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Abstracts in the The .New England jJournal of Medicine Estsblished in 1E12 as The NEW ENGLAND JODSNAL OF MEDICINE AND SIIRGEfiY n&'ertising sectiens VOLUME 310 3, 1984 NUMBER 18 Original Articles D ~ Thrombosis and Acite Coronary-Artery Le- w sions in Sudden Cardiac Ischemic Death 1137 MICHAEL JOHN DAt'IES AND ANTI-oN5' THOH?S The Cerebrohepatorenal (Zellweger) Syn- drome: Increased Levels and Impaired Degradation of Very-Long-Chain Fatty Acids and Their Use in Prenatal Diagnosis ............................ 141 A.\\ E. MOSER, INDERjrr SINGII, FRAxx R. BRoN.-N 111, GEORGE 1. $OLISH, RICHARD 1. KELLEY, PAC'L f. BENKE, .L\D HL'Go W. MOSER Culture-Independent Diagnosis of Chla- mydia trachomatis Using Monoclonal Antibodies ........................... 146 \fiLTON R. TAx, WALTER E. STAMN, H. HL'N"cER HA..DSrIELD, RICHARD STEPHENS, CHO-CHOU Kuo, 11ING K. HOLNES, 1\AY DITZE-NBERGER, MONICA KRIEGER, A.\D ROBERT C. NOwTSsAl Ventilatory Support by Pacing of the Condi- tioned Diaphragm in Quadriplegia .... 150 WILLL{g W. L. GLEx., JAatES F. HOGA.., JACOB S. O. lAi:E, THOLAS E. CIESIELSKI, MILDRED L. PHELPS, AND RO87\ ROWEDDER Cutaneous Squamous-Cell Carcinoma in Pa- tients Treated with PUVA ............ 156 ROBERT S. STER.\, NA.\ L{IRD, JOHN MELSKI, JOHN A. PARRISH, THOStAS B. FITZPATRICt;, AND HOWARD L. BLEICH Special Article The Monetarization of Medical Care ....... 162 Eu GINZBERG Medical Progress Biologic and Clinical Importance of Proinsulin ........................... 165 DAVtD C. ROBBINS, Ho%rARn S. TAGER, AND ARTHI'R H. Rl'BE.\SfEIN Case Records of the Massachusetts General Hospital A 32-Year-Old Woman with Proteinuria and Impaired Renal Function ............. 1176 ROBERT S. BROWN AND ROBF.RT T. MCCLUSKEY Editorial Dealing with Conflicts of Interest.......--. 1182 Editorial Retrospective Computed Tomography - A Controversy Revisited ............................ 1183 RONALD G. EvENs Massachusetts Medical Society... 1185 Correspondence Murder in Gtutemala ....................... 1186 Intncoronary Streptokinase for Myocardial Infarction ............................ 1186 Intracoronary Streptokinase for Acute Coronary- Artery Dissection ...................... 1187 Sudden Death and Myocardial Infarction in Minnesota ............................ 1187 Cardiovascular Effects of Arising Suddenly .... 1189 Factitious Cause of Unexpected Arterial Blood- Gas Results ........................... 1189 Low Urinary Calcium Excretion in Bartter's Syndrome ............................ 1190 Rigid vs. Flexible Bronchoscopy for Foreign-Body Aspiration ............................ 1190 Red-Cell Sodium-Lithium Countertransport in Snns of Normotensive and Hypertensive Par- ents: A Follow-up Study ................. 1191 Gastric Cancer after Gastric Opentions ........ 1192 Angiolipomas in Homosexual Men ....... 1193 Guidelines for the Care of Patients with AIDS -- 1194 Unnecessary Tests for Syphilis on Donated Blood 1194 Designated Blood Donations ................. 1194 Alternative Medicine ....................... 1195 Medical Effects of The Day Afkr .............. 1196 Book Reviews .......................... 1197 Books Received ........................ 1200 Notices ................................. 1200 Health Policy Report HMOs (For-Profit and Not-For-Profit) on the Move ................................ 1203 JOItN K. IGLEIIART Owned, Published, and ECopyrighted, 1984, by the Massachusetis Mcdical Society THE N(%. E]Ot.~ND JOl'A.NkL OF MED1ClSE (ISSN 002.4-Ii93) is published t~erlly fntm editurial o(licos at 10 Shauuck Street, 1kt±ton, \I.\ 0-'115. Subscriptiun price: $55.00 per year. Second-class postage paid at liaston and at additiunal mailing u(Tices. POST\IASTER: Send address chsnges to 1440 \lain Street, lValtham, \tA 0'?25}. D s 8 N 0

1182 TIIF. NE11' h;NGLANDJOL'RNAI.OF \IF.i)ICINE May 3. 1934 ~ V°l' i he New Eno-Iand Journal of iMedicine O, ncd and Publishcd b~ thc \{at ;achusetts \Icdicai Societ. Good.,ill M. Ste+art. \f.D. f'resilunt William B. Munier, M.D. Charles S. Amorosino, Jr. Ezerutire hice-preridenl Eztrulire Serretag THE COSfMtT7EE O\ PceLlcAnoss OF THE MA55ACHt:5ETI5 MEDICAL SOCIETY Samuel K. Stewart, M.D., Chairman John C. Ayres, M.D. William H. Sweet, M.D., D.Sc. Frank E. Bixby, Jr., M.D. Robert E. Tranquada, M.D. John I. Sandson, M.D. Percy NV. Wadman, M.D. Arnold S. Relman, M.D., EDrrott Marcia Angell, M.D., DEPITY EDITOR Edwin W. Salzman, M.D., DEPtrIY EDITOP. AssOGtnTE EDrrroRs Jane F. Dcsforges, M.D. Norman K. Hollcnberg, M.D., Ph.D. Ronald A. Malt, M.D. Morton N. Swartz, M.D. Franklin H. Epstein, NI.D., ' Francis D. lfoore,'.i.D., Boox REvmw EDITOR John C. Bailar, 111, M.D., STATtsnceL Cossct.TA:rT . John K. Iglehart, SPECIAL CORRESPO.NDF_%-T Joseph J. Elia, Jr., MANAGER OF EDITORIAL OPERA770ti5 Emily S. Boro, DIREGTOR OF COPy EDrTtNG \farlene A. Thayer,'EDrroRIAL OrFtcE MANAGER EDI7YJRIAL BOARD . . Kurt J. Bloch, M.D. HornayKazemi, M.D. Eugene