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PE R S PE C T IV E FDA’s Proposed Ban on Menthol Cigarettes

Waxman recently noted. Menthol winding, and uncertain. Oppo- and e-cigarettes, will also hinge
remained legal, pending review nents worry that a ban would on the history of marketing —
by the newly created TPSAC. create a black market for men- how companies have used these
In referring the issue to the thol cigarettes and profound dif- products to encourage blacks,
FDA, Congress set the stage for a ficulties in enforcement; propo- women, and young people to take
decade of litigation. In 2011, the nents insist that the science and up a behavior with serious pub-
TPSAC determined that evidence the law are on their side and that lic health consequences.
suggested that “removal of men- the public health benefits are Disclosure forms provided by the author
thol from the marketplace would overwhelming. Bans or restric- are available at NEJM.org.

benefit public health in the Unit- tions have been instituted in From the Woodrow Wilson School of Public
ed States” but made no recom- Canada and in several U.S. cities, and International Affairs, Princeton Univer-
sity, Princeton, NJ.
mendations about banning prod- including Somerville, Massachu-
ucts.5 Tobacco companies quickly setts, and San Francisco. New This article was published on February 20,
challenged the committee’s legiti- York’s City Council recently be- 2019, at NEJM.org.
macy, charging that some of its gan hearings on a ban. With bil- 1. Gottlieb S. Statement from FDA Com-
members harbored conflicts of lions of dollars at stake, it may missioner Scott Gottlieb, M.D., on proposed
interest. In 2014, a U.S. District take years of litigation for Gott- new steps to protect youth by preventing ac-
cess to flavored tobacco products and ban-
Court agreed, but in 2016, a fed- lieb’s promise of better health to ning menthol in cigarettes. Silver Spring,
eral appeals court overturned this be realized. MD:​Food and Drug Administration, Novem-
ruling. For the next 2 years, how- The questions surrounding ber 15, 2018 (https://www​.fda​.gov/​NewsEvents/​
Newsroom/​PressAnnouncements/​UCM625884​
ever, the FDA was reluctant to act menthol are intertwined with .htm).
on menthol. the agency’s decisions regarding 2. Family Smoking Prevention and Tobacco
Now, nearing the 10th anni- e-cigarettes. Although the indus- Control Act, Pub. L. No. 111-31, 123 Stat.
1804(e)(1) (111th Cong.) (https://www​.govinfo​
versary of the 2009 legislation, try argues that there’s no scien- .gov/​content/​pkg/​PLAW​-­111publ31/​html/​PLAW​
Gottlieb seems poised to act, tific evidence that menthol is haz- -­111publ31​.htm).
though the agency has yet to take ardous or addictive, the health 3. Brown & Williamson Tobacco Corpora-
tion. Stipulation as to the Facts and Agreement
the next crucial step by propos- effects of menthol smoking are to Cease and Desist, file no. 1-14737. 1942
ing the new rule. To date, no worrisome; similar concerns sur- May 22. Brown & Williamson Records;​
hearings on banning combustible round e-cigarettes. As the case is Minnesota Documents (https://www​.industry
documentslibrary​.ucsf​.edu/​t obacco/​docs/​
menthol tobacco products have made against menthols, the scien- mrdc0136).
been scheduled. The industry has tific issues will be extensively de- 4. Quinn M. Don’t aim that pack at us. Time.
responded to the proposal with a bated: the likelihood of increased January 29, 1990 (http://content​.time​.com/​
time/​magazine/​article/​0,9171,969261,00​.html).
familiar tactic: claiming that sci- addiction, the question of added 5. Food and Drug Administration. Prelimi-
ence does not support such a ban difficulty in quitting smoking, nary scientific evaluation of the possible
and threatening litigation. and the health consequences of public health effects of menthol versus
nonmenthol cigarettes (https://www​.fda​.gov/​
If the past is prologue, any deep inhalation. But the regula- downloads/​ucm361598​.pdf).
path to removing menthol ciga- tory debates and legal challenges DOI: 10.1056/NEJMp1900204
rettes from shelves will be long, to come, regarding both menthol Copyright © 2019 Massachusetts Medical Society.
FDA’s Proposed Ban on Menthol Cigarettes

