One of the most common problems in cancer patients who choose to undergo conventional cancer therapy is recurrence. They might think they have beaten their cancer with chemotherapy, radiation, and surgery, only to find a few years later that tumors have spread into other tissues -- usually the lungs, brain, or even the reproductive organs. Conventional medicine has not yet caught on to what's happening here, but the reason why this phenomenon occurs is quite simple: Conventional cancer treatments only treat the symptoms of cancer (tumors or growths) and do not actually do anything to help the patient regain a level of health necessary to keep cancer in check.A tumor is not technically a disease. It is a symptom of an underlying imbalance in the patient. Unless you treat and reverse the underlying imbalances, you will never eliminate the underlying cause of the cancer. You will continue to see more tumors and complications, even if you are able to treat the first tumors.Think of it like this: suppose you have a dam holding up a body of water such as a lake. One day, due to poor maintenance, the dam begins to crack and water starts leaking through. In the world of conventional cancer treatment, they would say the problem is the water, and they would begin treating the water. They would try to evaporate the water or eliminate the water from flooding the valley below. But the problem isn't the water leaking through the dam; the problem is the integrity of the dam itself. Unless you diagnose the problem with the dam and repair it, then you will never stop the leaking water. The same is true with cancer. Unless you address the underlying integrity of the immune system and the body's self-repairing technology, all you're doing is chasing symptoms. You can treat all the cancer tumors in the world and still do nothing to actually help the cancer patient solve his or her underlying problem.
The cancer industry remains ignorant of useful treatmentsAmazingly, after decades of research, and billions of dollars spent on cancer research, the conventional cancer industry remains oblivious to this simple truth about cancer. They don't teach cancer prevention, and they don't believe in cancer cures even though many exist. They are still treating the water rather than the dam by treating the tumors rather than the underlying problem. Conventional cancer treatments actually harm the patient and the patient's immune system, making it even more difficult to overcome cancer in the future. Chemotherapy harms the immune system and impairs organs such as the brain, liver, and the heart. It's sort of like using TNT to blow out the water leaking through the dam. You destroy the dam at the same time. It leaves the patient unable to stop the progression of the cancer. The real answers to cancer prevention and cure are found in nutrition, exercise, reduction of stress, and avoidance of environmental chemicals and toxins. Chemotherapy is not a cure for cancer, nor is radiation, because both of those treatments actually cause cancer.When you poison the immune system and irradiate tissues, you create physical imbalances which in turn can create cancer. This is the simple reason why so many people who subject themselves to conventional cancer treatments find themselves battling recurring cancer years later.
Where to start with curing cancerThe bottom line is that conventional cancer treatments are a sham and they do nothing to help the patient overcome the causes of cancer. They do a great job of creating repeat business for the cancer industry, however, and pharmaceutical companies now have a reliable market for the anticancer chemicals that have now become mainstream treatments for this entirely preventable and curable disease. But if you want to really cure cancer, you've got to focus on detoxification and healing from the inside out. Nearly all cases of cancer are caused in part by a burden of toxic, synthetic chemicals lodged in the liver, heart and digestive tract. Eliminating those is the first step towards a real cure, and cleansing the liver is probably the single most important thing to do when seeking to cure your own cancer (or to have a "permanent remission" as conventional oncologists might call it, since they don't believe there is such a thing as a cure for cancer).So, how do you cleanse your liver? I could write an entire article just on that, but here's something to get you started on what to investigate: The best modalities for liver cleansing are, in my opinion, Traditional Chinese Medicine and rainforest herbs (Amazon herbs). I'll be writing a lot more about Amazon Herbs in the next day or two, so come back to read more about that if you want to learn about which herbs and herbal products are best at removing toxins from your liver (and restoring healthy liver function).
Friday, September 7, 2007
Canadian Cancer Society announces national program to prevent cancer using vitamin D
Canada has done what the U.S. refuses to do: Protect the health of its people through a national program of encouraging vitamin D supplementation. While U.S. cancer groups like the American Cancer Society stubbornly refuse to acknowledge the benefits of vitamin D supplements in cancer prevention, the Canadian Cancer Society is launching a program to make sure every Canadian citizen receives a level of vitamin D sufficient to prevent most cancers, including breast cancer.The U.S., in contrast, has no interest in preventing cancer... even when a simple, virtually free substance like vitamin D could drop national cancer rates by more than 75 percent.New research published this month shows that vitamin D supplementation produces an astonishing 77 percent reduction in all cancers in women, making it the single most effective medicine for preventing cancer that has ever been discovered by modern medical science. The American Cancer Society, however, seems stuck in the nutritional dogma of the 1950's and continues to claim that only drugs, radiation and surgery can treat cancer, and that nutritional supplements have no role to play whatsoever in cancer prevention. This view is so out of date that it belongs in a museum of medicine, not on the agenda of an advanced nation. (Stating that vitamin D has no useful role in preventing cancer is as hopelessly outdated as claiming the Earth is flat.)
The politics of cancer: Keep 'em sick!As usual, America's abandonment of the world's best natural anti-cancer medicine has nothing at all to do with science, but everything to do with politics and profits. If vitamin D were a cancer drug made by Pfizer, the American Cancer Society would likely be pushing it as the next "miracle" drug and calling for everyone to be put on the drug. But since it's a nutrient that cannot be patented, and can actually be manufactured for free by exposing your skin to natural sunlight, the entire U.S. cancer industry now laughingly pretends that vitamin D supplementation offers no benefits.Each day that the American Cancer Society, the AMA, the FDA and others in conventional medicine refuse to acknowledge the benefits of vitamin D supplements for preventing cancer, they lose yet more credibility and slip one step closer towards global humiliation and irrelevance. It is difficult to imagine how anyone from conventional medicine can show up at a health event and say, with a straight face, that they're doing everything they can to fight cancer when in reality they are willfully ignoring a prevention medicine that really works: Vitamin D. It's simple, safe and virtually free, and it has no negative side effects, requires no patent royalties, and is available right now to everyone.If there were ever a cancer prevention strategy to get behind, this is it! The people in the cancer industry, if they had any sense, should be leaping out of their chairs, fumbling over each other in a mad rush to the press conference podium to announce their support for vitamin D. And yet what do we hear in the United States? Complete apathy. It's as if these people somehow believe that a vitamin manufactured by the human body itself has no role in human nutrition. The depth of blind ignorance at work here is mind boggling. Someone should actually start a psychological study of the people in the cancer industry to figure out how their minds can work that way. It should be called, "The Madness of Crowds and the Illusion of Cancer Treatments in Western Medicine."To not get behind vitamin D is to miss the cancer prevention opportunity of a lifetime. Imagine: For every 100 women that will someday get breast cancer, more than 75 of them could entirely avoid breast cancer through the use of vitamin D. That's 75 women out of 100 who could have their health (and their lives) given back to them through a nutrient that is essentially free. (Add in green tea and some rainforest herbs, and this number leaps to around 90 percent, by the way.) Why wouldn't everyone in the cancer industry want to save 75% of these women from breast cancer?I'll tell you why, and you won't like the answer. It's because the cancer industry depends on all 100 of those women being diagnosed with cancer and treated with profitable cancer "management" protocols like chemotherapy, radiation and surgery. Preventing cancer in 75 percent of women (or more) would deny the cancer industry three-fourths of its revenue. It would shrink the industry, reduce funding, and result in a mass exodus of cancer jobs. Donations would dry up and cancer non-profits (which thrive on the continuation of cancer) would lose big. This is why they won't support cancer prevention that really works. Preventing cancer is simply not in the self interest of the cancer industry. Prevention is bad for business.
When will America show interest in cancer prevention?Canada, not surprisingly, is a little quicker to catch on to the enormous benefits of vitamin D in preventing cancer. "We are monitoring the evidence and believe there is a real role for vitamin D to reduce our risk for cancer and so far there are very few side effects," the Cancer Society's Heather Logan said in a CTV News report. Actually, there are side effects: Reduced risk of diabetes, obesity, depression, mental disorders and all sorts of cancers. Vitamin D is the miracle medicine the cancer industry claims it's searching for when it asks you to donate for those "run for the cure" events. But the cure already exists, and it's available for free.When it comes to the cancer industry, Canada is the first western nation to stand up and say, "The Emperor has no clothes!" It makes you wonder how long it's going to take before America will finally stop supporting the cancer industry at the expense of hundreds of thousands of lives each year and, instead, start getting serious about cancer prevention. How many Americans have to die before the criminally-operated U.S. cancer industry will be forced to let go of its stranglehold over the American public and finally acknowledge that we can slash national cancer rates by nearly 80% right now by urging people to get more sunlight and vitamin D?Corporations and governments, of course, view lives as expendable. Encouraging sickness, disease and cancer is a high priority to those who profit from such sickness. And if a few hundred thousand Americans have to die in order to meet next quarter's corporate profits, then so be it. Americans are expendable. Lives are cheap. They're so cheap, in fact, that most of the people living in America today take no steps to protect themselves against cancer. I guess some corporations figure, hey, if the people are willingly giving themselves cancer through their foods, cigarettes, toxic cosmetics and chemical exposures, then why should we stop them?
Screening and treatment = Recruiting and profit-takingThe more cancer there is, the richer the drug companies and radiological equipment manufacturers become. More cancer means more profit, and more profit means more influence in Washington. And that explains why nobody in Washington seems to express any interest whatsoever in actually preventing cancer in this country. (Trying to get lawmakers to pass a cancer prevention bill is about as useless as trying to get them to pay off the national debt and balance the federal budget.)With the cancer industry, the entire focus is on "screening" and "treatment." Those terms can be more accurately translated into "recruiting" and "profit-taking." Screening is simply a way to recruit patients into a highly profitable assembly line of cancer treatments which offer no cures and no prevention, only the "management" of the disease so that the maximum profits can be extracted from the patient without actually eliminating their disease. It's quite a clever scam, and it explains why screening is so often offered for free: It's just like a crack dealer offering a free hit, but only once. After you're hooked, you gotta pay.The cancer industry tries to promote this "recruiting & profit-taking" propaganda through lies like, "Early detection saves lives." Oh really? Actually, early detection generates more profits, since 9 out of 10 "early detection" positives are, in fact, completely bogus. The cancer detection technology today is so incredibly advanced that it can even detect cancers that aren't there! (And then the patient is urged to undergo chemotherapy "just in case.")
Prevention is the only real solutionThe only way out of this cancer madness is through prevention. As Dr. Cedric Garland, professor at University of California, San Diego, Department of Family and Preventive Medicine and Moores Cancer Center said about Canada's decision, "I think this is an important and historic step in the right direction. I think it will offer leadership in the world... as Canada will be the first country in the world to adopt this public health recommendation... Over time, this finding has the potential of eliminating a quarter of a million cases of cancer in North America annually and about 100,000 deaths from cancer annually."The U.S., of course, will likely be the last modern nation to reluctantly admit that cancer can be prevented with vitamin D. That's because the U.S. is "profit central" for the disease industry that preys upon cancer victims and, in fact, encourages cancer by actively preventing cancer prevention. To learn more, click here to see my previous article on the cancer industry and vitamin D.The U.S. government has no interested in protecting its citizens from disease. Rather, the government actually conspires with pharmaceutical companies and non-profit disease groups to keep the American public in a state of chronic disease through nutritional deficiencies, exposure to toxic chemicals and side effects of pharmaceuticals. And it's working! The U.S. is the most diseased nation in the world, sporting higher rates of degenerative disease (cancer, diabetes, heart disease, depression and obesity, combined) than any other nation. On top of that -- get this -- we pay the highest health care costs in the world!All that money apparently isn't doing any good. Meanwhile, free cures for cancer are available right now in the form of natural sunlight. Nearly-free prevention methods are well documented and include nutritional supplementation with vitamin D. We know how to prevent cancer, it's just that the corrupt politicians and dirty non-profits in charge of this country won't allow the disease to be prevented at all. There's too much money to be made in treating cancer, and there's no incentive whatsoever to teach the public how to prevent cancer and avoid becoming cancer patients.
