BulletinALLEGHENY COUNTY MEDICAL SOCIETY September 2018

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Business • Employment • Estates and TTrrusts • Health Care Litigation • Oil and Gas • Public Finance • Real Estate BulletinALLEGHENY COUNTY MEDICAL SOCIETY SEPTEMBER 2018 / VOL. 108 NO. 9

Opinion Departments Articles

Medical Editor...... 330 Community Notes...... 350 Legal Report ...... 340 Explore Pittsburgh’s Hottest Fine Foundation, Jewish Healthcare Federal and Pennsylvania New Restaurants Foundation Announce Winners of 10th Telehealth Developments Deval (Reshma) Paranjpe, MD, FACS Anniversary Fine Awards for Teamwork Mike Cassidy, Esq Excellence in Health Care Editorial ...... 332 Materia Medica ...... 344 Disruptive Innovation? Community Notes...... 351 Eculizumab: A New Treatment Option John Kokales, MD Healthcare Council’s Annual For Myasthenia Gravis Fall Member Conference Lisa Yamagishi, PharmD Perspective ...... 334 Karen M. Fancher, PharmD, BCOP Pittsburgh and Society News ...... 354 the Pittsburgh Ophthalmology Society Special Report ...... 352 Kristen Ann Ehrenberger, MD, PhD Welcomes Shakeel R. Shareef, MD Reportable Diseases 2018: Q2 in October Allegheny County Health Department Perspective ...... 336 Genomic Tests Results Alliance News ...... 354 Special Report ...... 353 in Major Advances in Mark Your Calendar: December 2 Statement of Ownership, Management Breast Cancer Treatment ACMS Alliance Holiday Party and Circulation Adam Brufsky, MD, PhD

Perspective ...... 338 On the cover Why Neurosurgeons Should Re-Engage in the Palliative Care The Ibis of Cancer Pain Patients Nestor D. Tomycz, MD Apartment, Venice, FL Mark F. Thompson, MD

Dr. Thompson specializes in cardiology. EDITORIAL/ADVERTISING OFFICES: Bulletin of the Allegheny County Medical Society, 713 Ridge Avenue, Pittsburgh, PA 15212; (412) 321-5030; fax (412) 321-5323. USPS #072920. PUBLISHER: Allegheny Affiliated with Pennsylvania Medical Society and American Medical Association Bulletin County Medical Society at above ad- dress. The Bulletin of the Allegheny County 2018 PAMED DISTRICT TRUSTEE Medical Society welcomes Medical Editor Executive Committee Amelia A. Paré contributions from readers, physicians, Deval (Reshma) Paranjpe and Board of Directors medical students, members of allied ([email protected]) COMMITTEES professions, spouses, etc. Items may

President Awards be letters, informal clinical reports, Associate Editors Robert C. Cicco Keith T. Kanel editorials, or articles. Contributions Richard Daffner President-elect Bylaws are received with the understanding [email protected] Adele L. Towers William K. Johnjulio that they are not under simultaneous Charles Horton Vice President Finance consideration by another publication. ([email protected]) William K. Johnjulio Peter G. Ellis Issued the third Saturday of each Robert H. Howland Secretary Gala month. Deadline for submission of ([email protected]) Patricia L. Bononi David L. Blinn copy is the SECOND Monday John Kokales Treasurer Patricia L. Bononi preceding publication date. Periodical [email protected] Peter G. Ellis Nominating postage paid at Pittsburgh, PA. Scott Miller Board Chair Thomas P. Campbell ([email protected]) Bulletin of the Allegheny County David J. Deitrick Primary Care Amelia A. Paré Medical Society reserves the right to Lawrence R. John ([email protected]) edit all reader contributions for brevity, DIRECTORS Joseph C. Paviglianiti clarity and length as well as to reject 2018 ([email protected]) any subject material submitted. David L. Blinn The opinions expressed in the William F. Coppula Editorials and other opinion pieces Kevin O. Garrett Managing Editor are those of the writer and do not Raymond E. Pontzer Meagan K. Sable necessarily reflect the official John P. Williams ADMINISTRATIVE STAFF ([email protected]) policy of the Allegheny County 2019 Chief Executive Officer Medical Society, the institution with Thomas P. Campbell Jeremy T. Bonfini which the author is affiliated, or the Michael B. Gaffney ([email protected]) opinion of the Editorial Board. Keith T. Kanel Assistant to the Director Advertisements do not imply Jason L. Lamb Dorothy S. Hostovich sponsorship by or endorsement of Maria J. Sunseri ([email protected]) ACMS ALLIANCE the ACMS, except where noted. 2020 Accounting and Finance Manager President Publisher reserves the right to exclude Lawrence R. John Amanda S. Kemp Kathleen Reshmi any advertisement which in its opinion Bruce A. MacLeod ([email protected]) First Vice President does not conform to the standards of Amelia A. Paré Director of Publications Patty Barnett the publication. The acceptance of Matthew B. Straka Meagan K. Sable Second Vice President advertising in this publication in no Angela M. Stupi ([email protected]) Joyce Orr way constitutes approval or Assistant Executive Director, Recording Secretary endorsement of products or services PEER REVIEW BOARD Director of Member Relations Justina Purpura by the Allegheny County Medical 2018 James D. Ireland Corresponding Secretary Society of any company or its Sharon L. Goldstein ([email protected]) Doris Delserone products. Membership Relations Manager Treasurer Bruce A. MacLeod Subscriptions: $30 nonprofit Nadine M. Popovich Josephine Martinez 2019 organizations; $40 ACMS advertisers; ([email protected]) Assistant Treasurer Robert W. Bragdon $50 others. Single copy, $5. John A. Straka Sandra Da Costa Advertising rates and information sent 2020 upon request by calling (412) James W. Boyle 321-5030 or online at www.acms.org. Matthew A. Vasil

COPYRIGHT 2018: ALLEGHENY COUNTY MEDICAL SOCIETY www.acms.org POSTMASTER—Send address changes to: Bulletin of the Allegheny County Medical Society, 713 Ridge Avenue, Leadership and Advocacy for Patients and Physicians Pittsburgh, PA 15212. ISSN: 0098-3772 ® Medical Editor Explore Pittsburgh’s Hottest New Restaurants

DEVAL (RESHMA) PARANJPE, MD, FACS

Autumn evokes in most of us a features sourdough crusts made from you’ll be glad to know that chef/owner sense of buckling down and getting unbleached, nonbromated flour topped Chris Bonfili (also of B Gourmet in down to serious work that harkens back with fresh, local and organic Sewickley) is opening his next venture at to our own school days, even though we ingredients. At $19-24 for a 16 inch pie, the site of the former Mullen’s on East may have worked hard all summer. But it isn’t cheap, but quality tastes good Carson Street. The first floor will feature as the hot weather recedes and cool fall and the proof is apparently in the substantial and elegant comfort food and breezes arrive, a different mode of (nationally recognized) pie. a craft beer menu that will be sure to living comes to pass. Gone are the please as the cold weather arrives. The backyard barbecues, the casual salads 2) Bitter Ends Garden and second floor will feature seasonal and suppers on the deck, picnics, and Luncheonette, 4613 Liberty Avenue, American cuisine a la Avenue B and vacations. Your meal choices are back Bloomfield—Top 50 National Finalist for wine/craft cocktail service. to cooking indoors or venturing out and 2018 Bon Appetit’s Top 10 New rediscovering your own city. Restaurants. Serves breakfast and lunch 5) Lorelei, 124 S. Highland Ave, But where to go? What to try? Your Wed-Sun, featuring housemade East Liberty. Unique Alpine-inspired time and resources are limited, and the sandwiches, salads, pastries, cocktail bar and beer hall, this labor of array of culinary choices in Pittsburgh doughnuts, snacks and coffee. love features Executive Chef Jamilka is finally, happily, and utterly Vegetables are sourced from the Borges, the pastry chef formerly of the bewildering, as befits a city of note. owners’ organic farm in Verona, and you Twisted Frenchman, and the cocktail Fear not, gentle reader! Here’s a list can order online. Menu changes daily. and wine program is headed by talents of the dozen hottest new Pittsburgh from Hidden Harbor and the Rick restaurants to explore and make your fall 3) Fish Nor Fowl, 5523 Penn DeShantz restaurant group. Sure to free time enjoyable. Remember to take Avenue, Garfield (former Salt of the please during Oktoberfest. time to refresh and recharge yourself; Earth location). Another Rick DeShantz part of that includes taking pleasure in restaurant, this is a crowdpleaser with 6) Mediterra Café, 430 Beaver the simple things. I can think of no better upscale, unique and delicious fare under Street, Sewickley Village. Mediterra simple and deeply satisfying joy than a the headings of Farm, Field, Water, and artisan bakery (est. 2001) has now good meal with good company, whether Sweets. Craft cocktail powerhouse expanded to a bakery cafe format, with that company includes family, friends, or Maggie Meskey is the general manager, the head of erstwhile Smallman Galley even just yourself. so you know the attention to pairings will restaurant Josephine’s Toast designing be excellent. A worthy successor to Salt. the menu. Sandwiches and 1) Driftwood Oven, 3615 Butler Mediterranean deli delights from Street, Lawrenceville—Top 50 4) Bonfire Grill, 2100 East Carson cheeses to sardines, octopus and National Finalist for 2018 Bon Appetit’s Street, Southside (opening mid-late calamari will be available, along with Top 10 New Restaurants. This pizzeria fall). If you loved and lost Avenue B, their famous signature breads.