When Sparks Fly

When Sparks Fly — Or How Birding Beat My Burnout


Joshua Schor, M.D.​​

A  little more than a year ago, I


took up birding as a hobby.
As a child and into my 20s, I
the tragic disappearance of hob-
bies from young people’s lives,
though given that I’m approach-
my cognition and stave off other
erosions by a few more years.
What I’ve discovered is that a tiny
built model airplanes, shot rifles ing 60, my adoption of a new hob- part of me that long reveled in
(don’t ask), and chased the planets. by won’t really move the needle making a “great diagnosis” was
Since that time, I have not had a for the young. Nevertheless, I burning out, and birding has
bona fide hobby. I have read about thought maybe it would preserve helped me have some fun again.

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PERS PE C T IV E When Sparks Fly

piper are almost identical “peeps,”


but for the slightly richer, choco-
latey brown back on the former
and the darker legs on the latter.
Similarly, distinguishing two close-
ly related vasculitides, such as
Behçet’s and Buerger’s diseases,
depends on the caliber of the
blood vessel that’s inflamed. Mak-
ing such fine distinctions is what
birders and diagnosticians have in
common. More telling may be the
ways in which the two diverge.
In 1984, during a neurosurgi-
cal rotation in my fourth year of
medical school, a few classmates
American Oystercatcher. and I met a young woman with a
headache who had the subtlest in-
Many birders can recall a par- identifying a rare bird presents dications of frontal release. That
ticularly beautiful “spark bird” challenges not unlike those of she ended up in this particular
that materialized out of the sky deriving a diagnosis from a puz- clinic meant that someone had
and inspired them to take up the zling set of medical findings. suspected a neurologic condition,
binoculars. My spark bird ap- Birds have “field marks” such as but the attending physician had
peared across a shimmering blue wing bars, eye rings, and plum- us speak with and examine her
bay one fine Sunday morning last age changes, as well as distinct before committing to a diagnosis;
July. I was biking in Sandy Hook, habitats such as the salt marshes we settled on a frontal lobe tumor.
New Jersey, eager to get in my favored by oystercatchers or the When the CT scan confirmed
requisite miles, when I passed a tip-tops of trees chosen by glitter- that there was a meningioma in
turn-off that I’d passed many ing American goldfinches. These the anterior of her brain, my fel-
times before. I noticed a wood features, along with behaviors low students and I had to stifle
platform projecting into Sperma- such as pumping their tail up and our reflexive grins. Though we
ceti Cove near parking lot E. An down (palm warblers and phoebes) genuinely felt compassion for the
older man with a spotting scope or dashing off a tree limb to woman (who did well after resec-
was gazing out toward a sandbar. snag a tasty fly (great crested tion of the tumor), the awkward-
He offered me a peek, following flycatchers and eastern wood- ness of that moment helped crys-
Rule 4a of the American Birding pewees), are akin to signs and tallize for me that what may have
Society Code of Ethics: “Freely symptoms such as pallor, dyspnea, been a great day for me in terms
share your knowledge and expe- rusty sputum, and fatigue. Throw of my budding ability was possi-
rience. . . . Be especially helpful in the countless songs of the bly the worst day for the patient.
to beginning birders.” If you’ve songbirds — the rales and mur- With all our years of training
never seen an American oyster- murs of the avian world — and to “get it right,” is it a failing to
catcher (Haematopus palliates), I can you have yourself a set of clues celebrate making a correct rare
tell you that its graceful red beak worthy of a tricky CPC case. diagnosis? Imagine the oncologist
Keith Ramos, U.S. Fish and Wildlife Service.

