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V The. New England Abstrar.ts in the alvUtising sections journal of Meclicine Establtahed in 1$lt as The NEW EN(iLAND JOURNAL OF 3iEDIQINE AND SIIR4IE$y VOLUME 321 NOVEMBER 16, 1989 Original Articles Use of Corticosteroids to Prevent Progres- sion of Graves' Ophthalmopathy after Radioiodine Therapy for Hyperthyroidism ..................... .' 349 LUIGI BARTALENA, CLAUDIo MARCOCCT, FAUSro BoGAZZI, M.LCSIMO PANlcvcar, ANTONIo LEPRI, AND AI.DO PINCHERA Prednisone and Cyclosporine in the Treat- ment of Severt Graves' Ophthalmopathy 1353 MARx F. PRUHHEL, MAARTEN PH. MOURtrs, ARIE BERGHOVr, ERic P. KRENNIxG, RUTH VAN DER GAAG, LEO KooRNYE€P, AND WH.HAR M. WI€RStxGA Normal Fetal Hemoglobin Levels ic the Sudden Infant Death Syndrome ....... 1359 H. RoNALD ZIEI.L€, ROBERT G. MENY, M. JOHN O'BR-€H, JOHN E. SItIALEX, FERDANE KuTLAR, Trros H J. HtrtsYA14, AND GEORGE J. DovER Effect of Deprenyl on the Progression of Disability in Early Parkinson's Disease .............................. 1364 THE PARKINSON STUDY GROUP Mapping a Gene for Familial Hypertrophic Cardiomyopathy to C:hromosome 14q1 1372 JoHN A. JARCHO, WlusAU McKENVA, ,T.A. PETYR PAR€, Scorr D. SOfAl/oN, RANDALL F. HoLCOxBE, SHAUGHAN DIcJUE, TATJANA I.EVI, HELEN DoNts-KEt f~,4 J.G. SEIDHAN, AND CHRISTIN€ E. SEmHA.Y Special Article The Effect of the Medicare Prospective Pay- ment System on th. Adoption of New Technology: The Case of Cochlear Implants ............................. NANCY M. KANE AND PAUL D. MANOUfUAN 1378 Seminars in Medicine of the Beth Israel Hospital, Boston Oncogenes, Growth Factors, and Signal Transduction ........................ 1383 BRIAN J. DRUK=R, HARVEY,J. MnacoN, AND THOldAS M. ROBERTS NUMBER 20 Case Records of the Massachusetts General Hospital A 52-Year-Old Diabetic Man with Myocar- dial Infarction, Pericarditis, and Yersistent Fever ...................... 1391 PETER M. YURCHAK AND JAMES F. SOUTHERN Editorial Treatment of Graves' Ophthalmopathy..... 1403 Sounding Board Physicians' Conflicts of Interest: The Limi- tations of Disclostlre .................. 1405 MARC A. RODWIN Correspondence Importance of Age in Prognostic Staging Sy;tem for AIDS ............................. 1408 Effect of T-iglyceride Levels on Methyl and Meth- ylene Envelope Line Widths in Proton Nuclear Magnetic Resonance Spec- troscopy of Human Plasma .............. 1409 n-3 Fatty Acids in Eggs from Range-Fed Greek Chickens ............................. 1412 Hypokalemia and Hypertension .............. 1413 Natural History of Hypertrophic Cardiomy- opathy ............................... 1414 Iutnthecal Baclofen ........................ 1414 Neurologic Reactions after a Therapeutic Dose of Mefloquine ......................... 1415 False Positive Urinary Pregnancy Test in the Nephrotic Syndrome .... . . . . ... . . . ..... 1416 Short-Chain Fatty Acid Irrigstion in Sevcre Pouchitis ............................. 1416 Indiscr:minate Use of Iaser-Assisted Angio- plasty ................................ 1417 The Miracle Peddlers ....................... 1417 Book Reviews .......................... 1417 Notices ................................. 1419 Corrections A Controlled Trial of Leuprolide with and without Flutamide in Prostatic Carcinoma ......... 1420 Book Review of Clinical Aspiration Cytology ..... 1420 Owned, Published, and CCopyrighted, 1989, by the Massachusetts Medical Society W TE'E 1Ew ExctavDJoMxAt, oi MEOICUrE (ISSN 0028-4793) is published weekly from editorial offices at 10 Shattuck Street, Boston, MA U2115-Gtr,r'. °ubscription price: $74.00 per year. Second-class postage paid at Boston and at additional mailing offices. POSTMASTER Send address changes to P.O. Box 803, Waltham, MA 02254•0803.

