It’s not easy to change the world

1. It’s not easy to change the world From good epidemiological ideas to policy and legislation: The case of Beyond AIDS Ronald P. Hattis, MD, MPH President, Beyond AIDS Presented at California State University, San Bernardino, 10/4/12

2. “We don’t just do any darned thing just because it happens to be a good idea” • The world will not easily adopt anything that involves the need to change • Machiavelli: • “It must be considered that there is nothing more difficult to carry out, nor more doubtful of success, nor more dangerous to handle, than to initiate a new order of things. For the reformer has enemies in all those who profit by the old order, and only lukewarm defenders in all those who would profit by the new order, this lukewarmness arising partly from fear of their adversaries, who have the laws in their favour; and partly from the incredulity of mankind, who do not truly believe in anything new until they have had actual experience of it. Thus it arises that on every opportunity for attacking the reformer, his opponents do so with the zeal of partisans, the others only defend him half-heartedly, so that between them he runs great danger."

3. The Case of Beyond AIDS • The idea: Why not apply public health control measures used for some other diseases (TB, syphilis) for HIV? • The situation (1998, when organization founded): • Only AIDS (late stage reached after 10+ years) was reportable to public health (not all stages as for other diseases) • Little effort was made to find people exposed to HIV • Testing for HIV required special written consent (not required for other diseases) • Prevention strategy was directed at community education (not using control at the source as with other diseases)

4. Reasons HIV was an exception • When HIV test was developed (1985), only 5% of men who tested positive had AIDS • Staff at Centers for Disease Control (CDC) assumed that most people testing positive would not become ill • Stigma and discrimination triggered confidentiality laws protecting HIV results • It was not known that at all stages of HIV infection, virus is present and disease is contagious, and that almost everyone would get AIDS eventually • There was no treatment • First drug, AZT, approved 1987; effective drug combinations 1996

5. Sources of opposition to change • Gay rights advocates • Fearful of stigma, discrimination, and potential quarantine • Struggling to preserve sexual freedom and anonymity • Developed strong lobby, and organizations like “Act Up” that demonstrated • Funded agencies • Determined to continue programs (and budgets) as usual • Civil rights advocates (e.g., ACLU) • Privacy concerns

6. What motivates political action? • Defending interests (income, power, etc.) • Established AIDS organizations opposed change • Defending or fighting for rights • Gay activists sought equality, sexual freedom, treatment • ACLU fights for privacy • Solidarity with one’s group • Patriotic instinct can be invoked by sexual orientation, religion, etc. • Moral indignation • Beyond AIDS founders outraged that people not informed they were infected or exposed, and that public health couldn’t know who was infected • Conservatives opposed recognition of gays, sexual “deviance” • Altruistic principles • Beyond AIDS leaders wanted to save lives

7. Timeline in a long struggle • 1987: Future founders of Beyond AIDS met • Congressional hearing, book promotion, friends of friends • 1998: Beyond AIDS founded • 1998: First project to kill California bill reporting HIV by secret codes (AB 1663): Gov. Wilson vetoed • 1999: New similar bill passes (AB 103) and veto sought from new Governor: Gov. Davis vetoed • 1999: First Beyond AIDS bill for name reporting (SB 1029), failed • 2000: Reporting by secret codes passed in obscure part of state budget, signed by Gov. Davis • 2000: First Beyond AIDS bill passed to promote prenatal testing, but vetoed by Gov. Davis

8. Timeline in a long struggle, contd. • 2001: Beyond AIDS attempt to change regulations to implement “unique identifier” reporting codes, failed • 2002: Three Beyond AIDS bills introduced, all passed but 2 vetoed (HIV testing in prisons, prenatal testing); bill signed would re-examine coded reporting if not working (AB 2994) • 2002: Rep. Coburn, friend of Beyond AIDS, got language into Ryan White CARE Act requiring effective HIV reporting by 2006 (not mentioning names) • If reporting failed, funding would be based only on AIDS cases • By 2006, this provided financial incentive to holdout states to switch to name reporting • 2003: On 3rd try, Beyond AIDS gets prenatal testing bill passed and signed as one of last acts of Gov. Davis (AB 1676) • 2005: Supported second attempt to get name reporting of HIV (failed)

9. Timeline in a long struggle, contd. • 2006: Third attempt to get name reporting of HIV passes (SB 699), signed by Gov. Schwarzenegger • 2007: Testing without written consent approved and signed (AB 682), but with complicated requirements due to ACLU concerns • 2011: Bill to make it possible for physicians to refer partner services to public health passed and signed by Gov. Brown (SB 422), but with other desired changes deleted due to ACLU opposition

10. Can public health be science-driven? • Nothing can be done in public health without public authority, both for funding and for police power • This guarantees a political component to the design and maintenance of public health programs • What is scientifically true is usually controversial • Examples: global warming, abstinence education, born gay • Public health officials must steer a course between science and political reality, pushing to maximize the science while maintaining enough political support • Prevention does not have the same constituency as disease-driven programs (those who are well and would have become sick don’t know it and don’t lobby)

11. What is the scientific basis for HIV control? • Efforts targeting entire demographic groups • Screening directed at high-risk groups detects many infections • People who know they have HIV tend to reduce risk behavior • Uganda’s “A-B-C” program drove down incidence and prevalence • Abstinence • “Be faithful” • Condoms • First two achieved most of the change • Populations have changed behavior only when people see illness and deaths around them

