Do Patient-Reported Outcomes Matter? ... p. 32

40 Pages·2015·5.4 MB·English

Do Patient-Reported Outcomes Matter?
... p. 32
Your source for worldwide news and
perspectives on hematology/oncology
volume 01 | number 02 february 2015
CONTENTS
4… Editor's Corner
A Letter to the ABIM
8… Pulling Back the Curtain
Benjamin Ebert on
Juggling Work and Family
14… Hematology Link
The Endocrinologist’s
Perspective on Diabetes
Management
25… On Location
Highlights from the ASH
Annual Meeting
31… Best Practices
Choosing Wisely Across
the Internal Medicine
Spectrum
34… PASHions
Hagop Kantarjian’s “Beirut”
MOC Mea Culpa
DEPARTMENTS
5 UP FRONT
16 CLINICAL NEWS
Is the ABIM's apology
28 TRAINING AND EDUCATION
too little, too late?
32 FEATURES
34 BACK OF THE BOOK
www.ASHClinicalNews.org
Latest & Greatest: Literature Scan: Patient Education:
Drug and Device New & Noteworthy Sickle Cell Awareness
News ... 15 Research ... 20 ... 29
Bleed: 21.25”
Trim: 21”
Live: 20”
Although half are cured by transplant,1,2 relapse may be closer than you think for some
There will be an estimated 9,190 new cases of Hodgkin Among those who relapse after ASCT, prognosis
lymphoma (HL) in the US in 2014.3 HL is considered a has traditionally been poor, with a median survival
highly curable disease; however, up to 10% of patients of 1.3 years following relapse.6,7 Further, the majority
are refractory to frontline therapy, and up to 30% of of relapses occur within 1 year.7 As advances continue
patients will eventually relapse.4,5 The standard approach in the treatment of HL, utilization of clinical prognostic
for relapsed HL is autologous stem cell transplantation factors may help identify a group of patients who are
(ASCT), which has a 5-year progression-free survival rate at high risk of relapse.1,2,6,8-16
of approximately 50%.1,2,6
Risk factors that may help identify patients Progression-free survival based on a
who will relapse following ASCT prognostic model using risk groups1,*
1.0
(cid:127) Refractory disease or early relapse after frontline therapy2,8-11
(cid:127) Extranodal disease at pre-ASCT relapse2,8,10-12
0.8
(cid:127) B symptoms at pre-ASCT relapse1,8-11,13 Low-risk group
n
(cid:127) Lack of chemoresponsiveness pre-ASCT1,2,13 ortio 0.6
(cid:127) Residual disease at time of ASCT1 op
pr
(cid:127) Positive FDG-PET scan pre-ASCT14-16 ve Intermediate-risk group
ati 0.4
(cid:127) Bulky disease pre-ASCT2,12 ul
m
u
(cid:127) Higher disease stage at relapse8,9 C
0.2
High-risk group
(cid:127) Anemia pre-ASCT8,9 B
LTle
Knowing the risk factors can change the way (cid:127) >1 relapse or >2 prior regimens1,9 0.0 0 12 24 36 48 60 72 ive: 13”rim: 14”ed: 14.2
you see your patients with Hodgkin lymphoma MoMntohnsths 5”
* High, intermediate and low risk were defi ned as patients with 0-1, 2 or 3 risk factors,
respectively. The 3 factors incorporated into the model were B symptoms at pre-ASCT
relapse, transplantation in CR and chemosensitive disease at the time of ASCT.1
HLbelowthesurface.com
References: 1. Majhail NS, Weisdorf DJ, Defor TE, et al. Long-term results of autologous stem cell transplantation for primary refractory or relapsed Hodgkin’s lymphoma. Biol Blood Marrow
Transplant. 2006;12(10):1065-1072. 2. Sureda A, Constans M, Iriondo A, et al; for Grupo Español de Linfomas/Trasplante Autólogo de Médula Osea (GEL/TAMO) Cooperative Group. Prognostic
factors affecting long-term outcome after stem cell transplantation in Hodgkin’s lymphoma autografted after a fi rst relapse. Ann Oncol. 2005;16(4):625-633. 3. American Cancer Society. Cancer
Facts & Figures 2014. Atlanta, GA: American Cancer Society; 2014. 4. Derenzini E, Younes A. Predicting treatment outcome in classical Hodgkin lymphoma: genomic advances. Genome Med.