The curtain is closing on America's futureAmerica is a public health disaster. And it's going to pay the ultimate price: As I've stated before, I believe that health care costs and the mass poisoning of the American people will ultimately cause this nation to self destruct. The "America experiment" is nearly over, and when the whole giant mass of disease and debt collapses, we're going to be left with a nation of mutant humans hopped up on pharmaceuticals... infertile, mentally impaired, emotionally imbalanced and nutritionally devastated.We have very nearly lost the battle for the future of this country. The next generation of Americans is already being raised on junk foods, dosed on Ritalin, injected with mercury vaccines, coated in toxic sunscreen chemicals and taught a lifestyle of debt, over-consumption and use of natural resources that simply cannot be sustained for even one more generation. When reality hits the fan, these kids are going to be shocked beyond belief. They have no clue of the tidal wave of poverty, misery and destruction headed their way, courtesy of the extremely corrupt political leaders who have sold out the future of this country in order to win their next election.Cancer is one area where the science clearly and inarguably shows how we could save trillions of dollars and millions of lives over the next century. Here's a segment repeated from my previous story on vitamin D. It's important. Soak this in:Did you know that reducing the cancer death rate by just 1% would be worth almost $500 billion to the U.S. economy over the next hundred years or so? (Source: Centers for Disease Control and Prevention.) Drop the cancer rate by 10% and it's worth $5 trillion dollars to the economy. These gains are due to increased productivity and life spans of working, contributing people.We know right now that vitamin D and calcium can slash cancer rates by 77 percent. Do the math on that, and you realize that sunlight and calcium could result in a $38.5 trillion boost to the U.S. economy over the next century.That's enough economic productivity to pay off our entire national debt, build new schools in every town and city in the country, provide free college educations to all young people who wish to go to college, invest billions in new energy technologies and even fund massive health education campaigns to keep our population healthy. With that kind of increased abundance, we could build a whole new society of health, wealth and education.That's the future being denied by the cancer industry today. They have sold out our future in a desperate grab for next quarter's profits. They're not interested in the future of America, or the health of future generations or even the pain and suffering of people battling cancer right now. They're only interested in one thing: Power. Power over people and money. And the more cancer that exists in the world, the more power they have. Cancer prevention is a threat to the cancer industry, pure and simple. And yet, at the same time, the cancer industry is a threat to America's future. We cannot save this nation from self destruction if half our population is dying from cancer. (That statement should seem obvious, but it's way over the head of just about every politician in Washington these days.)
Action itemsHere's what you do:1) Get natural sunlight on your skin as often as you can. The darker your skin, the more sunlight you need. Read our free report on sunlight and vitamin D for more detailed tips.2) Never, ever submit to chemotherapy or radiation. These procedures cause severe harm and can ultimately kill you. Seek naturopathic cancer therapies only. Don't submit to mammograms, either, since they actually cause cancer!3) Don't ever give financial support to prominent cancer non-profits, which are almost universally allied with drug companies and radiology equipment manufacturers.4) Don't get suckered into visiting an oncologist. Using fear, intimidation and authority, they will lure you into an extremely harmful system of treatments that are dangerous to human health. Instead, visit naturopathic physicians only (N.D.).5) Prevent cancer in your own life by getting sunlight, eating lots of raw, fresh produce, taking superfood supplements (like spirulina, green tea and rainforest herbs) and engaging in regular exercise. Two of the best anti-cancer supplements I know of are Blood Support from www.BaselineNutritionals.com and Arcozon from the Amazon Herb Company: www.amazondreams.amazonherb.net (Note: I have absolutely no financial interest in any products mentioned in this article)6) Avoid all cancer-causing food ingredients (like sodium nitrite), cosmetics (all popular brands), personal care products, home cleaning products, cigarettes, etc. Nearly everyone who has cancer gave it to themselves! You can avoid that by avoiding the things that promote cancer (like hair coloring chemicals, nail polish, chlorine pools, etc.)7) Educate yourself. The more ignorant you remain of cancer, the more easily the cancer industry can manipulate you and seduce you into their system of harmful treatments. By teaching yourself the truth about cancer prevention, you'll avoid being exploited by an oncologist.Finally, I'd like you to know that among the well informed natural health practitioners, cancer is considered as easily curable disease in stages 1 - 3. (Only late-stage cancer is challenging.) One alternative cancer doc I know of describes cancer as, "More easily curable than the common cold." He has helped thousands cure cancer. Curing cancer is incredibly easy when you use natural medicine and make radical changes to your diet and lifestyle. Conventional medicine, however, is clueless, and conventional therapies like chemotherapy actually make the patient weaker and more susceptible to cancer. Once you undergo chemotherapy, all bets are off. Your immune system is severely compromised. So in my opinion, avoiding chemotherapy is essential to curing cancer.And don't think you can "play it safe" and do both chemotherapy and natural medicine. You have to make a choice: Death or life. If you want death, go with chemotherapy. It's known as "legalized euthanasia" in medical circles. But if you want to live, go with natural medicine.
There's really no such thing as "cancer"Remember this: I've had cancer a thousand times in my life already. So have you. We beat it automatically, unknowingly, routinely... with a functioning immune system and a little help from nature's medicines (found in foods and botanicals). Every person gets cancerous cells in their body, no exceptions. So don't be scared by talk that you've "GOT cancer." There is actually no such thing as a "cancer" disease. It's simply a name that doctors have given to observable symptoms that they can make money treating. A cancer tumor is not a disease, it is a symptom of a severe metabolic or immunological imbalance. You can't cure cancer by removing the symptom, you can only cure it by rebalancing the body and activating the body's own natural anti-cancer defenses.Preventing cancer is child's play. It's so simple that it should be taught in the first grade. And yet the whole subject mystifies all the cancer doctors and researchers who remain stuck in the upside-down universe of chemical treatments and medical reductionism. It's amazing how people who are so smart can ultimately act so stupid. But it just goes to show you: Being book smart doesn't necessarily help you in the real world. I'd rather be "sun smart" and soak up some healthy rays while the pale-skinned genius cancer docs are choking down chemo drugs and trying to figure out why they're all so diseased.Some folks just don't get it. You won't find answers in that microscope, my friends. Back away from the technical gear and start to look at the big picture: The human experience, the planet, the universe... nature! This is where the answers are found, on the macroscopic scale, not the microscopic. Mark my words: Cancer will never be cured chemically. It can only be prevented and overcome holistically. The massive "search for a cure" was doomed to fail from the very start, because it could not (and still cannot) view a patient from a holistic perspective.
The politics of cancer: Keep 'em sick!As usual, America's abandonment of the world's best natural anti-cancer medicine has nothing at all to do with science, but everything to do with politics and profits. If vitamin D were a cancer drug made by Pfizer, the American Cancer Society would likely be pushing it as the next "miracle" drug and calling for everyone to be put on the drug. But since it's a nutrient that cannot be patented, and can actually be manufactured for free by exposing your skin to natural sunlight, the entire U.S. cancer industry now laughingly pretends that vitamin D supplementation offers no benefits.Each day that the American Cancer Society, the AMA, the FDA and others in conventional medicine refuse to acknowledge the benefits of vitamin D supplements for preventing cancer, they lose yet more credibility and slip one step closer towards global humiliation and irrelevance. It is difficult to imagine how anyone from conventional medicine can show up at a health event and say, with a straight face, that they're doing everything they can to fight cancer when in reality they are willfully ignoring a prevention medicine that really works: Vitamin D. It's simple, safe and virtually free, and it has no negative side effects, requires no patent royalties, and is available right now to everyone.If there were ever a cancer prevention strategy to get behind, this is it! The people in the cancer industry, if they had any sense, should be leaping out of their chairs, fumbling over each other in a mad rush to the press conference podium to announce their support for vitamin D. And yet what do we hear in the United States? Complete apathy. It's as if these people somehow believe that a vitamin manufactured by the human body itself has no role in human nutrition. The depth of blind ignorance at work here is mind boggling. Someone should actually start a psychological study of the people in the cancer industry to figure out how their minds can work that way. It should be called, "The Madness of Crowds and the Illusion of Cancer Treatments in Western Medicine."To not get behind vitamin D is to miss the cancer prevention opportunity of a lifetime. Imagine: For every 100 women that will someday get breast cancer, more than 75 of them could entirely avoid breast cancer through the use of vitamin D. That's 75 women out of 100 who could have their health (and their lives) given back to them through a nutrient that is essentially free. (Add in green tea and some rainforest herbs, and this number leaps to around 90 percent, by the way.) Why wouldn't everyone in the cancer industry want to save 75% of these women from breast cancer?I'll tell you why, and you won't like the answer. It's because the cancer industry depends on all 100 of those women being diagnosed with cancer and treated with profitable cancer "management" protocols like chemotherapy, radiation and surgery. Preventing cancer in 75 percent of women (or more) would deny the cancer industry three-fourths of its revenue. It would shrink the industry, reduce funding, and result in a mass exodus of cancer jobs. Donations would dry up and cancer non-profits (which thrive on the continuation of cancer) would lose big. This is why they won't support cancer prevention that really works. Preventing cancer is simply not in the self interest of the cancer industry. Prevention is bad for business.
When will America show interest in cancer prevention?Canada, not surprisingly, is a little quicker to catch on to the enormous benefits of vitamin D in preventing cancer. "We are monitoring the evidence and believe there is a real role for vitamin D to reduce our risk for cancer and so far there are very few side effects," the Cancer Society's Heather Logan said in a CTV News report. Actually, there are side effects: Reduced risk of diabetes, obesity, depression, mental disorders and all sorts of cancers. Vitamin D is the miracle medicine the cancer industry claims it's searching for when it asks you to donate for those "run for the cure" events. But the cure already exists, and it's available for free.When it comes to the cancer industry, Canada is the first western nation to stand up and say, "The Emperor has no clothes!" It makes you wonder how long it's going to take before America will finally stop supporting the cancer industry at the expense of hundreds of thousands of lives each year and, instead, start getting serious about cancer prevention. How many Americans have to die before the criminally-operated U.S. cancer industry will be forced to let go of its stranglehold over the American public and finally acknowledge that we can slash national cancer rates by nearly 80% right now by urging people to get more sunlight and vitamin D?Corporations and governments, of course, view lives as expendable. Encouraging sickness, disease and cancer is a high priority to those who profit from such sickness. And if a few hundred thousand Americans have to die in order to meet next quarter's corporate profits, then so be it. Americans are expendable. Lives are cheap. They're so cheap, in fact, that most of the people living in America today take no steps to protect themselves against cancer. I guess some corporations figure, hey, if the people are willingly giving themselves cancer through their foods, cigarettes, toxic cosmetics and chemical exposures, then why should we stop them?
