APHA Technical Report Public Health Policy-Making in the Presence of Incomplete Evidence I. Introduction The American Public Health Association (APHA) plays an important role in assessing public health problems both in the United States and abroad, and in developing, recommending, advocating, and implementing approaches to their correction or amelioration. Often the impact ofagiven problem warrants action even though the evolving epidemiologic or other scientific evidence is considerably less than perfect. In such instances, however, definitive action may be prevented, delayed, or otherwise compromised by true scientific doubts, by concerns about costs, logistics and other issues, and by special interest groups that may be adversely affected by the action taken and therefore use scientific uncertainty to justify opposition. These factors, coupled with difficulty in understanding scientific issues, may impede regulatory action and the enlistment of public cooperation and support. Problemsinmakingpublic health decisions under such circumstances have increased in recent years and solutions are often disproportionately driven by economic and political considerations, due in part to Presidential Executive Order 122911 which granted greater authority to the Office of Management and Budget in the federal regulatory process. A. Purpose
The intent of this technical report is to ensure that APHA members and others concemed with public health problems are cognizant of the forces that compromise optimum solutions, particularly when the evidence concerning the need for, and efficacy of, such actions is under challenge. B. Objectives The objectives of the report are: 1. To delineate and explain the issues and forces that bear upon public health decisions; 2. To recommend guidelines to assist the APHA in the task of assessing public health problems and developing optimum solutions; and This report was prepared by an Ad Hoc Committee working under the auspices of the Program Development Board of the Aneican Public Health Association (APHA), and was received by theAPHA Executive Board at their meeting held April 24-25, 1989.
Members ofthe Committee: Edward A. Mortimer, Jr., MD, Chair Jeffrey P. Koplan, MD, MIPH Peter A. Lachenbruch, PhD Irving Lewis, MA Ruth Roemer, JD Linda Rosenstock, MD, MPH Robert F. Woolson, PhD i) 1990 American Journal ofPublic Health 746
3. To recommend strategies by which the APHA may develop constituencies for beneficial public health measures.
II. Issues In developing approaches to a public health problem in the presence of substantial but disputed scientific evidence, the APHA should consider the following: A. Need for Action
The needfor action, shouldbe measuredby the problem's impact, defined as the product of the numbers of people affected and the severity for the individual. An example of a problem with considerable impact because ofits severity in spite of small numbers is that of Reye syndrome and aspirin.2 In contrast, respiratory symptoms from exposure to formaldehyde may be more irritating than life-threatening, but nonetheless ofconsiderable impact because of the numbers of persons affected.3 The health consequences of tobacco are of major impact because of numbers and severity.4 Iinportant as a corollary is whether sub-groups in the population are particularly affected, e.g., children in urban slum dwellings exposed to lead, and other groups which lack a unified voice, such as migrant workers. B. Firmness of the Evidence
The firmness of the evidence usually lies somewhere along a spectrum from anecdote to absolute proof. This is a most difficult issue, because assessments must often be made in the face of incomplete, evolving, and contradictory epidemiologic and biologic data. The strength of the evidence required for action may vary inversely with the impact of the problem. It is important to note that regulatory agencies do not share with scientists the luxury of expressing uncertainty; either definitive action or no action is usually required. It must also be recognized that different scales ofproofmay be demanded depending on the perceived extent to which selfinterest may be affected.54 The difficulties inherent in assessing and acting on incomplete, evolving evidence are well exemplified by the issues of environmentally related disorders, especially cancer. The systematic development of evidence from anecdote through epidemiologicassociation tobiologic proof ofcarcinogenicity in humans is rarely attainable, and policy decisions must be made along the way. A case in point is that of benzene and leukemia.9 The National Institute for Occupational Safety and Health in 1977 recommended decreasing the permissible occupational exposure level for benzene because of increasing epidemiologic evidence, but a challenge by industry prevailed in the US Supreme Court on the grounds of imprecision in the estimates of risk reduction to be achieved by the lower standard. Even though stronger evidence and better qualification of risk AJPH June 1990, Vol. 80, No. 6
APHA Technical Report
evolved over the next decade, the allowable standard was not changed until 1988. Some uncertainty and imprecision pervade many or most public health decisions and cannot be entirely overcome. They must, however, be addressed in any health policy recommendation. C. Time Constraints
Sometimes an action must be taken in the absence of definitive data because of the anticipated temporal imminence of the perceived problem,10 administrative or legislative time constraints, or public demand as with the Love Canal and Times Beach episodes. D. Anticipated Benefits and Untoward Effects of Action
1. Estimated Efficacy - Of paramount importance is the estimated efficacy of the proposed measure. Fluoridation of public water supplies, smoking cessation, and childhood immunization are examples of measures of high efficacy, each of whichhas been challenged by snall but vocal minorities on scientific grounds. In contrast, enhancement of regular screening for some adult disorders may be of low efficacy.11 2. Secondary Benefits - Secondary benefits may play a role in public health recommendations. For example, the feeling of well-being associated with exercise may be as important as its debated effects on the prevention of cardiovascular disease. Mandated childhoodimmunizations require a visit to a health care provider, thus affording an opportunity for the child to be screened for other disorders, especially those related to growth and
development.