12. What is the scientific basis for HIV control (contd.)? • Efforts to control transmission at the source • Have had little emphasis; what is proper balance? • Testing exposed partners is high-yield, should be cost-effective • Intercepting exposed persons can avert infection before it happens • Infected persons can be helped and persuaded to reduce behavior that will expose others • Infected persons can be treated to reduce infectiousness • Idea postulated by Hattis and Jason in 1996, endorsed by CMA • Proven effective by 2011; Science Magazine “Science Breakthrough of the Year” • Biggest thing at 2012 International AIDS Conference

13. The Stages of Prevention: A new paradigm (Hattis and Law, 2011) • The development of diseases (esp. chronic) generally involves 5 stages, and each lends itself to preventive interventions: • 1. Exposure to agents/causes/risk factors of disease • 2. Acquisition of early disease due to exposure • 3. Progression of acquired disease from early to advanced • 4. Complications resulting from advanced disease • 5. Death or Disability, generally from complications

14. The Stages of Prevention: A new paradigm, contd. • Each stage of disease development has a corresponding stage of prevention • Stage 1: Avoidance of exposure to agents of disease • Sexual abstinence; anti-smoking efforts • Stage 2: Reduction of acquisition of disease (as a result of exposure) • Post-exposure prophylaxis; hepatitis B vaccine for drug users • Stage 3: Interruption of the progression of a disease (that has been acquired) • Screening tests (Pap, cholesterol, etc.) followed by treatment; INH for latent TB; some diseases can be cured or progression reversed • Stage 4: Avoidance of complications (from progressed disease) • Prophylactic antimicrobials for AIDS patients; anticoagulants • Stage 5: Delay of mortality, rehabilitation of disability, or palliative care for terminal disease • ICU care for stroke; physical therapy; hospice care

15. The Stages of Prevention applied to HIV/AIDS • Stage 1: Avoiding exposure - abstinence; sex only with faithful partners with both seronegative; not sharing needles • Stage 2: Mitigating exposure/harm reduction – condoms; needle exchange; post-exposure prophylaxis • Stage 3: Interruption of transmission (and of secondary infection) – screening; early treatment • Stage 4: Avoiding complications – antimicrobials, treating metabolic effects • Stage 5: Keeping complications from getting worse – hospital care of infections; rehabilitation; palliative care

16. Applying Stages of Prevention model to individual counseling • - Stage 1 prevention to avoid exposure to the disease (e.g., abstinence, not using drugs) • - Stage 2 prevention to avoid infection despite exposure (e.g., condoms, needle exchange) • - Stage 3 prevention to detect infection and treat it to avoid AIDS (e.g., get tested for HIV; take antiretroviral drugs if infected and CD4 count dropping, which also reduces exposure of partners) • - Stage 4 prevention to prevent complications of AIDS (e.g., antimicrobial drugs added to antiretroviral drugs) • - Stage 5 prevention after an episode of an opportunistic infection (e.g., treatment of the infection)

17. Applying Stages of Prevention model to public health planning • Each consecutive stage is targeted at a smaller population (a potential cost saving), but may be more expensive or difficult to apply to each member of that population as become more ill • Example: Hospitalization for advanced diseases/complications • Examples of exceptions: • - Changing behavior or an entire population to reduce risky sex or drug use (Stage 1) may be difficult and expensive per capita • - Trimethoprim-sulfa to prevent complications of AIDS (Stage 4) is inexpensive for each person treated • As each stage of prevention is applied, it can reduce the rate of its respective stage of disease development and of all subsequent stages, so early stage prevention pays off • Example: If fewer acquire disease, fewer complications occur

18. Using the Stages of Prevention for calculations of rates • Ultimately, the death rate in a defined population “p” per year or other time period “t,” due to complication-specific mortality, D/(p*t), is equal to the product of five factors: • E/(p*t ), the exposures per defined population per year • A/ E, the rate of disease acquisition per exposed persons • P/A, the progression rate of acquired disease per acquired cases • C/ P, the rate of complications per cases of progressed disease • D/ C, the complication-specific death rate

19. Using the Stages of Prevention for calculations of rates, contd. • The rate of an earlier stage will be the product of the rates of the stages up to that point; examples (note the algebraic cancellations): • The incidence rate of the disease is • A/(p*t) = E/(p*t) * A/E • The rate of a specific complication within the defined population is • C/(p*t) = E/(p*t) * A/E * P/A * C/P • The mortality rate is • D/(p*t) = E/(p*t) * A/E*P/A* C/P* D/C • Key: E = exposures, A= acquisitions, P = progressed cases, C = complications, D = deaths, p = popn., t = time

20. Limitations • Limitations of this particular classification system: • - Exposure to risk cannot always be avoided • - Not all diseases/conditions have preventable progression or complications, and some lack progression at all • - Use of term “stages” for disease development (though not of prevention) may be confused with stage classifications of specific diseases (various cancers, CHF) • Disadvantages of revising the classification of prevention: • - Will have difficulty competing with a paradigm over half a century old and in wide use • - New terms and 2 more divisions to remember

21. Limitations, contd. • Limitations of any classification system: • Cannot make universally applicable distinctions • The real world is messy • Prevention is complicated • Can be ineffective if the disease entity to be prevented, and each stage for each disease, are not clearly defined • Some articles identify attempts to prevent a complication as primary prevention of the complication • Others considered similar interventions as secondary or tertiary prevention of the disease