C M S Bulletin · social credit system, each of its 1.4 billion citizens will receive a personal...

Allegheny County MediCAl SoCiety

BulletinMAy 2018

CAR-T cell therapy

Perinatal palliative care

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Business • Employment • Estates and Trusts • Health Care Litigation • Oil and Gas • Public Finance • Real Estate

Care is Your Business, Change is OursThe healthcare environment is changing. Physicians must focus on providing the highest quality care with intense competition for their time. Medical practices face increased challenges tied to changes to regulation, insurance protocols, cost-management and revenue management.

Houston Harbaugh has over 30 years of experience in helping physicians and medical practices manage change through contract negotiations with hospitals and payors; contract management; advocacy and new practice start-up counsel. We have provided critical support in practice mergers and acquisitions. And we have provided sound advocacy on issues ranging from HIPAA compliance to medical staff and peer review matters.

Every challenge a medical practice can face, we have seen. We have helped practices of all size and structure meet these challenges. And we know what is ahead.

BulletinMAy 2018 / Vol. 108 No. 5

Allegheny County MediCAl SoCiety

hh-law.com

Business • Employment • Estates and Trusts • Health Care Litigation • Oil and Gas • Public Finance • Real Estate

Care is Your Business, Change is OursThe healthcare environment is changing. Physicians must focus on providing the highest quality care with intense competition for their time. Medical practices face increased challenges tied to changes to regulation, insurance protocols, cost-management and revenue management.

Houston Harbaugh has over 30 years of experience in helping physicians and medical practices manage change through contract negotiations with hospitals and payors; contract management; advocacy and new practice start-up counsel. We have provided critical support in practice mergers and acquisitions. And we have provided sound advocacy on issues ranging from HIPAA compliance to medical staff and peer review matters.

Every challenge a medical practice can face, we have seen. We have helped practices of all size and structure meet these challenges. And we know what is ahead.

ArticlesOpinion

Departments

Materia Medica .................... 196CAR-T cell therapy: Engineering the future of cancer treatmentChristian M. Thomas Karen M. Fancher, PharmD, BCOP

Legal Report ...................... 200Peer review: A ‘narrow evidentiary privilege’Beth Anne Jackson, Esq.

Editorial ................................162Dystopia nowDeval (Reshma) Paranjpe, MD, FACS

Editorial ................................164Finding a nicheRichard H. Daffner, MD, FACR

Perspective ......................... 166Centers of ExcellencePaul A. Gardner, MD

Perspective ......................... 168Mentorship in medicineGeoffrey Lim, MD

Perspective ......................... 170How to look your best this year: Anti-aging skin strategies to share with your patientNicole F. Vélez, MD

Perspective ......................... 172Contrasting views Sean Serio, MD

Perspective ......................... 174Perinatal palliative care Marta C. Kolthoff, MD, MA

Perspective ......................... 176Now is the time for change Jack Wilberger, MD

Society News ...................... 188• Pittsburgh Ophthalmology Society• Pennsylvania Geriatrics Society – Western Division• Fit with a Physician: Senior walk held• Science and Engineering Fair held at Heinz Field

ACMS Alliance News ......... 194

On the coverSummer Sunflowers

Adam Z. Tobias, MD

Dr. Tobias specializes in emergency medicine.

Opinion

Perspective ......................... 178Lighting the candleG. Alan Yeasted, MD, FACP

Perspective ......................... 180The birth of measures of physician practice Thomas James III, MD, FACP, FAAP

Perspective ......................... 184Sometimes less is more: Choose wisely Adebayo Fasanya, MD

Perspective ......................... 186Study linking fracking to low birth weights must be a wake-up call for regulators Edward C. Ketyer, MD

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Dystopia nowDeval (Reshma) PaRanjPe, mD, FaCs

Dystopian tales are back in vogue recently, ranging from “The Hun-

ger Games” to the runaway hit series based upon Margaret Atwood’s “The Handmaid’s Tale” to the Netflix series “Black Mirror.” All that’s left is a rework-ing of George Orwell’s “1984.” This may be because the technology that led to the dystopia in each of these tales is now a reality.

“The Handmaid’s Tale” concerns the fictional future takeover of the United States by conservative religious revolutionaries and the creation of a society that violently represses and enslaves all women, and forces fertile women into servitude as childbearing vessels for the childless elite. The nov-el was written in 1985 but resonates particularly with women who fear that the current political administration is unfriendly toward women’s rights and in danger of becoming authoritarian. The fictional revolution’s subjugation of women’s rights is made possible through the misuse of technology. All personal financial records are com-puterized, and gender is part of the demographic component of that record, thereby making it easy for the revolu-tionaries to erase – or transfer to men – the assets and thereby the agency of women. Thirty-three years ago, Margaret Atwood foresaw the advent of purely electronic financial records and

the potential misuse thereof; we are now seeing widespread hacking and electronic breaches of individual institu-tions. Imagine if a centralized electron-ic repository (such as a nationalized electronic health record) were to be breached and information either held hostage, selectively changed or totally erased by a hostile party.

“The Hunger Games” also features a brutally authoritarian central gov-ernment that represses any dissent and forces the masses to participate in self-subjugation. Each state sends two children, selected by lottery, to fight to the death in a yearly gladia-tor-style national contest. This be-comes a reality television spectacle, with the doomed children competing for advertisers and sponsors in an effort to outlast each other and avoid a grisly death. It skewers our nation’s current obsession with reality televi-sion. Television viewers’ demand for the psychological pain of others as entertainment is directly compared to Romans clamoring for more bloodshed in the arena as prisoners were thrown to the lions. Our citizenry, already desensitized to violence in films and on television, is being conditioned to actually enjoy watching the pain and struggles of other real human beings, and to compartmentalize any horrors that don’t directly affect the viewer. A

human being’s psychological state and value as a person become cheapened and disposable when reduced to entertainment for the masses. Online trolling occurs because trolls can hide behind the mask of digital anonymity; they are disconnected from their fellow man and thus from their own humanity. It is only a short leap toward physical human life becoming a disposable form of entertainment, and the dysto-pia of “The Hunger Games.”

“Black Mirror” is a modern-day version of “The Twilight Zone,” focus-ing on horror stories arising from the misuse of new technology but with the same powerful psychological effect and incisive social commentary as its predecessor. One “Black Mirror” tale, “Nosedive” is actually coming true today – in China. Under China’s new social credit system, each of its 1.4 billion citizens will receive a personal social credit score by 2020. It is billed as a “trustworthiness rating,” but one glance will prove that it is an ironclad technological method to control the citi-zenry and repress dissent of any kind.

Under this system, each citizen starts with 100 points, and gains or loses points based on actions. Things that will lose you points? Jaywalking, littering and tweeting, or otherwise voicing political dissent. Things that will win you points? Donating blood,

volunteering and being relentlessly positive online about the government. Doesn’t sound dystopian enough yet? Each citizen is rated by his or her fellow citizens, essentially encourag-ing people to inform on each other a la Nazi Germany. Being “friends” on social media or presumably otherwise with someone with a bad social credit score will lower your own credit score, thereby further isolating dissenters. The state will use artificial intelligence, facial recognition, “smart glasses” and other tools to identify citizens at every point of service and treat them accord-ing to their social credit scores.

What are the effects of a bad social credit score in China? Your ability to travel is restricted, you are barred from living in certain areas and you cannot send your children to certain private schools, among other things. In other

words, your and your family’s personal freedoms and opportunities for success are cut off. What are the effects of a good social credit score? The ability to buy property, travel, educate your children and *shorter wait times for health care.* Imagine a world where you are technologically enslaved by the state to the point where your very life and health depended on your sub-mission. The people of China already are experiencing that; CNET recently reported the case of a journalist who can no longer buy property or a plane ticket due to several politically dissent-ing tweets he sent in the past.

Technology often can empower and free us, but we must take great care to ensure that it is not used to enslave us. Think of the implications of these dystopian tales – and China’s real-life dystopia – on our field. Do we want

a breachable, centralized electronic health record repository? Do we want a society where a social credit score or economic credit score might affect someone’s access to health care? And do we want a populace that is so psychologically compartmentalized and disconnected from humanity that it is blind to the pain of fellow citizens?

Something to think about the next time you rate something on Yelp.

Dr. Paranjpe is an ophthalmologist and medical editor of the ACMS Bul-letin. She can be reached at [email protected].

Editorial

The opinion expressed in this column is that of the writer and does not

necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

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Editorial

Finding a nicheRiChaRD h. DaFFneR, mD, FaCR

One of the rewards of being a teach-er is the vicarious pleasure one

gets when a former student is honored. Several years ago, while I was coun-cilor for Pennsylvania to the American College of Radiology (ACR), one of my former residents was honored as a recipient of the Gold Medal, the College’s highest honor for service, not only to the ACR, but to the profession, as well. At the reception following the ceremony, I went to congratulate him. In addition to a warm handshake, he gave me a hug and said, “You know, this would never have been possible without your help.” At first, I wondered how what I had done was different from all the other faculty who had trained him during his residency. And then I remembered. …

I met Mac (not his real name) during his first bone rotation, about eight months into his radiology residency. He had an interesting history in that he had done a surgical internship before starting an orthopaedic residency. He left that program after two years and switched to otolaryngology, which he tried for a year before deciding it, too, wasn’t for him. And so, next, he tried diagnostic radiology.

On the day in question, I recall that Mac seemed a little glum. I asked him what was bothering him, and he reluc-tantly confessed that it seemed that ra-

diology wasn’t exciting him either. I said to him, “You know, you’ve done a year of general surgery, two years of ortho, and a year of ENT. Don’t you think it’s finally time to finish something?” I did get him to agree that radiology was interesting and that he’d give it a little more time. The rest, as they say, was history. He completed his residency, did a fellowship in cardiovascular and interventional imaging, and joined a large specialty-oriented private practice group. He became active in organized radiology, rose through the state and national societies, and eventually became president of the ACR. He had found his niche.

Few physicians end up in the same specialty they imagined practicing when they started out. I became fasci-nated by neurology during my neu-roanatomy course in medical school. It was the only freshman course that had frequent clinical correlation, which reinforced the concept that by carefully analyzing a patient’s symptoms, one could pinpoint the source of the cause. I had always been a fan of Sherlock Holmes and enjoyed the challenge of a tough diagnosis. However, during a summer student neurology fellowship, I was working in the radiology depart-ment of one of our teaching hospitals looking at radionuclide brain scans (this was during the “dark ages” of medicine

before CT scanning). In the morning, I would accompany the radiologists while they did fluoroscopy and went over X-ray studies with the different medical and surgical teams. I began to appreciate that radiology touched all aspects and specialties of medicine. Furthermore, I realized that radiology was very much like detective work in that the X-ray study represented the patient at that precise point in time and that by carefully analyzing the changes present, one could work backwards to identify whatever caused those chang-es. I had found my niche. Two years in the U.S. Air Force practicing as a general medical officer reinforced my belief that I had made the right decision – a decision I never regretted.

As I look back over my decision, I realize that there were many indi-cators along the way that suggested that diagnostic radiology was to be my career choice. I was always good at doing jigsaw puzzles, picking the right shaped piece, matching the colors, and putting it in the right place. In my begin-ning Hebrew class, when I was in third grade, the teacher would write a word on the blackboard. That word appeared only once in the text spread out in front of me, and I was always the first one to find it. I had, what we radiologists call the “eye.” In medical school, I loved my anatomy and pathology courses,

165ACMS Bulletin / May 2018

particularly the lab work.My son, Scott, while he was still in high school, decid-

ed that he wanted to become a physician. His exposure to medicine was strongly, not surprisingly, influenced by radiology. He attended meetings of the International Skel-etal Society, of which I was a member, as well as several ski meetings at which I spoke, while still in college. He was fascinated with spine injuries, an area that I special-ized in. During his junior year in medical school, he had his first exposure to orthopaedics. At Christmas break that year, he asked me if I’d be upset if he did ortho. I told him to follow his heart. Today, he is an academic orthopaedic spine surgeon. He found his niche as well.

Does it always work out that way? No. There have been several instances where I have counselled residents and advised them that they would be better off in another specialty. One individual deserves special mention. He was an older Russian immigrant who had been a gener-al practitioner in Russia. Although he had been able to pass the licensure exam, he had no affinity for radiology because of an inability to conceptualize images in three dimensions. We were fortunate to find him a position as a family practitioner in the Russian community in Philadel-phia, where he went on to a successful career. That was his niche.

It has been just over 50 years since I graduated from medical school. The practice of medicine has significantly changed as it has become more complex and more spe-cialized. When I started my residency, radiologists did a little bit of everything. There were no fellowships; we were mentored by a more senior colleague. Now, each area of the body has its own need for specialists, no matter what the discipline. There are many more niches to be filled as well as niches within those niches.

Dr. Daffner is associate editor of the ACMS Bulletin, and a retired radiologist who practiced at Allegheny Gen-eral Hospital for more than 30 years. He is emeritus clini-cal professor of Radiology at Temple University School of Medicine and is the author of nine textbooks. He can be reached at [email protected].

Editorial

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the

Editorial Board, the Bulletin, or the Allegheny County Medical Society.

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Centers of ExcellencePaul a. GaRDneR, mD

PerspectivePerspectivePerspective

Allegheny County has been a leader in innovations in health care

delivery, resulting in a robust medical economy and improved health care for the region. Each new paradigm shift, however, creates new challenges and opportunities. As the entire country looks for ways to improve the value of care, often using imperfect surrogates for quality paired with crude estimates of the costs of care, medical profes-sionals get caught in the middle, often unable to join this conversation. New policies and initiatives are enacted with little consideration for unintended consequences. As a result of legisla-tive changes, costs are passed along to patients and health care delivery becomes increasingly less profitable.

This has led to increasing merg-ers between individual hospitals and larger systems as well as a prolifera-tion of “integrated delivery systems,” combining insurance companies with hospital systems. This shift realigns the financial goals of the health care systems but carries the risk of creating competing goals: providing high-quality care while reigning in costs. This com-bination of provider and payer, howev-er, also may provide opportunities to improve health care delivery in western Pennsylvania. With an integrated delivery system, comprehensive data mining regarding utilization, outcomes

and cost can be used more effectively to develop new models of health care delivery. One such model is the estab-lishment of Centers of Excellence.

Centers of Excellence are recog-nized as regional centers that provide better value to patients and insurance providers by improving quality of care while controlling costs. Although Cen-ters of Excellence will vary depending on size and distribution of the health care network, they are generally best applied across a health care system in a disease-specific fashion. As such, they can provide access to expert care which can only come from high-volume providers serving a large health care community.

