar in number. We will continue tracking the medical malpractice case activity in Philadelphia in preparation for the two-year review of the rule mandated by the Supreme Court. The ACMS is a proud member of the PCCJR. The Pennsylvania Coalition for Civil Justice Reform (PCCJR) is a statewide, nonpartisan alliance of organizations and individuals representing businesses, professional and trade associations, health care providers, nonprofit entities, taxpayers and other perspectives. The coalition is dedicated to bringing fairness to our courts by elevating awareness of civil justice issues and advocating for legal reform in the legislature. To learn more, visit https://paforciviljusticereform.org/.

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Society News

MAYA Organization Catching Moms

By: MAYA Staff Member Isabella* first came to MAYA when she was pregnant in 2022. A recent immigrant from Guatemala, Isabella was only 21 years old, didn’t speak English, and had limited education. One of our mentors, Angela, started supporting Isabella with the basics: she visited her home and showed her how to download Zoom and enter a meeting. Isabella was able to join prenatal classes by Zoom, but it soon became clear that she needed extra help - so Angela again visited her at home to deliver one-onone lessons in Spanish, preparing her for birth and motherhood. Isabella was terrified of giving birth in a foreign hospital, but one of MAYA’s doulas, Majo, was able to support her through the process. She successfully delivered her baby via c-section and, with Majo’s guidance, soon discovered that she was a natural at breastfeeding. Tragically, when her baby was only a few months old, Isabella lost her mother, who still lived in Guatemala. Through telephone calls and visits, MAYA mentors provided crucial emotional support, helping Isabella grieve and find peace. When Isabella fell pregnant with her second child, she returned to MAYA for guidance and support. Soon after the second birth, Isabella applied for Emergency Medical Assistance (EMA) for her children and was sent a rejection letter, in English. She called MAYA on a Friday afternoon, and the team at MAYA discovered that she needed to resubmit her application documents by Monday the following week. Again, Angela stepped in to provide crucial support in preparing the necessary items to resubmit the application. With Angela’s help, Isabella

ACMS Bulletin / January 2024

was awarded EMA. She was so relieved that her children were protected. Angela translated her words for us: “I couldn’t have done it without you,” Isabella said, “and without MAYA.” * name changed for privacy A third of MAYA’s perinatal clientele are Latin American immigrants, like Isabella, and many struggle with language and culture shock. To some, the idea of delivering a baby at a hospital is contradictory and frightening, as in their experience hospitals are places of illness and death, while babies are born at home. To help these mothers feel more at ease, MAYA hires Spanish-speaking mentors and doulas, like Angela and Majo, who are also immigrants. They have shared experiences and special insights into participants’ lives and struggles. In addition to offering sensitive one-on-one support, our mentors teach online perinatal classes in Spanish up to five times a week, preparing moms for birth and parenting, and, more importantly, encouraging them to take care of themselves. One of the things that Isabella’s story also illustrates is MAYA’s responsiveness to our participants' needs, be it language support with a critical application or a companion for a doctor’s visit. MAYA is able to offer a supply of infant and parent-care items, help participants enroll in outside resources, and offer free mental health counseling in English and Spanish. Part of MAYA’s purpose is to respond to the alarming racial disparities in maternal experiences and outcomes. We do this not only through our

services to Latinx immigrants, but also by providing quality care and advocacy to our majority Black clientele. Our organization uses a model called the JJ Way®, developed by the Commonsense Childbirth Institute and proven to reduce disparities in birth care and improve outcomes. At the same time, the work our doulas do is a powerful tool for equity - research indicates that having a doula present at a birth improves outcomes and experiences and is a promising strategy for taking on race-based inequities. In addition to perinatal services, MAYA provides mental health care for incarcerated individuals. Our traumainformed approach contrasts with the hostile environment, offering valuable support to a most marginalized population. This year, MAYA will develop our programming for incarcerated people by extending prenatal and doula services to pregnant women incarcerated at Allegheny County Jail, addressing a critical gap in services. In the fields of obstetrics and midwifery we talk about “catching” babies; what MAYA aims to do is to “catch” birthing people: to hold and support them while they adjust to new realities. Donors, like the Allegheny County Medical Society Foundation, play a crucial role in “catching” and supporting MAYA. Their grant of $12,000, awarded in October, 2023, signifies a commitment to our cause, ensuring the sustainability of the impactful services provided by MAYA.

