Category: Public policy

SOURCE: Extract on my website | original FDA URL

1. Background

In September 1992. following an open meeting sponsored by the Centers for Disease Control (CDC) in Atlanta, GA (57 FR 29323) and based on reviews of the relevant scientific data, PHS recommended that all women of childbearing age in the United States consume 0.4 mg (400µg) of folate daily to reduce their risk of having a pregnancy affected with spina bifida or other neural tube defects (Ref. 1). In discussing this recommendation, PHS raised several issues that directly bear on FDA’s responsibilities under the Federal Food. Drug, and Cosmetic Act (the act). One of these issues was to identify the best approach for increasing intake of folate by women during their childbearing years. [Sanjeev: THIS IS THE LIVESTOCK MODEL OF PUBLIC HEALTH, NAMELY COMMUNISM, IN WHICH WOMEN HAVE THE EFFECTIVE STATUS OF SHEEP BELONGING TO THE STATE] PHS identified several possible approaches by which folate intake by the target population might be increased. These approaches included: (1) Improvement of dietary habits. (2) fortification of the U.S. food supply, and (3) daily use of folate supplements by women throughout their childbearing years. The PHS recommendation also cautioned against the effects of higher intakes of folate. The recommendation stated that a widely recognized adverse effect of high intakes of folate is masking the anemia of vitamin B12 deficiency and thus allowing the neurologic damage to progress untreated. PHS said that care should be taken to keep total folate consumption at less than 1 mg (1,000 µg)/day, except under the supervision of a physician (Ref, 1).

After the PHS recommendation was issued. FDA convened a subcommittee on folate of its Food Advisory Committee (hereinafter referred to as the “Folic Acid Subcommittee”) to consider some of the issues raised by the recommendation. At a meeting in November 1992. the Folic Acid Subcommittee discussed approaches for ensuring that the folate intakes of women would be increased. [Sanjeev: At every step FDA discloses its LIVESTOCK APPROACH TOWARDS WOMEN] It identified several approaches. These included: (1) Development of a fortification scheme such that 90 percent of women of childbearing age could receive at least 400 µg of folate per day from all sources, while preventing excessively high folate intakes by nontarget groups; (2) appropriate labeling of foods, including dietary supplements; and (3) implementation of an educational program directed primarily at women of childbearing age that emphasizes the importance of folate intake before, during, and after conception and its effect on the incidence of neural tube defects. The Folic Acid Subcommittee also recommended that a surveillance and monitoring system be established to provide baseline data on vitamin B12 status in subgroups of the population that might potentially be at greatest risk as a result of increased intakes of folate.

These issues and the Folic Acid Subcommittee’s recommendations are fully discussed elsewhere in this issue of the Federal Register in a proposed rule entitled “Food Labeling; Health Claims and Label Statements: Folic Acid and Neural Tube Defects” (hereinafter referred to as the health claims proposal).

1. The Proposal

In this document, the agency is proposing to implement its tentative conclusion, discussed at length in the health claims proposal, that food fortification should be limited to cereal-grain products. Specifically, FDA is proposing to establish a fortification scheme that will assist women in the target population in increasing their daily intake of folate. [Sanjeev: “ASSIST” IS FINE, but MANDATORY FORTIFICATION IS NOT ASSISTANCE: IT IS FORCE] This document also responds to a citizen petition (Docket No. 92P-0132), submitted by Glenn Scott, that requested that the agency amend the standards of identity for enriched cereal-grain products to include a requirement for the addition of folic acid, although the levels of addition suggested by the petitioner were lower than those that FDA is proposing to require in this document.

FDA is proposing to amend the following standards of identity to require the addition of folic acid: Enriched bread, rolls and buns (5136.115 (21 CFR 136.115)); enriched flour (5137.165 (21 CFR 137.165)); enriched self-rising flour (5 137.185 (21 CFR 137.185)); enriched corn grits (5 137.235 (21 CFR 137.235)); enriched corn meals (5137.260 (21 CFR 137.260)); enriched farina (5137.305 (21 CFR 137.305)); enriched rice (5137.350 (21 CFR 137.350)); enriched macaroni products (5 139.115 (21 CFR 139.115)); enriched nonfat milk macaroni products (5139.122 (21 CFR 139.122)); and enriched noodle products (5 139.155 (21 CFR 139.155)). FDA notes that the standards of identity for enriched bromated flour (5137.160 (21 CFR 137.160)), enriched vegetable macaroni products (5139.135 (21 CFR 139.135)), and enriched vegetable noodle products (5 139.165 (21 CFR 139.165)) cross-reference the standards of identity for enriched flour, enriched macaroni products. and enriched noodle products, respectively, and will thus also be amended by this proposal. FDA also points out that the standard for enriched macaroni products fortified with protein is stayed and thus will not be addressed in this rulemaking.

As fully discussed in the health claims proposal published elsewhere in this issue of the Federal Register, FDA has tentatively decided that the fortification of the food supply is an appropriate approach for increasing the intake of folate by women in the target population. [Sanjeev: NOT A STEP PASSES WITHOUT THE LIVESTOCK MODEL IN THE MIND OF FDA] As noted by the Folic Acid Subcommittee and expert speakers who testified before the Folic Acid Subcommittee, food fortification has the advantage of reaching a great number of women in the target population before conception and during early pregnancy, when the risk of neural tube defects is greatest. [Sanjeev: FDA conveniently didn’t mention that the NON-TARGET POPULATION WOULD ALSO BE FORCED TO CONSUME FOLIC ACID] It also has the advantage of providing folate in a continuous and passive manner and, thus, represents an effective means for improving the folate nutriture of women in their childbearing years.

In determining what foods would be appropriate for fortification with folic acid and at what levels, the agency used the U.S. Department of Agriculture (USDA) 1987-1988 national food consumption data (Ref. 2) to estimate daily intake of folate for the target population, as well as the general population, with fortification at different levels for cereal grains. dairy products, and juices. The agency estimated the effects of fortification using three values – 0.070, 0.140, and 0.350 mg of folic acid/100 g of cereal-grain products. As discussed in the health claims proposal, the value of 0.070 mg/100 g (0.3 mg/lb) is the amount, recommended in 1974 by the Food and Nutrition Board, National Research Council, National Academy of Sciences, that would restore folate lost in the milling of cereal-grain products and represents about a four-fold increase in the level of folate that ordinarily occurs in wheat floor (Ref. 3).  [Sanjeev: Restoration is a LEGITIMATE objective, but folic acid is not natural, hence problematic] The value of 0.140 mg,/100 g is twice that amount, and 0.350 mg/100 g is five times that amount. [Sanjeev: Since 0.070 mg is FOUR TIMES NATURAL LEVEL, 0.14 mg is EIGHT TIMES]

The different approaches that FDA used in estimating the effects of fortification of food with these levels of folic acid are fully discussed in the health claims proposal, published elsewhere in this issue of the Federal Register. in arriving at these estimates, FDA made provision for consumption of ready-to-eat cereals fortified with folic acid as well as dietary supplements containing folic acid.

In its analysis, FDA assumed likely underreporting biases in food intakes. The agency did so because national food consumption surveys generally underestimate the food intake of survey respondents. This fact is supported, in part, by the observation that when consumer-reported dietary intakes are used as a basis for designing intervention diets (not necessarily for weight reduction), subjects that follow the intervention diet frequently lose weight (Ref. 4). Further, calorie intakes that were estimated based on the survey respondents’ daily reported food intake fell below the current average calorie intakes recommended by the Food and Nutrition Board. For example, in the 1987-1988 USDA Nationwide Food Consumption Survey (Ref. 2) used for these estimates, calculated median energy intakes of women 19 to 50 years of age were only about 1,500 calories, whereas the most recent recommended average energy intake for this gender/ age group is 2,200 calories (Ref. 5).

FDA also took into account in performing its analysis that underestimation of folate contents of foods was likely in the analysis that had been done. Comparison of newer methods of sample preparation with older methods for determining the folate content of foods has revealed underestimates in the range of 20 percent for vegetables such as spinach and cauliflower and 50 percent for canned tuna. Thus, commonly used methods for folate analysis may significantly underestimate the folate content of foods.

As fully discussed in the health claims proposal published elsewhere in this issue of the Federal Register, results of FDA’s analysis show that when fortification included fruit juices and dairy products in addition to cereal grain and dietary supplements, folate intakes of some nontarget group consumers exceeded 1 mg/day regardless of the fortification level examined. However, when fortification was limited to cereal-grain products at levels of 70 µg/100 g or 140 µg/100 g, daily intake levels remained below 1 mg/100 g. At fortification levels of 350 µg/100 g, the estimated daily intake could reach levels of 1,220 µg/100 g, which exceeds the recommended safe upper limit.

The agency also estimated the daily intake of folate for consumers who follow Federal government dietary guidance, such as the U.S. Dietary Guidelines and the Department of Health and Human Services (DHHS)/ USDA Food Guide Pyramid, and consume cereal-grain products fortified with folic acid, to determine whether these consumers will have daily intakes in excess of the recommended safe upper limit of approximately 1 mg/day.

These estimates, as shown in Table 7 in the health claims proposal, indicate that consumers who followed even the low end of recommendations from the DRHS/USDA Food Guide Pyramid could, without supplement use, easily consume 420µg or more of folate per day from cereal-grain products fortified with 70 µg folic acid/100 g. Further. such consumers’ daily intake could triple if such products were fortified with 350 µg folic acid/100 g.

As a result of its analysis of fortification of several cereal-grain, dairy, and juice products, FDA has tentatively concluded that fortification should be limited to cereal-grain products and not extended to dairy products and fruit juices. (The agency notes that results of its analysis are presented in Tables 4 through 7 in the health claims proposal published elsewhere in this issue of the Federal Register.) The agency found that intakes by very large segments of the general population would reach several milligrams per day if all of these foods were fortified with folic acid.

The agency has also tentatively decided that the appropriate fortification level for cereal-grain products is 140 µg/l00 g. Based on the results of its analysis, fortification of cereal-grain products with 140 µg/100 g will provide daily intakes for the nontarget population that remain within the recommended safe upper limit of approximately 1 mg/day, while providing increased intakes of folate for women in their childbearing years. The agency notes that with supplement use, 95th percentile intakes by adults 51+ years of age could reach 840 to 860 µg/ day if these enriched cereal-grain products are fortified with 140 µg/100 g. While the agency recognizes that this level approaches the recommended safe upper limit and does not take into account likely underreporting biases regarding food intakes and underestimation of folate content of foods, it tentatively concludes that fortification of cereal-grain products with 140 µg/100 g folic acid is he most appropriate fortification level of the three levels analyzed to ensure that folate intakes by the target population will increase. Fortification at a lower level of 70 µg/100 g may not provide sufficient folate levels to that portion of the target population that have lower daily food intakes or that consume minimal amounts of cereal-grain products. For example folate intake estimates for the 25th percentile of the target population if cereal-grain products were supplemented with 70 µg/100 g of folic acid showed levels of 160 to 180 µg/day without supplement use and 200 µg/day with supplement use.

In this document, the agency is proposing to provide for folic acid fortification of the individual enriched cereal-grain products discussed below, which are subject to standards of identity.

Source: Bentham’s Constitutional Code

Section V.: Preventive Service Minister.

Enactive.

Art. 1. To the Preventive Service Minister, it belongs to give, under the Prime Minister, execution and effect to all ordinances of the Legislature, in so far as they have for their object the prevention of calamity; or of delinquency, otherwise than by exercise of the functions belonging to the Judiciary.

Enactive.

Art. 2. To this purpose, it belongs to him, under the direction of the Prime Minister, to exercise, as to all persons in so far as employed in the Preventive Service, the locative, suppletive, directive and dislocative functions; as to his own office, the self-suppletive function; as to things, in so far as thus employed, the procurative, custoditive, applicative, reparative, transformative, and eliminative functions: as to persons and things, the inspective; as to persons, things, and occurrences, thereto belonging, the statistic, recordative, publicative, and officially-informative: as to states of things, ordinances,  and arrangements, the melioration-suggestive.