One example of such a center is a Pituitary Center of Excellence. Pituitary tumors represent 17 percent of all primary brain tumors and 25 percent of non-malignant brain tumors.1 The care of patients with pituitary tumors re-quires a multi-disciplinary collaborative environment with full access to the best diagnostic and therapeutic services. The designation of “Centers of Excel-lence” is an attempt to concentrate the care of patients to improve outcomes. Management of these tumors involves multiple specialties, ideally co-located: neurosurgery, endocrinology, otolaryn-gology, neuro-ophthalmology, endovas-cular neurosurgery, radiation oncology/

radiosurgery, neuroanesthesia, neu-ro-oncology and neuropathology. The mission of such a center is to provide comprehensive care and support to patients with pituitary disorders; to pro-vide residency and fellowship training, and continuing medical education in the management of pituitary and neu-roendocrine disease; and to contribute to basic science and clinical research in pituitary disorders.

Numerous studies show better outcomes and lower complication rates in centers with more experienced pituitary surgeons.2-8 In a study involv-ing 958 neurosurgeons, the incidence of complications was higher with less experienced surgeons, and there was a significant decrease in morbidity and mortality after 200 and 500 operations.4 In another study, patients treated at high-volume hospitals by high-volume surgeons had lower mortality rates, better hospital discharge dispositions, and fewer complications.5 This expe-rience-outcome effect is likely more pronounced in complex cases such as invasive or recurrent adenomas, giant pituitary tumor, Cushing’s disease, acromegaly and craniopharyngiomas.3

One of the main concerns created by Centers of Excellence is restriction of practice. While there is some inher-ent redirection of subspecialty care toward these high-volume centers, the



impact on low-volume providers is min-imal, as the number of cases for these providers is small. In addition, the majority of overall care (for example, medical endocrinology and radiograph-ic follow-up) can be provided by local physicians in collaboration with experts at the Center of Excellence. This “hub and spoke” model provides subspecial-ty expertise from high-volume provid-ers while minimizing patient travel and disruption of local provider relation-ships and support. Health technology can assist this process via telemedi-cine with case conferences, commu-nication with individual specialists and direct patient consultation. This covers the entire temporal spectrum of care, from initial diagnosis through long-term management. In addition, if proper re-muneration for expertise can be shared between central and local specialists, this model has the potential to improve the value of care by decreasing overall cost yet improving quality of care.

There are other, indirect aspects of regional care that can be impacted by a Center of Excellence. Continuity of care is improved when care is directed through a single center. Data collec-tion is a necessary driver of quality

improvement. Outcomes research as well as participation in basic science research and clinical trials is another main function of such centers and serves to advance the field well beyond the health care system and region. Concentration of care also provides the necessary environment for train-ing the next generation of health care providers to employ the most advanced methods and techniques.

Finally, while a Pituitary Center of Excellence is a good example for a rarer condition, there are many other arenas where this applies, from rare conditions (pancreatic disease) to extremely common ones (joint re-placement, cardiac care). Like many diseases, these involve moments of highly specialized procedural care in-terspersed in a long continuum of care provided by a multidisciplinary team.

SummaryThe goal of value-based patient

care is to provide the best outcomes for the least cost. Generally, improved outcomes are noted at centers with a higher volume of cases. Within larger, consolidated health care systems, there often is a wide range in the

number of cases per provider with a long tail of infrequent practitioners. By applying Centers of Excellence for high-prevalence conditions such as pituitary tumors, it should be possible to use outcome measures in addition to structural and process criteria to create standards for hospitals and surgeons and improve the efficient delivery of high-quality care.

Dr. Gardner is fellowship-trained in endoscopic endonasal pituitary and endoscopic and open skull base surgery. His research has focused on evaluating patient outcomes following these surgeries and more recently on genomic analysis of rare tumors. Dr. Gardner is neurosurgical director of the Center for Cranial Base and Pituitary Surgery and executive vice chair, Sur-gical Services, within the Department of Neurological Surgery at the Universi-ty of Pittsburgh Medical Center. He can be reached at [email protected].



References1. Ostrum, et al: Neuro-Oncology 18: v1-v75, 2016.2. Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly

management: an update. J Clin Endocrinol Metab. 2009;94(5):1509–1517.

3. McLaughlin N, Laws ER, Oyesiku NM, Katznelson L, Kelly DF. Pituitary centers of excellence. Neurosurgery. 2012;71(5):916–926.

4. Ciric I, Ragin A, Baumgartner C, Pierce D. Complications of transsphenoidal surgery: results of a national survey, review of the lit-erature, and personal experience. Neurosurgery. 1997;40(2):225-236.

5. Barker FG 2nd, Klibanski A, Swearingen B. Transsphenoidal surgery for pituitary tumors in the United States, 1996-2000: mortal-ity, morbidity, and the effects of hospital and surgeon volume. J Clin

Endocrinol Metab. 2003;88(10):4709-4719.6. Shahlaie, K., N. McLaughlin, A.B. Kassam, and D.F. Kelly, The

Role of Outcomes Data for Assessing the Expertise of a Pituitary Sur-geon. Curr Opin Endocrinol Diabetes Obes, 2010. 17(4): p. 369-76.

7. Berker, M., D.B. Hazer, T. Yucel, A. Gurlek, A. Cila, M. Aldur, and M. Onerci, Complications of Endoscopic Surgery of the Pituitary Adenomas: Analysis of 570 Patients and Review of the Literature. Pituitary, 2012. 15(3): p. 288-300.

8. Halvorsen, H., J. Ramm-Pettersen, R. Josefsen, P. Ronning, S. Reinlie, T. Meling, J. Berg-Johnsen, J. Bollerslev, and E. Helseth, Surgical Complications after Transsphenoidal Microscopic and Endo-scopic Surgery for Pituitary Adenoma: A Consecutive Series of 506 Procedures. Acta Neurochir (Wien), 2014. 156(3): p. 441-9.

168 www.acms.org

Mentorship in medicineGeoFFRey lim, mD


As my colleagues and I approach the completion of our residency

training, it is only fitting that we con-template the people who helped us get here. Personally, I ponder a single act by a single individual at a single point in time and the influence it has had on me in the formative years of my career. In my third year of medical school, I distinctly remember my father, a der-matologist, encouraging me to attend a conference where I subsequently received an invitation to rotate at the University of Pittsburgh Department of Dermatology. That four-week elective led to a residency interview, and now five years later, I find myself on the eve of graduation as the product of not only my father’s mentorship, but also that of several other exceptional mentors whom I have encountered along the way. This immense ripple effect is as fascinating as it is incomprehensible, considering the multitudes of acts by mentors over a span of more than a decade of medical training.

The word “mentor” originates from Homer’s famous poem, “The Odys-sey.” An extremely wise man, Mentor advised Telemachus while he searched for his father, Odysseus. Literally, the Greek translation of mentor means “to endure,” while the modern English translation is “a trusted counselor or guide.” Together, these meanings could

not be more suitable to characterize my own experience with mentors, all of whom have epitomized these defini-tions and profoundly affected my life.

Mentorship is the lifeblood of faculty and trainee development in medi-cine. We use it to translate textbook knowledge into clinical application, to decide our career pathways, and most importantly, to influence our ethics. We find mentorship at every level of our training: between medical student and resident, resident and fellow, fellow and attending, medical student and attending, junior faculty and senior faculty, and so on. The permutations are innumerable, and each relationship is invaluable.

In my experience, there are a set of core qualities among mentors that define “healthy” mentorship. Good mentors:

1. Exude a genuine and infectious enthusiasm for their occupation and for teaching;

2. Are both approachable and ac-cessible to their mentees;

3. Show respect to their mentees as learners;

4. Modify their teaching strategies to adapt to learners’ needs;

5. Tailor their roles in each mentee’s unique development;

6. Have excellent interpersonal skills;

7. Are knowledgeable;8. Provide positive reinforcement

regularly and readily when deserved; 9. Provide honest criticism privately

and constructively, simultaneously elucidating ways for the mentee to improve;

10. Recognize the potential in each mentee and provide opportunities for growth, striking a balance between structured guidance and advancing autonomy;

11. Realize that even as mentors, they may learn from their less-experi-enced mentees.

Collectively, these traits enable mentors to advise and support their mentees in a non-threatening, permis-sive environment.

Yet, the responsibility of good mentorship does not depend solely on mentors. Mentorship itself implies a reciprocal relationship; “healthy” mentorship is just as much a function of the characteristics of the mentees as it is dependent on the attributes of the mentors. To optimize these rela-tionships with their mentors, mentees should:

1. Mirror their mentors’ enthusiasm and exhibit their own genuine interest;

2. Not abuse the privilege of their mentors’ accessibility;

3. Be cognizant of the additional responsibilities and time constraints of

their mentors outside of their relation-ships;

4. Take ownership of their own knowledge and be independent learn-ers;

5. Be adaptive to different teaching styles;

6. Learn to acquire knowledge; conversely, learn not to simply acquire strong evaluations;

7. Have structured goals and be flexible to change;

8. Express gratitude often and appropriately;

9. Be receptive to constructive criti-cism, devoid of emotional derailment;

10. Strive to implement feedback to create the best versions of themselves;

11. Remain grateful of opportunities afforded by their mentors, and continue to seek out additional responsibility as they feel comfortable;

12. Be accountable, earning their mentors’ trust that the tasks committed

to will be completed.By embodying these qualities, men-

tees intrinsically benefit and provide themselves the greatest opportunity to succeed.

Given the complex structure of med-ical education, which includes lecture-ships, clinical experience, research, community service and advocacy, men-torship in medicine must be a central focus of all institutions. At their core, the best medical schools, residency programs and fellowships uniformly invest in a strong network of mentors. Like a revolving door that circulates an average of four years, medical train-ing is full of transitions with unfore-seeable consequences that, without mentorship, would be impossible to surmount. Therefore, it is imperative that we entrust our future physicians to individuals who guide them to become well-rounded, knowledgeable and compassionate caretakers.

To all mentors, especially my own, thank you. Your encouragement, wisdom and selflessness cannot be overstated. To all trainees, I invite you not only to acknowledge your mentors in your own way, but ultimately to honor your mentors by “paying it forward.” Dr. Ahmed Mian described this to perfection in his own editorial on mentorship in medicine. By becoming “trusted coun-selors” ourselves, we ensure that the finest traditions of our noble profession continue “to endure” through the ages.

Dr. Lim is chief resident at the University of Pittsburgh Department of Dermatology. He can be reached at [email protected].





References 1. Wikipedia [encyclopedia on the

Internet]. Mentor. Los Angeles, CA: Wiki-pedia Foundation Ltd; 2010. Available from: www.en.wikipedia.org/wiki/mentor. Accessed 2018 April 7.

2. Merriam-Webster Online Dictio-nary. Mentor. Springfield, MA: Merri-am-Webster, Ltd; 2010. Available from: www.merriam-webster.com/dictionary/mentor. Accessed 2018 April 7.

3. Yeung M, Nuth J, Stiell IG. Mento-ring in emergency medicine: the art and the evidence. CJEM 2010;12(2):143-9.

4. Sutkin G, Wagner E, Harris I, Schiffer R. What makes a good clinical teacher in medicine? A review of the literature. Acad Med 2008;83(5):452-66.

5. Mian, A. True mentorship in medicine. Canadian Family Physician 2011;57:252.

2018 ACMS Foundation Award nominations are open!

Nomination form available on page 173.

Healthy Children, Healthy Communities, Healthy Future

170 www.acms.org

How to look your best this year: Anti-aging skin strategies to share with your patient

niCole F. vélez, mD


As summer approaches and we plan to spend more time outdoors,

patients, as well as your family and friends, may turn to you for advice on skin care. The largest organ in the body, the skin can be a reflection of the individual’s overall health and wellbeing. The increasing number of skin care lines and products available over the counter can be overwhelming and confusing. Furthermore, marketing and social media campaigns can be misleading about product efficacy and expected results. Patients often want to know what is worth their time and money.

Here is some advice you can share:1. Daily sun protection: Sun dam-

age is the number one cause of skin aging. Research has shown that expo-sure to UV radiation (UVR) increases the expression of matrix metallopro-teinases (MMP), proteolytic enzymes that degrade collagen and elastic fibers. Histologically, skin exposed to UVR shows disorganization and re-duction of these fibers fundamental to the structure of our skin.1 Clinically, this translates into wrinkles and loss of skin volume as well as altered skin texture and dyspigmentation. Daily use of a broad-spectrum sunscreen over one year has been shown to reduce and improve photoaging.2 I encourage my patients to wear a daily facial moistur-

izer with SPF 30 regardless of weather, and re-apply every 2 hours if active outdoors. Foundation and other make-up may offer some protection, but I strongly suggest the application of a SPF 30 product beneath. A wide range of excellent sunscreens are available on the market. These range from the generic pharmacy moisturizer to more expensive creams that may offer tinted formulations. Ultimately, the choice is a personal one, and I recommend my patients find a cream that they like, can afford and will wear daily.

2. Nightly retinol use: Retinol products show the best evidence for reversing the effects of photo aging. If my patients want to buy just one product, this is what they should invest in. Since the early 1980s, clinicians prescribing trans-retinoic acid (treti-noin) for their acne patients began to notice an unexpected improvement in the skin roughness, dyspigmentation and facial wrinkles of their patients.3 We now know retinoids, Vitamin A derivatives, exert their effect by binding nuclear receptors and influencing DNA transcription. Application of topical retinoids promotes cellular differentia-tion and extracellular matrix synthesis while downregulating MMP production. After regular use of tretinoin, histologic findings show epidermal thickening, dispersion of melanin granules and

increased dermal collagen synthesis.4 Significant clinical improvement can be seen in 3-6 months.

Unfortunately, cutaneous irritation often limits patient compliance. Here are some tips:

• Start with a low-strength retinol. I usually start with tretinoin 0.025 per-cent cream. The strongest prescription retinol is tazarotene 0.1 percent. Mul-tiple over-the-counter retinols are now available as well, such as adapalene 0.1 percent (which was previously prescription only).

• Only a small “pea-size” amount of cream is needed (i.e., half a fingertip). I encourage my patients to apply to their face, neck and back of the hands.

• Start by using only 3 nights a week and slowly increase the frequency. It is important to use at night because sunlight will inactivate the product.

• Tell your patients to expect some dryness initially. Encourage use of an emollient after application of the retinol and in the morning.

3. A ceramide emollient: Along with fatty acids and cholesterol, ceramides are key lipid components of the stratum corneum, our skin barrier. Aging is associated with loss of ceramides which leads to changes in skin texture and sensitivity. Topical ceramide use improves barrier function and reduces transepidermal water



loss; this translates into improved skin appearance and protection from environmental insult.5 Again, this need not be an expensive product. Several affordable emollients with ceramides, including Cerave®, are available over the counter.

