1. Dobson|DaVanzo & Associates, LLC
Allen Dobson, PhD
Health Economist
Co-Founder & President
Dobson|DaVanzo & Associates, LLC

2. Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements
PRESENTED TO: NHRI & ANA Symposium
PRESENTED BY: Al Dobson, PhD
October 28, 2011
Chicago

3. Introduction
“Nutrition is an input to and foundation for health and development.”
Interaction of infection and malnutrition is well-documented.
Better nutrition means stronger immune systems, less illness and better health.
Healthy people are stronger, are more productive and more able to create opportunities to gradually break the cycles of both poverty and hunger in a sustainable way.
Better nutrition is a prime entry point to ending poverty and a milestone to achieving better quality of life.
World Health Organization
“Nutrition is an input to and foundation for health and development. Interaction of infection and malnutrition is well-documented. Better nutrition means stronger immune systems, less illness and better health. Healthy children learn better. Healthy people are stronger, are more productive and more able to create opportunities to gradually break the cycles of both poverty and hunger in a sustainable way. Better nutrition is a prime entry point to ending poverty and a milestone to achieving better quality of life.”
World Health Organization, 2006

4. Presentation Overview
Update to Prior “Lewin Studies”:
A Study of the Health and Cost Effects of Five Dietary Supplements, 2004
An Evidence-Based Study of the Role of Dietary Supplements in Helping Seniors Maintain their Independence, 2006
Methodological Limitations to Longitudinal Observational Studies

5. The Dietary Supplements Selected for the “Lewin Studies” were…
Calcium with Vitamin D
Folic Acid
Omega-3 Fatty Acids
Lutein with Zeaxanthin

6. Conceptual Framework for the Study
Does the supplement produce a physiological effect as shown by a change in biological markers?
Is the change in health status associated with a decrease in health care expenditures?
Does the physiological effect create a change in health status?

7. Key Findings: Calcium with Vitamin D
There is considerable evidence supporting:
the association of reduced bone loss and reduced fractures, with the best evidence supporting a reduction in hip fractures
a reduction not only in the cost of the hospitalization to repair the hip, but also the post-acute stay for some portion of patients (about 25%) in a skilled nursing facility
Cost offsets result from the potential avoidance of approximately 776,000 hospitalizations for hip fractures over five years, as well as avoided skilled nursing facility stays for some portion of patients.
The five-year estimated net cost effect associated with avoiding hip fracture is approximately $16.1 billion (savings to Medicare).

8. Key Findings: Folic Acid
Of the approximately 44 million American women who are of childbearing age and not taking folic acid, if just 11.3 million began taking 400 mcg. of folic acid on a daily basis periconceptionally, 600 babies would be born without NTDs, saving as much as $344,700,000 in the first year as a result.
Over five years, taking into account the cost of the supplement, $1.4 billion could potentially be saved.

9. Key Findings: Lutein with Z
The estimate of the five-year ( ) potential net savings from avoided transitions to dependency associated with a reduction in the relative risk of age-related macular degeneration (AMD) through daily intake of 6-10 mg of lutein with zeaxanthin is $3.6 billion.
Across the five year period, approximately 190,927 individuals could avoid the transition to dependence either in the community or a nursing facility that would accompany a loss of central vision resulting from advanced AMD.

10. Key Findings: Omega-3 Fatty Acids
The estimate of the potential five-year ( ) savings in health care expenditures resulting from a reduction in the occurrence of coronary heart disease (CHD) among the over age-65 population through daily intake of approximately 1800 mg of omega-3 is $3.2 billion.
Approximately 374,301 hospitalizations and associated physician fees due to CHD could be avoided.

11. Literature Contains Broad Evidence Base of Multiple Studies
Calcium and vitamin D reduce bone loss and/or osteoporosis, especially among post-menopausal women
Folic acid reduces the occurrence of neural tube defects (NTDs) if women consume the supplement before they become pregnant, and continue to do so in the early stages of pregnancy
Omega-3 fatty acids reduce the relative risk of coronary heart disease (CHD)
Lutein with zeaxanthin reduces the risk of age-related macular degeneration (AMD)

12. Why These 4 Supplements? Levels of Evidence
Randomized controlled trial

13. Study Methods - Cost Estimation CBO Scoring Methodology
Gross Cost
Size of the at-risk population (Medicare Trustees Report)
Cost of supplement
Take up rate
Benefit
Number of users achieving therapeutic effect
Reduction in health service utilization
Net Savings ( )
Net Savings = Benefits less Costs
Using the Congressional Budget Office cost accounting approach, gross and net costs were determined for the five year period (08-12).
The size of the at-risk population is based on the Medicare Trustees report. The cost of the supplement is based on averages from many products, both generic and branded. And the take-up rate is based on what we’ve learned from many other preventive programs, like mammograms, flu shots, pneumonia shots.
We determine the benefits by looking at the number of users achieving (literature)

14. Methodological Limitations of Longitudinal Observational Studies
Generalizability
Loss to follow up and missing data
Repeated measures on same individual
Measurement at varying time points from symptom onset
Assessing effect of treatment

15. Evaluating Longitudinal Observational Studies
Source of cases
True population based, catchment population, or consecutive series
Timing of recruitment:
First presentation of disease, or prevalent cases
Inclusion criteria:
Classification criteria, age, ethnicity

16. Evaluating Longitudinal Observational Studies (continued)
Analyses:
Methods and rationale
Power to detect clinically meaningful change
Handling of missing data
Tests of internal and external validity
Temporal effects
Causality

17. Methodological Evaluation for Two Recent Studies. . .
Criteria
Mursu, 2011
Total Mortality with Multivitamins
Klein, 2011
Risk of Prostate Cancer with Vitamin E
Methods & Rationale
Cox Proportional Hazard Model
Proportional Hazard Model
Power to Detect Meaningful Change √
Handling of Missing Data
40.2% deceased during study
Not clear
Tests of Internal & External Validity
White women only – results not confirmed in literature
Interactions confound results of treatment in each group
Temporal Effects
Follow-up 22 years – repeated measure
Follow-up of 7 – 12 years
Causality No
No biological explanation
Single Study

18. Conclusions
A growing body of scientific research is beginning to provide important clues about how diet choices affect health. In some areas, the relationship between specific foods or dietary supplements and particular health outcomes is fairly clear; in other cases, more research is needed.
The rapid expansion of the population age 65 and older has a number of economic implications. The people in this group, about 18 percent of the population, account for about 30 percent of all health care expenditures.

19. Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements
PRESENTED TO: NHRI & ANA Symposium
PRESENTED BY: Al Dobson, PhD
October 28, 2011
Chicago

20. Nutrition Break