Exemplificational.

Art. 3. Examples of the principal calamities, to which prevention is capable of being applied, under the care of government, are as follows:

1. Collapsion: namely of the natural sort, in large masses, or of edifices in a ruinous state; or by means of earthquakes.
2. Inundation.
3. Conflagration.
4. Disease and mortality, the results of unhealthy and unmedicated situations.
5. Unhealthy employments, the unhealthiness of which is capable of being removed or lessened by appropriate arrangements.
6. Contagious disease.
7. Dearth and famine.

Exemplificational.

Art. 4. Examples of arrangements for the prevention or mitigation, of calamity in the above shapes, are as follows:

1. Against collapsion,—of earth, in hilly or mountainous situations, precautionary surveys: of edifices, particularly in towns, precautionary surveys: for reparation, or demolition of ruinous ones; also precautionary arrangements in the construction of new ones.
2. Against inundation,—surveys of bridges, dykes and embankments; also arrangements for the draining of lands.
3. Against conflagration,—precautionary construction of edifices: precautionary fabrication, custody and conveyance of gunpowder and other explodible substances: precautionary stowage and custody of spontaneously combustible vegetable matters in warehouses: the employment of precautionary operations and instruments in mines: Fire Insurance Associations.
4. Against suffocation in mines and manufactories,—precautionary arrangements and monitions.
5. Against disease and mortality from putrid water, naturally accumulated, drainage; from putrid water, artificially accumulated, drainage in enclosed tunnels.
6. Against disease and mortality from contagion,—temporary prevention or restriction of intercourse of persons or goods, with the persons, receptacles, or commodities, known or suspected to be the seats of a contagious disease.
7. Against disease and mortality from the consumption of articles of food or drink, in a state regarded as dangerous to health,—arrangements for preventing the vent of them.
8. Against disease and mortality, from medicinal and other drugs, liable to produce the effect of poisons,—precautionary restrictions on the vent of them: as for example, keeping them in cabinets under lock and key, with the word Poisonwritten on them.
9. Against extraordinary scarcity of necessaries,—precautionary supplies, in so far as freedom of trade is inadequate to the purpose.

Exemplificational.

Art. 5. Examples of things belonging to the department of the Preventive Service Minister are the following:

1. Things immoveable.

I. Against Delinquency, and Calamity by fire.

1. Offices for Police Directors and their subordinates.
2. Police Station-houses.
3. Receptacles for Fire-Engines, Ladders, and Fire-Escapes.

II. Against Inundation.

1. Dykes and Dams.

III. Against Contagion.

1. Lazarettos.

IV. Against extraordinary scarcity.

1. Government Magazines.

V. Things moveable.

1. Vehicles.
2. Beasts of draught and saddle.

Instructional.

Art. 6. In relation to the Defensive Force Service and the Preventive Service, the Legislature will consider, how far, by a mixture of Defensive Force Functionaries with Preventive Service Functionaries, the advantages of a stationary with those of a migratory body, may be combined, and the two branches of the official establishment rendered mutually subservient, each to the purpose for which the other is principally instituted.

Instructional.

Art. 7. Under the Legislature, this will be matter of special consideration for the Prime Minister. He will accordingly, if he sees reason, unless inhibited by the Legislature, attach from time to time, to the Preventive Service, (subjecting them for the time to the direction of the Preventive Service Minister,) certain portions of the stipendiary Defensive Force, Land or Sea Force, or both, as occasion may require.

Ratiocinative.

Art. 8. I. Advantages to the Stipendiary Defensive Force, more particularly the Land Force.

1. Those from the employment-extending principle, as per Ch. x. Defensive Force, Section 2. Leading Principles.
2. Those, from the time-occupying principle, as per Ch. x. Section 2.
3. Appropriate acquaintance with the territory in a military point of view, thence proportionable aptitude as to the purpose of defending it, against an invading enemy. In point of extent, the value of this advantage would increase, with the frequency of the migration. Nor would it proportionably decrease, in respect of correctness and completeness, within each portion of territory: for, sufficient for the military purpose would be a much smaller portion of the time of these military auxiliaries, than would naturally be applied to the use of the Preventive Service.

Ratiocinative.

Art. 9. II. Advantages to the Preventive Service.

1. Those resulting from the natural pre-eminence of the military functionaries, in respect of the qualities of vigilance, punctuality of obedience, promptitude of obedience, activity, simultaneity of obedience, and intrepidity.
2. Those resulting from the additional security, which such admixture will naturally give, against sinister connexions, between the functionaries and the internal adversaries, against whom they are employed to combat. Of this security, the degree and value, in the case of each body, would be inversely as the length of time during which it continued stationed in the same place.

Ratiocinative.

Art. 10. There seems to be but one qualification, in respect of which, functionaries belonging to the Defensive Force Service, land and sea, according to local circumstances, included, would not naturally possess more aptitude, with relation to the Preventive Service, than those would who are exclusively attached to this last-mentioned service: and this is local knowledge, including that of the characters, family circumstances, abodes and haunts of individual delinquents, and persons most in danger of falling into delinquency. But if of each military functionary’s time, one portion being employed in active service in this shape, another were employed in the performance of the military exercises, appropriate aptitude with relation to military service, might thus be continued unimpaired. As to the advantage derived from acquaintance with the characters, family circumstances, abodes and haunts of delinquents and persons liable to become delinquents, a due admixture of the migratory, with the stationary functionaries, might afford this advantage, and at the same time obviate the danger from sinister connexion.

Exemplificational.

Art. 11. Examples of subject-matters of such local knowledge, are—

1. Statistic circumstances: sites of the several habitations, thence abodes, of the respective householders, with their inmates of both sexes and all ages. Of these particulars, an adequate degree of notoriety would be necessitated, and effected, for the purposes of Election Service, as per Election Code, Section 10.
2. Moral circumstances: disposition of the several inhabitants, as resulting from habitual sources of livelihood and other occupations.
3. Circumstances purely topographical. Condition of the territory in respect of plains, hills, and mountains,—rivers, lakes, and seas,—soil, whether sandy, clayey, chalky, gravelly, rocky, &c., and natural productions,—ground woody, or woodless.

Of the knowledge of these last-mentioned particulars, the use is, the giving facility to the eventual accersition or say hither-calling, of individuals whose attendance is required, with or without such or such articles of his property, for the purpose of evidence or justiciability, and in case of need, the prehension of the supposed delinquent, or other defendant.

With the benefit of all these helps, scarcely would any band of malefactors be formed, whom the functionaries so employed, would not know where to find, together with the appropriate evidence requisite for their conviction.

Ratiocinative.

Art. 12. A consideration that will not escape observation, is—that, as to seduction of functionaries by sinister connexion with delinquents, the danger is considerably greater, in the case of contrabandists, than in the case of delinquents at large. In the case of the contrabandist, the mischief produced, is not so obvious and conspicuous, as in the case of most other sorts of malefactors. The community is indeed injured: but the community is an ideal and invisible being, of too aërial a texture, to be grasped by a mind of ordinary texture: the fair trader injured is indeed a real and visible being, but seldom is he determinate. Seldom is it known to what contrabandist any fair trader is indebted for the suffering which, by this or that one of his operations, the contrabandist  has produced. The consequence is—that, against the contrabandist, no such antipathy points itself as against the robber, the thief, or even the obtainer by false pretences: much less, any such antipathy as has place in the case of the housebreaker, or the assassin, in whose instance homicide has been employed, either for perpetration, or for concealment, of an enterprise of indiscriminating depredation.

Section X.: Health Minister.

Enactive.

Art. 1. To the Health Minister it belongs, under the Prime Minister, (frequently in conjunction with the Preventive Service Minister,) to give execution and effect to all legislative ordinances, having for their special object, the preservation of the national health.

Enactive.

Art. 2. To this purpose, under the direction of the Prime Minister, it belongs to him to exercise,—in relation to all persons, in so far as employed under him, the locative, suppletive, directive, and dislocative functions;—as to his own office, the self-suppletive function;—as to things, in so far as thus employed, but in concert with the Finance Minister, the procurative, custoditive, applicative, reparative, transformative, and eliminative functions;—as to persons and things, the inspective;—as to persons, things, and occurrences thereto belonging, the statistic, recordative, publicative, and officially-informative;—as to state of things, ordinances and arrangements, the melioration-suggestive.

Enactive.

Art. 3. So, in relation to all such institutions and establishments, as, for this purpose, are on foot or in progress, for the use of the public, at the expense or under the direction of the Sublegislatures, or of individuals, or bodies incorporated or otherwise associated,—the inspective, statistic, and melioration-suggestive functions.

Enactive.

Art. 4. To the Health Minister, in relation to all medical functionaries serving in the land, or say army branch of the Stipendiary Defensive Force,—belongs moreover the locative, suppletive, directive, dislocative, and suspensive functions: the functionaries so located by him being at all times subject also to the exercise of the suspensive function, exerciseable for special reasons, by the commanding officers of the several corps serving separately, from the grade of colonel of a regiment upwards. For the manner in which the suspensive function will, in this case, be exercised, see Ch. ix. Ministers collectively, Section 21, Oppression obviated.

Enactive.

Art. 5. So, as to all medical functionaries, serving in the sea, or say navy branch of the Stipendiary Defensive Force: the functionaries so by him located, being at all times subject also to the exercise of the suspensive function, exercisible for special reasons, by the commanding officers of the several navigable vessels, in and for which the several medical [444] functionaries are at the time in question serving.

Instructional.

Art. 6. For the consideration of the Legislature it will be, whether and how far the provision in Arts. 4, 5, shall be applied to the preventive service subdepartment: regard being had to the composition of this branch of the official establishment, and the distribution made of the functionaries thereto belonging.

Enactive.

Art. 7. So, as to all medical functionaries, serving under the Indigence Relief Minister,—it belongs to the Health Minister to exercise the locative, suppletive, directive, dislocative, and suspensive functions: the functionaries so by him located, being at all times subject also to the suspensive function, exercisable, for special reasons, by the functionary having charge of the establishment, for the service of which such medical functionaries have respectively been located.

Enactive. Expositive.

Art. 8. So, in relation to the things immoveable following, and the things moveable thereto respectively belonging,—to him it belongs, always in concert with the Finance Minister, to exercise the several functions procurative, custoditive, applicative, reparative, transformative, and eliminative: that is to say—

1. Hospitals,maintained at Government expense: army and navy hospitals, and preventive service hospitals, if any, included.
2. Lazarettos:that is to say places, within the limits of which, for the purpose of ascertaining the presence or absence of contagious disorders, persons, or property, or both together, are confined: in this case in concert with the Foreign Relation Minister likewise.
3. Laboratories,if any such there are, in which medicines, for the use of the stipendiary branch of the land and sea defensive services, are prepared.

Enactive.

Art. 9. In regard to the other things immoveable following, so far as regards health, as also the persons therein residing, the inspective function: that is to say—

1. Prisons:and all other places, in which any person is kept under confinement.
2. In particular, madhouses,at whose expense whatsoever and under whose care soever kept up, whether at the expense of the public at large, or that of the sublegislatures,—of bodies corporate, or otherwise associated, or of individuals.
3. Edifices,with their appurtenances, belonging to the field of service of the Indigence Relief Minister.
4. Edifices, with their appurtenances, belonging to the field of service of the Education Minister.

Enactive.

Art. 10. So, as to the contents of all shops and storehouses, in which drugs, designed to be employed for medical purposes, are kept for sale, or otherwise for distribution: more particularly with reference to the precautionary arrangements directed to be observed by the Preventive Service Minister as per Section 5, Article 4, relating to the sale of poisons.

Enactive.

Art. 11. So, as to the contents of all shops and storehouses, in which instruments, designed for chirurgical purposes, are kept for sale, or otherwise, for distribution.

Enactive.

Art. 12. In particular as to all such medicaments and drugs designed to be employed for medical purposes, as, from any general office or repository, have been conveyed or are appointed or designed to be conveyed, to any of the appropriate stations, in the Army Service, Navy Service, or the Indigence-Relief Hospital Service.

