C M S Bulletin2019/07/17 · a prestigious medical school. “Choles-terol intake has nothing to do with se-rum cholesterol, which is endogenously produced. In fact, eating cholesterol

Allegheny County MediCAl SoCiety

BulletinJuly 2017

Need to know: POLST

ACMS Foundationawards grants

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.

BulletinJuly 2017 / Vol. 107 No. 7


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 .................... 256Immune checkpoint inhibitors: A revolution in cancer treatmentKaren M. Fancher, PharmD, BCOP

Legal Report ....................... 262CSI: Your office – What to do when you get a subpoena, CID, or search warrantWilliam H. Maruca, Esq.

Materia Medica .................... 265Lixisenatide (Adlyxin®)Gina Ayers, PharmD Sydney P. Springer, PharmD, BCPS

Special Report .................... 268Need to know: POLSTRick Hoffmaster, MD

Special Report .................... 270ACMS Foundation awards grants to community organizations

Editorial ............................... 246Follow the moneyDeval (Reshma) Paranjpe, MD, FACS

Editorial ............................... 248What will you get for your nickel?Gregory B. Patrick, MD, FACP, FCCP

Society News ...................... 250• ACP, ACMS plan MOC program• Pittsburgh Ophthalmology Society• Pennsylvania Geriatrics Society – Western Division

ACMS Alliance News ......... 253

Activities & Accolades .. . ... 254

In Memoriam ....................... 254• Leonard A. Stept, MD

Classifieds .......................... 267

On the coverCarrick-a-Rede Bridge, Northern IrelandMichelle Kirshen, MDDr. Kirshen specializes in diagnostic radiology.

ACMS ALLIANCEPresident

Kathleen ReshmiFirst Vice President

Patty BarnettSecond Vice President

Joyce Orr Recording Secretary

Justina Purpura Corresponding Secretary

Doris DelseroneTreasurer

Josephine MartinezAssistant Treasurer

Sandra Da Costa

2017 Executive Committee

and Board of Directors

PresidentDavid J. DeitrickPresident-electRobert C. CiccoVice President

Adele L. TowersSecretary

William K. JohnjulioTreasurer

Patricia L. BononiBoard Chair

Lawrence R. John

DIRECTORS 2017

Peter G. EllisTodd M. HertzbergBarbara A. KevishDavid A. LoganJan W. Madison

Matthew B. StrakaAngela M. Stupi

2018David L. Blinn

William F. Coppula Kevin O. Garrett

Raymond E. Pontzer John P. Williams

2019Thomas P. Campbell Michael B. Gaffney

Keith T. Kanel Jason L. Lamb

Maria J. Sunseri

PEER REVIEW BOARD2017

Donald B. MiddletonRalph Schmeltz

2018 Sharon L. Goldstein Bruce A. MacLeod

2019Robert W. Bragdon

John A. Straka

PAMED DISTRICT TRUSTEEAmelia A. Paré

COMMITTEESAwards

Donald B. MiddletonBylaws

Adele L. TowersFinance

David J. DeitrickGala

Patricia L. BononiAdele L. Towers

Nominating Matthew B. Straka

Primary CareLawrence R. John

COPYRIGHT 2017:ALLEGHENY COUNTY MEDICAL SOCIETYPOSTMASTER—Send address changes to: Bulletin of the Allegheny County Medical Society, 713 Ridge Avenue, Pittsburgh, PA 15212.

ADMINISTRATIVE STAFFExecutive Director

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Membership Relations ManagerNadine M. Popovich

([email protected])

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 County Medical Society at above address.

The Bulletin of the Allegheny County Medical Society welcomes contributions from readers, physicians, medical students, members of allied professions, spouses, etc. Items may be letters, informal clinical reports, editorials, or articles. Contributions are received with the understanding that they are not under simultaneous consideration by another publication.

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The opinions expressed in the Editorials and other opinion pieces are those of the writer and do not necessarily reflect the official policy of the Allegheny County Medical Society, the institution with which the author is affiliated, or the opinion of the Editorial Board. Advertisements do not imply spon-sorship by or endorsement of the ACMS, except where noted.Publisher reserves the right to exclude any advertisement which in its opinion does not conform to the standards of the publication. The acceptance of advertising in this publication in no way constitutes approval or endorse-ment of products or services by the Allegheny County Medical Society of any company or its products.

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ISSN: 0098-3772Leadership and Advocacy for Patients and Physicians

Affiliated with Pennsylvania Medical Society and American Medical Association

www.acms.org

Bulletin Medical Editor

Deval (Reshma) Paranjpe([email protected])

Associate EditorsCharles Horton

([email protected])Robert H. Howland

([email protected]) John Kokales

[email protected] Miller

([email protected])Amelia A. Paré

([email protected])Gregory B. Patrick

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Editorial

246 www.acms.org

Follow the moneyDeval (Reshma) PaRanjPe, mD, FaCsMedical editor

When I was a first-year medical student, I went to visit my uncles

abroad. One was a businessman who ate two eggs for breakfast daily, and he asked what he should do to be more healthy. I suggested that he limit his cholesterol intake, as we were taught it was associated with heart disease. This brought on a tongue-lashing of epic proportions from my other uncle, who happened to be chairman of the department of medical biochemistry at a prestigious medical school. “Choles-terol intake has nothing to do with se-rum cholesterol, which is endogenously produced. In fact, eating cholesterol will actually suppress endogenous cholesterol production. Trust me – I’m a biochemist – I know. One of these days, all your fancy American teach-ings will be proven wrong and you will think of me and realize that I was right. There’s nothing wrong with eating eggs for breakfast every day.”

Twenty years later, both uncles have passed away, and I read the papers as my uncle the biochemistry professor is being proven right in many of his beliefs. A Journal of the American Medical Asso-ciation (JAMA) article last year revealed secret documents essentially showing decades of corruption in the public health sector caused by the undue influence of industry; this was further

publicized by the New York Times.The year was 1967. The sugar

industry trade group pays leading Harvard researchers the equivalent of $50,000 to publish a review article in the New England Journal of Medicine (NEJM) – with articles cherry-picked by sugar industry lobbyists – implicating fat rather than sugar in cardiovascular disease. This shifts popular medical opinion, as earlier studies were starting to link high sugar consumption with heart disease. One of the scientists becomes the U.S. Department of Agriculture’s head of nutrition and goes on to craft dietary guidelines in the 1970s. Another becomes chairman of Harvard’s Department of Nutrition, another position of high influence. The result? Fat – especially saturated fat intake – is villainized, and the role of sugar is minimized. Low-fat, high-sugar diets are officially sanctioned, and the obesity epidemic explodes.

Other recent articles have shown how Coca-Cola paid millions to fund studies aimed at downplaying the risk between sugar and obesity, and how candy makers funded studies to show that kids who ate candy were slimmer than those who didn’t. It also may surprise you that financial disclosures were not required by the NEJM until 1984. Common sense shows that in-

dustry will attempt to advance its profits and please its shareholders through any means and loopholes possible, and through shaping conventional medical wisdom to its own ends.

Why should it surprise us, then, that the opioid crisis was manufactured through a combination of industry greed, blind physician adherence to the medical teaching du jour, and the tendency of human nature to demand immediate gratification?

Mike DeWine, attorney general of the opioid crisis-riddled state of Ohio, recently filed a lawsuit against opioid manufacturers alleging exactly that – that aggressive marketing campaigns downplayed risks and touted benefits, and worse yet lobbied physicians to influence their opinions about opioid safety. He also might add that this lobbying effect indirectly extended to medical schools, which turned out suc-cessive classes of fledgling physicians indoctrinated to regard pain as the “fifth vital sign” and to treat it aggressively with opioids.

We are all guardians of public health and welfare, no matter how small our sphere of influence.

Editorial

247ACMS Bulletin / July 2017

The idea of pain as the fifth vital sign – a vital sign that needed to be treated – sounded ridiculous when introduced to my medical school class. Of course, pain was important in diag-nosis and management and needed to be treated. But pain pointed to the underlying problem which needed to be medically addressed; pain did not need to be addressed for its own sake. Once you treated the underlying problem, the pain would go away in most cases. If it didn’t, you had to find the reason why and treat it. Just like any other vital sign. You wouldn’t treat sinus tachycardia with a beta blocker for its own sake when the underlying cause was fever. Even if you did treat the vital sign, the underlying cause was the key issue. Any vital sign returning to baseline meant that the patient was getting better.

Opioids intuitively made sense for acute severe pain in the short term, cancer and other chronic pain. But some pain was to be expected, and the ability to feel pain was a necessary evil. Our older surgical attendings drummed into us that we were not to give pain medication to patients with acute appendicitis awaiting surgery; if they couldn’t feel pain, the appendix could silently suddenly burst and kill them. How many times did I apologeti-cally explain this to patients in the ER? Each patient grudgingly accepted this logic – nobody wanted to die. Patients then stopped pressing for the instant

gratification of pain meds and instead yelled, “How long until you get me to the OR? Get this thing out of me!”

