J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from MEDICAL PRACTICE Primum Non Nocere and the Quality of Evidence: Rethinking the Ethics of Screening

Robert M. Ewart, MD

Background: Screening is different from investigation, and these differences have important implica­ tions in the assessment of screening programs. Methods: I review the differences between screening and investigation and the implications of these differences derived from a consideration of the four ethical principles of beneficence, nonmaleficence, autonomy, and distributive justice. Results: Because most of the hanns of screening fallon the healthy and because screening is initi­ ated by physicians, nonmaleficence takes ethical precedence over beneficence. Issues related to cost and consent are also approached differently in screening compared with investigation, and both take on greater ethical importance. I contend further that these ethical implications require that screening pro­ grams be backed up by better evidence than is the usual case for investigative medicine. I suggest an outline for the appropriate assessment of screening programs and for the ethical responsibilities of those involved in screening. Conclusions: Many current medical screening practices are not concordant with our ethical princi­ ples and should be reassessed. (J Am Board Fam Pract 2000;13:188-96.)

Many current medical screening practices are in­ ing it. Screening is different from investigation, in consistent with the ethical principles underlying which tests are ordered after disease is suspected. medical care and are unsupported by acceptable Although screening can be done under many dif­ evidence. These practices could be regarded, there­ ferent circumstances, this article considers only the fore, as unethical. Recommendations supporting situation of screening competent, un coerced adults screening programs put physicians in the unenvi­ for their own benefit. able position of practicing according to the current There is a distinction between screening tests standard of care but in an unethical manner or and screening programs. A screening test is the http://www.jabfm.org/ practicing ethically but exposing themselves to pro­ initial test done to find a condition. A screening fessional and legal criticism. This article explores program, however, is the screening test (eg, a mam­ the differences between screening and investigation mogram), follow-up tests done to confirm the ini­ and the ethical implications of these differences. tial test (breast biopsy), and treatment given for Whereas some of these topics have been discussed abnormal findings (surgery, radiation, chemother­ individually by others, there has been no effort to apy). A program could, minimally, consist of a test on 24 September 2021 by guest. Protected copyright. examine the topic as a whole, although there have and telling the patient the result (which might be 1 3 been calls for such an examination. - reassuring and, therefore, beneficial). Screening tests by themselves have no benefit, but they always What is Screening? have some potential for harm, which could on oc­ Screening is looking for a disease in those not casion be serious.4 It is the screening programs that suspected (except on probabilistic grounds) of hav- ultimately are beneficial or harmful and that, there­ fore, form the appropriate unit of analysis. The commonly listed criteria necessary for a Submitted, revised, 31 August 1999. screening program are as follows: 5 From the Department of Family & Community Medi­ cine, Southern Illinois University School of Medicine, Springfield. Address reprint requests to Robert M. Ewart, MD, Department of Family & Community Medicine, SIU Center for Family Medicine, 520 North 4th St, Springfield, 1. The natural history of the disease should be IL 62702-5238. reasonably well understood.

188 JABFP May-June 2000 Vol. 13 No.3 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from 2. The burden of suffering from the disease must small adverse effect of screening on quality of be high enough to justify screening. life, health promoting behaviour, or individu­ 3. The screening test must be reasonably sensitive als' capacity to care for themselves could have and specific. an impact on the public health which out­ 4. The disease must be treatable. weighs any gain to be achieved by screening. 5. Treatment given earlier in the course of the In the present analysis I reject a simplistic utili­ disease must produce a better outcome than tarian approach to the ethical problems of screen­ treatment given late in the course of the disease. ing and move toward developing an alternative. My 6. Patients will comply with the offered testing and point of view will be, for the most part, fixed on the treatment. individual. This view is not to deny the public 7. Resources to run the program must be available. health implications of screening, but merely to 8. The costs of the program must justify the ben­ point out that man has no general ethical obligation efits. to be healthy, although a person might have obli­ gations to others that involve his or her health, and Many authors have expressed agreement with that person does have an obligation to not affect these criteria, with some adding a discussion of others with his or her own ill health (including the selected ethical aspects.6 Others have further im­ costs of care for that ill health). plied that there is no ethical requirement for phy­ sicians to follow recommendations that are not 7 8 based on these criteria. • How Is Screening Different From These recommendations are for the most part Investigation? technical, and although meeting technical condi­ Screening is different from investigation that is tions is necessary before a screening program is done on those thought to be sick. For example, if a begun, it is not sufficient. Recommendations about 60-year-old woman comes into the office with a screening should also be analyzed from an ethical new, hard lump in her breast, a mammogram might standpoint. be ordered to investigate this lump. The same woman might, however, have been invited to come in for a checkup, and a mammogram might then be Point of View: Public vs Individual Health arranged to screen her for breast cancer even in the Historically, screening has been associated with absence of complaints or findings on physical ex­ public health, for example, screening for infectious

