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National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Maryland, USA
Correspondence: Senior Advisor for Scientific Coordination and Outreach, National Center for Complementary and Alternative Medicine, National Institutes of Health, 9000 Rockville Pike, Bldg. 31, Room 2B-11, Bethesda, MD 20892-2182, USA. E-mail: nahinr{at}mail.nih.gov
| ABSTRACT |
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Key Words: disease burden NCCAM funding public health
| PRIORITY SETTING AT NCCAM |
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The present report provides evidence on whether the first of these criteria, public health significance, is reflected in NCCAMs research allocations to particular diseases and conditions. Following guidance developed by the IOM (3)
and the World Health Organization (WHO) (4)
, the public health significance of specific diseases was assessed using several measures of disease burden. Recommended core measures of disease burden include relatively straightforward measures such as disease prevalence, morality, and direct costs of illness (COI). Other recommended, albeit more subjective, measures include various assessments of health-adjusted life years (e.g., disability-adjusted life years or DALY) that assess the severity of disability or illness, as well as indirect COI. The IOM (3)
has found these evaluative measures to be increasingly relevant to both the publics health and individuals making healthcare policy decisions.
Since the purpose of this evaluation was to assess the relationship between NCCAM funding and disease burden at the time funding decisions were made, the evaluation compared fiscal year (FY) 2000 funding with seven measures of disease burden. FY 2000 was chosen as this was NCCAMs first full year of issuing grant awards. In addition, changes in funding patterns over time were determined by comparing disease burden to funding in the most recent year for which complete data are now available, FY 2003.
| DATA |
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While NCCAM research spans a very wide range of health conditions for which CAM approaches may be used, it was not possible to include all these diseases in this evaluation, as current data on measures of disease burden were not always available. To be included in this assessment, a disease or condition had to be among the top 15 rankings nationally for at least two of the following five criteria: prevalence (5)
, mortality (6)
, disability (7
, 8)
, direct COI (9)
, diseases and conditions for which CAM is used (10)
. Based on these criteria, 18 diseases or conditions were included in this evaluation (see Table 1
). These diseases represent a substantial portion of NCCAMs total research grant and contract expenditures (see below), as well as the major diseases associated with mortality and morbidity in the U.S.
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Prevalence data for 2000 were provided by the CDC (5)
for 11 diseases. For six diseases (Alzheimers disease, digestive diseases, HIV/AIDS, pneumonia, sleep disorders, and unipolar depression) CDC data were not available. Prevalence data for these diseases were identified in the published literature (see Appendix).
For 14 diseases, total mortality in 2000 was identified through the CDC (6)
. For four diseases (arthritis, migraine headache, sleep disorders, and unipolar depression), values for total mortality were identified in the published literature (see Appendix). No mortality data were identified for back problems.
Direct and total (direct plus indirect) cost data were extracted from the published literature (see Appendix). All values were adjusted to calendar year 2000 dollars using a medical care consumer price index (CPI) data (12)
. Total cost data were not available for kidney disease.
Data on YLL, YLD, and DALY were provided by WHO (8
, 13)
and combine data from the U.S. and Canada. Calendar year 2000 data for the U.S. alone are not available. YLL data were not identified for back problems.
The NCCAM Budget Office provided data on NCCAM spending on specific diseases. The reported amounts contain overlaps consistent with how NIH reports its funding to Congress each year.
| EVALUATION |
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41% of NCCAMs research budget; this increased to 56% of NCCAMs research budget in FY2003. In addition, the included diseases account for a substantial part of disease burden in the U.S. The total mortality from these diseases represented 73% of all deaths in the U.S. in 2000; the total costs of the diseases approached $1 trillion and 8 of the diseases were among the 15 most disabling diseases in the U.S. in 1999 (7)
A moderate but statistically significant correlation was seen between FY2000 funding, YDL, DALY, and total COI (Table 2
). No other measures of disease burden were statistically different from zero. For FY2003 funding, the strongest correlation was seen with direct and total COI, but moderate, statistically significant correlations were also seen with YLD and DALY.