What do the sugar industry and opioid manufacturers have in common, and how did they make untold millions while inadvertently causing obesity and addiction epidemics that are crippling our nation? They didn’t just influence public opinion through advertisements to the public – they subverted the medical profession by corrupting those of us in positions of academic influ-ence and power. And they relied on us to indoctrinate our most intellectually vulnerable – medical students and residents – to unknowingly carry out their financial mission.

The rest of us fared no better. To be sure, there are some bad apples who run pill mills. But these do not account for the majority of prescrip-tions. Administrators demanded that pain be treated according to the current vogue, put guidelines in place, and in addition imposed the ridiculous Press-Ganey score metric which essentially penalizes physicians for not acceding to the opioid demands of their patients. How many tired and harried physicians have been tempted to just write for the blasted opioids and shut the patient (or the family) up, in order to put out a fire and not risk a bad review? This is not conducive to good medicine. The road to hell is paved with good intentions … and Press-Ganey questionnaires.

So, what do we do now? Wake up.

Follow the money. Question everything, and treat any teaching, no matter from how hallowed an institution, with the critical eye it deserves. Treat nothing as holy writ, whether it comes from Harvard, the NEJM, the AMA, the Food and Drug Administration, or the government. In addition to the stan-dard evaluation of any study in journal club, look at the overarching financial biases of that study. Go beyond the “no financial interest” statements. Treat it as a murder investigation. Who stands to gain by the conclusion? Challenge things that don’t make sense. Being pain free – or something else – is a quality indicator? According to whom? Why?

We are all guardians of public health and welfare, no matter how small our sphere of influence. What other things are we accepting as holy writ that have been propped up in the same manner as sugar and opioids?

By the way, I eat two eggs for breakfast most days, and think of my uncles as I do.

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

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.


Leadership and Advocacy for Patients and Physicians

248 www.acms.org

Editorial

What will you get for your nickel?

GReGoRy B. PatRiCk, mD, FaCP, FCCPassociate editor

Charles Schulz was a genius. Many years ago, he wrote a Peanuts

comic strip that, in four panels, cogent-ly depicts one of the common issues complicating the practice of medicine.

Charlie Brown is visiting Lucy, his psychiatrist. We can assume from the signage and fees (Psychiatric Help – 5 cents) that she is in solo practice. Nev-ertheless, she is forward thinking: Her hours (The Doctor is IN) and her fees are clearly marked, and she is comfort-able talking with her patients about the cost of care.

Charlie Brown presents his chief complaint: “Can you cure Loneliness?” Lucy is clearly confident in her skills and that her fees will cover the cost of a care. “For a nickel, I can cure any-thing.” Charlie Brown then elaborates on his illness: “Can you cure Deep-Down, Black, Bottom-of-the-Well, No-Hope, End-of-the-World, What’s-the-Use Loneliness?” Lucy is incredulous. “FOR THE SAME NICKEL?!”

Lucy still does not doubt her abilities as a hero. Regardless of whether Loneliness should be medicalized, she never claims that Charlie Brown is incurable. However, as a physician and a businesswoman, she is con-cerned about the cost of care. Her Fee Schedule is not adjusted for severity of illness. Curing Deep-Down Loneliness

will require more effort than curing sim-ple Loneliness. Curing Deep-Down and Black Loneliness will be even harder. Adding Bottom-of-the-Well, No-Hope, End-of-the-World and What’s-the-Use into the mix magnifies the volume and intensity of resources that must be committed to the care of this individual patient. How will these extra costs be recognized and reimbursed?

As a patient, Charlie Brown de-mands that the doctor recognize him as a unique individual. He knows that what he has is greater than conventional Loneliness. He has thought about the details of his chief complaint before coming to see the doctor, and he is able to articulate the specifics of his condition. He comes to Lucy asking that she treat not just Loneliness, but the specific form of Loneliness that troubles him. She told him that she can cure anything for a nickel. Is it fair to charge him more just because his particular Loneliness is Deep-Down, Black, Bottom-of-the-Well, No-Hope, End-of-the-World and What’s-the-Use?

His medical treatment today prob-ably would not be much different. Lucy now may be able to look up best practices, and there may even be algo-rithms for treating Loneliness. Howev-er, guidelines are rarely adjusted for

complexity. She likely will have to treat Charlie Brown as doctors always have treated complex patients – spending time working with the patient and using medical expertise to try to solve the patient’s specific problem.

But getting paid for her efforts would be more complex today. Lucy’s practice likely would be computerized. How she codes her treatment will be important. Are Deep-Down, Black, Bot-tom-of-the-Well, No-Hope, End-of-the-World and What’s-the-Use separate modifiers under a diagnosis of General Loneliness or a separate category? If she charges more than the usual nick-el, her documentation will be intensely scrutinized: “I’m sorry Dr. Van Pelt, we don’t recognize End-of-the-World and What’s-the-Use Loneliness. Your documentation also does not meet our criteria for Bottom-of-the-Well. Your documentation adequately reflects Deep-Down and Black, but it barely covers No-Hope. We will be decreas-ing your payment accordingly.” If Lu-cy’s practice is part of a larger health system, this extra treatment will flag Charlie Brown’s case as a financial outlier. She will be audited internally, and an administrator will ask her to defend her negative patient throughput and resource utilization.

Charlie Brown may find that his

nickel does not cover complex Loneliness. He may be faced with larger co-pays and tiered payments. He may resent this, since he was told directly that: “For a nickel, I can cure anything.” At the same time, he will be asked to give Lucy’s care all “5s” on his patient satisfaction sur-veys.

How to cover the cost of complex care is an issue for individual doctors and patients, not just for society. The last panel of the cartoon reflects the conundrum. Lucy and Charlie Brown, doctor and patient, are looking at each other, each uncertain how much health care will be delivered for that nickel.

Dr. Patrick specializes in pulmonary disease and is associate editor of the ACMS Bulletin. He can be reached at [email protected].

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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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250 www.acms.org

PerspectivePerspectiveSociety News

ACP, ACMS plan MOC programThe Pennsylvania American College

of Physicians (ACP) Chapter, West-ern Region, along with the Allegheny County Medical Society (ACMS), is offering a joint Maintenance of Certifi-cation (MOC) session from 7:30 a.m. to 4 p.m. Saturday, Sept. 9, 2017, at the ACMS building, 713 Ridge Ave., Pittsburgh, Pa., 15212.

Registration information will be emailed. For additional details, con-tact Sharon Fahrer, PA-ACP meeting manager, at [email protected] or (888) 817-3813.

POS 2017-18 monthly meeting dates and speakers announced

Sharon Taylor, MD, president, is pleased to announce the 2017-18 monthly meeting series for the Pitts-burgh Ophthalmology Society (POS). Six meetings are scheduled beginning in September and concluding with the Annual Meeting in March. Mark your calendar for the following:

• Sept. 14 – The meeting sched-ule begins with John C. Hart Jr., MD, FACS. Dr. Hart is a board-certified oph-thalmologist practicing at Associates in Ophthalmology, Farmington Hills, Mich. He also serves as co-chief of Anterior Segment Surgery at William Beaumont Hospital, Royal Oaks, Mich.

• Oct. 5 – Sanjay Asrani, MD, is professor of Ophthalmology at Duke University and director of the Duke Eye Center of Cary and the Duke Glauco-ma OCT Reading Center. Dr. Arsani actively pursues research on pressure fluctuations, new devices and drugs for glaucoma treatment, drug delivery and new imaging modalities for glaucoma.

• Dec. 7 – TBD

• Jan. 11, 2018 – Sunir J. Garg, MD, FACS, is professor of Ophthalmology of The Retina Service of Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania. He is a member of the Retina Society, Macula Society, American Uveitis Society and the American Society of Retina Spe-cialists. His research interest is primar-ily in macular degeneration, diabetic retinopathy, uveitis and vitreoretinal surgery.

• Feb. 1, 2018 – TBD• March 23, 2018 – The 54th Annual

Meeting will be held at the Pittsburgh Marriott City Center, with the Duquesne Club hosting the Annual Banquet Friday evening.

Members will receive registration information one month prior to the date of each scheduled program. Registra-tion will be handled online only. Please visit the POS website, www.pghoph.org, periodically for updates and to register.

POS 54th Annual Meeting slated for March 23, 2018

The 2018 POS Annual Meeting will take place Friday, March 23, 2018, at the Pittsburgh Marriott City Cen-ter, with the Annual Banquet at the Duquesne Club.

The Society is pleased to announce Lisa Arbisser, MD, 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 professor 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. Her residen-cy at the University of Iowa Hospitals and Clinics prepared her to specialize in refractive and complex cataract surgery, both adult and pediatric. She has been on the Best Doctors list nationally multiple times, was voted as one of the top 50 opinion leaders in cataract and refractive sur-gery by the readership of Cataract and Refractive Surgery Today (CRST), and was chosen as one of the 250 lead-ing innovators in the field of premium IOL implant surgery by the editors of Premier Surgeon. She serves on the editorial board of CRST and Eye World and pens a quarterly column for each. She serves on the cataract committee for the AAO Online and Education Network and is the cataract editor for Focal Points. Dr. Arbisser was extend-ed the invitation by President Sharon L. Taylor, MD.