Screening and treatment = Recruiting and profit-takingThe more cancer there is, the richer the drug companies and radiological equipment manufacturers become. More cancer means more profit, and more profit means more influence in Washington. And that explains why nobody in Washington seems to express any interest whatsoever in actually preventing cancer in this country. (Trying to get lawmakers to pass a cancer prevention bill is about as useless as trying to get them to pay off the national debt and balance the federal budget.)With the cancer industry, the entire focus is on "screening" and "treatment." Those terms can be more accurately translated into "recruiting" and "profit-taking." Screening is simply a way to recruit patients into a highly profitable assembly line of cancer treatments which offer no cures and no prevention, only the "management" of the disease so that the maximum profits can be extracted from the patient without actually eliminating their disease. It's quite a clever scam, and it explains why screening is so often offered for free: It's just like a crack dealer offering a free hit, but only once. After you're hooked, you gotta pay.The cancer industry tries to promote this "recruiting & profit-taking" propaganda through lies like, "Early detection saves lives." Oh really? Actually, early detection generates more profits, since 9 out of 10 "early detection" positives are, in fact, completely bogus. The cancer detection technology today is so incredibly advanced that it can even detect cancers that aren't there! (And then the patient is urged to undergo chemotherapy "just in case.")
Prevention is the only real solutionThe only way out of this cancer madness is through prevention. As Dr. Cedric Garland, professor at University of California, San Diego, Department of Family and Preventive Medicine and Moores Cancer Center said about Canada's decision, "I think this is an important and historic step in the right direction. I think it will offer leadership in the world... as Canada will be the first country in the world to adopt this public health recommendation... Over time, this finding has the potential of eliminating a quarter of a million cases of cancer in North America annually and about 100,000 deaths from cancer annually."The U.S., of course, will likely be the last modern nation to reluctantly admit that cancer can be prevented with vitamin D. That's because the U.S. is "profit central" for the disease industry that preys upon cancer victims and, in fact, encourages cancer by actively preventing cancer prevention. To learn more, click here to see my previous article on the cancer industry and vitamin D.The U.S. government has no interested in protecting its citizens from disease. Rather, the government actually conspires with pharmaceutical companies and non-profit disease groups to keep the American public in a state of chronic disease through nutritional deficiencies, exposure to toxic chemicals and side effects of pharmaceuticals. And it's working! The U.S. is the most diseased nation in the world, sporting higher rates of degenerative disease (cancer, diabetes, heart disease, depression and obesity, combined) than any other nation. On top of that -- get this -- we pay the highest health care costs in the world!All that money apparently isn't doing any good. Meanwhile, free cures for cancer are available right now in the form of natural sunlight. Nearly-free prevention methods are well documented and include nutritional supplementation with vitamin D. We know how to prevent cancer, it's just that the corrupt politicians and dirty non-profits in charge of this country won't allow the disease to be prevented at all. There's too much money to be made in treating cancer, and there's no incentive whatsoever to teach the public how to prevent cancer and avoid becoming cancer patients.
The curtain is closing on America's futureAmerica is a public health disaster. And it's going to pay the ultimate price: As I've stated before, I believe that health care costs and the mass poisoning of the American people will ultimately cause this nation to self destruct. The "America experiment" is nearly over, and when the whole giant mass of disease and debt collapses, we're going to be left with a nation of mutant humans hopped up on pharmaceuticals... infertile, mentally impaired, emotionally imbalanced and nutritionally devastated.We have very nearly lost the battle for the future of this country. The next generation of Americans is already being raised on junk foods, dosed on Ritalin, injected with mercury vaccines, coated in toxic sunscreen chemicals and taught a lifestyle of debt, over-consumption and use of natural resources that simply cannot be sustained for even one more generation. When reality hits the fan, these kids are going to be shocked beyond belief. They have no clue of the tidal wave of poverty, misery and destruction headed their way, courtesy of the extremely corrupt political leaders who have sold out the future of this country in order to win their next election.Cancer is one area where the science clearly and inarguably shows how we could save trillions of dollars and millions of lives over the next century. Here's a segment repeated from my previous story on vitamin D. It's important. Soak this in:Did you know that reducing the cancer death rate by just 1% would be worth almost $500 billion to the U.S. economy over the next hundred years or so? (Source: Centers for Disease Control and Prevention.) Drop the cancer rate by 10% and it's worth $5 trillion dollars to the economy. These gains are due to increased productivity and life spans of working, contributing people.We know right now that vitamin D and calcium can slash cancer rates by 77 percent. Do the math on that, and you realize that sunlight and calcium could result in a $38.5 trillion boost to the U.S. economy over the next century.That's enough economic productivity to pay off our entire national debt, build new schools in every town and city in the country, provide free college educations to all young people who wish to go to college, invest billions in new energy technologies and even fund massive health education campaigns to keep our population healthy. With that kind of increased abundance, we could build a whole new society of health, wealth and education.That's the future being denied by the cancer industry today. They have sold out our future in a desperate grab for next quarter's profits. They're not interested in the future of America, or the health of future generations or even the pain and suffering of people battling cancer right now. They're only interested in one thing: Power. Power over people and money. And the more cancer that exists in the world, the more power they have. Cancer prevention is a threat to the cancer industry, pure and simple. And yet, at the same time, the cancer industry is a threat to America's future. We cannot save this nation from self destruction if half our population is dying from cancer. (That statement should seem obvious, but it's way over the head of just about every politician in Washington these days.)
Action itemsHere's what you do:1) Get natural sunlight on your skin as often as you can. The darker your skin, the more sunlight you need. Read our free report on sunlight and vitamin D for more detailed tips.2) Never, ever submit to chemotherapy or radiation. These procedures cause severe harm and can ultimately kill you. Seek naturopathic cancer therapies only. Don't submit to mammograms, either, since they actually cause cancer!3) Don't ever give financial support to prominent cancer non-profits, which are almost universally allied with drug companies and radiology equipment manufacturers.4) Don't get suckered into visiting an oncologist. Using fear, intimidation and authority, they will lure you into an extremely harmful system of treatments that are dangerous to human health. Instead, visit naturopathic physicians only (N.D.).5) Prevent cancer in your own life by getting sunlight, eating lots of raw, fresh produce, taking superfood supplements (like spirulina, green tea and rainforest herbs) and engaging in regular exercise. Two of the best anti-cancer supplements I know of are Blood Support from www.BaselineNutritionals.com and Arcozon from the Amazon Herb Company: www.amazondreams.amazonherb.net (Note: I have absolutely no financial interest in any products mentioned in this article)6) Avoid all cancer-causing food ingredients (like sodium nitrite), cosmetics (all popular brands), personal care products, home cleaning products, cigarettes, etc. Nearly everyone who has cancer gave it to themselves! You can avoid that by avoiding the things that promote cancer (like hair coloring chemicals, nail polish, chlorine pools, etc.)7) Educate yourself. The more ignorant you remain of cancer, the more easily the cancer industry can manipulate you and seduce you into their system of harmful treatments. By teaching yourself the truth about cancer prevention, you'll avoid being exploited by an oncologist.Finally, I'd like you to know that among the well informed natural health practitioners, cancer is considered as easily curable disease in stages 1 - 3. (Only late-stage cancer is challenging.) One alternative cancer doc I know of describes cancer as, "More easily curable than the common cold." He has helped thousands cure cancer. Curing cancer is incredibly easy when you use natural medicine and make radical changes to your diet and lifestyle. Conventional medicine, however, is clueless, and conventional therapies like chemotherapy actually make the patient weaker and more susceptible to cancer. Once you undergo chemotherapy, all bets are off. Your immune system is severely compromised. So in my opinion, avoiding chemotherapy is essential to curing cancer.And don't think you can "play it safe" and do both chemotherapy and natural medicine. You have to make a choice: Death or life. If you want death, go with chemotherapy. It's known as "legalized euthanasia" in medical circles. But if you want to live, go with natural medicine.
There's really no such thing as "cancer"Remember this: I've had cancer a thousand times in my life already. So have you. We beat it automatically, unknowingly, routinely... with a functioning immune system and a little help from nature's medicines (found in foods and botanicals). Every person gets cancerous cells in their body, no exceptions. So don't be scared by talk that you've "GOT cancer." There is actually no such thing as a "cancer" disease. It's simply a name that doctors have given to observable symptoms that they can make money treating. A cancer tumor is not a disease, it is a symptom of a severe metabolic or immunological imbalance. You can't cure cancer by removing the symptom, you can only cure it by rebalancing the body and activating the body's own natural anti-cancer defenses.Preventing cancer is child's play. It's so simple that it should be taught in the first grade. And yet the whole subject mystifies all the cancer doctors and researchers who remain stuck in the upside-down universe of chemical treatments and medical reductionism. It's amazing how people who are so smart can ultimately act so stupid. But it just goes to show you: Being book smart doesn't necessarily help you in the real world. I'd rather be "sun smart" and soak up some healthy rays while the pale-skinned genius cancer docs are choking down chemo drugs and trying to figure out why they're all so diseased.Some folks just don't get it. You won't find answers in that microscope, my friends. Back away from the technical gear and start to look at the big picture: The human experience, the planet, the universe... nature! This is where the answers are found, on the macroscopic scale, not the microscopic. Mark my words: Cancer will never be cured chemically. It can only be prevented and overcome holistically. The massive "search for a cure" was doomed to fail from the very start, because it could not (and still cannot) view a patient from a holistic perspective.
Aspartame found to cause breast cancer, leukemia and lymphomas in latest animal experiments
A new study on aspartame conducted by the Ramazzini Foundation reveals that aspartame causes a dose-dependent increase in cancers (lymphomas, leukemias and breast cancers) when consumed at levels approaching those consumed by humans in diet soft drinks. Specifically, the study shows (reprinted from the abstract):a) a significant dose-related increase of malignant tumor-bearing animals in males, in particular in the group treated at 2000 ppm; b) a significant increase of the incidence in lymphomas/leukemias in males treated at 2000 ppm and a significant dose-related increase of the incidence of lymphomas/leukemias in females, in particular in the group treated at 2000 ppm; c) a significant dose-related increase of the incidence of mammary cancer in females, in particular in the group treated at 2000 ppm. Conclusions. The results of this carcinogenicity bioassay not only confirm, but also reinforce the first experimental demonstration of [aspartame's] multipotential carcinogenicity at a dose level close to the acceptable daily intake (ADI) for humans. Furthermore, the study demonstrates that when lifespan exposure to [aspartame] begins during fetal life, its carcinogenic effects are increased.The study, entitled "Lifespan Exposure to Low Doses of Aspartame Beginning During Prenatal Life Increases Cancer Effects in Rats" has been accepted for publication in the peer-reviewed journal Environmental Health Perspectives (EHP), the most widely-read environmental science journal in the world.This is the second study conducted by the Ramizzini Foundation documenting the cancer-causing effects of aspartame in animals. Most sane people, when faced with such evidence, would ask the obvious questions: Could aspartame also cause cancer in humans? Should we review the safety of aspartame just in case?
Shutting down good science to protect profitsVirtually the entire health and medical system in the United States is not interested in these questions. Following the publication of this study, the U.S. Food and Drug Administration issued a statement flatly denying aspartame poses any safety risk whatsoever, rejecting the idea that its safety or approval as a food ingredient should be reviewed at all. Specifically, FDA spokesperson Michael Herndon said, "...the FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food."In other words, the FDA is not interested in any new science that might challenge a decision it already made. Long live scientific-sounding dogma!As reported by the CSPI in a recent press release, According to a 1996 report in the Minneapolis Star Tribune, the FDA rejected repeated proposals by NIEHS to test aspartame using more modern methods than were originally used. David Rall, the former director of NIEHS and its National Toxicology Program, said, "any compound that is that widely used needs to be retested with modern methods every once in a while." The State of California, too, has urged new testing of aspartame. The FDA also rejected NIEHS's proposal to test acesulfame potassium, which CSPI says was "abysmally tested" by its manufacturer and showed signs of causing cancer in animals.Clearly, the FDA only hears what it wants to hear when it comes to protecting the highly profitable aspartame market. Those who have studied a bit of aspartame history know that aspartame was pushed through the FDA by none other than Donald Rumsfeld. Click here to read more articles on aspartame and its dubious history. Since the very beginning, the FDA has done everything in its power to protect the aspartame industry, including denying approval for the natural herbal sweetener stevia as a way to suppress the competition and protect the market for corporate-manufactured chemical sweeteners like aspartame.