Society News

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Society News

Embracing Maternal Health Awareness Day: A Call to Action for Physicians

By: Sara C. Hussey, MBA, CAE -- ACMS Executive Director Maternal Health Awareness Day is on January 23, 2024. This day of awareness, initiated in an American College of Obstetrics and Gynecology (ACOG) chapter in New Jersey in 2017 and nationally launched in 2021 by the ACOG, prompts a reflection on the pivotal role each of us plays in ensuring the well-being of expectant mothers. Certainly, for Physicians, this role becomes much more significant. Access to maternal health care has increasingly become unobtainable for many patients in the United States. Ongoing financial, staffing, and policy challenges have led to the closure of labor and delivery units in hospitals, affecting both rural and urban areas. This forces patients to travel longer distances or go without the necessary care, a situation particularly evident in the state of Pennsylvania. In this edition of the ACMS Bulletin, you’ll hear from contributors who specialize in maternal health care. This month’s articles focus on topics such as learning how to support patients postdelivery, understanding how advances in immunizations can help curb RSV infections in infants, and discovering more about a local organization called MAYA, whose mission is centered around maternal health care, specifically for BIPOC. Beyond the articles in this Bulletin, there are other ways physicians can continue to advocate for stronger maternal health, irrespective of medical specialty. Advocacy for Prenatal Care: Maternal Health Awareness Day calls for heightened advocacy regarding the significance of prenatal care. As

ACMS Bulletin / January 2024

healthcare providers, you can use this occasion to reinforce the importance of early and regular check-ups, promoting a proactive approach to maternal health. Visit www.acog.org to learn more and find patient-facing resources. Empowering Patients with Information: Knowledge is a powerful tool. By providing information about healthy lifestyle choices, nutrition, and the importance of adhering to medical advice, physicians can empower expectant mothers to actively participate in their healthcare journey. These articles in the Bulletin are shareable, and we encourage you to educate yourself on ways to support your patients. Connect with the authors of these articles for follow-up questions and comments. Addressing Disparities: Physicians play a pivotal role in addressing health disparities. Maternal Health Awareness Day serves as a platform to advocate for equitable access to quality healthcare, ensuring that no woman is left behind due to socio-economic or cultural factors. Many organizations supported by the ACMS Foundation address social determinants of health directly related to maternal health. Interested in learning more or getting involved with one of these organizations? Contact our team at ACMS, and we’ll make the connection. Mental Health Advocacy: Maternal mental health is an integral part of overall well-being. It is crucial to acknowledge and address the mental health challenges that some women may face during pregnancy and the postpartum period, and to know where to send them for continued support.

Image from ACOG.org

By fostering open communication with patients, you can provide the necessary support and resources to promote mental well-being. Integrate discussions about maternal mental health into routine consultations. By normalizing conversations about mental well-being, physicians can break down stigmas and ensure that women receive the support they need. Maternal Health Awareness Day is an opportunity for physicians to recommit to the well-being of expectant mothers and contribute to a world where every woman experiences a safe and positive pregnancy journey. We hope the articles in this month’s Bulletin serve as a jumping-off point for you to do more to advocate for maternal health and access to care.

Opinion

Why We Need to Talk About the Risks of Childbirth By: Jocelyn Fitzgerald, MD, URPS Whether we want to admit it or not. pregnancy is likely the most physically demanding and dangerous thing that most women will ever do. Research across medical disciplines demonstrate that pregnancy is not a “health neutral” event and has known long-term maternal risks1. As a Urogynecology and Reconstructive Pelvic Surgeon, I see women whose ages span decades. 25% of women in the US has a pelvic floor disorder2 such as vaginal prolapse or urinary/fecal incontinence, and vaginal delivery is the most significant modifiable risk factor for these conditions3. Their presentation to my clinic is frequently delayed due to lack of awareness among patients and providers alike that pelvic floor disorders exist and that they are treatable with specialist care. Many of my patients are extremely frustrated when they learn how common pelvic floor disorders are and that it took so long to get treatment; they prevailingly want to know why “nobody ever told me that this could happen”. There seems to be a slowly changing paternalistic attitude in OB/Gyn of “prolapse is rare so I won’t mention it” or “she’s already pregnant, so why tell the patient about prolapse and worry her?” that has gotten many of my patients to this point. Pelvic floor trauma is not rare; 20% of women in the US will have prolapse surgery in her lifetime. Women just don’t talk about their symptoms out of fear that they are uniquely broken; and they haven’t been educated on the resources for conditions like incontinence and prolapse. In general; little attention is paid to women’s health

beyond pregnancy. There is also a pervasive idea that if you are the kind of doctor who openly discusses the maternal risks of childbirth in prenatal counseling that you are “fearmongering”; or being “anti-natalist”. (Which is a stunning accusation to direct at an Ob/Gyn or Urogynecologist, who literally makes their living secondary to women giving birth, but I digress.) Is clearly presenting historically omitted or downplayed information about how pregnancy realistically affects a woman's body really fearmongering? What are we afraid women will do with this information? I think we need to reckon with the idea that we are uncomfortable with the thought that not every woman would choose motherhood if presented with the facts. But, it is none of our business what reproductive choices women make with the information that they have. If all it takes to have a woman forego pregnancy and birth is to counsel her about the increased rate of anal incontinence with forcep deliveries4,

or the long term ramifications of preeclampsia on her heart attack or stroke risk5, or the 15% of women who experience postpartum psychiatric disorders6 then we have likely done that patient a valuable service in helping her make an informed decision about one of life’s most serious choices: whether or not to become a parent. Meanwhile, for women who strongly desire childbearing, more information on the physical, mental, and emotional effects of pregnancy is not going to deter them from parenthood, but rather benefit them from a preparation standpoint. How can we inform women where to find treatment for postpartum disorders if we don’t also educate and talk openly about the risks of those very disorders? By withholding information about maternal risks of pregnancy, we not only delay care for postpartum pathology and prolong women’s suffering, but we increase isolation and anxiety on the back end. The idea that describing the risks of birth trauma will lead to unnecessary