39th Annual Meeting for Ophthalmic Personnel set

The 39th Annual Meeting for Oph-thalmic Personnel, presented by the Pittsburgh Ophthalmology Society, is scheduled for Friday, March 23, 2018, at the Pittsburgh Marriott City Center.

Planning for this well-respected annual program, which is designed for ophthalmic technicians, assistants, technologists, scribes and administra-tive personnel, is currently underway. Course directors Pamela Rath, MD, and Laurie Roba, MD, are identifying clinical topics for presentation. POS members interested in presenting a breakout session are asked to contact

Continued on Page 252

Dr. Arbisser

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252 www.acms.org

Nadine Popovich ([email protected]). Last year, the program attracted more than 160 attendees and course directors look forward to planning an excellent program for 2018.

Complete information, including topics and speaker details, will be available on the Society website at www.pghoph.org.

Controversies in Geriatric Medicine program held

The Pennsylvania Geriatrics Society – Western Division welcomed more than 50 attendees at the 3rd Annual Controversies in Geriatric Medicine program held June 22 at the Herber-man Conference Center. The program was made possible with sponsorship from: Abbott Nutrition, Aging Institute of UPMC Senior Services and the Univer-sity of Pittsburgh, AHN Healthcare@Home, Gilead, Medtronic Inc., navi-health (a Cardinal Health Company), Optum and Sanofi.

“Who Might Benefit from TAVR for Aortic Stenosis?” presented the case of a 91-year-old woman with critical aortic stenosis who is now becoming symp-tomatic. She has mild cognitive and functional impairments and is largely homebound, but enjoys her life and her family and is interested in continuing her present status. The presentation focused on whether she would be a candidate for a transaortic valve replacement (TAVR).

Moderator for the evening was PAGS-WD President Fred Rubin, MD. Leading the panel discussion were Rachel Jantea, MD, geriatric medicine fellow, Division of Geriatric Medicine, University of Pittsburgh, and John

Schindler, MD, FACC, FSCAI, car-diologist, UPMC Heart and Vascular Institute; assistant professor of Medi-cine, University of Pittsburgh School of Medicine.

Dr. Jantea provided an overview of the case and engaged the audience with questions for their consideration during her lecture. She also updated the audience on the outcome and status of the patient. Dr. Schindler’s presentation focused on TAVR and included an overview of the minimally invasive procedure, which repairs the aortic valve in patients with severe aor-tic stenosis. The treatment greatly improves the quality of life for those who suffer from aortic stenosis, which affects as many as 500,000 people in the United States. The condition can interfere with daily activities, such as

walking or climbing stairs. Previously, a patient’s only option was to have open-heart surgery to replace the aor-tic valve, but the procedure often was deemed too risky for elderly patients, who are most prone to the condition. In his comments, Dr. Schindler noted that “open heart surgery is not the ideal option for every patient. TAVR provides an additional aortic valve replacement option for high-risk patients who would benefit from a less-invasive proce-dure.” A lively discussion from panelists and audience members concluded the presentation.

This program is one of a number of educational sessions offered by the Society throughout the year. The next program will be held Nov. 9 at the University Club. Members will receive information once planning is finalized

PerspectivePerspectiveSociety News

From Page 250 From left are Controversies in Geriatric Medicine panelists John Schindler, MD, FACC, and Rachel Jantea, MD; and moderator and PAGS-WD President Fred Rubin, MD.

NadiNe PoPovich / acMS


but may visit the society website for updates: www.pagswd.org. Guests are welcome to attend programs.

Membership is open to all health care professionals interested in im-proving the health and well-being of all

older persons. To inquire about becom-ing a member or additional program details, please contact Nadine Popo-vich at [email protected] or (412) 321-5030 or visit the society website at www.pagswd.org.

PerspectivePerspectiveAlliance News

WHO WE ARE AND WHAT WE DOACMS ALLIANCE

1925 XCII 2017: 92 Years of con-tinuous volunteer community service in partnership with Allegheny County Medical Society.

Join us in membership, on commit-tees and in leadership. We are dedicat-ed to work in, on, and for:

● issues of public health and wel-fare, including disaster relief and other charitable causes;

● legislative attentiveness in protecting medical ethics, science and practice from PAMED and ACMS in the interest of patient and physician;

● fundraising projects benefiting scholarship for medical school ed-ucation, nursing degree and health career programs including science and technology.

Traditional beneficiaries include, but are not limited to: Carnegie Science Center; CCAC; Henry the Hand Foun-dation; Operation Safety Net; Project Bundle-Up; University of Pittsburgh School of Medicine; in addition to AMAA for AMA-ERF; ACMS Foundation; Alliance of PAMED for AMES Fund; shelters for women and children; and disaster relief-direct giving. Selections are made each year by the ACMSA Governing Board.

The Alliance, commencing this

year, may and will direct proceeds from some ACMSA fundraising events to embrace a new mission of ACMS Foundation, in support of home and community environments which nurture and develop healthy children and families for a healthy Allegheny Coun-ty! Call Alliance at (412) 321-5030 for Alliance Membership, Alliance event details and RSVP information.

Benefits include: making a differ-ence in our community; mutual re-spectful exchanges among people and organizations; fellowship; camaraderie; and visibility.

ACMS member physician family members, ladies and gentlemen, are welcome to apply for Alliance Member-ship.

OUTLOOK FOR AUTUMN, WINTER 2017

AUTUMNAL GENERAL MEETING I and LUNCHEON

Date: Sept. 26, 2017 Venue: South Hills Country Club Leadership: Mrs. LeRoy Wible, Dr.

and Mrs. Wm.Hetrick, Mrs. F. Byron Kennedy, Mrs. Eugene Delserone

Committee: Mrs. Robert Bloom, Mrs. Richard Hershey, Dr. and Mrs. Wm. Hetrick, Mrs. F. Byron Kennedy, and Mrs. Eugene Delserone

Conduct Alliance Business and So-cialize among colleagues, family, friends.

*See details and invitation in August Bulletin.

PENNSYLVANIA MEDICAL SOCIETY ALLIANCE

Annual Meeting: Date pending, Hershey Lodge-Convention Center, Hershey, Pa.

ACMSA Representative: Mrs. John Da Costa and ACMSA in support of PAMED ALLIANCE Medical Education Fund (AMES) scholarship.

*Look for summary in December Bulletin

HOLIDAY CHAMPAGNE BRUNCH and GENERAL MEETING II

Date: Dec. 3, 2017 Venue: Edgewood Country ClubLeadership: Mrs. Rose (Dr. Wm.)

Kunkel Roarty, Mrs. Alan Barnett, Mrs. Eugene Delserone

Committee: Mrs. Robert Blume, Mrs. John Da Costa, Mrs. John B. Franklin, Mrs. George Gerneth, Dr. and Mrs. Hetrick, Mrs. Augusto Martinez, Mrs. Samuel Mines, Mrs. Marshall Levy , Mrs. Donald Orr, Mrs. Lawrence Purpura, Mrs. Chandra Reshmi

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PerspectivePerspectiveSociety News For advertising information,

email Bulletin Managing Editor Meagan Sable at

[email protected].

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PerspectivePerspectiveActivities & Accolades

ACMS member inducted into recognition program

Norman Wolmark, MD, an inter-nationally recognized cancer surgeon and medical director of Breast Surgi-cal Oncology, Cancer Research and Clinical Trials at Allegheny Health Network (AHN), has been inducted into the OncLive® 2017 Giants of Cancer Care® recognition program.

Dr. Wolmark is among 12 respect-ed health care professionals honored for advancing the field of oncology by their contributions in research and clinical practice. They represent some of the nation’s and world’s preeminent institutions, including Johns Hopkins Medicine, Yale Cancer Center, The University of Chicago Medicine and Harvard Cancer Center.

All finalists are selected by an elite five-member advisory board of world-renowned oncologists. The

finalists in each category are then voted on by a 90-plus member selection committee comprising the nation’s leading physicians in the field of oncology.

Dr. Wolmark is chairman of the NSABP Foundation and chair and principal investigator of the NCI-funded NRG Oncology. A member of a number of professional associations and organizations includ-ing the American Surgical Association, Dr. Wolmark is widely published, with more than 400 scientific journal articles and book chapters in print. He is a sought-after speaker and lecturer in his field and serves on the editorial board of The Journal of Clinical Oncology, JAMA and Lancet, on numerous advisory boards, and as an adviser to oncology programs, societies and

institutes throughout the United States and abroad.

“Dr. Wolmark is a truly deserving recipient of this distinguished recogni-tion,” said David Parda, MD, chair, Al-legheny Health Network Cancer Institute.

