Medical Technology and the Health Care System A Study of the Diffusion of Equipment-Embodied Technology (1979) / Chapter Skim
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APPENDIX D: GASTRIC FREEZING--A STUDY OF DIFFUSION OF A MEDICAL INNOVATION
APPENDIX D: GASTRIC FREEZING--A STUDY OF DIFFUSION OF A MEDICAL INNOVATION
Pages 173-200
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From page 173... ...
Fineberg INTRODUCTION Duodenal ulcer disease is a chronic condition that afflicts l in l0 Americans at some time during their lives.1 The disease is more common in men, who often first become symptomatic between the ages of 20 and 50 years, the most productive period of their lives. Peptic ulcer causes l percent of all disability due to chronic conditions in the United States.
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From page 174... ...
The preferred surgical procedure is controversial, but each operation carries some risk of mortality and may be followed by uncomfortable sequelae.8'9 Given the operative risk and postoperative morbidity, surgery has rightly been regarded as a treatment of last resort. Gastric freezing was developed as an alternative to surgical treatment for patients with intractable pain from duodenal ulcers.
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From page 175... ...
After trials in numerous animals, Wagensteen was prepared to try this gastric freezing method in ulcer patients with persistent pain in order to promote healing and obviate the need for surgery. A middle-aged lawyer with duodenal ulcer became, in October l96l, the first person treated with gastric freezing.
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For a scientific publication, this article is striking for its discursive and anecdotal style, as well as its enthusiastic tone.* The authors earnestly believed they had discovered a major breakthrough in the treatment of duodenal ulcer disease, and their writing conveys their excitement.
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From page 177... ...
duodenal ulcer now can be brought under control; that gastrectomy for duodenal ulcer will henceforth rarely be required. While Swenko was the first and probably the dominant manufacturer of gastric freezing devices, the devices did not have an exclusive market.
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From page 178... ...
0 Anyone familiar with the history of treatment for duodenal ulcer disease would have had reason to be skeptical of claims made for gastric freezing at professional meetings and in the popular media in l962. Peptic ulcers have been treated with an enormous variety of drugs and nostrums, and there even were claims of success for agents now used to provoke stomach acid secretion or now considered dangerous in patients with ulcer disease.
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From page 179... ...
20r CO LU 2 o u 1E 10 < 1962 1-3 4-6 7-9 10-12 1-3 4-6 7-9 10-121-3 4-6 7-9 10-12 > 1964 '62 '62 '62 '62 '63 '63 '63 '63 '64 '64 '64 '64 100r > 50 o < 1962 1-3 4-6 7-9 10-12 1-3 4-6 7-9 10-12 1-3 4-6 7-9 10-12 > 1964 '62 '62 '62 '62 '63 '63 '63 '63 '64 '64 '64 '64 FIGURE l Sales of gastric freezing machines by leading manufacturer. Based on date orders received by Swenko, Minneapolis, Minn.
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From page 180... ...
As it turned out, the absence of truly frozen tissue was fortunate because where patchy freezing did occur, necrosis followed.26,27 In July l963, Wangensteen and his colleagues extended their earlier work.28 Other clinical reports in l963 were generally favorable because of marked symptomatic relief.29 However, at least one early investigator failed to detect clinical improvement,33 and noteworthy side effects began to be documented, including gastric ulceration, bleeding which required transfusion,3 electrocardiographic changes, burnlike damage to gastric tissue, pneumonitis, and perforation of the lower esophagus due to faulty placement of the balloon.35 Questions were raised about the physiologic effects of gastric freezing,36 and one research group was unable to document any association between symptomatic improvement and changes in gastric acid secretion. Physicians attending the American College of Gastroenterology meeting in October l963 and the Southern Surgical Association meeting in December l963 expressed diverse opinions regarding the value and risks of gastric freezing and growing appreciation of the technical complexity of what initially appeared to be a simple technique.37,3fl For example, the extent to which stomach temperature would drop depended not only on the temperature of the alcohol and duration of the procedure, but also on volume and shape of the balloon, balloon wall thickness and material, flow rate of the alcohol, and blood flow to the stomach.18,38 Some also noted that the duration of symptomatic improvement was variable,37,38 and some patients required repeat freezings.
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From page 181... ...
Reports favorable to gastric freezing also continued to appear in l964. Wangensteen and his associates published temperate extensions of their clinical series showing continued excellent clinical results, though 25 percent of patients required refreezing and there were a few minor complications.50" The authors contended that gastric freezing produced immediate and complete symptomatic relief in 85 to 90 percent of patients and offered a direct rebuttal of criticisms leveled against the procedure.
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From page 182... ...
One editor introduced a l967 article on gastric freezing's effects on the heart by apologizing, "Though the clinical use of hypothermia for duodenal ulcer has 'come and gone,' a study ... is of interest for the record."73 A review of literature by the author produced 36 clinical reports on gastric freezing published between l962 and l969 (Table l)
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From page 185... ...