amination. http://www.jabfm.org/ diseases for quarantine or screening military re­ This distinction is based on the likelihood of cruits for fitness to fight.2 At least partly as a con­ disease. Everyone has some tiny chance of having sequence of this point of view, advocates of screen­ most diseases. Investigations are done on those ing have tended to adopt a utilitarian approach, the thought to have a high preexisting probability of greatest good for the greatest number.9 In overly disease, whereas screening is done on those with a simplistic terms, this strategy adds the benefits, low (usually very low) preexisting probability. This subtracts the harms (or costs), and if the result is on 24 September 2021 by guest. Protected copyright. distinction can often be modified to mean not positive, recommends proceeding. "probability of having disease" but "probability of In 1981 Rose lo was one of the first to comment benefitting from treatment." Most 95-year-old on some of the difficulties that can arise from this men have prostate cancer, but few of them will approach, referring to the "prevention paradox -a benefit from treatment. l2 Dr. Heidi MaIm (letter, measure that brings large benefits to the community 1996) has pointed out that this distinction implies offers little to each participating individual." He went that patients who are investigated "have greater on to point out that if "a preventive measure ex­ room for benefit than ... [those1 screened." Pa­ poses many people to a small risk, then the harm it tients who have symptoms have the potential of does may readily ... outweigh the benefits, since finding, through investigation, that they are not ill; these are received by relatively few." More recendy patients who are screened cannot benefit in this Stewart-Brown and Farmerll have said: way "except for the trivial benefit of knowing one Screening programmes affect a large number does not have a disease which one had no reason to of people relative to the number who benefit. A believe one had in the first place."

Ethics of Screening 189 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from The second difference between screening and What Are the Ethical Implications of These investigation relates to who initiates the action. In Differences? the usual course of medical care, patients come to It is generally accepted (and will not be argued physicians for advice; with screening, physicians go further here) that there is a duty to respect four to the patient and recommend tests, although this ethical principles in medical decision making. recommendation might be made indirectly. These principles are beneficence, nonmaleficence, A third difference is that screening programs are· autonomy, and justice.14 usually evaluated with respect to their effect on the health of a population rather than on the individ­ 3 uals in the population. I \Vhen a physician removes Harms and Benefits 15 16 someone's gall bladder, the benefit and harm to All screening programs can cause harm. • The l7 that person are known to at least some degree. If a doctrine of primum non nocere (first, do no harm) physician orders a screening mammogram, the tells physicians that their first ethical consideration harm will for the most part be known, but the should be the potential harm of intervention, and in benefit can never be known except statistically. For balancing benefits and harms, to attach more ethi­ cal weight to the injunction of nonmaleficence than instance, I know that symptomatic gall bladder dis­ ls ease tends to continue to cause symptoms and that to that of beneficence. I do not mean to imply taking out the gall bladder will usually relieve these that the duty of nonmaleficence is absolute or that it invariably takes precedence over other ethical symptoms. I have, however, only statistical infor­ responsibilities or even that it invariably takes pre­ mation about the natural history of most cancers, cedence over beneficence. I am instead arguing and I cannot ever know whether removing a par­ here that in most situations physicians have a stron­ ticular cancer 6 months earlier helped a particular ger obligation not to harm people than to help person. There are numerous exceptions to this gen­ them. I will develop below the specific argument eral rule, mostly involving screening for curable that, in screening, nonmaleficence almost always infectious diseases and congenital conditions. takes precedence over beneficence. A fourth difference between screening and in­ In the end a patient can be both benefitted and vestigation is that with screening, the costs and harmed by tests and treatments. \Vhen beginning a harms are immediate, while the benefits are often course of testing and treatment (whether screening considerably delayed. For example, a major pur­ or investigation), physicians can know only the sta­ pose of screening for and treating high blood pres­