CSPI urges re-evaluation of aspartame safetyThis latest study on aspartame and cancer caused the CSPI to issue a public press release calling for the FDA to review the study to determine whether aspartame is really safe. CSPI also downgraded its rating on aspartame and is now recommending that everyone should avoid using aspartame.(For the record, I've been recommending people avoid aspartame since I first began writing about nutrition. The toxicity of this chemical sweetener was obvious to me, and in my opinion there is no safe dose of a substance that breaks down into formaldehyde in the human body. In my view, aspartame is an obvious neurotoxin, not to mention its cancer-promoting effects. No one should consume it, and children or expectant mothers should avoid it like a poison.)Also reported by CSPI: Among those who today called on FDA Commissioner Andrew von Eschenbach to review the new aspartame study are former Occupational Safety and Health Administration officials John Froines (now at UCLA) and Peter F. Infante (now at George Washington University); James Huff, current Associate Director for Chemical Carcinogenesis at the National Institute of Environmental Health Sciences (NIEHS); and Kamal M. Abdo, a toxicologist formerly at the National Toxicology Program of the NIEHS.
Let's poison America!With its stubborn refusal to even review the safety record on aspartame, the FDA seems to be shouting out loud, "Let's poison America!" Of course, the FDA has no intention of initiating anything resembling real scientific scrutiny on aspartame because aspartame was never proven safe in the first place! It was force-fed through the FDA's approval process based purely on distorted, junk science constructed to win approval for a chemical that would earn billions of dollars for powerful corporations (and the powerful, evil bastards who run them).And ever since, aspartame has been poisoning Americans each and every day, contributing to seizures, blindness, migraine headaches, vision problems, neurological disorders and possibly even cancers. The fact that no health authority in America is interested in taking a new look at the safety of aspartame is nothing short of astonishing. That is, until you consider the fact that most medical authorities suffer from a severe case of Groupthink and posses no ideas other than the ones spoonfed them by their politically-motivated bosses. It takes real courage to break with the herd and actually state the obvious these days. Most people are satisfied just to go along with whatever the masses say, even if it makes no sense.Some people call this refusal by the FDA to review aspartame's safety an "oversight" or "mistake" on the part of the agency. Who are they kidding? I call it a crime against the People of America, because to knowingly allow a dangerous, cancer-causing, nerve-damaging chemical to be used in the national food supply -- even while receiving tens of thousands of health complaints from the people consuming aspartame -- is nothing less than negligent homicide. It's a felony, and those responsible for allowing this poison to contaminate America's food supply are, indeed, unindicted felons who deserve to be arrested and prosecuted for their crimes. (A fitting punishment, as always, would be to force-feed them high doses of aspartame and see what happens. If it's really as safe as they claim, there's no harm, is there?)Anybody with a brain that still functions in this country -- and I admit that number is shrinking by the hour -- knows that all the pro-aspartame studies upon which the FDA based its previous safety approval were partially or fully funded by the corporations making money from the sale of aspartame. The entire history of aspartame boils down to corruption, influence and profit-mongering.
Shutting down good science to protect profitsVirtually the entire health and medical system in the United States is not interested in these questions. Following the publication of this study, the U.S. Food and Drug Administration issued a statement flatly denying aspartame poses any safety risk whatsoever, rejecting the idea that its safety or approval as a food ingredient should be reviewed at all. Specifically, FDA spokesperson Michael Herndon said, "...the FDA finds no reason to alter its previous conclusion that aspartame is safe as a general purpose sweetener in food."In other words, the FDA is not interested in any new science that might challenge a decision it already made. Long live scientific-sounding dogma!As reported by the CSPI in a recent press release, According to a 1996 report in the Minneapolis Star Tribune, the FDA rejected repeated proposals by NIEHS to test aspartame using more modern methods than were originally used. David Rall, the former director of NIEHS and its National Toxicology Program, said, "any compound that is that widely used needs to be retested with modern methods every once in a while." The State of California, too, has urged new testing of aspartame. The FDA also rejected NIEHS's proposal to test acesulfame potassium, which CSPI says was "abysmally tested" by its manufacturer and showed signs of causing cancer in animals.Clearly, the FDA only hears what it wants to hear when it comes to protecting the highly profitable aspartame market. Those who have studied a bit of aspartame history know that aspartame was pushed through the FDA by none other than Donald Rumsfeld. Click here to read more articles on aspartame and its dubious history. Since the very beginning, the FDA has done everything in its power to protect the aspartame industry, including denying approval for the natural herbal sweetener stevia as a way to suppress the competition and protect the market for corporate-manufactured chemical sweeteners like aspartame.
CSPI urges re-evaluation of aspartame safetyThis latest study on aspartame and cancer caused the CSPI to issue a public press release calling for the FDA to review the study to determine whether aspartame is really safe. CSPI also downgraded its rating on aspartame and is now recommending that everyone should avoid using aspartame.(For the record, I've been recommending people avoid aspartame since I first began writing about nutrition. The toxicity of this chemical sweetener was obvious to me, and in my opinion there is no safe dose of a substance that breaks down into formaldehyde in the human body. In my view, aspartame is an obvious neurotoxin, not to mention its cancer-promoting effects. No one should consume it, and children or expectant mothers should avoid it like a poison.)Also reported by CSPI: Among those who today called on FDA Commissioner Andrew von Eschenbach to review the new aspartame study are former Occupational Safety and Health Administration officials John Froines (now at UCLA) and Peter F. Infante (now at George Washington University); James Huff, current Associate Director for Chemical Carcinogenesis at the National Institute of Environmental Health Sciences (NIEHS); and Kamal M. Abdo, a toxicologist formerly at the National Toxicology Program of the NIEHS.
Let's poison America!With its stubborn refusal to even review the safety record on aspartame, the FDA seems to be shouting out loud, "Let's poison America!" Of course, the FDA has no intention of initiating anything resembling real scientific scrutiny on aspartame because aspartame was never proven safe in the first place! It was force-fed through the FDA's approval process based purely on distorted, junk science constructed to win approval for a chemical that would earn billions of dollars for powerful corporations (and the powerful, evil bastards who run them).And ever since, aspartame has been poisoning Americans each and every day, contributing to seizures, blindness, migraine headaches, vision problems, neurological disorders and possibly even cancers. The fact that no health authority in America is interested in taking a new look at the safety of aspartame is nothing short of astonishing. That is, until you consider the fact that most medical authorities suffer from a severe case of Groupthink and posses no ideas other than the ones spoonfed them by their politically-motivated bosses. It takes real courage to break with the herd and actually state the obvious these days. Most people are satisfied just to go along with whatever the masses say, even if it makes no sense.Some people call this refusal by the FDA to review aspartame's safety an "oversight" or "mistake" on the part of the agency. Who are they kidding? I call it a crime against the People of America, because to knowingly allow a dangerous, cancer-causing, nerve-damaging chemical to be used in the national food supply -- even while receiving tens of thousands of health complaints from the people consuming aspartame -- is nothing less than negligent homicide. It's a felony, and those responsible for allowing this poison to contaminate America's food supply are, indeed, unindicted felons who deserve to be arrested and prosecuted for their crimes. (A fitting punishment, as always, would be to force-feed them high doses of aspartame and see what happens. If it's really as safe as they claim, there's no harm, is there?)Anybody with a brain that still functions in this country -- and I admit that number is shrinking by the hour -- knows that all the pro-aspartame studies upon which the FDA based its previous safety approval were partially or fully funded by the corporations making money from the sale of aspartame. The entire history of aspartame boils down to corruption, influence and profit-mongering.
Eating blueberries slashes colon cancer risk by 57 percent, animal study finds
A compound found in blueberries shows promise of preventing colon cancer, according to a new study. Scientists at Rutgers University and the U.S. Department of Agriculture conducted a joint study on animals, and found that the compound -- called pterostilbene -- lessened pre-cancerous lesions and inhibited genes involved in inflammation. Researchers presented the study at the American Chemical Society's annual meeting in March. "This study underscores the need to include more berries in the diet, especially blueberries," said study leader Bandaru Reddy, Ph.D., a professor in the chemical biology department at Rutgers. Although the blueberry compound won't cure colon cancer, it represents a strategy for preventing the disease naturally, said Reddy, who specializes in studying the relationship between nutrition and colon cancer.The researchers studied 18 rats in which colon cancer had been induced in a manner similar to human colon cancer development. All of the animals were placed on a balanced diet, with half of the animals' diets supplemented with pterostilbene. After eight weeks, the rats fed pterostilbene had 57 percent fewer pre-cancerous colon lesions compared to the control group. The researchers also noted that pterostilbene inhibited certain genes involved in inflammation, considered a colon cancer risk factor. Colon cancer is the second leading cause of cancer death in the U.S. It has been linked to a high intake of saturated fats and calories common in Western diets. Pterostilbene may be able to reverse this process, possibly by lowering lipids, Reddy said. Reddy cited a recent study by co-author Agnes Rimando of the Department of Agriculture. Rimando demonstrated that blueberries, particularly their skins, can lower cholesterol when fed to animals. Some thirty different species of blueberries are native to North America. The berries are rich in anthocyanins, widely recognized for their antioxidant qualities. Blueberries are also a good source of ellagic acid, which blocks metabolic pathways that can lead to cancer.
Absurd vaccine marketing calls for cervical cancer vaccinations for young boys!
The headline for this story is not a typo. The push to sell more vaccines and pharmaceuticals has now reached a level of absurdity that should astonish any intelligent person. The mainstream media is now reporting -- and I'm not kidding -- that young boys should be vaccinated with Gardasil (the drug now being pushed onto teenage girls to supposedly prevent cervical cancer) based on the idea that if they have oral sex with girls who carry HPV, they might get throat cancer!This is an incredible stretch of scientific credibility, and it's such a preposterous marketing campaign that only Big Pharma could have come up with it. It's obviously nothing more than a massive scare campaign to try to dream up some way to market this high-profit vaccine to a whole new group of customers who don't need it: teenage boys!Even the idea of mandatory vaccinations for teenage girls is little more than desperate disease mongering designed to sell vaccines. Carrying HPV doesn't automatically lead to cervical cancer any more than carrying chicken pox turns you into a walking biological weapon. Most people who carry the virus show no symptoms at all, and girls with healthy immune systems and healthy lifestyles (diet, nutrition, etc.) have a near-zero risk of ever developing cervical cancer, even if they're exposed to HPV on a repeated basis. The virus isn't the disease: It's the terrain of the person carrying the virus! If they're unhealthy and vulnerable, then of course they're not going to be able to keep the virus in check.We don't live in a sterile world, after all. There are more bacteria cells in your body right now than human cells, and we're surrounded by viruses, fungi and other germs. The whole idea of vaccinating against one particular strain that might someday, possibly, perhaps cause a problem if you have sex is just medical nonsense.But vaccinating young boys is an even dumber idea. It's so stupid that I can't find the words to even describe how low on the IQ chart these drug marketing "experts" must be to come up with this one. They must think the public is so gullible that they can just make up any sex-related story and use it to sell drugs. Next, we'll be hearing about young boys giving themselves HPV through masturbation! And the cries for vaccinating all young boys will be something along the lines of, "If you masturbate, VACCINATE!"Sadly, most consumers are so ignorant about reproductive health and germs in general that they'd probably buy into it. And if that campaign is successful, they'll go for the ultimate stupid scare tactic: The Doorknob Campaign (keep reading, if you dare...).