4. Vitamin C: A naturally occurring water-soluble antioxidant, ascorbic acid (vitamin C) provides protection from free radicals produced by UVR. It should be applied in the morning with sunscreen. Vitamin C is an essential cofactor for collagen synthesis as well as an inhibitor of tyrosinase, a key enzyme in melanin production. Use of vitamin C promotes collagen synthesis, offers photoprotection and lightens hyperpigmentation.5, 6 Unlike topical retinols, vitamin C is safe to use in pregnancy.

5. Beyond topicals: If your pa-tient is interested in treatment options beyond creams, here is a brief sum-mary of common and popular proce-dures. Neurotoxins, such as Botox®,

Dysport® and Xeomin®, improve the appearance of dynamic wrinkles, the lines that form with movement. This refers to the frown lines in the glabella, the forehead lines and the crow’s feet (periorbital lines with smiling). These toxins work by disrupting synaptic terminals in the muscle and their effect lasts approximately 3 months. Fillers, such as Juvederm® or Restylane®, improve the appearance of static wrinkles, the lines present at rest (i.e., the nasolabial folds). Fillers restore volume as well in areas such as the zygomatic arch. Laser resurfacing and chemical peels are options for surface rejuvenation and improvement of fine wrinkles. A relatively newer technology is microneedling, also known as percu-taneous collagen induction. Composed of multiple fine needles located on a barrel that rolls across the skin, the microneedling pen creates numerous punctures in the stratum corneum and superficial dermis that then triggers the release of growth factors which pro-

mote collagen and elastin formation.7 Microneedling also offers the potential of enhancing transepidermal drug de-livery of agents such as growth factors and peptides that may further assist in skin rejuvenation.7 While the effect may not be as dramatic as that of an ablative laser, microneedling requires less downtime and is more affordable.

Several non-invasive options now exist to improve skin appearance, tone and texture. At the end of the day, sun protection is still the most powerful tool against anti-aging.

Dr. Vélez is a dermatologist and Mohs surgeon with Allegheny Health Network and clinical assistant profes-sor at Temple University. She can be reached at [email protected].



References1. Lesiak A, Rogowski-Tylman M, Danilewicz M et. al. One week’s holiday

sun exposure induces expression of photoaging biomarkers. Folia Histochem Cytobiol. 2016;54(1):42-48.

2. Randhawa M, Wang S, Leyden JJ et. al. Daily use of a facial broad spectrum sunscreen over one-year significantly improves clinical evaluation of photoaging. Dermatol Surg.2016;42(12):1354-1361.

3. Kang S, Fisher GJ, Voorhees JJ. Photoaging and topical tretinoin: therapy, pathogenesis, and prevention. Ach Dermatol. 1997;133(10):1280-4.

4. Calikoglu E, Sorg O, Tran C, et al. UVA and UVB decrease the expres-sion of CD44 and hyaluronate in mouse epidermis, which is counteracted by topical retinoids. Photochem Photobiol. 2006; 82:1342-1347.

5. Bissett DL. Common cosmeceuticals. Clin Dermatol. 2009;27(5):435-45.

6. Farris PK. Topical vitamin C: a useful agent for treating photoaging and other dermatologic conditions. Dermatol Surg. 2005;31:814-7.

7. Hou A, Cohen B, Haimovic A, et al. Microneedling: A Comprehensive Review. Dermatol Surg. 2017;43(3):321-39.

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contact Bulletin Managing Editor

Meagan Sable at [email protected],

(412) 321-5030, ext. 105,

or visit www.acms.org.

172 www.acms.org

Contrasting viewssean seRio, mD


“We need the patient’s creatinine before we can do their CTA.” How many times have you heard this statement? As an Emergency Medicine resident working at one of the busiest trauma and stroke centers in the city of Pittsburgh, obtaining imaging that could potentially alter the course of a patient’s treatment is a daily occur-rence, and unfortunately, the medical phenomenon of Contrast-Induced Nephropathy (CIN) remains a contro-versial topic in our area of practice.

Beginning in 1954 with Bartels, et al., the possibility of CIN has led to un-controlled, retrospective and prospec-tive studies as well as meta-analyses and reviews, with the overall consen-sus being there is no well-established, reproducible evidence to support this process as a true medical condition. The American College of Radiology (ACR) published in their “Manual on Contrast Media” that “at the current time, it is the position of ACR Com-mittee on Drugs and Contrast Media that CIN is a real, albeit rare entity” and “published studies on CIN have been heavily contaminated by bias and conflation.” Therefore, even with over 60 years of studies up to this point, the medical community still cannot provide a definitive answer, so we continue to mold our form of practice around the concept that developing CIN is a

foregone conclusion. We as a medical society unfortu-

nately choose to support and quote literature based on studies that have looked at high-dose intra-arterial angiography or those that include many different types of contrast, when in actuality standards across the med-ical system including dose and type of contrast are extremely dynamic. This misconception leads to outdated material being quoted as absolute truth. We look at each of these studies and take them as written law and yet, when you take a step back, you cannot help but notice there is a trend. Most studies will quote the need for more research, the need for a randomized control trial to truly make a determination as to the validity of this diagnosis, and it seems as though we will continue to support this potential etiology until this is done. It is obvious that no singular study has been able to sway the minds of the majority; it is clear to me that the lack of evidence should lead to the end to an unwavering devotion to this “rare entity.”

There also seems to be a discon-nect as to what should truly matter when discussing CIN. We focus on a change in a number, not a clinical change in the patient. A creatinine change of 0.3 is apparently all that is needed to validate this entity. Yet, why is this truly important? Instead of

focusing on a short-term change in a number, we should be focusing on whether there is a long-term change in the patient’s quality of life and clinical status. Did the administration of con-trast lead to hemodialysis, which in and of itself would require invasive proce-dures such as a tunneled catheter or an arteriovenous fistula? Did contrast lead to a true change in morbidity and mortality? Or are we focusing on a number that would have changed regardless of the administration of contrast? Newhouse, et al., showed us that when followed over several days, as we do with all of our admitted patients, creatinine trends up and down irrespective of contrast administration. This begs the question – why discuss an entity as a possibility if its whole basis is on a value that changes no matter the intervention?

Overall, this notion of CIN, as rare as it may be, continues to play a role in our daily lives as physicians. Time delays while awaiting creatinine values and the reliance on inferior studies due to an inability to utilize contrast medium has become the norm. Instead of focusing on the lack of evidence as a whole, we focus on the individual literature that supports it. Even with all the advances in medicine to date, we unfortunately remain a society that is

Continued on Page 175

2018 Award NominationsHealthy Children, Healthy Communities, Healthy Future

Community Awards

Benjamin Rush Individual AwardRecognizes an individual who is not a physician and who devotes time, skills or resources to assisting others and contributes to the advancement of healthcare.

Benjamin Rush Community Organization AwardRecognizes a company, institution, organization or agency that is successfully addressing a community health issue.

Executive Leadership AwardRecognizes an individual who has demonstrated exemplary leadership and advocacy for physicians. Over a sustained time, the recipient shall have displayed administrative guidance and support to physicians to improve their ability to improve the lives and health of the people of our community.

Physician Awards

Nathaniel Bedford Primary Care AwardRecognizes a primary care physician for exemplary, compassionate, comprehensive and dedicated care of patients.

Ralph C. Wilde Leadership AwardRecognizes a physician who demonstrates exceptional skill in clinical care of patients and dedication to the ideals of the medical profession as a teacher or profession leader.

Physician Volunteer AwardRecognizes a physician for charitable, clinical, educational or community service activities, domestically or internationally, as a volunteer.

Richard E. Deitrick Humanity in Medicine AwardHonors a physician who has improved the lives of patients by caring for them with integrity, honesty, and respect for their human dignity, and is a role model for other physicians.

• You may nominate more than one individual or organization.• Individuals may not be practicing healthcare professionals. • Organizations may not be hospitals or care facilities.

• You may nominate more than one ACMS member.

Name:

Nominee Information:

Address:

City, State, Zip:

Name:

Submitted by:

Address:

City, State, Zip:

Phone:

Email:

I would like to nominate (please print):

Benjamin Rush Individual Award Benjamin Rush Community Organization AwardExecutive Leadership AwardPhysician Volunteer Award Nathaniel Bedford Primary Care AwardRalph C. Wilde Leadership AwardRichard E. Deitrick Humanity in Medicine Award

for the:

Please attach a letter explaining why you are nominating this individual or group. You may include a brief history of the individual or organization, letters of support, or up to 5 pages of supporting information. Please use one form for each nomination.

Nominations must be received by Wednesday,

July 18, 2018.

Nominations can be submitted online at:www.acms.org/awards

Awards will be presented at the ACMS Foundation Celebration of Excellence Gala Saturday, March 2, 2019.

Mail, fax, or email nominations to:

ACMS Foundation 713 Ridge Avenue

Pittsburgh, PA 15212Fax: (412) 321-5323 Email: [email protected]

174 www.acms.org

Perinatal palliative caremaRta C. KolthoFF, mD, ma


I recently watched an interview of Daniel Lubetsky, founder and CEO

of KIND healthy snacks and author of “Do the Kind Thing.” Mr. Lubetsky spoke about the important difference between nice versus kind: kind being active and engaging as opposed to the passivity of nice. Lubetsky believes it is kindness that can make a difference in the world and this is the mission of his not-for-profit company. This interview made me think about perinatal pallia-tive care, where kindness and compas-sion are practiced with purpose and thoughtfulness. It is both kindness and compassion that create a foundation for a successful perinatal palliative care program.

What is perinatal palliative care? Perinatal palliative care (PPC) is based on the principles of adult and pediatric palliative care but extended to the time of prenatal diagnosis when patients face a life-limiting fetal diagnosis. It is supportive care provided through-out pregnancy and continues to and beyond the baby’s death, be it stillbirth, neonatal or infant. It is holistic, fami-ly-oriented care that emphasizes the psychosocial and spiritual needs of the patient.1 The “patient” is the pregnant woman and her baby, along with the father/partner, children, or other family members.

The field of prenatal genetics has

progressed rapidly over the past decade, allowing for a wide range of fetal diagnoses to be made earlier and earlier in pregnancy. Cell-free DNA testing (aka non-invasive prenatal testing or NIPT) identifies chromosom-al and genetic disorders as early as 9 weeks gestation, needing no more than a few milliliters of a pregnant woman’s blood. Expert ultrasound can detect major fetal anomalies in the first trimester. As a result, it is not uncom-mon for a pregnant woman to face a severe or life-limiting fetal diagnosis. Historically, options for these women would be termination of a desired preg-nancy or continuing a pregnancy with limited support or guidance. PPC has emerged as an innovative, specialized and deeply compassionate alternative for these pregnant women and their families.

Common referral fetal diagnoses include trisomy 18, trisomy 13, bilat-eral renal agenesis and anencephaly. However, PPC is not limited to these diagnoses; it also can be utilized in the setting of life-threatening fetal diagno-ses or for babies born at the limits of viability. As in pediatric palliative care, PPC can be offered along with inten-sive neonatal management especially when prognosis is uncertain.

Why is perinatal palliative care important? As difficult as it may be to

reconcile, the death of a baby is not uncommon, with congenital anoma-lies representing the leading cause of these deaths.2 In addition, trisomy 13, trisomy 18 and bilateral renal agenesis complicate 2 percent of all pregnan-cies.3 Therefore, perinatal and neonatal deaths are not uncommon. However, in today’s society, where “baby bumps” and “gender reveal parties” are the norm, there is an expectation that every pregnancy is healthy and happy. For those patients and families who choose to continue their pregnancies after a severe fetal diagnosis, they may face a long, lonely journey. PPC can provide a much-needed “port in the storm.”

What does a PPC program look like? The first step is acknowledging grief and providing emotional support. Detailed, accurate information regard-ing fetal diagnosis and prognosis is provided, often through multiple visits. With time, PPC as a concept is intro-duced, emphasizing that PPC does not mean “giving up hope.” In addition, patients are reassured that they will not be “abandoned.”4 As the patient and her family are followed throughout the pregnancy, the PPC team also meets over time to review and document the plan of care. PPC functions as a multidisciplinary program, involving the referring OB or other health care



provider, Maternal Fetal Medicine, Genetics, Neonatology, Nursing, Bereavement Services, Pediatric Palliative Care and other specialists as dictated by the fetal diagnosis and needs of the patient (such as pediatric subspecialists and behavioral health). Coordination of care, advance care planning, consistent information and bereavement services are key com-ponents of a PPC program. Complex issues can and often do arise, making communication among all providers and the patient essential.5

Small interventions can go a long way. Remembering and stating their baby’s chosen name to making special arrangements to avoid time spent in common waiting areas can significantly impact a patient’s experience. Patients often are grateful for such endeavors and may readily express their ap-preciation. It has been observed that

patients who experience a life-limiting fetal diagnosis in the setting of PPC may have a “transformative” expe-rience and express a desire to help others facing similar situations. One recent family from our program at West Penn Hospital raised $6,000 following the loss of their daughter. As a provid-er, actions such as these can be both awe-inspiring as well as humbling.

The prenatal diagnosis of a se-vere or life-limiting fetal abnormality represents a tremendous moment in a pregnant woman’s life, likely one always remembered. Although PPC cannot alter the fetal diagnosis, it can dramatically change the patient experi-ence, particularly through the practice of kindness. Although challenging emotionally, I feel that PPC presents an opportunity for physicians to ex-perience some of the most rewarding aspects of medicine.

Dr. Kolthoff practices Reproductive Genetics at West Penn Hospital – Al-legheny Health Network. She can be reached at [email protected].

References1. Boss R, et al. Textbook of Interdis-

ciplinary Pediatric Palliative Care. Phila-delphia, PA: Saunders; 2011: 387-401.

2. https://www.cdc.gov/nchs/fastats/infant-health.htm

3. Cote-Arsenault & Denney-Koelsch. “My Baby is a Person:” Parents’ Experi-ences with Life-Threatening Fetal Diag-nosis.” Journal of Palliative Medicine. Vol. 14, No. 12. 2011

4. Munson D & Leuthner SR. “Palli-ative Care for the family carrying a fetus with a life-limiting diagnosis.” Pediatric Clin North Am. 2007; Vol 54.

5. Munson D & Leuthner SR.

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion

of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

slow to move on from what I would deem more folklore than evidence. Thus, we can only hope that one day the randomized control trial that the medical community so desperately wants will be completed so that we can finally put this debate to rest. If not, I hope we can set aside our contrasting views and do what is best for the patient, instead of focusing on a number.