2011;3(4):26. doi:10.1186/gm240. 5. Quddus F, Armitage JO. Salvage therapy for Hodgkin’s lymphoma. Cancer J. 2009;15(2):161-163. 6. Colpo A, Hochberg E, Chen Y-B. Current status of
autologous stem cell transplantation in relapsed and refractory Hodgkin’s lymphoma. Oncologist. 2012;17(1):80-90. 7. Arai S, Fanale M, deVos S, et al. Defi ning a Hodgkin lymphoma population
for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma. 2013;54(11):2531-2533. 8. Josting A, Franklin J, May M, et al. New prognostic score based
on treatment outcome of patients with relapsed Hodgkin’s lymphoma registered in the database of the German Hodgkin’s Lymphoma Study Group. J Clin Oncol. 2002;20(1):221-230. 9. Josting A,
Müller H, Borchmann P, et al. Dose intensity of chemotherapy in patients with relapsed Hodgkin’s lymphoma. J Clin Oncol. 2010;28(34):5074-5080. 10. Reece DE, Connors JM, Spinelli JJ, et al.
Intensive therapy with cyclophosphamide, carmustine, etoposide ± cisplatin, and autologous bone marrow transplantation for Hodgkin’s disease in fi rst relapse after combination chemotherapy.
Blood. 1994;83(5):1193-1199. 11. Moskowitz CH, Nimer SD, Zelenetz AD, et al. A 2-step comprehensive high-dose chemoradiotherapy second-line program for relapsed and refractory Hodgkin
disease: analysis by intent to treat and development of a prognostic model. Blood. 2001;97(3):616-623. 12. Smith SD, Moskowitz CH, Dean R, et al. Autologous stem cell transplant for early
relapsed/refractory Hodgkin lymphoma: results from two transplant centres. Br J Haematol. 2011;153(3):358-363. 13. Fermé C, Mounier N, Diviné M, et al. Intensive salvage therapy with
high-dose chemotherapy for patients with advanced Hodgkin’s disease in relapse or failure after initial chemotherapy: results of the Groupe d’Études des Lymphomes de l’Adulte H89 trial. J Clin Oncol.
2002;20(2):467-475. 14. Moskowitz AJ, Yahalom J, Kewalramani T, et al. Pretransplantation functional imaging predicts outcome following autologous stem cell transplantation for relapsed
and refractory Hodgkin lymphoma. Blood. 2010;116(23):4934-4937. 15. Smeltzer JP, Cashen AF, Zhang Q, et al. Prognostic signifi cance of FDG-PET in relapsed or refractory classical Hodgkin
lymphoma treated with standard salvage chemotherapy and autologous stem cell transplantation. Biol Blood Marrow Transplant. 2011;17(11):1646-1652. 16. Devillier R, Coso D, Castagna L, et al.
Positron emission tomography response at the time of autologous stem cell transplantation predicts outcome of patients with relapsed and/or refractory Hodgkin’s lymphoma responding to prior
salvage therapy. Haematologica. 2012;97(7):1073-1079.
Seattle Genetics and are US registered trademarks of Seattle Genetics, Inc.
© 2014 Seattle Genetics, Inc., Bothell, WA 98021 All rights reserved. Printed in USA USM/BVM/2014/0119
Bleed: 21.25”
Trim: 21”
Live: 20”
Although half are cured by transplant,1,2 relapse may be closer than you think for some
There will be an estimated 9,190 new cases of Hodgkin Among those who relapse after ASCT, prognosis
lymphoma (HL) in the US in 2014.3 HL is considered a has traditionally been poor, with a median survival
highly curable disease; however, up to 10% of patients of 1.3 years following relapse.6,7 Further, the majority
are refractory to frontline therapy, and up to 30% of of relapses occur within 1 year.7 As advances continue
patients will eventually relapse.4,5 The standard approach in the treatment of HL, utilization of clinical prognostic
for relapsed HL is autologous stem cell transplantation factors may help identify a group of patients who are
(ASCT), which has a 5-year progression-free survival rate at high risk of relapse.1,2,6,8-16
of approximately 50%.1,2,6
Risk factors that may help identify patients Progression-free survival based on a
who will relapse following ASCT prognostic model using risk groups1,*
1.0
(cid:127) Refractory disease or early relapse after frontline therapy2,8-11
(cid:127) Extranodal disease at pre-ASCT relapse2,8,10-12
0.8
(cid:127) B symptoms at pre-ASCT relapse1,8-11,13 Low-risk group
n
(cid:127) Lack of chemoresponsiveness pre-ASCT1,2,13 ortio 0.6