3. Compliance - Health measures of proven efficacy may fail in public health programs because of poor compliance. This is particularly true of measures that require understanding and motivation on the part of consumers who may have to do things they do not like, give up things they enjoy, or take medications that have unwelcome side effects. Additionally, preventive measures are often prescribed for a symptomatic persons to whom a future disorder seems remote, as with hypertension. 4. Benefits versus Risks - The anticipated risks or other undesirable effects ofthe projected measure must be estimated and weighed against the expected benefits. Not all risks can be predicted with certainty, and scales of perceived risk can vary among groups depending on how the health problem or its remedy affects them. An important consideration is whether any untoward effect is reversible or correctable. Amniocentesis for detection of a suspected fetal abnormality may rarely result in spontaneous abortion, but nonetheless does not produce permanent harm to the mother or interfere with subsequent pregnancies. Furthermore, an action may have indirect adverse effects. For example, not prescribing oral contraceptives or an intrauterine device because of rare but serious side effects might result in worse problems resulting from unwanted or contraindicated pregnancies. AJPH June 1990, Vol. 80, No. 6
E. Costs of the Proposed Action or Measure
Ordinarily the costs of a beneficial public health measure are far less than those of the disorder or problem that is prevented or ameliorated and, accordingly, economic implications are usuallya sellingpoint. However, if the cost is exorbitant and the benefit small, intervention may not be
deemed worthwhile. Further, given budgetary limitations, the costs of a new program may compromise other efforts, and therefore the expected benefits may be outweighed by harm done by cutting back other programs. An example is the recommendation ofthe US Public Health Service to give a second dose of measles vaccine to all children at school entry.1'3 Undoubtedly, such a program would be expected to reduce the incidence of measles considerably, but, because the costs could compromise other programs of high priority, the decision was delayed for several years. F. Availability of an Alternative to the Proposed Measure If there is great uncertainty as to the scientific validity of an intervention, a consideration should be whether there is an alternative technology or solution to the problem (e.g., substitution of a effective but safer, less costly pesticide).
G. Social and Political Implications 1. Effects of Social and Political Pressures on Public Health Programs - Strong influences are often exerted on public programs by certain population groups with special characteristics such as age, ethnicity, religion, and sociocultural, economic, or commercial interests. Such groups are often well organized and may wield considerable power, in part because they may comprise 'single issue voters" whose preferences at the ballot box are largely determined by the issue with which they are most concerned. Some are well-funded, particularly those related to industry, and therefore able to mount vigorous efforts to mold opinion, influence regulators and legislators, and undertake protracted legal maneuvers to delay, modify or prevent measures that are contrarytotheirperceivedinterests. In addition,because few public health issues are free of uncertainties, however minor, groups opposed to public health measures often garner support from a few scientific authorities. There are many frustrating examples of public health programs that have been thwarted, delayed, or weakened by political pressures from such groups. The successful use ofless than absolute proof ofcausation as a shield to protect special interests is epitomized by the sad saga of aspirin and Reye syndrome.6 A group of aspirin manufacturers and their attorneys exploited the recognized but, on balance, inconsequential epidemiologic problems in the studies that linked Reye syndrome to aspirin. Direct approaches by this near billion dollar industry, mistakenly aided by board members of the American Academy of Pediatrics whom the industry convinced that a mandated label warning requires absolute proofofcausation [Meyer KA: Personal communication (Letter to J. Gazmararian) March 7, 1988], persuaded the deregulation-minded Office of Management and Budget to block the Food and Drug Administration's proposal for such a warning from 1982 to 1986. Judging from the decline in reported cases of Reye syndrome 747
APHA Technical Report after warnings were required, there is little doubt that this politically and economically motivated delay resulted in death or disability to more than 100 children andadolescentsandneuropsychologic damage toasimilar number.14< Anotherexample is that ofgun control. Nearly 32,000 deaths from firearms occur annually in the US, ofwhich about 55 percent are suicides, 37 percent murders, and 5 percent accidents.16 About 60 percent ofall homicides are conmitted with firearms; homicide rates are increasing but those committed with guns have increased at about twice the overall rate.17 There is little disagreement among competent authorities that reasonable gun control would reduce this mayhem markedly. Although such laws exist in some communities, they are relatively ineffective because of access to gun ownership in neighboring jurisdictions. Thus federal control is necessary but has far been unachievable because ofthe political power ofthe National Rifle Association (NRA) as well its flimsy criticisms of epidemiologic data.7 Elected officials, locally and nationally, are intimidated by the NRA's ability to muster large numbers of single issue so
as
voters.
Somewhat similar are the problems offluoridation of water supplies. Althoughfluoridationisunquestionably
safe and effective, pseudo-scientific claims have vented or terminated many local programs.