Vol. 321 No. 20 SOUNDING BOARD 1405 uniformly effective nor innocuous. It is fortunate, theiAfore, that most patients do not need major ther- apy. For the minority who do, I would continue to advocate prednisone or orbital decompression. Per- haps the gradually enlarging body of knowledge about the nature of the process will lead to specific ways to minimize if not prevent antibody- or cell-mediated reactions in retroorbital tissue. ROBERT D. UTIGER, M.D. RFFExEIVcFs l. Bartaleaa 1., Marcocci C, Bogaai F, Panicucci M, Lepri A, Pinchera A. Use of corticostansds to prevent the ptogressioa of Graves' ophthalmopathy following nd'wiodine treatment for hyperthyroidism. N Engl J Mcd 1989; 321:1349-52. 2. Prummel MF, Momits MP. Bergboat A, et al. Pccdnisone and cyclosporine in the treatment of severe Graves' ophthalmopathy. N Engi J Med 1989; 321:1353-9. 3. HiromatsuY,FsBczztwaH,WrIIJR.Cycotozic anis**s inautoimmune thytoid dlsorders and thyroid-associaud opt~athy. Eadocrinot Metab C7in Nath Am l9£;; I6:2b9-86. 4. Sridama V, DeGroot I1. Ticat±ne= of Graves' disease and the course of ophthatmopzttry. Am J Med 1989; 87:70-3. 5. Wiersinga WM, Smit T. vaa der Gaag R, Kootneef L Temporal relatioa- ship between oeset of Graves' ophthatmopathy and onset of thyroidal Graves' d'sscue. J Fodocrinol Im + 1988; 11:615-9. 6. Marcocci C, BaRakaa L, Bogzm F, Panicucci M, Pinchera A. Studies on the occvaeace of ophthalmopatfry in Graves' dixase. Acta Endocrinol (Co- pea6) i989;120:473-8. 7. Streetea DHP, Anderson GH Jr, Reed GF, Woo P. Prevalence, natural histccy and surgical treatmeat of exophthalmos. Clin Endocrinol 19.7; 27:125-33. 8. Crocman CA. Temporal yda6oeship between onset of Graves' ophthalmop- athy and cEaposis of thyrow:cicosis. Mayo Ctin Proc 1983; 58:515-9. 9. Bahn RS, Gormm CA. Choice of therapy and cdteru for assessing treat- meM of outcome in thysvidassociated op6ttntmoQstby. F.ndoainol Metab Ctin Noctfi Am 1987; 16_391-4U7. 10. Bam3eaa 4 Matrcocci K C7vovato L. et al. Ocbital cobalt irrmdiation combined with syuemie earticasteroids for Graves' op6thalmopathy: com- parison with systemic cncticostuvids alone. J Gin coiocrinol Metab 1983; 56:1139-dA. 11. KeadaA-Yaybr P, Crombie AL, Stepheacoa AM, H&dwick M, Hall K. Intrneaoas mahytpre asso3ooe in the txeatmeat of Graves' ophthalmop- athy. Br Med J 1989; 298:1574-5. 12. Kahaly G, Scfirc=ameir J, Kssuse U, et al. Gclosporin and prednisone v. pcrdaisooe in treatment of Grnes' op6thalmopathy: a controlled, random- ized and prospective study E-ar I Clin invcst 1986; 16:415-22. SOUNDING BOARD PHYSICIANS' CONFLICTS OF INTEREST The Limitations of Disclosure CoNFtacrs between physicians' personal financial interests and those of their patients are now becoming a orominent issue in U.S. health care policy and medi- cal ethics. Physicians' conflicts of interest have been discussed in the fournal and elsewhere.t'12 The Insti- tute of Medicine has addressed the problem.13 So has the American College of Physicians." The American Medical Association has issued reports and opin- ions.ts " Congress is now considering legislation that would prohibit physicians from referring Medicare patients to facilities in which they have a finan- cial interest.'g20 Conflicts of interest are ubiquitous, and some should be tolerated because eliminating them would cause patients more harm than the conflicts them- selves. Still, the medical profession and the public are becoming increasingly concerned. Although the prob- lem can be formulated in different ways and there is disagreement about how to respond, one remedy - disclosure - has attracted more attention than. any other. Several states already require physicians to tell about financial conflicts of interest in making refer- rals21-2s The Council on Ethical and Tudicial Affairs of the American Medical Association says that physi- cians can adequately handle financial conflicts of in- terest by disclosing any ownership interest they have in a health care facility to which they refer patients.ts Other medical groitps and commentators also advo- cate