tisticallikelihood of disease and its various possible http://www.jabfm.org/ sure is to prevent stroke. Yet most people with high outcomes. Given a continuum in the preexisting blood pressure will never have a stroke, and pa­ probability of disease (and of benefitting from tients in their 40s will often need to take medica­ treatment), there is an equivalent continuum in the tion for 20 to 40 years to prevent stroke. This probability of who will be harmed-the healthy or distinction between screening and investigation is the sick. If a person probably has a disease, then any not absolute. It is reasonable to suppose that not all harm that comes from investigation will fall on on 24 September 2021 by guest. Protected copyright. patients who have symptoms benefit from the re­ someone who is already ill. If, at the other end of sulting investigations and treatment and that the the continuum, a person almost certainly does not benefits could be considerably delayed. This course have a disease, then any harm of screening will fall of events is, however, the usual in screening, on someone who was previously healthy. Because whereas it is unusual in investigation. the healthy have more to lose than the sick, harm­ These four distinctions argue for a dichotomous ing the healthy is, all other things being equal, approach to screening vs investigation. In practice, worse than harming the sick. Alternatively, if a this distinction is not so clearcut. The two exist on person probably does not have a disease (or would a continuum, with screening at one end and inves­ not benefit from finding the disease), a first and tigation at the other; and many of the arguments most important obligation is to not cause harm by presented in this article could be applied equally looking for it, and only then does the physician well to the treatment of asymptomatic conditions have an obligation to help. in otherwise healthy people (eg, giving female sex I am not arguing here the more ethically suspi­ hormones routinely to postmenopausal women). cious position that those with less to gain have a

190 JABFP May-June 2000 Vol. 13 No.3 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from lower entitlement to health care compared with there will be casualties and the innocent will suffer. those with more to gain. I am arguing that those This is the price that must be paid for victory. One with more to lose have the potential to suffer more is asked to count, not the cost, but only the victory, harm from intervention and that the potential for and remember the victims as heroes of the struggle. harm should therefore be given increased ethical weight. A second issue in the assessment of the balance Autonomy (Self-Determination) between harms and benefits involves who initiates Faden et al 19 have argued strongly for the prima the action. It seems obvious that the person initi­ facie primacy of respect for autonomy in medical ating an action has a greater responsibility for the decision making as opposed to the historical pater­ consequences compared with a person responding nalistic, beneficence-oriented model. Autonomy to the action. "\Vhen physicians invite patients to implies in turn that informed consent holds a cen­ come for screening, the responsibility not to harm tral place in our assessment of the ethics of medical 20 them increases, and the ethical weight attached to interventions. GilIon ,21 has taken a somewhat less harming them also increases. demanding position arguing for the importance, The implication of the above is that harm and but not necessarily the primacy, of autonomy. benefit should be assessed separately and given sep­ "\Vhichever of these approaches physicians take, arate ethical weights, and physicians should pro­ issues surrounding consent change when they move ceed only if the utilitarian calculus is then still from investigation to screening. There are two rea­ positive. By doing so, however, simple utilitarian­ sons for this change. First, whereas the ideal of ism is effectively gutted as a guiding ethical theory. completely informed consent is difficult to obtain, To put it in another way, when assessing a most reasonable persons understand that there is screening test, showing that a test is beneficial or some risk to the investigations and treatments that reduces disease-specific or overall mortality does are undertaken in the care of the sick. There is an not imply that the test is not harmful or that it implied risk in all medical encounters, and although should automatically be performed. consent should be substantially autonomous, it There are several reasons why this approach has does not need to be completely SO.19(pp 237-241) My not been accepted historically. The first is probably experience as a family physician has been that most that screening tests have often been seen to exist in reasonable persons do not understand (or under­ isolation, not as part of screening programs. Be­ stand much less well) that screening tests or pro­

