Barbara Freda06.01.06
It doesn't take more than a quick Google search to reveal the myriad studies currently focusing on the benefits of nutraceuticals and cancer. Part I of this article discussed some of this very research. As a result of growing research interest, more companies are turning their efforts toward developing products that can prevent or treat various cancers.
As the aging population grows, more people are being diagnosed with cancer than ever before. The 2006 American Cancer Society statistics show more than one million new cases are diagnosed every year; at the same time the disease is causing about half as many deaths. This translates into enormous market potential for treatments, including those based on nutraceuticals.
The general population today is also more motivated to maintain health. And while this is a good start, Karen Collins, RD, Nutritional Advisor at the American Institute of Cancer, believes consumers still have a long way to go in terms of education. "What we are learning now is that the health consequences of our eating aren't just limited to consuming less of the bad foods. It's also about getting enough of the good foods. That requires a mind shift," she said. That could be the perfect place for nutraceuticals to enter consumer's thinking. In addition to avoiding the bad, people will, in the future, be looking to get the good things too. And, as noted, studies are showing there appears to be plenty of good on the horizon.
Maitake mushrooms are certainly hot right now. In fact, they have even had some help from Oprah, who has mentioned them on her show. Carmine Lepore, national sales manager of Yukiguni Maitake Corporation of America, says the powder Maitake Gold 404, which is already on the market, has received an Investigational New Drug (IND) number from the FDA and is the focus of a study at Memorial Sloan Kettering Cancer Center. Studies have already shown that these mushrooms have the ability to enhance the immune system of breast cancer patients, which may in turn help improve chemotherapy results and lead to better tumor cell kill.
The Brassica Chemoprotection Laboratory has been hard at work studying broccoli sprouts, which have been found to detoxify carcinogens in the body and fight the chance of developing liver cancer. A human trial in China reached this conclusion, which was enough to lead to a study at Johns Hopkins School of Medicine.
Cranberries, long known to have beneficial effects against urinary tract infections (UTIs), are stirring new interest in the area of cancer, particularly because they have shown promise in fighting the growth of lung and colon cancers, as well as leukemia.
Curcumin, an extract of turmeric-once thought to be little more than a coloring agent-has been found to inhibit tumor growth in a wide range of cancers. The Curcumin C3 Complex has been patented by Sabinsa Corporation and is already on the market.
Few sanctioned health claims can be made about these compounds yet, but enough studies exist that the preponderance of evidence certainly helps the cause.
Jed Fahey, MS, ScD, director of the Brassica Chemoprotection Laboratory, holds some patents in the development and use of the broccoli sprouts and derivative products. He says you can always cite published studies, which are subject to peer review, as evidence of scientific interest in compounds (Fahey is involved in the broccoli sprout study at Johns Hopkins). But, he notes, the industry must be careful about claims, which can be frustrating. The wheels do move slowly. Companies are heartened, though, by good scientific studies that say "this is promising, it can't hurt you, it looks like it probably can help you," Mr. Fahey said.
Steven DeFelice, MD, chairman of The Foundation for Innovation in Medicine (FIM), is concerned about the lack of support from the government and the slow pace of approval of clinical trials, especially in vivo. "It costs a fortune, which prohibits people from conducting these important studies. The FDA policy has a lot to do with that," he says. Dr. DeFelice also blames the difficulty in getting patents for many of these products (although as noted, some have, indeed, been successful). Without patents, there is little financial incentive to do the clinical trials, and without the clinical trials, these studies progress more slowly than they should.
Despite these obstacles the studies continue to be carried out. As these studies advance, so does the study of how these products are going to do the work-fight the cancers. Bioavailability, the idea of how well these compounds are absorbed into the body to do their work, is a hot topic. Vladimir Badmaev, MD, PhD, vice president for scientific and medical affairs at Sabinsa, and one of the researchers involved in Sabinsa's curcumin studies, says this will continue to play an enormous role.
