Neuhauser, Duncan

English

Case Western Reserve University School of Law

Case Western Reserve Law ReviewVolume 36 | Issue 41986Commentary: Medical Technology Assessment asSocial ResponsibilityDuncan NeuhauserFollow this and additional works at: https://scholarlycommons.law.case.edu/caselrevPart of the Law CommonsThis Symposium is brought to you for free and open access by the Student Journals at Case Western Reserve University School of Law ScholarlyCommons. It has been accepted for inclusion in Case Western Reserve Law Review by an authorized administrator of Case Western Reserve UniversitySchool of Law Scholarly Commons.Recommended CitationDuncan Neuhauser, Commentary: Medical Technology Assessment as Social Responsibility, 36 Case W. Res. L. Rev. 878 (1986)Available at: https://scholarlycommons.law.case.edu/caselrev/vol36/iss4/11COMMENTARY: MEDICAL TECHNOLOGYASSESSMENT AS SOCIALRESPONSIBILITYDuncan Neuhauser*PROFESSOR MEHLMAN HAS done an extraordinary job re-viewing the state of the art of medical technology assessment aswell as providing a critique of appropriate analytical methods.Doctors Perry and Chu, the other commentators on ProfessorMehlman's article, have reviewed the growing number of organiza-tions involved in medical technology assessment in this country. Iwish to make the point that data are needed so that these assess-ments can be implemented.At the heart of technology assessment in medical care is a con-flict between what is good for the individual and what is good forsociety. There is a social cost that results from our failure to evalu-ate carefully. But careful evaluation requires a comparison betweenthose who receive a particular treatment with those who do not,and this requires patient involvement.One of many examples is prefrontal lobotomy, a surgical proce-dure introduced in 1935 and presumed to benefit mental patients.After tens of thousands of operations, this procedure lost favor inthe 1960's.1 In spite of the lack of evidence of its efficacy, EgasMoniz was awarded the 1949 Nobel Prize in Medicine for pioneer-ing the prefrontal lobotomy. In its heyday in the United States,there were about 5,000 patients per year who had large parts oftheir brains removed in accordance with this surgical treatment.These patients paid the social price for our failure to rigorouslyevaluate the efficacy of this technology.There is another reason why medical technology assessment isdesirable. Because I pay for your health care through taxes, social* Professor of Epidemiology and Biostatistics, Keck Foundation Senior ResearchScholar, Professor of Medicine, Adjunct Professor of Organizational Behavior, Co-DirectorHealth Systems Management Center, Faculty Editor HEALTH MATRIX, Case Western Re-serve University. B.A., Harvard (1961); M.H.A., University of Michigan (1963); M.B.A.(1966), Ph.D. (1971) University of Chicago.1. See E. VALENSTEIN, GREAT AND DESPERATE CURES 280, 284 (1986).MEDICAL TECHNOLOGY COMMENTARYsecurity, and insurance premiums, I want you to have only effectiveand appropriate medical care-no more and no less.Evaluation of medical technology is difficult due to at least fiveobstacles which must be overcome:First, the best methods of evaluation are new. The earliestknown Randomized Clinical Trial (RCT) occurred in 193 1;2 RCTsdid not become widespread until the 1950's. The first such trial toinclude a cost analysis was published in 1980. It was not until 1985that the first trial to measure all benefits, including full costs andpatient satisfaction, was published.3 Old technologies, such as lo-botomies, were not evaluated using these new methods.Second, patients differ substantially from each other. The factthat patient A with treatment X improved, while patient B withouttreatment X did not, is not necessarily due to treatment X. Thisreality makes evaluation much more difficult. The accurate com-parison between patients with and without treatment X requiresthat the patient populations be defined and uniform.Third, there are the all too human biases of inventors, manufac-turers, and users of medical technology. It is desirable that peoplestrive to find a cure for cancer. But, this effort creates the risk thatthe inventor will become a salesman who, in his own enthusiasm,will convince himself that he has a cure when he, in fact, does not.This problem is greatly exacerbated when the advocate has already,for other reasons, achieved a great reputation. Such was the casewith Dr. Wangensteen's advocacy of Gastric Freezing which waseventually shown to be harmful after 1500 machines were sold.4In addition, physicians, in their compassionate desire to help thesuffering patient before them, may prescribe a treatment that is de-monstratively efficacious for another type of condition but whichhas not been proven effective in treating the condition at hand. Theindiscriminate and inappropriate use of the drug cimetidine pro-vides such an example. The Food and Drug Administration's "yes"or "no" approval system is helpless against this large problem.2. See Amberson, McMahon & Pinner, A Clinical Trial of Sanocrysin in PulmonaryTuberculosis, AM. REV. OF TUBERCULOSIS 401 (1931).3. See Pineault, Contandriopoulos, Valois, Bastian & Lance, Randomized ClinicalTrial of One-Day Surgery. Patient Satisfaction, Clinical Outcomes and Costs, 23 MED. CARE171 (1985).4. See Miao, Gastric Freezing: An Example of the Evaluation of Medical Therapy byRandomized Clinical Trials, cited in COSTS, RISKS AND BENEFITS OF SURGERY 198-211 (J.Bunker, B. Barnes & F. Mosteller eds. 1977); Wangensteen, Peter, Nicoloff, Walder, Sosin &Bernstein, Achieving "Physiological Gastrectomy" by Gastric Freezing: A Preliminary Reporton an Experimental and Clinical Study, 180 J. A.M.A. 439 (1962).19861CASE WESTERN RESERVE LAW REVIEWMoreover, human memory is selective. The physician may remem-ber the cures and forget the failures (or vice