Image found in Reference 3

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Opinion anxiety has been debunked7; studies show that prenatal education on pelvic floor trauma mitigates anxiety, empowers women in their reproductive choices, and leaves them confident in seeking care postpartum. There are significant consequences to maternal morbidity that goes untreated; this has downstream effects in the health of her family8. We must move toward a time where we are practicing maternal health when it comes to pregnancy, first and foremost. Autonomy is at the core of medical ethics; and there is no autonomy without informed decision making and consent. Pregnancy, beautiful when desired, is also a deeply complex physiologic process with many risks. Our patients are strong, capable, and able to make the right decision for their lives, and it is our job to provide them with as much information for their long-term well being as possible.

ACMS Bulletin / January 2024

References 1. Neiger R. Long-Term Effects of Pregnancy Complications on Maternal Health: A Review. J Clin Med. 2017;6(8):76. doi:10.3390/jcm6080076 2. Wu JM, Vaughan CP, Goode PS, et al. Prevalence and Trends of Symptomatic Pelvic Floor Disorders in U.S. Women. Obstet Gynecol. 2014;123(1):141-148. doi:10.1097/ AOG.0000000000000057 3. DeLancey JOL, Masteling M, Pipitone F, LaCross J, Mastrovito S, Ashton-Miller JA. Pelvic floor injury during vaginal birth is life-altering and preventable: what can we do about it? Am J Obstet Gynecol. Published online January 2, 2024. doi:10.1016/j.ajog.2023.11.1253 4. Blomquist JL, Muñoz A, Carroll M, Handa VL. Association of Delivery Mode With Pelvic Floor Disorders After Childbirth. JAMA. 2018;320(23):2438-2447. doi:10.1001/ jama.2018.18315 5. Wu P, Haththotuwa R, Kwok CS, et al. Preeclampsia and Future Cardiovascular Health. Circ Cardiovasc Qual Outcomes. 2017;10(2):e003497. doi:10.1161/ CIRCOUTCOMES.116.003497

6. Heinisch C, Galeris MG, Gabler S, et al. Mothers With Postpartum Psychiatric Disorders: Proposal for an Adapted Method to Assess Maternal Sensitivity in Interaction With the Child. Front Psychiatry. 2019;10. Accessed January 4, 2024. https://www.frontiersin.org/articles/10.3389/ fpsyt.2019.00471 7. Johnson KT, Williams PG, Hill AJ. The Importance of Information: Prenatal Education Surrounding Birth-Related Pelvic Floor Trauma Mitigates Symptom-Related Distress. J Womens Pelvic Health Phys Ther. 2022;46(2):62. doi:10.1097/ JWH.0000000000000229 8. Koblinsky M, Chowdhury ME, Moran A, Ronsmans C. Maternal Morbidity and Disability and Their Consequences: Neglected Agenda in Maternal Health. J Health Popul Nutr. 2012;30(2):124-130.

Dr. Fitzgerald is a double board certified OBGYN and Urogynecologist at Magee Womens Hospital of UPMC. Follow her @jjfitzgeraldMD.

Opinion

Understanding Autonomy in Obstetrics By: Marta Kolthoff, MD Although the philosophical concept of autonomy originated in ancient Greece, it became established in the field of medical ethics in 1979 with the publication of the book: The Principles of Biomedical Ethics.1 At that time, newly recognized medical ethicists began to address advances in medicine and technology as well as the past abuses of humans under the guise of medical research and/or as part of war. The authors introduced the classic four principles (autonomy, beneficence, non-maleficence, and justice) of ethical behavior and discussed their application in the medical setting. There have been nine editions of this landmark textbook; starting in 1979 and continuing to the present day, principle-based medical ethics has become a mainstay of American medicine. Principle-based ethics (also known as principlism) involves applying and balancing each of these four fundamental principles when medical ethical dilemmas arise. Most American bioethicists and physicians now agree that autonomy is the most important ethical principle of the group.2 As a philosophical concept,

autonomy is understood as the unconditional right of a person to make their own decisions and moral choices because of their intrinsic worth as a human being.2 This is also known as the right to self-determination and originated in the writings of both Kant and Mills.3 In modern medicine, autonomy refers to the right of a person to make decisions about their personal medical care, not limited to the participation in research studies. Fundamental to this right is that these personal decisions be informed (i.e. patients are provided with sufficient information), they are free of coercion or undue influence, and the person is competent to make the decision. Autonomy is the underpinning of informed consent and serves to replace (or counterbalance) the practice of paternalism. Respect is key, and health care providers or teams must respect a person’s right to make decisions about their body and medical care. There is no doubt that principlebased ethics and autonomy are vital to the practice of American medicine - it would be difficult to picture current American medicine without the practice of informed consent! However, there has been a lot of change since the 1970’s in both medicine and medical ethics. As such, there are concerns that the “autonomy-dominant” model may not be advantageous (or appropriate) in all settings.6 As a reproductive bioethicist, I reside in the obstetrical world which provides a good example of when the “autonomy-dominant” model can become problematic. Logically, this makes sense given that the original formulation of principlism