(cid:127) Residual disease at time of ASCT1 op
pr
(cid:127) Positive FDG-PET scan pre-ASCT14-16 ve Intermediate-risk group
ati 0.4
(cid:127) Bulky disease pre-ASCT2,12 ul
m
u
(cid:127) Higher disease stage at relapse8,9 C
0.2
High-risk group
(cid:127) Anemia pre-ASCT8,9 B
LTle
Knowing the risk factors can change the way (cid:127) >1 relapse or >2 prior regimens1,9 0.0 0 12 24 36 48 60 72 ive: 13”rim: 14”ed: 14.2
you see your patients with Hodgkin lymphoma MoMntohnsths 5”
* High, intermediate and low risk were defi ned as patients with 0-1, 2 or 3 risk factors,
respectively. The 3 factors incorporated into the model were B symptoms at pre-ASCT
relapse, transplantation in CR and chemosensitive disease at the time of ASCT.1
HLbelowthesurface.com
References: 1. Majhail NS, Weisdorf DJ, Defor TE, et al. Long-term results of autologous stem cell transplantation for primary refractory or relapsed Hodgkin’s lymphoma. Biol Blood Marrow
Transplant. 2006;12(10):1065-1072. 2. Sureda A, Constans M, Iriondo A, et al; for Grupo Español de Linfomas/Trasplante Autólogo de Médula Osea (GEL/TAMO) Cooperative Group. Prognostic
factors affecting long-term outcome after stem cell transplantation in Hodgkin’s lymphoma autografted after a fi rst relapse. Ann Oncol. 2005;16(4):625-633. 3. American Cancer Society. Cancer
Facts & Figures 2014. Atlanta, GA: American Cancer Society; 2014. 4. Derenzini E, Younes A. Predicting treatment outcome in classical Hodgkin lymphoma: genomic advances. Genome Med.
2011;3(4):26. doi:10.1186/gm240. 5. Quddus F, Armitage JO. Salvage therapy for Hodgkin’s lymphoma. Cancer J. 2009;15(2):161-163. 6. Colpo A, Hochberg E, Chen Y-B. Current status of
autologous stem cell transplantation in relapsed and refractory Hodgkin’s lymphoma. Oncologist. 2012;17(1):80-90. 7. Arai S, Fanale M, deVos S, et al. Defi ning a Hodgkin lymphoma population
for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma. 2013;54(11):2531-2533. 8. Josting A, Franklin J, May M, et al. New prognostic score based
on treatment outcome of patients with relapsed Hodgkin’s lymphoma registered in the database of the German Hodgkin’s Lymphoma Study Group. J Clin Oncol. 2002;20(1):221-230. 9. Josting A,
Müller H, Borchmann P, et al. Dose intensity of chemotherapy in patients with relapsed Hodgkin’s lymphoma. J Clin Oncol. 2010;28(34):5074-5080. 10. Reece DE, Connors JM, Spinelli JJ, et al.
Intensive therapy with cyclophosphamide, carmustine, etoposide ± cisplatin, and autologous bone marrow transplantation for Hodgkin’s disease in fi rst relapse after combination chemotherapy.
Blood. 1994;83(5):1193-1199. 11. Moskowitz CH, Nimer SD, Zelenetz AD, et al. A 2-step comprehensive high-dose chemoradiotherapy second-line program for relapsed and refractory Hodgkin
disease: analysis by intent to treat and development of a prognostic model. Blood. 2001;97(3):616-623. 12. Smith SD, Moskowitz CH, Dean R, et al. Autologous stem cell transplant for early
relapsed/refractory Hodgkin lymphoma: results from two transplant centres. Br J Haematol. 2011;153(3):358-363. 13. Fermé C, Mounier N, Diviné M, et al. Intensive salvage therapy with
high-dose chemotherapy for patients with advanced Hodgkin’s disease in relapse or failure after initial chemotherapy: results of the Groupe d’Études des Lymphomes de l’Adulte H89 trial. J Clin Oncol.
2002;20(2):467-475. 14. Moskowitz AJ, Yahalom J, Kewalramani T, et al. Pretransplantation functional imaging predicts outcome following autologous stem cell transplantation for relapsed
and refractory Hodgkin lymphoma. Blood. 2010;116(23):4934-4937. 15. Smeltzer JP, Cashen AF, Zhang Q, et al. Prognostic signifi cance of FDG-PET in relapsed or refractory classical Hodgkin
lymphoma treated with standard salvage chemotherapy and autologous stem cell transplantation. Biol Blood Marrow Transplant. 2011;17(11):1646-1652. 16. Devillier R, Coso D, Castagna L, et al.
Positron emission tomography response at the time of autologous stem cell transplantation predicts outcome of patients with relapsed and/or refractory Hodgkin’s lymphoma responding to prior
salvage therapy. Haematologica. 2012;97(7):1073-1079.
