NUTRITION JIM GRIFFITHS Council for Responsible Nutrition 1828 L Street, NW, Suite 510 Washington, DC 20036, USA Tel Fax +1 202-204-7665 +1 202-204-7701 [email protected] www.crnusa.org www.crn-i.ch Jim Griffiths published by srl Via Mario Donati, 6 20146 Milano - Italy Tel. 0039 02 83241119 Fax 0039 02 8376457 w w w. b5 s r l . c o m [email protected] 4 MAY/JUNE 2014 An “eye” on cost savings with preventative action against eye diseases This is the second in a series on dietary supplements and health care cost savings, based on information from a Frost & Sullivan economic analysis, “Smart Prevention – Health Care Cost Savings Resulting from the Targeted Use of Dietary Supplements.” The report was funded through a grant from the CRN Foundation. O ptimal visual sensation is one of the most critical “necessities” irrespective of our age, as evidenced by eyeglasses, contacts, and refractive eye surgeries for a large percentage of the population desiring accurate and detailed optical experiences. But as we reach more advanced ages, age-related eye disease (ARED), such as macular degeneration and lenticular cataracts, become more likely, and are a much more serious and often uncorrectable condition. Any possible preventative strategy that allows the maintenance of visual acuity would be of utmost value, especially if the visual decrement would not be correctable by any surgical or pharmaceutical means. Any prevention or prolongation of normality would be orders of magnitude more desired than an uncorrectable conclusion that could not be reversed or undone. Age-related macular degeneration (AMD) usually affects older adults (greater than 55 years of age) and results in irreversible damage to the macula, which causes complete loss of the sensitive cells in the center of the retinal visual field. The area of the macula (approximately 2 cm wide) comprises roughly two percent of the total retina, but the loss of seemingly an insignificant percentage area-wise, is very significant as the loss of this central portion profoundly affects virtually all visual functioning, especially reading, watching television, videos and movies, driving and even recognizing faces. It is estimated that almost half of the visual cortex in the brain is devoted to processing just the macular information. There are two diagnosed forms of AMD. The “dry,” or nonexudative form, is characterized by the deterioration of the photoreceptors through infiltration of fatty yellow pigmented deposits called “drusen.” Drusen is similar in molecular composition to plaques and deposits in other age-related diseases, such as Alzheimer’s disease and atherosclerosis. As the drusen deposits enlarge and multiply over time (slowlyprogressive), the pigmented cell layer under and around the macula are disrupted and atrophy, losing their ability to transmit light and images. The photoreceptors, particularly the rods and blue-light sensitive cones are most affected. The dry form of AMD accounts for nearly 90 percent of diagnosed cases and is considered the early, slowly-progressive less debilitating form of AMD. In the “wet,” or exudative form, of AMD, blood vessels grow up from the choroid behind the retina, often disrupting and detaching the retina causing severe distortion of central straightforward vision. It rapidly develops, but also may be treatable via specific laser surgery and/or with medication that could arrest and sometimes even reverse the growth of the wayward blood vessels. Wet AMD accounts for the remaining nearly 10 percent of cases, is more severe and more sudden, and accounts for the majority of the cases of significant loss of vision. Unfortunately, AMD is a disease that affects a large percentage of the aged population and poses a significant financial burden, not to mention psycho-social burdens and a dramatic loss in the quality of life. Approximately 10 percent of patients 66 to 74 years of age will have some form of macular degeneration and the prevalence for the disease increases to 30 percent in patients 75 to 85 years of age. A cataract is clouding of the lens inside NUTRITION Figure 1 the eye, which leads to a decrease in vision just as a cloudy window or dirty eyeglasses would in a similar fashion decrease visual clarity. In short, the degenerative opacification of the lens prevents light from passing through and being focused on the retinal layer at the back of the eye. Cataracts are the most common cause of blindness and for the most part are conventionally treated with surgery. It is most commonly due to the unavoidable aging process, but other extrinsic and intrinsic factors such as oxidative insult that may cause insoluble oxidized lens proteins, may also play a role in the age of onset, progression and severity. The most common visual problems include difficulty in appreciating colors and changes in contrast and coping with glare from bright lights. If not surgically corrected, it greatly affects reading, operating automobiles and machinery, and recognizing faces. Lutein (Figure 1) is a xanthophyllic carotenoid synthesized only by plants, and is found in high quantities in leafy green vegetables, such as spinach, kale, Swiss