and autonomy did not necessarily have modern obstetrics in mind as opposed to the realms of research on endof-life decision-making (obstetrical ultrasound was in its infancy in the 1970s). Principle-based ethics and autonomy were applied or extrapolated to ethical dilemmas in obstetrics rather than evolving organically. The modern perinatal world is unique and filled with ever-changing complexities that often exceed the capacity of principlism to resolve conflict and maximize outcomes for the pregnant patient and baby. To state clearly: autonomy is just as important in the perinatal world as in the non-pregnant world. Pregnant patients certainly deserve the same rights as non-pregnant patients, and this includes with regards to their medical care. However, it is the “autonomy-dominant” model that is problematic within obstetrics. The principle of autonomy is deeply rooted in classic American values such as self-sufficiency, individualism, limited emotionality and self-control.6 This results in a bias – the autonomydominant bias – that creates significant difficulties (my words and my opinion). First, this bias distracts from the inherent relationality of pregnancy. By definition, pregnancy is about at least two if not more persons. This number of persons directly or indirectly involved with a pregnancy continues to increase when we consider living children, partners/spouses, assisted reproductive technology with biologic and non-biologic parents, extended family and so on. Although these “associated/affiliated” people do not

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Opinion have the right to make decisions for a pregnant person without their consent, they often are the primary motivators/influencers when it comes to that person’s medical decisionmaking. An excellent example of this is demonstrated by the case study “A Small Town Heart” where a pregnant patient chooses neonatal comfort measures for her baby who had been diagnosed with hypoplastic left heart syndrome.5 The patient’s decisionmaking was influenced by concerns about continuing to adequately care for her two living children while also being responsible for a critically ill newborn located in a hospital far from home. Rather than acting as an individual alone in her decisionmaking, this patient was immersed in a world of several incredibly significant relationships, limited resources, and, unfortunately, a judgmental medical team. This case begs the question: if she had had more resources, would she have chosen the surgical pathway for her baby rather than comfort care? The answer: most likely, as earlier in pregnancy she had considered the option of her child undergoing staged surgical repairs. This exposes another problem with the autonomy-dominant model: there is too little emphasis on removing the undue burdens that reduce a patient’s decisionmaking abilities. Without addressing autonomy-reducing factors such as poverty, race, substance use disorder, limited education and other barriers , autonomy can easily become a hollow promise rather than an intrinsic right as originally conceptualized. Furthermore, pregnancy is an inherently vulnerable time which can be associated with a profound loss of control, especially when emergencies (e.g. prenatal diagnosis of a lifelimiting or life-threatening anomaly) arise. This vulnerability can lead to the exacerbation of power differentials between the pregnant patient and their health care providers. Both the vulnerability of pregnancy and the

ACMS Bulletin / January 2024

exacerbation of power differentials can limit a pregnant patient’s ability to exert their autonomy. Like other bioethicists, I think alternative approaches to obstetrical medical ethics are needed in to address the limitations of the “autonomy-dominant” principlebased approach.6 Both care-based ethics and relational autonomy with emphasis on family-centered care come to mind as applicable examples of alternatives to the traditional model. Care-based ethical theory emphasizes interpersonal relationships and kindness towards others in terms of moral significance. Relational autonomy emphasizes the vital role other people play in a person’s decision-making, the social context that humans exist within, and the emotional experience of patients and their personal/family relationships.6 Both theories are deeply complex and, in my opinion,

well suited for the perinatal world - not to replace principle-based ethics, but as added layers to the foundation that Beauchamp and Childress originally created in 1979. References 1.T.L. Beauchamp and J. F. Childress. The Principles of Biomedical Ethics. 1st Edition. Oxford University Press. 1979. 2. T. C. Saad. “The history of autonomy in medicine from antiquity to principlism”. Med Health Care Philos. 2018. Mar 21(1):125-137. 3. A. Elsner & V. Rampton, “Accompanied Only by My Thoughts: A Kantian Perspective on Autonomy at the end of Life”. J Med Philos. 2022. Dec 47(6): 688-700. 4. B. Varkley. “Principles of Clinical Ethics and Their Application to Practice.” Med Princ Pract. 2021.30(1): 17-28 5. J. Herbst et al. “A Small Town Heart”. Hastings Center Report. 2020; 50(6); 4-7. 5. S. Reis-Dennis. “Understanding Autonomy: An Urgent Intervention”. Journal of Law and Biosciences. 2020. 7(1): 1-10 6. C. Gomez-Virseda et al. “Relational Autonomy: What Does it Mean and how is it used in end-of-life care?” BMC Medical Ethics. 2019. 20(76)

