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S TATEMENT' BY J. MICHAEL MCGINNIS, M. D. COMMITTEE' ON HUMAN RESOURCES UNITED STATES SENATE 6 WEDNESDAY, JUNE 7, 1978 $ c FOR RELEASE ONLY UPON DELIV'E'RY' DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE. DEPUTY ASSISTANT SECRETARY FOR' HEALTH (SPECIAL HEALTH INITIATIVES) SUBCOMMITTEE ON HEALTHAND' SCIENTIFIC RESEARCI3 BEE'ORE~THE

MR. CHAIRMANiAND MEMBERS @F' TH'E SUB.CaMMITTEE : I am pleased to have the opportunity to appear before, you this morning to discuss the Administration"s views on prevention and many of'the issues addressed by the Disease Prevention and Health Promotion Act of 19'7'8, S. 3'115. I would like to introduce to you the witnesses who accompany me, Donald Millar of'the Center for Disease. Control and Taylor Quinn of the Bureau of'Foods, Food and Drug Administration. In addition, officials from the Bureau of Community HealthServices, the National Center for Health Statistics, the National Heart, Lung, and Blood' Institute,. and others from the Center for Disease Control will be available to~address any questions you may have regarding this broadiarea. Mr. Chairman, the introduction of this legislation is evidence of your continued interest:in working toistrengthenn theNation's efforts in the prevention of disease and the promotion of'health. I j'oin, my colleague, Dr. Foege, who conveyed to you the appreciation of'Secretary Califano 0 and Assistant Secretary Richmond for the leadership you have shown inidrawing attention to prevention. The issuess addreseed in Titles I through~III of S. 3115, like Title IV 0 discussed by Dr. Foege, are central tolthe design of a comprehensive prevention proQrazn..

2 As you know, Mr. Chairman, the issues relatedito disease prevention and health promotion are of particular concern to the Administration. In addition to the $30 million smoking andiheallth initiative, discussed by Dr. Foege, special initiatives have already been launched to address problems related to childhood immunization and adolescent pregnancy. Iniaddition, a D'epartmental Task Force on Prevention is currently examining the renewal andd strengthening of efforts in the broadd range of'issues encompassediby prevention. The Role ofP'reyention in our Health Strategy As you know, historically the most important gains inr the reductionlof morbidity and mortality have been achieved through efforts tolprevent disease and promote health, rather than gains in medical treatment. Yet the focus of' health care and' health policy has shifted in recent years from preventive healthlactivities to the delivery of acute care. The implications f©r our national budget have been astounding. The share of our economic resources going to payments for health care has increasedi drama- tically. Yet there is little.indication that those W increases in expenditures are yielding prop rtionate decreases'in morbidity and mortality for our population. These costs, along withidefici.encies in financial and

3 geographic access to care and the qua7lity of' hea lth care delivered are all immediate and important problems for health policy. We must not lose sight, however, of' the fact that the central objective of our health policy must be reduction of the burden of disease. Frevention - not expiensive _.t-herapeutic- techniques: - clearly constitutes the most direca and Effective approach to that objective. An illustrationimay serve to underscore this point. A child born in 190'0' could expect to live 4'7 years,- a child, born in 19,76, on the other hand', had' a life expectancy of about 73 years. This difference of nearly a quarter of a century is attributable to a remarkable decline in infant and child'mortality--in laage: measursR a result of'improved environmental sanitation, better nutrition, milk pasteurii- zation, infectious disease control, a reduction in crowding as well as increased and improved'immunizations. On the other hand, a 4S year old man in 1914 could expect to live