Seattle Genetics and are US registered trademarks of Seattle Genetics, Inc.
© 2014 Seattle Genetics, Inc., Bothell, WA 98021 All rights reserved. Printed in USA USM/BVM/2014/0119
AMERICAN SOCIETY OF HEMATOLOGY CONTENTS
HEADQUARTERS
2021 L Street NW, Suite 900
Washington, DC 20036 VOLUME 01 | NUMBER 02 | FEBRUARY 2015
www.hematology.org
Tel: [phone]

EDITOR-IN-CHIEF
Mikkael Sekeres, MD, MS
Vice-Chair for Clinical Research
Director, Leukemia Program
Cleveland Clinic, Taussig Cancer Institute
Cleveland, OH

ASSOCIATE EDITORS
Beth Faiman, CNP, PhD
Cleveland Clinic
Cleveland, OH
Alice Ma, MD
University of North Carolina School of Medicine
Chapel Hill, NC
David Steensma, MD
Dana-Farber Cancer Institute
Boston, MA MOC MEA CULPA
Keith Stewart, MBChB, MBA
The ABIM announced immediate
Mayo Clinic
Scottsdale, AZ changes to its MOC program, but is
the apology too little, too late?... p. 6
PUBLISHER
American Medical Communications
4 EDITOR’S CORNER by Mikkael A. Sekeres, MD
EDITORIAL
MANAGING EDITORS UP FRONT FEATURES
Ariel Jones, AMC
Karen Learner, ASH 5 The Society Pages
ART DIRECTOR 6 ASH Directions Who Cares About What Patients Think?
Ari Mihos 8 Pulling Back the Curtain Patient-reported outcomes are nothing new in
the field of medicine, but they may now be newly
ASSISTANT ART DIRECTOR 12 Calendar
Charlene DePrizio appreciated. ASH Clinical News takes a look at why
the FDA, insurance payers, and researchers are
DIGITAL PROJECTS MANAGER
looking more closely at PROs.
Chris Gedikli
CLINICAL NEWS 32

14 Hematology Link
ADVERTISING
15 Latest & Greatest
ACCOUNT MANAGER 16 Data Stream
Nick Luciano
[email protected] 18 Written in Blood BACK of the BOOK
20 Literature Scan
Gene Conselyea
34 PASHions
[email protected] 23 Trial Roundup
36 Heard in the Blogosphere
25 On Location

Recruitment advertising orders can be sent to:
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John Baltazar, CSMR TRAINING and EDUCATION
[email protected]
28 You Make the Call
29 Patient Education
31 Best Practices
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Clinical News magazine do not represent official policy of the American Society of Hematology unless so stated. No responsibility is assumed by the American
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Editor’s Corner
Letter From a Cleveland Jail
to the ABIM Redux
American Board of Internal Medicine
Mikkael A. Sekeres, MD, MS,
Philadelphia, PA
is director of the Leukemia
Program at the Cleveland Clinic
February 2015 in Cleveland, OH.
DEAR AMERICAN BOARD of Internal Medicine,
Remember me? I’m the guy who sent those other letters to you ing the recertification exam, I suddenly started receiving mailers
over the past couple of years, in which I channeled the spirits of advertising Keri lotion for dry and flaky skin?
Henry David Thoreau and Martin Luther King Jr., both of whom On the way into the testing room, the agent has us empty our
wrote passionate epistles while they were in jail — Thoreau for fail- pockets to prove they are empty of anything we might have on us
ing to pay his taxes and King for his role in a non-violent protest. every day when we see patients, like a smartphone. In my case, said
This time, I’m imprisoned behind the cinderblock walls of agent made a nearly career-ending discovery.
incredulity as I hear yet more stories from colleagues who had to “What’s that?” The Pearson Vue Commandant asked me.
recertify their boards, and from others who now have to fulfill the “Um, it’s a ball of lint,” I answered, holding it in my dry and
new maintenance of certification (MOC) requirements. flaky palm.
Did you read Paul Teirstein’s recent Perspective in The New Eng- “You know you can’t bring anything into the testing room,”
land Journal of Medicine, “Boarded to Death — Why Maintenance of PVC said, glaring at me.
Certification is Bad for Doctors and Patients”? It mentions a petition “I didn’t know my pocket had lint,” I answered, hoping this
signed by almost 20,000 people against MOC, and another signed by sounded innocent enough. It wasn’t even big enough to write “Fac-
6,000 people taking a “pledge of noncompliance.” tor Xa” on, even if I had intended to use it for cheating purposes.