"We can absorb something, but the question is whether it's effective. We have to make sure the target tissue gets the benefit," he says. "It's not what you eat, but what you absorb." Ultimately, he says, these answers are found in human studies.
As the studies continue to pile up and the educational efforts come to fruition, it seems the market for nutraceuticals and cancer is poised to grow explosively. Remember, a big reason why nutraceuticals became a multi-billion dollar business has to do with education.
"The media has played a tremendous role informing the trade and consumers about nutraceutical products, and research that can afford individuals exciting new health benefits, which include preserving their good health," according to Suzanne McNeary, vice president of Tradeworks Group, Inc., which produces MaitakeGold 404.
Along with that education comes regulation. Many producers of these products welcome the regulation. In spite of the fact that it can be frustrating to some, "Regulation can only further strengthen and protect this industry along with consumers' confidence in dietary supplement products," says McNeary, and that means that fewer "bad apples" will be able to take advantage.
Dr. Badmaev, from Sabinsa, believes INDs establish a level for discussion with the FDA. That discussion, he adds, is productive in critiquing the protocol. If the FDA doesn't like the protocol, a company has a chance to fix it, and ultimately the effectiveness of these compounds can be validated.
The study of nutraceuticals and their relationship to fighting cancer is still in its early phases. The medical world and consumers are embracing possible alternative treatments more readily every day. Furthermore, since these products or ingredients are not classified as drugs, successful nutraceuticals may well come to market more quickly.
In spite of the rapid growth in the market, the small companies can't really compete with "big pharma." Instead, said Mr. Lepore of Yukiguni Maitake Corporation of America, "While pharmaceutical companies remain at the forefront of cancer research, nutraceuticals can move along with them. Maybe nutraceuticals can counterbalance the effects of chemotherapy, or work in conjunction with it."
He added, "We don't have to compete, but if we can complement the work drug companies are doing, then why not? The ultimate objective is to make people's lives better, to live longer and eradicate the effects of harmful disease. Each of us can compete and still survive."
As the aging population grows, more people are being diagnosed with cancer than ever before. The 2006 American Cancer Society statistics show more than one million new cases are diagnosed every year; at the same time the disease is causing about half as many deaths. This translates into enormous market potential for treatments, including those based on nutraceuticals.
The general population today is also more motivated to maintain health. And while this is a good start, Karen Collins, RD, Nutritional Advisor at the American Institute of Cancer, believes consumers still have a long way to go in terms of education. "What we are learning now is that the health consequences of our eating aren't just limited to consuming less of the bad foods. It's also about getting enough of the good foods. That requires a mind shift," she said. That could be the perfect place for nutraceuticals to enter consumer's thinking. In addition to avoiding the bad, people will, in the future, be looking to get the good things too. And, as noted, studies are showing there appears to be plenty of good on the horizon.
Mushrooms and Broccoli and Cranberries, Oh My!
Maitake mushrooms are certainly hot right now. In fact, they have even had some help from Oprah, who has mentioned them on her show. Carmine Lepore, national sales manager of Yukiguni Maitake Corporation of America, says the powder Maitake Gold 404, which is already on the market, has received an Investigational New Drug (IND) number from the FDA and is the focus of a study at Memorial Sloan Kettering Cancer Center. Studies have already shown that these mushrooms have the ability to enhance the immune system of breast cancer patients, which may in turn help improve chemotherapy results and lead to better tumor cell kill.
The Brassica Chemoprotection Laboratory has been hard at work studying broccoli sprouts, which have been found to detoxify carcinogens in the body and fight the chance of developing liver cancer. A human trial in China reached this conclusion, which was enough to lead to a study at Johns Hopkins School of Medicine.
Cranberries, long known to have beneficial effects against urinary tract infections (UTIs), are stirring new interest in the area of cancer, particularly because they have shown promise in fighting the growth of lung and colon cancers, as well as leukemia.