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Opinion

Safeguarding Infants From RSV Infection By: Raymond E. Pontzer, MD – 2024 ACMS President Respiratory syncytial virus (RSV) infections are common and usually result in mild, cold-like symptoms. However, RSV infections can be severe, especially in the very young and in older adults. An estimated 58,000 children and 177,000 adults are hospitalized each year in the U.S. Regarding children, RSV is the most common cause for lower respiratory tract infection in those less than one year of age and the most common cause for hospitalization in those less than five. It is responsible for half a million annual pediatric emergency department visits and is the number one cause of deaths in infants less than one year old in the U.S. Up until this past year we were helpless to prevent the morbidity and mortality due to this ubiquitous virus. During RSV season, fall and winter, over the past couple of years UPMC Children’s Hospital found it necessary to construct a large tent in their parking lot to extend the size of their emergency department in order to accommodate the treatment of the large influx of RSV afflicted children. But now the tide is hopefully turning. The history for development of RSV vaccines is long and troublesome. As soon as the virus was first discovered in 1956, scientists began working on a vaccine, hoping to replicate the success of polio vaccine. Unfortunately, the vaccine clinical trials in the 1960’s turned into disaster. These early RSV vaccine trials utilized a formalin deactivated virus, similar to the successful polio vaccine developed here in Pittsburgh by Jonas Salk. Instead of providing protection, the children in the early RSV vaccine trials

experienced a paradoxical effect. The vaccine recipients experienced much more severe illness than expected. In one of these early trials, 80 percent of the vaccinated children were hospitalized after contracting RSV infection. This compares with the expected hospitalization in the single digit range. At least two otherwise healthy toddlers died secondary to RSV, which was also unexpected. The results of the early RSV vaccine trials set back the development of an effective vaccine for half a century. The catastrophic results of the early trials were traced to a phenomenon called antibody-dependent enhancement. The antibodies produced by the early vaccines, instead of providing protection, exacerbated the infection. These antibodies coated the virus particles causing them to attach to each other. The resultant viral clumps created a inflammatory cascade leading to a more severe illness. Subsequent trials focused on attenuated RSV. Although these attenuated vaccines did not exacerbate the disease, they failed to provide significant protection. The recent successful vaccine

resulted from work led by two researchers at the National Institutes of Health Vaccine Research Center. Barney Graham had dedicated his career to developing an effective RSV vaccine. He eventually became focused on the F protein, believing that neutralizing this protein on the RSV could prevent it from fusing and infecting cells. However the F protein had a prefusion and postfusion configuration. Making antibodies against the postfusion protein was ineffective. This antibody is what the early vaccines had created. Dr. Graham felt that neutralizing the prefusion F protein might be effective. However, constructing the configuration of this protein proved to be elusive. In 2008 Jason McLellan, a molecular biologist , began a postdoctoral fellowship at the NIH where he met Graham. His specialty was mapping the atomic structure of proteins. McLellan became interested in discovering the prefusion F protein structure when it became clear to him that RSV was one of the major childhood pathogens for which no vaccine was available. He was eventually able to determine the

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Opinion structure of the stable postfusion F protein. He and Graham then screened over 13,000 mouse antibodies until they found one that neutralized the virus without binding to the postfusion F protein site. The researchers then used a similar human antibody to determine the prefusion F protein’s structure. This discovery led to the development of an effective RSV vaccine. It is noteworthy that the work done to determine the RSV prefusion F protein paved the way for McLellan to subsequently determine the spike protein structure of SARS-CoV-2 virus. Had it not been for the years spent in research refining protein structure for RSV vaccine, the remarkably rapid development of a vaccine for COVID-19 would not have occurred. As a result of this ground-breaking research, we today have available two recently approved vaccines for RSV as well as an immunoglobulin treatment targeting prefusion F protein. In May 2023 the FDA approved GSK’s Arexvy and Pfizer’s Abrysvo for adults 60 and older. Later in 2023 the FDA approved Abrysvo for pregnant women to be administered once in the weeks 32 through 36 of pregnancy during September through January (RSV season). Pfizer’s study results demonstrated 82 percent effectiveness at 3 months and 69 percent effectiveness at 6 months for the prevention of severe RSV infections in the infants with negligible side effects. It is noteworthy that only the Pfizer Abrysvo is approved for pregnant women. The GSK Arexvy is not to be used in pregnancy as their trial in pregnant women was stopped because the incidence of premature births was 38% greater in the vaccine group. This was not observed in the Abrysvo study and may be attributable to the differing chemical makeup of the two vaccines. In addition to the protection against RSV infection afforded to infants by vaccinating the mother, AstaZeneca and Sanofi received FDA approval in 2023 for nirsevimab, a monoclonal antibody treatment for infants targeting

ACMS Bulletin / January 2024

the prefusion F protein. Their clinical trial demonstrated similar efficacy, approximately 75 percent, as was demonstrated by the immunization of mothers to prevent serious RSV infection during the first year of life. Nirsevimab is administered as a single IM dose for neonates and infants born during or entering their first RSV season. It is also approved for children up to 24 months who remain vulnerable to severe RSV through their second RSV season. It should be noted that this product has been in somewhat short supply this winter. Additionally, it is not recommended for infants to receive nirseviamb when their mother has received RSV vaccine as outlined above.