“Clinical trials and research of the biology and treatment of breast and colorectal cancer led by Dr. Wolmark have resulted in practice-changing and groundbreaking advances for all cancer patients. His collaborative work has resulted in significant worldwide improvements in cancer prevention, diagnosis, treatment, survival and qual-ity of life for cancer patients. His work has also resulted in more personalized cancer care based on genomic testing and targeted biologic treatments. He has always kept his focus on improving patient care, and has offered the most compassionate and skilled care as a clinician.”

Dr. Wolmark

PerspectivePerspectiveIn Memoriam

Leonard A. Stept, MD, 80, of Shadyside, died Tuesday, June 6, 2017.

Dr. Stept graduated in medicine from the University of Pittsburgh and completed his residencies and fellow-ship in surgery and urology at Alleghe-ny General Hospital, Western Pennsyl-vania Hospital and New York University Upstate in Syracuse.

He served as a captain in the U.S. Air Force.

Dr. Stept practiced urology for 53 years; he died on what would’ve been his first day of retirement.

He was assistant professor of urology at the University of Pittsburgh School of Medicine. Hospital affiliations included UPMC hospitals St. Margaret, Magee-Womens and Shadyside; as

well as St. Clair. He recently had trav-eled to Zambia, Africa, to treat patients and educate medical professionals.

Surviving are his wife of more than 30 years, Kathy; and numerous nieces, nephews, great-nieces and great-neph-ews.

Services were held Friday, June 9, 2017, in Ralph Schugar Chapel, Inc., Shadyside.

Allegheny County Medical Society: www.acms.org

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Materia Medica

kaRen m. FanCheR, PhaRmD, BCoP

Surgery, radiotherapy and chemo-therapy have been the main treat-

ment modalities for cancer over the last 50 years. Despite significant advances in all three fields, mortality from cancer remains high.1 Recently, an increased understanding of tumor immunology has led to the identification of novel agents that harness the patient’s own immune system.2 This breakthrough treatment strategy has resulted in remarkable success for patients with numerous types of both solid and liquid malignancies.3

Immunotherapy as a cancer treatment

Traditional cytotoxic chemotherapy agents act directly on cells to cause cell death. These agents employ mecha-nisms of actions such as inhibiting cell division, interrupting DNA synthesis and prohibiting DNA replication, which can be effective in reducing or eliminating cancer cells. However, traditional che-motherapy agents are unable to differ-entiate cancer cells from normally divid-ing host cells, causing the well-known adverse effects of myelosuppression, hair loss, gastrointestinal symptoms and loss of fertility, as well as potentially life-threatening toxicities to organs such as the heart, liver or lungs.2

The ability of the immune system to

detect and eliminate cancer was first proposed more than a century ago. Fur-ther studies suggested that tumors may escape detection and destruction by the host immune system by manipulating the tumor microenvironment and stimulating immunosuppression, ultimately prohibit-ing the host from mounting an effective immune response to eradicate the cancer cells.2 Stimulating the immune system to eliminate cancer cells became an area of interest, and vaccinations and other immune-based strategies showed transient responses in some patients. In more recent years, more novel targets have been identified for immunotherapy. The approval of ipilimumab for the treat-ment of metastatic melanoma in 2011 headlined the development of anticancer therapies with immune-mediated mecha-nisms of action.2

Immune checkpoint inhibitorsT cells play a critical role in tumor

immunity. The T cells are part of an intricate equilibrium of stimulatory and inhibitory signaling that occurs between components of the immune system. This system of “checks and balances” is necessary to allow a powerful de-structive response against pathogens and malignant cells, but also to prevent immune responses from being gen-erated against normal host tissues.4 Several critical checkpoints regulate and adjust the immune system in this complex signaling process, either by

“turning on” or “turning off” T cell sig-nals.4 It is postulated that cancer cells exploit these checkpoints to “turn off” T cells and ultimately avoid detection and destruction by the immune system. Drugs known as immune checkpoint inhibitors prevent the “turning off” of T cells by tumors, allowing the T cells to perform their usual functions to discov-er and eradicate abnormal cells.5

The two immune checkpoint path-ways that are best understood are cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and programmed death-1 (PD-1) pathways. Both CTLA-4 and PD-1 binding have similar negative effects on T cell activity. However, the timing and signaling mechanisms of immune inhibition by these two immune checkpoints differ, and may play com-plementary roles in regulating immunity.6

CTLA-4 is a molecule that down-regulates T cell activation. Persistently high levels of CTLA-4 expression result in immune cells that are primed but no longer able to respond. This critical immunity check-point controls both the duration and the intensity of an immune response.7 CTLA-4 is considered the “leader” of checkpoint inhibition since it prohib-its T cell activation at early points of an immune response.7 The resulting blockade of CTLA-4 signaling prolongs T cell activation and restores T cell proliferation, both of which intensify T cell-mediated immunity and augment

Immune checkpoint inhibitors: A revolution in cancer treatment


Materia Medica

the patient’s capacity to mount an an-titumor immune response.6 Ipilimumab is a first-in-class monoclonal antibody targeted against CTLA-4.

PD-1 is another inhibitory recep-tor expressed on T cells, but it has non-overlapping functions from those of CTLA-4.2 The binding of PD-1 to one of its ligands, PD-L1, on the surface of tumors leads to inhibition of T cell proliferation, decreased production of inflammatory cytokines and a blunt-ed antitumor response.2,4 The three monoclonal antibodies that work on this pathway inhibit PD-1:PD-L1 binding and therefore restore antitumor immune responses.2 Clinical studies are investigating whether the level of expression of PD-L1 can serve as a biomarker to identify patients more likely to respond to PD-1 pathway inhibitors.2 However, there currently is not a consensus on this practice since early studies used various staining methods, scoring algorithms and posi-tivity thresholds.1 Thus, the practicality of PD-L1 biomarker testing in clinical practice continues to evolve.

Current indicationsThe currently approved immune

checkpoint inhibitors, their mecha-nisms of action and approval dates are summarized in Table 1 (see page 258). Starting in 2011, approvals have been granted for the treatment of metastatic melanoma, non-small cell lung cancer, head and neck cancer, renal cell carci-noma, urothelial cancer, colon cancer and classical Hodgkin lymphoma. In May 2017, pembrolizumab was grant-ed accelerated approval for patients with any unresectable or metastatic solid tumor that has been identified as microsatellite instability-high (MSI-H)

or mismatch repair deficient (dMMR) who have progressed following prior treatment and who have no satisfactory alternative treatment options.8 Tumors that are MSI-H or dMMR contain abnormalities that prevent the proper repair of damaged intracellular DNA. The approval of pembrolizumab for this indication marks the first time in history that the Food and Drug Administration (FDA) has approved a cancer treatment based on a biomarker instead of the tumor type or location.8,9

Measuring efficacyDuring the development and trials of

immunotherapy agents, investigators noted patterns of response that differ from those of conventional cytotoxic chemotherapy.4 Cytotoxic chemother-apy agents often shrink tumors within days or weeks, but responses to all of the immune checkpoint inhibitors can be delayed for many weeks.2,4,10 Time to response appears to be faster for agents that block PD-1 or PD-L1 compared to those with anti-CTLA-4 activity.4 Further, clinicians should be aware of the possibility of “pseudopro-gression,” a phenomenon in which the tumor transiently increases in size in response to the infiltration of immune cells into the tumor. This increase in size should not be mistaken for treat-ment failure, as a brief increase in size may be followed by shrinkage or even eradication of the tumor.2,10

Consequently, conventional re-sponse criteria may not capture or adequately describe the responses produced by these novel agents.4 The traditional World Health Organization (WHO) response criteria rely heavily on tumor shrinkage and do not account for potential pseudoprogression or other

observed response patterns of the checkpoint inhibitors. Therefore, new response criteria, known as irRC, have been established that are specific to patients receiving these agents.4

Adverse reactionsImmune checkpoint inhibitors

appear to cause less of the “usual” adverse effects associated with cyto-toxic chemotherapy, such as nausea, vomiting, myelosuppression and alopecia. However, since these agents increase immune system function, they are associated with adverse effects that are immunologic in nature.3 Autoimmune adverse reactions occur in approximately 10 percent of patients and typically include rash, colitis and/or chemical hepatitis.10 Disorders of endocrine function, including hyperthy-roidism, hypopituitarism, hypophysitis, thyroiditis and adrenal insufficiency also may occur.2 Immune-mediated adverse effects typically occur four to 12 weeks after initiating treatment but may occur as late as one year after starting therapy.1

These immune-mediated adverse reactions may be unfamiliar to many cli-nicians, but close monitoring and swift action is imperative.2 Most immune-me-diated adverse effects can be managed with prompt initiation of corticosteroids, although endocrine-related events may be permanent.1,11 Steroid-refractory autoimmune reactions may respond to immunosuppressive agents such as infliximab or mycophenolate mofetil, but should only be attempted in close collaboration with organ specialists.1

Given the potential for autoimmune reactions with the immune checkpoint inhibitors, patients with underlying


autoimmune disorders were exclud-ed from the clinical trials of these agents.1,3 The safety of these agents in patients with an underlying auto-immune disorder such as rheumatoid arthritis or systemic lupus erythemato-sus is unknown.3 Therefore, the risk of toxicity should be carefully balanced against the benefits that may be de-rived from these agents.1,3

Future directionsThe introduction of immune check-

point inhibitors into the cancer treat-ment arsenal has provided remarkable

successes in large numbers of pa-tients. Responses have been seen in both solid and liquid tumors, including in cancers that are not traditionally considered to be “immunogenic,” such as lung and bladder cancers. The number of cancer patients who already receive these agents is significant, and is predicted to dramatically increase in the near future.1 The adverse effects of these agents are different than those of traditional cytotoxic chemotherapy, but are usually manageable and reversible if identified early and treated appropri-ately. Further research is necessary to determine these agents’ places in

sequential therapy, the feasibility of their use in combination with traditional chemotherapy, and their appropriate use in patients with underlying auto-immune conditions, but this approach to cancer treatment has indeed been revolutionary.