disclosure as a remedy.26-28 Nevertheless, the ra- tionale for disclosure and its anticipated effects are rarely examined critically. There has been little dis- cussion of what must be disclosed and to whom, the manner of presentation, or measures to ensure com- pliance. This article examines disclosure policies in four oth- er contexts - medical informed consent, consumer- protection laws, disclosure by lawyers to clients, and disclosure by government officials - and their impli- cations and limitations as models for disclosing physi- cians' conflicts of interest. MEDICAL INFORMED CONSENT Common law requires that physicians obtairt their patients' consent before treating them. To ensure that consent is informed, physicians must disclose the risks and benefits of alternatives, including nontreatment, to any medical intervention they propose."1 Ideally, disclosure promotes communication and fosters trust between patients and their physicians. When in- formed of the risks and choices, patients can tell the physician of their concerns, values, and wishes, and these may modify the medical treatment the physician recommends 32 Since the 1970s the increased sensitiv- ity of physicians to informed consent has promoted the autonomy and welfare of their patients. Neverthe- less, evidence suggests that full disc:osure still occurs relatively infrequentlv and not as envisioned by the law.33,34 One observer has suggested that physicians sometimes couch their disclosure in terms designed to promote more costly procedures.' Psychological stud- ies a'.so indicate that even with accurate disclosure, patients may not understand the information provided or its implications.36,37 Patients also misunderstand because of poor communication by physicians.38,39 New information often does not lead patients to re- consider proposed treatments?9 The detailed written forms used in obtaining consent sometimes obscure understanding.' Patients often treat them as mean- ingless paperwork and do not remember what they have signed.1,38 Ever. when doctors avoid making decisions, their patients typically choose what the physicians wish or suggest.'," In other words, full disclosure in obtaining informed consent does not always give the patient understanding or control, and without supervision physicians generally do not disclose all pertinent information to their pa- tients. We can expect similar problems with physi-

Nov. 16,1989 THE NEW ENGLAND JOURNAL OF MEDICINE 1406 cians' disclosing their financial interests in facili- ties to which they refer patients. The disclosure of financial interests alone is insuffi- cient to inform most patients. To understand their importance, patients need to know that virtually every major study indicates that physicians who make refer- rals to medical facilities they own recommend more (or more expensive) medical tests and procedures than physicians without ownership interests.'5,'2-45 This occurs evt.n in states that require the disclosure of financial interests?5 But providing this information is not enough. Conflicts of interest can affect a physi- cian's assessment of whether a medical service is need- ed, not just who should providc it. Rather than merely inform their patients of a conflict and list alternative providers, physicians who recommend expensive tests or procedures in facilities in which they have a finan- cial interest should probably advise their patients to seek a second opinion from a physician without a con- flict of interest. CONSUDER-PROTECTTON LAWS Federal and state consumer-protection laws prohib- it businesses from using deceptive practices - such as omitting pertinent information - to sell goods or serv- ices's'57 In effect, businesses are often required to dis- close any information that may be important in a buyer's decision 52 Similarly, the Food, Drug, and Cosmetic Act prohibits the mislabeling of food, and federal regulations require that ingredients and nu- tritional content be listed ss-ss Disclosure sometimes lowers consumers' costs in evaluating products and promotes market efI'icienry .