Although we still have no effective treatment for the severe RSV respiratory infections afflicting the very young and the elderly, we have entered a new era of RSV infection prevention through the efforts of the research team led by Drs. Graham and McLellan. We now have tools to significantly reduce the health burden incurred by RSV on our infant population, as well as the elderly. I feel strongly that is our duty to inform and encourage our patients, friends, and family members to take advantage of these newly released vaccines and antibody treatments. Wishing you all a healthy and enjoyable 2024! Dr. Pontzer is Chief of the division of Infectious Diseases at UPMC St Margaret Hospital and senior partner at Romano Pontzer and Associates, an independent infectious diseases practice servicing multiple hospitals in the Pittsburgh metropolitan region. Additionally, he serves as Clinical Associate Professor of Medicine at the University of Pittsburgh Medical School and is the 2024 president of the Allegheny Medical Society.

Society News

Specialty Group Updates January 2024

By: Nadine Popovich, Eileen Taylor and Melanie Mayer The Allegheny County Medical Society provides administrative services to several speciality medical groups in the region. Our staff facilitate conferences, events, membership, and back-office administrative work for these groups. Here are some 2024 updates from the speciality groups. If you are interested in learning more about joining a specialty group, you can visit www.acms.org and click on the specialty groups tab. ACMS Alliance (ACMSA): Vintage Pittsburgh was the setting for the ACMSA's Fall General Meeting & Luncheon. On September 21, 2023, members gathered at the Pittsburgh landmark Grande Concourse Restaurant. The guest speaker was Ozzy Samat, President of Brother's Brother Foundation. The ACMSA generously pledged $1000 to the Maui Hawaiian Disaster Relief.

Left to right: Ozzy Samat, Barbara Wible, Charlie Blume, Liz Blume, Sandra DaCosta, Patty Barnett, Tina Purpura, Dr. Larry Purpura

Left to right: Barbara Wible (CoPresident), Sandra DaCosta, Patty Barnett (Event Chair & Co-President), Ozzy Samat, Tina Purpura

Allegheny County Immunization Coalition (ACIC) — 2024 Chair - Ashley Ayers, BS, CIC: In 2024, the vaccine champions of ACIC will continue to work proactively to increase vaccination rates among people of all ages in Western Pennsylvania. ACIC's members will play a crucial role by volunteering to organize various events aimed at increasing vaccination rates. They will also commit to attending the four annual meetings. Their active involvement in organizing and participating in these initiatives will highlight their collective dedication to advancing immunization efforts in Western Pennsylvania. Additionally, members will have ample opportunities to stay informed and engaged in shaping the organization's impact on public health in the region, with four general membership meetings per year and a half-day conference on November 6, 2024. Membership to the ACIC is free – visit immunizeallegheny.org for more information.

American College of Surgeons Southwestern Pennsylvania Chapter (ACS-SWPA) — 2024 President – Richard Fortunato, DO, FACS: The ACS-SWPA welcomes Hiram Gonzales, MD, Washington Health System, as society Treasurer. The society plans to host their annual meetings, Debates & Dilemmas, Most Interesting Cases, and Surgical Jeopardy in 2024. The society also plans to install a quarterly newsletter for members. Please visit acs-swpa.org for updates and more information on 2024 programming. Greater Pittsburgh Diabetes Club (GPDC): The GPDC is currently in the planning process for 2024. Stay tuned for more updates regarding programming and membership as the year progresses. Pennsylvania Geriatric Society Western Division (PAGS-WD) — 2024 President - Heather Sakely, PharmD, BCPS, BCGP: The PAGS-WD is hosting the 32nd Annual Virtual Clinical Update in Geriatric Medicine on April 25-26, 2024. The goal of this conference is to help provide superb care to older adults by ensuring that each session provides evidence-based “pearls” that you can immediately incorporate into your practice. Conference registration will open in late January. Please visit www. pagswd.org for updates and to register. The Pittsburgh Ophthalmology Society (POS) — 2024 President Pamela P. Rath, MD: Past and Upcoming Meetings: POS members gathered on December 14 in the PNC Champions Club at Acrisure Stadium to welcome guest faculty Natasha Nayak Kolomeyer, MD, Glaucoma Specialist, at Wills Eye Hospital, Philadelphia, PA and Assistant

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Society News Professor of Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA. Wrapping up the 2023-2024 monthly meeting series, the February 8, 2024 speaker features Alon Kahana, MD, PhD with Kahana Oculoplastic & Orbital Surgery. Dr. Kahana is a Professor & Vice Chair of Ophthalmology; Oakland University William Beaumont School of Medicine; Rochester, MI. The meeting will be held in the PNC Champions Club at Acrisure Stadium. 2024 Annual Meeting: The 59th Annual Meeting of the Pittsburgh Ophthalmology Society, and the 44th Meeting for Ophthalmic Personnel, will take place on March 8, 2024, at the Omni William Penn Hotel in Pittsburgh, PA. With a commitment to providing an enriching experience for attendees and exhibitors in a welcoming environment conducive to learning and networking, the organization is proud to feature Daniel F. Martin, MD, as the 43rd Harvey E. Thorpe Lecturer. Dr. Martin, Chair of the Cole Eye Institute at Cleveland Clinic, will contribute valuable insights across various aspects of eye care. Distinguished guest faculty, including Jane C. Edmond, MD; Mark A. Rolain, MD; and Joshua D. Stein, MD, MS, will also enhance the event. Visit: https://pghoph.org/ for more information and to register.