cause the tests themselves often have few and trivial grams can harm them (apart from the often trivial http://www.jabfm.org/ harms, it has been commonly accepted that even harm of the tests themselves); as a consequence, minimal benefit will always outweigh these harms; they need to be more informed by giving them therefore, a separate assessment is not necessary. both more detailed information (the process of The second reason is that, as noted above, screen­ consent) and by paying more attention to the in­ ing has often been accepted as part of public health, formation being understood (the outcome of con­ and public health physicians commonly adopt some sent). Further, many do not seem to understand the variation of utilitarianism in their assessments. This implications of a screening test being only the first on 24 September 2021 by guest. Protected copyright. approach, in turn, reinforces an attitude of looking step in a screening program. Consent for the initial only at the final result rather than the component screening test, therefore, should include at least parts. This perspective is strengthened by the de­ some minimal discussion of the risks and benefits of sign of randomized, controlled trials, which tend to the follow-up tests and treatments.22 have a single main outcome measure (although one I am not arguing that every person screened should note that many, if not most, screening rec­ should be given detailed information on every pos­ ommendations are not backed up by the results of sible outcome of screening. Obviously, judgment is any well-designed trials.) The third reason is more needed regarding the information provided. I am, psychologic: medicine has come to be viewed as a however, arguing that patients should be aware that battle against disease. This attitude is reflected in they are entering a program with some associated slogans -"The War Against Cancer"- and in simple risks and should be given clear and appropriate things, such as obituaries -"he succumbed after a information about the nature and likelihood of long fight with cancer." It is accepted in war that these risks (as well as the benefits).

Ethics of Screening 191 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from A further point concerning the issue of consent spend more money. This choice, of course, simply is that screening is done by invitation. As noted moves issues of distributive justice to a higher level; above, patients have a stronger right to not be what is the public willing to give up to have better hanned by tests and treannents that they did not health? ask for in the first place. This right imposes a greater burden for consent than that which exists Screening and the Quality of Evidence when the patient requests care. As noted above, one difference between screening and investigation is in who initiates the proce­ Justice dure-the physician or the patient. The ethical Distributive justice refers to the problem of ensur­ implication relates to the quality and quantity of ing an equitable distribution of benefits given the 23 the evidence that a physician must have before constraints of limited resources. ,24 Or, as Drum­ making a recommendation. mond and Mooner5 have put it, "There are not In the usual practice of medicine, the physician's and never will be enough resources to enable the evidence should be pretty good. VVhen a patient community to pursue all desirable objectives. If this seeks advice, physicians have an obligation to do notion of scarcity of resources is accepted, then the their best with the evidence at hand. A physician's logic of comparing the costs and benefits to the assessment of the benefits and harms is a best ed­ community of alternative actions has much appeal." ucated guess, and the weighing of this balance is Screening programs must take their place in the correspondingly inexact. In screening, both the ongoing debate on the fair distribution of re­ quality and quantity of the evidence must exceed sources. Screening is, however, different from in­ this standard. Harming someone who has not asked vestigation because it tends to have high up-front for help is worse than harming someone who has. costs with delayed benefits, and much of the cost is Patients who want medical help accept that occa­ borne by those who will never benefit. sionally tests and treannents will cause hann. This Accordingly, at least in insurance-based systems implied contract exists to a much lesser degree of payment, an ethical conflict will often result when the patient has been invited for screening between the right of individuals to beneficial care tests. The invitation implies that physicians have an and the right of society to determine spending obligation to obtain better evidence regarding the priorities. This conflict is real and admits to no hanns and benefits than they do in investigative general resolution. On the one hand, the one who care.