chard and turnip and collard greens. Animals can only obtain lutein through ingestion of plants (or animals that have eaten plants) and is most strikingly observed as the yellow coloring of egg yolks, and chicken skin and fat deposits. Lutein is lipophilic, insoluble in water and is present in plants as fatty-acid esters, with one or two fatty acids bound to the two hydroxyl-groups. The principal natural stereoisomer of lutein is (3R,3’R,6’R)beta,epsilon-carotene-3,3’-diol. The presence of the conjugated double bonds provides the distinctive light-absorbing properties of lutein and other carotenoids of interest. Lutein predominates in the retina, functioning as a photoprotectant for that sensitive tissue layer from the damaging effects of free radicals produced primarily by blue light (wavelengths shorter than 480 nm). Zeaxanthin (Figure 1) is one of the most common carotenoid alcohols found in nature. It is synthesized by plants and some micro-organisms. It is the xanthophyll pigment that gives the characteristic orange-yellow color to corn, oranges, saffron, and paprika. Xanthophylls occur primarily in plant leaves, and their NUTRITION function is thought to modulate and quench light energy that manifests as triplet chlorophyll (an excited state) that is overproduced during photosynthesis. Animals derive zeaxanthin from a plant diet, or from animals that have eaten primarily plants. Both lutein and zeaxanthin are available as dietary supplements. Lutein and zeaxanthin carotenoids are the two major components of the macular pigment of the retina and in the primate lens; acting as powerful antioxidants and filters of high-energy blue light. Lutein and zeaxanthin differ from other carotenoids in that they each have two hydroxyl groups, one on each side of the molecule. Zeaxanthin is a stereoisomer of lutein, differing only in the location of a double bond in one of the terminal C6 rings. The hydroxyl groups appear to control the biological function of these two xanthophylls. Some dietary lutein appears to be converted to a non-dietary form, meso-zeaxanthin, which may also play a role in optimal eye health. Lutein appears to have an affinity for the peripheral retina and rods, while zeaxanthin seems to be preferentially taken up by the cones of the macula. Because xanthophylls are fatsoluble nutrients, bioavailability to these eye tissues is dependent on a number of factors, including nutrient source (whole food or supplement), state of the food (raw, cooked, or processed), extent of disruption of the cellular matrix via mastication and digestive enzymes, and absorption by the enterocytes of the intestinal mucosa (primarily the duodenum). In 2012, an estimated 2.1 million people developed the wet-form of age-related macular degeneration, resulting in severe vision loss less than six months from onset of symptomology. During the same 12 month period, it is estimated that more than 3.7 million Americans over the age of 55 suffered a cataract event and pursued surgery or other direct hospitalization services to treat the condition, with a total affected cataract-inflicted population (individuals with some stage of cataract opacity in progress) of nearly 25 million. In 2012, for the 55 year old and older U.S. demographic, the total direct medical costs associated with both AMD and cataracts, plus the related expected costs of postprocedure nursing care and assisted living services was estimated at approximately $ 17 billion. Additional indirect costs such as loss of independence and the assistance needed to perform daily tasks associated with both work and home life are not captured but could be many times the cost of the direct hospitalization services. Emotional distress and quality of life decrements are also unaccounted for. With the available data on the incidence of age-related (55 year olds and older) eye diseases (AMD and cataracts) and hospital utilization expenditures, coupled with the role (as a percentage) of the carotenoids, lutein and zeaxanthin that could be expected to play in protecting the eye from oxidative damage, one could perform a health care cost savings assessment. In fact, with a grant from the CRN Foundation, the highly respected economic analysis firm, Frost & Sullivan, did just that. Based on their findings, here are some things to consider. The expected event rate for AMD in the target population of U.S. adults over the age of 55 is 2.8 percent. The expected event rate of cataracts in the same target population is 33.0 percent (Table I). The weighted AMD event relative risk (weighted for sample size variance) is 77% for AMD and 84.7 percent for cataracts. The number of people needed to be treated to avoid one age-related macular degeneration event (NNTAMD) is 159 persons, i.e., for every 159 persons over the age of 55 that would take the Table I MAY/JUNE 2014 5 Lutein and zeaxanthin dietary supplements and Age-Related Eye Disease (ARED). lutein + zeaxanthin dietary supplements at the preventative daily intake levels, one AMD event could be avoided. The NNTCAT for cataracts is 28. Based on the incidence rate of AMD and cataracts in the target population, and the