The n e w e ng l a n d j o u r na l of m e dic i n e

impasse. Gun-control advocates blame the NRA,
but perhaps the NRA is less like a foreign patho-
gen that has invaded our body politic, to which
we could mount an immune response, than like
a cancer, growing from our own mutated cells.
And that dangerous mutation seems to be a sad
distortion of the American principle of individu-
alism that prioritizes ones right to live the way
one wants, without any government interference,
not be able to diminish its power. Too many
Americans will continue to get their hands on
assault weapons, too many will kill or maim
other Americans, and we will continue to bicker
about whether the first step is more research or
better mental health care while we continue
to do nothing to cure the disease.
Disclosure forms provided by the authors are available with
the full text of this article at NEJM.org.

over other peoples right to live at all a distor-
tion that has found one of its key expressions in
firearm-related freedoms. But gun violence is an
assault on the health of the public. An equally
fundamental American principle holds that en-
suring the public health sometimes requires curb-
ing the rights of individuals in order to benefit
and protect the community as a whole.
Previous commentators including Hemenway
and Miller have listed among the steps toward
reducing gun violence changing social norms.6
Given that it requires deep cultural changes,1
however, that is far easier said than done it
is, as Wintemute has argued, the work of gen-
erations.7 But it is work that we need to begin.
This article was published on December 16, 2015, at NEJM.org.
1. Kassirer JP. Guns, society, and medicine. N Engl J Med 2015;
372:874-5.
2. Sacks CA. In memory of Daniel reviving research to pre-
vent gun violence. N Engl J Med 2015;372:800-1.
3. Steinhauer J. Mass shootings stoke ideological fighting in
Congress. New York Times. December 3, 2015 (www.nytimes.com/
2015/12/04/us/politics/congress-shifts-attention-to-americas-role
-in-the-world.html?_r=0).
4. Quealy K, Sanger-Katz M. In other countries, youre as likely
to be killed by a falling object as by a gun. The Upshot. December
4, 2015 (www.nytimes.com/2015/12/05/upshot/in-other-countries
-youre-as-likely-to-be-killed-by-a-falling-object-as-a-gun.html).
5. Friedman RA. Violence and mental illness how strong is
the link? N Engl J Med 2006;355:2064-6.
6. Hemenway D, Miller M. Public health approach to the pre-
vention of gun violence. N Engl J Med 2013;368:2033-5.
7. Wintemute GJ. Tragedys legacy. N Engl J Med 2013;368:397-9.

If we never address the underlying beliefs that DOI: 10.1056/NEJMe1515975

sustain this guns-everywhere extremism, we will Copyright 2015 Massachusetts Medical Society.

Califf for the FDA

JeffreyM. Drazen, M.D.

Robert M. Califf, M.D., has been nominated to
be the next head of the Food and Drug Admin-
istration (FDA); he currently serves as Deputy
Commissioner for the Office of Medical Prod-
ucts and Tobacco. We think his confirmation as
commissioner should proceed as quickly as pos-
sible. Because the FDA oversees the safety and,
in some spheres, the efficacy of products that
constitute about 25% of our economy, the coun-
try needs a strong and experienced leader who
can keep the FDA focused on its mission.
Since Califf was nominated to succeed Mar-
garet Hamburg, numerous individuals and groups
have endorsed his candidacy.1-3 His noted
strengths include his experience in the testing of
new and established drugs for efficacy; his suc-
cessful career at Duke University, where he was
the founding director of the Duke Clinical Re-
search Institute, by many measures one of the
premier academic research organizations in the
world; and until his FDA nomination, his tenure
as head of the Duke Translational Medicine In-
stitute and professor of medicine at Duke Uni-
versity. Over his 30-year academic career, he has
published more than 1200 peer-reviewed publi-
cations, work he has authored has been cited
over 50,000 times, and his Web of Science h-index
is 118. But academic output has not been his
primary goal; instead, he has worked to accrue
the data needed to improve patient care. Despite
this laudable aim, a few concerns have been
expressed about his associations with industry,
and these concerns may have caused some to
withhold support for his nomination.4-6
Like Califf, we believe that our actions should
be driven by data, not innuendo. Since 2005,
Califf has reported, as an investigator, the out-
comes of seven clinical trials sponsored solely by
industry in primary publications in major gen-
eral medical journals.7-13 Of these trials, four had