Enactive.

Art. 13. So, as to persons, things and occurrences, the statistic and recordative functions: as to states of things, ordinances, and arrangements, the melioration-suggestive function.

Enactive. Instructional.

Art. 14. In addition to the above generally-applying functions, belong to this Minister the specially-applying functions following:—

1. Authoritatively-eliminative function.

In the exercise of this same function, subject to appeal to the Judge immediate, he causes to be employed the appropriate means, for the elimination of all such medicaments, as, by deterioration, natural or accidental, have been rendered unfit for medical service: and on this occasion, takes care that they be either destroyed, or if put to use for any other purpose, so prepared for such use, as not to be capable of being, in their relatively unapt state, applied to any medical purpose.

Enactive. Expositive. Instructional.

Art. 15. II. Aqua-procurative, or say Water-supply-securing function. In the exercise of this function, he will take for the subject-matter of examination, the supply of water which has or may have place in such towns as the Prime Minister (consideration had of their extent and the density of their population) shall, for this purpose, have given to him in charge: on which occasion, he will include in his observation the quantity, quality, and proportionality of distribution, of the subject-matter of this supply.

Enactive. Expositive. Exemplificational.

Art. 16. III. Malaria-obviating, or anti-malarial [445] function. To this function exercise will be given, by keeping under review all such local situations, as are liable to harbour or give rise to exhalations detrimental to health.

Of the sources of such exhalations, examples are the following:—

1. Lands which, to whatsoever proprietors belonging, are habitually or occasionally covered with stagnant water.
2. Mines, considered in respect of such inflammable or dangerously respirable gases, as they are liable to contain.
3. Common sewers and drains.
4. Places of interment.
5. Theatres and other similarly crowded places of public entertainment.
6. Manufacturing establishments, considered in respect of the several ways by which they are liable to deteriorate the air, by the several modes in which the operations belonging to them are respectively carried on.

Enactive. Expositive. Instructional.

Art. 17. IV. Health-regarding-evidence-elicitative-and-recordative function. To this function exercise will be given by the elicitation and recordation of the documents following:—

1. Bills of Mortality. The matter belonging to these documents he will receive from the Local Registrars of the several Bis-subdistricts: in virtue of their several functions,—death-recordative, marriage-recordative, birth-recordative, maturity-recordative, and insanity-recordative, as per Ch. xxvi. Local Registrars, Sections 5, 6, 7, 8, 9. On this occasion, separate notice will be taken, and report made of the state of mortality and disease, in the several Hospitals and Establishments, under the management or inspection of the Army Minister, the Navy Minister, the Preventive Service Minister, the Indigence Relief Minister, and the Education Minister.
2. From the several different places, Registers of the Weather, in so far as habitually framed and preserved in the several establishments above-mentioned; also from any other public sources, from whence they may conveniently be procurable: and from private sources, so far as procurable from those sources, with the free consent of the individuals interested.

Enactive. Expositive.

Art. 18. V. Appropriate oustoditive function. In the exercise of this function, he has charge in chief of all medical museums, belonging to Government.

Instructional. Exemplificational.

Art. 19. Of the contents of a Medical Museum, examples are the following:—

1. Anatomical Preparations.
2. Chirurgical Instruments.
3. Specimens of the Materia Medica, preserved for standards of comparison.
4. Herbaries.
5. Medical Books and Graphical imitations.
6. Registers of the Weather, and Instruments for the formation of such Registers.
7. Mortality Reports, as above.
8. Models of the human form, in its natural state.
9. Models of distortions.

Enactive. Expositive.

Art. 20. VI. Aptitude-securing function. In the exercise of this function, to the Health Minister it will belong to watch over the aptitude and efficiency of the application made, of the Probationary Examination system, (as per Ch. ix. Ministers collectively, Section 16, Locable who,) with reference to all aspirants to those offices, the functions of which, are exercises of the art of medicine, in any of its several branches, and to whatsoever subject applied: in such sort that, by the operation of sinister interest,—whether self-regarding, sympathetic, or antipathetic,—no person relatively unapt be admitted, or relatively apt excluded: mindful, that in self-regarding interest, are included not only love of money, but love of ease.

He will, therefore, preside at all such examinations, having for Assessors, persons three or five, elected by all who, in consequence of Examinations antecedently undergone by them, have received certificates of appropriate aptitude.

Enactive. Expositive.

Art. 21. VII. Professional confederacy-checking function. To the Health Minister, under the direction of the Prime Minister and the Legislature,—and with the assistance of the Public-Opinion Tribunal, as per Ch. v. Constitutive, Sections 4, 5, it will especially belong, to be upon the watch against all injury to the health of the community, by the operation of particular interests, in the breasts of medical practitioners, at the expense of public interest: (and, as occasion calls, to make report accordingly:) for example, by associations among themselves for the formation of regulations and arrangements, express or tacit, concerning division of labour, rate of payment, terms or mode of attendance, or otherwise.

Enactive. Instructional.

Art. 22. VIII. Appropriate-publication function. To this function he will give exercise, by giving, to the result of the exercise given to the several preceding functions, the utmost publicity that can be given to them, consistently with a due regard to public economy in respect of the expense, and to the feelings of persons subjected to the exercise of his several functions: yet not so as to give concealment to delinquency, in whatever shape exemplified.

March 5, 2010 conference in Washington: Role of Disease Containment in Control of Epidemics

Source video

The panel was made up of Jennifer Nuzzo, Center for Biosecurity of UPMC (University of Pittsburgh Medical Center?), Moderator; Jeffrey Levi, Trust for America’s Health; D.A. Henderson, Center for Biosecurity of UPMC; Ronald St. John, Public Health Agency of Canada; Marcelle Layton, NYC Department of Health and Mental Hygiene; James Blumenstock, Association of State and Territorial Health Officials.

JENNIFER NUZZO

Well, I’m very pleased to be moderating this panel on the public health response to emerging infectious disease. Just like the last panel, in this one we’re also going to use a scenario to sort of limit our conversation. But in this panel we’re going to discuss what specific measures we would take to respond to a new contagious virus for which there are no medicines, vaccines available now or on the horizon.

As we all know, in the early phases of the H1N1 pandemic, many countries employed measures to either slow or to stop the spread of influenza. The measures we’re talking about, you know, some closed schools, others isolated sick people. Others pursued even more intensive strategies, like implementing travel restrictions, installing fever screens in airports, quarantining people who are not yet sick but who had arrived from affected areas.

Some countries continued some of these measures throughout the pandemic and in some cases against the recommendations of the WHO. Whether or not these interventions significantly delayed, stopped, or reduced the number of cases is unknown, and it’s probably up for debate among experts. These are the measures we’re going to talk about today. And so we don’t necessarily expect that we will come to any closure on which specific measure we would use. But we are interested in understanding what the decision-making process would be for which measures we would use under what circumstances.

So to set up this discussion, we have asked our panelists to put themselves in the role of state health officer. For some it’s not a real stretch. For others, they might have to remember back to the days when. And to imagine what they would do if faced with the job of trying to control the spread of a new virus, one that’s causing significant sickness and death, that’s occurring in small clusters in the United States as well as in multiple locations abroad. And as with SARS in our scenario today, we’re going to assume that there are no medicines or vaccines or rapid diagnostic tests available.

And we’d like to hear which measures our panelists would consider using to limit the spread of this new virus and why. For our panel today, we will give each of our panelists an opportunity to make introductory remarks followed by a moderated discussion. And then we’ll open it up for questions from the audience.

So today we are lucky to be joined by five esteemed individuals. First we’ll hear from Ron St. John, who you met in the Q&A session before. Ron has a longer than 35-year career in public health and infectious disease control. As he mentioned, he served the Public Health Agency of Canada as the first director general of the Center for Emergency Preparedness and Response. And he led the agency’s response to the aftermath of September 11th and SARS. He also led policy and planning efforts for Health Canada on issues related to counterterrorism, quarantine, and migration and travel health. Since retiring from government service in 2007, Ron continues to consult in the realm of infectious disease control.

Then we’ll hear from Jim Blumenstock. Jim is the chief program officer for public health practice for the Association of State and Territorial Health Officials. He works on behalf of state public health agencies on issues related to infectious and emerging diseases, immunization, environmental health, and public health preparedness. And before joining ASTHO, Jim was a deputy commissioner for health in the New Jersey Department of Health and Senior Services, which he held for an impressive 32 years. In New Jersey government, that’s very impressive.

And then we’ll hear from D.A. Henderson. D.A. is a distinguished scholar and founding member of the Center for Biosecurity of UPMC. He held several senior-level positions in the U.S. government, including director of the Office of Public Health Emergency Preparedness at the U.S. Department of Health and Human Services. And as many of you know, he also led the World Health Organization’s successful campaign to eradicate smallpox, a job for which he has received top honors from governments across the world.

We’ll then hear remarks from Jeff Levy. Jeff is executive director of Trust for America’s Health, where he leads the organization’s advocacy efforts on behalf of a modernized public health system. Jeff oversees TIFA’s work on a number of public health policy issues, including their annual assessments of the nation’s public health preparedness. And he and his colleagues have written extensively and spoken extensively about pandemic preparedness, including U.S. response to H1N1.

And then finally, we’ll hear from Marcy Layton. Marcy is the assistant commissioner for the Bureau of Communicable Disease at New York City Department of Health and Mental Hygiene. And it’s difficult to sum up everything that she’s done there, except that I think I at one point saw a figure that she’s led more than 1,000 outbreak investigations. That figure is a few years old, so maybe it’s tripled by now. But anyway, and countless other health crises, including September 11th attacks, anthrax attacks, global SARS epidemic, and the first cases of West Nile virus in this hemisphere.

So now that you’ve met our panelists, I will let Ron start with his remarks.

RON ST JOHN

Thank you very much, Jennifer. And thank you very much to the organizers for the invitation. And to maybe present a little bit of Canada here today.

First of all, a bit of a disclaimer, like my colleague from Minnesota, who said many of you represent your organizations. I am the former director general of the Center for Emergency Preparedness Responses, you’ve heard. So I want to make it clear I do not repreesnt the center, and I do not represent the public health agency, and I do not represent Health Canada. And that means that I can say whatever the hell I want to say. Without political spin.

I’m going to spin off of this scenario a little bit. I never was a state health commissioner, nor was I a provincial chief medical officer of health in Canada. I’ve always been a Fed, and I have a certain bias inherent in that.

But I’ll spin off this scenario. And the scenario says this is a significant disease. And that means to me that it sits somewhere on that continuum between a mild disease and a severe disease. And, you know, where does it fit? That will drive a lot of the decisions that governments will make in response to the threat. And I’d like to say that, in my opinion, my experience, the biggest driver of that decision-making process will be fear of death.     [Sanjeev: This is great stuff – that an experienced PH professional admits that everything in such situations is driven by fear.] And fear of death is obviously a human thing, and that is a major driver. And we tend not to think about that too much, but mortality is a critical driver. And the overestimation of mortality in Mexico was a major driver in the early days of response and concern.

So let me deal quickly with the significant disease scenario and assume that this is really a highly lethal disease, and maybe even it’s even the highly transmissible avian influenza virus with its 50 to 70 percent mortality rate with no treatment available. And I would postulate that the responses of governments would be radical. If I were in Canada and there was a cluster like this in the United States or France, somewhere like that, this would be the close-the-border situation.

CLOSURE OF BORDER

This would be the question put, do we close the borders? And I asked myself, and this has come up, can this be done? Not should it be done, but can it be done? And the answer is, yes, it can be done. In fact, we did it. We did it in 2001. We closed the airspace in Canada and the USA within hours, within hours. So, yes, it can be done.

But then, no, it can’t, because a lot of people between Canada and the United States, a lot of people don’t realize there are 1,300 border crossings that have people on them. Now, somewhere up in Minnesota, and I may be corrected by my colleague from Minnesota, there’s a lake, and somewhere the border runs through the middle of that lake, and there are canoes going back and forth. And I know that somewhere out in Montana there’s a dusty road that goes north, and there’s a sign along that road that says, Welcome to Canada. Will you please stop 50 miles up the road at that house on the right and let us know you’re here? That’s our border between our countries. So can it be closed? In one sense, yes. Can it not be closed? In another sense, it cannot be closed.