Dr. Fancher is an assistant profes-sor of pharmacy practice at Duquesne University School of Pharmacy. She also serves as a clinical pharmacy specialist in oncology at the University of Pittsburgh Medical Center at Passa-vant Hospital. She can be reached at [email protected] or (412) 396-5485.

Materia Medica

From Page 257

Table 1. Currently available immune checkpoint inhibitors and approved indications.12-15

Generic Name Approved Indication Approval

DateCTLA-4 Inhibitor

Ipilimumab (Yervoy®)

Unresectable or metastatic melanoma March 2011Adjuvant treatment cutaneous melanoma with involvement of regional lymph nodes after surgical resection October 2015

Unresectable or metastatic melanoma in combination with ipilimumab October 2015

PD-1 Inhibitors

Nivolumab(Opdivo®)

BRAF V600 wild-type unresectable or metastatic melanoma December 2014

BRAF V600 mutation-positive unresectable or metastatic melanoma

December 2014

Metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy March 2015

Unresectable or metastatic melanoma in combination with ipilimumab October 2015

Advanced renal cell carcinoma who have received prior anti-angiogenic therapy

November 2015

Classical Hodgkin lymphoma in adult patients that has relapsed or progressed after autologous stem cell transplantation or 3 or more therapies

May 2016

Recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy

November 2016

Locally advanced or metastatic urothelial carcinoma February 2017


Materia Medica

Pembrolizumab(Keytruda®)

Unresectable or metastatic melanoma September 2014

Metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy

October 2015

Recurrent or metastatic head and neck squamous cell cancer with disease progression on or after platinum-containing chemotherapy

August 2016

First-line treatment of metastatic non-small cell lung cancer whose tumors have high PD-L1 expression October 2016

Adult or pediatric patients with refractory classical Hodgkin lymphoma or who have relapsed after three or more prior lines of therapy

March 2017

In combination with pemetrexed and carboplatin as first-line treatment of metastatic nonsquamous non-small cell lung cancer

May 2017

Locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy May 2017

Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

May 2017

Adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

May 2017

Adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options

May 2017

Atezolizumab(Tecentriq®)

Locally advanced or metastatic urothelial carcinoma have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy

May 2016

Metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy

October 2016

Locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy April 2017


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Materia Medica

From Page 259

References1. Michot JM, Bigenwald C, Champiat S,

et al. Immune-related adverse events with immune checkpoint blockade: a comprehen-sive review. Eur J Cancer. 2016;54:139-148.

2. Kreamer KM. Immune checkpoint blockade: a new paradigm in treating advanced cancer. J Adv Pract Oncol. 2014;5(6):418-431.

3. Postow MA. Managing immune check-point-blocking antibody side effects. Am Soc Clin Oncol Educ Book. 2015:76-83.

4. Shih K, Arkenau HT, Infante JR. Clin-ical impact of checkpoint inhibitors as novel cancer therapies. Drugs. 2014;74(17):1993-2013.

5. Immune checkpoint inhibitors to treat cancer. American Cancer Society. Available at https://www.cancer.org/treatment/treat-

ments-and-side-effects/treatment-types/im-munotherapy/immune-checkpoint-inhibitors.html. Accessed June 7, 2017.

6. Tarhini A, Lo E, Minor DR. Releasing the brake on the immune system: ipilimum-ab in melanoma and other tumors. Cancer Biother Radiopharm. 2010;25(6):601-613.

7. Buchbinder E, Hodi FS. Cytotox-ic T lymphocyte antigen-4 and immune checkpoint blockade. J Clin Invest. 2015;125(9):3377-3383.

8. FDA approves first cancer treatment for any solid tumor with a specific genetic feature. Food and Drug Administration. Available at https://www.fda.gov/newsev-ents/newsroom/pressannouncements/ucm560167.htm. Accessed June 7, 2017.

9. Merck News Release. Available at https://www.keytruda.com/static/pdf/keytru-

da-msi-h-press-release.pdf. Accessed June 7, 2017.

10. Immune checkpoint inhibitors. The JAMA Network. Available at http://jamanet-work.com/journals/jamaoncology/fullarti-cle/2174768. Accessed June 7, 2017.

11. Wolchok JD, Kluger H, Callahan MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013;369(2):122-133.

12. Ipilimumab [package insert]. Princ-eton, NJ: Bristol-Myers Squibb Company, 2017.

13. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company, 2017.

14. Keytruda [package insert]. White-house Station, NJ: Merck & Co., 2017.

15. Tecentriq [package insert]. South San Francisco, CA: Genentech, Inc., 2017.

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Do you and your staff know what to do if you are served with a subpoe-

na? Do you know what a Civil Investi-gative Demand (CID) is? How should you respond if a government investiga-tor appears with a search warrant? As Douglas Adams (of “Hitchhiker’s Guide to the Galaxy” fame) would say, DON’T PANIC. More importantly, contact your attorney right away.

It is important to understand the differences between these investiga-tive tools. A subpoena is a command to either appear to testify in a legal proceeding, to produce documents, or both. A subpoena that requires the production of documents is known as a subpoena duces tecum. In Latin, “subpoena” means “under penalty,” and refusal to comply with a valid subpoena may result in fines or even imprison-ment. A subpoena may be issued by an attorney on behalf of a court, or by the court itself.

Your attorney should be able to determine if the subpoena is valid and enforceable. A subpoena must generally be served personally, i.e., hand-delivered, either to the person named in the subpoena or to anoth-er party at their place of business, although it also may be served via certified mail if the recipient signs a verification. Many subpoenas for patient charts are simply addressed to

the custodian of medical records. Your attorney also should verify that

the subpoena was issued by a court with appropriate jurisdiction. Physi-cians sometimes receive subpoenas from out-of-state courts, which in most cases are not enforceable. Don’t try to determine this on your own – let your attorney make the call.

Grand jury subpoenas may re-quest testimony or documents or both. Unlike a trial jury (“petit jury”), the role of a grand jury is to determine whether there is sufficient evidence (probable cause) to return an indictment, i.e., charge someone with a crime. A grand jury may be investigating a number of unrelated criminal violations at the same time. If you receive a grand jury subpoena, that generally means a criminal investigation is underway. Wit-nesses called to testify before a grand jury may not take attorneys with them into the grand jury room, and grand jury proceedings are subject to strict secrecy rules.

Civil Investigative Demands (CIDs) are similar to civil subpoenas, and may be issued by the Office of Inspector General (OIG) of the Depart-ment of Health and Human Services, the FBI, the U.S. Attorney’s office, and certain other government agencies. They may include interrogatories, which are a list of questions that must

be answered under the penalty of perjury, as well as in-person testimo-ny and/or demands for production of documents.

Search warrants must be ap-proved by a judge or magistrate upon a showing of probable cause, based on a sworn affidavit made by a law enforcement officer attesting that a criminal offense has been committed or is about to take place. The warrant must describe in detail the areas to be searched and the items to be seized. Although you may request that the gov-ernment agents wait until your attorney arrives or is consulted by telephone be-fore beginning the search, they are not obligated to honor that request. (Or as the Grateful Dead famously admitted, “If you’ve got a warrant, I guess you’re going to come in.”) In either event, it is important to advise the agents that the search may include documents or infor-mation protected by the attorney-client privilege, the attorney work product doctrine, the physician-patient privi-lege or other applicable privilege, and flag those documents if possible. You should identify the agent in charge and the agency he or she represents, and get a copy of the warrant and inventory of seized items to transmit to your attor-ney immediately. You cannot obstruct or interfere with the search, but if the agents seize items you believe are

CSI: Your office

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What to do when you get a subpoena, CID, or search warrant


Legal Report

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privileged, you should identify them so that your attorney can file a motion to suppress those documents.

If the search warrant includes computers, you may want to ask the agents if they can copy the hard drives and leave them in your possession so that you can retain the information necessary to operate your practice. Many investigators have the technical capability to image a hard drive on-site, which makes an exact copy of its contents.