-6 When the available in- formation is too voluminous or complex for the aver- age consumer to interpret, outside groups - such as consumer associations and professional assessors - can evaluate the data. Nonetheless, studies show that consumers are less likely to search for alternative products and services when time is important or when they are ill equipped to distinguish among cru(*al, deferrable, and unnecessary services s''-19 Despite efforts to foster competition in the health care market,60 patients are particularly vulnerable. Frequently, they are involuntary consumers who can- not plan their purchases and assess alternatives care- fully. They often have little opportunity to learn from personal experience, or the cost of doing so may be high. These constraints distort their choices as con- sumers and increase their reliance on the recommen- dations of their physicians. Although self-help groups and publications that provide advice can be usefu1,61 patients still have great difficulty in assessing physicians and choosing ancil- lary medical care facilities. In a 1989 survey, over half the consumers interviewed said they found it some- what or very hard to shop for doctors and hospitals, and nearly three quarters found it somewhat or very hard to shop for ancillary medical services.62 Consum- ers even have a hard time determining physicians' specialties and training.63 No Consumer Reports exists to assess the competence and integrity of physicians and their advice, and institutions to perform these func- tions will not be developed easily. The large number of physicians an3 the generally decentralized market for most medical care make such evaluations costly. Consumers who are considering elective surgery can obtain second opinions, but shopping for advice is often impractical. The disclosure o: financial conflicts of interest will not make patients less dependent on physicians. The medical profession and society must still protect patients. Making more information available can play some part in helping patients as consumers. But without careful guidelines, sellers often present information in a way that counteracts its beneficial effects. For exam- ple, labels sometimes stress that foods contain no cho- lesterol but neglect to mencion that they contain hy- drogenated oils and are thus undesirable for similar reasons." Studies show that the mandated warnings of health hazards on cigarette packages and in adver- tisements are overshadowed by the rest of the material and are often not assimilated ss Cigarette manufactur- ers have also used their disclosure of health risks as a way to limit their liability to smokers.' Disclosure thus protects the seller rather than the purchaser. Some physicians may consciously martpulate disclo- sure to limit their obligation to act on behalf of their patients rather than to protect them. Even well-inten- tioned physicians may disclose their financial interests in a way that encourages passive acceptance rather than increased patient awareness and scrutiny. DISCLOSURE BY LAWYERS TO CLIENTS Codes of legal ethics,67,68 adopted as rules of court in virtually every jurisdiction, require lawyers to dis- close conflicts of interest to their clients. These include conflicts that arise from representing two or more cli- ents with differing (or potentially differing) inter- ests69,70 and conflicts between the lawyer's personal or financial interests and the client's interests.6'-8 Law- yers must describe the risks involved and must some- times counsel their clients to seek independent pro- fessional advice.68•lt Unfortunately, compliance with these conflict-of-interest policies is not complete.69,12 Using their powers to regulate the legal profession, courts supervise lavryers' conflicts of interest. Courts can specify the content and timing of disclosure 67-s9 They can also decide that a conflict of interest is serious enough to disqualify a lawyer from represent- ing a client despite full disclosure and informed con- sent 67~9,'s•74 To increase compliance with conflict-of- interest policies, courts use a -ange of sanctions, among them fines, prohibiting lawyers from collecting fees for work performed, and other penaities.6° No equivalent institutions oversee physicians' conflicts of interest. The adversat-.al nature of the U.S. judicial system also help.; to enfocce disclosure, the disqualification of lawyers, and other conflict-of-interest rules. In litiga- tion, lawyers are expected to use every substantive and procedural device to advance the interests of their cli- ents.'S,'6 This include.