176 n engl j med 374;2nejm.org January 14, 2016

The New England Journal of Medicine

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Copyright 2016 Massachusetts Medical Society. All rights reserved.
 Editorials
a negative outcome (i.e., not favoring the inter-
vention), two favored the intervention, and one,
with a factorial design, had a mixed outcome.
Given this performance, it is impossible to argue
that Califf has a pro-industry bias. On top of this,
for the past 3 years the vast majority of his fund-
ed salary came from leadership roles in the Clini-
cal Translational Science Award from the Na-
tional Institutes of Health (translational medicine),
the NIH Collaboratory, the Patient-Centered Out-
comes Research Network (large-scale population
health research), and the Duke Center for Medi-
care and Medicaid Innovation (CMMI) project,
which developed a model approach to health
care disparities in diabetes, using geospatial
mapping to deliver clinical care and social sup-
port more effectively.
Our association with Califf grows from a
decade of mutual service on the Forum on Drug
Discovery, Development, and Translation of the
Institute of Medicine (now the National Acade-
my of Medicine). Through this decade of service,
Califfs primary interest was clearly in gathering
and using solid information to promote the
health and well-being of people suffering from
disease. His aim was always to find better ways
to diagnose and treat illness. He wanted well-
gathered data on which to base all our clinical
decisions and wanted to design and implement
health systems that worked effectively to im-
prove the outcomes of individuals and popula-
tions. Califfs experience, his proven leadership
abilities, his record of robust research to guide
clinical practice, and his unwavering dedication
to improving patient outcomes are unsurpassed
qualifications for the post of commissioner of
the FDA; we strongly endorse his nomination
and urge the Senate to act favorably on it.
Disclosure forms provided by the author are available with the
full text of this article at NEJM.org.
The Obesity Epidemic Understanding the Disease
and the Treatment
CarolineM. Apovian, M.D.
The prevalence of severe obesity in the United
States has increased dramatically, not only among
adults but also among children. The increase in
childhood severe obesity, defined as 120% of the
age-specific 95th percentile of body-mass index
n engl j med 374;2nejm.org January 14, 2016
The New England Journal of Medicine
Downloaded from nejm.org on February 10, 2017. For personal use only. No other uses without permission.
Copyright 2016 Massachusetts Medical Society. All rights reserved.
This article was published on October 28, 2015, at NEJM.org.
1. American Heart Association. American Heart Association
praises Califf nomination for FDA commissioner. September 17,
2015 (http://newsroom.heart.org/news/american-heart-association
-praises-califf-nomination-for-fda-commissioner).
2. Herper M. Robert Califf could transform the FDA the
right way. Forbes. September 16, 2015 (http://www.forbes.com/
sites/matthewherper/2015/09/16/robert-califf-could-transform
-the-fda-the-right-way).
3. Ginsberg S. Why Robert Califf deserves to be FDA commis-
sioner. U.S. News and World Report. October 7, 2015 (http://
health.usnews.com/health-news/patient-advice/articles/2015/10/
07/why-robert-califf-deserves-to-be-fda-commissioner).
4. Tavernise S.F.D.A. nominee Califfs ties to drug makers
worry some. New York Times. September 19, 2015 (http://www
.nytimes.com/2015/09/20/health/fda-nominee-califfs-ties-to-drug
-industry-raise-questions.html).
5. Wagner J. Bernie Sanders to oppose Obamas nominee to
lead the FDA. The Washington Post. October 8, 2015 (https://
www.washingtonpost.com/news/post-politics/w p/2015/10/08/
bernie-sanders-to-oppose-obamas-nominee-to-lead-the-fda/).
6. Achen P. Shumlin:oppose FDA chief nominee. Burlington
Free Press. September 23, 2015 (http://www.burlingtonfreepress
.com/story/news/2015/09/23/shumlin-oppose-fda-chief-nominee/
72684804/).
7. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe
added to statin therapy after acute coronary syndromes. N Engl
J Med 2015;372:2387-97.
8. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus
warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;
365:883-91.
9. The NAVIGATOR Study Group. Effect of valsartan on the
incidence of diabetes and cardiovascular events. N Engl J Med
2010;362:1477-90.
10. The NAVIGATOR Study Group. Effect of nateglinide on the
incidence of diabetes and cardiovascular events. N Engl J Med
2010;362:1463-76.
11. Giugliano RP, White JA, Bode C, et al. Early versus delayed,
provisional eptifibatide in acute coronary syndromes. N Engl J
Med 2009;360:2176-90.
12. Mahaffey KW, Cohen M, Garg J, et al. High-risk patients
with acute coronary syndromes treated with low-molecular-
weight or unfractionated heparin: outcomes at 6 months and 1
year in the SYNERGY trial. JAMA 2005;294:2594-600.
13. Alexander JH, Hafley G, Harrington RA, et al. Efficacy and
safety of edifoligide, an E2F transcription factor decoy, for pre-
vention of vein graft failure following coronary artery bypass
graft surgery: PREVENT IV: a randomized controlled trial. JAMA
2005;294:2446-54.
DOI: 10.1056/NEJMe1513828
Copyright 2015 Massachusetts Medical Society.
(BMI), has been alarming; the prevalence has
risen from 4% during 19992004 to 6% during
20112012.1,2
Although the use of healthy lifestyle ap-
proaches to treat younger children with obesity
177