When serving a subpoena, CID or warrant, agents may ask you and your staff questions. Although you should be cooperative and professional, you are under no obligation to answer their

inquiries. You may not discourage or forbid your employees from speaking to the agents, but you may advise them that they are not obligated to answer questions if they do not want to do so. Many practices and other organiza-tions will close for business and send patients and non-essential personnel home during a search. It is common but not required for an employer to offer to pay for separate legal repre-sentation of staff who are questioned in a government investigation. It also is common for investigators to visit indi-viduals at their home in the early morn-ing hours or in the evening, in hopes of eliciting unguarded statements. The best approach is to politely decline to

answer questions until your attorney is present and refer the investigators to your attorney.

Document preservation and retention

Once you are aware of a subpoe-na, CID or search warrant, you have certain obligations regarding preserva-tion and retention of documents. Your attorney may recommend a Document Hold Memorandum, which advises all personnel to preserve relevant infor-mation and not to delete any relevant electronic records, even if those records would otherwise be deleted


264 www.acms.org

Legal Report

in accordance with your regular document retention/destruction policy. This includes computer hard drives as well as external storage media such as USB drives, SD cards, cell phones, tablets and other similar devices which may contain evidence that has been requested in the investigation.

HIPAA complianceIf patient information has been requested, what about

HIPAA? There is a specific exception that applies to law enforcement subpoenas and other enforceable, official demands for production of protected health informa-tion (PHI). Under that exception, a covered entity may disclose PHI for a law enforcement purpose to a law enforcement official in compliance with and as limited by the relevant requirements of a court order or court-or-dered warrant, or a subpoena or summons issued by a judicial officer; a grand jury subpoena; or an adminis-trative request, including an administrative subpoena or summons, a civil or an authorized investigative demand, or similar process authorized under law, provided that: the information sought is relevant and material to a le-gitimate law enforcement inquiry; the request is specific and limited in scope to the extent reasonably practica-ble in light of the purpose for which the information is sought; and de-identified information could not reason-ably be used.

Note: Subpoenas issued by an attorney on behalf of a private litigant in connection with discovery for a lawsuit require additional protections before you pro-duce PHI. In general, you must comply if the requestor provides assurances that they have notified the patients whose records were requested; the requestor has sought a protective order; or the patient has signed a valid authorization.

Government investigations of physicians are becom-ing more frequent, but they don’t have to cause pande-monium in your professional practice. Experienced legal counsel can help you respond to these investigations and steer you away from making regrettable mistakes.

Mr. Maruca is a health care partner with the Pitts-burgh office of Fox Rothschild LLP. He can be reached at (412) 394-5575 or [email protected].

From Page 263

Ruby Marcocelli


Materia Medica

Gina ayeRs, PhaRmD syDney P. sPRinGeR, PhaRmD, BCPs

Lixisenatide (Adlyxin®) is FDA-approved for the treatment of adults

with type 2 diabetes mellitus (T2DM). It is a glucagon-like peptide-1 (GLP-1) re-ceptor agonist available as a once-daily subcutaneous injection. According to the American Diabetes Association 2016 guidelines, GLP-1 receptor agonists can be added to a patient’s regimen as a second-line option in addition to metformin, or third-line when combined with metformin and sulfony-lureas, thiazolidinediones, or insulin. 1

SafetyLixisenatide should not be used in

patients with type 1 diabetes mellitus, a history of chronic or unexplained pancreatitis, diabetic ketoacidosis, gastroparesis, or end-stage renal dis-ease.2 Patients with a history of chronic or unexplained pancreatitis were not included in clinical trials due to the oc-currence of pancreatitis in post-market-ing studies with other GLP-1 receptor agonists. In clinical trials, pancreatitis occurred at an incidence of 21 per 10,000 patient-years compared to 17 per 10,000 patient-years with placebo.2

Patients receiving lixisenatide with acute kidney injury or an eGFR less than 60 mL/min/1.73m2 should be monitored for gastrointestinal adverse effects and hypoglycemia.2 Lixisenatide should not be used in patients with an eGFR less than 15 mL/min/1.73m2.2

Additionally, renal function should be monitored when initiating or increasing the dose in patients with renal im-pairment and in patients with severe gastrointestinal adverse effects.2

When compared to placebo, lix-isenatide had similar incidence of symptomatic hypoglycemia, defined as clinical symptoms resulting from a plasma glucose less than 60 mg/dL.2 Incidence of symptomatic hypoglycemia occurred in 14.5 percent versus 10.6 percent of patients receiving lixisenatide and a sulfonylurea ± metformin versus a sulfonylurea ± metformin, respectively.2

Incidence of symptomatic hypoglycemia was higher when lixisenatide was com-bined with basal insulin ± sulfonylurea compared to basal insulin ± sulfonylurea alone (47.2 percent vs. 21.6 percent, respectively). Severe symptomatic hypoglycemia, defined as an event re-quiring assistance, medical intervention, or serum blood glucose less than 36 mg/dl, occurred in less than 1 percent of patients using lixisenatide.2

There is limited data supporting use of lixisenatide in pregnant or lactating women.2

Tolerability Tolerability of lixisenatide has been

studied for up to 12 weeks as mono-therapy and up to 24 weeks in combi-nations with metformin, basal insulin, pioglitazone and/or sulfonylureas.2 In comparison to placebo, patients receiving lixisenatide were more likely to experience the following adverse ef-fects, respectively: nausea (25 percent vs. 6 percent), vomiting (10 percent vs.

2 percent), headache (9 percent vs. 6 percent), diarrhea (8 percent vs. 6 percent) and dizziness (7 percent vs. 4 percent).2 The following adverse events occurred in more than 2 percent of patients using lixisenatide: dyspepsia, constipation, abdominal distension and abdominal pain.1

In a 12-week, double-blind, random-ized, controlled trial (n=361), lixisenati-de monotherapy was compared to placebo in patients 20 to 85 years with T2DM.3 More than 50 percent of all participants using lixisenatide experi-enced a treatment-emergent adverse effect (TEAE). Three participants (2.5 percent) using lixisenatide at FDA-ap-proved dosing discontinued therapy due to a TEAE compared to one participant (0.8 percent) in the placebo group.3 Gastrointestinal disorders were the most common reason for discon-tinuation of lixisenatide. Nausea was more common during the first three weeks of treatment compared to later in therapy (weeks seven-12).

In a 24-week, randomized, open-la-bel, parallel-group, multicenter study (n=634), patients with uncontrolled T2DM on metformin were treated with either once daily lixisenatide or twice daily exenatide (GLP-1 receptor ago-nist) in addition to metformin therapy.4 Rates of adverse events and serious adverse events were similar in both groups. Rates of discontinuation for any reason were higher in the exen-atide group (13.0 percent) than the lixisenatide group (10.4 percent) and discontinuation due to gastrointestinal

Lixisenatide (Adlyxin®)


266 www.acms.org

adverse effects was significantly great-er in the exenatide group (7.6 percent) compared to the lixisenatide group (6.3 percent). There also was a significant difference in the incidence of symptom-atic hypoglycemia (7.9 percent in the exenatide group versus 2.5 percent in the lixisenatide group).4

EfficacyIn a 12-week, double-blind, random-

ized, controlled trial (n=361), patients with an average hemoglobin A1c (HbA1c) of 8 percent received daily lixisenatide or placebo. More patients achieved HbA1c of less than 7 percent with lixisenatide at FDA-approved dosing compared to placebo, 52.2 percent and 26.8 percent, respectively.3

Patients experienced an average of 2 kg weight loss in both groups.3

Lixisenatide also provided an additional benefit to patients receiving metformin with or without basal insulin. In a 24-week, double-blind, multina-tional, randomized, controlled trial with patients receiving metformin (n=484), more patients receiving lixisenatide at FDA approved doses achieved a HbA1c of less than 7 percent compared to placebo (42.1 percent, and 24.1 per-

cent, respectively).5 Similar results were seen in another 24-week double-blind, randomized, controlled trial (n=495) comparing lixisenatide to placebo in those already on basal insulin with or without metformin.6 Compared to placebo, patients receiving lixisenatide showed a significant reduction in both HbAlc (mean HbA1c reduction of 0.6 percent vs. 0.3 percent) and basal insulin requirement (-5.6 units/day vs. -1.9 units/day, respectively).6

PriceThe cash price of one carton of

Lixisenatide (Adlyxin®) 20 or 10 mcg/day (containing two 3-milliliter pens, pre-filled with 14 doses per pen) is approximately $580, a cash price similar to other GLP-1 agonists on the market.7 Exenatide (Bydureon®) costs approximately $640 for four single-use, once-weekly pens, correlating to a 28-day supply; Exenatide (Byetta®) costs approximately $570-690 for one pre-filled pen containing 60 doses, correlating to a 30-day supply.8,9

SimplicityLixisenatide is a once-daily sub-

cutaneous injection. Each prefilled lixisenatide pen provides 14 pre-set doses of either 10 mcg or 20 mcg. This

medication requires a dose increase after 14 days from 10 mcg daily to 20 mcg daily.2 There is no dosage adjust-ment necessary for geriatric patients, patients with hepatic dysfunction, or patients with mild to moderate renal impairment.2 Lixisenatide should be administered within one hour of the patient’s first meal of the day.2 Pens should be stored in the refrigerator pri-or to activation and expire 14 days after activation.1 Additionally, pen needles are not included with the medication. The medication administration process is similar to other GLP-1 receptor ago-nists. Several GLP-1 receptor agonists require once-weekly dosing (exenatide, dulaglutide, albiglutide) as compared to once-daily dosing with lixisenatide. For this reason, it is unclear how lixisenati-de will be favored in clinical practice.