_ 41 _ added, little to adult life expectancy. We have become increasingly aware that the road to better health is not necessarily paved withibetter medicine, only three years longer than his counterpart living in 19'0'0. The science and technology of modern medicine has evidently Factors other than medical therapies must clearly be given principal credit for the significant declines in deaths related' to infectious diseases which predated' introductic.n of medical interventions. These factors include better nutrition, improved hygiienic measures such as effective sewage disposal, water purification, andipasteurization of milk. A British authority, Dr. Thomas McKeon, credits hygiene for at least 20'percent of the total reduction of mortality which has occurred in the last century. In singTingiout nutrition as particularly important, he further notes that the decline in mortality causediby infections began even before the introduction of sanitary measures. Improvements in nutrition during the course of the nineteenth century are the likely explanation for increased resistance to infectious diseases. _."._;e - . .. .k,.y„ ..

c - S - These lessons highlight the'importance of lifestyle factors in preventing the infectious disease killers of the past. The impact of infectious disease has diminished to the point that these killers of the past now account for only about two percent of the mortality among persons over one year of age. Of infectious diseases, only influenza,, when associated with, pneumonia, persists among the ten leadiing causes of death in the country. Presently over three-quarters of all deaths in the country are attributable to chronic diseases. Cardio- vascular disease, including both heart disease and stroke, account for over 50'percent oflthe deaths. Cancer accounts for another 20 percent and'diabetes and cirrhosis together account for almost four percent more. Ma,ny of'the deaths due to these chronic diseases are also preventable with changes in lifestyle. However, the focus of productive interventions has shifted from the community to the individual. There are indications that the developALent of effective measures to improve people's behavior with respect. to smoking, exercise, nutrition, and alcohol abuse, in addition s to improving control over hypertenslon, couldiresult inn significant decreases in morbidity and mortality due to these chronic diseases.

critical factors in the major chronic diseases.. brief, we know that c Time will not permit a complete review of the growing body of evidence which~ implicate&these habits as deaths and ranks first as the leading cause of Smoking causes at least 80 percent of all lung C cancer among men. Smoking is also a primary risk factor for cardiovascular disease. The death toll from smoking-relatedheart disease eclipses the signif icant death toll from cancer caused by smoking. I need not elaborate on the additional misery which smoking inflicts through emphysema and chronic bronchitis. Reasons for o Exercise has been shown by many studies to reduce our identification of smoking as public health enemy number one are evident. The Department appreciates your leadership, Mr. Chairman, in drawing attention to this issue. the risk of fatal heart attack. Research is continuin;gi to identify the specific mechanism of' action, but the preventive impact is clear. Furthermore, anecdotal may also be useful in rehabilitative programs for evidence is now accumlating to indicate that exercise patients who have suffered heart attacks.

-7 - Nutrition~has~played a role~ in enhancing r~e~s~istance~ to infectious diseases, but has more recently been~ f©und' to be a major contributor to the chronic diseases that plague our population. Stud'ies, such as the ]Framingham Study conducted~ in your home State, Mr. Chairman, point to thee importance of elevated cholesterol levels as a contributor to heart disease and stroke. Other studies linking serum levels with dietary intake point ta the need to strengthen our nutrition efforts in the control of heart disease and in the search for the cause of a number of other diseases. o Alcoholism afflicts almost 10 million problem the sixth most common cause of death in t1ie S~~tate~s~~ more~~ than $'4~5: m~illion~ annually. drinkers in the adult population of the United States today and, most alarmingly, one in four teenagers are moderate to heavy drinkers. Despite some leveling off, cirrhosis remains United States, with up to 9'5' percent of the cases estimated to be alcohol-relaited. Alcohol use has ~ been implicated in over 50 percent of all fatal highway accidents, and its toll in death and disease, lost productivity, and property damage, inirecent years is estimated to cost the United