DOMINO EFFECTS

But there were huge domino effects, and there were huge unanswered questions about closing the border.

For example, there were planes in the air at the time of the closure, planes that had passed the no return point. They can’t go back. Where do they go? Do we let them crash? If they have asymptomatic people on board that might be infected? Well, we didn’t let them crash. They landed in Halifax, and they landed in Nova Scotia and Newfoundland. We had planes bumper to bumper, wingtip to wingtip, and we had about 20,000 to 40,000 people stranded during the 2001 episode.

Then there are other considerations like stranded citizens in other countries. During the SARS, I was asked by the Department of Foreign Affairs, Ron, what are we going to do if all the Chinese Canadians holding Canadian passports in Hong Kong want to come home? I said, well, how many are there? And they said 200,000. And I said, I’m not going to think about that because I really don’t have an answer for that. And fortunately, they didn’t elect to come home. But there are questions like, what do you do with your citizens when you close your borders?

And then there’s the economic loss from the border closure versus mortality losses, and how do you measure that? Every day between Canada and the United States, one and a half billion dollars of goods cross the border every day, every single day. And Canada is the biggest supplier of oil to the United States. And we in Canada have only a three-day supply of perishable foods in the country. So border closure is not a particularly good idea.

What about border? I just don’t know. Because the political decisions and the fears may overwhelm any rationality. [Sanjeev: Another great point] But it’s clear that it’s an extremely complex issue.

And from a public health point of view, I feel like it should never happen.

But let me deal with the less severe situations. The things we’ve done so far in SARS and H1N1 that don’t seem to be too impressive.

OTHER TOOLS

Besides close the border, there are about five tools that we have.

a) TRAVEL ADVISORIES
We have travel advisories and restrictions, and I’ll deal with that real quick. Unless the restriction is you can’t get there from here, there’s not much impact that that can have. We used to advise, we still advise Canadians about non-essential travel. Don’t avoid non-essential travel to place X or Y. What’s non-essential travel? Well, if my uncle just died and I have to go to the funeral, that’s non-essential for me. If I’m closing a $4 million deal in China, that’s pretty essential travel for me.

And it becomes so subjective, we couldn’t define it. So I’m not too impressed, unless it’s a total restriction, which is close to closing the border.

b) STOPPING SELECTED FLIGHTS

Stopping selected flights. Well, there are over 5,000 major international airports in the world. And Argentina, in a few days after the episode began in Canada, Mexico, and the United States, canceled all flights from Mexico, Canada, and the United States into Buenos Aires. Yet you can fly from Toronto to Sao Paulo, Brazil, and from Sao Paulo, Brazil to Buenos Aires, which would have been permitted. So the permutations make it rather silly to think about stopping selected flights.

c) QUESTIONNAIRES

What about questionnaires? During SARS, we distributed over a million questionnaires to inbound passengers. And we had three questions: Do you have a cough? Do you have a fever? Have you been in contact with someone with SARS?

I was always impressed by how many people were honest and said yes. I smoke three packs a day and I have a cough. But whenever you set up a screening, you have to deal with the false positives. And we had over 2,800 people that said yes to one of the questions. So we had to set up a $17 million system of nurses and secondary screening to make sure that they did or did not have SARS, and none of them had SARS.

d) THERMAL SCANNERS

We had thermal scanners and we scanned over 970,000 people. And in spite of the technical challenges for setting those things up, we had 373 positive results and no SARS.

The problem there is prevalence. The prevalence of disease, prevalence of SARS in travelers was so low, it was searching for a needle in a haystack. So the positive predictive value of any positive test was nil. Now, in a highly infectious disease, the prevalence would change and maybe those measures might be useful. [Sanjeev: THAT IS BEING TOTALLY STUPID – since infectious disease would transmit asymptomatically, making even true positives worthless, since most disease would go undetected, anyway.]

e) QUARANTINE

Finally, quarantine, the fifth measure. We have probably, I think, the only modern day quarantine experience for SARS in Toronto. We quarantined between 20,000 and 25,000 people. On any given day, there were 7,000 to 8,000 people in a self-imposed quarantine.

Now, what were the problems? They were unanticipated.

i) Number one, compensation. How do you compensate people? Who’s going to compensate the people who stay home in their self-imposed quarantine because we asked them to go into quarantine?

ii) There were the other fallout dominoes, I call them. We had telephone calls like, you know, “I just got to go down to the local bank machine, get 20 bucks, can I go out for half an hour, and I’ll be right back”. “Baby’s out of diapers, can I run down to the supermarket, get some diapers, I’ll be right back”. And the social support that is necessary for quarantine is not there, was not there, still isn’t there, if you were thinking about quarantining large numbers of people.

iii) And then finally, the logistics are huge. We talked about, well, what do we do with… [Sanjeev: the sheer size of quarantine]

We were thinking H1N1 was going to come from Southeast Asia. The first plane comes into Vancouver, great, there’s 173 people on board, we put them over there. Holy smokes, two hours later, three hours later, there’s another plane from Hong Kong. There’s another 170, 180 people, 200 people, we put them over there. By the end of day one, we’d exhausted where we’re going to put people.

And then how are you going to support those people?

Well, you wait to see whether they get sick or don’t get sick. We decided that if it were to happen and we had any advance notice, anybody who was sick, we’d send them home. Please stay home. And we’ll try to look after you at home.

So quarantine in a modern global world with intense movement of people is not a particularly attractive proposition, especially from a logistical point of view. Yet the public will demand responses from the government, and the government will put these measures in place, one, more, or all, thinking that they can gain the public trust.

And it’s a two-edged sword, because if you oversell it and tell the public this is going to keep the disease out, and it won’t, then you’ve lost the public trust. So you’re on a difficult two-edged sword as to how you sell these things to the public. [Sanjeev: THE STUDPIDITY LIES IN TRYING TO “SELL” THESE TO THE PUBLIC]

So finally, just to close, I think the real challenge is not so much trying to figure out how to use these tools. They WILL be used one way or the other.

But the real challenge is to prepare to deal with the problem when it arrives, because it will arrive.

In Canada we kept saying over and over again that the new border for infectious disease is the door of our hospital, because that’s where people who are sick will come, and you have to be prepared to consider what you’re going to do with people who turn up with serious disease.

We used to tell our physicians, my closing remark is, there are two questions you need to ask your patients that come in with fever or indications of an infectious disease. And that question was, have you traveled anywhere? We learned from SARS that you have to ask a second question. Has anybody in your family traveled somewhere? Because the first case was a Chinese grandmother who died at home.  he case that showed up in the hospital was her son. And he said, I haven’t traveled. And nobody thought to consider the second question.

Thank you.

JENNIFER

Thank you very much. I think there’s a lot of points there that we’ll probably come back to at the end. So, Jim?

JIM (James Blumenstock)

Great. Jennifer, thank you. Good afternoon, everyone.

I certainly will do my very best to complement the points that Ron made and anticipate the comments that the other panelists will provide and hopefully set you up very nicely.

But before I do, I wanted to reflect on Admiral Lurie’s presentation earlier today where she shared a personal reflection. She disclosed her love for folk music, and I think she did an excellent job, sort of connecting that, to the H1N1 experience in a way or a process to transfer lessons learned to the following generations.

Well, I’m going to follow that lead and disclose something personal with you all as well. I, too, love music, but I’m a country music fan, which is pretty weird for a guy from New Jersey when we were born and raised on Springsteen, Bon Jovi, Frankie Valli, and Frank Sinatra. But there’s the point that I want to get to here.

So, for those of you who have any familiarity with country music, you can appreciate there’s usually four major themes or components that are in any country music song. Number one, the cowboy loses his job. Secondly, his lady leaves him. His pickup truck breaks down, and his dog usually dies.

So what is the connectivity between those four themes and social distancing laws and other types of restrictions of movement?

Well, as you can imagine, the cowboy’s life was turned upside down, and he’s experiencing significant disruption. Well, clearly, in considering the issues of isolation, quarantine, border closings, and other types of restriction of movement, you could only imagine the disruption of society that that would turn into.

So the point here really is that in this topic, where we’re talking about isolation, quarantine, movement restrictions, these are very, very powerful legal public health tools that our profession has. And I believe we were very fortunate that we did not need to use many of them, if any of them, and if so, sort of in a very isolated, modest fashion during the recent H1N1 experience. So because of that, there’s not much material to work with as far as connecting the last six or eight months with a more catastrophic or severe event.

But there are a few that I would sort of like to touch upon.

First, clearly, they are serious actions that can be taken, and they do have some degree of utility and value. But a lot of times, when you talk about isolation, quarantine, and travel restriction, they’re sort of talked about as a suite of mitigative actions. But they really are all very different. They have different triggers, different outcomes, and different ramifications. And I think that’s a point that needs to be accentuated.

Secondly, the key here is I believe that making those decisions probably will be one of the most difficult decisions a public health officer will have to make when they’re in a command-and-control environment managing a response to an infectious disease activity.

When you look at the H1N1 experience – and I want to link two experiences that weren’t specific to this type of community mitigation but I think they’re good illustrations. One is the issue of standardization and consistency and how the public will perceive triggers and decisions that are made across the country.

There are two examples that come to mind. One was the school closings in the spring, and second was the vaccination priority groups and how different jurisdictions at different times were vaccinating different groups. If we thought that that was a significant communications and public relations issue, dealing with those two fairly limited and well-defined issues, you could only imagine the public reaction, questioning of trust, and possibly chaos as if we move forward in a nation that has varying degrees of those triggers for isolation, quarantine, and restriction of movement, including closing of borders.

So as a public health official – and I’m sure the other three panelists will really delve into that as far as the triggers in the real-world examples – the first thing that I would want to make sure [is] that while I know I will need to make those decisions in the future, but the first thing that has to be put in place is I have to have the assurance that I have the legal authority and the capabilities to make those decisions and take those actions.

So I wanted to take this opportunity to share with you what CDC and a lot of the other practice partner associations have done to support decision-makers at a state and local level to ensure that they are capable of at least making the legal decision and having the necessary support should those significant actions take place.

What we have done is we’ve created a legal sufficiency template on all social distancing law legal interventions that a state or a local health official could possibly contemplate in protecting their community. Such things as restriction of movement of persons, inter-jurisdictional coordination, closure of public places, school dismissal, and cancellation of mass gatherings.

So it provided a standardized assessment tool drilling down to no less than 100 features to assess whether or not that jurisdiction has legal sufficiency, to create a table of authorities so that if it has to be referred to in a quick fashion, it’s at their fingertips, and as part of it, it also required a legal consultation meeting between the sectors of public health, law enforcement, and the judiciary to make sure that they were all very familiar with the laws and had a decent playbook to follow should those types of community mitigation legal strategies need to be played out.

Another benefit of this activity was to ensure that the judiciary had a bench book, that they basically were very familiar with these public law legal interventions if in fact it was necessary.

Because as Ron had mentioned, these are not everyday decisions and actions, and whether it be a municipal, county, or state judge, they very rarely have had the opportunity to make any decisions on this. And if it was, it was probably just on an isolated, non-compliant TB patient. And quite frankly, when they talk about quarantine to them, it’s usually a municipal court whose dog owners refuse to follow a public board of health order on quarantining an animal.

So that was clearly a significant learning opportunity to ensure that the judiciary was up to speed on that particular issue. So, tying H1N1 to a more serious infectious disease response.

The four takeaway messages I’d like to share before I turn it over to D.A.

a) RESOURCES

First is the issue of resources.

I counted no less than 14 times this morning reference to the need of a public health infrastructure with significant resources to effectuate an appropriate response. If you all agree that isolation, quarantine, restriction of movement was not really a major feature in H1N1, what would it look like from a resource drain if it was?