Warning: Doorknobs can give you cancerHere's how this campaign works. (Warning: This contains some graphic language, but it's the only way I can accurately describe just how stupid these vaccination scare tactics have become. If you're offended by certain words, you probably shouldn't be reading anything on this website in the first place...) To pull this off, the drug companies start floating scare stories about how anyone can get cancer by touching doorknobs. How? Because you never know when some HPV carrying person might have touched a doorknob after touching themselves. Therefore, doorknobs can give you sexually transmitted diseases, and if you happen to touch yourself after touching the doorknob, then -- watch out! -- suddenly you're going to die from cervical cancer, throat cancer, crotch cancer or whatever other fear mongering diseases they can dream up. Doorknobs are dangerous, didn't you know?The only way to protect yourself from these germified doorknobs is to get a vaccine. And since doorknobs are everywhere, everybody should get the vaccine! This includes children, teens, adults and senior citizens. It's a brilliant way to sell hundreds of millions of doses of a dangerous injected substance that nobody actually needs, and it's all made possible by the doorknob scare campaign! (And if doorknobs aren't convincing enough, they can start scare stories about public toilet seats instead.)
Drug companies have turned the United States into a nation of hypochondriacsIf they can convince parents that their male children need to be vaccinated against a virus linked to cervical cancer, I suppose they can sell just about anything to anyone. What's next? Are they going to demand that all girls be vaccinated against prostate cancer just in case they engage in oral sex with men who have enlarged prostate glands? Yes, this sounds stupid. It IS stupid. And yet it's not too stupid to be embraced by Big Pharma.Remember, Big Pharma is the same industry that has essentially declared womanhood to be a disease. They have a pill that stops all menstruation -- for life, and the marketing materials imply that a woman having a monthly period is some sort of disorder that needs to be halted to live a normal, happy life. It won't be long before they've got women scared half to death about simply being a woman! (Notice, too, that conventional medicine is dominated by males who all too easily declare various female experiences to be "diseases" or "disorders.")Big Pharma's primary weapon in promoting these silly scare stories is the mainstream media. All they have to do is start floating stories about how dangerous oral sex can be, and then once everybody is scared half to death of oral sex, they can float the "solution" as yet another vaccine.
Inventing the problem, then marketing the "solution"Did you ever notice how the press never even talked about Restless Legs Syndrome until the drug companies had a new pharmaceutical for sale that claimed to treat the condition? The press sets up the fear campaigns for one fictitious disease after another, and then Big Pharma just happens to introduce a new high-profit chemical that treats the disease. In this latest example, the press has been floating stories about the dangers of oral sex for several days, and then -- whammo! -- a story magically appears about vaccinating young boys to protect them from the dangers of oral sex.You have to understand that almost nothing appears in the mainstream media without an agenda. The news isn't news, it's a way of shaping public perception in order to market something: War, drugs, products, paradigms, etc. The U.S. press is a vehicle of shaping the belief systems of the public. It invents and promotes cultural fears, beliefs and perceptions. It has nothing whatsoever to do with bringing people useful news and information. Instead, it is almost entirely focused on getting people to believe what the folks in charge want them to believe.The current news about the housing bubble, for example, is all designed to delay the coming collapse of both the global real estate market and the U.S. stock market (not to mention the U.S. dollar). By shaping public perception and telling people it's only a temporary downturn in the market, they can convince enough people that we should all keep on paying sky-high prices for houses and thereby delay the inevitable real estate market collapse for a little longer.Similarly, virtually every story you read about health is designed to shape your beliefs about nutrition, pharmaceuticals, health care and the (false) causes of diseases. Stories about the genetic causes of disease, for example, are designed to strip away your power and get you to believe that you have no control over your own health. Stories about the dangers of nutritional supplements are designed to convince you to fear nutrition and trust only in pharmaceuticals. Stories about oral sex, as we've seen here, are designed to rally the nation into a state of irrational fear out of which they will react by calling for mandatory vaccinations of teenage boys.David Icke describes this as "Problem - Reaction - Solution." First, they set up the fictitious problem and scare everybody, then they wait for the public reaction (which is quite predictable and actually planned out from the beginning). Finally, they introduce the "solution" which is war, or martial law, or forced vaccinations or whatever was on their agenda in the first place. It's the way all power brokers have ever managed to get things done in a society that pretends to be free. If you want to sell useless pharmaceuticals to hundreds of millions of people who don't need them, you can't just march in and force people to buy them. That would never fly. Instead, you have to convince the people to demand the vaccinations themselves! And you do that by propagandizing scare stories like this one on the dangers of oral sex. If you scare the people enough, they'll demand that you take action, and then your "solution" looks like you're just responding to the needs of the people.Modern medicine is a hoax. It mostly comes down to brainwashing doctors, playing mind games with the public and controlling the media. Disease mongering is rampant, and drug companies are now resorting to the most absurd, ridiculous leaps of the imagination to try to convince people they need more vaccines and medications. Just five years ago, the idea that teenage boys needed to be vaccinated against a cervical cancer virus would have been considered lunacy, but today, the Big Pharma propaganda machine is pushing it with a straight facing, hoping that within a year or two, the population will be so utterly frightened over oral sex viruses that every sexually active person in the country will line up and fork over cash for their "sex vaccines."
Warning: Doorknobs can give you cancerHere's how this campaign works. (Warning: This contains some graphic language, but it's the only way I can accurately describe just how stupid these vaccination scare tactics have become. If you're offended by certain words, you probably shouldn't be reading anything on this website in the first place...) To pull this off, the drug companies start floating scare stories about how anyone can get cancer by touching doorknobs. How? Because you never know when some HPV carrying person might have touched a doorknob after touching themselves. Therefore, doorknobs can give you sexually transmitted diseases, and if you happen to touch yourself after touching the doorknob, then -- watch out! -- suddenly you're going to die from cervical cancer, throat cancer, crotch cancer or whatever other fear mongering diseases they can dream up. Doorknobs are dangerous, didn't you know?The only way to protect yourself from these germified doorknobs is to get a vaccine. And since doorknobs are everywhere, everybody should get the vaccine! This includes children, teens, adults and senior citizens. It's a brilliant way to sell hundreds of millions of doses of a dangerous injected substance that nobody actually needs, and it's all made possible by the doorknob scare campaign! (And if doorknobs aren't convincing enough, they can start scare stories about public toilet seats instead.)
Drug companies have turned the United States into a nation of hypochondriacsIf they can convince parents that their male children need to be vaccinated against a virus linked to cervical cancer, I suppose they can sell just about anything to anyone. What's next? Are they going to demand that all girls be vaccinated against prostate cancer just in case they engage in oral sex with men who have enlarged prostate glands? Yes, this sounds stupid. It IS stupid. And yet it's not too stupid to be embraced by Big Pharma.Remember, Big Pharma is the same industry that has essentially declared womanhood to be a disease. They have a pill that stops all menstruation -- for life, and the marketing materials imply that a woman having a monthly period is some sort of disorder that needs to be halted to live a normal, happy life. It won't be long before they've got women scared half to death about simply being a woman! (Notice, too, that conventional medicine is dominated by males who all too easily declare various female experiences to be "diseases" or "disorders.")Big Pharma's primary weapon in promoting these silly scare stories is the mainstream media. All they have to do is start floating stories about how dangerous oral sex can be, and then once everybody is scared half to death of oral sex, they can float the "solution" as yet another vaccine.
Inventing the problem, then marketing the "solution"Did you ever notice how the press never even talked about Restless Legs Syndrome until the drug companies had a new pharmaceutical for sale that claimed to treat the condition? The press sets up the fear campaigns for one fictitious disease after another, and then Big Pharma just happens to introduce a new high-profit chemical that treats the disease. In this latest example, the press has been floating stories about the dangers of oral sex for several days, and then -- whammo! -- a story magically appears about vaccinating young boys to protect them from the dangers of oral sex.You have to understand that almost nothing appears in the mainstream media without an agenda. The news isn't news, it's a way of shaping public perception in order to market something: War, drugs, products, paradigms, etc. The U.S. press is a vehicle of shaping the belief systems of the public. It invents and promotes cultural fears, beliefs and perceptions. It has nothing whatsoever to do with bringing people useful news and information. Instead, it is almost entirely focused on getting people to believe what the folks in charge want them to believe.The current news about the housing bubble, for example, is all designed to delay the coming collapse of both the global real estate market and the U.S. stock market (not to mention the U.S. dollar). By shaping public perception and telling people it's only a temporary downturn in the market, they can convince enough people that we should all keep on paying sky-high prices for houses and thereby delay the inevitable real estate market collapse for a little longer.Similarly, virtually every story you read about health is designed to shape your beliefs about nutrition, pharmaceuticals, health care and the (false) causes of diseases. Stories about the genetic causes of disease, for example, are designed to strip away your power and get you to believe that you have no control over your own health. Stories about the dangers of nutritional supplements are designed to convince you to fear nutrition and trust only in pharmaceuticals. Stories about oral sex, as we've seen here, are designed to rally the nation into a state of irrational fear out of which they will react by calling for mandatory vaccinations of teenage boys.David Icke describes this as "Problem - Reaction - Solution." First, they set up the fictitious problem and scare everybody, then they wait for the public reaction (which is quite predictable and actually planned out from the beginning). Finally, they introduce the "solution" which is war, or martial law, or forced vaccinations or whatever was on their agenda in the first place. It's the way all power brokers have ever managed to get things done in a society that pretends to be free. If you want to sell useless pharmaceuticals to hundreds of millions of people who don't need them, you can't just march in and force people to buy them. That would never fly. Instead, you have to convince the people to demand the vaccinations themselves! And you do that by propagandizing scare stories like this one on the dangers of oral sex. If you scare the people enough, they'll demand that you take action, and then your "solution" looks like you're just responding to the needs of the people.Modern medicine is a hoax. It mostly comes down to brainwashing doctors, playing mind games with the public and controlling the media. Disease mongering is rampant, and drug companies are now resorting to the most absurd, ridiculous leaps of the imagination to try to convince people they need more vaccines and medications. Just five years ago, the idea that teenage boys needed to be vaccinated against a cervical cancer virus would have been considered lunacy, but today, the Big Pharma propaganda machine is pushing it with a straight facing, hoping that within a year or two, the population will be so utterly frightened over oral sex viruses that every sexually active person in the country will line up and fork over cash for their "sex vaccines."
Choline in meat, dairy products linked to colon cancer risk in women
Researchers may have discovered a relationship between the risk of colorectal cancer in women and their consumption of choline, which has until now been thought to be an essential nutrient. The link was reported in a study published in the Journal of the National Cancer Institute.Choline is a nutrient found in eggs, meat (especially liver) and dairy products. It plays an important role in the functioning of cells and the distribution of nutrients through the body, including a process called one-carbon metabolism. Prior studies have shown that people with a high dietary intake of other nutrients involved in one-carbon metabolism, such as folate, have a decreased risk for colorectal polyps.Colorectal polyps are often-benign tumors that develop in the colon and can eventually lead to cancer. In the first study to examine the issue, researchers expected to find that consumption of choline, like folate, decreased a person's risk of developing colorectal polyps.To their surprise, researchers found the opposite. In a survey of 39,246 women, researchers used food-frequency questionnaires to estimate the choline contents of participants' diets. All the women had no cancer or polyps when the study began, and had at least one endoscopy between 1984 and 2002. Increased consumption of choline was found to be correlated with a higher risk of colorectal polyps."Clearly, one-carbon metabolism and its role in [cancer development] is more complicated than originally anticipated, and our understanding of the underlying mechanisms is probably incomplete," wrote Regina Ziegler and Unhee Lim, of the National Cancer Institute in Bethesda, Maryland, in an accompanying editorial.While a correlation does not necessarily mean that choline is to blame for the increased colon cancer risk, the authors speculated that it may indeed play a role."Once a tumor is initiated, growth into a detectable [polyp] depends in part on choline availability, because choline is needed to make membranes in all rapidly growing cells," they wrote.Prior studies have linked choline deficiency to fatty liver and muscle damage.
