In this health video you will learn about the cancer prevention trials that are taking place.
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Dr. Mark Whitacre: Paul, what is Cypress's involvement with the National Cancer Institute, commonly known as the NCI? Paul A. Willis: To really answer that, I need to back up a little bit in history, back to the 1980s when we developed, then at Fleischmann's Yeast, we developed the high Selenium yeast, the organically bound form of Selenium that was used in the clinical cancer prevention trial called the Nutritional Prevention of Cancer Trial, conducted by Dr. Larry Clark and Jerry Combs, Dr. Gerald Combs, then at Cornell University. Our involvement then was to supply the intervention agent that was used in that trial, the 200 microgram supplementation and the placebo for that product. Really, the trial ran for 14 years until 1994 and was unblinded in 94 and published in the Journal of American Medical Association in 1996 because it showed a 50-63% reduction in colon, lung and prostate cancer. So our involvement with the National Cancer Institute really stems from our involvement in that trial and the publication in the Journal of the American Medical Association. Following that publication, on Christmas Eve of 1996, it was deemed to be a landmark trial. It was the first time that a nutritional agent like Selenium and organically bound Selenium had been shown to prevent cancer to that level. It was a landmark. It was a paradigm shift in the way the oncology world was looking at the prevention of cancer. We're going for a public health recommendation, much like oat and oat fiber reduces cholesterol, and we see that on our Cheerios, and this type of thing. We're going for a public health recommendation with the FDA, that Selenium and SelenoExcell, the organically bound form will prevent cancer. That's a long process, a very rigorous process, and it should be. If we're going to recommend to our public through their nutrition an ingredient, it should be a very rigorous process. In order to do that, we have to do what's called confirming trials. We can't make that decision on even a gold standard trial like the NPC Trial. We can't make that kind of recommendation on one single trial. So the oncology groups, the oncology world, the research community began putting together grant applications related to confirming the original NPC Trial results. Before the National Cancer Institute would proceed with ongoing research, they wanted the product to be standardized, because many times in the pharmaceutical area we're dealing with a single chemical compound which is well defined. But in this area, we're dealing with a food form of organically bound Selenium. So there are a lot of opportunities for variability there unless the product was standardized. In fact, in the industry, the nutritional industry, we have many adulterated type products where the true nature of the product is that the yeast has been grown in a Selenium rich environment. It has organically bound all of the Selenium into its protein structure and there is no free inorganic Selenium available. But unfortunately in many cases, we have products that are out there that are dealing with brewer's yeast, which comes from beer manufacturing and they're just dumping inorganic Selenium in and blending it up and calling it a high Selenium yeast. So, the National Cancer Institute was, prior to going on with ongoing research, was very concerned with the lack of standardization. So we began a two year effort in 1997 of showing them the standard for the product, that fundamentally, the number one standard is it has to be 100% organically bound Selenium. Then much like you would with any other product you manufacture, whether it would be a food product or any product, you want to set a standard that shows that there is minimal variance in it. You know what you're doing. So we showed them from batch to batch that we could produce a product that was fully replicated. It was the same every time. And through this process we gave them the confidence that there truly was a standard