The numbers that were shared by Dr. Frieden and others earlier, $1.4 billion could grow to $1.9 billion between now and June to the state and local public health. That funding (unpublished data suggests that that funding alone) can be attributed to 15,000 response jobs, whether they’re full-time, part-time, contract employees, term-limited employees to help support the public health response, all of which won’t exist come July 30th of this year. Again, that surge, throwing money at an emergency. If we had to effectuate these types of community mitigation strategies, what additional resources would that lay on top of that?

Secondly is the issue of community-trusted agents. A lot of examples today about how folks in the community made the difference in reaching hard, disenfranchised, at-risk individuals. We could clearly imagine the level of potential distrust, societal or social justice issues if we were to launch an isolation, quarantine, or restriction of movement activity. Those local agents that could be your best representatives in helping the public understand those types of decisions is critical.

The third is regional coordination. There’s no doubt in my mind that H1N1 further galvanized the ability for jurisdictions to work together in harmony in a regional basis. Many great examples of not only state and local improved coordination, but also state to state, because clearly they built upon each other’s experiences. They basically joined in making command decisions, and certainly with the issue of isolation, quarantine, and restriction of movement, the issue of variance from jurisdiction to jurisdiction, or why one town or state is doing it and why others are not, will be a significant policy and public relations issue.

The last one is an endgame strategy. Whenever you turn something on, you need to know when to turn it off and what’s going to give you those indicators that time is right and the way to do it. As soon as you have a decision point to initiate any one of these mitigation activities, you should immediately start developing your exit strategy or your endgame strategy, because it will be as challenging to demobilize and suspend a decision as it was when you had to make the decision in the first place.

Thank you.

JENNIFER

DA?

DONALD HENDERSON

I think Jim and Ron have given you quite a summary of what is possible to do when you don’t know the agent and you’ve got a mysterious disease here.

But I’ve been in a lot of epidemics over my past 30, 40 years, and they have a remarkable consistency. One is the first thing that happens is a chief politician goes before the public and assures the public that the government is in full control of the problem and don’t worry about it. This is patently false. Everybody knows it.

But he announces then that the government is taking prompt action, and he’s never quite sure what prompt action he could take, so he looks for a border to close, an international border or a state border. In fact, at one time I had to stop our government from closing the border with Canada when Canada had one case of smallpox in 1962, which had passed through the United States, and he developed a rash in Canada, and they wanted to close the border. And we solved the problem because I was able to persuade them that the Canadians would do just about the same as well as maybe they would do in Pennsylvania or Ohio. We wouldn’t close the border there, and they agreed. So I happily called the Canadians and said, “Well, we’ve decided Canada is a 51st state, so we’re taking no action”. And that seemed to make everybody quite happy.

And the third thing that happens, and I’ve had this happen with me on several outbreaks arriving, and the chief health officer has promptly vanished from public sight and leaving it to one of us to fill in and keep the press informed. I think it was here in Washington, as a matter of fact, that the chief health officer liked to play tennis, and we’d have a 7 o’clock meeting, and he was gone for the rest of the day, and we handled it from there on. That, too, was a suspect smallpox importation.

Well, the question is, what could you do? And it is a problem. I guess what one would be inclined to do is to talk to the public and tell them what you know, be honest about it, talk about calling a meeting of hospital people and trying to figure out what we’re going to do about taking care of a lot of people. And then you really want the public to do something, so a harmless thing is to tell them to wash their hands, and if they have a cough, cough into their sleeve.

It doesn’t hurt, and it might be something they could do. And finally, you’d have to look at the question of isolation. And here, I think this would be important. It’s an accepted thing to isolate cases, infectious cases. Well accepted. It’s humanitarian. It makes sense and may mitigate the effects of the epidemic. And in some cases, even mandatory isolation may be necessary. I don’t think that happens very often, although it has in recent years, but we should have the necessary authority to do that.

Well, the question comes up, but what about stopping a disease from entering a country? And I think we’re indebted to Howard Markle and his colleagues who documented the experiences with 1918 influenza and how successful were countries in keeping out the [Spanish] flu. And they were successful. American Samoa never had 1918 flu. They interrupted all travel. I mean, there were no boats allowed to land for about six months, and they missed the 1918 flu.

And there’s another example. I think it’s Gunniston, Colorado, if I remember correctly. They put up a posse, an armed posse, and they had a single road that went up to Gunniston, and the armed posse got there and simply staved off anybody coming up.

Now, somehow or other, that didn’t seem terribly applicable in today’s day, and that was about 1918, so it is different.

FAILURE OF BORDER SCREENINGS EVEN FOR SMALLPOX

Now, in the smallpox program, there was a question, what do we do about screening people? And this was something we were really deeply concerned about with smallpox. And so we went into the records rather thoroughly since about 1945, and there were about just under 50 importations of smallpox that could be well-documented. And the question is, how many might we have intercepted who might have had just fever or rash? And the fact was, none.

So anything we were doing at a border crossing to try to interrupt smallpox coming across the border would have been quite futile. I then had some discussions with our CDC colleagues and the quarantine group down there and thought about this. I thought, you know, as I said to them, CDC investigates a lot of different outbreaks, and many of these you can tell which is the first case and so forth, and it would be interesting to see how many instances we could identify in which that first individual might have been intercepted coming into the country. And I’m still waiting for one example so far.

So I think the point is that this idea that in this day and age, one is going to intercept people coming across the border and you’re going to stop the spread of the disease is a concept that was antiquated a very long time ago. Nevertheless, during the course of this outbreak, I had an argument with one of our colleagues and said, what do we do if we have a 747 about to land in New York and it has – and this was well, I guess, before the H1N1 – and it has a case of H5N1 influenza aboard? What are you going to do? [He said] “We have to isolate them after arriving”.

HUMAN FAILURE OF QUARANTINE

Well, first of all, I didn’t know how many 747s were carrying diagnostic kits aboard and could make that diagnosis in the first place. But then if they did land, then what? Are you going to house these people and quarantine them as a group? Now, here you’re dealing with quarantine. People are perfectly well, and quarantine means housing or isolating those who are perfectly well.

You would have to keep each of them in a separate room because if you’re assuming that one might infect another and therefore if they’re milling around, you’re really condemning everybody else to possibly getting infected. So you’d have to have separate rooms.

So you’ve got one 747 coming in and everybody in separate rooms for a proposed at that time 10-day isolation, and how many planes are going to come in with people with respiratory disease aboard and how many planes are really going to have to be – plane loads of people – isolated in how many rooms? Well, you didn’t want to look for a reservation in New York at a hotel if we really adopted that. [Sanjeev: Henderson anticipated the farcical “hotel quarantine” of Melbourne in 2020] But that seriously was being discussed as recently as even the H1N1. So I think there are concerns here that we really have to be quite clear, and I think there’s a tendency to overreact and not to realize what the problems are.  [Sanjeev:  Correct. THE PROBLEM OF HUMAN FACTORS IS COMPLETELY IGNORED BY PUBLIC HEALTH]

And then go on, lastly, finally, to quarantine. That, of course, goes back hundreds of years, and quarantine was really quite effective in times when we had yellow fever, in times, let’s say, in the 19th century, even into the 20th century. Smallpox was virtually kept out of Australia because of being able to block ships coming in. [Sanjeev: Henderson is COMPLETELY WRONG HERE!]

So far as further elements of quarantine, the question is, what do we do? Now, in the smallpox program, we looked at this, and what we found very quickly was that if you tried to quarantine whole families, you quickly found that people were hiding cases. You immediately, everywhere you went, they hid the cases because they didn’t want to be in quarantine. If you’re going to take them away to a quarantine camp, they certainly didn’t want that. So you quickly lost all control of the outbreak very quickly.

And I think this is what we could anticipate at this time if we were to think in terms seriously of quarantine as an element. So we’re really looking at the question of, yes, isolation of patients, but quarantine I have trouble with.

And I’ve tried to look at the situation not too long ago as we were thinking about this. When in the last 50 years have we really used quarantine, and it was effective? Well, Toronto provided us the great experience here in trying to quarantine what they did in regard to SARS, and talking with the chief health officer, I think at that time, mit was an absolute nightare. And, in fact, one of the chief physicians in the hospital who felt he played a key role, and he was talking to me, and he said there was one day when he had a slight fever and he coughed, and I said, what did you do? He said, “I was too critical. I couldn’t be quarantined. I was isolated at this point. I had to work.”

And so I think the concept of quarantine is something that, I would say at this point in time, this was prevalent in the 20th century and probably sort of faded around 1950, 60 in terms of significance. I’m a little surprised we have a unit actually still at CDC or newly formed at CDC on quarantine, which I don’t really see where we’re using it, and I don’t see the utility of it at this point in time as little as I see the utility of blocking borders. So I think we’ve learned something about epidemiology and microbiology over recent years, and I think we need to apply these intelligently and not revert to earlier times when we didn’t understand the spread of disease.

So with that, let me conclude.

JENNIFER

Jeff?

JEFF (Jeffrey Levi)

Well, I think my colleagues have done a good job of sort of successfully destroying any suggestion of using some of these measures. But I think in any situation we’re going to need to come up with some sort of response and probably we’ll come up with some sort of recommendations around social distancing of some kind.

And so it may not be quarantine, it may not be closing the borders, but part of it is policymakers aren’t going to want to be able to say we’re doing something, and part of it is because there may be instances where it makes sense. So rather than talking about specific measures, what I’d like to talk about is what needs to be in place before the event happens. So how are we going to, in any of these situations, whether relatively minimal or very stringent, these will only work if we have the cooperation of the public. We don’t have enough law enforcement officials to make these things happen unless there’s some level of compliance, voluntary compliance.

And so what are the things that we need to have in place or have done in advance? I think there are a number of things. First, and some of this is going to be very obvious, but first is we do have to communicate and engage and educate the public about what the risks may be and what the interventions are, why they might work, why they might not work.

The public is far more educable if you truly engage them rather than lecture to them, is truly can be reached if there is good community engagement. We saw that, I think, with the vaccine prioritization. We heard that earlier today about, in some instances, the public was in the right place before handed down public health wisdom was able to reach where the public was in terms of prioritization. So I think with the right effort, the public can understand this kind of complexity.

And I think we want them to understand this complexity for two reasons. It can cut really in both ways. We don’t want them to be so afraid that they demand some kind of action. Don’t just sit there and do something, even if that action is unwarranted. Or when it is time to do something, we don’t want them to be resisting that simply because they don’t understand it, because we ultimately will need voluntary compliance.

The second thing is, to be very blunt, the faces and the voices communicating about these issues have to look different than they do on this panel. We need to make sure that there is true community involvement and that every part of our very diverse country is being heard and understands and that we are giving meaningful leadership roles to everyone.

And finally, the term that we all throw around but don’t spend a whole lot of time defining how we’re going to go about building, is we need community resilience, so that people can actually comply with what we ask them to do, because if we don’t give them that capacity, they won’t do it regardless of the law.

We heard some of that today. The most obvious is the one about sick leave. And we actually have some good anecdotes, if not fully documented evidence, of people with H1N1 going to work, even though they knew they shouldn’t, because they had no choice. [Sanjeev: This is just one of the infinity of human factors] They had no sick leave. We are the only developed country that does not mandate sick leave for employees.

We also need to make meaningful the steps that we ask people to do, whether it’s stockpile food, stockpile supplies. Government hasn’t issued an extra 20% of a food stamp allocation once a year for people to replenish their stockpiles of whatever food and water they’re supposed to be keeping on hand, assuming they have a place to do it. If you live in a New York apartment, your apartment is about as big as this table. Where are you stockpiling your food and resources? It can be a practical issue.

But we also need to think about if we’re going to ask people to stay home when they are sick and not go to the grocery store when they run out of diapers or go to the ATM, then we need to provide the social support services that can provide those services and that kind of support. [Sanjeev: RIDICULOUS SUGGESTION:  the devil is in the detail] Those things aren’t cheap to do, but those are quite practical.

I think probably the more important thing is that we need to be establishing the credibility of public health in working with everyone and in showing and demonstrating concern about people’s health throughout the year at all times, not just in response to an emergency.