= asking that an opposing party's lawyer be barred wh,-n conflicts of interest threaten one's own client.69 Other rules impute one lawyer's

Vol. 321 No. 20 SOUNDING BOARD conflicts of interest to all affiliated lawyers.E'•`'s An en- tire law firm can be disqualified from representing a client because one lawyer has a conflict of interest. Law firms thus have an incentive to police themselves. Disclosure by lawyers is part of a larger institutional apparatus for dealing systematically with conflicts of interest. No such framework exists in the medical pro- fession. DISQ.ostrRE BY CsovERNI1fENT OFFICIAtS Federal employees and appointed officials exercise power on behalf of the public. To help ensure ac- countability, the Freedom of Information Act allows citizens access to government documents, and the Ethics in Government Act requires that workers in the executive, legislative, and judicial branches make information about their financial interests public- ly available through the Office of Governmental Ethics." These laws help curb abuses arising from conflicts of interest. In government, disdosure laws work in conjunction with statutes and regulations that seek to avoid con- flicts of interest by prohibiting certain forms of behav- ior."" These prohibitions cover many activities. They limit the source and amount of outside income that officials in the executive branch can earn while in government,~ and they prohibit officials from par- ticipating in decisions that may affect their private economic interests.14 They restrict former employees in representing clients before the agencies where they worked P i"hey prohibit officials from receiving gifts,"' and they establish institutional mechanisms to deal with conflicts of interest. Disclosure is used to deter ethically dubious activities and to identify and publi- cize violations of conflict-of-interest laws. Some critics charge that government prohibitions and disclosure laws are so strict that they deter talented people from entering public service.' Others say that standards are too low' and that scandals abound.89 Individual citizens rarely inspect the information kept on file, but the press and watchdog groups such as Common Cause and Ralph Nader's group, Public Citizen, do. They scrutinize government documents and publicize any unsavory financial ties they find. In addition, members of Congress often disclose the em- barrassing conflicts of interest of their opponents as part of the political process. Together, these groups ignite concern and arouse the electorate, which can vote public officials out of office. Disclosure thus helps hold elected officials accountable. But without the press, public watchdog groups, and the political proc- ess, fina.r-.-_ial disclosure would not be effective. IMPLICATIONS FOR PHYSICIANS Studies of informed consent suggest that without some supervision of the disclosure process, patients are unlikely to receive helpful information. And disclo- sure alone will not eliminate patients' dependence on their physicians for advice or meaningfully change their options. The history of conaumer-protection laws suggests that disclosure is more helpful when its manner and content are specified and when outside 1407 organizations assess the information disclosed and provide independent advice. These conditions do not now exist in medicine. Moreover, disclosure can be used to shield physicians rather than to reduce the risk that they will abuse their trust. The experience of law- yers' disclosure to clients