pre-
2. The Issue of Individual Rights Versus the Welfare of Inherent in many public health policy deciSociety sions is the issue of the rights of the individual versus those of society. As stated in a recent Office of Technology Assessment report,16 the balance between these two interests is increasingly stressed by two factors: augmented technical abilities to influence our environment; and enhanced emphasis on self-determination and individual rights. Several examples are cited below: -
*
*
What measures will control acquired immunodeficiency syndrome (AIDS) and at the same time protect individual privacy? Can mentally ill individuals who are deemed dangertoothers and themselvesbeinvoluntarilyinstitutionalized or forced to undergo treatment? Should society continue to mandate childhood immunizations to protect not only the recipient but also the public? Even this mandate is presently under serious challenge by some parents in state legislatures and the courts on the basis of self-determination. Therefore, an important issue in many public health decisions is the potential for infringement on individual rights, real or perceived. ous
*
H. Public Understanding of Science
Public health policy recommendations are based in part combinations of laboratory, clinical, and epidemiologic evidence developed by scientists. However, ultimate decisions to implement recommendations are often made by regulators or legislators who have little comprehension of science. Moreover, many recommendations require the support of individuals for enactment or their personal participation by making informed decisions, as with cessation of smoking, prevention of human immunodeficiency virus (HIV) infection, and acceptance of medications and vaccines. It is apparent that the escalation of scientific
knowledge has not been paralleled by enhanced public understanding ofscience in the US, at least as measured by testing in schools,19 or in the United Kingdom.20 Indeed, among US junior and senior high school students, comprehension of and achievement in science are below that oftwo decades ago. Most adults in the US, whether they bear responsibility for decisions at the governmental, public, or personal level, are inadequately versed in science and its methods. Accordingly, comprehensible communication of the rationale for public health measures to those who must take action is often sorely compromised. I. Legal Issues Measures designed to protect or enhance the health of the public always have legal implications. These implications include: 1) jurisdiction (national, state, or local); 2) legislative or agency authority to make regulations; 3) challenges in the courts undertaken by parties whose interests may be jeopardized; 4) litigation initiated by individuals who believe that their health problems have been caused by risks that were avoidable; and 5) challenges on the ground that the measure infringes improperly on rights guaranteed by the US Constitution. In determining the validity ofa measure enacted under the state police power, courts may adopt the rational basis or the close scrutiny standard. Normally, governmental action under the state police power need only meet the rational basis test - i.e., serve a rational purpose and be undertaken by reasonable means. However, ifthe governmental action conflicts with fundamental individual right, then the state must show a compelling state interest to sustain the action and override the individual right (the close or strict scrutiny standard.) The rational basis test allows broad scope for the exercise ofthe state police power, whereas adoption of the compelling interest standard requires close scrutiny and the least possible intrusion on the right in question. A perennial problem is the need to balance the constitutional rights of the individual against the welfare of society as a whole. The degree to which individual rights are honored should bear an inverse relationship to the extent of publicjeopardy. Wherever possible, use ofthe least restrictive alternative should be favored. But the greater the danger of harm, the more intrusive is the response permitted. Inextricably intertwined with legal issues are the political and economic pressures and poor comprehension of science on the part of the courts.
III. Recommendations The Committee recognizes that in many ways the following recommended approaches are not new. However, the Committee believes that certain aspects demand special attention when the scientific evidence on which to base public policy is less than optimum.
on
748
A. Assessment of the Evidence
In these situations, careful evaluation of the epidemiologic evidence, and the full exploration by appropriate technical groups are most important. Doubts or recognized weaknesses in the studies must be acknowledged and aired in any proposal while refuting them, if possible, or explaining why they are outweighed by the problem's impact. Full assessment of the evidence should be provided to all who AJPH June 1990, Vol. 80, No. 6
APHA Technical Report
may play roles in advocacy, decision-making, and implementation. B. Development of the Recommended Public Health Measure In the development of the optimum solution to a problem, alternatives and priorities are customarily considered. However, when the epidemiologic evidence is imperfect, benefits to the public, costs, and methods of implementation should be considered along with assessment of the evidence. Most importantly, all considerations that have led to the recommended action should be made available for those who are expected to play roles in implementation. In some situations, especially if new evidence becomes available, it may be helpful to provide for periodic re-assessment of the evidence. C. Assessment of the Opposition When a recommendation can be challenged because of less than absolute proof, a successful conclusion is much more likely if the potential for opposition is anticipated. Factors that may compromise success are detailed under Issues (Section II). Clear understanding and prediction of challenges to the proposed action and their origins should lead to means by which negative impact may be prevented, neutralized, or ameliorated. Whenever possible, it is most important that opponents and their motivations, strategies, and capabilities be anticipated in the planning process.