Thwarting Skin Cancer with Sun Sense
by Carolyn J. Strange
"This looks like skin cancer," the dermatologist told the woman as he examined the spot on her leg. Later, after removing the tumor and several other precancerous growths from her face and hands, he looked her in the eyes and said, "You've had enough sun."
More and more people are hearing similar messages from their doctors. Viewed as an undeclared epidemic by dermatologists, skin cancer is the most prevalent of all cancers, and it's increasingly common. About a million Americans will develop skin cancer this year.
"Skin cancer is now about as common as all other cancers combined," says Martin A. Weinstock, M.D., Ph.D., director of Brown University's Dermatoepidemiology Unit and Chief of Dermatology at the Providence (R.I.) Veterans Affairs Medical Center. And there's no evidence that the epidemic has peaked.
But there is a bright side. Skin cancer is quite curable when treated early. More than 90 percent of skin cancers are completely cured. Even better, it's largely preventable, simply by avoiding sun and sunlamp exposure.
As more consumers become sun smart, they're finding new ways to protect themselves. For example, FDA has cleared for marketing one manufacturer's clothing for sun protection. Eating a healthier diet can't hurt--less fat, more fruits, vegetables and grains--and preliminary studies indicate it may help. And the National Weather Service provides a measure of ultraviolet (UV) exposure with its UV Index, which is part of the daily weather forecast for many cities.
Experts agree that sunlight, particularly the UV wavelengths, damages the skin. UV radiation causes the obvious short-term damage seen in a sunburn or a tan, as well as the long-term damage that accumulates with each exposure. Not only is there no such thing as a safe tan, "There's no known safe amount of sun," Weinstock says.
Americans are getting the message. Increasingly, we're protecting ourselves from the sun, according to a 1994 survey commissioned by the American Academy of Dermatology. But we're not all sun savvy yet. Only 2 in 5 people consistently use sunscreen whenever they're in the sun. Fewer people say they sunbathe, but about 1 in 5 adults still does. And some people have the mistaken impression that sunlamps or tanning salons are somehow better or safer than natural sunlight. They aren't. No matter what the source, UV exposure increases your risk of skin cancer. (See "Sunlamps--Not a Bright Idea.")
There are three main types of skin cancer. Melanoma is the least common but most serious because this killer is responsible for three-quarters of the nearly 10,000 skin cancer deaths per year. The other two types--basal cell and squamous cell carcinomas--are often referred to together as non-melanoma skin cancer. Basal cell cancer is by far the most common skin cancer, followed by squamous cell carcinoma, which can also become a killer. Between 1980 and 1989, the incidence of non-melanoma skin cancers increased 65 percent, and melanoma 21 percent. And skin cancer is striking at ever younger ages. One-quarter of the more than 30,000 people expected to develop melanoma this year will be 39 or younger.
A fourth type of growth, actinic or solar keratosis, is also of concern because it can progress into cancer. It's the most common pre-malignant skin condition, occurring in more than 5 million Americans.
UV's Double Whammy
While there's no question that UV damages DNA, scientists had long suspected that it delivers a double whammy. Recent research supports that idea. Developing skin cancer is at least a two-step process, involving initiation and promotion of malignant growth. "UV plays both roles," says Douglas Brash, Ph.D., a biophysicist at Yale University School of Medicine. In studies with mice, Brash and colleagues showed that UV harms a mechanism for repairing cell damage. Once the repair system is impaired, cells become increasingly vulnerable to injury. Subsequent UV exposures just make matters worse, and can initiate malignancy.
After UV exposure, the repair mechanism normally directs damaged cells to commit suicide. That's why skin peels after a sunburn. "It's a mop-up operation," says Brash. But previously damaged cells with a malfunctioning repair system escape this mop up. Genetic damage accumulates as normal cells die and abnormal ones survive.
Brash said the level of UV used in their experiments was about equivalent to exposure from a day at the beach. Skin doesn't have to be badly sunburned, he said, adding that such damage also accumulates with chronic, everyday exposure.
To increase awareness of the damaging potential of UV radiation, the Environmental Protection Agency and the National Weather Service developed the UV Index. Besides skin cancer, UV radiation also increases the risk of cataracts and certain other eye problems, and can suppress the immune system. And although dark-skinned people are generally less likely to get skin cancer than light-skinned people, they are just as susceptible to cataracts or immune suppression.
The UV Index number, ranging from 0 to 10+, indicates the amount of UV radiation reaching the Earth's surface during an hour around noon. (See "UV or not UV.") It's forecast daily for 58 cities, based on local predicted conditions. The UV Index is valid only for about a 30-mile radius from the city, and, as with any forecast, local variability in cloud cover and other factors may change actual levels experienced. But it serves as a reminder to take precautions against UV exposure.
For many people, sunscreens are the first line of defense.
"With most sunscreens it's important to apply them before you're in the sun," says FDA microbiologist Jeanne Rippere, who evaluates over-the-counter drugs, including sunscreens. They should be applied liberally, and reapplied at least every two hours (more often if you're sweating) or after swimming or toweling off. Sunscreens are rated by an SPF (sun protective factor) number, which is a multiplier of your skin's exposure time before burning. For example, an SPF of 4 means you can stay in the sun four times longer before burning than if you were wearing no sunscreen. Keep in mind that you can't add SPF numbers. If an SPF 4 product gives you an hour in the sun, reapplying won't give you another hour. Your time's up. If you want longer exposure, next time use a higher SPF before going into the sun.
Something else to remember is that two types of UV radiation reach the Earth, UVA and UVB. Both contribute to skin damage, including skin cancer. There are no "safe" UV rays. But the SPF numbering system was devised as a guide to protect against sunburn, which is caused mostly by UVB. Because sunscreens allow you to stay out in the sun longer without burning, you may be increasing your exposure to UVA.
FDA has not approved a rating system for UVA protection because experts haven't reached a consensus as to what constitutes a good test. FDA is working to develop one, but until such a test exists, there's no way to compare products or verify claims made for UVA protection. Manufacturers are allowed to claim UVA or broad-spectrum protection on a product, as long as it contains an ingredient that absorbs UVA.
The American Academy of Dermatology recommends that everyone use a broad-spectrum sunscreen having an SPF of at least 15, and advises consumers to check for ingredients that screen UVA: benzophenone, oxybenzone, sulisobenzone, titanium dioxide, zinc oxide, and butyl methoxydibenzoylmethane (also called avobenzone and known by the trade name Parsol 1789).
"People should not depend totally on sunscreens," Rippere says.
While sunscreens protect against sunburn, they don't necessarily prevent cancer. If you use sunscreens to spend more time in the sun, your skin could collect about the same total exposure to damaging radiation. So it's still a good idea to stay out of the sun at midday, and to protect yourself with a wide-brim hat and clothing.
Wear Some Shade
Clothing offers the advantages of even, non-sticky protection that you don't have to remember to reapply. But many summer-weight fabrics don't give enough protection. Some are well below the minimum SPF 15 that dermatologists recommend. And fibers like cotton offer even less protection when wet.
"You can't just put on any old shirt and expect it to protect you," says Julian Menter, Ph.D., research professor of medicine at Morehouse School of Medicine in Atlanta, Ga. "Fabrics can differ greatly in their ability to shield you from UV radiation."
The ideal sun protective fabrics are lightweight, comfortable, and protect against exposure even when wet. Clothing that is labeled or promoted as providing protection against the sun or limiting exposure to UV rays is considered a medical device and is regulated by FDA. Sun Precautions, Inc., of Seattle, Wash., has received FDA clearance to market its Solumbra clothing for sun protection and is allowed to claim an SPF of 30 for its products.
In an experiment with mice, Menter and colleagues compared a so-called "typical" summer clothing fabric (a tightly woven cotton used in a gardening shirt) with the Solumbra fabric, a proprietary, tightly woven synthetic. With an SPF of 6.5, the cotton fabric protected mice against short-term UV effects, but it didn't protect against long-term skin damage, including skin cancer. In fact, the incidence of tumors in these mice was comparable to that of the mice who received no UV protection. Mice not subjected to any UV radiation and the mice protected by the Solumbra fabric showed no signs of skin damage.
How do fabrics block UV? "It's a combination of factors--fabric thickness, composition of the fiber itself, and especially tightness of weave," says Deborah F. Lumbardo, an FDA biomedical engineer. Dye can be a factor too, she says.
"But remember that you still need to be using sunscreen on whatever areas are exposed," Lumbardo says.
Inside-Out Protection?
Some studies estimate that diet may be involved in 40 to 60 percent of all cancers. More specifically, a high-fat diet has been implicated in colon and breast cancers. In animal studies, a high fat intake increased the likelihood of skin cancer after exposure to UV radiation, while switching to a low-fat diet after exposure reduced the incidence of skin cancer.
Homer S. Black, Ph.D., a researcher at the Veterans Affairs Medical Center in Houston, and his colleagues found a dietary effect in humans as well. In their study, published in the New England Journal of Medicine, a low-fat diet decreased the incidence of actinic keratosis in non-melanoma skin cancer patients. "The risk factors for actinic keratosis and non-melanoma skin cancer are basically the same," says Black.
The high-fat group ate their usual diet, consuming 36 to 40 percent of their caloric intake as fat, about average for Americans. In the low-fat group, no more than 20 percent of total caloric intake was fat. Overall, the high-fat group had a nearly five times greater risk of developing one or more actinic keratoses during the two-year study.
"Reduced incidence of this common skin tumor is just another added benefit to a long litany of those that can be attributed to a low-fat diet," Black says.
The National Academy of Sciences recommends a diet in which 30 percent or less of the calories come from fat. The National Cancer Institute, the American Cancer Society, the American Heart Association, and other health organizations support this recommendation.
Although many researchers are studying the effects of certain vitamins and various other nutrients on skin cancer, it's too soon to make specific recommendations. But so far, the research trends point toward what we already know to be a healthier diet--less fat, more fruits, vegetables and grains.
Once cancer develops, early detection and treatment are the best defense. Get familiar with your skin and your own pattern of moles and freckles with monthly skin self-exams. If any growth, mole or discoloration appears suddenly or begins to change, or if a sore appears that doesn't heal, see a dermatologist.
For any type of skin cancer, treatment involves removing the lesion, usually in an outpatient procedure. The treatment goal is to remove or destroy the growth completely with as little damage as possible to healthy tissue. Doctors evaluate numerous factors in planning treatment. Considerations include type of cancer, tumor size and location, extent of disease, whether it's new or recurrent, potential for scarring, and the patient's overall health.
Types of surgery include cryosurgery (destruction by freezing), laser surgery (using a laser beam to cut away or vaporize growths), and curettage and electrodessication (using a spoon-like blade to scoop out the growth, followed by destruction of surrounding tissue with an electric needle). Occasionally, other treatments, such as radiation therapy or chemotherapy, may be used alone or in combination.
Even after successful treatment, people who have had skin cancer remain at increased risk of developing it again. Protecting their skin from UV exposure is critical in helping to prevent a recurrence. It should become a life-long habit.
Carolyn J. Strange is a science writer in Saratoga, Calif.
