Avalanches, Air Pockets, and Advertisements

Avalanches pose a serious hazard for mountain climbers, skiers, and snowmobile riders. During the winter of 1998-1999, avalanches accounted for approximately 50 deaths in the United States and Canada and 150 deaths in Europe.¹ The likelihood of survival in an avalanche is largely related to how quickly the victim buried in snow is located and extricated. The probability of survival in relation to the time buried in an avalanche is estimated to be approximately 90% at 15 minutes but decreases to 30% at 35 minutes, with the increased mortality representing deaths from acute asphyxiation.² Survival is impossible without an air pocket.²

In this issue of THE JOURNAL, Grissom and colleagues³ report the results of a unique study of the physiologic changes that occur in experimental burial in snow, designed to simulate being covered with avalanche debris. The authors first measured changes in respiratory parameters that occurred in 8 study participants during a snow burial while breathing through a 500-mL artificial air pocket built into a vest designed to separate inspired from expired air. The authors then compared these respiratory changes with those that occurred in 7 of the same participants during a second snow burial in which the subjects did not wear the vest device, but breathed within a similarly sized air pocket in the snow. Compared with snow burial without the device, use of the artificial air pocket device resulted in greater duration of mean burial time (58 vs 10 minutes), less decrease in oxygen saturation, and less increases in end tidal CO₂ and inspired CO₂, but a greater decrease in body temperature. During snow burial without the device, heart rate and respiratory rate increased significantly and oxygen saturation decreased within 5 to14 minutes. The authors suggest that if this device provides similar effects for persons buried in an actual avalanche, it may reduce the probability of asphyxiation before a rescue.

This preliminary study adds potentially important data on the dynamics of oxygenation and ventilation during snow burial. Given the potential hazards involved, performance of the study required concerted measures by the investigators to ensure the safety of the participants. Accordingly, the authors performed careful monitoring of study participants, including constant measurement of several critical respiratory parameters and continuous monitoring of vital signs, and also had an emergency backup oxygen source in place. The investigators were in continuous communication with the buried participants via intercom (and required the participant to tell the surface team he or she was "OK" after every fourth breath) and were prepared to extricate the buried participant immediately on his or her request or if oxygen saturation decreased. In addition, because it isn't every day that THE JOURNAL publishes an article on experimental burial, the JAMA editors asked the authors for and received documentation of approval of the study by the LDS Hospital Research and Human Rights Committee and the informed consent document.

However, the study by Grissom et al³ should be interpreted in light of several limitations. For instance, the number of study participants was small, and neither the researchers nor the participants could be masked to the use of the device. The study sequence was such that the artificial air pocket device was always used in the first snow burial and not in the second. The study participants had constant communication with the investigators, potentially mitigating a panic response. Moreover, although the authors suggest that the "experimental setup simulated avalanche debris," the participant was always buried in the sitting position, snow coverage consisted of gradual rather that sudden snow burial, and it appeared that the amount and density of snow was not sufficient to lead to chest or abdominal compression with concomitant limitation of ventilatory effort. Of course, the study participants did not incur any of the associated trauma that avalanche victims may sustain during unexpected falls caused by the sudden force of snow. Thus, although the artificial air pocket device appears to provide ventilatory benefit in the simulated setting, there is no evidence to suggest that it will be effective in actual field conditions or will prove cost-effective.

Additional important considerations are that the study was funded by the manufacturer of the artificial air pocket device, 1 of the authors is the inventor and patent holder of the device, and another author is an employee of and stockholder in the company that manufactures the device. These facts are disclosed clearly in the article, as they would be if the same relationship existed in a trial of a pharmacologic agent or a medical device. However, the combination of these interests and the unique nature of the artificial air pocket device may, perhaps, create an extra potential for the manufacturer to tout publication of this study in THE JOURNAL and possibly to use the JAMA name for promotion of the artificial air pocket device.

That type of promotional activity has happened in the past. For instance, the Florida Department of Citrus ran television and print advertisements in which a recent study⁴ and the name of THE JOURNAL were featured prominently, thereby suggesting endorsement by JAMA of their product to prevent stroke. However, allowing the name of THE JOURNAL to appear in advertisements creates an implied endorsement of the product. Without actual evaluation, JAMA can never give endorsements for any products. Accordingly, with the Florida Department of Citrus case, the JAMA name was removed from their advertisement following notice from American Medical Association (AMA) legal counsel expressing "strenuous objection" to the unauthorized use of JAMA's name for commercial purposes.^{5 - 6}

We can, and did in the case of the study by Grissom et al, subject the manuscripts to rigorous peer review by experts and careful scrutiny by the editors. But neither the editors nor the peer reviewers monitored the study on the spot, so we cannot take responsibility for the data, which is a prerequisite for endorsement. Given these circumstances and concerns, the editors requested, and both Grissom et al and the manufacturer of the artificial air pocket device agreed, that the JAMA name would not appear anywhere in the body of any advertising or promotional materials about this device. However, it is permissible for the manufacturer to include a standard citation to the article as a footnote at the bottom of advertisements, similar to references that are included in advertisements for drugs or medical devices.

Having said that, we are delighted that Grissom and colleagues have had the originality and perseverance to develop a device that might help save lives and to begin its early scientific evaluation. We certainly do not wish to imply that these investigators or the manufacturer of the artificial air pocket device would have done anything to misuse the JAMA name. Rather, we believe their study provided an excellent opportunity for us to provide information about this issue to our readership, to investigators who submit research studies to THE JOURNAL, and to companies and organizations that may sponsor such studies as well as other companies that may contemplate using any information published in JAMA to promote their products.

Unauthorized use of the JAMA name or any content for commercial purposes or to promote commercial goods and services, even if the information cited is not misleading or deceptive, is not permitted by JAMA or the AMA in any format, including print, video, audio, and digital. Effective with this publication, THE JOURNAL will apply the author requirements described herein in all similar circumstances. This policy also will be incorporated in the next published version of the JAMA Instructions for Authors.