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This evaluation revealed an increasing relationship between NCCAM research funding and several measures of disease burden over a 4-year period (FY2000 to FY2003). Larger coefficients were seen for FY2003 vs. FY2000 for mortality, YLL, DALY, direct COI, and total COI, with the greatest increase seen for direct COI and the least increase seen for DALY. These increases reached statistical significance for both direct and total COI (Table 2)
.
The significant correlation of NCCAM funding with DALY and YLD is consistent with the general publics disproportionate use of CAM for chronic diseases associated with high morbidity (10)
. The analysis also found moderate, but significant, correlations between DALY and both measures of COI (rdirect=0.505, P<0.05; rtotal=0.612, P<0.01), reinforcing the economic impact of chronic disabling disease.
On the other hand, disease prevalence was not associated with NCCAM funding. This is not surprising given that several diseases on the list with high prevalence, such as back pain or migraine headache, are very frequent problems for which CAM treatments are sought (10)
yet are rarely associated with severe or life-threatening outcomes, whereas some less prevalent diseases, such as Alzheimers disease or HIV/AIDS, are always severe and/or life threatening. In fact, the rank order of disease varied between the measures of disease burden used. These data are consistent with analyses of disease burden both nationally (14
, 15)
and internationally (8)
that demonstrate incongruity between rank order of prevalence, mortality, and morbidity for many different diseases. Thus, the use of only one disease burden measure as a funding criterion could lead to under- or over-allocations of resources. The finding that four of seven measures of disease burden were in general agreement strengthens the conclusion and demonstrates a clear relationship between disease burden and NCCAMs research funding.
| NCCAM FUNDING VS. TOTAL NIH FUNDING AND DISEASE BURDEN |
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Another difference between these two studies is that Grosss group examined six measures of disease burden vs. seven in the current evaluation. Four measures were the same in both studies: prevalence, mortality, YLL, and DALY.
Like the current study, Gross et al. did not find a meaningful correlation between research funding and disease prevalence, but did find strong, statistically significant correlations between funding and DALY. However, unlike Gross et al., the present study did not find an association between funding and mortality but did see a strong correlation between funding and both COI measures. At least part of the discrepancy results from differences in the measures employed in the two studies. Gross et al. use "the number of hospital days" as a surrogate for COI. Hospitalization probably underestimates COI for many chronic diseases, such as arthritis or back pain, and does not consider indirect costs associated with disease.
| IMPACT ON NCCAM FUNDING |
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| DISEASE BURDEN VS. OTHER PRIORITIZATION CRITERIA |
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In line with its prioritization criteria, NCCAM closely monitors the use of CAM by the U.S. Public. For instance, a comparison of the 1991 (26)
and 1997 (27)
national surveys of CAM use by Eisenberg and colleagues with the 2002 data of Barnes et al. (10)
shows that the publics use of CAM practitioners (e.g., acupuncturists, chiropractors, naturopathic physicians, etc.) has remained relatively stable on a percentage basis over time whereas use of dietary supplements greatly increased. Therefore, NCCAMs largest research investments have emphasized the safety and efficacy of dietary supplements. NCCAM thinks that preclinical studies, pharmacokinetics testing, and developmental phase I/II trials are necessary before these products can be launched into definitive clinical trials (28)
. NCCAM has encouraged research in these areas through a series of focused initiatives (http://nccam.nih.gov/research/announcements/past.htm), with the result that
50% of NCCAMs annual research budget has been used to support investigations of dietary supplements in each fiscal year since FY2000.
As suggested elsewhere (20)
, it is not necessarily the level of burden that matters when setting national research priorities, but the ability of federally supported research to improve the publics health. Therefore, NCCAM places a priority on the most promising uses of CAM as identified in the literature (e.g., 21
22
23
24
25
) in hopes of providing definitive evidence concerning safety, efficacy, and mechanisms of action. Thus, it can be seen that although disease burden is an important factor, it does not have a simple one-to-one relationship with NCCAMs research funding.
| CONCLUSIONS |
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The author is indebted to Dr. Kimberly McFann for statistical advice and to numerous staff of NCCAM and the NIH Office of Science Policy for their helpful comments on earlier versions of this manuscript
| Appendix |
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Received for publication February 4, 2005. Accepted for publication March 30, 2005.
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