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7) Pie for Breakfast, 200 North the Azores, a group of islands off the Craig Street, Oakland. An offshoot of Portugese coast. Enjoy seafood, stews, the stellar Legume and Butterjoint next soups and casseroles as well as door, this gem serves (you guessed it) a Azorean pastries. A rare find outside multitude of fine pies for breakfast, lunch New England, which has a large and dinner, along with diner classics, population of Azorean immgirants. homestyle favorites with a twist, craft cocktails, wine and beer. 12) Siempre Algo, 414 East Ohio Street, North Side. Newly opened on 8) La Riviera, 5925 Baum waiters carving mouthwatering authentic August 26, this restaurant serves dinner Boulevard, East Liberty. Bar roasted meats for you tableside on an nightly (closed Mondays) and features Frenchman, the casual downstairs sister ongoing basis throughout your meal. You upscale seasonal American cuisine with to fine dining star The Twisted stop when you’re full, and you’ll want to many appetizer choices and a Frenchman, has rebranded as La try everything. well-curated entrée menu, as well as a Riviera. (Too many people confused the seasonally inspired cocktail service. A two Frenchmen, apparently.) La Riviera 10) Soju, 4923 Penn Avenue, North Side destination. features a menu that expands its range Garfield. The brainchild of owner and Wishing you a delicious Autumn of across the Mediterranean and combines chef Simon Chough, this new landmark exploration and delight! the beloved French bistro menu with features classic Korean dishes from Spanish, Italian, Portugese and other bibimbap to beef bulgogi, as well as Dr. Paranjpe is an ophthalmologist flavors. The cocktail service remains Hawaiian dishes including Poke. The and medical editor of the ACMS stellar, with the summer service inventive cocktail menu features unique Bulletin. She can be reached at organized by colors of the rainbow. Korean spirit Soju. [email protected]

9) Fogo de Chao, 525 Smithfield 11) Azorean Café, 4715 Liberty The opinion expressed in this column Street, Downtown (former Saks Fifth Avenue, Bloomfield. Open for breakfast is that of the writer and does not necessarily reflect the opinion of the Avenue store). This branch of the and lunch daily, and dessert/drinks/ Editorial Board, the Bulletin, or the famous international Brazilian coffee in the evenings. Featuring the Allegheny County Medical Society. churrascaria (steakhouse) features delicious and unique specialty cuisine of Thank you for your membership in the Allegheny County Medical Society The ACMS Membership Committee appreciates your support. Your membership strengthens the society $I¿OLDWHGZLWK3HQQV\OYDQLD0HGLFDO6RFLHW\DQG$PHULFDQ0HGLFDO$VVRFLDWLRQ and helps protect our patients. Please make your medical society stronger by encouraging your colleagues to become members of the ACMS. For information, call the membership depart- ment at (412) 321-5030, ext. 110, or email [email protected].

ACMS Bulletin / September 2018 331 Editorial

Disruptive Innovation?

JOHN KOKALES, MD

I think most of us are familiar with Dave. There the computer human gained by analyzing the enormous that famous exchange between Hal interface became a disruptive force. amount of data being collected on our and David in the movie “2001.” Dave Instead of it being a sustainable patient’s health, I just don’t know that is outside the ship in his spacesuit innovation that enabled humans to applying it via a computer - (Artificial trying to fix the space ship and asks extend their intellect exponentially, it Intelligence (AI) - is the best way to Hal to let him back in. Hal the all become disruptive. It became a arrive at the diagnosis and best knowing evolving computer with “monster from the Id” as foretold in that treatment option. When I was a 4th artificial intelligence that is supposed to classic 1950s sci-fi classic movie year medical student in 1973, I worked enhance Dave’s abilities to pilot, “Forbidden Planet.” In that movie with Dr. Jack Myers on a computer navigate, and repair the ship has machines replaced life forms as the program called “Internist” which used instead evolved to a point that it next evolutionary step. inductive reasoning instead of assumes total control and retorts A few years ago I heard a highly deductive to arrive at the most likely “Sorry Dave I can’t do that.” Hal has placed hospital system administrator at diagnosis. It basically asked if you had decided that Dave is a threat and no a conference state that the next symptom A and what was the likelihood longer necessary. industry that will be disrupted will be you had diagnosis B and if you had An American businessman, Tom healthcare. He predicted that primary diagnosis B what was the likelihood Preston said, “Innovation is taking two care physicians would no longer be you had symptom A. By doing that things that already exist and putting necessary in his ‘Brave New World’. with all the symptoms and findings them together in a new way.” So here He outlined how he planned to be in obtained in the H&P it came up with we are trying to marry traditional the lead in disrupting the health care the 4 or 5 most likely diagnoses by medicine or what is left of it with the industry by bringing “big data” into rank. It was pretty good and turned into brave new world of artificial intelligence artificial intelligence and combining it a great teaching tool. It was powered by big data. While that may with personalized medicine to create dependent on the accuracy of the data be by definition innovative it may also the next disruptive industry. it was fed. Today all too often our be disruptive. Look what Hal did to While I feel there is much to be hospital records contain incorrect

Moving? Be sure to let us know .... We can update our system to better serve you! When your patients call, we will know where to send them. Call (412) 321-5030 to update your information.

332 www.acms.org Editorial information. Our young students and happens to the body language and information management and doctors trained in the computer age too intonations that if picked up on lead us traditional medicine together in ways often take the shortcuts of cut and to what really is going on. Bottom line that will improve patient care not paste and forego the thoughtful as Dr. Myers taught me over and over disrupt it. We must safeguard what we narrative that reflect inductive again is that nothing replaces a good have already achieved not risk it on a reasoning. The data fed to big data’s history. bet that a businessman makes. memory banks is often inaccurate. So what I am trying to say is that Therefore, any conclusions reached we should be very careful in rushing Dr. Kokales is a retired internist and are subject to doubt. AI can only work headlong into the future thinking we associate editor of the ACMS Bulletin. if it is fed accurate information. Of are innovating and improving with He can be reached at more concern is that too often the integrating AI with the practice of [email protected] history is incomplete as interviewing medicine. I still feel that nothing can skills are being replaced by replace a good primary care physician questionnaires patients fill out and then caring for their patient in the traditional The opinion expressed in this column are entered into the health care record way. To even think we can replace that is that of the writer and does not by an assistant. How many times have key person with a computer program is necessarily reflect the opinion of the Bulletin we asked a question that was folly and I must say not only disruptive Editorial Board, the , or the Allegheny County Medical Society. answered in such a way that we felt but also destructive. Let’s in the words there was more going on. What of Mr. Preston innovate by bringing

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ACMS Bulletin / September 2018 333 PerspectivePerspective Pittsburgh and the Polio Vaccine

