Page 11 - 2022 Spring JSOM

To the Editor: While the device used and described in our manuscript is not
FDA approved, it was used on a very select group of patients
In the Spring Vol 21, Ed 1, 2021 Journal of Special Operations
Medicine (JSOM), we published the following article: “Mak- in a resource-constrained setting with strong precautions in
ing Use of Your Assets: Clinical Use of EOD Radiography in place. The information gained from its use impacted medical
the Forward Deployed Setting.” This article was a collabora- decision making and prevented critical disruption to the mis-
tive effort between deployed joint Servicemembers regarding sion. Ultrasound, the only other imaging device available, did
austere medical care from 2018 through 2019 and was ac- not provide the same information.
cepted for publication by JSOM in 2020. The Summer 2021
edition of JSOM included a removal notice of our article from The two claims directed at us implied a lack of integrity and
the digital platform based on two claims: (1) prepublication honesty. Off-label use, improvised devices, and use of non–
approval by commander and public affairs officer (PAO) was US-developed medicines and treatments have all faced scru-
not obtained and (2) only FDA-approved devices/products are tiny. These differences of opinions have a place in academic
eligible for use. medicine and help to guide future research and development
of technologies and practices. This is especially important for
the military in austere environments with limited capabilities.
The authors did receive prepublication approval. Per AR 360-
1, The Army Public Affairs Program, manuscript clearance is We applaud JSOM for continuing to support discussions re-
handled by the PAO at the local level and is escalated only if garding innovative uses of resources to further medical re-
the material cannot be cleared at the local level. JSOM author search and battlefield medicine.
1
requirements state all submissions must be preapproved by Very respectfully,
one’s commander and PAO prior to submission. At the time of MAJ Caitlin Howard, MD
manuscript development, all authors were assigned or tasked CPT Shawn Veach, BSN
to units reporting to the Combined Joint Task Force (CJTF). LtCol Regan Lyon, MD
Respective unit commanders, the Special Operations Joint MAJ K. Aaron Shaw, DO
Task Force (SOJTF), and the CJTF approved the manuscript
for submission.
References
1. United States Government US Army. Army Regulation 360-1. The
The second claim is the provision of care using non–FDA- Army Public Affairs Program. Washington, DC: Department of
approved devices. The US Food and Drug Administration the Army, 2020.
(FDA) regulates the sale of medical devices and certain treat- 2. AAPM Task Group 121. Off-Label Use of Medical Products in
ments; the FDA does not claim to exercise authority over phy- Radiation Therapy. College Park, MD: American Association of
sician practice. According to the FDA, Physicists in Medicine, 2010.
2,3
3. US Food and Drug Administration. FDA’s Role in Regulating Med-
“Good medical practice and the best interests of the pa- ical Devices. Washington, DC: US Food and Drug Administration,
2018.
tient require that physicians use legally available drugs, 4. US Food and Drug Administration. “Off-Label” and Investiga-
biologics and devices according to their best knowledge tional Use of Marketed Drugs, Biologics, and Medical Devices.
and judgement. If physicians use a product for an indi- Washington, DC: US Food and Drug Administration, 1998.
cation not in the approved labeling, they have the re-
sponsibility to be well informed about the product, to
base its use on firm scientific rationale and on sound
medical evidence, and to maintain records of the prod-
uct’s use and effects.” 4

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