Sunlamps--Not a Bright IdeaLike the sun, sunlamps give off UV radiation--both UVA and UVB--and can be harmful. Exposure to UV radiation from sunlamps adds to the total amount of UV radiation your skin accumulates during your lifetime, and increases the risk of skin cancer. Other risks include premature skin aging, skin and eye burns, allergic-type reactions, cataracts, reduced immunity, and blood vessel damage.
FDA has a radiation safety performance standard for sunlamp products. Such products must have a warning label, an accurate timer, an emergency stop control, and include an exposure schedule and protective eyewear.
Tanning devices aren't recommended for anyone, and should never be used if:* You sunburn easily and don't tan. Skin that doesn't tan in the sun probably won't tan with sunlamps either.* You get frequent cold sores. UV radiation may cause them to appear more frequently.* You're taking medicines that can make you more sensitive to UV radiation. Check with your doctor or pharmacist.
If you choose to ignore the risks and seek an indoor tan, follow all the safety precautions. Stick to your time limit. Be sure to wear the goggles provided, making sure they fit snugly and aren't cracked.
Remember that there's no safe tan and there's no safe UV radiation. That's why tanning devices are best avoided altogether.
--C.J.S.
UV or Not UV?It's a good rule of thumb to guard against overexposure whenever sunlight is strong enough that you can see your shadow. But you can't rely on your perception of brightness and shadows to gauge UV exposure because your eyes can't see UV wavelengths. Up to 80 percent of UV radiation can pass through clouds. The UV Index can help.
While you should always guard against UV exposure, be extra vigilant when the UV Index is 5 or higher. Remember that exposure doesn't come only from above--snow, sand, water, and even concrete reflect UV radiation. Also, UV radiation increases at higher elevations. The UV Index for mountain cities takes this into account, but keep it in mind if you travel.
Protect your eyes and skin from UV radiation with these simple safeguards:* Wear a wide-brim hat to protect your eyes, ears, face, and the back of your neck.* Wear sunglasses that block 99 to 100 percent of UV radiation. Check the label.* Protect as much of your skin as possible with clothing.* Use sunscreen with an SPF of 15 or higher. Reapply every two hours and after swimming.* Avoid midday sun--10 a.m. to 2 p.m.--when UV radiation is strongest.
"This looks like skin cancer," the dermatologist told the woman as he examined the spot on her leg. Later, after removing the tumor and several other precancerous growths from her face and hands, he looked her in the eyes and said, "You've had enough sun."
More and more people are hearing similar messages from their doctors. Viewed as an undeclared epidemic by dermatologists, skin cancer is the most prevalent of all cancers, and it's increasingly common. About a million Americans will develop skin cancer this year.
"Skin cancer is now about as common as all other cancers combined," says Martin A. Weinstock, M.D., Ph.D., director of Brown University's Dermatoepidemiology Unit and Chief of Dermatology at the Providence (R.I.) Veterans Affairs Medical Center. And there's no evidence that the epidemic has peaked.
But there is a bright side. Skin cancer is quite curable when treated early. More than 90 percent of skin cancers are completely cured. Even better, it's largely preventable, simply by avoiding sun and sunlamp exposure.
As more consumers become sun smart, they're finding new ways to protect themselves. For example, FDA has cleared for marketing one manufacturer's clothing for sun protection. Eating a healthier diet can't hurt--less fat, more fruits, vegetables and grains--and preliminary studies indicate it may help. And the National Weather Service provides a measure of ultraviolet (UV) exposure with its UV Index, which is part of the daily weather forecast for many cities.
Experts agree that sunlight, particularly the UV wavelengths, damages the skin. UV radiation causes the obvious short-term damage seen in a sunburn or a tan, as well as the long-term damage that accumulates with each exposure. Not only is there no such thing as a safe tan, "There's no known safe amount of sun," Weinstock says.
Americans are getting the message. Increasingly, we're protecting ourselves from the sun, according to a 1994 survey commissioned by the American Academy of Dermatology. But we're not all sun savvy yet. Only 2 in 5 people consistently use sunscreen whenever they're in the sun. Fewer people say they sunbathe, but about 1 in 5 adults still does. And some people have the mistaken impression that sunlamps or tanning salons are somehow better or safer than natural sunlight. They aren't. No matter what the source, UV exposure increases your risk of skin cancer. (See "Sunlamps--Not a Bright Idea.")
There are three main types of skin cancer. Melanoma is the least common but most serious because this killer is responsible for three-quarters of the nearly 10,000 skin cancer deaths per year. The other two types--basal cell and squamous cell carcinomas--are often referred to together as non-melanoma skin cancer. Basal cell cancer is by far the most common skin cancer, followed by squamous cell carcinoma, which can also become a killer. Between 1980 and 1989, the incidence of non-melanoma skin cancers increased 65 percent, and melanoma 21 percent. And skin cancer is striking at ever younger ages. One-quarter of the more than 30,000 people expected to develop melanoma this year will be 39 or younger.
A fourth type of growth, actinic or solar keratosis, is also of concern because it can progress into cancer. It's the most common pre-malignant skin condition, occurring in more than 5 million Americans.
UV's Double Whammy
While there's no question that UV damages DNA, scientists had long suspected that it delivers a double whammy. Recent research supports that idea. Developing skin cancer is at least a two-step process, involving initiation and promotion of malignant growth. "UV plays both roles," says Douglas Brash, Ph.D., a biophysicist at Yale University School of Medicine. In studies with mice, Brash and colleagues showed that UV harms a mechanism for repairing cell damage. Once the repair system is impaired, cells become increasingly vulnerable to injury. Subsequent UV exposures just make matters worse, and can initiate malignancy.
After UV exposure, the repair mechanism normally directs damaged cells to commit suicide. That's why skin peels after a sunburn. "It's a mop-up operation," says Brash. But previously damaged cells with a malfunctioning repair system escape this mop up. Genetic damage accumulates as normal cells die and abnormal ones survive.
Brash said the level of UV used in their experiments was about equivalent to exposure from a day at the beach. Skin doesn't have to be badly sunburned, he said, adding that such damage also accumulates with chronic, everyday exposure.
To increase awareness of the damaging potential of UV radiation, the Environmental Protection Agency and the National Weather Service developed the UV Index. Besides skin cancer, UV radiation also increases the risk of cataracts and certain other eye problems, and can suppress the immune system. And although dark-skinned people are generally less likely to get skin cancer than light-skinned people, they are just as susceptible to cataracts or immune suppression.
The UV Index number, ranging from 0 to 10+, indicates the amount of UV radiation reaching the Earth's surface during an hour around noon. (See "UV or not UV.") It's forecast daily for 58 cities, based on local predicted conditions. The UV Index is valid only for about a 30-mile radius from the city, and, as with any forecast, local variability in cloud cover and other factors may change actual levels experienced. But it serves as a reminder to take precautions against UV exposure.
For many people, sunscreens are the first line of defense.
"With most sunscreens it's important to apply them before you're in the sun," says FDA microbiologist Jeanne Rippere, who evaluates over-the-counter drugs, including sunscreens. They should be applied liberally, and reapplied at least every two hours (more often if you're sweating) or after swimming or toweling off. Sunscreens are rated by an SPF (sun protective factor) number, which is a multiplier of your skin's exposure time before burning. For example, an SPF of 4 means you can stay in the sun four times longer before burning than if you were wearing no sunscreen. Keep in mind that you can't add SPF numbers. If an SPF 4 product gives you an hour in the sun, reapplying won't give you another hour. Your time's up. If you want longer exposure, next time use a higher SPF before going into the sun.
Something else to remember is that two types of UV radiation reach the Earth, UVA and UVB. Both contribute to skin damage, including skin cancer. There are no "safe" UV rays. But the SPF numbering system was devised as a guide to protect against sunburn, which is caused mostly by UVB. Because sunscreens allow you to stay out in the sun longer without burning, you may be increasing your exposure to UVA.
FDA has not approved a rating system for UVA protection because experts haven't reached a consensus as to what constitutes a good test. FDA is working to develop one, but until such a test exists, there's no way to compare products or verify claims made for UVA protection. Manufacturers are allowed to claim UVA or broad-spectrum protection on a product, as long as it contains an ingredient that absorbs UVA.
The American Academy of Dermatology recommends that everyone use a broad-spectrum sunscreen having an SPF of at least 15, and advises consumers to check for ingredients that screen UVA: benzophenone, oxybenzone, sulisobenzone, titanium dioxide, zinc oxide, and butyl methoxydibenzoylmethane (also called avobenzone and known by the trade name Parsol 1789).
"People should not depend totally on sunscreens," Rippere says.
While sunscreens protect against sunburn, they don't necessarily prevent cancer. If you use sunscreens to spend more time in the sun, your skin could collect about the same total exposure to damaging radiation. So it's still a good idea to stay out of the sun at midday, and to protect yourself with a wide-brim hat and clothing.
Wear Some Shade
Clothing offers the advantages of even, non-sticky protection that you don't have to remember to reapply. But many summer-weight fabrics don't give enough protection. Some are well below the minimum SPF 15 that dermatologists recommend. And fibers like cotton offer even less protection when wet.
"You can't just put on any old shirt and expect it to protect you," says Julian Menter, Ph.D., research professor of medicine at Morehouse School of Medicine in Atlanta, Ga. "Fabrics can differ greatly in their ability to shield you from UV radiation."
The ideal sun protective fabrics are lightweight, comfortable, and protect against exposure even when wet. Clothing that is labeled or promoted as providing protection against the sun or limiting exposure to UV rays is considered a medical device and is regulated by FDA. Sun Precautions, Inc., of Seattle, Wash., has received FDA clearance to market its Solumbra clothing for sun protection and is allowed to claim an SPF of 30 for its products.
In an experiment with mice, Menter and colleagues compared a so-called "typical" summer clothing fabric (a tightly woven cotton used in a gardening shirt) with the Solumbra fabric, a proprietary, tightly woven synthetic. With an SPF of 6.5, the cotton fabric protected mice against short-term UV effects, but it didn't protect against long-term skin damage, including skin cancer. In fact, the incidence of tumors in these mice was comparable to that of the mice who received no UV protection. Mice not subjected to any UV radiation and the mice protected by the Solumbra fabric showed no signs of skin damage.
How do fabrics block UV? "It's a combination of factors--fabric thickness, composition of the fiber itself, and especially tightness of weave," says Deborah F. Lumbardo, an FDA biomedical engineer. Dye can be a factor too, she says.
"But remember that you still need to be using sunscreen on whatever areas are exposed," Lumbardo says.
Inside-Out Protection?
Some studies estimate that diet may be involved in 40 to 60 percent of all cancers. More specifically, a high-fat diet has been implicated in colon and breast cancers. In animal studies, a high fat intake increased the likelihood of skin cancer after exposure to UV radiation, while switching to a low-fat diet after exposure reduced the incidence of skin cancer.
Homer S. Black, Ph.D., a researcher at the Veterans Affairs Medical Center in Houston, and his colleagues found a dietary effect in humans as well. In their study, published in the New England Journal of Medicine, a low-fat diet decreased the incidence of actinic keratosis in non-melanoma skin cancer patients. "The risk factors for actinic keratosis and non-melanoma skin cancer are basically the same," says Black.
The high-fat group ate their usual diet, consuming 36 to 40 percent of their caloric intake as fat, about average for Americans. In the low-fat group, no more than 20 percent of total caloric intake was fat. Overall, the high-fat group had a nearly five times greater risk of developing one or more actinic keratoses during the two-year study.
"Reduced incidence of this common skin tumor is just another added benefit to a long litany of those that can be attributed to a low-fat diet," Black says.
The National Academy of Sciences recommends a diet in which 30 percent or less of the calories come from fat. The National Cancer Institute, the American Cancer Society, the American Heart Association, and other health organizations support this recommendation.