KRISTEN ANN EHRENBERGER, MD, PHD “MMR causes autism.” “Gardasil of Pittsburgh School of Medicine. The coup de gras was a randomized, makes girls promiscuous.” Today’s National Foundation for Infantile double-blind, placebo-controlled trial of highly publicized debates about Paralysis (NFIP, now March of Dimes) an injectable killed vaccine against all are often compared wanted to sponsor him to work on three serotypes involving almost 2 (unfavorably) to the heyday of vaccine polio. At that time, paralytic million children funded entirely by the development in the mid-twentieth poliomyelitis was epidemic in the NFIP (i.e. no federal dollars) and run century, when smallpox was eradicated United States, sickening >50,000 by Salk’s old mentor at Michigan, and schoolchildren lined up by the people a year, killing thousands, and Thomas Francis, Jr. millions to be protected against polio. putting almost half on crutches, in On April 12, 1955—10 years to the At a time when presidential candidates wheelchairs, or in iron lungs. day since President Franklin Delano are asked about their stance on Summer—when children were free Roosevelt’s death(1)—the Federal Drug vaccines and when famous comedians from school to go swimming and buy Administration announced that Salk’s make internet videos about how their ice cream cones—had become a polio vaccine was safe and effective. In benefits outweigh their risks, it may be season of panic. those optimistic post-World War II mete to recall that those campaigns Salk was hardly the only years after the demonstration of were no less political or fraught with researcher looking for a vaccine for this nuclear power at Hiroshima and uncertainty. “dread disease.” Marcus Brodie (NYU) Nagasaki, and before the Tuskegee Across the street from the and John Kolmer (Temple) had Syphilis Study became front-page School of developed killed and attenuated news, most Americans put their faith in Medicine and its Oakland hospital vaccines, respectively, but their clinical science, technology, and medical complex is a sand-colored building with trials in 1935 both ended in disaster, advances such as Salk’s new shot. many windows: Salk Hall. It is named with recipients suffering allergic That faith was immediately tested, as for one of the researchers who worked reactions, paralyzation, or even death. vaccination was temporarily halted less on the first successful polio vaccine Hilary Koprowski and Herald Cox than one month later after hundreds of there in the 1940s and 1950s. The son (Lederle Labs, NY) then created an children were infected by faulty of Russian-Jewish immigrants, Jonas attenuated oral vaccine that they tested batches out of Cutter Laboratories in Salk (1914-1995) was a on chimpanzees and themselves California, and 11 died. Nevertheless, first-generation college and medical before giving it to children with epilepsy Salk entrusted his laboratory’s work to student. While a post-doc at the and intellectual disabilities in 1950. the common good and never patented in the 1940s, he Salk also used disabled the vaccine. What he lost in monetary collaborated on the development of the institutionalized children for his first rewards he gained in fame and public first influenza vaccine, an inactivated human trials, in 1952. Another Pitt acclamation. The National Foundation whole-virus vaccine. In 1947 he was researcher, William M. Hammon, for Infantile Paralysis touted Salk as a recruited as director of the Virus single, heroic scientist—and he let Research Laboratory at the University showed the efficacy of IVIG for short-term protection against polio. The them.

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Salk is often juxtaposed with Albert at the University of Rochester during Kristen Ann Ehrenberger, MD, PhD Sabin (1906-1993), another World War II before coming to the (History), is an Internal NFID-supported polio researcher. University of Pittsburgh in 1949. His Medicine-Pediatrics Resident, UPMC. Sabin was born in Poland and fled contributions to the polio vaccine anti-Semitism in 1921. During WWII, included devising a way to grow large For further reading: he developed vaccines for amounts of poliovirus in monkey cells, Jeffrey Kluger, Splendid Solution: trypanosomiasis, sand-fly fever, and figuring out how to reliably inactivate and the Conquest of Polio dengue fever. He was one of two the virus so it could be injected safely, (New York: Berkley Books, 2004). scientists to demonstrate that the polio and creating an antibody assay to Bernard Seytre and Mary Shaffer, virus does not enter the nervous measure vaccine efficacy after The Death of a Disease: A History of system via the nasal mucosa but rather administration. Youngner continued a the Eradication of Poliomyelitis (New via the bloodstream from the productive career at Pitt, Brunswick, NJ: Rutgers University gastrointestinal tract. His lab at the working on interferon gamma and a Press, 2004). University of Cincinnati created an vaccine for equine influenza, but as his Marc Shell, Polio and Its attenuated oral vaccine that was tested obituary in the Pittsburgh Post-Gazette Aftermath: The Paralysis of Culture in an uncontrolled, unblinded study on put it, Youngner “never forgave Jonas (Cambridge, MA: Harvard University 10 million Soviet children from 1957 to Salk for his failure to acknowledge Mr. Press: 2005). 1959. Youngner and the other members of David M. Oshinsky, Polio: An The FDA licensed it for use in the research team that created the American Story (New York: Oxford 1960, and it was the standard in the vaccine against the crippling University Press, 2005). United States from 1968 until the late disease.”(2) 1990s. The oral polio vaccine (OPV) The polio vaccine was Salk’s stimulates faster individual immunity, greatest lifetime achievement. He References fosters herd immunity, and is more spent the rest of his career at an (1) FDR was America’s most famous palatable to administer but is no more eponymous institute in La Jolla, CA, polio patient, and he co-founded the NFIP, or less efficacious than the working on other vaccines, notably one but it is likely he actually had Guillain- intramuscular inactivated polio vaccine for HIV/AIDS. Today, American children Barré Syndrome. He died of a stroke. (IPV). It is responsible for the receive four injections of IPV, while (2) Mark Roth, “Obituary: Julius near-eradication of polio. However, OPV is used to vaccinate the rest of Youngner: Last surviving member of Salk vaccine team right here at Pitt someone else’s the world. Only Afghanistan, Pakistan, Oct. 24, 1920¬-April 27, 2017,” contributions to “Salk’s” vaccine were and Nigeria are still known to have Pittsburgh Post-Gazette (28 April 2017), overshadowed. circulating wild-type virus. Twenty two http://www.post-gazette.com/news/obitu- Many other Pitt researchers and cases were reported in 2017. aries/2017/04/28/Julius-Youngner-Salk- technicians had contributed to the Interestingly, none of these men vaccine/stories/201704280215. discovery, among them Julius received a Nobel Prize. The 1954 Prize Youngner (1920-2017). If Salk was “Mr. in Physiology for Medicine went to The opinion expressed in this column Outside,” the public face of the lab, Harvard scientists John Enders, is that of the writer and does not Youngner was “Mr. Inside,” the Thomas Weller, and Frederick Robbins necessarily reflect the opinion of the scientific whiz. The son of a Jewish “for their discovery of the ability of Editorial Board, the Bulletin, or the businessman in New York, Youngner poliomyelitis viruses to grow in cultures Allegheny County Medical Society. had worked on the Project of various types of tissue.” www.acms.org

ACMS Bulletin / September 2018 335 PerspectivePerspective Genomic Tests Results in Major Advances in Breast Cancer Treatment

ADAM BRUFSKY, MD, PHD As a practicing medical oncologist with a specialty in stage breast cancer received chemotherapy in addition to breast cancer for the past 22 years, I have been fortunate to anti-hormonal therapies, such as tamoxifen or anastrozole. We see substantial advances in treatment. A majority of women would make an educated guess as to the need for are now diagnosed with early stage disease, and five-year chemotherapy based on the size of the cancer, presence and survivals without recurrence for women with estrogen receptor number of involved axillary lymph nodes, and how aggressive positive stage I and II breast cancer now exceed 85-90%. The the tumor looked under the microscope. Chemotherapy can question I now deal with is not: “Will I survive this,” but rather, be very toxic, and around 15-20 years ago some of us were “What will it take to get me there?” curious as to whether we could come up with a test to When I started 22 years ago, many women with early determine whether we could identify those women with early stage breast cancer who could avoid chemotherapy altogether, take an anti-hormonal therapy alone, and still have an EHR Documentation, excellent long-term outcome. Genomic tests were developed in the early 2000s to Coding, and Billing address this problem. These tests looked at the expression of various genes in the cancer itself which not only could tell us whether a woman with early stage estrogen receptor positive Consulting Services breast cancer would recur in 10 years, but also which women would benefit from chemotherapy. The biology of the disease (Analysis, Training, and Audits) could therefore individualize treatment, leading to excellent outcomes with less toxicity for the 50-60% of women who Contact: John Fenner or would now not need chemotherapy. Currently there are 4 to 5 Beth Ann Fleischmann, RN, BSN, CPC of these tests available, with Oncotype Dx (21 genes) and Mammaprint (70 genes) being the most popular. The TAILOR-Rx trial, recently published in the New England Journal of Medicine, is one of the first trials 3 PENN CENTER WEST prospectively demonstrating that a genomic test (Oncotype Dx) PITTSBURGH, PA 15276 in early stage estrogen receptor positive breast cancer can be 412-788-8007 used to avoid chemotherapy with outcomes identical to women [email protected] receiving chemotherapy. Pittsburgh oncologists were central [email protected] contributors to this trial. In TAILOR-Rx, over 11,000 women with estrogen receptor positive, node negative early stage breast cancer had an SPECIALIZING IN HEALTH CARE Oncotype Dx test of their breast cancer. Thosewith a low score CONSULTING SINCE 1991 (less than 11, about 20% of women) received hormonal therapy alone, and had an excellent 9-year distant recurrence