That’s where I think we fall into a little trap in setting up this competition, for example, between fighting chronic diseases and preparedness, or any kind of public health intervention and preparedness. We’ve come to recognize in the chronic disease world, and I’m hoping soon, and also in the traditional infectious disease world, that community prevention is an important thing, and building stronger communities and dealing with structural impediments to people making healthy choices, getting a better understanding of why people take risks and what we can do to mitigate that risk-taking. If we do that well throughout the year or in the normal course of activities, then we will have, (A), established good relationships with folks, and (B), made them healthier and stronger to begin with, to have their own capacity to respond to these challenges. So if we think about reducing risk throughout our life, then it crosses from preparedness for emergencies all the way to whether I exercise or eat well.

The other part of preparedness is preparing policymakers, preparing those politicians who want to be able to get up and say, I’m doing something, I’m responding. I actually found Rich Besser’s story about Rahm Emanuel sitting in a corner wanting to rewrite the guidelines, in some respects reassuring, because it’s important for public health not to be questioned, not to be challenged, and not for us to assume that just because this is the perceived wisdom and the conclusion of our evidence-based analysis within the closed world of public health, that that’s necessarily the right answer. We have too many examples of public health being wrong to be that arrogant and to be challenged, but challenged in an appropriate way, because that story ended the right way. So there was a challenge, there was a pullback from the political folks in saying, oh yeah, well we’re not completely interfering, but you really need to think about it this way. And ultimately, the reality, ultimately the public health guidance reflecting the reality that the political people were articulating to them.

That interaction is incredibly important, but for that interaction to work well, there has to be a good, established, ongoing relationship between the political people and the public health policy people, because that relationship, when you’re trying to make these very difficult decisions, you can’t just be introducing yourselves to one another. Now, that was one of the challenges of responding to H1N1 in the middle of a transition, but I would argue that some of the key people who were involved in that transition were people who were coming back, who actually had long-term relationships with some of the public health officials, and that was a good thing about what we experienced in the transition.

Finally, whatever is decided, there needs to be consistency across the country, and I think Jim spoke to some of that, but others have spoken to it today. Yes, we are a diverse country with very diverse capacities and approaches in local health departments, but as someone who lives here in Washington, D.C., where you have the D.C. Health Department, Prince George’s County, Montgomery County, Arlington, Alexandria, all surrounding us, and each jurisdiction managed to take the same prioritization list for H1N1 vaccines and implement them differently. And so people who were not able – I know of cases of people who somehow didn’t make it into that first tier in D.C., – walked over to Prince, or drove over to Prince George’s County and got their vaccine, and vice versa. And there was no coordinated mechanism among the metropolitan governments, even though there is allegedly a coordinating mechanism, to articulate either why they are different or try to resolve those differences.

And each decision was individually justifiable, but it created incredible confusion among the public, and we need to make sure that we are a good deal more consistent. The more extreme the measures we take, the more consistent they have to be, because otherwise it will be even more undermining and evasion, and ultimately it will be ineffective.

Thank you. [Sanjeev: I FOUND THIS TO BE ENTIRELY NONSENSICAL, since he didn’t even try to address the points raised by Henderson. We are NOT interested in implementing something that will fail, and cause harm]

JENNIFER

Marcy?

MARCY (Marcelle Layton)

Thanks. I guess I have the privilege or challenge of being the last speaker on the last panel.

And I just was reflecting, listening to D.A. talk, that the last time I followed D.A. was, I think, back in 1998 at the first International Conference of Emerging Infectious Diseases, when he gave his first keynote address on bioterrorism. And I probably stupidly agreed to be on a panel to talk about the local capacity to respond to bioterrorism that became a headline story in New York City. I think I gave a Rich Besser-like honest assessment of what our capabilities were and almost got fired. For better or for worse, I guess I survived that. Hopefully it won’t be so challenging today.

Anyway, I decided to focus my remarks on quarantine, which, to be honest, is probably one of the more difficult issues that I’ve been involved in numerous discussions, both in New York City and at national meetings over the years, about if and if so when to consider using quarantine as an outbreak control measure.

QUARANTINE

And I think, you know, from a purely scientific perspective or theoretical perspective, it almost sounds like there’s no question. It seems obvious that if you have people who’ve been exposed to a life-threatening contagious illness, especially one that you don’t have any countermeasures for, that you should separate them until they develop illness, in which case you would isolate them, or if they remain asymptomatic through the incubation period, it’s okay to let them go.

So on the surface it seems obvious, but obviously, as everyone else has alluded to, to actually put this in place is much harder. The practicalities of doing this in a place like New York City, I can just amplify on all the comments that have been said. The logistics of housing, feeding, monitoring, and otherwise caring for people, whether they’re at home or in a quarantine facility, and all the unintended consequences, personal, social, political, and economic.  So in New York City, you know, we recognize that it’s probably a very rare scenario. I can probably think of one or two examples where we might implement it and where containment we actually think is possible. We don’t want to do it unless we think it actually is going to succeed.

We’ve done a number of things in New York City to prepare for it. Just to give you some examples, as I think Jim said, we actually did critically look at our existing public health laws about, I want to say almost ten years ago, and looked at what we needed to strengthen to give ourselves both the authority and the flexibility to implement both isolation, but as importantly quarantine, if we thought they were needed. And the criteria that we’ve established for when we would implement a larger scale quarantine include a number of factors.

One, obviously, like the scenario that it was a potentially contagious disease that may pose an imminent and significant threat to the public health with significant morbidity and obviously high mortality. It has to be a disease that’s not already out there in New York City circulating in the general population. We have to think that if we implement quarantine, that there’s the possibility of either preventing introduction or delaying the introduction and community transmission in the city. [Sanjeev: THESE STUPID PEOPLE HAVE NO THEORY OF CONTAGION/ ISOLATION – and just because a disease might lead to significant mortality doesn’t mean any thing about whether isolation is suitable, let alone quarantine. See my TOI piece and PH textbook]

And then most importantly, we need to convince ourselves that less restrictive measures aren’t potentially viable or effective alternatives to preventing or delaying the spread of the disease among the city’s population.

Small scale quarantine in New York

In addition to strengthening our laws, we’ve actually done some real logistical operational planning about where we would put people. We’ve actually funded two New York City hospitals to develop quarantine facilities for a smaller scale event, and we’ve done a lot of work with the staff there to plan for and exercise the medical, social, psychological, and basic support needs that we would need to put in place if we had to activate either or both of these units.

And then we’ve done a lot of planning on these bigger picture issues, both policy, legal, and operational, of how we would do a larger scale quarantine, whether it’s the voluntary home quarantine that was done in Toronto or a more restrictive quarantine in a dedicated facility.  Our decisions on whether we would implement quarantine would obviously need to be based on, first off, science, the clinical and epidemiologic characteristics of the disease, if they’re known, and the sort of things we would weigh in, or whether people are contagious prior to or early on after illness onset. Obviously, if they’re contagious while they’re asymptomatic, it’s almost impossible for quarantine to be effective. [Sanjeev: Here she’s getting more sensible]

How effectively the disease is transmitted, the route of transmission and the efficacy of that, the length of the incubation period, and how extensively the disease is spread, both worldwide and in the United States, at the time the first cases or contacts are detected in New York City.

And obviously, all of these factors would be really difficult to determine if it’s a new disease that has just emerged, whether it’s elsewhere or in New York City.

That’s really what we faced in the spring when very little was known yet about H1N1. And I’ve been struck by how long it takes and how hard it is to determine those factors in close to real time. I think for SARS, it took a very long time for us to fully understand incubation period and generation time and secondary attack rates, and the same was true for H1N1.

The other issue is, obviously, we don’t want to do it unless we think we can do it successfully, so all the capacity and resource issues that would need to be in place, especially for an involuntary quarantine, we would need to be able to enforce it with our law enforcement partners as well as afford the due process rights of those that we’re detaining and promote their safety, well-being, and compliance.

In New York City, we actually did not need, fortunately, to implement quarantine for any event that I’ve been involved in during the SARS outbreak in 2003. We only focused on isolating cases and actively monitoring their contacts, but not restricting their movement. None of our suspect cases ended up being confirmed, so whether that would have been successful if we had true cases, obviously, it’s hard to say.

And in the spring of 2009, when we were one of the first, as Tom Frieden said earlier today, and definitely for the spring, more severely impacted cities during the initial wave of the H1N1 pandemic, we again focused on isolating ill cases, either voluntarily at home or using infection control precautions in the hospital, but we never considered quarantine given what we knew about the epidemiology of influenza.

We made the assumption, and I think it was mostly borne out by later studies, that the spread of flu, H1N1, would be similar to what we knew about influenza in general, and also given that it was clear even by the time we detected the school outbreak in New York City that we were hearing about sporadic cases elsewhere in the U.S. and eventually in the world, so we knew we wouldn’t be able to contain it, so similar to what Rich Besser said earlier. [Sanjeev: this is an important para which suggestst that there were sensible people in USA during the swine flu. Maybe the term “flu” was helpful. But the fact that they realised they couldn’t contain it, was a crucial scientific insight]

My last point was going to echo what Jeff just said about the importance of public engagement, that even if we ever did face a situation where we decided we want to implement quarantine, it’s only going to be as effective as we can gain the public and community and political leaders’ cooperation in our doing so, and that will really require explaining why and how we are planning to implement quarantine and quarantine measures and getting their acceptance and cooperation.

JENNIFER

Great. Thank you. Well, we had a number of strong opinions on this panel, so I’m wondering if any of the panelists want to respond to anything that’s been said.

Q&A FROM PANEL

RON

A comment, a small argument with DA, and a question for Jim.

A comment. Intercepting disease at the border, just to let you know, there were five SARS cases in Toronto that were international travelers. None could have been detected at the border. They all were asymptomatic when they came. They all got sick in Canada, so I also don’t think you can intercept disease at the border.

The little argument with DA, and it’s about the need for a quarantine service. I grudgingly got to the point where I thought, yeah, Canada needed to have a quarantine service, and the reasons were twofold.

First of all, some of you may remember in 1995 there was a pneumonic plague outbreak in the city of Surat in India. I happened to be sitting in my office with a television set, watching CNN broadcast pictures of Indians fleeing the city of Surat, and I thought, well, isn’t that interesting? And, of course, that’s a long way from Ottawa. One hour later I got a call from Toronto Pearson Airport.

It said, Dr. St. John, there’s an Air India flight arriving nonstop from New Delhi, not Surat, New Delhi, and it’ll be arriving here in about three hours, and everybody at the Toronto Pearson Airport is going to walk off the job because they think there might be plague on the plane. There are 30,000 people that work at Toronto Pearson Airport. It was not trivial, and the person said, do something.

At that time, Canada had effectively dismantled its quarantine service, and there were four quarantine officers all in Ottawa for the whole country who hadn’t responded to anything in about 10 years. I sent one of them on a plane to get to Toronto before the Air India flight. He got there 20 minutes before the Air India flight, and that big 747 parked not up to the ramp, but just not quite there.

And he was the one that went out and climbed a ladder, opened the big bay, looked inside and said, there are no rats and no fleas in here. It’s okay. That is a true story, but it was a wake-up call.

And it was a wake-up call that you need somebody who will make people feel comfortable when they all know that now disease is traveling by airplanes. And so we rebuilt a quarantine service, minimal, small, relatively small, in the six international airports, big international airports we have. And it’s their presence that makes everybody happy.

Not that they’re stopping disease. Once a week, about once a week, one of them boards a plane because the captain has read it ahead and said there’s somebody sick on the plane who drank too much. But the fact that there’s somebody there that is an authority and knows something about health and public health and infectious disease can go on that airplane, everybody is really happy.

And the only other argument in favor of it, but that is important. The presence is important. The only other argument is if you’re going to have a law about quarantine, then you should have an enforcing agent. Because if you did need, if there was no quarantine officer and you did need to stop somebody for whatever reason, there’d be nobody there to enforce it. So I grudgingly had to admit that we needed a quarantine service. [Sanjeev: These are good points, but the main reason you need a quarantine service is that you need people whose whole life is about studying quarantine and who can explain to the public about how it DOESN’T WORK.]