D. Implementation of the Proposed Strategies 1. Development and Assessment of Strategies - The promulgation of a solution to a public health problem when one or more aspects are controversial requires as much time and effort in strategy development as does assessment of the problem and its solution. Obviously, approaches will vary according to the nature of the problem and the remedy, and may require orientation toward the legal, political, social, or economic spheres. Sometimes implementation of a solution in several phases provides an opportunity to test the waters and mobilize support. Yet, it should be recognized, as pointed out by a biophysical-lawyer, that postponing regulation because of imperfect scientific data "really means using humans as 'guinea pigs,' and should be considered socially unaccept-
able."2'
2. Constituency Building - Of maximum importance are the identification and organization of the most effective constituencies for the proposal. First, constituents should be identified, and then the constituents should be provided with a complete review ofthe problem and its proposed solution. The rationale for this approach is to obtain active support from all of those constituents most qualified to present the position locally and nationally. This approach must include support from various geographic areas to encourage the use oflocal experts in developing widespread, knowledgeable advocacy. Working liaisons with other health-related professional organizations interested in the same problem should also be established. Many such links are AJPH June 1990, Vol. 80, No. 6
possible and should be fully explored in each issue undertaken. The nature of the specific issue must determine who are the ultimate decision-makers; herein lies a most difficult task, particularly in relation to scientific issues. Every effort must be made to communicate the rationale for recommendations in comprehensible form to these decision-makers. E. Coordination between Public Health Science and the Health Professional
APHA should continue efforts to strengthen training in schools ofpublic health in the analysis ofscientific evidence on public health problems. It should also extend its assistance to public health officials concerned with development ofpolicy, legislation, andregulations within theAssociation's spectrum ofinterests and concerns. Additionally,because deficitsinunderstandingepidemiology, biostatistics and other facets of public health exist amonghealth care providers, APHA should encourage and support enhanced teaching ofthese sciences in other health professional schools by working with national organizations including the Association of American Medical Colleges and the like. F. Improvement of Consumer Understanding of Public Health Science
Communication of the need and rationale for public health recommendations is a major requirement for their achievement, as noted above. However, such communication is hampered by the widening gap between scientific achievement and the public understanding of science and its methods. Because society is increasingly influenced by science and technology and because decisions regarding public health issues are ultimatelymadebytheindividuals and society or its representatives, improved public understanding of science is a major educational priority. For the short term, efforts should be made to communicate succinctly to the public and its decision-makers the rationale for recommendations including their scientific aspects. For the long term, science education should be enhanced by coordination of efforts with the US Department of Education, the National Education Association, and other national and local organizations. Recognizing that this brief document does not cover in detail the current state of public health decision-making in the US, with or without complete evidence, this document will serve as a set of guidelines to assist in analyzing current issues and their possible solutions, so that they can be widely disseminated to policy-makers in government and tothe public. Accordingly, the Committee recommends that APHA develop an appropriate mechanism by which a more complete report to the nation on the status of public health decision-making be prepared for wider dissemination.
IV. Summary In conclusion, when it can be demonstrated that the need is great, an action produces the desired benefits, the risks are not too high, the intervention is economically feasible, and there are no viable, more scientifically certain alternatives, then policy-makers should proceed even in the face of less than complete evidence. It should be remembered that 749
APHA Technical Report scientific uncertainty may be exploited by special interest groups as a shield for opposition to the measure. Public policy decisions may be said to be made or not made on the basis of scientific uncertainty, but they may in actuality be driven by political or economic considerations. With respect to balancingindividual rights and the public interest, it is clear that, in many instances, these two interests will be congruent. Ifthey conflict, however, then weight should be given to the public interest in line with the principle that public health is social justice.
REFERENCES 1. Executive Order 12291, 46 Fed. Reg.13193 (Feb. 19, 1981). Title III - The President. Federal Regulation. 2. Centers for Disease Control: Reye syndrome surveillance - United States, 1986. MMWR 1987; 36:689-691. 3. Alexanderson R, Kolmodin-Hedman B, Hedenstierna G: Exposure to formaldehyde: effects on pulmonary function. Arch Environ Health 1982; 37:279-284. 4. Advisory Committee to the Surgeon General of the Public Health Service: Smoking and Health. Public Health Service Pub. No. 1103. Washington, DC: US Govt Printing Office, 1964. 5. Mortimer EA Jr: Reye's syndrome, salicylates, epidemiology, and public health policy. JAMA 1987; 257:1941. 6. Whelan EM: A Smoking Gun: How the Tobacco Industry Gets Away with Murder. Philadelphia: G.F. Stickley Co, 1984. 7. Goldsmith MF: Epidemiologists aim at new target: Health risk of handgun proliferation. JAMA 1989; 261:675-676. 8. Silver L: An agency dilemma: regulating to protect the public health in light of scientific uncertainty. In: Roemer R, McKray G: Legal Aspects of Health Policy, Issues and Trends. Westport, CT: Greenwood Press, 1980. 9. Rosenstock L, Landrigan PJ: Occupational health: The intersection between clinical medicine and public health. Annu Rev Public Health 1986; 7:337-356.
10. Neustadt RE, Fineberg HV: The Swine Flu Affair. Decision-Making on a Slippery Disease. Washington, DC: US Govt Printing Office, 1978. 11. Friedman GD, Collen MF, Fireman BH: Multiphasic health checkup evaluation: A 16-year follow-up. J Chronic Dis 1986; 39:453-463. 12. Centers for Disease Control: Recommendations of the Immunization Practices Advisory Committee (ACIP): Measles prevention: supplementary statement. MMWR 1989; 38:11-14. 13. Centers for Disease Control: Recommendations of the Immunization Practices Advisory Committee (ACIP): Measles prevention: MMWR 1989; 38(no. S-9)1-18. 14. Centers for Disease Control: Reye syndrome surveillance - United States, 1987 and 1988. MMWR 1989; 38:325-327. 15. Brunner RL, O'Grady DJ, Partin JC, Partin JS, Schubert H: Neuropsychologic consequences of Reye syndrome. J. Pediatr 1979; 95:706-711. 16. Mercy JA, Houk VN: Firearm injuries: A call for science. (editorial) NEnglJMedl988; 319:1283-1285. 17. Sloan JH, Kellerman AL, Reay DT, et al: Handgun regulations, crime, assaults andhomicide. A tale oftwo cities. N Engl J Med 1988; 319:1256. 18. US Congress, Office of Technology Assessment: Biology, Medicine and the Bill of Rights - Special Report. OTA-CIT-371, Washington, DC: US Govt Printing Office, 1988. 19. Mullis IVS, Jenkins LB: The science report card. Elements of risk and recovery. Trends and achievement. Based on the 1986 National Assessment, Report No.1 7-S-01. Princeton, NJ: Education Testing Service, 1988; 151 pp. 20. The Public Understanding of Science. London: The Royal Society, 1985; 41 pp. 21. KarstadtML: Protectingpublichealthfromhazardous substances: Federal regulation of environmental contaminants. Environ Law Rep 1975; 5 ELR:5016550178.