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free survival (over 97%). Those with a Oncotype Dx or Mammaprint, close to node negative breast cancer can now high score (greater than 25, about 14% 60-70% of women with node negative, avoid chemotherapy, Pittsburgh has of women) received chemotherapy and estrogen receptor positive breast cancer been at the center of innovation in breast hormonal therapy, and also had an can now avoid the toxicity of cancer. We are fortunate in Allegheny excellent 9-year distant recurrence free chemotherapy with excellent outcomes. County to be frontline observers and survival of about 87%. Women with an This represents a major advance, as contributors to this revolution in intermediate score (11-25, about 65% of many women with early stage breast personalized therapy. women) all received hormonal therapy, cancer can now to get to the ultimate but half received chemotherapy. These goal of living a life free from breast Adam Brufsky, MD, PhD, is women had no benefit to chemotherapy, cancer recurrence without the side Professor of Medicine at the University and both arms of this intermediate group effects of chemotherapy. of Pittsburgh. had a 9-year distant recurrence free From the National Surgical Adjuvant survival in excess of 95%. The trial could Breast and Bowel Project (NSABP) trials not rule out some chemotherapy benefit in the 1980s (spearheaded by Dr. Bernie The opinion expressed in this column in women under 50 years of age with Fisher) demonstrating that lumpectomy is that of the writer and does not recurrence scores of 15-25, but this and radiation is equivalent to necessarily reflect the opinion of the Bulletin benefit was likely small (perhaps 2% mastectomy in terms of outcome, to the Editorial Board, the , or the Allegheny County Medical Society. fewer distant recurrences at 9 years). trials of today demonstrating that more With genomic tests such as than 60-70% of women diagnosed with

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ACMS Bulletin / September 2018 337 PerspectivePerspective Why Neurosurgeons Should Re-Engage in the Palliative Care of Cancer Pain Patients

NESTOR D. TOMYCZ, MD

Some of my most rewarding pain operations such as myelotomy percentage of cancer patients. (2) operations have been palliative pain have become near extinct and have Although degenerative spine disease procedures in patients with metastatic been replaced with better medications has become the lion’s share of modern cancer. I have rarely encountered and neuromodulation (implants for drug neurosurgery practice, there is patients so appreciative for seemingly delivery or electrical stimulation). In arguably less evidence for many of so little provided by the surgeons’s fact, the first spinal cord stimulator – an these interventions than for some of hands. Although we can neither offer electrical device implanted to block the “antiquated” neurosurgery pain cure or longer survival, my experience pain – was surgically placed in 1967 in operations such as cordotomy. In has been that terminal cancer patients a patient suffering from pain secondary addition, neurosurgical technical and their families exude memorable to bronchogenic carcinoma.(1) advances in neuroimaging, gratitude for any degree of pain However, today spinal cord stimulators neuronavigation, robotics, and alleviation that might be surgically are almost never implanted for cancer intraoperative neuromonitoring may achieved. Perhaps absent are the pain. now be embraced to revive and make secondary gains of illness which Many colleagues across the ablative neurosurgery safer. There are obfuscate the surgical outcomes in country have offered reasons why multiple advantages of ablative non-cancer chronic pain syndromes. It neurosurgeons have reduced operations as compared to implant therefore becomes surprising that few involvement in the pain management of operations for cancer pain: significantly neurosurgeons attempt to actively cancer patients. Some neurosurgeons lower cost, no insurance requirement involve themselves with end-of-life lament that these patients are never for a trial procedure, no requirement for cancer pain management. referred but admittedly have not put routine follow-up for stimulator The history of modern forth effort to seek appropriate patients programming, dose adjustment, or neurosurgery has been closely for surgical referral. Others have told pump refills, and lower risk intertwined with lesioning different me that they simply were not exposed due to absence of implanted hardware. parts of the brain and spinal cord to to these surgical techniques during However, implanted hardware is ameliorate the pain of malignancy. As training and some fear operative risks programmable and non-destructive and the neuroarchitecture of pain of surgery in the terminally ill cancer may therefore be the better option in transmission began to be elucidated in patient population. The World Health patients with longer life expectancy. the 19th century, neurosurgeons were Organization (WHO) “analgesic ladder” Recently, I treated a 59 year-old eager to explore severing such of cancer pain management guidelines man with stage IV rectal cancer pain pathways with a scalpel and multiple does not mention surgery at all, with thoracic cordotomy. He was effective destructive nervous system although multiple studies have admitted to the hospital with intractable operations were developed to palliate confirmed that application of WHO right buttock, hip, and leg pain despite pain. Although often very effective, guidelines may fail to achieve 124mg/12 hours of hydromorphone much of these ablative neurosurgery adequate pain reduction in a significant PCA and methadone. The surgery

338 www.acms.org PerspectivePerspective

took about an hour and his postoperative pain was reduced Nestor D. Tomycz, a neurologist, is currently director of from 8/10 to 2/10. He was able to rapidly wean off neurosurgical pain management and director of hydromorphone and was discharged home soon after stereotactic/functional neurosurgery at Allegheny Health surgery. He died 66 days after cordotomy but his family and Network. Dr. Tomycz is actively involved in clinical research caretakers confirmed that his pain control remained good at involving deep brain stimulation and spinal cord stimulation the end of life. Some of the oncologists had never heard of as well as basic research involving infection prevention in this procedure and were quite impressed with the results. I neuromodulation. did use modern intraoperative monitoring techniques and a microscope but had to remind them that this surgery was References first described in 1912.(3) Outside the United States in 1. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of countries such as Turkey, results of cordotomy have been pain by stimulation of the dorsal columns. Preliminary clinical report. Anesth Analg (Cleve) (1967);46:489-91. reported in hundreds of cancer patients with outstanding 2. Carlson CL. Effectiveness of the World Health Organization (4) pain relief outcomes. cancer pain relief guidelines: an integrative review. J Pain Res It is a great privilege to be a neurosurgeon, and I look (2016);9:515-534. forward to bringing my skillset to more patients suffering 3. Spiller W, Martin E. The treatment of persistent pain of organic from pain at the end of life. It is our responsibility to origin in the lower part of the body by division of the anterolateral inculcate residents with these surgical techniques so they column of the spinal cord. JAMA (1912);58(1):489-90. 4. Kanpolat Y, Ozdemir M, Al-Beyati E. CT-guided percutaneous are not assigned to only subspecialists and to establish cordotomy for intractable pain in what is more than a disease: lung relationships with oncology, pain management, and malignancies. Turk Neurosurg (2013);23(1):81-7. palliative care specialists to determine who might benefit from palliative neurosurgery. The opinion expressed in this column is that of the writer and As the prevalence of cancer and cancer survivors does not necessarily reflect the opinion of the increases, pain from cancer and pain from its treatment will Editorial Board, the Bulletin, or the likely burgeon in parallel. Even patients with “cured” Allegheny County Medical Society. cancers or in remission may benefit from interventions such as spinal cord stimulation to alleviate the neuropathic pain Pennsylvania Geriatrics Society – Western Division resulting from radiation and chemotherapy. Presents the Most patients with cancer pain will not require any surgical intervention, however it is crucial that neurosurgeons recognize their unique ability to access the Fall Program nervous system pain pathways and continue to provide Living a Good Life – Not Just a Long One surgical options for cancer patients that are poorly managed Guest Speaker

on opioids. Karren Wolk Feinstein, PhD One risk of increased regulations imposed in response President and Chief Executive Officer of the Jewish Healthcare Foundation (JHF) and its three operating arms, the Pittsburgh Regional Health Initiative (PRHI), Health Careers Futures (HCF), to the opioid abuse epidemic is a greater barrier to obtaining and the Women’s Health Activist Movement Global (WHAMglobal)

opioids for cancer patients, making surgical interventions The University Club Thursday 123 Universsity Place Pittsburgh PA 15260 even more relevant in the foreseeable future. If we are to

NOVEMBER gain a step on the cancer pain management ladder, Complimentary Registration for Members Guessts welcome (guest fee $50) neurosurgeons must not only publish outcomes of such ON-LINE REGISTRATION interventions but must also collaborate with industry to th 1 beggins September 27

improve technology for palliative care surgery. 6:00 pm Visit www.pagswd.org Registration, Networking periodically for program updates or contact Naddine Popovich, Administrator Although still a neophyte, my experience treating cancer and Visit with Exhibitors for details: [email protected]

patients has been extremely positive, and I hope that our 7:00 pm - 8:00 pm field can someday respond to these patients with the alacrity Program Thank you to the following who provided support for the program meted to the herniated disk.