respective NNT’s, if the entire target population took the prescribed dietary supplements, then 14,408 AMD events could be avoided and close to one million cataract events could be avoided per year. At close to $ 3,500 cost to treat per AMD or cataract event (lumped together for further analyses as 6 MAY/JUNE 2014 Age-related eye disease (ARED)) the savings per year would be almost $ 4 billion in direct hospitalization utilization expenditures. In considering these conclusions, it is important to note there are, however, some assumptions and limitations that need to be stated. There are also significant direct and indirect potential savings that are not counted in this simplistic model. Because several of the dietary supplement versus disease-related event scenarios examined the same disease end point (e.g., coronary heart disease (CHD)), and each dietary supplement regimen independently yielded a positive (beneficial) net cost savings, crosscomparisons cannot be calculated. The disease risk reduction for each dietary supplement regimen was undertaken in a controlled setting, independent of use of other dietary supplements. It is still reasonable to assume that there could be an even more beneficial health care cost savings realized if the at-risk population NUTRITION took a combination of dietary supplements each of which has been shown to be independently advantageous. Future research may substantiate whether such combination products are accumulative (the sum of the independent cost savings), synergistic (a higher value than a simple summation of the independent cost savings), or antagonistic (a lower value than a simple summation of the independent cost savings). Cost estimates also have built-in assumptions regarding the current and forecast increases in health care costs, i.e., the average annual growth rate of the hospital utilization events. The at-risk target population also depends upon forecasted growth rates. The incidence rate of the medical events attributed to each disease is also assumed to remain stable. The cost to treat each disease was derived from the hospital utilization and attendant costs as provided by the Agency for Healthcare Research and Quality (AHRQ) Medical Expenditure Panel Survey (MEPS), 2010 (http://meps.ahrq.gov/ mepsweb/). There was no effort to consider the additional cost of related preand post-disease pharmaceutics and health care providers, nor any long-term rehabilitation or assistance costs. Though impossible to quantify, but perhaps most important to each of the individuals who would “avoid” the expected disease, NUTRITION would be the maintenance or at least nondiminishment of “quality of life” and personal financial and psychosocial norms, a very important consideration for the generally aged (greater than 55 year old) at-risk populations. The infographic accompanying this article demonstrates a “Lutein and Zeaxanthin Cost Analysis: Net Health Care Cost Savings Summary Results 2013-2020.” One corrective factor that will be applied to this health care cost savings analysis will be to take into account the segment of the target population (U.S. adults over the age of 55) who already are using the prescribed preventative regimen, in this case lutein + zeaxanthin. According to the 2012 Council for Responsible Nutrition (CRN) Consumer Survey on Dietary Supplements conducted by Ipsos Public Affairs, four percent of the target population are regular users of lutein (which is often manufactured and sold as a supplement also containing the similarlyacting and chemically similar, zeaxanthin). This segment already has a reduced risk of experiencing a costly ARED event because they are benefiting from the scientifically established risk reduction. However, the remaining 96 percent do not yet have this benefit. Therefore, of the nearly $ 970 million dollars in net potential direct health care cost savings from reduced hospitalization utilization services, nearly $ 40 million is subtracted as that subpopulation is already taking lutein + zeaxanthin in a daily preventative regimen. In summary, there would still be an estimated 972,000 “avoidable” ARED events per year to be realized at a total net savings of $ 928 million. The principle source of these potential costs is attributable to post-ARED-event reduced vision and the costs to surgically and/or pharmaceutical address some of the deficiencies. Cataracts and AMD obviously limit a person’s independence and precipitate many intangible costs such as a decrease in the quality of life and emotional and physical stress and distress. It is estimated that five percent of the target population who suffer a catastrophic ARED event will require costly post-AREDevent assisted living and/or nursing care at an estimated $ 59,000/year. These costs will be borne most likely by governmental Medicare programs or relatives. Any opportunity to limit or reduce these potential societal costs should be actively explored and preventative measures actively adopted. For more information on the Frost & Sullivan economic report, visit www.supplementforsmartprevention.org MAY/JUNE 2014 7
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