Single copies of APHA Technical Reports are available from the American Public Health Association, Division of Professional Affairs, 1015 15th Street, NW, Washington, DC 20005.
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AJPH June 1990, Vol. 80, No. 6
The intent of this technical report is to ensure that APHA members and others concemed with public health problems are cognizant of the forces that compromise optimum solutions, particularly when the evidence concerning the need for, and efficacy of, such actions is under challenge. B. Objectives The objectives of the report are: 1. To delineate and explain the issues and forces that bear upon public health decisions; 2. To recommend guidelines to assist the APHA in the task of assessing public health problems and developing optimum solutions; and This report was prepared by an Ad Hoc Committee working under the auspices of the Program Development Board of the Aneican Public Health Association (APHA), and was received by theAPHA Executive Board at their meeting held April 24-25, 1989.
Members ofthe Committee: Edward A. Mortimer, Jr., MD, Chair Jeffrey P. Koplan, MD, MIPH Peter A. Lachenbruch, PhD Irving Lewis, MA Ruth Roemer, JD Linda Rosenstock, MD, MPH Robert F. Woolson, PhD i) 1990 American Journal ofPublic Health 746
3. To recommend strategies by which the APHA may develop constituencies for beneficial public health measures.
II. Issues In developing approaches to a public health problem in the presence of substantial but disputed scientific evidence, the APHA should consider the following: A. Need for Action
The needfor action, shouldbe measuredby the problem's impact, defined as the product of the numbers of people affected and the severity for the individual. An example of a problem with considerable impact because ofits severity in spite of small numbers is that of Reye syndrome and aspirin.2 In contrast, respiratory symptoms from exposure to formaldehyde may be more irritating than life-threatening, but nonetheless ofconsiderable impact because of the numbers of persons affected.3 The health consequences of tobacco are of major impact because of numbers and severity.4 Iinportant as a corollary is whether sub-groups in the population are particularly affected, e.g., children in urban slum dwellings exposed to lead, and other groups which lack a unified voice, such as migrant workers. B. Firmness of the Evidence
The firmness of the evidence usually lies somewhere along a spectrum from anecdote to absolute proof. This is a most difficult issue, because assessments must often be made in the face of incomplete, evolving, and contradictory epidemiologic and biologic data. The strength of the evidence required for action may vary inversely with the impact of the problem. It is important to note that regulatory agencies do not share with scientists the luxury of expressing uncertainty; either definitive action or no action is usually required. It must also be recognized that different scales ofproofmay be demanded depending on the perceived extent to which selfinterest may be affected.54 The difficulties inherent in assessing and acting on incomplete, evolving evidence are well exemplified by the issues of environmentally related disorders, especially cancer. The systematic development of evidence from anecdote through epidemiologicassociation tobiologic proof ofcarcinogenicity in humans is rarely attainable, and policy decisions must be made along the way. A case in point is that of benzene and leukemia.9 The National Institute for Occupational Safety and Health in 1977 recommended decreasing the permissible occupational exposure level for benzene because of increasing epidemiologic evidence, but a challenge by industry prevailed in the US Supreme Court on the grounds of imprecision in the estimates of risk reduction to be achieved by the lower standard. Even though stronger evidence and better qualification of risk AJPH June 1990, Vol. 80, No. 6
APHA Technical Report
evolved over the next decade, the allowable standard was not changed until 1988. Some uncertainty and imprecision pervade many or most public health decisions and cannot be entirely overcome. They must, however, be addressed in any health policy recommendation. C. Time Constraints
Sometimes an action must be taken in the absence of definitive data because of the anticipated temporal imminence of the perceived problem,10 administrative or legislative time constraints, or public demand as with the Love Canal and Times Beach episodes. D. Anticipated Benefits and Untoward Effects of Action
1. Estimated Efficacy - Of paramount importance is the estimated efficacy of the proposed measure. Fluoridation of public water supplies, smoking cessation, and childhood immunization are examples of measures of high efficacy, each of whichhas been challenged by snall but vocal minorities on scientific grounds. In contrast, enhancement of regular screening for some adult disorders may be of low efficacy.11 2. Secondary Benefits - Secondary benefits may play a role in public health recommendations. For example, the feeling of well-being associated with exercise may be as important as its debated effects on the prevention of cardiovascular disease. Mandated childhoodimmunizations require a visit to a health care provider, thus affording an opportunity for the child to be screened for other disorders, especially those related to growth and
development.