Mr. Chairman, not only db we now have a better under- standing of the impact orf chronic dis ase, but, just as importantly, we are now beginning to see evidence that effective programs can be mounted~to facilitate lifestyle change. We see, for example, that since 1964 the percent of males smoking cigarettes has' dropped dramatically. Inaddition, we have seen a significant decrease'in the tar andinicotine level of the cigarettes consumed. Eighty percent of the adults who smoke would like to quit, more than half' the adult smokers of both sexes have tried at least once to stop smoking, and physicians have succeededin stopping in impressive numbers. In,195'0 about 65 percent of U.S. physicians smoked by 19Z5 just over 20, percent smoked. The growing_awareness of the importance of exercise is apparent on the streets of every American city. Estimates indicate that there are 11 million jogge,s, 15 million swimmers, 151million bicyclists, andd almost - , -- -------- ---- - -- --- - - -- - - ---- - -. _ _ 14 million regular tennis players in the U.S. today. number of adults who exercise has more than doubled since 1960', and 5D percent --of the -American population The claims to engage in some form of exercise. The President's Q CrJ

Council on Physical Fitness and Sports has played an important role in raising the level of consciousness .of the American public on the importance of exercise. If efforts can be strengttiened to enhance these trends,, the health benefits may be significant. __ Controlled studies of community programs to help, individuals change their risky behavior have been limitedi to date, but those whichihave been undertaken are yielding optimistic results. For, eexample, the National Heart, Lung and Blood Institute has sponsored a community inter- vention study~through the Stanford Heart Disease Program in California which has attempted'to use community health education and counseling tolimprove people''s behavior with regard to diet, smoking, and adherence toihyper- tensive medication regimens. Results there have shown more improvement in the community-wide behavior of those communities which were subjected to intervention programs versus the community which was not provided any spccial effarts. Another study, conducted in Finland; also indicated s:uccess at community-wide efforts to reduce multiple cardiac risk factors.- In the Finnish study, success has been reported in significantly reducing the incidence of smoking and the use of high fat dairy

products, as well as increasing the number of persons under hypertensive medication. Most importantly, reduction in the incidence of'stroke and myocardial infarction for the middle-aged population has been reported. Another systematic effort which may be bearing fruit on a national scale is the National High Blood Pressure "Education Program which the Department has been sponsoring since 1972'. This program1has promoted appropriate therapiess for a high proportion of the 35 million Americans %ith high blood pressure. At least partial]1y as a result of this program, 50'percent more patients visit the doctor to have their high blood pressure treated and the proportion of people with untreated high blood pressure has dropped f rom 49 percent, estimated in 19'72„ to 30 percent in 19'74, based on astudy of'fourteen communities. More importantly, since 1972', the death rate from stroke has fallen by over 20 percent and from1heart attack by over 15 perceni"~. Life expectancy in the Black population has increased almost three years in the last f ive years. Part of this gain can .be attributed to improved hypertension control. The Administration concurs in your identification of the importance of these activities and has requested $11 million to support its hypertension activities in,1979.

the budgetary provisions contained in S. 3115 have substantial implications for FY 198:0~and beyond', and the Department has Just begun to formulate its budget recommendations for FY 1980. Certain general comments can, however, be made today. Title I - Title I of S. 3115 establiishesformu~la and' project g;rantsfarpreventivehealthservices:.The:heallth,promotion and disease prevention~activities proposed in Title I incorporate many of the activiti.es currently underway in~HEW and proposed for consolidation in S. 3099. As you ltnowr Mr. Chairman, you have recently introduced the Administration's services proposal, S. 3'09'9, which consolidates a number of the authorities, coveredlin. Title I of S. 3115, into a comprehensive grant which woul'd provide States with sufficient flexibility to determine their ownipriorities for usingiFederal funds. We appreciate your introduction of this measure and'would' urge your consideration of' the approach embodied in the Administration bill.-

0 C In addition, I would like to note the key role provided for the States as mediator in the preventive programs of S. 3115. We have also stressed the importance of' this Federal/State relationship in the consolidated grant authorities proposed~lin our bill. We feel it is, essential to revive the strong Federal/State alliance whi;chwas~forged earlier thhiscenturyin the:faceof a dramatic toll of death and disease from communicable diseases through environmental measures to improve sewage disposal andd water purification, measures to assure a safe food and milk supply, and mass immunization campaigns. The record of this strong Federal/'State partnership was impressive. However, as the disease profile for the country changed and chronic diseases and accidents became the leading cause of morbidity and mortality, the close public health relationship between the States and the Federal government changedialso. Change in disease patterrrs toward chronic diseases does not preclude aggressive prevention programs aimed at lifestyle and environmental factors. Some of the States have already begun to ~ exhibit leadership inithis effort and the Federal govern- ment should do what it can tolpromote their activities.