ACMS Bulletin / September 2018 339 LegalPerspective Report Federal and Pennsylvania Telehealth Developments

MIKE CASSIDY, ESQ I. Introduction provisions are significant. Section 6 1. Healthcare providers validly CMS has been actively promoting entitled “Insurance Coverage of licensed in the Commonwealth are telehealth since 2000, when Social Telemedicine,” provides as follows: authorized to practice telemedicine in Security Act §1834(m) was adopted, and 1. Health insurance policies issued, accordance with the Act, which CMS has continued to expand the delivered, executed or renewed in the essentially means they may deliver covered telehealth services. Commonwealth after the effective date telemedicine services to residents of the Pennsylvania is a late comer to the of this Section (which has not yet been Commonwealth of Pennsylvania. telehealth legislative field, but its determined) shall provide coverage for Delivery of telemedicine services in other proposed Telemedicine Act is a telemedicine delivered by a participating states is regulated by the other states comprehensive payment parity and state network provider who provides a and usually requires licensing in the licensing/enabling piece of legislation. covered service via telemedicine state of the patient’s location. This article will provide summaries consistent with the third party insurers’ Conversely, an out-of-state provider of both developments, and access to the medical policies. providing telemedicine services to foundational documents. 2. A health insurance policy may not residents of the Commonwealth must exclude a healthcare service for comply with this Act, and be licensed by II. New Telemedicine Act in coverage solely because the service is Pennsylvania. Pennsylvania provided through telemedicine. a. Physicians already licensed in A new Telemedicine Act is wending 3. A health insurer shall reimburse a Pennsylvania treating their patients in its way through the legislative process in healthcare provider for telemedicine if Pennsylvania obviously need not be Pennsylvania. Senate Bill 780 of 2017 the health insurer also reimburses the concerned with the licensing has been unanimously passed by the same participating provider for the same requirement, but the Act also establishes Senate and referred to the House service through an in-person encounter. a minimum standard of care. Professional Licensure Committee on This concept is known in the 2. Physicians licensed in June 19, 2018. Pennsylvania is one of industry as payment parity because it Pennsylvania, whether physically located the few states that does not have a seeks to provide equal coverage and here, providers providing telemedicine dedicated Telemedicine Act and payment. services to individuals located in the Pennsylvania is attempting to address Commonwealth who do not have an the two major issues in telemedicine in Telemedicine Regulation established physician-patient one Act, i.e. payment parity and The telemedicine regulation section relationship must do the following: professional regulation. is essentially a licensing provision, but it a. Verify the location and identify of also defines the key concepts regarding the individual receiving care, and Payment Parity the performance of telemedicine. The b. Disclose the physician’s identity, Although the payment issues are regulatory provisions of this Act provide geographic location and medical only addressed briefly in the Act, the as follows: specialty or credentials. Continued on page 342

340 www.acms.org Support your patients with standout specialists

Ellen Lu, MD Allergy, Asthma, and Immunology Dr. Lu cares for individuals who suff er from rhinitis, environmental and food allergies, eczema, asthma, sinusitis, and other conditions. She provides testing, treatment, allergy shots, and education about these conditions.

Dr. Lu earned her medical degree and completed her Internal Medicine residency at the University of Arkansas for Medical Sciences in Little Rock. She gained additional expertise during her fellowship in allergy and immunology at the University of Iowa Hospitals and Clinics in Iowa City.

She is a diplomate with the American Board of Internal Medicine and with the American Board of Allergy and Immunology. She is a member of the American College of Physicians and a Fellow of the American Academy of Allergy, Asthma, and Immunology, as well as the American College of Allergy, Asthma, and Immunology.

Dr. Lu sees patients ages 2 and older at AHN Allergy, Asthma, and Immunology at Allegheny General and West Penn hospitals.

Barbara K. O’Connell, MD Neurology Dr. O’Connell provides advanced and innovative care for patients with complex neurological disorders. Her special interests are multiple sclerosis and movement disorders.

Dr. O’Connell earned her degree at Pennsylvania State University College of Medicine in Hershey. She completed her neurology residency at the Milton S. Hershey Medical Center.

She is a member of the American Academy of Neurology, American Chemical Society, Movement Disorder Society, and Multiple Sclerosis Society, serving on the medical advisory board in the central Pennsylvania region.

Dr. O’Connell sees patients ages 18 and older at Allegheny Neurological Associates in Brackenridge and at West Penn Hospital.

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

AHN.org LegalPerspective Report

From page 340 ––––––––––––––––––– 3. Physicians must: an unauthorized manner, or at least established in Section 1834(m) of the a. Obtain informed consent negligent conduct. Social Security Act, which CMS does not regarding the use of telemedicine Note that the Act excludes intend to do. technologies. provider-to-provider consultations from Following is a list of discrete b. Provide an appropriate the definition of telemedicine, but that technology base services which CMS examination or assessment using has always been the case and it is fairly proposed to add as separately telemedicine technologies. obvious since the other physician is identifiable physician services payable c. Establish a diagnosis and presumably not a patient and the under the Medicare Physician Fee treatment plan. consulting physician is not providing a Schedule, and for which CMS is seeking d. Create and maintain electronic service it could be billed to a patient; comment: medical records within 24 hours. there is no face-to-face encounter and 1. Brief Communication e. Provide a visit summary to the no telemedicine encounter. Technology-Based Service, e.g. virtual individual if requested and have an III. 2019 Proposed Medicare Fee check-in (HCPCS Code GVCI1) emergency action plan in place for Schedule Telehealth Expansion 2. Remote Evaluation of medical and behavioral health The 2019 proposed Medicare Fee Pre-Recorded Patient Information emergencies and referrals. Schedule was published on July 27, (HCPCS Code GRAS1) 2018 by CMS and can be found at 3. Interprofessional Internet Telemedicine Technologies https://s3.amazonaws.com/public-inspec Consultation (CPT Codes 994x6, 994x0, The appropriate telemedicine tion.federalregister.gov/2018-14985.pdf, 99446, 99447, 99448 and 99449) technologies are defined as electronic as well as the CMS website. The Executive Summary goes into information and telecommunication Pages 61 through 91 of the great detail regarding the explanation of technologies including but not limited to Executive Summary are devoted to: these types of services, and explaining interactive audio and video, remote Modernizing Medicare Physician in the blog post would occupy too much patient monitoring or store and forward Payment by Recognizing space, but you can refer directly to the systems that meet the requirements of Communication Technology-Based link to the executive summary. HIPAA. Healthcare providers may utilize Services. (To view the pdf document On page 74 of the summary, CMS interactive audio without interactive online, the link is http://bit.ly/CMS1693p) provides an additional list of services video if used in conjunction with store This subsection is devoted to they propose to expand under Section and forward technology and the provider explaining both additions to the existing 1834(m) of the Social Security Act. You makes a determination that the same list of covered Medicare Telehealth should refer to the Executive Summary standard of care can be provided, but Services and an identification of and an for that as well. the provider must inform the patient that explanation for covering those additional IV. Conclusion the patient has an option to request services by Medicare. The links identified above can be interactive audio and video. CMS is careful to distinguish its accessed on the ACMS website at Allowable technologies do not process for simply adding services to the http://bit.ly/CMS1693p. include audio only medium, voicemail, existing list of covered Medicare fax, email, instant messaging or text Telehealth Services and the addition of Mr. Cassidy is a shareholder at messaging or online questionnaires--or new types of services outside of the Tucker Arensberg and is chair of the any combination thereof. That raises the existing telehealth structure. CMS firm’s Healthcare Practice Group; he issue of how the Board of Medicine believes that simply adding services to also serves as legal counsel to ACMS. would react to a physician performing the existing list of Medicare telehealth He can be reached at (412) 594-5515 or those acts, since it is defined as “not services would require those additional [email protected]. being telemedicine”. I presume that services to be subject to the limitations would be seen as practicing medicine in on Medicare telehealth services as