And finally, the question for Jim.

Jim, how long do you think it took for me to discontinue thermal scanning after the last case of SARS in the world was reported?

JIM
Probably longer than you wanted it to take.

RON

It took six months before I could convince the minister to stop thermal scanning. And why, she said, we need the public’s trust that we’re doing something. [Sanjeev: THIS IS WHERE PANIC COMES INTO POLICY MAKING, and it is crucially important to educate the public IN ADVANCE why these measures can’t work]

JIM

If I could just add to it, and I know Jeff and others touched upon it, and it was raised several times today, is the whole issue of trying to reconcile the issue of national consistency and standardization with sort of the tenet that local conditions drive local decisions. And I don’t have a magic fix to that other than to say, over time I think the delta is getting smaller, but it still exists. So the issue here is when, for all good reasons, it happens, how best to convey that message so that the public and the policymakers and anybody who has the potential to be a second guesser can appreciate and possibly respect or at least tolerate that type of circumstances.

That being said, I think even when we’ve done the interim in-progress reviews for H1N1, the state and local public health community has verbalized that maybe we should have been a little bit more prescriptive in the way we would do things. Again, not encouraging the U.S. government to dictate the public health response, but maybe being more willing to accept stronger, more forceful guidance and direction. So that was sort of a retrospective from the state and local public health perspective.

Not that anyone is willing to surrender local home rule or local authority or also realizing that at a local level there’s a lot of influencing factors that go into decision-making, but I think overall it is much, much better in my career – as far as an honest and sincere effort – to basically have as much consistency and conformity as possible.

JENNIFER

I’d like to actually follow up on that point. We’ve heard about it all day long.

We hear this tension between wanting consistency and also wanting flexibility at the local level.

JIM

And there’s a sweet spot somewhere in there that we just haven’t found it yet.

JENNIFER

So I’m going to push the panelists a little bit, and I’m going to suspend you temporarily from your duties as state health officers to ask the question, who should be making decisions? At what level in the government should we be making decisions about using these measures? Because clearly the actions taken by one state could affect the trade and travel of another state.

So who should be making these decisions? Where should the decision-making happen? And then also, given what we heard earlier today about it’s both a scientific and yet also a political decision, where does that, you know, who has the authority? I mean, we understand who has the legal authority, potentially, maybe not as clear, but who has the legal authority to make decisions. But where should that decision-making happen? And do we have the right process for that? So I’ll ask any panelists that would like to respond. Hopefully someone will give us an answer.

JEFF

I don’t have an answer, but I think I want to tell a story about why it can be so important. And it’s not just consistent between the federal level and the state level, but also within the federal government. The second worst hearing of my – congressional hearing of my life – first was involved with Strom Thurmond, and it was many years ago, was a very recent one on H1N1 that was essentially taking TSA to task, Transportation Security Administration, for not, quote, protecting inspectors at the airports.

And what it all really came down to was at some airports, people were being told that they should wear gloves and masks, and others they were forbidden from wearing gloves or masks. And there was not, there didn’t appear to be a consistent way within the federal government for there to be a clear communication about what sort of protection should be taken and what should not. And so when you have that kind of, so you had CDC saying one thing, DHS as an agency saying another, TSA as part of DHS saying a third, and then it being implemented a fourth way, well, forget the state and local thing, this is a real problem.

And created this real opening for a member of Congress to, you know, to demagogue the issue, and essentially say no one knows what they’re doing, you don’t care about the workers. So I’m just saying it’s important for someone to decide. And I think it ultimately needs, you know, I would argue that these sorts of things, there needs to be a single standard and it needs to come out of HHS, it needs to be a public health position.

MARCY

Thank you. I’ll grab it, I’m not sure why. I think it really depends on what the decision is.

There’s no one answer to that question. I think things like interstate travel or obviously international travel that relies at the federal level, I think when you, I mean, I think it’s important to realize, especially for a new disease that’s emerging where you don’t really understand everything yet. And I can’t emphasize enough how long it takes to get enough information to truly understand it, that it’s really hard for anyone to come up with a clear decision that makes sense for everyone to stick with no matter what.

And I think there does need to be some flexibility. And I thought the way that Rich presented how they acknowledged it around school closures is that these are our guidance, they were guidances, and that different places will need to implement them differently or may decide to implement them differently based on their local circumstances. There are some decisions where that makes sense, there are others where it doesn’t. [Sanjeev: THIS WOMAN IS DEEPLY CONFUSED – that’s because there is no standard science in PH, everyone cooks up their own “science”. This is a priesthood, not a scientific profession. How does this kind of GOBBLEDYGOOK solve the problem of some TSA agents wearing masks and others not? There is a SCIENCE behind this and that’s what this CONFUSED WOMAN doesn’t understand. ]

So I think it really depends on what issue is being decided, and both the regulatory issue and how much data there is to make that decision, and if there isn’t much, acknowledging the flexibility that may be needed to implement it.

JIM

Just to add quickly, a lot of this, all of this discussion has been on a governmental agency making a decision to do something. But there’s another dimension to that, and that’s sort of the spontaneous decision or action of a citizen, a business, a school, to take their own action, even if it’s sort of in a very authoritative sense, and having a local official reverse that because it wasn’t consistent with the agency’s policy and practice and it was unwarranted. [Sanjeev: this is why there needs to be widespread understanding of the actual science in the community. Currently, PH textbooks are a dog’s breakfast – or worse: recipes for mass murder]

And that itself has a whole suite of complications and public relations issues too, so we can’t lose sight of that.

RON

Just to share some of the idiosyncrasies of Canada, it’s pretty clear that these measures, travel advisories, quarantine, all this kind of stuff, for anything at the border is a federal decision. Anything within a province is a provincial decision, and nobody has any authority between provinces. So if you wish to move or move yourself from Manitoba to Ontario, nobody has any authority to stop or impede or do anything.

DONALD

Well, effectively, this is true, I think, for the United States too. There are state authorities here who prevail over a lot of different things.

But I think, in fact, what we’re looking for is, and the way things generally work, is an authoritative site which gains sufficient in the way of recognition that what they’re advising and what have you are generally accepted as a result of that. And there are various advisory committees feeding into it. Much of what we do in immunization practice goes through the advisory committee in immunization practice.

But that’s an advisory committee. It is not making a decision. It is an advisory committee to the secretary.

So that I think it’s kind of a muddy area, but I think you muddle through. And trying to draw, I think, strict lines here, you get into trouble with it, I think. [Sanjeev: This is weird stuff, coming from Donald. The focus of PH should be to document and disseminate the actual science, not to further muddle the already muddled situation]

JENNIFER

We heard throughout the day that states, and I think, Jim, you spoke to this, that more specific guidance was a number of states and localities wanted it.

But then on this point again about the flexibility of where decisions get made, you can imagine the folks in the federal government possibly feel like that’s a bit of a catch-22. So I guess if you were to give them advice regarding the kinds of guidance that you’re looking for, what would it be? I mean, we have an opportunity now in the inter-pandemic period or at least this relative quiet to try to figure out what to do next time.

JIM

Yeah. Well, I guess, you know, my takeaways on this was, number one, overall the quality of guidance from the federal government was outstanding to state and local practitioners and extremely helpful. That’s a fact. Number two, in large part, the U.S. government was very respectful of local and state decision-making, home rule, and that whole issue of local conditions.

So where does that leave us? The issue of maybe shrinking the four corners a little bit more on the range of guidances and options is one possible, or maybe being a little bit more directive or forceful in nudging decision-making in one direction without mandating it. I mean, those are other techniques and strategies without sort of violating those tenets. But I think the key here is that there is general recognition that there should have been a little bit more consistency in a national response.

And the issue now is for individuals to figure out how, through an after-action process, to answer your question, how to get to that point. And I personally don’t know the magic to that other than the recognition that people feel that we would definitely be in a better place if we were in that situation.

DONALD

I think in recent years, and watching it evolve, that HHS has been issuing consistently advice, I now see DHS sort of intruding with advice in various ways. I won’t comment on it. Some of this is contradictory.

I think where I’m a little concerned, and I think a number of us are, that, for example, we don’t have anyone from medicine or public health in the Office of Science and Technology Policy or in the higher levels of government in the White House.

I mean, this has been a very dearth of people with a public health background who understand many of the issues. And, in fact, this has been true, I think through the Clinton administration, it was scarce. And, certainly, I think it’s not been improved.

We did have, I think, in public medicine and public health, I think more in the way of input into Bush I, and the Office of Science and Technology Policy was playing a fairly prominent role. But that office is up and down, and various other offices are kind of up and down depending on the president. And, at this point in time, I think we’ve got a dearth of public health and medical experience at the highest levels of government, and I would hope we’d see that change.

In fact, we don’t have, we have an office for international health in the Department of Health and Human Services. That job hasn’t been filled yet. No one has been nominated, to the best of my knowledge.

JEFF

I guess the thought that I want to add is – I mean, I agree that there isn’t a cut-and-dried answer as to should it be the federal government setting all the standards and locals just follow, and, obviously, things have to be adapted to the local level.

But I also think that we have not addressed, and need to, the tremendous varied capacity of local health departments across the country. With almost 3,000 local health departments, there is no consistency.

If every local health department were like New York City, I’d have no problem with leaving those decisions at the local level. But we are leaving a lot of people essentially poorly protected because we have such a variety of capacity, and we have not figured out a way to address that.

We give out a lot of money to state and local health departments. It may not be enough, Jim, but we do give a lot. And it’s very hard, but that has been money that has not been attached to setting a minimum standard of capacity. That needs to be achieved, and we actually don’t give the money out based on how much additional capacity people need to develop. [Sanjeev: WHAT IS THIS MINIMUM STANDARD OF CAPACITY? No one has a clear understanding of the actual science, and everyone is running around like headless chooks. Fauci was not an exception but the rule. Constantly flipping from one to another position, not following his own advice, etc. THAT is the real problem with PH – the complete absence of a SCIENTIFIC UNDERSTANDING OF CONTAGION]

If we’re going to give a lot of discretion to local health departments, then we need to make sure that they have the knowledge and the resources to actually exercise that discretion.

JENNIFER

At this point, if folks want to come up to the microphone to ask questions, you’re welcome to do so. I’m going to continue with the panelists.

Marcia, you articulated some of the key points. Very specific information that goes into making decisions about which measures to use. You also acknowledge that decisions have to be made in the face of uncertainty. We’ve heard throughout the day about how it was excellent to maintain flexibility during H1N1, particularly as the situation evolved.

I guess, have we put into place since H1N1, or is there an ongoing effort in your mind, adequate to try to address, get a better handle on information earlier? Are we putting systems into place that can try to close the gaps in terms of the information we need to make critical decisions?

MARCY

I think many of us, as we were planning for how we would respond during a pandemic – there’s no question local and state health departments were planning for, and probably some easier than others – put in systems to count cases. We count hospitalized cases mostly, and we count deaths, and we can estimate milder infections.

There were two critical issues that struck me when I went back and looked at our 2006 pandemic plan, several weeks into the spring outbreak, that I really hadn’t thought about.

One is I thought I’d have more warning, and unfortunately, I didn’t have that.

The other is how hard it was. The decisions about community measures were always going to be based on severity of illness. As somebody else alluded to, Mexico initially, I was on a conference call with CDC that Thursday before we recognized our school outbreak the next day on Friday, when I first heard about Mexico, but it was a rumor. It wasn’t confirmed yet. It was confirmed actually the next morning that I heard it was the same virus as those several cases in California. To me, that was, oh no, this is a potential pandemic, and I had an outbreak of what sounded like fever and sore throat and flu-like illness literally the same day that morning that I heard about it.

In Mexico, initially, it was supposedly very severe, and I think it’s because you’re looking at the tip of the iceberg. Something that really struck us in the midst of – unlike SARS, where I got to watch it from afar and be frustrated by the fact that there’s all this data being collected, and I wasn’t privy to it or the details of it, it takes weeks or months for it to become published – I was in that same position in some ways in the spring, so we really tried to prioritize what are the things we need to know to estimate things we hadn’t really thought about in retrospect getting in near real time. Things like case fatality rate requires knowing how many people were infected, and though it’s relatively easy to count 1,000 or so hospitalizations, it’s really hard to estimate the number of infected, especially for a disease like influenza.