Curcumin, an extract of turmeric-once thought to be little more than a coloring agent-has been found to inhibit tumor growth in a wide range of cancers. The Curcumin C3 Complex has been patented by Sabinsa Corporation and is already on the market.
Compiling the Evidence
Few sanctioned health claims can be made about these compounds yet, but enough studies exist that the preponderance of evidence certainly helps the cause.
Jed Fahey, MS, ScD, director of the Brassica Chemoprotection Laboratory, holds some patents in the development and use of the broccoli sprouts and derivative products. He says you can always cite published studies, which are subject to peer review, as evidence of scientific interest in compounds (Fahey is involved in the broccoli sprout study at Johns Hopkins). But, he notes, the industry must be careful about claims, which can be frustrating. The wheels do move slowly. Companies are heartened, though, by good scientific studies that say "this is promising, it can't hurt you, it looks like it probably can help you," Mr. Fahey said.
Steven DeFelice, MD, chairman of The Foundation for Innovation in Medicine (FIM), is concerned about the lack of support from the government and the slow pace of approval of clinical trials, especially in vivo. "It costs a fortune, which prohibits people from conducting these important studies. The FDA policy has a lot to do with that," he says. Dr. DeFelice also blames the difficulty in getting patents for many of these products (although as noted, some have, indeed, been successful). Without patents, there is little financial incentive to do the clinical trials, and without the clinical trials, these studies progress more slowly than they should.
Despite these obstacles the studies continue to be carried out. As these studies advance, so does the study of how these products are going to do the work-fight the cancers. Bioavailability, the idea of how well these compounds are absorbed into the body to do their work, is a hot topic. Vladimir Badmaev, MD, PhD, vice president for scientific and medical affairs at Sabinsa, and one of the researchers involved in Sabinsa's curcumin studies, says this will continue to play an enormous role.
"We can absorb something, but the question is whether it's effective. We have to make sure the target tissue gets the benefit," he says. "It's not what you eat, but what you absorb." Ultimately, he says, these answers are found in human studies.
Education & Regulation
As the studies continue to pile up and the educational efforts come to fruition, it seems the market for nutraceuticals and cancer is poised to grow explosively. Remember, a big reason why nutraceuticals became a multi-billion dollar business has to do with education.
"The media has played a tremendous role informing the trade and consumers about nutraceutical products, and research that can afford individuals exciting new health benefits, which include preserving their good health," according to Suzanne McNeary, vice president of Tradeworks Group, Inc., which produces MaitakeGold 404.
Along with that education comes regulation. Many producers of these products welcome the regulation. In spite of the fact that it can be frustrating to some, "Regulation can only further strengthen and protect this industry along with consumers' confidence in dietary supplement products," says McNeary, and that means that fewer "bad apples" will be able to take advantage.
Dr. Badmaev, from Sabinsa, believes INDs establish a level for discussion with the FDA. That discussion, he adds, is productive in critiquing the protocol. If the FDA doesn't like the protocol, a company has a chance to fix it, and ultimately the effectiveness of these compounds can be validated.
Near Future
The study of nutraceuticals and their relationship to fighting cancer is still in its early phases. The medical world and consumers are embracing possible alternative treatments more readily every day. Furthermore, since these products or ingredients are not classified as drugs, successful nutraceuticals may well come to market more quickly.
In spite of the rapid growth in the market, the small companies can't really compete with "big pharma." Instead, said Mr. Lepore of Yukiguni Maitake Corporation of America, "While pharmaceutical companies remain at the forefront of cancer research, nutraceuticals can move along with them. Maybe nutraceuticals can counterbalance the effects of chemotherapy, or work in conjunction with it."
He added, "We don't have to compete, but if we can complement the work drug companies are doing, then why not? The ultimate objective is to make people's lives better, to live longer and eradicate the effects of harmful disease. Each of us can compete and still survive."