Dr. Serio graduated in medicine from Rush Medical College in Chicago, Ill., and is an Emergency Medicine resident at Allegheny General Hospital, Pittsburgh. He can be reached at [email protected].

Perspective

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial

Board, the Bulletin, or the Allegheny County Medical Society.

References1. ACR Manual on Contrast Media. Vol. 10.3, 2017. 2. Bartels. “Acute Anuria Following Intravenous Pyelography in

a Patient with Myelomatosis.” Acta Med Scand, 1954. 3. Newhouse, Jeffrey H., et al. “Frequency of Serum Cre-

atinine Changes in the Absence of Iodinated Contrast Material: Implications for Studies of Contrast Nephrotoxicity.” American Journal of Roentgenology, vol. 191, no. 2, 2008, pp. 376–382., doi:10.2214/ajr.07.3280.

From Page 172

2019 ACMS Board and Delegate Nominations open! See page 179.

Allegheny County Medical Society

176 www.acms.org

Now is the time for change

jaCK WilbeRGeR, mD


I appreciate the opportunity to write again for the Bulletin. For those of you

“young” enough to remember, I served as the editor of the Bulletin for 10 years in the 1990s and wrote frequently. It is propitious that this is my birthday month. I have spent my entire almost 40-year professional career in Alleghe-ny County.

There are arguably three issues at the forefront in the grand scheme of health and welfare today.

Gun violence: The current situa-tion is untenable in this and any other non-terrorist-based society. I cannot recall a week in the year to date with-out killing of innocents. Since the first school-related incident, 438 children have been shot, 138 killed. When the other mass shootings are included, that number doubles. In the first two months of 2018, 2,292 have died, 3,900 injured. In addition, night after night on the news are our public de-fenders needing to use up to 20 bullet rounds to defend us from those armed with cell phones and screwdrivers. While unknown objects being extracted from pockets against warnings cer-tainly justify some type of force, does it really take 20 shots to deter such aggression?

Numerous medical organizations have put out policies on gun con-trol through the years. Nothing has

changed, even though the violence continues unabated and escalated. The results remain to be seen, but the most “aggressive” attack on this unten-able situation was recently initiated by the students from the Florida school most recently affected and have gone nationwide. Many others have joined.

It was very disturbing that during the recent special congressional election in western Pennsylvania that one of the candidates was shown on a firing range with the statement: “He still loves to shoot.”

As I write, the national children’s movement continues to grow and the violence continues.

The Center for Responsive Politics (CRP), a nonpartisan group that tracks political spending, followed itemized contributions in the days before and after the Florida school shooting. The information collected revealed that in the two weeks after the shooting, item-ized contributions to the NRA of $200 or more by an individual doubled from the previous two weeks. According to the CRP, the NRA contributed $50.2 million on seven key races during the 2016 elections. I personally have no hope whatsoever that dealing with the NRA will yield even any partial solution.

Just recently, a supreme court jus-tice – perhaps sarcastically – said the only way to deal with the problem was

to simply abolish the second amend-ment.

Why would anyone want to go to their office in the morning finding armed guards on site to continually protect them, much less a 6-year-old child?

It brings to mind the civil rights movement of the ’50s and ’60s, when the children peacefully took to the streets in Birmingham Alabama and the Freedom Riders rode to their highly likely deaths.

Maybe the innocent shall prevail while intelligent adults fail – or just don’t care.

As physicians, we must be mindful of the critical role we play in hopefully decreasing the aftermath of these devastating events.

Drug abuse: The sorry situation that exists today with the shameful “ep-idemic” of “drug dealers” looking to get rich on the addictive illnesses of others needs to be refocused. Physicians, for the most part unwittingly, bought into the concept that no one should ever be in any pain. Most recall the Joint Commission requirement – pain is the fifth vital sign and the lack of aggres-sive treatment a “sin.” This carried over much further in the outpatient setting, where more than $3 billion of a single opioid was prescribed last year. Then when patients can’t get their physicians to give them even more, that’s when



the “drug-dealers” take control. When many physicians realized they were doing more harm than good, patients sought whatever they needed from wherever they could find it.

In 2017, there were more than 64,000 drug-related deaths. If this trend continues, that number will be almost the same as deaths caused by gun violence.

As everyone knows, the Pennsyl-vania Prescription Drug Monitoring Program (PDMP) was put into place to “police” physician prescribing. To what end remains to be seen. I have checked the registry multiple times and have seen unbelievable instances of multiple prescriptions for hundreds of opioids at a time. What type of over-sight, then, does the registry provide?

Doctors are caught in the middle. If we don’t alleviate pain, we are criti-cized. If we believe what patients tell us and prescribe opioids, we can be sanctioned. We have to have a middle ground. Reasonable physicians, using sound clinical judgement, must have the ability to responsibly treat in the patient’s best interest.

In my opinion, this is creating/has created a schism between a physician and their patient. It is easy to stand be-hind the cover of the registry in denying pain medications. But who does the patient blame? Their physician. And I have had multiple encounters over this issue and lost the respect of a num-ber of patients. Especially since the resources to move from the physician to a legitimate next step or recovery

program remain few and far between.Hopefully, our state medical societ-

ies can be a voice of reason. Everyone owns the problem.

Physician health and well-being: The issues of physician depression, burnout and suicide have been of con-cern for quite a while. The incidence of significant depression is 4x the rate of the general population; burnout is up to 70 percent in some subspecialties; sui-cides in male physicians is 1.5 percent and female physicians 2.5 percent x the rate in the general population.

Aside from the personal toll, there are effects on quality of care, practice efficiency and organizational effective-ness.

The primary barrier to seeking treat-ment appears the perceived stigmata of psychological disturbances and concerns over their effects on profes-sional standing, licensure and other career-related issues.

The issue is no less real in medical students and residents.

In a recent study, Mata, et al., analyzed longitudinal studies, which tracked residents before their residen-cy started and through a portion of residency. They found an increase of about 15 percent in symptoms within a year of the start of residency.

In the past year, the Accreditation Council on Graduate Medical Educa-tion (ACGME) has focused intense scrutiny on the issue. Teaching institu-tions have mandated protected time for organized health and wellness activi-ties and have made available numer-

ous resources (www.acgme.org).Many institutions are providing offer-

ings through their employee assistance programs, and many insurers are doing the same.

Hopefully, physicians will realize their psychological limits and reach out to these new resources.

There have been, and always will be, issues confronting the medical profession. While some may seem insurmountable today, we have per-ceived many of them in that way as we have gone through our practices in the past decades. But the one thing we must remember is that our patients are our legacy. Whatever we may be able to do for one of them may go on to benefit their entire family. No matter how much change is coming, there will always be a patient looking to us to help them make sense of it all and, most importantly, ease their suffering.

Dr. Wilberger is professor of Neurosurgery, Drexel Department of Medicine; Allegheny General Hospital Department of Surgery; DIO, Chairman Graduate Medical Education, Alleghe-ny Health Network Medical Education Consortium; and vice president, Grad-uate Medical Education, Allegheny Health Network. He can be reached at [email protected].



www.acms.org

178 www.acms.org

Over my four decades of practic-ing medicine, many things have

changed. Undoubtedly, one of the most discouraging changes, though, has been that many physicians have become disheartened. And certainly there are very good reasons for that. Physicians have lost much of their au-tonomy to administrators and insurers. They are becoming employed in ever larger numbers causing them to spend more time attending administrative meetings where they are informed how their reimbursement will change based on criteria for which they had no input. And, I believe, most importantly the collegiality which had been widespread among physicians has been lost.

However, let us not curse the dark-ness. We need to discover new ways to overcome the negativity which has beset our profession. We need to light the candle. And the major pathway for that is to become involved.

First, become involved in your practice. It has always amazed me how so many physicians “just want to prac-tice medicine” and state that as their

reason for not utilizing their leadership abilities to individualize their practice and their lifestyle to keep themselves fresh. Second, get involved on your hospital staff. We need to encourage young physicians to attend staff meet-ings and join committees to ensure that their needs are represented when rules and regulations are made.

Third, join the medical societies. The county and state medical societ-ies are crucial to guarantee physician interests are protected. These orga-nizations are not social clubs. They are constantly representing physician interests and need your support both financially and personally. Join the societies, get on committees, go to meetings, and make a difference.

Next, physicians need to join their respective specialty societies. In addi-tion to the state and county societies which support all specialties, your specific specialty society understands the issues which are unique to your specialty and is there to represent you in your professional endeavors. Each of these organizations exists and func-tions solely from the income derived from the dues of its members. That is why we all need to join and become involved. Both the county, state and specialty societies need your member-ship and your involvement. They must remain strong if our profession is to

remain viable.Next, learn the legislative issues

which affect physicians and support the political action committees. Physicians never want to “get into politics,” but the more one understands the issues, the more each physician would realize how vitally important this course of action is. PAC contributions need not be large, but again they are very important to protect our ability to practice medicine as we were trained to do. Those who are making laws in Harrisburg and Washington do not understand the complexities of practicing medicine, but the laws they pass can greatly affect us. Our lobbyists in Harrisburg and Washington do understand these issues. But their work is funded solely by our PAC contributions. Without our financial support, they are unable to effectively counter the pressure put on the legislators by varied competing interests including hospitals, attorneys and insurers.

Finally, and this is perhaps the hardest candle to light, get to know your legislators personally and consid-er contributing to their campaigns. Far too often when I have been speaking to local and national legislators they have commented that they never get physician support. Unfortunately, they remember this when controversial bills come before them and they need to

Lighting the candleG. alan yeasteD, mD, FaCP


It is better to light one candle than to curse the darkness.

-Ancient Chinese proverb

decide which course to take. Admitted-ly, this is a time consuming request and one which again requires a financial commitment. However, the payback is vital to all of us patient advocates regardless of our specialty.

In summary, it is the responsibility of all of us to get involved. Give of your time and resources for the good of our valued and respected profession. Join

the ACMS, PAMED Alliance and your specialty society and become involved. Give at least something to the political action committees. They truly represent your interests whatever your specialty.

Don’t curse the darkness. Light that candle. The rewards are immense.

Dr. Yeasted is senior vice president and chief medical officer at St. Clair

Memorial Hospital and past president of the Allegheny County Medical So-ciety. He can be reached at [email protected].





2019 Board and Delegate Nominations

A Candidate for the ACMS Board of Directors:• Represents physicians on issues impacting the practice of medicine and makes policy decisions for the medical society.• Meets four times per year, special meetings as needed.

[Please print name] I am interested in the Board of Directors (Phone)

A Candidate for the ACMS Delegation to the PAMED:• Represents physicians of Allegheny County in creating statewide policy on issues impacting physicians, patients and the practice of medicine. • Meets as necessary prior to attending House of Delegates in October in Hershey, PA.

(Please print name) I am interested in the ACMS Delegation (Phone)

I would like to recommend the following individual(s) [Please print]

for Board Delegate

Please FAX completed form to (412) 321-5323 by Monday, June 25.

for Board Delegate

180 www.acms.org

The birth of measures of physician practice

thomas james iii, mD, FaCP, FaaP


Restaurants often tout that they sup-port “Farm to Table” as a demon-

stration of food freshness. But does it work that way for clinical practice measures? One would like to think that clinical standards of care would be the basis for measures of physician perfor-mance. In that case, outliers would fall out on measures while the majority of physicians would meet those stan-dards. Clearly, there is lack of consen-sus on the kind of clinical standards passed down from long-coated attend-ing to short-jacketed medical students. What many of us learned was that we could tell quality when we see it.

That is the basis for the field of heu-ristics, which is defined as “the process of gaining knowledge or some desired result by intelligent guesswork rather than by following some pre-established formula” (http://whatis.techtarget.com/definition/heuristic). Physicians tend to learn through experience, where didactic learning tends to be a reinforc-er rather than a primary methodology. That sets up the expectation for phy-sicians that evaluation of quality also should be based upon this “best guess” of what is quality care.

But that is not the way the rest of the world thinks. The general view of metrics of physician care is based more on adherence to specific sets of quality measures. Those measures

are typically based upon Donabedian’s view that quality can be represented by elements of structure, processes and outcomes.

The structural measures provide both the physician and the public with a frame of reference. This may repre-sent the organizational structure, board certification status, use of electronic records, or digital appointment ca-pabilities. By themselves, structural measures only indicate the capacity of a medical practice or organization to achieve specific quality goals, but structural measures don’t assure that will happen. For that reason, structur-al measures are not used in serious public reporting. They are more likely to be used in advertising, such as robotic surgery capability or extended hours.

The use of process measures is much more commonly used in devel-oping physician report cards. These measures represent both what the physician and the patient do. Such measures may be preventive services measures such rates of mammogra-phy, diabetic retinal examination or screening colonoscopy over age 50. There are discussions going on as to the reliability of a measure that is so dependent upon both physician and patient. What happens to the physician whose patients don’t comply with these recommendations? What is the impact

of patient populations where there are significant barriers to access to care? The National Quality Forum has devel-oped social determinates of health risk adjustment factors that can be used to mitigate the impact of populations with barriers to accesses. Additionally, from personal communication with leadership of the American College of Physicians, the Board of Governors of the ACP discussed this issue and came to a determination that some physi-cians are better able to engage their patients so that there may be higher participation in these measured clinical services.

Outcome measures would seem to be the most important of the three. Some of these outcomes measures are ones that can be measured fairly readily. Mortality rates and all-cause readmissions are examples of such outcomes measures. For chronic conditions, there can be intermediate outcome measures such as HbA1c as correlated with final diabetic outcomes. Most chronic conditions do not have outcomes measures that can be ascer-tained in a relatively short time period.

But this is a society that likes to rate and rank our experiences, whether it is sports teams, academic institutions, or doctors. Twenty years ago, consult-ing houses advising large employers and insurers felt that if the public had



information about the costs and quality of care that rational people would select the physicians and hospitals with the best quality scores and the lowest costs. Large national insurers engaged in “an arms race” in develop-ing measures. Some of these payers developed large stables of measures. However, since health care is compli-cated and involves personal relation-ships with health care, the public rarely used such information in medical deci-sion making. Insurance protects many patients from the real costs of care so

that cost comparisons often can have little meaning.

In 1999, a public-private organiza-tion, the National Quality Forum (NQF) was formed after the President’s Advi-sory Commission on Consumer Pro-tection and Quality in the Healthcare Industry felt that there was a need for an organization to provide consumer protections and advance clinical quality through endorsement of standard mea-sures and public reporting. NQF does not develop measures but receives measures developed by professional

societies, Medicare, insurers, advoca-cy groups and others, and evaluates those measures using a methodolog-ically sound basis. Workgroups come from physicians representing specialty societies and primary care, advocacy groups, federal programs, academic institutions and other interested parties. Typically, a workgroup has a specific interest area and reviews new and existing measures related to that area.