3. Compliance - Health measures of proven efficacy may fail in public health programs because of poor compliance. This is particularly true of measures that require understanding and motivation on the part of consumers who may have to do things they do not like, give up things they enjoy, or take medications that have unwelcome side effects. Additionally, preventive measures are often prescribed for a symptomatic persons to whom a future disorder seems remote, as with hypertension. 4. Benefits versus Risks - The anticipated risks or other undesirable effects ofthe projected measure must be estimated and weighed against the expected benefits. Not all risks can be predicted with certainty, and scales of perceived risk can vary among groups depending on how the health problem or its remedy affects them. An important consideration is whether any untoward effect is reversible or correctable. Amniocentesis for detection of a suspected fetal abnormality may rarely result in spontaneous abortion, but nonetheless does not produce permanent harm to the mother or interfere with subsequent pregnancies. Furthermore, an action may have indirect adverse effects. For example, not prescribing oral contraceptives or an intrauterine device because of rare but serious side effects might result in worse problems resulting from unwanted or contraindicated pregnancies. AJPH June 1990, Vol. 80, No. 6
E. Costs of the Proposed Action or Measure
Ordinarily the costs of a beneficial public health measure are far less than those of the disorder or problem that is prevented or ameliorated and, accordingly, economic implications are usuallya sellingpoint. However, if the cost is exorbitant and the benefit small, intervention may not be
deemed worthwhile. Further, given budgetary limitations, the costs of a new program may compromise other efforts, and therefore the expected benefits may be outweighed by harm done by cutting back other programs. An example is the recommendation ofthe US Public Health Service to give a second dose of measles vaccine to all children at school entry.1'3 Undoubtedly, such a program would be expected to reduce the incidence of measles considerably, but, because the costs could compromise other programs of high priority, the decision was delayed for several years. F. Availability of an Alternative to the Proposed Measure If there is great uncertainty as to the scientific validity of an intervention, a consideration should be whether there is an alternative technology or solution to the problem (e.g., substitution of a effective but safer, less costly pesticide).
G. Social and Political Implications 1. Effects of Social and Political Pressures on Public Health Programs - Strong influences are often exerted on public programs by certain population groups with special characteristics such as age, ethnicity, religion, and sociocultural, economic, or commercial interests. Such groups are often well organized and may wield considerable power, in part because they may comprise 'single issue voters" whose preferences at the ballot box are largely determined by the issue with which they are most concerned. Some are well-funded, particularly those related to industry, and therefore able to mount vigorous efforts to mold opinion, influence regulators and legislators, and undertake protracted legal maneuvers to delay, modify or prevent measures that are contrarytotheirperceivedinterests. In addition,because few public health issues are free of uncertainties, however minor, groups opposed to public health measures often garner support from a few scientific authorities. There are many frustrating examples of public health programs that have been thwarted, delayed, or weakened by political pressures from such groups. The successful use ofless than absolute proof ofcausation as a shield to protect special interests is epitomized by the sad saga of aspirin and Reye syndrome.6 A group of aspirin manufacturers and their attorneys exploited the recognized but, on balance, inconsequential epidemiologic problems in the studies that linked Reye syndrome to aspirin. Direct approaches by this near billion dollar industry, mistakenly aided by board members of the American Academy of Pediatrics whom the industry convinced that a mandated label warning requires absolute proofofcausation [Meyer KA: Personal communication (Letter to J. Gazmararian) March 7, 1988], persuaded the deregulation-minded Office of Management and Budget to block the Food and Drug Administration's proposal for such a warning from 1982 to 1986. Judging from the decline in reported cases of Reye syndrome 747
APHA Technical Report after warnings were required, there is little doubt that this politically and economically motivated delay resulted in death or disability to more than 100 children andadolescentsandneuropsychologic damage toasimilar number.14< Anotherexample is that ofgun control. Nearly 32,000 deaths from firearms occur annually in the US, ofwhich about 55 percent are suicides, 37 percent murders, and 5 percent accidents.16 About 60 percent ofall homicides are conmitted with firearms; homicide rates are increasing but those committed with guns have increased at about twice the overall rate.17 There is little disagreement among competent authorities that reasonable gun control would reduce this mayhem markedly. Although such laws exist in some communities, they are relatively ineffective because of access to gun ownership in neighboring jurisdictions. Thus federal control is necessary but has far been unachievable because ofthe political power ofthe National Rifle Association (NRA) as well its flimsy criticisms of epidemiologic data.7 Elected officials, locally and nationally, are intimidated by the NRA's ability to muster large numbers of single issue so
as
voters.
Somewhat similar are the problems offluoridation of water supplies. Althoughfluoridationisunquestionably
safe and effective, pseudo-scientific claims have vented or terminated many local programs.
