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Evaluating Biomarkers of Cardiovascular Disease Risk
CHORI Scientist Asked to Participate in NIH and NAS Panels

“We’re basically going to investigate how far we think you can go with the science, how strong is the evidence for a connection between an individual biomarker and reduced heart attacks?”

CHORI senior scientist Ronald Krauss, MD, of the Center for the Prevention of Obesity, Cardiovascular Disease & Diabetes, has been asked to participate in two different investigatory panels for the Foundation for National Institutes of Health (NIH) and the Institute of Medicine (IOM) of the National Academy of Sciences, two highly prestigious organizations engaged in the investigation of biomarkers for cardiovascular disease.

Dr. Krauss is uniquely positioned to help spearhead the efforts of both panels as a result of his pioneering research on nutrition, cholesterol, heart disease risk, and in particular, his groundbreaking work in the area of low-density lipoproteins as biomarkers for heart disease risk.

“A biomarker is anything you measure in a biological organism that relates in some way to a biological process – you want to look at markers that are indicative of disease risk,” explains Dr. Krauss.

“Beyond that, you also want to know what is a predictor of beneficial treatment, what is called a surrogate marker, one that actually has a strong probability of telling you the disease process is actually changing as the result of some intervention.”

Both scientific panels are geared toward evaluating the status of different biomarkers and their relationship to atherosclerosis and heart disease, but each has a slightly different focus. The Atherosclerosis Biomarkers of the Foundation for NIH panel seeks to develop a research agenda that would focus research on developing meaningful predictive formulas for heart disease risk and benefits of treatment in order to better facilitate the development of new treatment protocols.

“This particular panel is being driven by concerns that it is very difficult for drug companies to take the risk of testing a drug for cardiovascular disease that has a new mechanism that might be beneficial but would need to be proven in order to show the benefit,” Dr. Krauss says.

Companies must spend huge amounts of capital in order to undertake large clinical studies showing a new mechanism is both safe and reduces heart attacks. There are only a few companies that could afford to take that kind of risk on a novel treatment without having the confidence ahead of time that it was going to move forward and be successful.
“What biomarkers for cardiovascular disease can do is to allow companies to do smaller, more feasible studies that are much less intensive and much less expensive by utilizing tests that could be seen as strongly predictive of real heart disease benefit."
“It’s a much less demanding developmental process. A ‘go’ or ‘no-go’ decision could be made based on those biomarker results, to reduce risk for companies.”

Given that only a tiny percent of the research and development that drug companies embark on actually warrants coming to the point where it yields an actual drug, the use of clinical tests based on biomarkers makes a much more feasible way for companies to embark on new discoveries and be willing to take a little risk that would be much greater otherwise.

The IOM panel for the Evaluation of Biomarkers of Cardiovascular Disease is similarly focused on evaluating the potential benefit of biomarkers, but for a distinctly different purpose: the Food and Drug Administration wants to evaluate how strong a relationship is between an individual biomarker and an individual food product in order to properly assess health claims related to food products.

As Dr. Krauss explains, “There are a lot of food companies that try to ride the coattails of various research to claim their food product will have benefit because it reduces cholesterol, for example.
"It becomes a very soft predictor if you’re just using one test in the overall contest of the rest of the biology involved. Foods may have a lot of fiber but if they also have a lot of sugar, how does that impact the claim? The FDA is really looking for help with dealing with the complexity of the issue.”

As a result, Dr. Krauss will be helping to spearhead a greater understanding on the part of the FDA of how well certain biomarkers correlate with certain foods.

“We’re basically going to investigate how far we think you can go with the science, how strong is the evidence for a connection between an individual biomarker and reduced heart attacks?” says Dr. Krauss.

Both panels are expected to convene for about 2 years, during which time they will establish both the efficacy of biomarkers as well as protocols for biomarker evaluation.

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Tuesday, May 17, 2011 8:19 AM

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