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ABIM Releases
Assessment of Its
Maintenance of
Certification Program
The American Board of Internal Medicine’s
(ABIM) Assessment 2020 Task Force has released a report evaluating the organization’s
Certification and Maintenance of Certification (MOC) programs. The Assessment
2020 Task Force, convened in 2013 to “develop a vision for the future of assessment in
internal medicine and associated subspecialties,” included members of ABIM leadership
and experts in assessment, education, health
care, and consumer advocacy, according to a
press release from the agency.
The report, “A Vision for Certification
in Internal Medicine in 2020,” is designed to
guide ongoing reform of ABIM’s Certification and MOC programs and offers three
key recommendations:
• Change the MOC exam by replacing
the 10-year MOC exam with more
meaningful, less burdensome assessments.
• Focus assessments on cognitive skills
(to assure the public that physicians are
staying current with the clinical knowledge relevant to patient care) and technical skills (to ensure that physicians
can apply that knowledge to adequately
perform the technical procedures appropriate to the discipline).
• Recognize the need for certification in
specialized areas, without the requirement to maintain underlying certificates, while being transparent about
specialization to the public.
“Feedback collected by the Assessment
2020 Task Force is very consistent with feedback ABIM is hearing from the community
regarding the MOC program,” said Richard
J. Baron, MD, president and chief executive
officer of ABIM. “These recommendations
are meant to be a catalyst for further discussion and can ultimately lead to an improved
MOC program for diplomates.”
ABIM reported that it has started
actively exploring the implementation of the
recommendations through a subcommittee
consisting of members of both the ABIM
Council and Board of Directors.
“The Assessment 2020 Task Force
members provided useful insights and
recommendations that will be instrumental
as we reshape certification to meet physicians’ and society’s changing needs,” said
Clarence H. Braddock III, MD, chair of the
24
ASH Clinical News
ABIM Board of Directors. “We now need to
hear constructive feedback from the internal
medicine community on these recommendations, begin to determine their feasibility,
and develop implementation plans where
needed.”
In response to criticism from multiple
medical associations and members of the
internal medicine community that at times
has been vitriolic over the past year – since
it announced that physicians must complete
some MOC activity every two years and accrue 100 MOC points every five years or be
labeled as “not meeting MOC requirements”
– ABIM has made a number of changes to
its Cert ification and MOC programs. ASH
Clinical News will be taking a more in-depth
look at the proposed changes – and ASH’s
response – in the coming issues.
Source: ABIM press release, September 16, 2015; ABIM, “A Vision for
Certification of Internal Medicine in 2020.”
At press time, ASH was in the process of drafting comments to ABIM to be submitted by October 30.
ASH’s comments will address both the recently
released Task Force’s report and ASH’s concerns with
the reform of ABIM’s Certification and MOC program
in general.
USPSTF Issues Draft
Report Recommending
Aspirin Use to Prevent
Cancer
The United States Preventive Services
Task Force (USPSTF) published a draft
report recommending daily use of lowdose aspirin among people 50 to 69 years
of age to prevent colorectal cancer and
cardiovascular disease; aspirin is currently
recommended for the prevention of heart
attacks and stroke. The new report states
that the benefits of taking 81 mg of aspirin
daily outweigh the risks in adults 50 to 69
years old who are at an increased risk for
cardiovascular disease and who are not
at an increased risk for bleeding. Notably,
the largest benefit was seen for adults in
their 50s, and the recommendation does
not extend to people younger than 50
years old or older than 70.
The recommendation is based on a
series of evidence reviews commissioned
by the USPSTF, which found that aspirin
use decreased colorectal cancer deaths by
33 percent and reduced colon cancer incidence by 40 percent. The review indicated
that people should take aspirin for five
to 10 years to see this reduction in risk.
Aspirin use, however, increased stomach
bleeds by approximately two-thirds and
it increased the risk for hemorrhagic
stroke by 33 percent – although incidence
remained low (2.54 strokes per 1,000
person-years). Use of low-dose aspirin
could also result in up to two bleeding
adverse events per 1,000 people each year,
according to the report. The USPSTF
noted that more research on this was necessary to determine how aspirin interacts
with other medications used.
whole-genome sequencing on this scale
would cost $2 billion to perform on the
intended 1 million participants, while genotyping costs just $30 to $40 per participant. President Obama has called for $130
million in funding for the study, though
the funding is not currently guaranteed.
Source: Reuters, “NIH takes next steps in Obama’s precision medicine plan,”
September 17, 2015.
Source: USPSTF, “Draft recommendation statement: Aspirin to prevent
cardiovascular disease and cancer,” September 14, 2015.
Supplemental New Drug
Application Submitted
NIH Approves Study
Blueprint for the Preci- for Ibrutinib in
sion Medicine Initiative, Treatment-Naïve Chronic
Lymphocytic Leukemia
Plans Enrollment for
The U.S. Food and Drug Administration
Early Next Year
(FDA) has received a supplemental new
The National Institutes of Health (NIH)
approved the framework for building a
large research cohort as part of President
Obama’s Precision Medicine Initiative.
Josephine Briggs, MD, the director of
the National Center for Complementary
and Integrative Health, will serve as acting
director of this new initiative.
The NIH will examine data from U.S.
citizens of all ages, races, and socioeconomic groups, looking at the associations
among genetic, molecular, environmental,
and behavioral factors and disease onset,
treatment response, and health outcomes.
The study aims to enroll 1 million volunteers over the next three to four years.
NIH Director Francis Collins, MD,
PhD, said he would “act immediately”
on recommendations delivered by the
Precision Medicine Initiative Working
Group that developed the framework for
the study; he hopes that study recruitment
will begin as early as 2016. Participation is
open to all individuals who want to take
part, but Dr. Collins noted that volunteers
in the study will come from two paths:
individuals who wish to take part and
people already enrolled in large studies
through their health-care providers.
Study participants will undergo a
standard baseline examination for vital
signs and a medication assessment, and
will provide a medical history and blood
sample. Electronic medical data and
health survey information will also be collected. The study also aims to tap into data
gathered via smartphone fitness trackers,
which will provide information on lifestyle habits and environmental exposures.
Though the study seeks eventually to
include whole-genome sequencing data,
initial genetic tests will likely only include
genotyping. Dr. Collins estimated that
drug application (sNDA) for ibrutinib as
frontline therapy in patients with chronic
lymphocytic leukemia (CLL). The sNDA
filing is based on the results of the phase
III, randomized, multicenter, open-label
RESONATE-2 trial that compared the
safety and efficacy of ibrutinib with chlorambucil in 269 patients who are 65 years
or older with treatment-naïve CLL or small
lymphocytic lymphoma (SLL). Ibrutinib
led to longer progression-free survival
(PFS; the study’s primary endpoint) and
was superior to chlorambucil on secondary efficacy endpoints, including overall
survival (OS), overall response rate, and
hematologic function. The most commonly
reported adverse events associated with
ibrutinib included thrombocytopenia,
neutropenia, diarrhea, anemia, fatigue,
musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash.
Ibrutinib has been previously approved in the United States to treat patients with CLL who have received at least
one prior therapy and CLL with del17p, as
well as those with Waldenström macroglobulinemia and those with mantle cell
lymphoma who have received at least one
prior therapy.
Source: Janssen Biotech press release, September 14, 2015.
FDA Grants Priority
Review to Carfilzomib
for Relapsed Multiple
Myeloma
The U.S. FDA granted priority review
for the sNDA submitted for carfilzomib
November 2015