Each work group evaluates mea-sures submitted according to the following criteria:

Criteria CommentsImportance to Measure and Report This is to represent a measure that is important

to help drive changes in clinical quality but is subjectively determined

Scientific Acceptability Validity and reliability of the measure

Feasibility Some measures are more easily implemented than others.

Usability and Use To look to accountability and improvement to meet this requirement.

Overall Suitability for Endorsement This element looks at all of the above to determine if the measure can be utilized.


0536: 30-Day All-cause Risk-Standardized Mortality Rate following Percutaneous Coronary Intervention (PCI) for Patients with ST Segment Elevation Myocardial Infarction (STEMI) or Cardiogenic Shock0642: Cardiac Rehabilitation Patient Referral From an Inpatient Setting0643: Cardiac Rehabilitation Patient Referral From an Outpatient Setting3309: Risk-Standardized Survival Rate (RSSR) for In-Hospital Cardiac Arrest

Over the past several years, I have been a member of the Cardiovascular Work Group of NQF. This year, the measures reviewed and endorsed include:

So how do the measures developed through this project help the clinician in practice? Or, perhaps more to the point, how do the measures help pa-tients? Perhaps it is best to think from the alternatives. In 1990, large national employers, Group Health Association of America (now America’s Health Insurance Plans), and the Robert Wood Johnson Foundation formed the National Committee on Quality Assurance (NCQA) to help generate standards of quality. From that effort, a new set of quality metrics was gen-erated under the acronym of HEDIS. Originally, that body of measures was known as the HMO Effectiveness Data and Information Set, as the focus was on measuring the quality of care within staff model and group model HMOs. Over the years, the scope of measure-ment expanded to include all forms of third party-payers (Health plan Effec-tiveness Data and Information Set) to today’s measurement of all aspects of health care (Healthcare Effectiveness Data and Information Set).

With the turn of the millennium, employers were hearing from consult-ing firms that they could better control health care costs if they measured “quality” and cost at the physician practice level. The consultants went on to advise large employers that by pub-lishing the results of measures of cost and quality that their employees would all change to physicians with scores for quality and lower costs. The large na-tional insurers developed measures to go beyond HEDIS. Doctors were caught off guard. Many of these measures had common English definitions but had completely different coding algorithms. The results were that diabetic measures for one insurer could generate entirely different results with another carrier.

The American Medical Association (AMA) fought back feeling that as physicians they could better ascertain quality. The AMA Physician Consortium on Practice Improvement (PCPI) was formed. My own journey in the quality measurement sphere began with my appointment to the AMA-PCPI Cardio-vascular Workgroup, where we worked on developing measures related to hypertension, coronary artery disease and heart failure.

Twenty years after the initiation of NCQA, NQF was formed to standard-ize measures and endorse the best measures. Their role was to bring order to the cacophony and in doing so, present to the Department of Health and Human Services a set of measures that the Department of Health and Human Services (DHHS) could use in Medicare and Medicaid programs. With the enactment of the Patient Protection and Affordable Care Act (PPACA, ACA, or “Obamacare”) a new public-private enterprise had to be formed to fill these roles. So simply, NQF soon developed a side organization, the Measurement Application Partnership, or MAP, to take what was endorsed by NQF for the same purpose.

I was fortunate enough to continue my quality measurement journey within both NQF and MAP. I am currently continuing working on the cardiac measures from the NQF Cardiovas-cular Work Group. The AMA PCPI workgroup was comprised largely of physicians. The NQF and the MAP workgroups are comprised of research-ers, practitioners, advocacy groups, federal employees, methodologists and ancillary services professionals. The level of discussion goes from medical evidence to patient experience, to social determinants of care to meth-odologic discussions on the variety of forms of validity. The results of the

meetings are engaging if not consis-tent. From these proceedings, some held in person in Washington D.C., and most via conference call, the NQF staff prepares documents for higher level review within NQF before they are sent to the secretary of DHHS.

The new administration is looking for reductions in government programs. The mantra now in CMS is “patients over paper,” meaning that there is a serious effort in CMS to reduce the number of measures by removing ones no longer needed and those that should not have been put in place. The measures now are intended to be become ones that matter to patients and to physicians. Time will tell if the aspirations in CMS are realized.

Note: My comments are my own and do not represent the views of the National Quality Forum or the Cardio-vascular Work Group.

Dr. James is senior medical director at Highmark. He can be reached at [email protected].


From Page 181

References1. Agency for Health Care Research

and Quality: Process -> Types of Quality Measures https://www.ahrq.gov/profes-sionals/quality-patient-safety/talkingquali-ty/create/types.html last accessed March 12, 2018

2. Birth of the National Committee for Quality Assurance https://kaiserperma-nentehistory.org/latest/birth-of-the-nation-al-committee-for-quality-assurance/ (last accessed March19, 2018)

3. NQF’s History https://www.qualityforum.org/about_nqf/history/ (last accessed on March 19, 2017)



The Care Centered Collaborative, a true physician-led organization, has introduced its clinically integrated network

to assist you

Practicing medicine now means demonstrating your quality, helping to lower costs of care, managing a population of patients – and then being compensated for those results.

The Care Centered Collaborative was developed by The Pennsylvania Medical Society to assist you with this transition. We have developed a state-wide Clinically Integrated

Network (CIN) that provides you with the support and the know-how to succeed.

We’d like to talk with you. Contact Jaan Sidorov, MD/ CEO of The Collaborative at The Pennsylvania Medical Society at 570-490-6618 or [email protected]

To learn more about our organization, our services and our leadership, check us out at www.patientccc.com

184 www.acms.org

Sometimes less is more: Choose wisely

aDebayo Fasanya, mD


Daily CBC, daily CMP, daily CXR, daily blood gas and routine labs.

What about Pan CT scan? If you are scanning the head and abdomen, why don’t we go ahead and scan the chest, too? These are familiar terms we hear every day in the medical intensive care unit. Sometimes, these translate to the general medical ward.

Estimates of the money wasted on unnecessary service and tests each year in the United States ranges from about $210 billion to more than $750 billion. Apart from the financial aspect, unnecessary tests have the potential of harm as evidenced by studies show-ing increasing antibiotics resistance as a direct result of overprescribing antibiotics, and anemia and increased transfusions in hospitalized patients from overly frequent blood draws, to name a few. Also, abnormal results could potentially lead to more tests and invasive procedures with significant risks including postoperative complica-tions and death.

One study tackled routine blood tests performed consecutively and daily in the ICU, and documented how often the results were normal. About half of the results were normal and one-third were consecutively normal.

Although there are no clear evi-dence-based guidelines regarding rou-tine and daily blood testing in the ICU,

most studies and general consensus suggest that the ordering of routine and daily blood tests in the ICU could be limited without compromising patient safety, while providing significant cost savings.

This matter is not for debate. The first, and what I perceive to be the most important of the critical care choosing wisely, is quoted below:

“Don’t order diagnostic tests at reg-ular intervals (such as every day), but rather in response to specific clinical questions.

Many diagnostic studies (includ-ing chest radiographs, arterial blood gases, blood chemistries and counts and electrocardiograms) are ordered at regular intervals (e.g., daily). Com-pared with a practice of ordering tests only to help answer clinical questions, or when doing so will affect manage-ment, the routine ordering of tests increases health care costs, does not benefit patients and may in fact harm them. Potential harms include anemia due to unnecessary phlebotomy, which may necessitate risky and costly trans-fusion, and the aggressive work-up of incidental and non-pathological results found on routine studies.”

The statement was made on behalf of a critical care societies collaborative. The contributing societies included the American Association of Critical Care

Nurses, American College of Chest Physicians, American Thoracic Society and Society of Critical Care Medicine. Both doctors and nurses agree on the subject, yet we still order unnecessary and wasteful tests.

It is important to address the main reason doctors order unnecessary tests or procedures. In a study pub-lished in September 2017, the top three cited reasons for overtreatment were fear of malpractice, patient request and difficulty accessing prior medical records.

The fear of malpractice is real. The litigious nature of the United States does not help the situation. Thankfully, only 2 to 3 percent of patients harmed by negligence end up suing the doctor and half of those were compensated. It shows that our perception of malprac-tice is higher than in reality. Possible solutions are better training on appro-priateness criteria for tests and proce-dures, and staying up to date with the guidelines.

Once armed with better knowledge and up-to-date indications for tests and procedures, we can better educate our patients on the risk vs. benefit of tests.

The difficulty accessing outside records is improving with the advent of the electronic health record. I expect this to continue to improve over time. Physicians also must be diligent in



seeking out these records when not easily accessible. Having said all that, care must be taken to avoid

swinging the pendulum too much to the other side. Otherwise, the next challenge would be tackling under-treatment.

Dr. Fasanya is chief fellow in Pulmonary and Critical Care, Allegheny General Hospital, and is part of the hospital’s newly launched pulmonary embolism response team. He can be reached at [email protected].

References/Good readings1. Lyu H, Xu T, Brotman D, Mayer-Blackwell B, Cooper M,

Daniel M, Wick EC, Saini V, Brownlee S, Makary MA. Overtreat-ment in the United States. PloS one. 2017 Sep 6;12(9):e0181970.

2. Flabouris A, Bishop G, Williams L, Cunningham M. Routine blood test ordering for patients in intensive care. Anaesth Inten-sive Care. 2000;28(5):562–5.

3. Ganapathy A, Adhikari NKJ, Spiegelman J, Scales DC. Routine chest x-rays in intensive care units: A systematic review and meta-analysis. Crit Care. 2012;16(2):R68.

4. May TA, Clancy M, Critchfield J, Ebeling F, Enriquez A, Gal-lagher C, Genevro J, Kloo J, Lewis P, Smith R, Ng VL. Reducing unnecessary inpatient laboratory testing in a teaching hospital. Am J Clin Pathol. 2006;126(2):200–6

5. http://www.choosingwisely.org/wp-content/uploads/2015/02/SCCM-Choosing-Wisely-List.pdf



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186 www.acms.org

Study linking fracking to low birth weights must be a wake-up call for regulators

eDWaRD C. KetyeR, mD


*This article was first published in the Observer-Reporter.

The dangers of fracking are well-doc-umented from more than a decade

of peer-reviewed scientific studies. The process pollutes groundwater and leaks methane – one of the most pow-erful greenhouse gases contributing to climate change – into the environment.

As a pediatrician, I also see first-hand the negative health effects of these emissions. Volatile organic com-pounds, which leak alongside methane from every point of natural gas infra-structure, contribute to ground-level ozone – the main component of smog. Smog affects every human’s lung func-tion, increases the frequency of asthma attacks, aggravates bronchitis and emphysema, inhibits early childhood lung growth, and is linked to long-term lung damage, increased hospital ad-missions and heart failure. In addition, the VOC benzene is a known human carcinogen associated with childhood leukemia, lymphoma and liver cancer. Symptoms of benzene exposure can include eye, skin and respiratory tract irritation along with drowsiness, dizzi-ness and headaches.

A recent study from Princeton University underscores and affirms another devastating association with pollution from fracking found in several

previous studies: low birth weights in newborn infants. The researchers found babies born to mothers living less than a mile from hydraulic fractur-ing wells were 25 percent more likely to weigh less than 5.5 pounds at birth. These results from the first large-scale study of its kind should be a wake-up call to Gov. Wolf, the Department of Environmental Protection (DEP) and every Pennsylvanian. We must do more to control the pollution leaking from natural gas sites throughout the state.

Low birth weight can create immedi-ate dangers and lifelong challenges for a child, from increased rates of infant mortality, attention deficit hyperactivity disorder, and learning differences to a greater likelihood of dropping out of high school and having dismal employ-ment opportunities. Life may be harder for these children simply because they lived near natural gas infrastructure.

Unlike other states that have concluded that fracking is too great a public health and environmental hazard, Pennsylvania has not banned fracking, in spite of a call from the state’s medical society representing thousands of doctors to do just that. Pennsylvanians shouldn’t have to de-cide between preserving the health of our communities and environment, and short-term financial gain. Pennsylva-

nia’s children don’t have a say in such policy decisions, but they do deserve strong health protections.

Late last year, the DEP issued a final draft of permits to control methane emissions at modified and new natural gas operations. This is an important step in an ongoing effort to lessen the damage to health that fracking and other natural gas development causes in our communities. It also brings the governor closer to fulfilling an outstand-ing campaign promise.

But during his campaign nearly four years ago, Gov. Wolf also promised to control methane pollution from existing natural gas infrastructure. The Prince-ton study highlights just how vital those controls are. Wolf has taken steps to outline the scope of what these air pollution standards could look like, but unfortunately, the proposal does not currently include a plan to control methane. This omission risks leaving a significant amount of pollution from ex-isting natural gas sources uncontrolled.

Newborn children are our most vulnerable population. They are highly vulnerable to environmental hazards, and can’t yet raise their voices to fight for basic environmental protections. That’s why it’s up to us. We must advocate for the next generation and for families who are forced to deal with circumstances beyond their control in


their own backyards. We must call for Gov. Wolf to enact the strong methane pollution controls he promised during his campaign. Pennsylvania’s children can’t afford to wait any longer.

Dr. Ketyer is a pediatrician with Pediatric Alliance, a member of the AAP Council on Environmental Health and serves on the board of Physicians for Social Responsibil-ity – Pennsylvania. He can be reached at [email protected].



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188 www.acms.org

PerspectivePerspectiveSociety News

POS hosts 54th Annual MeetingThe Pittsburgh Ophthalmology So-

ciety’s 54th Annual Meeting was held March 23 at the Pittsburgh Marriott City Center Hotel. More than 85 physicians attended this year’s meeting, which featured renowned ophthalmologist Lisa Brothers Arbisser, MD, who served as the 38th Annual Harvey E. Thorpe Lecturer.

Dr. Arbisser teaches cataract and anterior segment surgery worldwide and is a Princeton University graduate. She is an adjunct associate profes-sor at University of Utah Moran Eye Center. She authors, edits and reviews textbook chapters, journal articles and the American Academy online news network, Focal Points, and has two regular journal columns.

The named lecture honors Harvey E. Thorpe, MD, an ophthalmologist whose techniques and inventions of medical instruments contributed to the study of the eye. In 1980, Dr. Thorpe was named “Man of the Year” by the Pittsburgh Ophthalmology Society and established the Harvey E. Thorpe Lecture, delivering the first lecture in the series.