In-Memoriam: Dr. Dick Katzin, born October 28, 1934, passed away on January 4, 2024, at 89. A Cornell University and Medical School graduate, he served as a first lieutenant in the U.S. Marine Corps. Completing his ophthalmology residency at the Eye and Ear Hospital in 1969, he served as interim Chair of the Department of Ophthalmology from 1972 to 1974 and as Assistant Chief from 1969 to 1980. He chaired the ophthalmology division from 1980 to 1999, with subsequent consultancy until 2023. His 55 years of service had a lasting impact on veterans' eye care. Recognized for compassionate patient care, Dr. Katzin received the Distinguished Teaching Award in 1983. He influenced over 200 ophthalmology residents, continuing oversight of training at the Veteran's Hospital after joining private practice in Monroeville in 1975. Survived by four

children and nine grandchildren, Dr. Katzin's legacy, marked by dedication to patient care and medical education, endures in ophthalmology. Dr. Katzin’s full obituary can be found online: https://www.burket-truby.com/ obituary/dr-dick-katzin-md

Pamela Rath, MD, President, Natasha Nayak Kolomeyer, MD and Jeffrey Wincko, MD, Board member

ACMS Bulletin / January 2024

Materia Medica

Tofersen (Qalsody™)

A novel amyotrophic lateral sclerosis (ALS) treatment option By: Madeline Dillen, PharmD; Abigail Reigh, PharmD, BCPS Introduction: Qalsody™ (tofersen) received FDA accelerated approval for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.1 This toxic gain of function mutation in the SOD1 gene is present in 2% of ALS cases and is diagnosed by genetic testing. This mutation is thought to increase SOD1 protein synthesis, impacting the degeneration of motor neurons, although the mechanism is not fully understood.2 Tofersen acts as an antisense oligonucleotide that causes degradation of SOD1 messenger ribonucleic acid (mRNA) through binding to SOD1 mRNA. This results in a reduction of SOD1 protein synthesis, thus reducing the rate of disease progression.1 Tofersen is an intrathecal injection manufactured by Biogen given as three loading doses at 14-day intervals, then a maintenance dose every 28 days thereafter. There is no established duration of treatment.1 Safety: During a phase 1-2 dose ascending trial of tofersen in adults with SOD1 ALS, a total of 50 participants were split evenly across five cohorts: those receiving tofersen at 20, 40, 60, or 100 mg doses, and those receiving placebo. At least one adverse event occurred in all groups. Serious adverse events (defined as death, immediate risk of death, hospitalization, persistent or significant disability, or congenital abnormality) occurred in 5 participants in the tofersen group and 2 participants in the placebo group. Three deaths occurred, one in the placebo group, one in the 20 mg tofersen group, and one

in the 60 mg tofersen group. Cause of death was not reported.2 In a phase III randomized controlled trial of 108 patients with SOD1 ALS, overall incidence of adverse effects was 96% in the tofersen 100 mg group and 94% in the placebo group. The incidence of adverse events related to puncture was 81% in both groups, while drug-related adverse events was 39% in the tofersen group and 6% in placebo group. Common (occurring in >15% of patients) adverse effects included headache, procedural pain, fall, back pain, extremity pain, arthralgia, fatigue, and myalgia. Serious adverse events (same definition as above) occurred in 14% of patients in the placebo group, none of which led to drug discontinuation or death. In the tofersen group, 18% of patients experienced a serious adverse event, with 6% leading to drug discontinuation and 1% leading to death (cause not reported).3 Tolerability: Adverse effects seen in a phase III trial of tofersen were mostly mild to moderate in severity. Adverse effects that occurred in ≥15% of patients in the tofersen and placebo groups respectively included headache (46% and 44%), procedural pain (57% and 58%), fall (24% and 42%), back pain (21% and 6%), arthralgia (14% and 6%), fatigue (17% and 6%), nausea (12% and 17%), and constipation (8% and 11%). Serious adverse effects that occurred in ≥2% of patients were aspiration pneumonia (3% and 0%) and pulmonary embolism (4% and 3%) in the tofersen and placebo groups, respectively.2 Effectiveness: In the phase 1-2 trial comparing doses of 20, 40, 60,