versa), thus providing abiased view of efficacy. In short, physicians are human beings likethe rest of us.Fourth, medical technology, disease, and the environment donot stand still. The decline in tuberculosis from 1850 to 1950 al-most certainly had more to do with changing housing conditionsthan with treatment advances. Comparing coronary bypass surgerywith prior and more conservative medical treatment is misleading,because both treatment methods have been improving with time.These changes require concurrent evaluation of the alternatives, ne-cessitating some patients to forego a treatment while a similar groupreceives it.Fifth, evaluation of medical care technologies establishes the de-manding standard that a treatment effect exceed the placebo effect.The placebo effect is created by the patient's belief that a particulartreatment will alleviate or cure the medical problem. The placeboeffect is very well documented. In 1955, Beecher estimated that athird of the benefits of medical care resulted from the placebo ef-fect.5 This makes medical care unique among economic markets inthat the consumer can maximize benefits of medical care by his orher own ignorance.To evaluate whether or not the treatment effect exceeds the pla-cebo effect, drug trials may be conducted. These are referred to as"double-blind" trials, because neither the patient nor the physicianknows whether any one patient receives the drug or the placebo.This is not an exhaustive list of the problems inherent in tech-nology assessment. In addition to these is the problem of long-termeffects. For example, diethylstilbesterol's harmful effects were notfound until the daughters of the patients became teenagers and de-veloped vaginal cancer. Another problem is establishing causation.Some diseases can be self limiting; yet the "cure" may be inappro-priately attributed to treatment. Finally, the results of animal test-ing are not completely transferable to humans; because a treatmentcures mice does not necessarily mean it will cure men.Obtaining better information about the efficacy of medical carerequires the individual patient's willingness to participate in clinical5. See Beecher, The Powerful Placebo, 159 J. A.M.A. 1602 (1955). For a more recentlisting of the studies undertaken which have verified this effect, see J. FRANK, PERSUASIONAND HEALING 136-51 (1973).[Vol. 36:878MEDICAL TECHNOLOGY- COMMENTARYz"2 E0 00m.4.- oz EuCo 0Z 1:40< ,-00o .0 F-ODqID$,l0o C300P-4C<0z cs-"o u C~ 000CASE WESTERN RESERVE LAW REVIEWtrials. Thus, to some degree, an individual contribution is requiredin order to achieve the social good of better knowledge about medi-cal care efficacy. An attempt to show this tradeoff is presented inDiagram 1.Various methods of evaluation are placed on this graph accord-ing to both their accuracy (vertical axis) and the individual commit-ment to the social good required (horizontal axis). Readers maynot agree with the location of these methods and should feel free tocreate their own diagram. For example, a Hindu believing in rein-carnation may equate animals and human beings and, therefore,place animal experiments to the far right of this diagram.The worst form of evidence is the proverbial snake oil salesman.The individual is free to purchase, and negligible evidence of effi-cacy results. This has long been criticized by the courts. In 1630 inBoston, the very first year of settlement, the court convictedNicholas Knopp for selling a cure for scurvy "of no worth orvalue." 6The best evidence would be obtained by compulsory, uniform,double-blind, randomized, clinical trials. However, proper evalua-tion of surgical procedures using this metbod would require shamoperations, where an incision is made but nothing done beyondthat.' It is generally accepted that such evaluations demand toogreat an individual sacrifice in the name of social good. Yet, if anyone of this method's characteristics is deleted, accuracy and knowl-edge are sacrificed. If one eliminates the compulsion, representa-tiveness is sacrificed; if patients are informed and blinding iseliminated, one loses control of the placebo effect; if randomizationis eliminated, one loses assurance that the experimental and controlgroups are comparable; if one studies animals rather than humans,one is not sure that the results will be similar in humans. Thus,there are trade-offs between patient participation, informed consent,choice, and the quality of evidence obtained.The fiduciary relationship between physician and patient impliesthat the physician can only recommend participation in a trial if heor she believes that both treatments are equally beneficial. Ifpushed hard, it would be exceedingly rare for a physician to be trulyindifferent. As the true indifference point is more sharply defined,6. See J. YOUNG, TH' TOADSTOOl. MILLIONAIRES 16-17 (1961).7. See. e.g., Cobb, Thomas, Dillard, Merendino & Bruce, An Evaluation of Internal-Mammary-Artery Ligation by a Double-Blind Technique, 260 NEw ENG. J. MED. 1115(1959).['Vol. 36:87819861 MEDICAL TECHNOLOGY COMMENTARY 883the number of physicians who could ethically recommendrandomization becomes exceedingly small.Lawyers, physicians, and all of us who are absolutist in our be-lief in the fiduciary relationship between physician and patient (andabsolutist in our belief of the individual good over social good)should be willing to accept the consequences of these beliefs and, asa result, be willing to receive unnecessary or harmful treatments forourselves and our families.

Commentary: Medical Technology Assessment as Social Responsibility

bepress Legal Repository

https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=2478&amp;context=caselrev

Commentary: Medical Technology Assessment as Social Responsibility

Abstract

Similar works

Full text

Available Versions

Case Western Reserve University School of Law

bepress Legal Repository