Attendees were enlightened with presentations from the following prom-inent guest faculty: Ronald Gross, MD, professor and chairman of Ophthalmol-ogy, director, West Virginia University Eye Institute, Jane McDermott Schott Chair of Ophthalmology, West Vir-ginia University, Morgantown, W.Va.; Michael X. Repka, MD, MBA, David L. Guyton, MD, and Feduniak Family Professor of Ophthalmology, professor of Pediatric Medicine, Johns Hopkins University School of Medicine, Balti-more, Md.; José-Alain Sahel, MD, pro-fessor and chairman, The Eye and Ear

Institute, endowed chair, Department of Ophthalmology, director, UPMC Eye Center, University of Pittsburgh School of Medicine, Pittsburgh, Pa.;

and David Sarraf, MD, professor at the Stein Eye Institute at UCLA, member of the Retinal Disorders and Ophthalmic

From left are Pittsburgh Ophthalmology Society Annual Meeting guest speak-ers Ronald Gross, MD, and Michael X. Repka, MD; POS President Sharon Tay-lor, MD; Thorpe Lecturer Lisa Brothers Arbisser, MD; and guest speakers José-Alain Sahel, MD, and David Sarraf, MD. Below left, Dr. Arbisser and Dr. Taylor stand with the Thorpe Scroll and Thorpe Award. Below right, Dr. Taylor pres-ents ACMS Executive Director John Krah with a Thorpe Circle membership.


190 www.acms.org


Genetics Division at JSE, UCLA, Los Angeles, Calif.

The POS gratefully acknowledges all industry representatives who sponsored or exhibited at the event. A complete list of exhibitors can be found on the Society website, www.pghoph.org.

Following the meeting, members and their guests enjoyed networking and dinner at the Duquesne Club. In her remarks, Sharon Taylor, MD, pres-ident, thanked the POS Board, Mem-bership and Allied Course Directors for their assistance throughout the year. A special recognition and honor was held for Mr. Jack Krah, executive director of the Allegheny County Medical Society. Mr. Krah, who announced he will retire this year, was inducted as a member of the Thorpe Circle to recognize his many years of dedication and support of the POS.

Planning for the 2018-19 educa-tional series is underway. If you know of an exceptional speaker whom you would like to see present at an upcom-ing meeting, contact Nadine Popovich, administrator, at [email protected].

2018 Annual Meeting for Ophthalmic Personnel held

Running concurrently with the POS Annual Meeting was the 39th Annual Meeting for Ophthalmic Personnel. This year, close to 160 ophthalmic technicians, assistants, coders, pho-tographers and front staff attended this full-day program. The well-respected program is designed specifically for ophthalmic personnel to enhance the quality, expertise and safety of ophthal-mic patient care.

The program featured 28 breakout

sessions, many of which were accred-ited by JCAHPO. Participants had the opportunity to create their own track of programming, and receive up to 7.0 CE credit hours based on course atten-dance. A balance of front- and back-of-fice sessions were offered to educate office personnel. Popular workshop sessions also were offered as part of the full-day course curriculum.

Course directors Pamela Rath, MD, Laurie Roba, MD, and Pradeepa Yoga-nathan, MD, worked tirelessly to plan this high-level educational offering. The Society depends and relies on local expertise and talent to present each session. This year was no exception, with local physicians and health care professionals providing quality presen-tations. The course directors would like to thank all Pittsburgh Ophthalmology Society (POS) members who present-ed a lecture.

The POS is proud to host this yearly educational forum for ophthalmic personnel for the past 39 years. Mark your calendar for next year’s meeting, scheduled for Friday, March 29, 2019, at the Pittsburgh Marriott City Center. If you have a topic that you believe would be beneficial for presentation at next year’s meeting, please contact Nadine Popovich at [email protected].

26th Annual Clinical Update in Geriatric Medicine

More than 380 geriatrics profession-als from all disciplines, including physi-cians, nurses, pharmacists, physician assistants, social workers, long-term care and managed care providers, and health care administrators participated in the 26th Annual Clinical Update in Geriatric Medicine conference held at the Pittsburgh Marriott City Center

Hotel April 5-7. The course attracted registrants from numerous states, in-cluding California, North Carolina, New York and Washington.

Previously and recently awarded the American Geriatrics Society Achieve-ment Award for Excellence in a CME program, this conference continues to be a well-respected resource to edu-cate health care professionals involved in the direct care of older persons by providing evidence-based solutions for common medical problems that afflict older adults daily and for which rapidly evolving research (much done in Pitts-burgh) is revealing new approaches that are feasible for the real world.

Under the leadership of course directors Shuja Hassan, MD, Judith S. Black, MD, MHA, and Neil M. Res-nick, MD, who worked tirelessly with the planning committee, the course is a premier educational event in the region. The course attracts prominent international and national lecturers and nationally renowned local faculty. William Applegate, MD, and Barbara Messinger-Rapport, MD, comprised this year’s exceptional guest faculty.

Nearly 40 state-of-the-art sessions taught by highly regarded clinician-ed-ucators and researchers were offered during the three-day event. Each lec-ture, symposium and breakout session offered participants evidence-based “pearls for practice” designed to be im-mediately incorporated into the realities of daily practice.

The conference is jointly sponsored by the Pennsylvania Geriatrics Society – Western Division; UPMC/University of Pittsburgh Aging Institute; and Uni-versity of Pittsburgh School of Nursing, in partnership with the University of Pittsburgh School of Medicine Center

From Page 188



for Continuing Education in the Health Sciences.

Geriatrics Society honors David C. Martin awardee

The Pennsylvania Geriatrics Society – Western Division is proud to announce the 2018 recipient of the David C. Martin Award: Mr. Benjamin Cahill, a medical student attending the University of Pittsburgh School of Medicine.

Mr. Cahill was recognized at the 2018 Clinical Update in Geriatric Medi-cine dinner symposium, where he was presented with a certificate of excel-lence and honorarium. The honorarium will aid in defraying expenses to attend the 2018 Annual Scientific Meeting of the American Geriatrics Society conference, where he will present his abstract, Contact Frequency and Older Adult Participation in Cardiac Rehabil-itation.

The award was named after David C. Martin, MD, who established the first geriatrics fellowship in Pittsburgh, Pa. The goal of this prestigious award is to encourage and prepare future physi-cians in the field of geriatric medicine.

Since its inception, the Society is proud to have awarded more than $81,000 to area medical students inter-ested in the field of geriatric medicine.

PAGS-WD recognizes award recipients

The 2018 Geriatrics Teacher of the Year Award presentation was held on April 5 at the Pittsburgh Marriott City Center, prior to the dinner symposium at the 26th Annual Clinical in Geriatric Medicine conference. Jordan F. Karp, MD, and Heather Sakely, PharmD, BCPS, BCGP, were honored with a

special recognition for their dedication and commitment to geriatrics education.

Rollin Wright, MD, MS, MPH, awards chair, and Fred Rubin, MD, president, shared the podium to high-light the achievements and significant contributions each awardee has made to the education and training of learn-ers in geriatrics and to the progress of geriatrics across the health profes-sions. More than 65 attendees were on hand for the plaque presentation.

Dr. Karp received the 2018 Geriat-rics Teacher of the Year Award, recog-nizing a physician.

Dr. Karp has maintained a clinical practice of psychiatry since 2003, in which he focuses on the care of older adults and patients living with both psy-chiatric and chronic medical conditions, in particular, chronic pain.

He has served as medical director

for psychiatry at UPMC Pain Medicine at Centre Commons from 2006 to 2017, is the director of Student Mental

NadiNe PoPovich / acMSFrom left are PAGS-WD President Fred Rubin, MD; Course Director Judith Black, MD, MHA; Joanne Lynn, MD; Dinner Symposium Guest Speaker Wil-liam Applegate, MD; Course Directors Neil Resnick and Shuja Hassan, MD; and Guest Faculty Barbara Messinger-Rapport, MD. Below is 2018 David C. Martin Awardee Mr. Benjamin Cahill.


192 www.acms.org


Health Services at the University of Pittsburgh School of Medicine, serves as medical director for the UPMC LifeSolutions Employee Assistance Program, and is a staff physician at the VA Pittsburgh Medical Center.

He is a prominent teacher, mentor, and researcher in geriatric psychiatry and has worked to help strengthen the relationships between the educational missions of the geriatric psychiatry and geriatric medicine training programs at the University of Pittsburgh Medical Center. He has provided scholarly mentorship to 20 trainees and serves as a faculty mentor on the University of Pittsburgh NIH-funded training grant, “Clinical and Translational Research Training in Geriatric Mental Health.”

Dr. Sakely received the 2018 Healthcare Professional Geriatrics Teacher of the Year Award.

Dr. Sakely is a leader in teach-ing geriatrics to both physicians and pharmacists. She directs UPMC St. Margaret’s PGY2 Geriatric Pharmacy Residency program and has developed a curriculum for a geriatric pharmacy residency that includes an integrated system of collaborating pharmacists and doctors in inpatient, outpatient and long-term care settings.

Dr. Sakely is faculty in the Family Medicine Residency Program and Geri-atric Fellowship at UPMC St. Margaret and adjunct instructor at the University of Pittsburgh School of Pharmacy. Dr. Sakely complements her role as an edu-cator with strong research experience.

She has been principal investigator and leader of the PIVOTs research (Pharmacist-led Reduction of Drug Therapy Problems in an Interprofes-sional Geriatric Practice) since 2012,

which has helped assess the impact of collaboration between pharmacists and doctors in nursing home, assisted living and independent living environment for seniors.

A call for nominations for the 2019 Geriatrics Teacher of the Year award will begin in September 2018. Award eligibility, criteria and details will be available on the society website in August (www.pagswd.org).

Longtime Clinical Update course director honored

The Pennsylvania Geriatrics Society – Western Division honored Judith S. Black, MD, MHA, during the Clinical Update in Geriatric Medicine confer-

ence April 6.Dr. Black, who

has served as course director for the Clinical Update for more than 26 years, is stepping down from her leader-ship role. Co-course di-rectors Shuja Hassan, MD, and Neil Resnick, MD, presented Dr. Black with a plaque and expressed grateful appreciation for her exceptional leadership, dedication and commit-ment. The conference continues to be a well-respected course which attracts close to 400 attendees and was award-ed the American Geriatrics Society Achievement Award for Excellence in a CME program in 2009 and in 2018.

From Page 191

NadiNe PoPovich / acMSAt left, PAGS-WD Awards Committee Chair Rollin Wright, MD, presents Jor-dan F. Karp, MD, with the Physician Teacher of the Year Award. At right, Dr. Wright presents Heather A. Sakely, MD, BCPS, BCGP, with the Healthcare Professional Teacher of the Year Award.

Dr. Black


Science & Engineering Fair held at Heinz FieldThe 79th Annual Covestro Pittsburgh Regional Sci-

ence and Engineering Fair was held March 23 at Heinz Field. More than 1,200 of the region’s youth participated, representing more than 100 schools from across Western Pennsylvania.

Allegheny County Medical Society Foundation partic-ipates as a corporate sponsor and provides two student awards. Additionally, ACMS member physicians Maria

Sunseri, MD, and Angela Stupi, MD, participated as sponsor judges, as well as category judges for the fair.

2018 Award Winners• David Ban (North Allegheny High School, Grade 10);

Project: “Mechanism of Mesobiliverdin against Oxidative Stress in Retinal Cells”

• Sophia Yurkovetsky (Pittsburgh Science and Technolo-gy Academy, Grade 12); Project: “Sex Differences of vSMC Functionality in BAV Patients”


Fit with a Physician: Senior walk held

The Senior Connections Fit with a Physician program hosted another senior walk at Schenley Park May 9 led by ACMS member physician Terence Starz, MD. Participants included members of Greenfield and Mount Washing-ton Senior Centers. For a list of upcoming walks and locations, visit www.ventureoutdoors.org.

ACMS Members:Professional announcement advertisements

are available to ACMS members at our lowest prices.Contact Meagan Sable, managing editor, at [email protected].

Congratulatory message?

Retiring? New Partner?

New Address?

PerspectivePerspectiveAlliance News

194 www.acms.org

LEADERSHIP PROFILES(Part Seven of Seven)

Beyond Board members and com-mittee chairs, there are many lead-ership roles crucial to the function of ACMS Alliance. In recent times, almost all past presidents continue to serve, or otherwise support the Alliance. Mrs. Earl Davis is a three-term President of ACMS Alliance. Mrs. Davis also served at the state level as president of Pennsylvania Medical Society Alliance. In addition, for decades, Mrs. Davis served as Legislative Liaison with reg-ular reports and insights into legislative concerns affecting the medical profes-sion, doctor/patient matters and public health issues. Mrs. William Hetrick, president, ACMS Alliance (2002-03) continued with legislative reports and updates for many years. Past Presi-dent Mrs. Kal Goshhajra, (Grace, PhD) (1993-94) for a decade or more served as chair of Long Range Planning, articulating the status and making rec-ommendations to benefit the Alliance. Again, Mrs. Hetrick stepped in as Long Range Planner when Mrs. Goshhajra relocated beyond the area. The late Letha Barber, MD, served as county president of ACMSA, 1997-98, then at the state level, president of PAMED Alliance, 1999-2000.

Honorary members of our Alliance, Dr. Mark Thompson, MD, and his sister, Janet Thompson, enhanced our organization by establishing and funding the THOMPSON AWARD in 1999 as an enduring tribute to their late parents, Thomas Ewing Thompson Jr., MD, a very active member in ACMS, and Ruth Daubenspeck Thompson, also an enthusiastic, active member in ACMSA. The Thompson Award is

presented to a member of ACMSA in recognition of extraordinary participa-tion and support of family, of our ACM-SA organization and of our community and beyond. All 15 recipients since 1999 graciously and brilliantly fulfill every tenant embodied as designated guidelines in the Thompson Award. The AVANTI AWARD, created by our Alliance in 2000, was established as a means of recognizing outstanding indi-viduals from academic, cultural, civic, business and professional realms for programs, activities, services including contributions via volunteer actions which benefit others. The Avanti Award highlights our Alliance involvement in community affairs.

Nominees for both Thompson and Avanti Awards are suggested by the ACMSA Governing Board. Awards Committee, with Rose Kunkel Roarty, chair, research candidates and final-ize decisions. The Thompson Award brings special energy to Holiday Champagne Brunch in December, and the Avanti Award adds interest and vi-tality to Annual Meeting and Luncheon in May.