And then transmission factors. We were lucky that the initial outbreak in New York City occurred in a relatively contained environment of this school, so we did prioritize very quickly doing some epi studies at that school, but it took time for that data to be available to analyze even as quickly as we did it. We made some estimates early on that, to be honest, ended up being good estimates based on some quick surveys that we did with the school. So I think in retrospect what I hope to have engaged the CDC influenza folks in as things are calming down and we have time to think is let’s think about what we need to put in place to answer these sort of questions quickly the next time: So how severe is it and how easily is it spread? Because those two factors are the two factors I’m going to weigh in, or not I, but I’ll be advising leadership as far as how restrictive we should be with community measures.

RON

Marcy, a question about that. Counting the cases is one thing. I think we find that rather easier to do. But then you also have the question of the contacts of the cases. And that can quickly mushroom, as you know, into large numbers. And that requires personnel to go out and find them, talk to them, all that kind of stuff. How did you manage, did you find problems with recruiting enough people to start to pursue that investigation out to the fringes?

MARCY

Again, I think something I hadn’t thought as clearly about when I wrote the surveillance section of our pandemic plan that we had to think about at the time and then for the fall was we don’t need to count every case. We almost get caught up in the media gets caught up in how many cases, how many deaths. The things that I needed to know were how severe it was and how is it spreading. And you can do that in a more focused way if you’re not expending resources trying to contact or find every case. We never attempted to identify and track every contact in the spring.

We knew, you know, for the same reason we never thought about implementing quarantine. We had thought about how we might do that for smallpox because of the concern about needing to not just find them but vaccinate them in the event that we were able to contain a small intentional introduction into the city. I mean, that is probably the one scenario where we would consider a strict quarantine if it was introduced in small numbers intentionally and we had the chance to contain it.

So, you know, I think the strategy is really thinking through, you know, what is the information you need to know and what is the most efficient way to get it? You know, in the spring we did count every hospitalized case, but we also and we tried very actively to count every death working very closely with our medical examiner’s office and we estimated infection rates by very quickly putting in place these population-based surveys. And then at the school we did a focused epi study to look at transmission factors, again, because we were lucky in that that’s the setting that the outbreak emerged in. So we were able to do it.

And, you know, we thought about for the fall the need to recognize if the virus changed, but I didn’t feel as responsible for being the one, you know, by the time the fall came around, you know, there were many opportunities for many people to be looking at changes in the virus. But thinking through how the place where it’s first recognized or one of the first places that it’s recognized, how important it is to find a way to collect that information quickly. And we tried to get that information up quickly on our web and through our alert systems, you know, and we’re still struggling to publish what we did, but most of the information that we found we got out as quickly as we could both in forums like this and through the web.

General audience Q&A

JENNIFER

Eric?

ERIC

Yeah, this week is the seventh anniversary of the eruption of SARS out of China. And so the recognition of the lack of utility of the kinds of things that we’ve been discussing, quarantine, travel restrictions, were pretty clear not only in Canada but in Hong Kong and elsewhere. And there’s great agreement among the panel that these measures are of limited utility at best.

So why during the pandemic did such advanced countries as China, Great Britain, Mexico, and others implement travel screening, travel restrictions, and quarantine? Is it just public health responding to political pressure? And if so, is that right?

RON

In Argentina, for that winter epidemic that they had last summer, they had a scientific advisory committee for the Minister of Health and the President. The scientific advisory committee recommended against any quarantine, against stopping flights, basically said, let’s prepare, it’s going to come. They were overruled by the highest political level, and orders were issued to stop the flights. And a military hospital was sent to the airport and a few other silly things.

I go back to some of the SARS experience in which the public, the political level, the political leadership felt enormous pressure to be seen as being proactive and be, quote unquote, doing something. And what are the available tools? Well, there are only about five or six. So, you know, do something.

And I think that is the primary pressure. That they’re under.

DONALD HENDERSON

Yeah, I would agree with this. I think the political pressure is there. And as an official, you want to respond and tell the public we’re doing something to mitigate this or do something positive. And it’s pretty hard to identify what is going to make a difference.

I think in the folders is the 1957 epidemic, which I lived through as head of the influenza surveillance unit for the time, as a matter of fact. And we were grasping at straws trying to figure out what did we do. And the one thing we found as a measure, one of the most best ones we had was actually elementary school absenteeism. That went up first, and you could pick that up quickly at various places. But then that would tell us where it was, but how many cases there were, goodness knows. Fortunately, at that time, we weren’t pressed to have a number. And I think one of the problems that we did get very much absorbed with was how many confirmed cases do we have. And this, I think, just the publicity of it, getting a count, getting the number of deaths, is a problem. And I didn’t really have a very good alternative during the time. But if we’d been pressed back in 1957, I have no idea what we’d do to come up with a number. It would be just purely a guess.

So we were using basically very crude data and surveys and what have you. But I don’t know what you do, actually, in terms of what do you do to assure the public you’re doing something. And what is it you decide?

And I would note in Asia, it’s very common to put on face masks, as you may know. I mean, it’s certainly very common, which is something you could do. And did we recommend face masks? Well, we chose not to recommend face masks. And I think the feeling is they wouldn’t make very much difference.

But if we then look to the data we have on hand washing and what difference does that make and how good is our data on that, frankly, it’s not very good.

And what does it do when you’re stifling your sneeze in your sleeve? You think it would do some good. I mean, intuitively it would make sense, but does it? And how much do we mitigate by isolating the patients and what way and for how long? This is a very hard disease, I think, to get quantitative data. And we looked at this in every possible way trying to get studies that we could quantitate things. And in 1957 we did do a huge study in Louisiana, the earliest cases. And this was a detailed survey and serologic studies were done. And we got a lot of data, but it doesn’t help you in many of the other places.

So this is a very nasty disease to deal with.

With smallpox, we knew when a smallpox case was there. They had a big, beautiful rash on every case and had no trouble. It was an epidemiologist’s dream. But with influenza, you don’t really have that.

JENNIFER

Monica.

MONICA

This is for Jim and Marcy. There’s been a theme today that an informed and involved citizenry is a critical asset in managing any epidemic. But to follow up something that Jeff brought up, I mean, what capacity exists at the state and local level to effectively interact with the public so that they trust us when we say, you know, it’s going to be disruptive, but the social distancing is a value to you? You know, this countermeasure is new, but we think it’s what is going to be what is necessary now. And then what can the Feds do to improve that capacity?

JIM

Sure. I mean, in general terms, I think certainly in the last year or so, we have made significant progress in cultivating better relationships with community organizations, grassroots, faith-based organizations, those that really represent the best interests of those at risk, vulnerable, and in many cases disenfranchised. It doesn’t mean that we have a perfect or a full relationship, but I think clearly H1N1 has brought us to a higher or better place in that regard. I believe Dr. Frieden said earlier today that probably in general populations, we did a much better job than we did in some of the possibly minority sectors, and there are still significant legacy concerns and issues that we need to overcome.

But, I mean, I think that’s clearly a focal point of state and local public health going forward, where we really need to invest our time and efforts on, because that is what’s going to make the difference at the end of the day.

MARCY

I’ll just echo that, that it’s not just talking to the public through the media, it’s actually trying to engage them directly in many different ways, both local political leadership as well as community groups, faith-based groups, et cetera.

And I think something that was eye-opening to me, there was a project that we got funded for by CDC to look at how we do essential medical services during a pandemic that had been funded for several years, and we were finishing it up. And the last thing that we were doing with that group was around risk communication issues, around how we would address some of the challenging issues around limited scarce resources, et cetera. And we used some of those focus groups to actually look at how the messages we were getting out in New York City at the time were being received by specific vulnerable groups, whether they were geriatrics, an immigrant community, health care workers, et cetera, and messages that, to me, seemed clear. The focus groups were coming back and telling us, that’s not what we’re hearing from you.

So I think, you know, it’s a constant learning about, you know, just because we think that we’re saying something, you know, that is at an appropriate level of language and appropriate simplicity and focusing on trying to get our message out clearly is not necessarily how it’s being heard. And the importance of, you know, ideally doing it ahead of time, I think that’s easier said than done for some of these issues. But at least at the time of the emergency, to have that be part of the effort in the communication strategy to sort of, with everything that we’re doing, somebody should be saying, you know, is this the best way to do it? What isn’t getting through? How can we do this better? Both by bringing community leaders in as well as directly engaging.

JIM

You know, if I could just add to it, several times today the reference to public engagement or community engagement was used, and that’s used in two different ways. One is sort of a broad, generic phrase of getting them involved. And the other one is more of a rigorous, structured, truly engagement to basically identify and synthesize the public’s beliefs and values that would help shape and form public policy and action.

And using the true public engagement tool and approach in the last two or three years, I think, has made outstanding benefits to developing some of the guidance we have. We’re working with some of the vaccine safety concerns and issues. So I think clearly that it’s a tool, it’s an approach, it’s a methodology, and it’s getting a lot of traction within the public health community to better shape policy.

JEFF

If I could just add two very quick points. One is, I mean, I think this notion of doing polling and focus groups and testing our messages is incredibly important because it’s always amazing to me how the language that we consider to be so incredibly clear is heard in an entirely different way by the public. And we just have to constantly be testing what we are doing.

I think the second is, you know, there were several moments where we talked about vaccine hesitancy today. And that’s not just among traditional, you know, this is across the population, I think, where there’s a lot of questioning and a lot of resistance. And, you know, the question that came up this morning about adjuvants was, I think, a very good example of, I think, an appropriate decision being made not to try a new technology in a population that is already so suspicious of vaccines.

And I think the second question that is directly related is here we have health care workers who have incredibly low rates of influenza vaccination, and they’re the ones who are supposed to be setting the example. So we have a huge educational campaign to do around vaccines to begin with. And if we did that for all of existing vaccine-preventable diseases and we convinced people that vaccines were safe and that new technologies actually can be a good thing when it comes to vaccines for everything else, you know, we throw out our cell phones every year, but with new technology and vaccines, we’re not going to trust.

We need to get to a different place in that. And if we get to a different place, this is, again, sort of, you know, all hazards type approach, we’ll be preventing disease and we’ll make people more willing to accept new interventions, new countermeasures when they’re available.

JENNIFER

Great. I’m glad we’re closing on a positive note. Anyhow, I’d like to thank all the panelists for a thought-provoking discussion today.

You know, I think what I take from the panel discussion today and some of what we heard earlier today is that we know that government leaders and health officials should anticipate that there’s going to be political pressure in the midst of infectious emergencies to demonstrate that they’re responding swiftly and with certainty.

We heard pretty clearly from our panel today that just employing measures for the sake of looking as though you’re taking strong action is not recommended, that there are a number of measures that may have serious adverse consequences.

We also heard that communication and public engagement can go a long way in terms of maintaining credibility and faith in leadership in the midst of an event.

We also heard that the decisions of which measures get taken will largely depend on the specific epidemiology of the disease, but that, you know, many factors go into deciding which measure to use. And the measures used for one virus may not be the same as another, but we also understand that decisions are not entirely up to science, that there’s also politics behind it as well, and that decisions will often have to be made in the face of uncertainty, and so we have to maintain sort of the flexibility of response and constant reassessment as we go along.

I think we also heard pretty clearly that there would be a number of actions that may be theoretically possible, but given the current state, which we also heard throughout the day of, you know, public health staffing and even in the medical care sector that some measures may not be practically or operationally feasible.

And we did hear that some either more guidance or maybe coordination between responding agencies is important. It’s not entirely clear how to proceed, but clearly it’s something that was brought up a lot, and we should probably be using this time now between events to figure out exactly, you know, what that should look like.

So I’d like to thank our panelists for a great discussion today, and do I have a minute to give them a round of applause?

Thank you.