Our proposal would consolidate a number, of'current .preventive health authorities into a single program of State formula grants for preventive health activities, with funds earmarked'for immunization activities. ~ Programs consolidated by the Administration proposal would include currently authorized immunization, disease control, venereal d'ise se, rat control, and lead-based paint authorities. The consolidation would also incorporate public health~grants _to gtates, with the excepti=of hypertension and mental health programs. Formula grant funds would be distributed so that each~State would be allocated at least the amount it had received from funds appropriated under these authorities in~FY 1978. iWe are well aware, Mr. Chairman, that this proposal does not comprise a comprehensive prevention program. For the immediate future--that is, for FY 1979--however, we have determined that the combination of current budget priorities skyrocketing hospital costs, and'the imminent prospect of developingia national health program prevent us fromm entertaining significantly larger appropriations at this time. The mand'ate of'our Task Force on Prevention, however,, is to fully analyze all present and future preventive healthh needs, in order to make legislative, administrative and budgetary proposals for the future.

C In addition, Mr. Chairman, we also have a number of specific suggestions regarding provisions of Title I which we would b happy to share with your staff. For example, Mr. Chairman, we have reservations regarding the requirement that States use their formula grant funds for programs aimed at one or more of the five leadingicauses of death withinitheir States. Priorities set by either mortality or morbidity would vary with different age and ethnic groups and with different classification schemes. Other factors also. complicate the use of simple mortality levels as program doterminants and we believe States should.have greater flexibility in determining program priorities. The wordingifor the medical record confidentiality requirements set out in sections 315 ('h) _and 317 (g) of your proposal appears to have beenitaken from the confidentiality provision found in the venereal disease provisions of the PHS Act. However, venereal disease programs/have significantly different confidentiality requirements than the rest of the PHS Act. Yet this language in S. 3115 would be app~ied to a far broader range of activities and programs.

- 11 - Mr. Chairman, thus far I have focused primarily on %he importance of lifestyle factors in disease prevention and health promotion. I would ailsoili}ce. to note the importance the Department ascribes to environmental efforts and other preventive services. With your support, the Department will continue to strengthen its efforts to protect the Nation's~ children against the immuniaable diseases, to promote expanslon of fluoridation of the Nation''s water supplies, to reduce the threat of lead-basedipaint as a poison to the physical and mental health of children, to eliminate rat infestation and to reduce the broad range of' occupatiional and environmental hazards which imperil our health. Administration Views on S. 3115 Clearly we share a similar objective--to:focusattention on preventive measures as a key element in our health care strategy. We read the same statistics and share the same disappointment in the health status improvement achieved throughuniprecedented expenditures,on health~services. Yet, while we support many of the objectives of S. 31151,. analysis of alternative approaches to design of a compre- hei~sive prevention program are currently beinqanalyzed by the Departmental Task Force on Prevention. Purthermore,

As Senator Schweiker is well aware, this innovative program -of Public Health, the major voluntary agencies,, industries and prIvate philanthropy, have been~combined to provide a wide range of educational and health promotional services. The Center conducts classes, for,bothyoung,peopleand adu~ltsin many aspects of prevention and lifestyle education, operates one of the Nation's best dial-access systems for the general public, provides technical consultation in health education and preventionito health planning agencies~in the region, andd has been developed almost entirely throughilocal resources. Resources of the public health agencies, the University School has become in a very few years a widely recognized resource. At the State level, a less fully developed but highly promising activity is underway in New Mexico. The New Mexico,Health Education Coalition was established several years ago throughithe Regional Medical Program, and supported in part by contracts with the Bureau of Health Education at the Center for Disease Control and more recently by the'National Cancer Institute. This formal confederation of public and voluntary health :. agencies has d~irectedparticularattention to problems of healthipromotion and disease preventioniamong, Mexican-American and American Indian communities in. New Mexico.. =~ ,-~ -~.-~-._