Wow, I guess I’m not alone. I think that adds up to 26,000 “Are you going to tell my Mom I had lint in my pocket?”
people who won’t be sending you a holiday letter this year. “Just put it in the trash can,” PVC responded, shaking his head
Dr. Teirstein went on to call the “research” supporting certifica- in disappointment.
tion “inadequate” – citing a lack of studies showing an association Then, we sit down to finally take the test, absorbing question
between recertification and performance on quality measures after question like bullets on a firing range. Because we are doc-
– and accused you of being a bully. Quite a statement against a tors, we recognize the telltale signs of increased sympathetic tone
Board that prides itself on basing certification on evidence-based indicating extreme anxiety (sweating, increased heart rate, and
medicine. The author stopped just short of saying that your mother accelerated respiratory rate) as we try to convince ourselves that
wears combat boots. Not that there’s anything wrong with that, the truly perplexing questions are actually just questions the ABIM
mind you. I’m sure they’re quite becoming. is piloting – that they don’t really count.
You’re probably reading this from the overstuffed leather chair Wait a second.
and ottoman in your office, which you purchased with some of You mean to tell me that we pay the ABIM millions of dollars a
the $55 million in fees you received in one year from physicians year to go through this Cold War experience so that we can test the
seeking certification. To be clear, you bought the chair, but were psychometric properties of their own questions for them?
resting your legs on a man named Otto, an internist who so feared Are you kidding me?
complaining to you and then being listed as “certified, not meeting Isn’t that a violation of the Declaration of Helsinki? I suffer
MOC requirements” that he offered his prostrate services to better emotional and psychological trauma from trying to answer items
assist the venous return to your generous heart and brain so that that ask more than one question, or for which there may be more
you could think up more board questions that don’t correlate to than one response, or that may have dangling participles or mis-
better patient care. placed modifiers. Can’t the ABIM at least use some of the $55 mil-
My favorite part of the Perspective was when the author raised lion dollars per year they collect from us to hire people to do this?
the same point I’ve raised before to you: how relevant are closed So, ABIM, given all the outcry against your requirements, I
book/computer/colleague consulting/smartphone tests in an era think it’s time you reconsider what you are having tens of thou-
when Magnum PI isn’t must-see TV? I mean, I’m sure Flexner was sands of doctors do to try to satisfy you.
a huge fan of this method of assessing knowledge. I think he also Here’s a suggestion: Get rid of the sit-down exam. It’s anach-
voted for Roosevelt for President. Teddy, that is, not Franklin D. ronistic. It’s embarrassing. Its results only correlate with results on
In addition, think about just how humiliating the entire pro- other sit-down exams. As MOC doesn’t help patient care, why not
cess is. We spend weeks or months shunning family, friends, and just replace it with documentation of CME? We all genuinely want
other social stimuli to memorize facts we could otherwise access to learn throughout our careers to provide the best contemporary
How do you feel about
the ABIM MOC exam? within seconds in our clinic workrooms. The day of the dreaded care to our patients. MOC gets in the way of that.
Let us know at exam, we huddle in a small waiting area in a building hidden And, for God’s sake, can you please let Otto go home to see his
[email protected] within a larger industrial complex, along with our residents and family, or spend more time with his patients, or conduct research
or tweet us at fellows, to check in. Sometimes, the surly Pearson Vue employee that will cure terrible diseases – instead of wasting his valuable
@ASHClinicalNews behind the desk can find our names and sometimes, for a few time trying to fulfill your requirements?
stomach-plunging minutes, he can’t. Then, to verify our identities Sincerely,
over the course of the day, he scans our palms. Mikkael Sekeres, MD, MS
The ABIM has announced Editor-in-Chief
Scans our palms?