Braunwald, M.D. Samuet•A: latt, M.D., Ph.D. Paul Calabresi, M.D. . Robtrt J. Mayer, M.D. Aram V. Chobanian, M.D. Kcnrxth 1`ic[ntosh, M.D. Theodore Colton, SeD. Da.id G. Nathan, M.D. Richard H. Egdahl, hI.D.' Cattiaice G. Raisz, ai.D.. John T. Harrington, M.D, Kennethj4,~tothman„Dr.P.H. , Thomas J. Ryan, 11.D,: . DEALING WITH CONFLICTS OF INTEREST CONNECTIONS between industry and academic medi- cal scientists arc not new. It has long bcen common practice for manufacturers of pharmaceuticals and medical devices to retain the services of academic sci- entists as consultants or to subsidize their research studies - particularly clinical trials of marketable products in which the company is interested. But in recent years, as the commercial possibilities of new biomedical discoveries have become increasingly at- tractive, these connections have become more perva- sive, complex, and problematic. Now, it is not only possible for medical investigators to have their research subsidized by businesses whose products they are studying, or act as paid consultants for them, but they are sometimes also principals in those businesses or hold equity interest in them. En- treprencurialism is rampant in medicine today. Any new research development that has or might have commercial application attracts attention from estab- lished corporations or venture capitalists. Reports of such developments released at press conferences, pre- sented at scientific meetings, or published in journals may cause stock prices to rise abruptly and fortunes to be made almost overnight. Conversely, reports of un- favorable outcomes or serious side elFects may rapidly devalue a particular stock. On more than one occasion during the past few years, the publication of an article in the fournal has been the direct cause ofsharp fluctu- ations in stock prices. If the investigators reporting these studies own equity or have other kinds of financial interest in a company whose fortunes are affected by the results, ' conflicts of interest may develop. One does not have to assume -th'at researchers are venal to appreciate that they may be afI'ected (consciously or unconsciously) by economic incentives, which can influence the way they design or conduct their studies, how they inter- pret the results, or how and when they choose to re- pot•t them. This is not the place to discuss the arguments for and against the involvement of academic scientists with the biotechnology industry. The subject has drawn thoughtful commentary from the presidents of some of our leading universities,t,2 but it is not the topic here. The question I wish to discuss is of more immediate concern to the,Journal because it confronts us with increasing frequency. It is this: What policies should govern the review and publication of research work when cinflicts of interest may exist? The fournal has had no stated policy on this matter until no'w, but my editorial associates and I think it is time we formulated one. In our view the basic ele- ments of that policy should be the following: NVe recognize that in some sense, authors may be affected by conflicts of interest even when no commer- cial considerations are involved. Competitive pres- sures and concerns about research grants, peer recog- nition, or academic advancement may adversely in(i bus: pret 11 mat thei the ciat not bcc. \ met the~ oug sup; on t tanf cior ized It r the aler the\ rou sou* any be : ttOn rcpk sis bod S ev tha' stut ed i ati( for C nes ice int( con dle, ati( cor jus' tan tee• edi era wil t1Qt an\ beG res tliC SS$ .'O1 Frederick Bowes, III, DtREcroR OF PcsLiStittrG OPEUAttoNi Ronald H. Brown, \tAxAGER OF ADVER'nstr;G & :liAhttETIt:G William H. Paige, !-SA.AbER oF PAOOeertoN & DISTttlnurto. Milton C. Paige, Jr., COSCt.-rAnT` ;., PQOSPEGTR'E authors should consuit -information for Authors," which appears in the first issueofevery volume and may beobtained from theJoun.aL office. ARTtet.ES with original material are accepted for consideration with the understanding that, except for abstruts, no part of the dasa ha's been pub- lished, or will be submitted for publication eLsewhere, bcfore appeating here. 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influence behavior. Connections with investor-owned businesses, therefore, may simply be another form of a preexisting problem. In addition, we reaffirm our conviction that all manuscripts should be selected solely on the basis of their merits and their suitability for our journal, not on the basis of any consideration of the commercial asso- ciations or presumed motives of the authors. We will not reject an otherwise acceptable manuscript simply because of conflict of interest. Nevertheless, it is obvious that business arrange- ments have an increasing role in medical research these days, and common sense suggests that readers ought to be told about those arrangements. Public support for medical research rests in no small measure on trust in the integrity of investigators. When