At the time of authorship, Dr. Ayers was a PGY1 pharmacy practice res-ident at UPMC St. Margaret and can still be reached at [email protected]. Dr. Springer is a PGY2 geriatric phar-macy resident at UPMC St. Margaret and can be reached at [email protected]. Heather Sakely, PharmD, BCPS, provided editing and mentoring for this article and can be reached at [email protected].

Materia Medica

From Page 265

References1. American Diabetes Association: Stan-

dards of Medical Care in Diabetes. Diabetes Care; 2015 Jan; 38(Supplement 1):S41-S48.

2. Adlyxin [package insert], Bridgewater, NJ. Sanofi-aventis U.S. LLC: 2016.

3. Fonseca VA, Alvarado-Ruiz R, Raccah D et al. Efficacy and safety of the once-daily GLP-1 agonist Lixisenatide in monotherapy. Diabetes Care. 2012;35(6):1225-31.

4. Rosenstock J, Raccah D, Koranyi L, Maffei L, Boka G, Miossec P, Gerich JE.

Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 dia-betes inadequately controlled on metformin: a 24-week, randomized open-label, active controlled study (GetGoal-X). Diabetes Care. 2013 Oct;36(10):2945-51.

5. Bolli GB, Munteanu M, Dotsenko S, et al. Efficacy and safety of lixisenatide once daily vs. placebo in people with type 2 diabetes insufficiently controlled on metformin (GetGoal-F1). Diabet Med. 2014;31:176-84.

6. Riddle MC, Aronson R, Home P, et

al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by estab-lished basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013;36:2489-96.

7. “Adlyxin.” GoodRx. GoodRx, 2017. Web. 19 March 2017.

8. “Bydureon.” GoodRx. GoodRx, 2017. Web. 19 March 2017.

9. “Byetta.” GoodRx. GoodRx, 2017. Web. 19 March 2017.

AlleghenyMedcare

“The best solution to your medical supply needs.”

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Michael L. Gomber, MBAMore than 30 years meeting

physicians’ needs(412) 580-7900

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@henryshein.com

Allegheny MedcareHenry Schein, a Fortune 500 CompanyTogether to serve to provide a one-stop

solution for all your needs

AlleghenyMedcare

“The best solution to your medical supply needs.”


Michael L. Gomber, MBAMore than 30 years meeting

physicians’ needs(412) 580-7900

Fax (724) 223-0959Email: michael.gomber

@henryshein.com

Michael L. Gomber, MBAMore than 30 years meeting physicians’ needs 412.580.7900 Fax: 724.223.0959E-mail: [email protected]

Allegheny MedcareHenry Schein, a Fortune 500 Company

Together to serve to provide a one-stopsolution for all your needs

Allegheny Medcare

ALLEGHENYCOUNTYMEDICALSOCIETY

endorsed by


3 reasonsto consult

Mike Gomberfor your medical supply needs

Mike isn’t just a “sales rep.” Mikeis a professional consultant withan MBA and 30 years experienceserving physicians.

Mike will find the best solution toyour medical supply needs, notjust the “product of the month”that others are pushing.

Allegheny Medicare is endorsedby the Allegheny County MedicalSociety—the only medical supplycompany that is!

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We will reduce yourmedical office and

supply costs.

Michael L. Gomber, MBAMore than 30 years meeting physicians’ needs 412.580.7900 Fax: 724.223.0959E-mail: [email protected]

Allegheny MedcareHenry Schein, a Fortune 500 Company

Together to serve to provide a one-stopsolution for all your needs

Allegheny Medcare

ALLEGHENYCOUNTYMEDICALSOCIETY

endorsed by


3 reasonsto consult

Mike Gomberfor your medical supply needs

Mike isn’t just a “sales rep.” Mikeis a professional consultant withan MBA and 30 years experienceserving physicians.

Mike will find the best solution toyour medical supply needs, notjust the “product of the month”that others are pushing.

Allegheny Medicare is endorsedby the Allegheny County MedicalSociety—the only medical supplycompany that is!

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Per-PerspectiveClassifieds


FOR SALE: Steelers Seat Licenses. 4 seats, Section 110, row GG, Seats 11-14. These are great seats on the 45-yard line behind the visitor’s bench. Will include this year’s tickets. Contact [email protected] for details, price.

Classified ad ratesClassified ad rates are available

to ACMS member physicians at a significant discount:

For more information, call Meagan Sable at (412) 321-5030, ext. 105.

The deadline for submitting photos is Friday, September 1, 2017.

All photos should be vertical with a resolution of at least 300 dpi

and should be emailed to [email protected].

For more information, email Bulletin Managing Editor

Meagan Sable at [email protected].

Don’t forget to submit your photos

for the 2017 Bulletin Photo Contest!

$25 for first 20 words or less;$5 for each additional 10 words or less.

268 www.acms.org

Special Report

RiCk hoFFmasteR, mD

The Pennsylvania Orders for Life-Sustaining Treatment (POLST)

form has become a staple of ad-vance care planning in Pennsylvania and across the country. The POLST document allows a medical provider to record and communicate a patient’s specific treatment preferences across various care settings, including home, the hospital, skilled nursing facility, long-term care and hospice. POLST forms help direct medical providers to deliver the treatments that patients want, while avoiding interventions that do not fit their wishes.

In Pennsylvania, Act 169 of 2006 mandated formation of a statewide advisory committee – the Patient Life-Sustaining Wishes (PLSW) Advisory Committee – to examine the advisability and possible adoption of a standardized form such as POLST, that was in use in other states. In October 2010, a standard form – the POLST form – that was recommended by that committee, was approved. The use of the term “Pennsylvania” in the form name was simply to distinguish it from other state forms and to reflect the fact that the orders may be signed by cer-tified nurse practitioners or physician assistants.

While POLST forms are widely used in Pennsylvania, they do not current-ly have the status of legally binding medical orders. In April 2017, with the support of the Pennsylvania Medical Society, new POLST legislation was

introduced as Senate Bill 623 by Sen. Gene Yaw and in the House by Rep. Bryan Cutler as House Bill 1193. These bills would codify the legal authority of POLST and protect health care pro-fessionals who comply with a POLST form. Seriously ill and elderly patients in the community are at particular risk of receiving aggressive and invasive emergency medical treatments that may not fit with their preferences. The legal framework introduced in this legislation would empower front-line emergency medical services to fol-low POLST form orders without first consulting their medical command, as is currently mandated.

Physicians may contact their state representatives and senators and ask them to support this legislation, which will allow patients to specify treatment measures and preferences following discussion with their physician. Under the new legislation, POLST will consti-tute lawful medical orders across care settings to guide physicians, nurses, emergency medical technicians and other medical professionals to provide care that is consistent with a patient’s preferences with respect to end of life care.

For information on contacting your state legislators, visit the ACMS website at www.acms.org or call (412) 321-5030.

The intended POLST population

The POLST Paradigm is intended to be used for patients who are seri-

ously ill or frail and whose health care professionals wouldn’t be surprised if they died within a year – regardless of patient age or what facility a patient is in. For example, most 65-year-olds are too healthy to have POLST orders and not all residents in a nursing home may be appropriate for a POLST form. Many online tools are available to aid in assessing prognosis (http://eprogno-sis.ucsf.edu/).

The POLST conversationConversation is the cornerstone

of the POLST Paradigm: The POLST form is only as good as the conver-sation(s) preceding it. Completion of POLST requires a conversation between a health care provider (a physician, physician assistant or nurse practitioner) and a patient or their legally designated surrogate decision maker (a health care agent or health care representative). This conversation is critical to ensuring that the patient, or their surrogate, understands the im-plications of the medical decisions as outlined in the completed POLST form.

Once the POLST form is completed, it must be signed by both the provid-er and the patient or their surrogate. In this respect, the requirement that patients or their legal decision-maker review and sign the form provides a safeguard for patients that the orders on the form accurately convey their preferences.

The following are examples of some frequently asked questions about POLST:

Need to know: POLST

Special Report

Does the POLST replace an ad-vance directive?

No. The POLST is not intended to replace an advance health care direc-tive document or other medical orders. It is recommended that people with advanced illness and/or advanced frail-ty have both an advance directive and a POLST form. The POLST process and health care decision-making works best when the person has appointed a health care agent to speak for them if they are unable to speak for them-selves. A health care agent can only be appointed through an advance health care directive called a health care power of attorney. A good practice is to attach a copy of the advance health care directive to the POLST form.