immediate changes to the Board-certified through 2022
Since when did I volunteer to share the secrets my palm holds
MOC program. Read more
about these changes in ASH with the Pearson Vue Stasi agents? How will they use this palm
Directions on page 6. information against me in the future? Is that why, soon after tak-
4 ASH Clinical News February 2015
UP FRONT
The Society Pages
Multiple Researchers Awarded Damon Runyon-Rachleff Innovation
Awards Given to Six Early-Career
Scientists
NIH Grants to Decipher the
The Damon Runyon Cancer Research Foundation an-
nounced that six scientists with novel approaches to
Language of Gene Regulation fighting cancer have been named 2015 recipients of the
Damon Runyon-Rachleff Innovation Award. The grant
of $300,000 over two years is awarded each year to
early-career scientists whose projects have the poten-
The National Institutes of Health has awarded treatments for diseases affected by faulty gene tial to significantly impact the prevention, diagnosis,
multiple grants totaling more than $28 million regulation, such as cancer, diabetes, and Parkin- and treatment of cancer. Each awardee will have the
aimed at deciphering the language of how and son’s disease. opportunity for up to two additional years of funding
when genes are turned on and off. These awards “We do not have a good way to predict (up to four years total for $600,000). Continued sup-
originate from the recently launched Genom- whether particular regulatory elements are port for years three and four will be granted to those
ics of Gene Regulation (GGR) program of the turning genes off or activating them, or whether awardees who demonstrate significant progress on
National Human Genome Research Institute these elements make genes responsive to a their proposed research during the first two years of the
(NHGRI), part of NIH. condition, such as infection,” said Mike Pazin, award. The Damon Runyon-Rachleff Innovation Award
With these new grants, researchers will PhD, a program director in the Functional funds cancer research by exceptionally creative thinkers
study gene networks and pathways in differ- Analysis Program in NHGRI’s Division of Genome with “high-risk/high-reward” ideas who lack sufficient
ent systems in the body, such as skin, immune Sciences. “We expect these new projects will preliminary data to obtain traditional funding. This
cells, and lung. The resulting insights into the develop better methods to answer these types year’s 2015 Damon Runyon-Rachleff Innovators are:
mechanisms controlling gene expression may of questions using genomic data.”
• Nicholas T. Ingolia, PhD, University of California,
ultimately lead to new avenues for developing
Berkeley
Recipients of the new GGR three-year grants include:
• Christopher M. Jewell, PhD, University of Maryland,
$3.2 million College Park
Memorial Sloan Kettering Cancer Center, New York City, NY • Ning Jenny Jiang, PhD, University of Texas, Austin
PRINCIPAL INVESTIGATORS: Christina Leslie, PhD, and Alexander Rudensky, PhD 
• Guillem Pratx, PhD, Stanford University, Stanford
$5.9 million • Brian H. Shirts, MD, PhD, University of Washington,
Seattle
Duke University, Durham, NC
PRINCIPAL INVESTIGATOR: Timothy Reddy, PhD • Elçin Ünal, PhD, University of California, Berkeley
Source: Damon Runyon Cancer Research Foundation press release
$6 million
University of California, Los Angeles, CA
PRINCIPAL INVESTIGATORS: Alexander Hoffmann, PhD, and Douglas Black, PhD
Victor Marder, Pioneer of
Hematology (1935–2015)
$6.1 million
Victor Marder, MD, a scientist at the University of California,
University of Massachusetts Medical School, Worcester, MA
PRINCIPAL INVESTIGATORS: Jeremy Luban, MD, and Manuel Garber, PhD Los Angeles, and a recognized leader in the field of hematol-
ogy research, died January 29, 2015, at the age of 80.
Source: National Institutes of Health press release Born and raised near Baltimore, Maryland, he went
on to serve as chief of the Division of Hematology at
the University of Rochester School of Medicine and
University of Wisconsin Names Ruth O’Regan to Lead Strong Memorial Hospital. During his tenure, he built an
Hematology/Oncology Division outstanding group with international recognition in the
area of hemostasis and thrombosis.
Ruth O’Regan, MD, has been of hematology and medical Cancer Center for Excellence Dr. Marder joined UCLA’s faculty in 1999 as director of
appointed division head oncology at Emory University, at Grady Memorial Hospital. In the Vascular Medicine Program at Los Angeles Orthopae-
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ASHClinicalNews.org ASH Clinical News 5
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UP FRONT
ASH Directions
BiTE®
An investigational
technology from
Amgen
Bispecifi c T cell Engager (BiTE®):
Speaking Up for
Engaging the immune system to
Hematology target malignant cells*
Change Comes at ABIM After Years of
ASH Advocacy
Since 2001, ASH has challenged the American Board of Internal Medi-
cine (ABIM) on its Maintenance of Certification (MOC) program, citing
a lack of evidence for the value of MOC. On February 3, the ABIM
announced a number of changes to its MOC program in response to the
wave of backlash it experienced from ASH and other groups in response
to the changes announced last year. In a letter addressed to the internal
medicine community, ABIM President and CEO Richard J. Baron, MD,
opened with a straightforward apology: “ABIM clearly got it wrong. We
launched programs that weren’t ready and we didn’t deliver an MOC
program that physicians found meaningful. We want to change that.”