342 www.acms.org NORCAL GROUP OF COMPA N IES

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© 2016 NORCAL Mutual InsurancceCe Comppany nm5001 MateriaPerspective Medica Eculizumab: A New Treatment Option For Myasthenia Gravis

LISA YAMAGISHI, PHARMD AND KAREN M. FANCHER, PHARMD, BCOP Myasthenia gravis (MG) is a rare due the rapidly aging population.3 therapy may be added. Corticosteroids autoimmune disease. The hallmark of The diagnosis of MG is confirmed by such as prednisone or prednisolone may the disease is skeletal muscle weakness the combination of relevant symptoms be used, with clinical response beginning that worsens after periods of repetitive and a positive test for autoantibodies within days. However, evidence from exercise and improves after periods of against acetylcholine receptors or randomized clinical trials is limited and rest.1,2 MG is the result of an error in the muscle-specific kinase.1 long-term adverse effects pose transmission of nerve impulses to significant challenges.4 Azathioprine may muscles. In healthy individuals, the Recommended Treatment be added as an adjunct in order to neurotransmitter acetylcholine is The goal of MG treatment is a full or decrease the amount of corticosteroid released from nerve endings and binds nearly full pharmacologic remission, required.1 to acetylcholine receptors on skeletal which is defined as the absence of signs If symptoms still persist, other muscle, which ultimately results in or symptoms for two years while immunosuppressant agents such as muscle contraction. In patients with MG, receiving stable doses of medications.1,4 mycophenolate mofetil, intravenous antibodies block, alter or destroy Unfortunately, there is significant immunoglobulin, methotrexate, acetylcholine receptors at the variation in the treatment of MG, in part cyclosporine or tacrolimus may be neuromuscular junction, preventing because large randomized controlled considered.7 In recent years, the muscle contraction.2 The thymus gland trials are lacking in such a rare disease. monoclonal antibody rituximab has been also plays a role in MG, perhaps Further, the general application of utilized for refractory cases, but there is instructing the body to produce available trials is limited, given the no consensus on the efficacy or acetylcholine receptor antibodies, heterogenous nature of the disease.5,6 appropriate use of this agent in MG at although its exact function is not fully For relief of symptoms, initial this time.1,7 understood.1,2 treatment choices should include In severely symptomatic patients The degree of muscle acetylcholinesterase inhibitors to slow with who require rapid-acting treatment, weakness varies widely among patients the breakdown of acetylcholine at the plasma exchange may be warranted. with MG, ranging from a localized form neuromuscular junction. Currently, the Plasma exchange removes pathogenic that is limited to the eye muscles to a synthetic acetylcholinesterase inhibitor autoantibodies and cytokines, with severe or generalized form that inhibits pyridostigmine is the preferred agent.7 clinical improvement observed by the respiratory function.2 Up to 90% of Pyridostigmine can be used long-term, third treatment. Such a rapid onset patients will develop generalized as its effectiveness does not diminish allows the initiation of other more weakness, typically within the first three over time.4 Patients may also be intensive immunotherapies. However, years of diagnosis.3 considered for a total thymectomy, as this treatment method is not readily MG occurs in all racial and several studies have shown a significant available and requires the placement of ethnic groups and most commonly reduction in symptoms and decreased a central venous catheter.4 affects women under age 40 and men use of additional medications in patients A summary of the agents most over age 60.2 The worldwide prevalence who undergo this procedure.1 commonly used in the treatment of MG is estimated at 700,000 persons, but this If pyridostigmine and/or thymectomy is provided in Table 1. rate is expected to increase over time is not successful, immunosuppressive Continued on page 346

344 www.acms.org 2018 ACMS Bulllletin Photo Contest

Please note instructions below for participating in the 2018 ACMS Bulllletin Photo Contest: 1. Email your VERTICAL jpg photos with a resolution of 300 dpi or higher to [email protected]. Photos should be 8”W x 10”H. 2. You must be an ACMS member physician to submit photos. 3. Include the name of the photo as well as your name, specialty, address and phone number in the email. to be entered in the contest. a) Horizontal photos will not be considered. b) Photos with low resolution will not be considered. relatives will not be considered. 5. The deadline for submission is Friday, October 5, 2018. After this date, a group of individuals selected by the ACMS Board of Directors and ACMS Editorial Board will vote on the top 12 photos. 6. Winners will be announced on the ACMS website, in the Bulllletin and via email. The 1st-place winner’s photo will appear on the January 2019 cover; the remaining winning photos will appear on Bulllletin covers throughout the year. 9. Please continue to check the ACMS website and future issues of the Bulllletin for further updates and reminders. 10.If you have any questions, please call (412) 321-5030

ACMS Bulletin / September 2018 345 MateriaPerspective Medica

From page 344 –––––––––––––––––––

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346 www.acms.org MateriaPerspective Medica

Treatment-Refractory MG New Drug Therapy: the formation and deposition of the The majority of patients with MG Eculizumab (Soliris®) membrane attack complex (MAC) achieve disease control with standard Eculizumab (Soliris®) is a C5b-9 at the neuromuscular junction.9 therapies. However, approximately recombinant humanized monoclonal Eculizumab is the first drug 10-15% of patients have IgG2/4κ antibody produced by murine approved by the Food and Drug treatment-refractory disease.8 The 2016 myeloma which has been Administration (FDA) to treat patients Myasthenia Gravis Foundation of previously been approved to treat with generalized myasthenia gravis America Task Force consensus paroxysmal nocturnal hemoglobinuria (gMG) in over 60 years.11 It is a guidelines define refractory MG as and atypical hemolytic uremic first-in-class targeted complement unchanged or worse functional status syndrome.9 Acetylcholine receptor inhibitor and also the first and only after treatment with corticosteroids and autoantibodies found in patients with treatment to be approved for adults at least two other immunosuppressive MG cause complement activations that with anti-acetylcholine receptor (AChR) agents, used in adequate doses for an cause injury to post-synaptic antibody positive generalized adequate duration, with persistence of membranes in the neuromuscular myasthenia gravis (gMG) or refractory symptoms or side effects that limit usual junction.10 While its exact mechanism gMG. activities.3,7 In these patients, more is unknown, it is thought that aggressive treatment is warranted to eculizumab binds to the complement The REGAIN Trial preserve quality of life and prevent protein C5, which prevents its cleavage The FDA approved eculizumab for life-threatening complications.8 to C5a and C5b; this, in turn, reduces Continued on page 348

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ACMS Bulletin / September 2018 347 MateriaPerspective Medica