There is a special segment among our Alliance membership who, for

many reasons, are unable to serve on the Governing Board, to attend meetings, or participate out and about in the community. All have careers, businesses, family commitments, per-sonal commitments. Stellar examples include Mrs. Anthony Colatrella, Mrs. Hugo Cerri, Mrs. John Franklin, Dr. and Mrs. John DaCosta, Mrs. George Gerneth, Mrs. Michael Kutsenkow, Mrs. Augusto Martinez, Mrs. Isamu Sando, and others. Individually and collec-tively, the silent sector does, however, generously contribute. Here is how and what they do. All generously participate in absentia with support of fundraising by providing wonderful in-kind items, for auction and raffle, and by soliciting weekend hotel packages, ticketing for sporting events, theatre and other performing art events, vouchers for specialty and fine dining, also, basket of fine wine pairs and more, original works of art (Dr. Al Zido) and exquisite original photography pieces (Dr. Kal Goshhajra). Other Alliance members also contribute generously by sending donations to Alliance when unable to attend meetings.

Stellar among Alliance membership support are family and friends who can and do, when able, attend the three General Meetings and events on the Alliance calendar. Thanks, and appreciation to all, for your remarkable ongoing commitments of time and at-tention to Alliance matters, and for your extraordinary generosity in monetary and other contributions to benefit our organization events!

AVANTI AWARD

CHRIST CHILD SOCIETYPITTSBURGH CHAPTER

in recognition of outstanding volunteer commitment in addressing needsof underprivileged children through community service

projects, programs and charitable giving

Allegheny County Medical Society Alliance2012 ~ 2013

Kathleen Jennings Reshmi,President, ACMSA

John G. Krah,Executive Director, ACMS

PE ANN

O 5R 2G 9A 1N DI Z E

`Amelia Pare,President, ACMS

`

1925-2018

Content and text by Kathleen Jennings Reshmi

Kathryn McCarthy, PhDBehavioral Health and Integrated Care

Dr. McCarthy provides specialized care for people suffering from psychiatric complications associated with a medical diagnosis or chronic illness. Within the primary care setting, she offers ADHD evaluations and psychological assessments for diagnostic clarification, as well as short-term therapy for individuals of all ages. As part of the Bariatric and Metabolic Institute, she conducts pre-surgical psychological evaluations, in addition to providing individual therapy and behavioral support to the bariatric population.

After earning her doctoral degree in behavioral health at Alliant International University in San Diego, California, Dr. McCarthy completed a postdoctoral fellowship at Allegheny General Hospital specializing in behavioral health and integrated care.

Dr. McCarthy is a member of the American Psychological Association, the Association for Contextual Behavioral Science, and the National Register of Health Service Psychologists.

Dr. McCarthy sees patients of all ages at Murrysville Internal Medicine and Family Practice, as well as Bariatric and Metabolic Institute locations in Pittsburgh, Monroeville, and Wexford.

AHN.org

Standout specialists to support your patients

Call (412) DOCTORS to schedule an appointment. Most major insurance plans are accepted.

Mati Friehling, MDCardiac Electrophysiology

Dr. Friehling provides exceptional care and treatment for individuals with heart rhythm abnormalities. He specializes in treating patients with atrial fibrillation and supraventricular tachycardia (SVT) utilizing advanced catheter ablation techniques. In addition, he has extensive experience implanting pacemakers, defibrillators, and cardiac resynchronization devices.

After earning his degree at the University of Virginia School of Medicine in Charlottesville, Dr. Friehling completed his residency in internal medicine at the University of Pittsburgh Medical Center. He extended his skills and training during fellowships in cardiology and cardiac electrophysiology.

Certified by the American Board of Internal Medicine, Dr. Friehling has additional certifications in cardiac electrophysiology and cardiovascular disease. He is a member of the Heart Rhythm Society and American College of Cardiology.

Dr. Friehling welcomes patients ages 18 and older at West Penn Hospital.

196 www.acms.org

Materia Medica

ChRistian m. thomas KaRen m. FanCheR, PhaRmD, bCoP

The human body is comprised of trillions of individual cells, all

working together to achieve a similar goal. While these cells grow, divide, fulfill their programmed mission, and ultimately die, a multitude of complica-tions can arise along the way. Nature has devised a way to keep our cells “in check” by utilizing negative feedback loops, where cell growth, division, and certain metabolic pathways are stopped or initiated appropriately.

Ideally, the processes of cell growth, division and death would work flaw-lessly and all systems would function as a well-oiled machine. However, per-fectly replicating the genetic sequence of such a vast number of dividing cells over time is quite unlikely. This is where a cancerous disease state aris-es. According to the National Cancer Institute, “Cancer is the name given to a collection of related diseases…[where] the body’s cells begin to divide without stopping and spread into sur-rounding tissues.”1 The World Health Organization estimated that nearly 1.7 million new cancer cases would be diagnosed in 2017, with approximately 1,650 Americans dying each day from cancer.2 Patients who do not respond to first-line therapies have an especial-ly dismal prognosis. Thus, this area

represents a significant opportunity for novel therapies.

Background Historically, cancer was treated with

surgical intervention alone. Over the past century, treatments have expand-ed to include radiation and convention-al chemotherapy, both of which were designed to destroy any rapidly dividing cell which they encountered. Cancer-ous cells are terminated only slightly more preferentially than non-cancerous cells due to their rapid rate of replica-tion; however, other, healthy rapidly dividing cells may also experience a detrimental outcome. Such non-specif-ic cell death results in the “traditional” adverse effects of chemotherapy, including hair loss, gastrointestinal disturbances, myelosuppression and loss of fertility.

In recent years, therapies have evolved alongside our expanding understanding of cancerous etiology and pathophysiology. Agents that specifically target receptors expressed by some cancerous cells, such as trastuzumab (Herceptin®) for the treatment of breast cancer and imatinib (Gleevec®) for the treatment of chronic myelogenous leukemia, are considered groundbreaking in their mechanisms of action. Regretfully, these agents are not available for all types of cancer and numerous factors must be in place before such treatments can be a viable alternative to traditional chemotherapy.

What if we could utilize the best de-fense system we know of – the human immune system – to eradicate these cancerous cells? The human immune system is extremely efficient at killing off potential invaders, but can it also become adaptable enough to recog-nize cells which have gone rogue? How can scientists program immune cells to preferentially target and destroy the very cells they have been created to protect? In this arena, novel Chi-meric Antigen Receptor T-Lymphocyte (CAR-T) therapy represents an exciting new option.

General conceptsCAR-T is a type of autologous

cellular immunotherapy. In the CAR-T process, a patient’s T-cells are re-moved through apheresis, genetically engineered to recognize and attack specific receptors on cancer cells and expanded in vitro. The engineered T-cells are then returned to the patient, where the newly programmed killers can then circulate and specifically destroy the cells which they have been programmed to recognize.3

While this is a novel idea in theory, it is not without limitation. Patients are still required to undergo large doses of chemotherapy prior to CAR-T cell infusion to destroy any innate immune cells which remain. Destroying the pa-tient’s “reserve” will allow for the newly infused T-cells to do their job properly. Unfortunately, since patients are still

CAR-T cell therapy: Engineering the future of cancer treatment


Materia Medica

exposed to high doses of conventional chemotherapeutic agents, they may experience all of the traditional side effects typically associated with tradi-tional chemotherapy.

The initial results of phase I and II trials of CAR-T therapy have shown impressive results. To date, two CAR-T agents have received approval from the United States Food and Drug Ad-ministration (FDA). Both agents were studied in heavily pretreated patients with refractory B cell malignancies and the approvals were based on two trials discussed in detail below.

Adverse effectsUnique and potentially serious

adverse effects of CAR-T therapy may occur, since a modified cell is being introduced into an already weakened patient. Prompt recognition and man-agement of these adverse effects are of utmost importance.4

Patients receiving CAR-T therapy can experience cytokine release syn-drome (CRS), a collection of constitu-tional symptoms that arises after the newly introduced T-cells begin to prolif-erate. The new T cells can stimulate a general inflammatory response which peaks within one to two weeks of cell administration, resulting in high fevers and hypotension in the days following infusion.4-6 These patients experience a drastic increase in interleukin-6 (IL-6) and may subsequently develop hypoxia and multiorgan failure.4, 6 Such symptoms can be treated with acet-aminophen, antiemetics, vasopressors, methylprednisolone, and fresh frozen plasma if warranted, along with general supportive care measures. Additionally, toclizumab (Actemra®), a humanized monoclonal antibody that is approved

for the treatment of rheumatoid arthri-tis and directed towards IL-6, can be initiated.6 The most effective use of toclizumab in this setting is still being explored, since decreasing IL-6 levels without reducing the efficacy of CAR-T therapy is a delicate balance.

Neurotoxic effects may also occur, resulting in patient confusion, head-ache, and seizures, as well as dimin-ished attention, agitation, delirium, tremors, and encephalopathy.4, 5 These symptoms tend to have a rapid onset and short duration.6 Fortunately, the majority of these symptoms resolve on their own and only require supportive care. Patients who are at increased risk of seizures, such as having a history of epilepsy, may be started on prophylactic levetiracetam (Keppra®) at the onset of CRS.4, 6

MonitoringTo prevent detrimental outcomes,

patients receiving CAR-T therapy must be carefully observed. Current rec-ommendations suggest that patients be closely monitored for a minimum of seven days after cell infusion. This includes vital signs every 4 hours, daily review of organ systems, complete blood count, metabolic and coagu-lation profiles, and measurement of serum C-reactive protein.7 Naturally, these patients are immunosuppressed; therefore, close temperature, blood culture and blood count monitoring is necessary in order to identify infec-tion. Cardiac, respiratory, liver, kidney, and gastrointestinal function should also be consistently assessed.7 Since these patients also received condi-tioning chemotherapy, they also may experience symptoms associated with traditional chemotherapy such as

nausea, vomiting, and fatigue. These symptoms, however, may represent a greater risk of CRS or neurotoxicity; therefore, rapid recognition and initia-tion of supportive care is crucial.7

The ELIANA TrialThe ELIANA trial was a multicenter,

single-cohort phase II study of tisagen-lecleucel transgene CAR-T therapy in 75 pediatric and young adult patients with CD19+ relapsed or refractory B-cell acute lymphocytic leukemia (ALL). Patients were eligible to partic-ipate if they were at least 3 years old at the time of screening and no more than 21 years of age at diagnosis. Patients also had to have at least 5% lymphoblasts in the bone marrow at study entry and relapsed or refractory disease; enrolled patients were heavily pretreated, with a median of 3 (range, 1-8) lines of prior therapy and 61% had previously undergone hematopoietic stem cell transplantation. Enrolled patients received conditioning with cyclophosphamide and fludarabine, followed by a single infusion of tisagen-lecleucel. The primary endpoint was overall remission rate, defined as the rate of complete remission or complete remission with incomplete hematologic recovery, within three months.8

At a planned interim analysis of 50 enrolled patients, the primary endpoint of overall remission rate was 82% (95% CI, 69-91; p < 0.001). In an updated analysis of all 75 patients, the overall remission rate was 81% (95% CI, 71-89); the complete remission rate was 60%, and 21% of patients had complete remission with incomplete hematologic recovery. Among patients with a com-plete remission with or without hemato-


Materia Medica

198 www.acms.org

logic recovery, the median duration of response was not reached. The rate of event-free survival was 73% (95% CI, 60-82) at 6 months and 50% (95% CI, 35-64) at 12 months; median event-free survival was not reached. The rate of overall survival was 90% (95% CI, 81-95) at 6 months and 76% (95% CI, 63-86) at 12 months.8

All patient in the ELIANA study had at least one adverse event. The most common non-hematologic events of any grade were CRS (77%), pyrexia (40%), decreased appetite (39%), febrile neutropenia (36%), and head-ache (36%). Grade 3 or 4 adverse events occurred in 88% of patients, including grade 3 or 4 CRS (46%) or neurologic events (13%). Nearly half of the patients enrolled in the study required admission to the intensive care unit for management of CRS, and 37% of patients received tocilizumab as treatment.8

The results of the ELIANA study indicate that tisagenlecleucel trans-gene can produce high remission rates and durable remissions in pediatric and young adult patients with relapsed or refractory B-cell ALL. Conversely, adverse effects may be severe and require intensive treatment.8

The ZUMA-1 trialThe ZUMA-1 trial was a multicenter

phase II trial of axicabtagene ciloleu-cel anti-CD19 CAR-T therapy in 111 patients with refractory large B-cell lymphoma. Eligible patients had diffuse large B-cell lymphoma, primary medi-astinal B-cell lymphoma or transformed follicular lymphoma who had refractory disease despite undergoing at least two prior therapies. Patients received

a conditioning regimen of low-dose cyclophosphamide and fludarabine, followed by a target dose of 2 x 106 anti-CD19 CAR-T cells per kilogram of body weight. The primary endpoint was the rate of objective response, which was calculated as the combined rates of complete and partial responses. Secondary endpoints included overall survival, safety and assessments of biomarkers.9

The objective response rate was 82% (95% CI, 73-89), and the com-plete response rate was 52%. Time to response was rapid, occurring at a median of 1 month. At a median fol-low-up of 15.4 months, 42% of patients maintained their response and 40% continued to have a complete response. Response rates were consistent among subgroups, including age, stage of dis-ease, and the presence or absence of bulky disease. Overall survival was 59% (95% CI, 49-68) at 12 months and 52% (95% CI, 41-62) at 18 months; median overall survival had not been reached at the time of study publication.9

Adverse events occurred in all 111 patients in the ZUMA-1 trial, with 95% of patients experiencing at least one grade 3 or higher event. The most common adverse events of any grade were pyrexia (85%), neutropenia (84%) and anemia (64%). Among adverse events of grade 3 or higher, the most common were neutropenia (78%), anemia (43%) and thrombocytopenia (38%). Cytokine release syndrome occurred in 93% of patients, with 13% being grade 3 or higher. Neurologic events occurred in 64% of patients, with 21% of patients experiencing grade 3 or higher encephalopathy. Most CRS symptoms and neurologic events resolved without clinical conse-

quences, but 43% of patients received tocilizumab and 27% received gluco-corticoids for the management of CRS, neurologic events or both.9

The authors of the ZUMA-1 study concluded that axicabtagene ciloleucel anti-CD19 CAR-T therapy can be an effective therapeutic option in adult pa-tients with relapsed or refractory large B-cell lymphomas.9, 10

A comparison of the ELIANA and ZUMA-1 trials can be found in Table 1 (page 202).

Place in therapyCAR-T therapy against CD19+ B

cell malignancies is currently the most developed. As of April 2018, two CAR-T therapies have been approved for use by the United States Food and Drug Ad-ministration.11, 12 Their use is also recom-mended by the National Comprehensive Cancer Network (NCCN): tisagenlecleu-cel transgene is currently recommended for use in patients under 26 years of age with relapsed or refractory B-cell ALL or who have relapsed after two or more lines of therapy, including two tyrosine kinase inhibitors.13 Conversely, axicabtagene ciloleucel is recommend-ed for use in patients with diffuse large B cell lymphoma who have a partial response to second line therapy or who have relapsed after two or more lines of therapy.14

There are also numerous other CAR-T products being studied in more than 275 active clinical trials of both blood cancers and solid tumors.15 While these therapies represent an exciting new paradigm for cancer treat-ment, several challenges remain.