Cytotoxic T cells play an important role
“I am extremely proud of ASH’s role in communicating our mem-
bers’ concerns to ABIM,” ASH President David A. Williams, MD, told in the immune defense mechanism by identifying
ASH Clinical News. “The Society took a principled position, raising a T cell Target cell and eliminating malignant target cells. T cells bind
series of concerns in a letter to the ABIM 14 years ago, and we have con- • By the end of 2015, ABIM will assure new and more flexible ways to antigens on the surface of target cells, inducing
tinued to press for change.” for internists to demonstrate self-assessment of medical knowl-
the release of cytotoxic components.1,2
The changes to the MOC program announced in 2014 included mov- edge by recognizing most forms of ACCME-approved Continuing
ing the once-every-10-years MOC program to a more continuous one, Medical Education.
requiring physicians to complete some MOC activity every two years
and accrue 100 MOC points every five years. Under the new program, “While ABIM’s Board believes that a more-continuous certification helps
physicians failing to do so would be reported as “not meeting MOC all of us keep up with the rapidly changing nature of modern medical However, malignant cells can evade
requirements.” practice, it is clear that parts of the new program are not meeting the
destruction by cytotoxic T cells. Mechanisms
Not surprisingly, those requirements were met with much contro- needs of physicians like yourself,” Dr. Baron concluded. “We got it wrong
of evading the immune system can include
versy, as evidenced by an anti-MOC petition started in March 2014 and sincerely apologize. We are sorry.”
(currently signed by more than 22,000 physicians) and another 7,000+ The ABIM has also pledged to work more closely with medical soci- T cell Malignant cell impaired antigen presentation, blockade of
pledging “non-compliance” in protest of the MOC changes. eties and diplomates to open up the lines of communication regarding T-cell receptor signaling, loss of regulatory
“This change generated legitimate criticism among internists and the MOC program, via meetings, webinars, forums, online communica- control of negative costimulatory signals,
medical specialty societies,” Dr. Baron wrote in the press release from tions channels, surveys, and more. and secretion of immunosuppressive factors.3
ABIM. “Some believe ABIM has turned a deaf ear to practicing physi-
cians and has not adequately developed a relevant, meaningful program ASH Continues to Advocate for Its Members
for them as they strive to keep up to date in their fields.”
When the sweeping changes to ABIM’s MOC program were announced
last year, ASH ramped up efforts to make sure its members’ voices were
What Do These Changes Mean for Clinicians? Novel Bispecifi c T cell Engager (BiTE®)
heard.
In response to those concerns, ABIM announced the following changes In March 2014, the American College of Physicians (ACP) convened antibodies are designed to bridge T cells and target
a meeting of internal medicine and subspecialty societies. The ACP then
to its MOC program on February 3: cells with the goal of overcoming malignant cells’
presented the ABIM with a letter, co-signed by ASH, outlining concerns T cell Malignant cell
evasion of the immune system.3,4 The clinical signifi cance
• Effective immediately, ABIM is suspending the Practice Assessment, and recommendations discussed during that meeting, including: BiTE®
of this is currently being investigated by Amgen.
Patient Voice and Patient Safety requirements for at least two years
– meaning that no internist will have his or her certification status • Proving the benefit of MOC
changed for not having completed activities in these areas for at * Proposed mechanism of BiTE® function.
least the next two years. • Increasing financial transparency
• Within the next six months, ABIM will change the language used to • Streamlining the approval process for societies’ Part II products
publicly report a diplomate’s MOC status on its website from “meet-
ing MOC requirements” to “participating in MOC.” (Dr. Baron did “While action taken by ABIM this week marks a critical first step to-
For more information
note that, because the changes being made are significant, it will ward addressing the concerns voiced by ASH, several additional steps www.BiTEAntibodies.com
about the immediate Learn more about BiTE® technology at
take time until providers’ individual status pages to be updated on must be taken by ABIM and other Boards requiring MOC, including
changes, visit the ABIM’s
the ABIM website.) moving away from a closed-book examination delivered in a secured
MOC FAQ page at www.
location to an examination experience that reflects current access to
abim.org/maintenance-of-
• ABIM is updating the Internal Medicine MOC exam. The update medical information,” Dr. Williams said in a statement. “ASH also certification, or scan the
will focus on making the exam more reflective of what physicians in believes that steps must be taken that recognize the unique contribu- QR code below:
tions and circumstances of physician scientists. ASH looks forward
practice are doing, with any changes to be incorporated beginning
to working with ABIM as it makes these important changes to the
fall 2015, with more subspecialties to follow.
recertification program.”