From page 347 ––––––––––––––––––– gMG after a 26-week phase 3 clinical trial called REGAIN.11 (MG-ADL) scores, an assessment tool that provide a score on This study was a randomized, double-blind, MG disease severity, before and after treatment.8,12 placebo-controlled, multicenter study that tested the safety The REGAIN study did not find a significant difference in and efficacy of the drug in refractory gMG patients who MG-ADL scores between the treatment and placebo group tested positive for anti-acetylcholine receptor antibodies.8 when measured by the worst-rank analysis (rank-based Study participants were considered were considered to be treatment difference -11.7, 95% CI 24.3 to 0.96; p = 0.0698).8 refractory based on inadequate symptom control with Alexion Pharmaceuticals, Inc. attributed the non-significant previous treatment of at least two immunosuppressive findings to using worst-rank as the analysis tool.13 However, therapies, one immunosuppressive therapy and chronic mean scores for the treatment group did show improvement intravenous immunoglobulin, or plasma exchange for 12 when compared to placebo for MG-ADL scale, the months.8 Quantitative Myasthenia Gravis (QMG) scale, the One hundred and twenty-five patients were equally given Myasthenia Gravis Composite (MGC) scale, and the 15-item either the investigational drug or placebo during the trial. Myasthenia Gravis Quality of Life (MG-QOL15) Patients received 900 mg of eculizumab or placebo weekly for questionnaire.8 Recent secondary analyses have found that 4 weeks, followed by 1200 mg of eculizumab or placebo one the differences in MGC score and MG-QOL15 scores were week later, then 1200 mg of eculizumab or placebo every two statistically significant.13 The improvements appeared during weeks thereafter. The primary objective compared the the first four weeks of treatment and lasted for the six difference in Myasthenia Gravis-Activities of Daily Living months of the study.14 The treatment group was also found to have less MG exacerbations, required less rescue therapy, and required less hospitalizations compared to the placebo group.8 Common adverse reactions found noted in the REGAIN trial were musculoskeletal and abdominal pain, diarrhea, arthralgia, upper respiratory tract infection, and nausea.8 Most adverse events were mild to moderate in severity and consistent with the known safety profile of eculizumab. MG exacerbations were reported by 10% of patients in the eculizumab group and 24% in the placebo group, but there were no patient deaths during the study period.8

Prescribing Eculizumab Eculizumab carries a Black Box Warning for potential life-threatening meningococcal . According to the manufacturer, eculizumab is associated with an approximate 2,000-fold increased risk of meningococcal disease in comparison to the general U.S. population annual rate. Consequently, the manufacturer recommends that patients are immunized with meningococcal vaccines according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations at least two weeks prior to the initiation of eculizumab. Patients are also more susceptible to other infections, especially those who are immunocompromised or neutropenic; thus, all patients should also be vaccinated to prevent Streptococcus pneumoniae and

348 www.acms.org MateriaPerspective Medica

Haemophilus influenza type b (Hib) corticosteroids and at least two other advance in the treatment of anti-AChR infections as well.9 immunosuppressive agents.7 These antibody-positive adults with gMG or Prescribers of eculizumab must patients experience functional refractory gMG. While studies have enroll in the Risk Evaluation and limitations and may have not yet determined duration of Mitigation Strategy (REMS) program exacerbations, some of which lead to treatment, cost effectiveness, or prior to prescribing to ensure that hospitalizations.8 The REGAIN trial long-term efficacy and tolerability, it patients are properly immunized with revealed that eculizumab may provide provides a new treatment option for meningococcal vaccines before the potential benefit for refractory gMG patients that may have failed all initiation of therapy, provided REMS patients who test positive for previous therapies.14 education materials, and counseled anti-AChR antibodies and have about these risks.9 symptoms that are difficult to control. Dr. Yamagishi is a clinical Although the most Myasthenia Gravis pharmacist at Delta Care Rx. Dr. Place in Therapy Foundation of America treatment Fancher is an assistant professor of Recent research has focused on guidelines were updated prior to the pharmacy practice at Duquesne new targets for patients with MG that approval of eculizumab, its use has University School of Pharmacy, and also are refractory to therapies already been included in the German serves as a clinical pharmacy specialist recommended by the Myasthenia Neurological Society guideline for in oncology at the University of Gravis Foundation of America. These patients with refractory gMG with Pittsburgh Medical Center at Passavant patients have not achieved severe symptoms.5,15 Hospital. Dr. Fancher can be reached at symptomatic relief after treatment with The approval of eculizumab is an [email protected] or (412) 396-5485.

REFERENCES 2018;1412(1):5-13. lizumab-treatment-patients-generalized- 1. Gilhus NE. Myasthenia gravis. N Engl J 7. Sanders DB, Wolfe GI, Benatar M, et myasthenia. Accessed July 19, 2018. Med. 2016;375(26):2570-2581. al. International consensus guidance for 12. Myasthenia Gravis Foundation of 2. Myasthenia Gravis Fact Sheet. management of myasthenia gravis: Executive America. Available at National Institute of Neurological Disorders summary. Neurology. 2016;87(4):419-425. http://myasthenia.org/HealthProfessionals/Ed and Stroke. Available at 8. Howard JF, Jr., Utsugisawa K, Benatar ucationalMaterials.aspx. Accessed July 19, https://www.ninds.nih.gov/Disorders/Patient- M, et al. Safety and efficacy of eculizumab in 2018. Caregiver-Education/Fact-Sheets/Myasthe- anti-acetylcholine receptor antibody-positive 13. New Data from Phase 3 REGAIN nia-Gravis-Fact-Sheet. Accessed July 19, refractory generalised myasthenia gravis Study of Eculizumab (Soliris®) in Patients 2018. (REGAIN): a phase 3, randomised, double- with Refractory Generalized Myasthenia 3. Hehir MK, Silvestri NJ. Generalized blind, placebo-controlled, multicentre study. Gravis (gMG) Presented at ICNMD Annual myasthenia gravis: classification, clinical Lancet Neurol. 2017;16(12):976-986. Congress. Alexion. Available at presentation, natural history, and epidemiol- 9. Soliris [prescribing information]. New http://news.alexionpharma.com/press-re- ogy. Neurol Clin. 2018;36(2):253-260. Haven, CT: Alexion Pharmaceuticals, Inc., lease/product-news/new-data-phase-3-re- 4. Farmakidis C, Pasnoor M, Dimachkie 2018. gain-study-eculizumab-soliris-patients-refrac- MM, Barohn RJ. Treatment of myasthenia 10. Howard JF, Jr. Myasthenia gravis: the tory-gene. Accessed July 19, 2018. gravis. Neurol Clin. 2018;36(2):311-337. role of complement at the neuromuscular 14. Gilhus NE. Eculizumab: a treatment 5. Sanders DB, Wolfe GI, Narayanas- junction. Ann N Y Acad Sci. option for mysthenia gravis? Lancet Neurol. wami P, et al. Developing treatment guide- 2018;1412(1):113-128. 2017;16(12):947-948. lines for myasthenia gravis. Ann N Y Acad 11. FDA Approves Soliris® (Eculizumab) 15. Melzer N, Ruck T, Fuhr P, et al. Sci. 2018;1412(1):95-101. for the Treatment of Patients with General- Clinical features, pathogenesis, and treat- 6. Benatar M, Howard JF, Jr., Barohn R, ized Myasthenia Gravis (gMG). Alexion. ment of myasthenia gravis: a supplement to Wolfe GI, Cutter G. Learning from the past: Available at the Guidelines of the German Neurological reflections on recently completed myasthenia http://news.alexionpharma.com/press-re- Society. J Neurol. 2016;263(8):1473-1494. gravis trials. Ann N Y Acad Sci. lease/product-news/fda-approves-soliris-ecu-

ACMS Bulletin / September 2018 349 CommunityPerspective Notes

Fine Foundation, Jewish Healthcare Foundation Announce Winners of 10th Anniversary Fine Awards for Teamwork Excellence in Health Care