At present, CAR-T therapy is only available at specialized cancer cen-ters. Both tisagenlecleucel transgene

From Page 197

Materia Medica

and axicabtagene ciloleucel are only available through a Risk Evaluation and Mitigation Strategy (REMS) pro-gram.11, 12 Under the REMS program, healthcare providers who prescribe, dispense or administer CAR-T therapy must be trained in the management of CRS and neurological toxicities, as well as complete an assessment of their knowledge of these potential issues. Furthermore, the facility administering the CAR-T cells are required to have immediate access to two doses of tocilizumab for each patient within two hours of the infusion.11, 12

Economic considerations are paramount in the setting of CAR-T ther-apy. It is estimated that each CAR-T infusion costs between $373,000 and $475,000, and this estimation does not include the use of tociluzumab, hospital stay or treatment of other complica-tions.16 With such a hefty price tag, this therapy may not be available to all patients. Fair allotment of resources as

well as responsible spending of health-care dollars will certainly continue to be debated as use of these agents increases.17, 18

Both long-term adverse effects and durability of response are of concern with current CAR-T therapies. Despite promising short-term results, ap-proximately half of the patients in the ZUMA-1 trial did not maintain a remis-sion. At this time, superiority or inferi-ority of CAR-T therapies compared to other available agents or hematopoietic stem cell transplantation for refractory B cell malignancies is unknown; there have been no head-to-head trials to date. Combining CAR-T therapy with other available agents also is an area of interest, but resultant greater rates of toxicity is of significant concern.17

Future directionsCAR-T therapy represents an

important advancement in the treatment of refractory B cell cancers. Induction of

remission and improved clinical out-comes have been demonstrated in this challenging patient population; however, the unique adverse effect profile and intensive monitoring protocols may be a limitation of therapy. Further, issues such as cost, patient selection and long-term outcomes continue to be points of contention. Additional long-term studies and standardized management proto-cols are eagerly awaited.

Mr. Thomas is a doctor of pharma-cy candidate at Duquesne University School of Pharmacy. Dr. Fancher is an assistant professor of Pharmacy Prac-tice at Duquesne University School of Pharmacy. She also serves as a clin-ical pharmacy specialist in Oncology at the University of Pittsburgh Medical Center at Passavant Hospital. She can be reached at [email protected] or (412) 396-5485.

References1. National Cancer Institute. What is

cancer? Available at https://www.cancer.gov/about-cancer/understanding/what-is-cancer. Accessed april 12, 2018.

2. World Health Organization. Cancer. Available at http://www.who.int/mediacentre/factsheets/fs297/en/. Accessed april 12, 2018.

3. Maude SL, Teachey DT, Porter DL et al. CD19-targeted chimeric antigen receptor T-cell therapy for acute lymphoblastic leuke-mia. Blood. 2015; 125(26): 4017-23.

4. Neelapu SS, Tummala S, Kebriaei P et al. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018; 15(1): 47-62.

5. Brudno JN and Kochenderfer JN. Chime-ric antigen receptor T-cell therapies for lympho-ma. Nat Rev Clin Oncol. 2018; 15(1): 31-46.

6. Smith L and Venella K. Cytokine release syndrome: inpatient care for side effects of CAR T-cell therapy. Clin J Oncol Nurs. 2017; 21(2 Suppl): 29-34.

7. American Journal of Managed Care.

Physicians develop guidelines to manage CAR T-cell toxicity. Available at http://www.ajmc.com/journals/evidence-based-oncolo-gy/2017/october-2017/in-conversation-with-a-pharmacist-management-of-car-t-cell-treat-ment. Accessed april 12, 2018.

8. Maude SL, Laetsch TW, Buechner J et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018; 378(5): 439-48.

9. Neelapu SS, Locke FL, Bartlett NL et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017; 377(26): 2531-44.

10. Schuster SJ, Svoboda J, Chong EA et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas. N Engl J Med. 2017; 377(26): 2545-54.

11. Kymriah [package insert]. East Ha-nover, NJ: Novartis Pharmaceuticals Corpora-tion, 2017.

12. Yescarta [package insert]. Santa Monica, CA: Kite Pharma, Inc., 2017.

13. National Comprehensive Cancer Net-

work Clinical Practice Guidelines in Oncology - Acute Lymphoblastic lLeukemia, v1.2018. Available at https://www.nccn.org/profession-als/physician_gls/pdf/all.pdf. Accessed April 12, 2018.

14. National Comprehensive Cancer Net-work Clinical Practice Guidelines in Oncology - B Cell Lymphomas, v2.2018. Available at https://www.nccn.org/professionals/physician_gls/pdf/B-cell.pdf. Accessed April 12, 2018.

15. Clinicaltrials.Gov. Available at https://clinicaltrials.gov/. Accessed April 12, 2018.

16. Majhail NS, Mau LW, Denzen EM et al. Costs of autologous and allogeneic hema-topoietic cell transplantation in the United States: a study using a large national private claims database. Bone Marrow Transplant. 2013; 48(2): 294-300.

17. Tran E, Longo DL and Urba WJ. A milestone for CAR T cells. N Engl J Med. 2017; 377(26): 2593-96.

18. Rosenbaum L. Tragedy, perseverance, and chance - the story of CAR-T therapy. N Engl J Med. 2017; 377(14): 1313-15.


Legal Report

200 www.acms.org

On March 27, 2018, the Penn-sylvania Supreme Court once

again issued an opinion that favored “hypertechnical rules” not explicitly established by statute1 over legislative intent, adversely affecting health care providers in the process. The first case was Shinal v. Toms,2 in which the Court held that only the physician (and not qualified staff) may provide information and obtain a patient’s informed con-sent. In Reginelli v. Boggs,3 the Court obliterated the health care communi-ty’s presumption that nearly all “peer review” activities were protected from discovery under the Peer Review Pro-tection Act (PRPA or the Act). Parsing certain key definitions in the Act and applying a strict statutory interpreta-tion, the Court opened up to plaintiffs the confidential records of peer review activities that don’t meet each literal element of those definitions.

Case background. This decision stemmed from a discovery dispute in a medical malpractice suit. The plaintiff, Eleanor Reginelli, was transported to Mon Valley Hospital (MVH) in January 2011 for what she had reported at the time was gastric discomfort. She was treated by Dr. Boggs and released af-ter, among other testing, an EKG. Sev-eral days later, the symptoms recurred. She was transported to a different hos-pital and diagnosed as having suffered

a heart attack. Mrs. Reginelli and her husband subsequently filed multiple claims against the parties involved:

• Negligence against Dr. Boggs.• Corporate negligence against

MVH, for failing to hire appropriately trained staff and oversee them.

• Negligence claims against both MVH and UPMC Emergency Medicine Inc. (ERMI, Dr. Boggs’ employer), contending they are vicariously liable for Dr. Bogg’s negligence.

• Loss of consortium against all three parties.

After learning during depositions that the medical director of the hospi-tal’s emergency department (an ERMI employee) had kept a performance file on Dr. Boggs, the plaintiffs sought discovery of the performance file from MVH. The hospital objected to the disclosure. The trial court granted a motion to compel, an appeal to the Pennsylvania Superior Court affirmed the trial court’s order, and MVH, ERMI and Dr. Boggs further appealed the issue to the Pennsylvania Supreme Court, resulting in this decision.

Statutory background. The Penn-sylvania General Assembly’s goal in passing PRPA was “to serve the legitimate purpose of maintaining high professional standards in the medical practice for the protection of patients and the general public.” The General

Assembly determined that “because of the expertise and level of skill required in the practice of medicine, the medical profession itself is in the best position to police its own activities.” As noted in the amicus curiae brief submitted to the Court jointly by the Pennsylvania Med-ical Society and the American Medical Association (the Brief):

“[T]he willingness to criticize peers that an effective review process requires cannot occur without ironclad confidentiality.”

The Brief summarized the issue well: “Here, the Medical Director of a hos-

pital Emergency Department reviewed treatment records of a Department physician. That is the paradigm for pro-tected activity under the Peer Review Protection Act.”

The Court’s decision. Alas, the Court disagreed. It held that:

• ERMI did not qualify as a “pro-fessional health care provider” for the purposes of the Act. The definition of “professional health care providers” includes, among other providers, phy-sicians and entities operating licensed health care facilities. Even though ERMI was comprised of physicians and was operating the Emergency Depart-ment of a licensed facility – and there-fore was of the same type of entities and individuals specifically enumerated in the Act – the Court held that ERMI

Peer review: A ‘narrow evidentiary privilege’

beth anne jaCKson, esq.

Legal Report


did not qualify as a professional health care provider because it was not “ap-proved, licensed or otherwise regulated to practice or operate in the healthcare field,” which the Court considered to be a “fundamental” requirement. Accordingly, any peer review activities that ERMI had undertaken were not protected by PRPA and thus subject to discovery in the underlying medical malpractice case. This applied to peer review ERMI had undertaken on its own behalf as well as the activities that it performed on behalf of the hospital pursuant to its contract.

• MVH could not claim the peer review privilege for the reviews per-formed by the Emergency Depart-ment’s Medical Director (an ERMI employee) because (a) an individual is not a “committee,” and (b) the Medical Director was not on the hospital’s peer review committee.

• Even though ERMI was required under its staffing agreement with MVH to conduct quality reviews, the hos-pital could not claim the peer review privilege for the reviews in this case because the agreement itself was not made part of the record and the issue had not been appropriately preserved for appeal.

• The sharing of the information regarding the reviews between MVH and ERMI constituted a waiver of any privilege that may have existed.

The Court also held – in dicta – that credentialing activities were not pro-tected by PRPA’s evidentiary privilege.

How this affects physicians. Health care payment systems, governmental and private, have been moving consis-tently toward payment for quality and value. Peer review – defined as “the procedure for evaluation by profession-

al health care providers of the quality and efficiency of services ordered or performed by other professional health care providers” – is essential to meet-ing the statutory and contractual obli-gations of providers. By removing the confidentiality of the evaluation process from physician groups, this decision puts them in an untenable position: (1) conduct peer review to meet your obli-gations and have any resulting analysis and decisions be subject to discovery, or (2) decline to conduct peer review, fail to meet required quality goals and forgo a substantial portion of payment for your services.

In addition, the decision will require hospitals and any third-party staffed departments (e.g., emergency de-partment, radiology, anesthesia and pathology) to re-examine and restruc-ture their contractual relationship and their interactions with respect to peer review. Medical staff bylaws may have to be amended, at great effort and expense, to clarify how such depart-ments’ own review processes fit within the peer review privilege. The decision also will ensnare every defendant in medical malpractice cases in protract-ed litigation over whether documents are protected from discovery by the peer review evidentiary privilege. (The discovery issue in this case took four years to litigate.) Finally, by gratuitous-ly4 removing the evidentiary privilege from credentialing files, the decision could result in increased difficulty for physicians seeking to obtain privileges and increased difficulty for hospitals seeking to obtain information from applicants’ references. Neither result is desirable, but perhaps inevitable: Physicians may be hesitant to pro-vide wholly honest references if the

reference will not be protected from disclosure. Consequently, they may decline to provide them at all for fear of providing a less than honest descrip-tion of the physician’s skills or profes-sional conduct.

Conclusion. This case does not elim-inate the peer review privilege. Rather, it restricts the privilege to formal pro-ceedings and records of a peer review committee of a “professional health care provider,” notwithstanding the fact that the goal of PRPA is to encourage peer review. The Court’s decision in Reginelli v. Boggs seriously undermines that goal as it will have a chilling effect on physicians’ intra-group peer review and put into question the confidentiality of credentialing and other significant peer review activities carried out by health care providers, especially those conducted jointly with other health care providers. Fortunately, as with the Shinal case, the Pennsylvania General Assembly would be able to effectively overturn this decision by amending the underlying statute. But, of course, that takes time and significant effort.

This blow to the peer review eviden-tiary privilege is on the radar of both the Pennsylvania Medical Society and the American Medical Association, as evidenced by their submission of the Brief in this case. Interested parties may contact either entity to inquire about any planned legislative advocacy efforts on this issue.5

DISCLAIMER: This article is for informational purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.


Legal Report

202 www.acms.org

Ms. Jackson has practiced health care law for more than 20 years and is the sole member of Beth Anne Jackson, Esq. LLC, a law firm that serves the legal needs of health care practitioners and facilities throughout Pennsylvania. She may be reached at (724) 941-1902 or [email protected]. Her website is: www.jackson-healthlaw.com. Follow her on Twitter @bajhealthlaw1.

From Page 201

Materia Medica

References1. Quoted from the amicus curiae brief of the American

Medical Association and the Pennsylvania Medical Society in support of appellants (Dr. Boggs, MVH and ERMI).

2. See “Recent decision may change how physicians obtain informed consent” in the September, 2017 issue of The Bulletin.

3. Reginelli v. Boggs, J-25A-2017 (Pa. Mar. 27, 2018).4. The term “gratuitously” is used because the issue was

not directly before the court. 5. The author is not affiliated with either of these groups.

Table 1. Comparison of commercially available CAR-T cell agents.8, 9, 11, 12, 16

Tisagenlecleucel transgene Axicabtagene ciloleucelBrand name Kymriah® Yescarta®Mechanism of action Anti-CD19 Anti-CD19Manufacturer Novartis Kite Pharmaceuticals

FDA-approved indications

B-cell ALL in children and young adults (ages 2-25 years) that is refractory or in second or later relapse

Age ≥ 18 years with relapsed or refractory B-cell NHL who have failed two or more lines of systemic therapy

Approval trial ELIANA (n = 75) ZUMA-1 (n = 111)

Conditioning chemotherapy Fludarabine and cyclophosphamide

Fludarabine and cyclophosphamide

Overall remission rate / objective response rate 81% (95% CI, 71-89) 82% (95% CI, 73-89)

Overall survival 76% at 12 months(95% CI, 63-86)

52% at 18 months(95% CI, 41-62)

Cytokine release syndrome 77% 93%Neurotoxicity 40% 64%Required tocilizumab treatment 37% 43%Estimated cost $373,000 $475,000

ALL = acute lymphocytic leukemia; CI = confidence interval; FDA = Food and Drug Administration; NHL = non-Hodgkin lymphoma.

From Page 199

Open doorsto .

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May is National Preeclampsia Awareness Month, National Nurses Week May 6-12, and National Women’s Health Week May 14-20.

Open Doors 8-625x11-25 Connections March2018 Ad.indd 4 4/20/2018 3:33:57 PM

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