and fiery orange-yellow eyes throw The birder, author, and artist for the first time piecing the clues
its black and brown feathers into David Sibley has said that the together to diagnose a newly re-
eye-catching relief (see photo). In trick to identifying a baffling bird ported rare cancer. Does the phy-
the 1800s, the species had been is not finding the traits it has in sician’s repeated repression of so
hunted to near-extinction for its common with another similar many feel-good moments contrib-
plumage and for sport, but now bird, but discerning with a sensi- ute in even a tiny way to burnout
there are nearly 50,000 along the tive eye and ear the differences in medicine? Has it resulted in too
U.S. Eastern Seaboard alone. between them. The least sand- much gallows humor, too many
Intriguingly, I’ve found that piper and the semipalmated sand- dehumanizing moments of “us

998 n engl j med 380;11 nejm.org March 14, 2019

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PE R S PE C T IV E When Sparks Fly

versus them”? The real challenge, of me. I’m now good at hiding microscopes whose H&E-stained
of course, is to align your won- that pleasure, but too much con- images and Gram stains I once
der as a medical scientist with cealment can hurt. Osler called gazed at with awe. Birding even
your compassion as a fellow hu- pneumonia the “captain of the includes in its code of ethics a
man and so ally with your pa- men of death,” and as someone directive to be kind to the nov-
tient in fighting the disease. Per- who cares for the frail elderly, I ice, much like medical training’s
haps birding has enabled me to know exactly what he meant — well-intentioned “see one, do one,
enjoy the diagnostic thrills of but would I dare toss off such a teach one.”
medicine that I once so appreci- characterization to a patient or I have prided myself on avoid-
ated but that I often quashed in her family? ing frank, diagnosable burnout,
an effort to be “professional” and So maybe birding has saved me but maybe there was a subclini-
compassionate. from zero-sum and landed me in cal form that needed treatment.
A colleague tells me that to win–win. When I nail a tricky Others with more talent can stave
diagnose occult depression, he identification by distinguishing off burnout with sculpting or
sometimes asks a patient “When between the common tern and music or marathoning. Though I
was the last time you had fun?” the Forster’s tern using only my strive to be a sober and sensitive
Ask yourself the same about your eyes and ears, I feel the joy of a physician, some days I miss the
medical life. We know that ours differential diagnosis well played. joy of making a tough diagnosis
is a solemn occupation, and we I immerse myself in the majestic and singing it from the treetops.
have committed under oath to be migrations of fall and spring, the Birding helps me beat the burnout.
serious and sober practitioners. trace of a bird on the wing bring- Disclosure forms provided by the author
But there is a zero-sum feature to ing the loveliness of a common are available at NEJM.org.
the way I sometimes seem to prac- yellowthroat and its soft song. As From Daughters of Israel, West Orange, NJ,
tice medicine, as if my pleasure the new joy of diagnosing bird and OptumHealth, Eden Prairie, MN.
in my craft subtracts from the species suffuses my life, perhaps DOI: 10.1056/NEJMp1812109
emotions of the patient in front my binoculars substitute for the Copyright © 2019 Massachusetts Medical Society.
When Sparks Fly

Interactive Perspective: Major Events in


the Life Course of New Drugs, 2000–2016
An interactive
This interactive graphic allows viewers to explore data — gathered by Reed F.
perspective is Beall, Thomas J. Hwang, and Aaron S. Kesselheim — on the time required for
available at investigational drugs to reach important U.S. milestones, such as new drug
NEJM.org applications, FDA approval, expiration of market exclusivity, and market entry of
a generic version. Data may be viewed by individual drug, therapeutic class,
approval pathway, and approval year, as well as in aggregate.

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Downloaded from nejm.org at EAST CAROLINA UNIVERSITY on March 13, 2019. For personal use only. No other uses without permission.
Copyright © 2019 Massachusetts Medical Society. All rights reserved.

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