As I am sure you are aware, considerable thought has gone into the issue of' medical record confidentiality since this provision was first drafted--much of it reflected inn th Report of the President's Commission onlP'rivacy. As aa result of that attention, we are now in the process of preparing comprehensive medical record confidentiality proposals, and would urge youlto postpone consideration of these particular provisions until that legislation has been submitted. Title II of S~_ 3115 ca~llsfor the provision ofresources for disease prevention and health promotion, including the development of five regional centers for health promotion, the development of'community-based demo strations of preventive health services, and the formulation of periodic national disease prevention data profile. Mr. Chairman, the Administration is acutely aware of the needs addressed'by these provisions. Disease prevention, health promotion and heallth education are essentially community affairs. They are, to a great extent, the product' of'the li:festyles of individuals and families - the,,environment surrounding them and the services available tolthem.. There are a growing number of community activities developing M ~ throughout the country. For example, at the local level, a Health Education Center has been developed in Pittsburgh.

In your own Region, Mr. Chairman, the New Eng an Health Promotion Council, initiated three years ago with the heTp of'a CDC contract, is providing a focus for inter- agency planning and activity in the six New England States. A,mong the significant spin-offs of this very modest endeavor has been the effective involvement of' the Cooperative Extension Service of'New Hampshire in the State's childhoodimmunization program, which in turn has provided a model for other States. The three examples I-have cited!are not unique, nor a_e they illustrative of' the full range of problems implicit in disease prevention andlhealth promotion. They do, however, point to the potential for local, State and regional collaboration in these fields. We need to work with, and through, the resources in our communities. We would oppose, however, the specific .mandate to develop five centers, in order to provide the Secretary the flexibility to use the funds most appropriately.. I am~ pleased to note, Mr. Chairman, that the Office jf Health Information and Heailth Promotion, established as a result of your leadership in enacting Public Law 9'4-317, is undertaking a number of activities to strengthen the Federal support of locally-based! health promotionlefforts, the national data base for prevention. Specifically, a series 0.-: w . ~. ~:' ~ ;

We also support the requirement that colors be specifically identified on food labels. Indeed earlier this year FDA Commissioner Kennedy wrote to the presidents of the major food companies and urged that they voluntarily undertake to disclose the use of colors in their products. In addition, we support the provision of discretionary authority to require declaration of'individual spices and flavors on labels'. The bill also provides explicit authority to require nutrition labeling. Under present authority FDA has issued regulations requiringinutritional labeling where nutrients are added or where nutritional claims are made for the product in labeling or advertising. The bill would extend FDA's authority and enable us. to require nutritional labeling support this provision,although m2ndi that for some foods (e.g., on all foods. We it should be kept in condiments such as~ salt and pepper) nutritional labeling,would be unnecessary and we would not intend to require it. However,_we do not favor the requirement in the bill to list certain specific nutrition information. Nutrition s labe~lingiscurrently aldynamicsubject areawhichis

of regional health promotion conferences will be sponsored in order to provide a forum for community leaders and' organizations to exchange experiences in co'mmunity health promotion/risk reduction intervention programs. In addition, a technical assistance program is being,developed which will aid selected communities in the planning of community health promotion/'risk reduction programs. Furthermore, through~the provision of'funds to the National Center for Health Statistics, the Office of Health Information and Health Promotion is supporting a national study to obtain a better understanding of the impact of lifestyle factors on morbidity and mortality. We are also working with private industry to develop risk reduction programs appropriate for occupational settings. hope to have more detailed comments andiadditional suggestions ~Title~~ II will be ~~ c1o~~sel:y~ evaluated in these~~ effo~r~t~s'~.~ imTe~ ~ We are reviewing these activities to determine their adequacy in~meeting the need for research and innovation on which to build a sound prevention program. The approach outlined in Title III 47 Ti itle III of S. 3115 would increase the Secretary' s authority over food labeling. We are gratified by this specific focus on nutrition - an area in which the Department is moving aggressively to strengthen its activities. We support the