indicates the need for inde- pendent supervision and sanctions to ensure compli- ance. It also suggests that other approaches, such as establishing rules prohibiting certain conflicts of inter- est, may be useful. The lesson to be learned from the experience of government officials is that public dis- closure - especially when it is publicized by watch- dog groups and the media - can reveal ethically sus- pect behavior or illegal financial activities that can then be penalized. Disdosure may help in dealing with physicians' conflicts of interest, but by itself, it is insufficient to protect patients, and it may even place them at a dis- advantage. Physicians should not be allowed to limit their obligation to act for the good of their patients simply by disclosing conflicts of interest. Therefore, government and the medical profession - rather than patients and physicians individually - should assess the risks and benefits that different kinds of conflicts of interest pose and develop policies to deal with them. Disclosure has a useful role only as part of a co- ordinated policy that sets high standards of ethical conduct, clearly delineates the permissible from the unacceptable, develops institutions to monitor behav- ior, and imposes meaningful sanctions to ensure com- pliance. Community Health Program of Tufts University Medford, MA 02155 MARC A. RODWIN, J.D. Supported in part by a grant from the Pew Memorial Trust as part of an ongoing study. I am indebted to Robert J. Condlin, J.D., Mark N. Cooper, Ph.D., Tamar Frankel, J.D., Dwight Golann, J.D., John D. Lantos, M.D., France..c H. Miller, J.D., Bruce Spitz, Ph.D., Deborah A. Stone, Ph.D., Saul Touster, J.D., Helen R. Trilling, J.D., and Irving K. Zoia, Ph.T., for their comments. REFERFNCEs 1. Relman AS. 'Ibe new medica!-industrial complex. N EnEI J Med 1980; 303:963-70. 2. /dem. Dealing with condicts of intenxt. N Engl 1 Med 1985; 313:749-51. 3. ldem. Prsctieing medicine in the new busincss climate. N Eng11 Med 1987; 316:1150-1. 4. ldem. Salaried physicians and economic incentives. N Engl J Mcd 1988; 3t9:784. 5. Idem. Economic incentives in clinical investigation. N Engl J Mcd 1989; 320:933-4. 6. Milkr FH. Secondary income from recommended treatment: shoutd fidu- ciary principlcs constrain physician behavior? In: Gray B, ed. The new health caro for profit: doctors and hospitals in a competitive environment. Washington, D.C.: Nntional Academy Pres.s, 1983:153-70. 7. Veatch RM. Ethical dilemmas of for-profit enterprise in health care. In: Gray B. ed. The new health care for pcofiu doctors and hospitals in a competitive environment. Washington, D.C.: National Academy Press, 1983:125-52. 8. Schwartz H. Coaflicts of interest in fee for scrvice and in HMO's. N Engl J Med 1978; 299:1071-3. 9. Hillman AL. Fnancial incentives for physicians in HMOs: is there a conflict of interest? N Engl 1 Mcd 1987; 317:1743-8. 10. Baenson RA. Capitation and conflict of interest. Hcalth Aff (Millwood) 1986; 5(l):141-6. 11. Hyman DA, Williamson JV. Fraud and abuse: scning the limits on physi- cians' entrspcencu„hip. N Eng11 Med 1989; 320:1275-8. 12. Scovern H. Hired hdip: a physician's experiences in a for-pro6t staff-modcl It4i0. N Engl 1 Med 1988; 319:787-M.

1408 THE NEW ENGLAND JOURNAL OF MEDICINE Nov. 16, 1989 13. Committee on Implications of For-Profit Enterprise in Health Care, Institute of Medicine, Gray B. ed. For-profit enterprise in health care. Washington, D.C.: National Academy Press, 1986. 14. Ad Hoc Committee on Medical Ethics, American College of Physicians. American college of pbysiciaas ethics manual. 1. History of mcdical ethics, the physician and the patient, the physician's relationship to other physi- cians, the physician and society. Ann Intetn Med 1984; 101:129-37. 15. Council on Ethical and Judicial Affairs. Conflicts of interest: Report A (1-86). Chicago: American Mcdical Association, 1986. 16. ldem. Current Opinioos 4.05, 8.03, 8.12. Chicago: American Medical As- sociarioa, 1986. 