pre-
2. The Issue of Individual Rights Versus the Welfare of Inherent in many public health policy deciSociety sions is the issue of the rights of the individual versus those of society. As stated in a recent Office of Technology Assessment report,16 the balance between these two interests is increasingly stressed by two factors: augmented technical abilities to influence our environment; and enhanced emphasis on self-determination and individual rights. Several examples are cited below: -
*
*
What measures will control acquired immunodeficiency syndrome (AIDS) and at the same time protect individual privacy? Can mentally ill individuals who are deemed dangertoothers and themselvesbeinvoluntarilyinstitutionalized or forced to undergo treatment? Should society continue to mandate childhood immunizations to protect not only the recipient but also the public? Even this mandate is presently under serious challenge by some parents in state legislatures and the courts on the basis of self-determination. Therefore, an important issue in many public health decisions is the potential for infringement on individual rights, real or perceived. ous
*
H. Public Understanding of Science
Public health policy recommendations are based in part combinations of laboratory, clinical, and epidemiologic evidence developed by scientists. However, ultimate decisions to implement recommendations are often made by regulators or legislators who have little comprehension of science. Moreover, many recommendations require the support of individuals for enactment or their personal participation by making informed decisions, as with cessation of smoking, prevention of human immunodeficiency virus (HIV) infection, and acceptance of medications and vaccines. It is apparent that the escalation of scientific
knowledge has not been paralleled by enhanced public understanding ofscience in the US, at least as measured by testing in schools,19 or in the United Kingdom.20 Indeed, among US junior and senior high school students, comprehension of and achievement in science are below that oftwo decades ago. Most adults in the US, whether they bear responsibility for decisions at the governmental, public, or personal level, are inadequately versed in science and its methods. Accordingly, comprehensible communication of the rationale for public health measures to those who must take action is often sorely compromised. I. Legal Issues Measures designed to protect or enhance the health of the public always have legal implications. These implications include: 1) jurisdiction (national, state, or local); 2) legislative or agency authority to make regulations; 3) challenges in the courts undertaken by parties whose interests may be jeopardized; 4) litigation initiated by individuals who believe that their health problems have been caused by risks that were avoidable; and 5) challenges on the ground that the measure infringes improperly on rights guaranteed by the US Constitution. In determining the validity ofa measure enacted under the state police power, courts may adopt the rational basis or the close scrutiny standard. Normally, governmental action under the state police power need only meet the rational basis test - i.e., serve a rational purpose and be undertaken by reasonable means. However, ifthe governmental action conflicts with fundamental individual right, then the state must show a compelling state interest to sustain the action and override the individual right (the close or strict scrutiny standard.) The rational basis test allows broad scope for the exercise ofthe state police power, whereas adoption of the compelling interest standard requires close scrutiny and the least possible intrusion on the right in question. A perennial problem is the need to balance the constitutional rights of the individual against the welfare of society as a whole. The degree to which individual rights are honored should bear an inverse relationship to the extent of publicjeopardy. Wherever possible, use ofthe least restrictive alternative should be favored. But the greater the danger of harm, the more intrusive is the response permitted. Inextricably intertwined with legal issues are the political and economic pressures and poor comprehension of science on the part of the courts.
III. Recommendations The Committee recognizes that in many ways the following recommended approaches are not new. However, the Committee believes that certain aspects demand special attention when the scientific evidence on which to base public policy is less than optimum.
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A. Assessment of the Evidence
In these situations, careful evaluation of the epidemiologic evidence, and the full exploration by appropriate technical groups are most important. Doubts or recognized weaknesses in the studies must be acknowledged and aired in any proposal while refuting them, if possible, or explaining why they are outweighed by the problem's impact. Full assessment of the evidence should be provided to all who AJPH June 1990, Vol. 80, No. 6
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may play roles in advocacy, decision-making, and implementation. B. Development of the Recommended Public Health Measure In the development of the optimum solution to a problem, alternatives and priorities are customarily considered. However, when the epidemiologic evidence is imperfect, benefits to the public, costs, and methods of implementation should be considered along with assessment of the evidence. Most importantly, all considerations that have led to the recommended action should be made available for those who are expected to play roles in implementation. In some situations, especially if new evidence becomes available, it may be helpful to provide for periodic re-assessment of the evidence. C. Assessment of the Opposition When a recommendation can be challenged because of less than absolute proof, a successful conclusion is much more likely if the potential for opposition is anticipated. Factors that may compromise success are detailed under Issues (Section II). Clear understanding and prediction of challenges to the proposed action and their origins should lead to means by which negative impact may be prevented, neutralized, or ameliorated. Whenever possible, it is most important that opponents and their motivations, strategies, and capabilities be anticipated in the planning process.
D. Implementation of the Proposed Strategies 1. Development and Assessment of Strategies - The promulgation of a solution to a public health problem when one or more aspects are controversial requires as much time and effort in strategy development as does assessment of the problem and its solution. Obviously, approaches will vary according to the nature of the problem and the remedy, and may require orientation toward the legal, political, social, or economic spheres. Sometimes implementation of a solution in several phases provides an opportunity to test the waters and mobilize support. Yet, it should be recognized, as pointed out by a biophysical-lawyer, that postponing regulation because of imperfect scientific data "really means using humans as 'guinea pigs,' and should be considered socially unaccept-
able."2'
2. Constituency Building - Of maximum importance are the identification and organization of the most effective constituencies for the proposal. First, constituents should be identified, and then the constituents should be provided with a complete review ofthe problem and its proposed solution. The rationale for this approach is to obtain active support from all of those constituents most qualified to present the position locally and nationally. This approach must include support from various geographic areas to encourage the use oflocal experts in developing widespread, knowledgeable advocacy. Working liaisons with other health-related professional organizations interested in the same problem should also be established. Many such links are AJPH June 1990, Vol. 80, No. 6
possible and should be fully explored in each issue undertaken. The nature of the specific issue must determine who are the ultimate decision-makers; herein lies a most difficult task, particularly in relation to scientific issues. Every effort must be made to communicate the rationale for recommendations in comprehensible form to these decision-makers. E. Coordination between Public Health Science and the Health Professional
APHA should continue efforts to strengthen training in schools ofpublic health in the analysis ofscientific evidence on public health problems. It should also extend its assistance to public health officials concerned with development ofpolicy, legislation, andregulations within theAssociation's spectrum ofinterests and concerns. Additionally,because deficitsinunderstandingepidemiology, biostatistics and other facets of public health exist amonghealth care providers, APHA should encourage and support enhanced teaching ofthese sciences in other health professional schools by working with national organizations including the Association of American Medical Colleges and the like. F. Improvement of Consumer Understanding of Public Health Science
Communication of the need and rationale for public health recommendations is a major requirement for their achievement, as noted above. However, such communication is hampered by the widening gap between scientific achievement and the public understanding of science and its methods. Because society is increasingly influenced by science and technology and because decisions regarding public health issues are ultimatelymadebytheindividuals and society or its representatives, improved public understanding of science is a major educational priority. For the short term, efforts should be made to communicate succinctly to the public and its decision-makers the rationale for recommendations including their scientific aspects. For the long term, science education should be enhanced by coordination of efforts with the US Department of Education, the National Education Association, and other national and local organizations. Recognizing that this brief document does not cover in detail the current state of public health decision-making in the US, with or without complete evidence, this document will serve as a set of guidelines to assist in analyzing current issues and their possible solutions, so that they can be widely disseminated to policy-makers in government and tothe public. Accordingly, the Committee recommends that APHA develop an appropriate mechanism by which a more complete report to the nation on the status of public health decision-making be prepared for wider dissemination.