pays the piper calls the tune. On the other, every­ http://www.jabfm.org/ A good analogy is the evidence necessary in one has a right to dance to his own music. I favor a court. In a civil court, the evidence need only be on double-veto system in which each person has a the balance of probabilities, while in criminal court right to refuse screening even if it is beneficial to it must be beyond any reasonable doubt. Evidence society (arguing from autonomy), and society has a in routine medical care is like that in civil law: it will right to refuse to pay for screening programs on the probably help. With screening, the situation is grounds of excessive cost (or excessive hanns) even much more like that in criminal law; and the ben­ on 24 September 2021 by guest. Protected copyright. if they benefit some members of society (arguing efits and hanns must be known beyond any reason­ from distributive justice). able doubt. My plea is that these issues be brought out to This viewpoint is supported by Cochrane and face the light of day so they can be properly dis­ 3 Holland (quoted in McCormick ): cussed and analyzed. It is happening to some extent in American health maintenance organizations, We believe that there is an ethical difference where there is an explicit attempt to ensure equi­ between everyday medical practice and screen­ table distribution of resources to the membership. ing. If a patient asks a medical practitioner for Crisp et al26 and Ne~7 have discussed some of help, the doctor does the best he can. He is not these issues in the context of the British National responsible for defects in medical knowledge. Health Service. If, however, the practitioner initiates screening Problems in slicing pies can always be solved by procedures he is in a very different situation. making the pie bigger. That is, if screening pro­ He should, in our view, have conclusive evi­ grams are expensive, the public can simply elect to dence that screening can alter the natural his-

192 JABFP May-June 2000 Vol. 13 No.3 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from

tory of disease in a significant proportion of I am not arguing that all screening programs those screened. need to be justified by an RCT. I am arguing that RCTs are necessary in all situations in which they 8p3 Miller has similarly stated that: are possible, and in situations where RCTs are The crucial distinction between screening and unnecessary or inappropriate, the next best evi­ normal medical diagnosis and care is that the dence must be obtained. I am arguing strongly provider of screening initiates the process, not against the position that screening should proceed the individual who is the subject of screening. based on the best available evidence, which might ... When a patient goes to see a physician for be of fairly low quality and not meet the standards diagnosis of and hopefully relief from a symp­ referred to above. tom, or for treatment of an established condi­ tion, the physician is required to exercise his or Specific Examples her skills only to the extent that knowledge is I am somewhat reluctant to include specific exam­ currently available .... At the very least, there­ ples of screening programs that I feel are good or fore, those planning to introduce screening bad, as I do not want to confuse the general argu­ have an ethical responsibility to be able to ment with the pros and cons of particular pro­ guarantee an overall benefit to the community. grams. With that caveat in mind, the following This has to be coupled with the responsibility examples might be considered. to minimize by all possible means the harm that could accrue to some participants. These 1. PSA screening fails because of a lack of good responsibilities imply that if valid evidence is evidence showing benefit. 12 not available from properly conducted research 2. Advising women to examine their breasts regu­ studies ... screening programs should not be larly fails because there is evidence that it is offered. ineffective,31 and there is no good evidence that it is effective. The approach to evidence presented here is con­ 3. Stool occult blood screening fails because of siderably more conservative than that advocated by prohibitive costs even though the program has many organizations. For example, both the Cana­ well-defined benefits.n .B dian Task Force on the Periodic Health Examina­ 4. Screening low-risk women for hypercholester­ tion28 and the US Preventive Services Task Force29 olemia fails on the grounds of excessive costs allow for fairly low-quality evidence to justify http://www.jabfm.org/ and harms and unknown benefits.34 screening under some circumstances. I think this 35 36 5. Papanicolaou screening is probably good. • approach is incorrect. As a corollary, it would seem Although there are no randomized trials sup­ the organizations that make recommendations for porting the program, there are sufficient epide­ screening based on no, or almost no, good evidence miologic data to continue. The costs are reason­ (for example, the American Cancer Society recom­ ably well understood, and the harms are fairly mendation for screening for prostate cancer using well understood. Further research could be use­ on 24 September 2021 by guest. Protected copyright. prostate-specific antigen [PSA] 12) are acting in a ful in the areas of harm and consent. way that can only be described as unethical. 6. Blood pressure screening passes most of the tests, at least as long as treatment is restricted to What Is Good Evidence? those at substantial risk. There is good evidence from controlled trials about the benefits, harms, Having said that good evidence is necessary, it 37 behooves me to say more precisely what is meant and costs. An understanding of consent is poor by good evidence. For the most part, I mean ran­ but could be easily rectified. domized controlled trials (RCTs). Nonrandomized and uncontrolled trials suffer from volunteer bias,3° Conclusions lead-time bias, and sampling interval bias, which To date, for health policy decisions regarding make screening appear to be beneficial regardless whether screening tests and programs should be of whether it actually is. These biases can be offered, mostly technical aspects have been consid­ avoided by the use of the RCT. ered: does the program work in the small sense of