17. Judicial Council. Ethical implications of hospital-physician risk-sharing ar- rangements under DRGs: Report D(1-84). Chicago: American Medical Association, 1984. 18. The eshia in patient referraLc act of 1983, H.R. 939. 19. Physician ownership and refatal to health care entities, H.R. 3150 Scction 1057. 20. Igkltart JK. The dcbate over physician ownership of health care facilities. N Engl J Med 1989; 3z1:198-204. 21. Cal. Bus. & Prof. Co&, Sectiaos 654.1, 654.2 (1986). 22. Fio[ida Medical Practices Act, Fla. Stat. Sections 458.327 (c) (1), (2), and (3)- 23. Mass Cxn Laws Ch 112, Scc. 1. 24. Mass Gen Laws Ch 440, Sec. 2. 25. Kuswow RP. Fiasncial amagements betwaa physicians and health care businesses: state laws and tcgnLfioas: a managemeat advisory report, 1989. (Publication no. OAI-12-88-01412.) 26. The Royal Colkge of Physiciaae. The relationship between physicians and the pharmacezibal iadustry. J R Coll Physicians Lood 1986; 20:235-42. 27. Leviason DF. Towwd full disclosure of referral resiricSoas and financial inceatives by prepaid bealdt ptaas. N Engl J Med 1987; 317:1729-31. 28. Macreim EH. Conflicts of interew profits and problems in physician refer- rals. JAMA 1989; 26~. 29. Appelbaum PS, Lidz CW, Meisel A. Infotmed 'coasent legal theory and climal praciice. New Yodc Oxford University Press, 1987. 30. Canterbury v. Sp==, 464 F.2d 772 (D.C. C'uctut. 1972). 31. Cobbs v. Grant, 502 P.2d 1(Cal. 1972). 32 Katz J. The st7eat world of doctor and pa6eai. New York: Free Press, 1984. 33. Empaicat studies of informed coasent. In: Przsideat's Commission for the Study of Ethial Problems in Medicine and Biomedical and Behavioral Research. Making health are decisions: a report on the ethi«1 and legal implications of informed consent in the patieat-practitiooer relationship. Vol. 3. Washington, D.C.: Government Printing Office, 1982401. 34. Waitzkin H. Doctac-patieat eommuniation: clinical implications of social sc'teatiSe research. JAMA 1984; 252:2441-6. 35. Scbneyder TJ. Informed consent and the danger of bias in the formation of medical disclosure practices. Wis Law Rev 1976; 1976:124-70. 36. Fadea RR, Beanchunp '1L. A history and theory of infocmcd consent. New Yodc Oxford University Pnss, 1986:298-336. 37. McNeil BJ, Pauku SG, Sox HC Jr, Tversky A. On the elicitaSon of prefer- eaas for alternative therapies. N Engl J Med 1982; 306:1259-62. 38. lidz CW, Meisel A, Zetubavel E, Carta M, Sestak RM, Roth LH. In- formed consent: a study of decisionmaking in psychiatry. New York: Guil- ford, 1983:128-9. 39. Katsch BM, Ncgete VF. Doctor-patient communication. Sci Am 1972; 227(2):66-74. 40. Caundaer TM. On the readability of surgical coastat fortns. N Eng11 Med 1980;302100-2. 41. Beecber HK. Consent in clinical expaimenta6on: myth and reality. JAMA 1966; 195:34-5. 42. Utilintlon of Medicaid laboratay services by physicians witblwithoat own- ership interest in clinical laboratories: a comparative aaalysis of six selected laboratories. Medical Services Admiaistratioo, State of Michigan, Depatt- meat of Social Servias, Medicaid Monitoring and Compliance Division, 1981. 43. Childs AW, Hunter DE. Patterns of primary medical csre-use of diagnos- tic x ray by physicians. Beriteley: Institute of E¢siness & Economic Re- search and tbe School of Public Health, University of Califomia, 1970. 44. Departmeat of Health and Human Services, Health Care Financing Admin- istration, Division of Health Standards and Quality, Region V. Diagnostic clinical laboratory services in region V., 1983. (No. 2-05-200411.) 45. A comparison of laboratory utilization and payout to ownership. Blue Cross and Blue Shield of Michigan, Medical Affairs Division, 1984. 46. Federal Trade Commission Act, 15 U.S.C., Sec. 41, a seq. 47. Regulation of Business Practices and Consumer P:otcct}on Act, Mass Gen Lawt Ch 93-A. 48. Bailey PB, Pertschuk M. The law of deccptioa: the pist as prologue. Am Law Rev 1984; 33:849-97. 49. 15 U.S.C. Sec 55(axl). 50. Raymond Lee Org., Inc., 92 F.T.C. 489 (1978). 51. FTC v. Simcon Mgnx. Corp., 532 F.2d 708 (9th C"v. 1976). 52. Slaney v. Westwood Auto, 366 Mass 688,705 (1975). 53. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Secs. 201, 403. 54. United States v. Ninety-Five Barrels of . . . Apple Cider Vinegar, 265 U.S. 438 (1924). 55. 21 C.F.R. Seca 101.4,101.22-101.35. 56. Reich R. Towards a new consumer protection. Penn Law Rev 1979; • 128:1- 40. 57. Newman JW, Staelin R. Multivariate analysis of differences in buyer deci- sioa time. J Mark Res 1971; 8:192-8. 58. Claxton JD, Fry JN, Portit B. A taxonomy of pcepurchzce information gathering. J Consum Res 1974; 1:35-42. 59. Beaay SF., Smith SM. External search effort: an investigation across severa" product categories. J Coasum Res 1987; 14:83-95. 60. Altman SH, Rodwin MA. Halfway canpetit3ve markets and ineffective tcgulation: the American health care system. J Health Polit Policy Law 1988; 13:323-39. 61. The Bosion Womea's Health Book Collective. The new our bodies, our- selves: a book by and for women. New Yock: Simon & Schuster, 1984. 62. Public op'mion about health are purchases: cost, ease of shopping and availability. Washingtoo, D.C.: Consumer Federation of America, 1989. 63. Reade JM, Ratzan RM. Access to information - physicians' credentials and where you can't find them. N Engl J Med 1989; 321:466-8. 64. Kessler DA. Tbc federal regulation of food labeling: promoting foods to prevent disease. N Eng1J Med 1989; 321:717-25. 65. Department of Haltfi and Human Services. Reducing health consequence of smoting: 25 years of ptvgess: a report of the surgeon gencal. Washington, D.C.: Government Printing Office, 1989:478-81. (DHHS publication no. 89-8411.) 66. Cipollone v. Liggette Group Inc., ':89 F.2d 181 (3rd Cir 1986). 67. Code of professional responsibility. Chicago: American Bar Association, 1969. 68. Model rules of professional cunduct. Chicago: American Bar Association, 1983. 69. Wolfram CW. Modern legal ethics. St. Paul: West Publishing, 1536. 70. Developments in the law: condicts of inrestisi in the legal profession. Hazv Law Rev 1981; 94:1247-83. 71. In re Batt1ett, 584 P.2d 296 (1978). 72. ClukT.Specialcommitteeoneval=soaofdisciplinaryenforcementprob- lems and tecommeaAtioas (the Clarf committee teport). Chicago: Ameri- can Bar Associa6oa, 1970. 73. In re Cobn, 216 A.2d 1(1969). 74. Valky Titk Co. v. Superior Court, 124 Cal. App.3d 867, 177 Cal. Rptr. 643 (1981). 75. Curtis C. The uhics of advocacy. Stan L Rev 1951; 4:3-23. 76. Freedman MH. Lawyers' ethics in an adversary system. Indianapolis: Bobbs-MeriB, 1975. 77. Ethics in Gnvemment Act of 1978, 5 U.S.C. Sec. 201 et seq. 78. 18 U.S.C. Sx. 201 et seq. 79. 28 U.S.C. Sec. 591 et seq. 80. 5 C.F.R. Part 734 Executive Personnel Financial Disclosure Requirements. 81. 5 C.F.R. Part 735 Agency Regulations Governing Ethical and Othc.r Con- dtkt and Responsibilities of Employees. 82. 5 U.S.C. Src. 210. 83. 5 C.F.R. 734.501. 84. 18 U.S.C. Sec. 208 (a). 85. 18 U.S.C. Sec. 207. 86. 5 C.F.R.735.202. 87. Manning B. The purity potlatch: an essay on conflict of interest, American govemmeat, and moral escalatiott. Fed Bar J 1964; 24:239-56. 88. Cutler L. And cut out the honorariums. New York Times. April 20, 1989:A27. 89. Roberts RN. White House ethics: the history of the politics of conflict of interest regulation. New York: Greenwood Press, 1988. CORRESPONDENCE IMPORTANCE OF AGE IN PROGNOSTIC STAGING SYSTEM FOR AIDS To the Edilor: The prognostic staging system for the acquired immunodeficiency syndrome (AIDS) that was recently developed by Justice et al. (May 25 issue)t is based on a scoring system for clinical and physiologic deficits at the time of the AIDS diagnosis. These include nutritional, respiratory, and neurologic deficits, c~to- penias (anemia, leukopenia, lymphop:nia, 6rombocytopcnia), or both. Survival trends in their cohort of patients, mostly homosex- ual, showed distinct differences based on the zev^;, :.f the physio- logic deficits present at the i,iitial diagnosis of AIDS. Such a staging system is appealing, not only because the data are available and can easily be gathered with noninvasive methods, but also because it is independe nt of immunologic data (e.g., CD4 counts), which are so