MOC issues will continue to be a hotly debated issue, and ASH
• MOC enrollment fees will remain at or below the 2014 levels will continue to advocate on behalf of its ABIM-certified members
through at least 2017. through multiple channels. ●
© 2014 Amgen Inc. All rights reserved. 79963-R1-V3 Visit BiTEAntibodies.com
References: 1. Leone P, Shin EC, Perosa F, Vacca A, Dammacco F, Racanelli V. J Natl Cancer Inst. 2013;105:1172-1187. 2. Warrington R, Watson W, Kim HL, Antonetti FR. Allergy Asthma Clin Immunol. 2011;7(suppl 1):S1.
3. Rabinovich GA, Gabrilovich D, Sotomayer EM. Annu Rev Immunol. 2007;25:267-296. 4. Baeuerle PA, Reinhardt C. Cancer Res. 2009;69:4941-4944.
6 ASH Clinical News February 2015
08-04395_R01_AAUS_BiTE_JAKingSze_ASH_ClnNws.indd 1 1/14/15 5:23 PM
Amgen Journal Ad Tabloid Size - ASH_ClnNws
Trim: 10.5”x 14” Bleed: 10.75”x 14.25”
BiTE®
An investigational
technology from
Amgen
Bispecifi c T cell Engager (BiTE®):
Engaging the immune system to
target malignant cells*
Cytotoxic T cells play an important role
in the immune defense mechanism by identifying
T cell Target cell and eliminating malignant target cells. T cells bind
to antigens on the surface of target cells, inducing
the release of cytotoxic components.1,2
However, malignant cells can evade
destruction by cytotoxic T cells. Mechanisms
of evading the immune system can include
T cell Malignant cell impaired antigen presentation, blockade of
T-cell receptor signaling, loss of regulatory
control of negative costimulatory signals,
and secretion of immunosuppressive factors.3
Novel Bispecifi c T cell Engager (BiTE®)
antibodies are designed to bridge T cells and target
cells with the goal of overcoming malignant cells’
T cell Malignant cell
evasion of the immune system.3,4 The clinical signifi cance
BiTE®
of this is currently being investigated by Amgen.
* Proposed mechanism of BiTE® function.
www.BiTEAntibodies.com
Learn more about BiTE® technology at
© 2014 Amgen Inc. All rights reserved. 79963-R1-V3 Visit BiTEAntibodies.com
References: 1. Leone P, Shin EC, Perosa F, Vacca A, Dammacco F, Racanelli V. J Natl Cancer Inst. 2013;105:1172-1187. 2. Warrington R, Watson W, Kim HL, Antonetti FR. Allergy Asthma Clin Immunol. 2011;7(suppl 1):S1.
3. Rabinovich GA, Gabrilovich D, Sotomayer EM. Annu Rev Immunol. 2007;25:267-296. 4. Baeuerle PA, Reinhardt C. Cancer Res. 2009;69:4941-4944.
08-04395_R01_AAUS_BiTE_JAKingSze_ASH_ClnNws.indd 1 1/14/15 5:23 PM
Pulling Back the Curtain
Benjamin Ebert, MD, PhD
We can learn much more from the innovators and mentors in hematology and
oncology than clinical expertise. In Pulling Back the Curtain, we speak with
hematology/oncology professionals about how they approach their leadership
positions and what advice they would give those just getting started in the field.
Benjamin Ebert, MD, PhD, from Brigham and Women’s Hospital and Harvard
Medical School, spoke with ASH Clinical News about the importance of great
mentors and juggling work and life outside of medicine.
Benjamin Ebert, MD, PhD,
with his family.
What was your first job? in math were actually just afraid think that clinical medicine is Is there any other career
In high school, I built up a little of it; my role was often just to impenetrable, and biochemists you can see yourself in
business for myself as a math help them realize that it wasn’t may think computational ap- besides medicine?
tutor for kids of all ages – kin- that hard, and they became proaches are unfathomable, but Despite a distinct lack of talent,
dergarten through high school. excited to be able to do it. all these scientists can under- I always thought I’d enjoy being
This is when I first realized that I see that still today: clini- stand the other disciplines given an architect. The idea of creating
I enjoy teaching. So many of the cians may think that biochem- time and effort. something with a defined set of
kids I tutored who had trouble istry is difficult, geneticists may tools and approaches appeals to
me in the same way as scientific
research. Both have the potential
The number of things one is asked to
for tremendous creativity within
physical or technical constraints.
do rapidly exceeds the available time, so
My mother is an artist and pho-
tographer, but I, unfortunately,
prioritizing and deciding what you can and
did not inherit her artistic talents.
My attempts at making drawings
cannot agree to do is essential. in gross anatomy class in medical
school were indecipherable.
8 ASH Clinical News February 2015