Ethics of Screening 193 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from reducing morbidity or mortality from the disease in about distributive justice at the societal level (ie, question? The medical establishment is now in a in making health policy decisions). It is possible position to expand the requirements to include an that some programs are simply too expensive to ethical dimension. implement in any population even though they have well-defined health benefits. 1. In screening, in contradistinction to investiga­ 2. Expert organizations have the responsibility to tion, most of the harm falls on healthy persons, collect, assess critically, and present the evidence and in this situation particularly, the doctrine of regarding the harms and benefits (to both those nonmaleficence becomes of prime importance. found to have disease and those not), the costs, Harms should be assessed separately from the and the procedures and outcomes of getting benefits, and screening should proceed only if consent at the population level, but not to make the harms are thought to be acceptable. any further recommendations regarding screen­ 2. Consent for screening (autonomy) needs to be ing. more informed than is usual in investigative 3. Individual physicians have the ultimate respon­ medicine and needs to address not simply the sibility of recommending screening tests to their screening test but the screening program. A for­ patients. They have three responsibilities: to as­ mal evaluation of the ability to get consent at the sess critically the evidence presented to them by population level must be undertaken and must recommending organizations and insurers, to be judged to be acceptable before a screening assess issues of distributive justice that exist at program is implemented. After implementation, the level of their individual practices, and to consent must still be obtained on an individual insure that informed consent is obtained. level. 4. Patients have an obligation to assess critically 3. Issues of distributive justice must be addressed at the information they have been given and to both the population and the individual levels make an individual assessment of the balance before screening recommendations can be between harms, benefits, and costs (both indi­ made. vidual and social) and to decide whether they 4. Because screening is done by invitation, and wish to be screened. because it is always possible to get good evi­ dence before screening tests are recommended, Expert organizations, insurers, physicians, and the acceptable evidence for screening must be patients have a positive ethical obligation to not

much better than the evidence used for routine proceed until the above criteria have been fulfilled http://www.jabfm.org/ care. Evidence for screening for risk factors and, if they do not do so, they could be regarded as should include evidence of the effect on the acting in an unethical manner. underlying disease as well as general health and An effect of these recommendations is that well-being. screening becomes messier. Those involved in screening move from a system of very clean recom­ The analysis presented here differs considerably

mendations to a much less tidy, more uncertain, on 24 September 2021 by guest. Protected copyright. in its implications from that presented by others. and often inconsistent situation. These differences can be approached from several points of view: the government, the expert organi­ zation, the insurer, the physician, and the patient. Implications for Further Research The first implication is that most current recom­ 1. The government has the overall responsibility mendations need to go back to the drawing board. for laying out the rules of the game with respect Although there is sometimes reasonable informa­ to both the general distribution of resources and tion regarding the benefits of screening, the under­ to the legal rules under which medicine is prac­ standing of the harms is limited. Much more debate ticed. These would include rules regarding phy­ needs to take place regarding how ethical weight is sicians' general responsibility toward patients attached to harming the healthy and how these and about standards of care. Insurers (both pub­ harms are balanced against benefits. An under­ lic and private) have the primary responsibility standing of the process of getting consent (both at of translating these general rules into decisions the societal and the individual level) is almost non-