.k I l (USDA) and the Federal Trade Commission (FTC),. C objectives of these provisions, Mr. Chairman. However, before commenting in detail on this title, I would like to briefly mention the Food and Drug Administration (FDA's) recent and planned, activities in the food~labeling area. FDA is currently reviewing its foo dlabeling regulations in order to develop an overall approach to labeling that responds to the needs of'consumers. The Agency's review began with a series of informal meetings with consumers in late 19'77 and early 1978. Currently, FDA is preparing for legislative-style hearings this summer and fall to eliclt further ideas and concerns of consumers about a wide range of food labeling issues, including the use of ingredient, nutritional and other dietary information. This reviewof current foodilabeling regulations is being closely coordinated with the U.S. Department of'Agriculture Now let me turn to the specific provisions of Title III. Department understands~that many consumers have a strong full ingiredient labeling on all foods. We are pleased that past. FDA has attempted within the limits of the law to require The interest in informative content labeling of the prroducts they buy, and the Department agrees with this principle. In the • the legislation requires manufacturers of standardized foods to 1ist their ingredients in the order of predominance. We same labeling requirements as nonstandardized foods. believe that standardized'foods should be placed'under the

- 23 ' - Section 3'©2 (b)~ ('1) of Title III requires the Secretary to prescribe a symbol to signify the presence of an artificial flavor or color. A similar symbol has been~ suggested in other legislation to indicate the absence of artificial flavor or color. These contradictory approaches highlight the need for further study. In fact, this issue has beenitargeted for discussion in our regional hearings on food labeling. We would be - happy to share the results of this ana]:ysis with your staff. Section 3'06(b)of Title III requirestheFed'eral Trade Commission (FTC) to report to Congress on how it has responded to Department of Health, Education, and Welfare recommendations for advertising reg;ulationss corresponding to nutritional labeling regulations. We defer to the FTC regarding the need for preparing a formal report to Congress~. The D'epartmentiscomanitted to making every effort to coordinate its'regulationss with those of'the FTC in order to assure that product claims made in advertising are consistent with those made on the label. a

- 24 - Title III would preempt all State laws concerning labeling requirements which are in addition to or different from information required under this Act. Adminisitrati=analysis regarding this provision and the provision relating to alcohol labeling is currently underway. We would be pleased to~provide our suggestions in our report on this bill. In summary, Mr. Chairman, the issues addressed by S. 3115 are among the most important health policy issues facing the country today. Your leadership in focusing attention tothese issues,is very much appreciated. We regret we are unable to offer detailed responses to many of the bill's provisions today, but hope to provide more specific reactions, as well as additional proposals, in the very near future. We appreciate the opportunity to appear before you and look forward' to workingiwih th you in~ the effort to strengthen the nation's program in disease prevention and health promotion. 9

developing and changing at a rapid pace. We do not believe that specific listings should be loclted in statutory language when such matters could be handled more appropriately by regulation. Therefore, we wouldistrongly recommend that the specific listing,of nutrition labeling requirements, as found in Title I=, be deleted. Section 4013(g) (2) would~ authorize the Secretary to prescribe by regulation a system of symbols, figures, or other devices that would enable consumers to readily comprehend the nutrition information on labels as required by the preceding section. We fully support the objiective of establishing a system of symbols or figures to convey certain nutrition information to consumers. However, we would'not wish to see this authority li'mited~ to only those items listed in, section 403 (g) (1) of the bill. There may be other nutrition information for which a symbol would be extremely useful. Nevertheless, the Secretary wouldibe unable to require additional symbols if this authoriity is limited to those listed in the bill. We urge an amendment giving the Secretary the discretion to determine when the use of such symboTs is 4V appropriate and to req,uire it for any nutritional information.