Here the authors conclude: The technology of the gastric freeze procedure has now progressed sufficiently to justify prospective controlled clinical studies of its effectiveness in the management of some aspects of the peptic ulcer diathesis by interested, qualified, and critical investigators. One can only wonder how the course of medicine's misadventures with gastric freezing might have been different had so circumspect a conclusion been offered l0 years earlier.
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From page 186... ...
In his pathbreaking study of resistance to medical innovations written 50 years ago, Stern recounts how nineteenth century advocates of antisepsis bitterly opposed the later idea of surgical asepsis.85 Factors that help explain the early, rapid dissemination of gastric freezing include Dr. Wangensteen"s stature, confidence, and optimism, the high prevalence of duodenal ulcer disease and its natural tendency toward exacerbations and remissions, morbidity and mortality of alternative surgical treatments, promotion in the public media, ease with which physicians could learn to perform the procedure, and the opportunity for financial gain by physicians.
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From page 187... ...
Technical entrepreneurs in industry are characteristic of many medical innovations,86'"7 but gastric freezing had none. Essentially, gastric freezing for duodenal ulcer was a new application of existing refrigeration technology.
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From page 188... ...
The value of any medical technology is inseparable from the clinical context in which it is applied; procedures that may be beneficial in a particular set of circumstances are liable to be used as well where they are not worthwhile. The second and most disheartening aspect of this study is the minimal relation between properly designed clinical trials and the diffusion process, a problem that might be described as the inefficacy of efficacy studies.
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POLICY LESSONS In general, the desirability of disseminating a medical innovation depends on five features: l. Technical practicability -- performance characteristics of the new drug, device or equipment.
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From page 190... ...
This dual risk is reflected in the contradictory functions of different government agencies; some, such as the National Institutes of Health and National Science Foundation, encourage development and dissemination of new medical practices, while others, such as the Food and Drug Administration, serve to retard the availability of new practices. Most case studies of medical and other innovations have concentrated on triumphs, "good" innovations that sometimes were delayed in their full development and dissemination.87,93 These studies attempt to discern the causes of delay or "lag periods" in diffusion and the reasons for successful dissemination.
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From page 191... ...
Well-designed and carefully conducted clinical trials are essential, but it may be possible to obtain useful information more efficiently with study designs other than randomized, double-blind.94 Issues of cost and appropriate utilization, outside of FDA's authority, are to some extent within the ambit of other health regulatory and planning activities, such as PSRO and utilization review, certificate-of-need laws, rate-setting commissions, and health systems agencies. At present, no single body both has responsibility for assessing all five features of medical innovations and authority to intervene in the diffusion process, either to speed or to slow it.
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From page 192... ...
As we collectively assume a greater proportion of the costs of health care and as these costs continue to rise, the financial implications of medical innovations increasingly become a societal concern. Every decision, whether explicit or implicit, to apply or withhold a medical innovation, is in effect a resource allocation decision.
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From page 193... ...
l93 APPENDIX: CAPSULE HISTORY OF GASTRIC FREEZING Background l924 Prout l953 l958 Kay Wangensteen Conception l959 Initial research l960-6l and development Clinical availability l962 Wangensteen Wangensteen Wangensteen Swenko Corporation Dissemination l962-64 Proves stomach acidity due to free HCl Augmented histamina test to measure gastric acid production Introduces gastric hypothermia for control of gastrointestinal bleeding Describes possibility of gastric freezing to treat peptic ulcer First human application in October l96l Success announced at professional meeting in May; widely publicized in popular media Full production capability by second half of year Over l,000 machines sold by latter part of l963, l0,000l5,000 treatments Substantial risks to patients become evident by end of l963 Unfavorable conclusions reached by some investigators in l964 because of lack of efficacy and high risk
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From page 194... ...
"Chronic duodenal ulcer." Chapter 54 in Gastrointestinal Disease: Pathophysiology, Diagnosis, Management.
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From page 195... ...
E "Basal and histalog-stimulated gastric secretion in control subjects and in patients with peptic ulcer or gastric cancer." Gastroenterology 45 (l963)
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B "Facts and fallacies of current medical therapy for uncomplicated duodenal ulcer." Journal of the American Medical Association l87 (l964)
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From page 197... ...
R., et al. "Clinical evaluation of gastric freezing for duodenal ulcer." Journal of the American Medical Association l88 (l964)
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H "Rationale and results of gastric freezing for peptic ulcer." American Journal of Surgery l07(l964)
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From page 199... ...
R., et al. "Gastric hypothermia for duodenal ulcer." Journal of the American Medical Association 200(l967)
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From page 200... ...
W., Jr., et al. "An evaluation of the long term results of gastric freezing for duodenal ulcer." Surgery, Gynecology and Obstetrics l2l (l965)
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