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Interesting Article from the Salk Institute
Posted: Thursday, March 1, 2012 3:11 PM
Joined: 12/6/2011
Posts: 3326

Written by David Schubert, professor at The Salk Institute for Biological Studies in La Jolla.


The numbers 100 million and 50 million recently gained significance in the context of Alzheimer’s disease (AD). Since old age is the greatest risk for AD and the ranks of the elderly are increasing, 100 million people worldwide may have AD by 2050, with about 16 million in the U.S. The estimated cost is $1 trillion per year for this country.


President Obama recently committed an additional $50 million to AD research, and a slightly greater amount in next year’s budget. While this funding is welcomed, it is critical to evaluate it with respect to the potential cost of developing an effective treatment.


AD is the sixth-leading cause of death in the U.S. and the only one of the top 10 where there is no way to slow its progression or cure the disease. What is not widely appreciated is how little funding for AD research and drug discovery is actually available. According to the National Institutes of Health (NIH), for every $10 per patient spent on AIDS research, a disease with a means of prevention and a viable method of treatment, only $1 is spent per patient for AD research. Funding for AD research at research institutions is largely from the NIH, which provides about $450 million per year, with only a fraction going for work directly on therapeutic treatments. Is the additional $50 million promised by the administration a significant amount in relationship to the actual cost of getting an AD drug candidate approved by the Food and Drug Administration (FDA)?

Our laboratory at the Salk Institute has used a unique drug discovery program to identify a compound that we believe has exceptional potential as an AD drug. This compound is probably one of many in academic labs across the country that is ready to start the journey toward the clinic. The completion of three clinical trials is required. Following initial toxicology studies in animals, which cost $1.5 million, Phase 1 trials determine potential human toxicity and proper drug dosing, with a price tag of about $2 million. Phase 2 trials are the initial tests for drug efficacy, and cost around $25 million. For final FDA approval, the candidate must pass Phase 3 trials, which can cost well over $200 million. Therefore, the $50 million increase in the AD budget will, at best, only support one new drug candidate through Phase 2 testing. Because the probability of any drug making it successfully through clinical trials is low and many may have to be tested, the $50 million in additional NIH funding should not be an encouraging number for the nearly 6 million Americans who already have AD and the millions more that will develop it in the near future.


However, until the time that a good AD drug is identified, there are actions that can be taken to forestall the disease. Lifestyle is a major contributing factor to its development. Dr. Ronald Petersen, director of the Alzheimer’s Research Center at the Mayo Clinic, recently said on ABC: “Regular physical exercise is probably the best means we have of preventing Alzheimer’s disease today, better than medications, better than intellectual activity, better than supplements and diet.”


In addition, epidemiological studies as well as experimental data from our laboratory and others have shown that diabetes increases the risk for AD, and that this risk may further increase if diabetes occurs at a younger age. There is an epidemic of Type 2 diabetes in the Western world caused primarily by obesity. Of particular concern is that childhood obesity frequently leads to early-onset Type 2 diabetes, potentially exacerbating the future development of AD. Type 2 diabetes is largely related to lifestyle, and can often be avoided or reversed by proper diet and exercise.


In conclusion, there needs to be a much greater awareness of the immense medical, social and fiscal burden of AD; 100 million individuals with the disease by 2050 unless dramatic improvements in prevention and treatment occur. A major public commitment to supporting the research that will ultimately find a cure is desperately needed. Fifty million dollars a year additional funding is not nearly enough. At the same time, we should be equally committed to changing our lifestyles such that AD and conditions such as Type 2 diabetes that predispose people to AD are reduced, thereby improving mental health now and in the future.

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