The Fine Foundation and the healthcare teams that had previously exploring these concepts and partnering Jewish Healthcare Foundation (JHF) received Fine Award recognition. Based with Fine Award-winning teams that announced winners of the 2018 Fine on what they learned, the Patient Safety display them, the Patient Safety Fellows Awards for Teamwork Excellence in Fellows then voted for the healthcare understand what helps or hinders Health Care. This year’s Fine Awards, organizations that demonstrated the long-term quality improvement. They’re which mark the 10th anniversary of the strongest commitment to continuous poised to serve as leaders within our program, recognize and reward excellence in safety, quality, efficiency, health institutions and practices, and to healthcare organizations that have and innovation. be skilled champions of quality and proven to be wired for excellence by Health implementation science safety.” developing, sustaining, and spreading considers the broader context in which The 2018 Fine Award winners were quality improvement initiatives. quality improvement takes place, recognized during a ceremony on The 2018 Fine Award winners are examining factors such as policies and August 27 from 5-6 PM at the QI2T (award amount in parentheses): incentives; organizational culture and Center (Centre City Tower, Suite 2600, • UPMC Palliative Care Institute structure; individual values and beliefs; Pittsburgh PA 15222). ($15,000 award) and the planning, execution, and • St. Clair Hospital ($10,000) evaluation of projects. Joel Stevans, About the Jewish Healthcare • VA Pittsburgh Healthcare System PhD, DC, a senior implementation Foundation - The Jewish Healthcare ($10,000) scientist at the University of Pittsburgh Foundation (JHF) and its three operating • Prevention Point Pittsburgh Health Policy Institute, instructed and arms—the Pittsburgh Regional Health ($7,500) guided the Patient Safety Fellows Initiative (PRHI), Health Careers Futures • The Open Door, Inc. ($7,500) through their journey. (HCF), and the Women's Health Activist • Community LIFE ($5,000) “We are proud of the teams’ Movement Global (WHAMglobal)— • Jewish Family and Community commitment not only to implement develop and manage programs, Services ($5,000) unique solutions to improve patient care research, training, and grantmaking to Since 2008, JHF has partnered with but to find systematic ways to perfect patient care. JHF is also the The Fine Foundation to celebrate teams disseminate and spread this important fiscal agent for State HIV/AIDS funding that demonstrate exceptional work to other health care partners,” said in southwestern Pennsylvania. performance around patient safety and Milton Fine, chair of The Fine quality improvement within and beyond Foundation. About The Fine Foundation - The their organizations. In 2018, the Fine “During this year’s Patient Safety Fine Foundation is a Pittsburgh-based Award winners were selected by the 34 Fellowship, we had the unique family foundation established in 2007 multidisciplinary healthcare graduate opportunity to marry Perfecting Patient by Milton and Sheila Fine. The students and professionals who CareSM, —our methodology to improve foundation is interested in projects that participated in JHF’s Patient Safety healthcare quality, safety, and have an impact in arts and culture, Fellowship. This summer, the Patient efficiency—with exciting new constructs science and medicine, and/or the Safety Fellows delved into the emerging from the world of health implementation enrichment of the Pittsburgh region. In field of health implementation science, science,” said JHF President and CEO 2008, The Fine Foundation established and then interviewed and analyzed Karen Wolk Feinstein, PhD. “By the Fine Awards.

350 www.acms.org CommunityPerspective Notes Healthcare Council’s Annual Fall Member Conference

Shape the Future of Policy and Medicine is the theme of Healthcare Council’s Fall Member Conference. The Conference will be held on September 28, 2018 at the Pittsburgh Marriott North in Cranberry Township, Pennsylvania. The keynote speaker for this year’s Conference is healthcare futurist Kent Bottles, MD. He will provide a practical tool box for healthcare leaders to deal with uncertainty, confusion and chaos. He will also discuss some of the causes of this uncertainty and will articulate creative and effective ways to deal with uncertainty. Jon Delano, the Money & Politics Editor for KDKA-Television, will open the Conference with a presentation and a discussion on Campaign 2018: Why Pennsylvania Could Make the Difference. He will entertain questions and discussion from participants and will provide an up-to-the minute view of the November elections. Healthcare Council’s President, A.J. Harper, will also provide remarks at the Conference. Members will also have the opportunity to network with sponsors. For more information, visit http://hcwp.org

5 This statement applies equally to the well-known issue of Correction shortages of some commonly used and essential drugs that, not by In the August issue of the ACMS Bulletin, Dr. Bruce coincidence, are usually not profit-makers for the manufacturers. See Wilder's article “Pharmaceutical Pricing in the United States Thomas K, Emergency Rooms Run Out of Vital Drugs, and Patients of America: Disease or Symptom” (page 302) did not include Are Feeling It, New York Times, 7/1/18, his footnotes in the print issue. Please visit www.acms.org or https://www.nytimes.com/2018/07/01/health/emergency-rooms-run- http://bit.ly/2O6ohlW for complete article with footnotes. The out-of-vital-drugs-and-patients-are-feeling-it.html (access 7/16/18). 6 Hiltzik M, Pfizer, pocketing a bug tax cut from Trump, will end footnotes are also listed below: investment in Alzheimer's and Parkinson's research, Los Angeles Times, 1/8/18, http://www.latimes.com/business/hiltzik/la-fi-hiltzik- 1 Rosenthal E, Why Competition Won't Bring Down Drug Prices, pfizer-20180108-story.html (access 7/16/18). New York Times, 6/21/18, https://www.nytimes.com/2018/06/21/opin- 7 Perrone M, and Colvin J, Trump's plan to reduce drug prices ion/competition-drug-prices.html (access 7/16/18). doesn't include campaign pledge to allow Medicare to negotiate 2 Vokinger K, et al, Strategies That Delay Market Entry of Generic prices, Chicago Tribune, 5/11/18, http://www.chicagotribune.com/busi- Drugs, JAMA Intern Med 2017;177(11):1665-1669, https://jamanet- ness/ct-trump-drug-prices-plan-20180511-story.html (access 7/16/18). work.com/journals/jamainternalmedicine/fullarticle/2653452 (access 8 Gaffney A, et al, Healing an ailing pharmaceutical system: 7/16/18). prescription for reform for United States and Canada, BMJ 3 Ablavsky G, and Oullette L, Selling Patents to Indian Tribes to 2018;361:k1039, https://www.bmj.com/content/361/bmj.k1039.long Delay the Market Entry of Generic Drugs, JAMA Int Med 2018;E1, (access 7/16/18); http://www.pnhp.org/pharma (access 7/16/18). https://www-cdn.law.stanford.edu/wp-content/uploads/2018/01/jamain- 9 Lessig L, Republic, Lost, Twelve, New York-Boston, p. 17. ternal_Ablavsky_2018_vp_170035.pdf (access 7/16/18). 10 Braillton A, Euthanizing a terminally ill system that does not 4 Krellenstein J, et al, Greed Allows an Epidemic to Persist, New want to die!, BMJ 2018;361:k1039, York Times, 7/17/18, https://www.bmj.com/content/361/bmj.k1039/rapid-responses (access https://www.nytimes.com/2018/07/16/opinion/prep-hiv-aids-drug.html 7/16/18). (access 7/17/18). Retiring?N$&060HPEHUV ew Partner? New Address? Congratulatory Professional announcement advertisements message? are available to ACMS members at our lowest prices. ContactContact MACMSeagan at Sab (412)321-5030le, managing ed ori toremail, at [email protected]@acms.org.

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352 www.acms.org Special Report

For advertising information, call (412) 321-5030, email [email protected]. ALLEGHENY COUNTY MEDICAL SOCIETY www.acms.org

ACMS Bulletin / September 2018 353 SocietyPerspective News Pittsburgh Ophthalmology Society Welcomes Shakeel R. Shareef, MD, in October

The October 4 meeting of the Pittsburgh Ophthalmology Society (POS) features guest speaker Shakeel R. Shareef, MD, Professor, Department of Ophthalmology, University of Dr. Shakeel R. Rochester Medical Center, Rochester, NY. Shareef Dr. Shareef is a specialist who treats glaucoma and offers patients the most up-to-date diagnosis and treatment options including medication and laser therapy as well as complex surgeries using topical anesthesia such as Pittsburgh Ophthalmology filtering procedures, tube-shunt implants and minimally invasive glaucoma Society September 6 Meeting - surgeries such as the iStent. The Society would like to thank Ian Conner, MD, PhD Guest speaker, Steven G. for inviting Dr. Shareef and Alcon, who is sponsoring the meeting. Safran, MD (center) pictured Members are reminded that registration begins at 4:00 pm with the first lecture with (left to right) Deepinder beginning at 4:30 pm. Andrew Williams, MD, will present a Resident case Dhaliwal, MD (who invited Dr. presentation at 5:35 pm. The POS business meeting begins at 5:50 pm, followed Safran) and Sharon Taylor, MD, by a social. Dinner and the 2nd lecture will commence at 7:05 pm. Registration is President of the Society. required. Please visit www.pghoph.org on or before the September 30th deadline. Fit With A Physician The Venture Outdoors Again program provides outdoor experiences to individuals ages 50 and older who would like to become more active. Join Venture Outdoors and a local medical professional for an easy-paced walk that gets our bodies moving and stimulates our minds. Easy discussion and helpful tips are shared along the way. For more information or to register for an upcoming program, please visit the Venture Outdoors website: Ventureoutdoors.org or call 412-255-0564. Upcoming Dates: October 10 – North Park October 27 – Frick Park November 7 – Schenley Park December 12 – Allegheny Commons Alliance News

Mark Your Calendar! December 2, 2018 ACMS Alliance Holiday Party Edgewood Country Club

354 www.acms.org We’’re MoMoving!

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