and 100 mg of tofersen to placebo, the secondary endpoint was change in baseline in SOD1 protein concentration in cerebrospinal fluid (CSF) at day 85. The results were dose dependent, with a 1% reduction in SOD protein concentration at day 85 in the 20 mg, 27% in the 40 mg group, 21% in the 60 mg group, and 36% in the 100 mg group. This reduction from baseline was significant in the 40 mg group (-25%; 95% CI, -40 to -5) and 100 mg group (-33%; 95% CI,-47 to -16). The same study assessed exploratory outcomes of clinical function (as assessed by the total ALS Functional Rating Scale-Revised [ALSFRS-R] score), respiratory function (assessed by predicted slow vital capacity), and strength (assessed by the handheld dynamometry megascore).4,5 Those in the 100 mg tofersen group did not have a significant change in baseline ALSFRS-R score at day 85 (-1.19 points; 95% CI, -4.67 to 2.29) versus placebo which had a statistically significant worsening in clinical function (-5.63 points; 95% CI, -8.90 to -2.36). There was also no significant decline in lung function in the 100 mg group (-7.08%; 95% CI, -14.69 to 0.54) compared to placebo which had a significant decline in lung function from baseline to day 85 (-14.46%; 95% CI, -21.79 to -7.12). Finally, there was less decline in strength in the 100 mg group compared to placebo.2 In the phase III trial of patients treated with tofersen 100 mg or placebo, the primary endpoint was change in baseline ALSFRS-R score at week 28. There was a -6.98 point change from baseline to week 28 in the tofersen group, and a -8.14 point

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Materia Medica change in the placebo group. The difference between groups was not significant (1.2 points; 95% CI, -3.2 to 5.5; p=0.97). For secondary outcomes, there was numerically greater reduction in the concentration of SOD1 protein in CSF in the tofersen group compared to placebo, however they were not significantly different. There was a numerically different reduced rate of decline in predicted slow vital capacity in the tofersen group compared to the placebo, but there was no difference in the change in baseline of the handheld dynamometry megascore between tofersen and placebo.6 Price: The average wholesale price for one administration of tofersen is estimated at $14,230, which is approximately $199,200 for the first year of the medication (14 doses).6 There is additional cost associated with tofersen as it needs to be administered by a healthcare professional in a healthcare setting. In comparison, riluzole has an average wholesale price of about $30 per tablet, which would cost about $60 per day, or $21,900 per year.7 Simplicity: Tofersen is a complex medication given its intrathecal administration that must be completed by a trained healthcare professional. It may reduce pill burden in patients, but at the cost of a monthly procedure associated with common side effects including back pain, headache, etc.1,6 At this time, there is no adjustment in dosing for patients with renal or hepatic impairment. There have been no studies to evaluate the impact of renal or hepatic impairment on the pharmacokinetics of tofersen, however it is not expected to be metabolized by the liver. No major drug-drug interactions have been observed.1 Bottom line: Tofersen (Qalsody™) an antisense oligonucleotide that causes degradation of SOD1 mRNA through binding to SOD1 mRNA, thus reducing the concentration of SOD1 in the CSF and improving symptoms of SOD1 ALS.1 Clinical trials have shown some effectiveness in reducing worsening of

ACMS Bulletin / January 2024

ALSFRS-R scores and reducing decline in pulmonary function. However, side effects including headaches, pain, and falls are very common due to the intrathecal route of administration. Drug discontinuation due to serious adverse events occurred in 6% of patients and mortality benefit has not been assessed.2,3 This medication has not been studied head-to-head to any other treatments for ALS and is only indicated for a mutation present in approximately 2% of ALS cases.2 Additionally, tofersen is expensive and complex to administer.1 Given the limited options for treatment of SOD1 ALS, this medication may be an option if tolerability and cost are not barriers.

Madeline Dillen, PharmD is a PGY1 Pharmacy resident at UPMC St. Margaret and can be reached at dillenmg@upmc. edu. Abigail Reigh, PharmD, BCPS is a PGY2 Geriatric Pharmacy resident at UPMC St. Margaret and can be reached at reigha@upmc.edu. Heather Sakely, PharmD, BCPS, BCGP, the Director of Clinical Pharmacy Services 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. Qalsody (tofersen) [package insert]. Caimbridge, MA: Biogen MA Inc; 2023. 2. Miller T, Cudkowicz M, Shaw PJ, et al. Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. Jul 9 2020;383(2):109-119. doi:10.1056/NEJMoa2003715 3. Miller TM, Cudkowicz ME, Genge A, et al. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. Sep 22 2022;387(12):1099-1110. doi:10.1056/NEJMoa2204705 4. Bromberg MB, Anderson F, Davidson M, Miller RG. Assessing health status quality of life in ALS: comparison of the SIP/ALS-19 with the ALS Functional Rating Scale and the Short Form-12 Health Survey. ALS C.A.R.E. Study Group. Clinical Assessement, Research, and Education. Amyotroph Lateral Scler Other Motor Neuron Disord. Mar 2001;2(1):317. doi:10.1080/146608201300079391 5. Shefner JM, Liu D, Leitner ML, Schoenfeld D, Johns DR, Ferguson T, Cudkowicz M. Quantitative strength testing in ALS clinical trials. Neurology. Aug 9 2016;87(6):617-24. doi:10.1212/ WNL.0000000000002941 6. McKenzie H. FDA Approves Biogen and Ionis' Qualsody as Fourth-ever ALS Therapy. Biospace. online2023. 7. Riluzole: Drug Information. Lexicomp. Accessed October 24, 2023.