194 JABFP May-June 2000 Vol. 13 No.3 J Am Board Fam Pract: first published as 10.3122/15572625-13-3-188 on 1 May 2000. Downloaded from existent. There is some ability to assess costs, al­ 9. Gillon R. Utilitarianism. Br Med ] (Clin Res Ed) though exactly how to do it remains controver­ 1985;290:1411-3. sia1. 38- 40 Future screening trials should gather 10. Rose G. Strategy of prevention: lessons from cardio­ information prospectively on harms, costs, and vascular disease. Br Med] (Clin Res Ed) 1981;282: 1847-51. consent as well as benefits. Decisions about distrib­ 11. Stewart-Brown S, Farmer A. Screening could seri­ utive justice remain contentious, as evidenced by 41 ously damage your health: decisions to screen must recent debates about rationing in Oregon and take account of the social and psychological costs. British fundholding.42 Should spending decisions BM] 1997;314:533-4. be made rationally, by physicians, by social consen­ 12. Woolf SF. Screening for prostate cancer with pros­ sus, or by the squeaky-wheel-gets-the-grease prin­ tate-specific antigen. An examination of the evi­ ciple?43 dence. N EnglJ Med 1995;333:1401-5. Further research needs to be undertaken on the 13. Cribb A, Haran D. The benefits and ethics of screen­ process by which screening recommendations ing for breast cancer. Public Health 1991;105:63-7. move from opinions to guidelines to standards and 14. Gillon R. Medical ethics: four principles plus atten­ tion to scope. BM] 1994;309:184-8. the implications of this process in the organization 15. Haynes RB, Sackett DL, Taylor DW, Gibson ES, of medical care and for legal liability. Currently, Johnson AL. Increased absenteeism from work after influential organizations make recommendations detection and labeling of hypertensive patients. based on incomplete assessment, and physicians N Engl] Med 1978;299:741-4. feel obliged to follow them because of fear of crit­ 16. Stoate HG. Can health screening damage your icism (both medical and legal). As a result,. these health?] R ColI Gen Pract 1989;39:193-5. recommendations become the standard of care. 17. Gillon R. "Primum non nocere" and the principle of This outcome is obviously unacceptable (and un­ non-maleficence. Br Med J (Clin Res Med) 1985; ethical), and the process by which it happens needs 291:130-1. reassessment. 18. Gillon R. Beneficence: doing good for others. Br Med] (Clin Res Med) 1985;291:44-5. 19. Faden RR, Beauchamp TL, King NMP. A history Particular thanks to Dr. Heidi Maim for ideas and criticism. and theory of informed consent. New York: Oxford Other colleagues too numerous to mention have provided con­ University Press; 1986. structive criticism of earlier drafts of this manuscript. Acknowl­ 20. Gillon R. Autonomy and the principle of respect for edgment is also given to the anonymous referees who reviewed autonomy. Br Med ] (Clin Res Med) 1985;290: earlier drafts. 1806-8. 21. Gillon R. Consent. Br MedJ (Clin Res Med) 1985; http://www.jabfm.org/ References 291:1700-1. 1. Skrabanek P. \Vhy is preventive medicine exempted 22. Edwards PJ, Hall DM. Screening, ethics, and the from ethical constraints? J Med Ethics 1990;16:187- law. BMJ 1992;305:267-8. 90. 23. Gillon R. Justice and medical ethics. Br Med J (Clin 2. Horner JS. Medical ethics and the public health. Res Med) 1985;291:201-2. Public Health 1992;106:185-92. 24. Gillon R.]ustice and allocation of medical resources.

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196 JABFP May-June 2000 Vol. 13 No.3