impor- tant commercial associations are not disclosed, suspi- cions inevitably arise, and the public trust is jeopard- ized. Disclosure, we believe, is in everyone's interest. It recognizes legitimate public concerns, it protects the reputation and credibility of investigators, and it alerts readers to information they may wish to have as they assess the published report. We will therefore suggest to our authors that they routinely acknowledge in a footnote all funding sources supporting their submitted work. Likewise, any relevant direct business associations should also be acknowledged, such as employment by a corpora- tion that has a financial interest in the work being reported. An article in this week's issue, on the diagno- sis of chlamydia infections with monoclonal anti- bodies,a provides an example of how this can be done. Several of the authors are employees ofa business firm that developed the monoclonal antibody used in the study. Their connections with the firm are clearly stat- ed in a footnote that also gives the institutional affili- ations of the other authors and the sources of support for their work. Other kinds of commercial associations with busi- nesses involved in the research, such as part-time serv- ice as a consultat-it, ownership of stock or other equity interest, or patent-licensing arrangemens, are more complicated, and their disclosure will need to be han- dled on an individual basis. The commercial associ- ation may be indirect, through a business marketing a competing product, but the conflict of interest may be just as real and the need for disclosure no less impor- tant. We propose henceforth to ask authors to volun- teer all such information in a covering letter to the editor when their manuscript is submitted for consid- eration. Ifacceptance seems likely after review (which will be conducted without reference to the informa- tion), the editors will decide how much disclosure, if any, is relevant and will discuss with the author how best to communicate it to readers. It should be noted that this policy would leave final responsibility for disclosure where it belongs, with au- thors. We expect them to tell us about any commercial associations that might pose a conflict of interest in connection with the research work or the scientific 1183 opinions they are submitting for publication. We arill remind authors of ~hat expectation, but it is up to them to decide what they will report to us. As noted before,4 trust is a fundamental element in the research enterprise. We believe that once they un- derstand our policy and the reasons for it, the vast majority of potential contributors will agree and willl comply with it in good faith. We plan to implement this policy in the near future, but we would welcome comments from our readers. AR.\OLD S. RELMA.'Q, M.D. RExEtzENC.ts 1. Bok DC. Bus'mess and the andemy. Harrxfd Mag 1951: 83(5):23-35. i. ciaautd AB. The uni.rrsity, in+2sny. and cooprarive reseurh. sctenct 1982; 218:1278-80. 3. Tam MR. Stvmm 'A'E. Hands&ld HH, et aL C1utaue•indepcn&-w diicnosis of Chamodla vachanaris using mooockaal mtibodies. N Ez&t J Med 1984; 31 tr. t 146-50. 4. Relman AS. t.es5oas from the Daisca affait. N Fngi 7!4d 1433: 30fi:13I5-7. EDITORIAL RETROSPECTIVE COMPUTED TOMOGRAPHY - A CONTROVERSY REVISITED Ttts year 1983 marked the 10th anniversary of the introduction of computed tomography (CT) in the United States. In 1978 this diagnostic technique was still the focus of intense controversy,t•2 primarily be- cause of its cost. Considered by physicians to be revo- lutionary and a major advance, it was widely regarded as an example of "technology running wild" by those who focused on the increasing cost of medical care, including health planners, regulatory agencies, and politicians. The critical issues were the technical as- pects, the clinical use and efficacy, the costs and their control (specifically through national and regional health planning), and the future of new medical tech- nology in a time of national economic crisis. What has happened in the past five years? CT technology improved rapidly for several years but has now reached a plateau. Equipment from most manufacturers is similar in design, and the accepted standards include scanning times of 3 seconds or less, "higkt"-resolution images, computer reconstruction accomplished in a few seconds, and the ability to im- age anatomic sections only a few millimeters thick. Virtually all CT units are multipurpose (i.e., for use in both the head and the body) and cost between 3600,000 and $1,200,000. The purchase price, adjust- ed for inflation, is approximately the same as it was five years ago, despite considerable improvement in technical capabilities. lt was predicted that the intro- duction of CT would mark the beginning of a new "high-technology" industry; at first. more than 40 cor- porations competed for the market. but relatively few manufacturers remain. The top fivr share 80 per cent