As with an advance directive, can a POLST form be completed by

a patient or legal decision-maker and then forwarded to a physician, CRNP or PA for their signature?

A distinction between an advance directive and a POLST form is that a POLST form is a legal medical order and is completed by a health care professional after a discussion of end-of-life choices with a patient or his/her legal decision-maker.

Does one document, the advance directive or POLST, supersede the other?

If a POLST order conflicts with a provision of an advance health care di-rective, the provision of the instrument latest in date of execution prevails to the extent of the conflict. In such a sit-uation, it is recommended that patient values be elicited and then confirm the POLST is consistent with those

values. If in crisis and goals of care are not clear, a higher level of care should be provided until more information is known.

How can I obtain further informa-tion on POLST?

Contact Marian Kemp, POLST coordinator for the Coalition for Qual-ity at the End of Life, at [email protected]. The POLST form and various educational materials, including tools to improve POLST communica-tion, are available through the website of The Aging Institute of UPMC Senior Services and the University of Pitts-burgh (http://www.upmc.com/services/aginginstitute/partnerships-and-col-laborations/pages/polst.aspx). Users should download and print the form on Pulsar Pink stock (#65).

Community AwardsBenjamin Rush Individual AwardBenjamin Rush Community Organization AwardExecutive Leadership Award

Physician AwardsNathaniel Bedford Primary Care AwardRalph C. Wilde Leadership AwardPhysician Volunteer AwardRichard E. Deitrick Humanity in Medicine Award

Nominations must be received by Wednesday, July 19, 2017.Awards will be presented at the ACMS Foundation Celebration of Excellence Gala

Saturday, February 24, 2018.

2017 Award Nominations

Healthy Children, Healthy Communities, Healthy Future

For more information or to submit a nomination, visit:www.acms.org/awards

Special Report

270 www.acms.org

The Allegheny County Medical So-ciety (ACMS) Foundation recently

awarded grants to the following com-munity organizations:

• Pittsburgh Youth Leadership, Inc.: $2,000 grant for 2017 Pitts-burgh Youth Leadership Bicycle Trips

Pittsburgh Youth Leadership supplies, funds, organizes and leads strenuous and innovative programs for area high school students.

The primary emphasis of Pittsburgh Youth Leadership is developing, train-ing, supplying and leading participants with extremely limited experience, future vision and life direction on multi-week, cross-country bicycle trips. The bicycle is the “vehicle” to teach and motivate inner-city, low-income, at-risk youths to make good life choices, seek higher education, live healthy lifestyles and reach their limitless potential.

“Pittsburgh Youth Leadership (PYL) is honored to receive a generous grant from the ACMS Foundation to support our strenuous bicycling programs for inner-city, low-income, at-risk youth. We will utilize this grant to provide more opportunities to more participants to experience and learn the positive values of long-distance cycling. We strongly believe that the ACMS Foun-dation grant will assist deserving youth in reaching their full potential. PYL shares the goal of the ACMS Founda-tion of encouraging our community to make healthy lifestyle choices, which

is one of the primary objectives of our mission,” said Mark Rubenstein, PYL president.

• The First Tee of Pittsburgh: $10,000 grant each year for three years for its Life Skills Curriculum

The First Tee is an international youth development organization run by volunteer faculty that introduces the game of golf and its inherent values to young people. First Tee of Pittsburgh believes that kids have the capacity to effect positive change in their lives given caring adult role models who provide tools for success.

The Life Skills Experience curric-ulum provides practical application of knowledge and skills to transform children’s lives and is offered to underserved and at-risk youth from The Neighborhood Academy, Allegh-eny Youth Development, Sto-Rox Youth Partnership, Friendship Circle and Gwen’s Girls. The program offers participants an opportunity to learn, demonstrate and exhibit life skills, core values and healthy habits they may not be exposed to in their communities.

“The Allegheny County Medical Society Foundation grant funds the ex-pansion of The First Tee of Pittsburgh’s ‘Nine Healthy Habits’ curriculum. This has increased access and participation for area kids who learn and experience lessons that promote healthy, active lifestyles,” said Marc Field, executive director.

• ACHIEVA: $9,800 grant to train

individuals in Infant Massage for Children with Developmental Delays or Disabilities

Founded 65 years ago, ACHIEVA is built upon a foundation rooted in the passion and dedication of parents who came together to ensure that their children with disabilities had the same chances in life that all children should be given.

Research suggests infant massage can help alleviate symptoms associ-ated with developmental delays. For infants, massage promotes relaxation and helps babies self-regulate calm, which reduces crying; helps normalize muscle tone; improves midline orien-tation; improves sensory and body awareness; and enhances neurological development. For parents and care-givers, it teaches them to read their infants’ cues and recognize their states of awareness; encourages pre-verbal communication between caregiver in-fant; and provides essential indicators of intimate parent-infant bonding.

“ACHIEVA is thrilled and honored to receive this grant from the Allegheny County Medical Society Foundation. These funds will allow us to provide infant massage training for our Early Intervention therapists working with children with developmental delays or disabilities. Our therapists will become equipped to teach families these tech-niques to help alleviate some symp-toms associated with developmental delays and help parents feel more

ACMS Foundation awards grants to community organizations


confident and competent in caring for their children,” said Sharon Richards, vice president, ACHIEVA Early Inter-vention.

• Jeremiah’s Place: $15,000 grant per year for two years for its Charting Impact: Evaluation to Build Capacity project

Jeremiah’s Place offers free, tempo-rary short-term care to all children ages 6 and under when families are in crises or experiencing an emergency situation and need safe care for their children. Situations may include emergency medical care, urgent childcare needs, and care of children at risk for child abuse.

Partnering with the University of Pittsburgh’s Collaborative for Eval-uation and Assessment Capacity, Children’s Hospital of Pittsburgh of UPMC and Jewish Family & Children’s Services, Jeremiah’s Place will conduct surveys and collect client feedback to understand how its programs and services are impacting families.

This evaluation will allow Jeremiah’s Place to develop and implement new programming; identify additional re-sources and supports for families; and determine how the organization should consider expanding in the coming years.

“We are so honored to have been selected as a grant recipient of the ACMS! Receiving this grant means that Jeremiah’s Place can continue to stand in the gap for children and families in crisis,” said Lisa Perry, executive director.

• Ward Home, Inc.: $10,000 per year for two years for its Health and Well-Being Enhancement Program

Ward Home supports the health and well-being of at-risk foster teens and

young adults in the region by teaching critical life skills; supporting academics; strengthening employment retention; advising on personal safety, health and wellness; and guiding successful transition into adulthood.

The Health and Well-Being En-hancement Program teaches foster teens and young adults ages 16 to 21 the importance and value of living a healthy lifestyle, such as nutritious cooking and the importance of physical exercise.

“Thanks to the support from the ACMS Foundation, Ward Home is able to teach our foster teens the importance of proper nutrition and exercise. This is a very important part of teaching them to grow into produc-tive, healthy adults. The support is also helping future generations. The teen moms at Ward Home have learned the importance of providing healthy meals for their young children. These children are starting life with healthy habits!” said Bill Wolfe, executive director.

• Parkinson Foundation of West-ern Pennsylvania: $5,000 grant for the Living Well with Parkinson’s Conference

The Parkinson Foundation is dedi-cated to a single goal: assisting those with Parkinson’s and their families overcome the debilitating effects of Parkinson’s Disease. The Foundation offers assistance in three primary ar-eas: Support and Social; Exercise and Lifestyle; and Education and Answers.

The Living Well with Parkinson’s Conference gives people living with Parkinson’s practical tools to live life to its fullest and healthiest. Participants leave with less stress and newfound connections that improve their lives. The conference assists with disease

management by informing patients and families of current programs in our region and by introducing them to valuable resources, people and programs.

“The Parkinson Foundation of Western Pennsylvania is so grateful to be selected as one of the Allegheny County Medical Society Foundation’s grant recipients for 2017. The grant will support our annual Living Well with Parkinson’s Disease conference on November 4. This has become the largest gathering of people with Par-kinson’s, their families and friends of its type in the tristate area. The full-day conference energizes and informs fam-ilies, and brings them new connections and ideas that make a positive impact on their lives. We are very grateful for the Allegheny County Medical Associ-ation’s assistance in reaching out and supporting our regional Parkinson’s community,” said David Von Hofen, director of programs.

The ACMS Foundation mission statement is “ACMS Foundation grants will support home and community environments that nurture and devel-op healthy children and families for a healthy Allegheny County.”

Organized in 1960, the Allegheny County Medical Society started the Foundation with contributions from the polio immunization program. The immunization effort was undertaken by ACMS and sparked a public outpour-ing of donations. The Foundation has since provided more than $3 million in grants to support community health improvement.

For more information on the ACMS Foundation, contact the Allegheny County Medical Society at (412) 321-5030.

Special Report

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C M S Bulletin2019/07/17 · a prestigious medical school. “Choles-terol intake has nothing to do with se-rum cholesterol, which is endogenously produced. In fact, eating cholesterol