IV. Summary In conclusion, when it can be demonstrated that the need is great, an action produces the desired benefits, the risks are not too high, the intervention is economically feasible, and there are no viable, more scientifically certain alternatives, then policy-makers should proceed even in the face of less than complete evidence. It should be remembered that 749
APHA Technical Report scientific uncertainty may be exploited by special interest groups as a shield for opposition to the measure. Public policy decisions may be said to be made or not made on the basis of scientific uncertainty, but they may in actuality be driven by political or economic considerations. With respect to balancingindividual rights and the public interest, it is clear that, in many instances, these two interests will be congruent. Ifthey conflict, however, then weight should be given to the public interest in line with the principle that public health is social justice.
REFERENCES 1. Executive Order 12291, 46 Fed. Reg.13193 (Feb. 19, 1981). Title III - The President. Federal Regulation. 2. Centers for Disease Control: Reye syndrome surveillance - United States, 1986. MMWR 1987; 36:689-691. 3. Alexanderson R, Kolmodin-Hedman B, Hedenstierna G: Exposure to formaldehyde: effects on pulmonary function. Arch Environ Health 1982; 37:279-284. 4. Advisory Committee to the Surgeon General of the Public Health Service: Smoking and Health. Public Health Service Pub. No. 1103. Washington, DC: US Govt Printing Office, 1964. 5. Mortimer EA Jr: Reye's syndrome, salicylates, epidemiology, and public health policy. JAMA 1987; 257:1941. 6. Whelan EM: A Smoking Gun: How the Tobacco Industry Gets Away with Murder. Philadelphia: G.F. Stickley Co, 1984. 7. Goldsmith MF: Epidemiologists aim at new target: Health risk of handgun proliferation. JAMA 1989; 261:675-676. 8. Silver L: An agency dilemma: regulating to protect the public health in light of scientific uncertainty. In: Roemer R, McKray G: Legal Aspects of Health Policy, Issues and Trends. Westport, CT: Greenwood Press, 1980. 9. Rosenstock L, Landrigan PJ: Occupational health: The intersection between clinical medicine and public health. Annu Rev Public Health 1986; 7:337-356.
10. Neustadt RE, Fineberg HV: The Swine Flu Affair. Decision-Making on a Slippery Disease. Washington, DC: US Govt Printing Office, 1978. 11. Friedman GD, Collen MF, Fireman BH: Multiphasic health checkup evaluation: A 16-year follow-up. J Chronic Dis 1986; 39:453-463. 12. Centers for Disease Control: Recommendations of the Immunization Practices Advisory Committee (ACIP): Measles prevention: supplementary statement. MMWR 1989; 38:11-14. 13. Centers for Disease Control: Recommendations of the Immunization Practices Advisory Committee (ACIP): Measles prevention: MMWR 1989; 38(no. S-9)1-18. 14. Centers for Disease Control: Reye syndrome surveillance - United States, 1987 and 1988. MMWR 1989; 38:325-327. 15. Brunner RL, O'Grady DJ, Partin JC, Partin JS, Schubert H: Neuropsychologic consequences of Reye syndrome. J. Pediatr 1979; 95:706-711. 16. Mercy JA, Houk VN: Firearm injuries: A call for science. (editorial) NEnglJMedl988; 319:1283-1285. 17. Sloan JH, Kellerman AL, Reay DT, et al: Handgun regulations, crime, assaults andhomicide. A tale oftwo cities. N Engl J Med 1988; 319:1256. 18. US Congress, Office of Technology Assessment: Biology, Medicine and the Bill of Rights - Special Report. OTA-CIT-371, Washington, DC: US Govt Printing Office, 1988. 19. Mullis IVS, Jenkins LB: The science report card. Elements of risk and recovery. Trends and achievement. Based on the 1986 National Assessment, Report No.1 7-S-01. Princeton, NJ: Education Testing Service, 1988; 151 pp. 20. The Public Understanding of Science. London: The Royal Society, 1985; 41 pp. 21. KarstadtML: Protectingpublichealthfromhazardous substances: Federal regulation of environmental contaminants. Environ Law Rep 1975; 5 ELR:5016550178.
Single copies of APHA Technical Reports are available from the American Public Health Association, Division of Professional Affairs, 1015 15th Street, NW, Washington, DC 20005.
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