Although many researchers are studying the effects of certain vitamins and various other nutrients on skin cancer, it's too soon to make specific recommendations. But so far, the research trends point toward what we already know to be a healthier diet--less fat, more fruits, vegetables and grains.
Once cancer develops, early detection and treatment are the best defense. Get familiar with your skin and your own pattern of moles and freckles with monthly skin self-exams. If any growth, mole or discoloration appears suddenly or begins to change, or if a sore appears that doesn't heal, see a dermatologist.
For any type of skin cancer, treatment involves removing the lesion, usually in an outpatient procedure. The treatment goal is to remove or destroy the growth completely with as little damage as possible to healthy tissue. Doctors evaluate numerous factors in planning treatment. Considerations include type of cancer, tumor size and location, extent of disease, whether it's new or recurrent, potential for scarring, and the patient's overall health.
Types of surgery include cryosurgery (destruction by freezing), laser surgery (using a laser beam to cut away or vaporize growths), and curettage and electrodessication (using a spoon-like blade to scoop out the growth, followed by destruction of surrounding tissue with an electric needle). Occasionally, other treatments, such as radiation therapy or chemotherapy, may be used alone or in combination.
Even after successful treatment, people who have had skin cancer remain at increased risk of developing it again. Protecting their skin from UV exposure is critical in helping to prevent a recurrence. It should become a life-long habit.
Carolyn J. Strange is a science writer in Saratoga, Calif.
Sunlamps--Not a Bright IdeaLike the sun, sunlamps give off UV radiation--both UVA and UVB--and can be harmful. Exposure to UV radiation from sunlamps adds to the total amount of UV radiation your skin accumulates during your lifetime, and increases the risk of skin cancer. Other risks include premature skin aging, skin and eye burns, allergic-type reactions, cataracts, reduced immunity, and blood vessel damage.
FDA has a radiation safety performance standard for sunlamp products. Such products must have a warning label, an accurate timer, an emergency stop control, and include an exposure schedule and protective eyewear.
Tanning devices aren't recommended for anyone, and should never be used if:* You sunburn easily and don't tan. Skin that doesn't tan in the sun probably won't tan with sunlamps either.* You get frequent cold sores. UV radiation may cause them to appear more frequently.* You're taking medicines that can make you more sensitive to UV radiation. Check with your doctor or pharmacist.
If you choose to ignore the risks and seek an indoor tan, follow all the safety precautions. Stick to your time limit. Be sure to wear the goggles provided, making sure they fit snugly and aren't cracked.
Remember that there's no safe tan and there's no safe UV radiation. That's why tanning devices are best avoided altogether.
--C.J.S.
UV or Not UV?It's a good rule of thumb to guard against overexposure whenever sunlight is strong enough that you can see your shadow. But you can't rely on your perception of brightness and shadows to gauge UV exposure because your eyes can't see UV wavelengths. Up to 80 percent of UV radiation can pass through clouds. The UV Index can help.
While you should always guard against UV exposure, be extra vigilant when the UV Index is 5 or higher. Remember that exposure doesn't come only from above--snow, sand, water, and even concrete reflect UV radiation. Also, UV radiation increases at higher elevations. The UV Index for mountain cities takes this into account, but keep it in mind if you travel.
Protect your eyes and skin from UV radiation with these simple safeguards:* Wear a wide-brim hat to protect your eyes, ears, face, and the back of your neck.* Wear sunglasses that block 99 to 100 percent of UV radiation. Check the label.* Protect as much of your skin as possible with clothing.* Use sunscreen with an SPF of 15 or higher. Reapply every two hours and after swimming.* Avoid midday sun--10 a.m. to 2 p.m.--when UV radiation is strongest.
The Risks of Smoking
You have undoubtedly heard the warnings: if you smoke cigarettes, stop now, and if you don't smoke, don't start. Why? Because cigarette smoke is made up of over 4,000 chemicals, including 43 known to cause cancer. According to the American Cancer Society, tobacco use accounts for 30 percent of all cancer deaths in the United States, and smoking is responsible for 90 percent of lung cancers in men and more then 70 percent in women. The ACS estimates that 28 percent of men, 23 percent of women, and about 30 percent of adolescents smoke.
According to the American Lung Association, the more you smoke and the longer you smoke, the more likely you are to develop lung cancer. But the ACS contends that if you quit smoking when precancerous signs are found, the damaged lung tissue often may return to normal, oftentimes within five years.
There has been some debate, however, on this subject. In 1997, researchers at the University of Pittsburgh Cancer Institute concluded after a preliminary study, that just because people quit smoking doesn't mean they won't develop lung cancer at some point in their lives. The study, which was published in the American Journal of Respiratory and Critical Care Medicine, determined that 77 percent of the people who smoked at least a pack of cigarettes a day for 25 years had irregularities in their lung cells even if they weren't smoking at the time the lung tissue was examined. While those who smoked fewer cigarettes weren't home free, they were less likely to develop abnormal lung cells. Only about 15 percent of the people who smoked for less than 25 years showed similar cellular changes.
More research still needs to be conducted on this topic, and most doctors still recommend that people stop smoking, no matter how long they've been keeping up the habit. This is especially true for people who have been diagnosed with lung cancer. "People with lung cancer who stop smoking live longer and have higher cure rates and lower rates of second cancers, which is a major problem for these patients," says Paul Bunn Jr., M.D., director of the University of Colorado Cancer Center and past president of the International Association for the Study of Lung Cancer. "They also have lowered risk of death from other problems such as heart disease." Bunn says it's a myth that most lung cancer patients don't quit smoking; in fact, they have a much higher quit rate, he says.
For more information on how to quit smoking, see "It's Quittin' Time" in the November-December 1997 FDA Consumer.
According to the American Lung Association, the more you smoke and the longer you smoke, the more likely you are to develop lung cancer. But the ACS contends that if you quit smoking when precancerous signs are found, the damaged lung tissue often may return to normal, oftentimes within five years.
There has been some debate, however, on this subject. In 1997, researchers at the University of Pittsburgh Cancer Institute concluded after a preliminary study, that just because people quit smoking doesn't mean they won't develop lung cancer at some point in their lives. The study, which was published in the American Journal of Respiratory and Critical Care Medicine, determined that 77 percent of the people who smoked at least a pack of cigarettes a day for 25 years had irregularities in their lung cells even if they weren't smoking at the time the lung tissue was examined. While those who smoked fewer cigarettes weren't home free, they were less likely to develop abnormal lung cells. Only about 15 percent of the people who smoked for less than 25 years showed similar cellular changes.
More research still needs to be conducted on this topic, and most doctors still recommend that people stop smoking, no matter how long they've been keeping up the habit. This is especially true for people who have been diagnosed with lung cancer. "People with lung cancer who stop smoking live longer and have higher cure rates and lower rates of second cancers, which is a major problem for these patients," says Paul Bunn Jr., M.D., director of the University of Colorado Cancer Center and past president of the International Association for the Study of Lung Cancer. "They also have lowered risk of death from other problems such as heart disease." Bunn says it's a myth that most lung cancer patients don't quit smoking; in fact, they have a much higher quit rate, he says.
For more information on how to quit smoking, see "It's Quittin' Time" in the November-December 1997 FDA Consumer.
Waging War on Lung Cancer
by Ellen Brown
Five years ago, when Ken Giddes was vacationing with his wife in Vancouver, British Columbia, the 61-year-old resident of Atlanta began feeling short of breath. But since he was "running around quite a bit," Giddes chalked up his problem to being an overachieving tourist. When he returned home, though, his shortness of breath persisted. The cause--uncovered by an x-ray--was a collapsed lung.
But it wasn't until he underwent surgery to repair his lung, that the cause of the collapse was clear: lung cancer had eaten a hole in the air sack of his lung. After surgeons removed his lung in an effort to contain the cancer, they checked Giddes for any traces of cancer every three months. Within a year there was more bad news: a CT scan revealed 13 spots on his remaining lung.
Surgery revealed the cancer had spread throughout his remaining lung. Giddes recalled that he was given less than a 30 percent chance of living another two years. But he decided to battle the cancer "with all the energy, hope and positive attitude I could muster." After 30 weeks of chemotherapy, he was told his cancer was in remission.
Today, he's glad he didn't give up because he's beaten the odds, surviving five years since his cancer was diagnosed. And as the head of the Caring Ambassador Program, sponsored by Republic Financial Corporation, he's helping other cancer survivors wage war on lung cancer, too.
Survival and Detection
Lung cancer is the leading cause of cancer deaths among both men and women, according to the American Cancer Society. Since 1987, more women have died each year of lung cancer than of breast cancer.
Detecting lung cancer in its early stages is difficult in some cases because the disease spreads very quickly and symptoms often don't appear until the disease is advanced. Only about 15 percent of lung cancers are found before the cells have spread to lymph nodes or distant organs.
Still, the survival rate for the disease has improved over the years. The one-year survival rate for patients is about 40 percent today compared with 32 percent in 1973. And five-year survival is up from 8 percent in the 1960s to 14 percent today. Improvement in survival rates can be attributed, at least partially, to diagnostics and new drugs that the Food and Drug Administration has approved.
Lung cancer can be diagnosed by:
a chest x-ray or CT scan to check for spots on the lungs
a microscopic analysis of phlegm cells
a bronchoscopy, which involves passing a lighted tube through the tubes that carry air to the lungs to see if tumors or blockages exist.
If suspicious tissue or spots are detected, a needle biopsy is typically performed, so that a sample of the tumor can be obtained to confirm the diagnosis of lung cancer.
There also are two other diagnostic tools that may be used in place of a biopsy.
The Xillix LIFE-Lung Fluorescence Endoscopy System is a medical device FDA approved in 1996 for detecting bronchial tissue abnormalities in patients with previous, current or suspected lung cancer. A tube inserted through a patient's mouth into the bronchi (tubes leading from the trachea to the lungs) delivers a blue laser light to the bronchial tissue. The image the laser reveals is projected onto a video monitor. While normal tissue appears green, abnormal tissue will appear reddish brown. Suspicious areas can then be biopsied. The system was approved for use in conjunction with conventional white light bronchoscopy. While the illumination provided by the white light helps doctors identify tissue that looks abnormal, the new blue laser system detects more tissue changes than can be seen with the white light alone.
The approval of this device is significant, says Harry Sauberman, chief of the ear, nose and throat devices branch in FDA's Center for Devices and Radiological Health. It can spot moderate to severe dysplasia (irregular tissue), "some of which may turn out to be malignant and you'll have a case of lung cancer," he explains. Patients with dysplasia can then be closely monitored, and if cancer appears, it can be treated in its earliest stages.
The second diagnostic tool is an imaging agent called Nofetumomab (verluma). Approved by FDA in 1996, it can determine the extent of disease in patients already diagnosed with small cell lung cancer through a biopsy but who have not yet been treated. Nofetumomab is a fragment of a monoclonal (synthetic) antibody that, when tagged with a radioisotope, can detect a protein found on the surface of most small cell lung cancers. The antibody collects in tumor sites and other areas of the body where protein is detected and, using special cameras, doctors can see the areas as "hotspots." This information helps physicians see how far the cancer has spread without exploratory surgery or other diagnostic tests and allows them to develop a more effective treatment plan.
According to Patricia Keegan, M.D., deputy director for the division of clinical trials design and analysis in FDA's Center for Biologics Evaluation and Research, the major advantage of using the imaging agent is that it allows doctors to do a full body scan of a patient. "The disadvantage is that it isn't as sensitive in any one area as other scans," she says. "It's not as good as a CT scan for picking up every liver metastasis. And it isn't as good as an MRI or CT scan of the head to pick up brain metastasis. But if all you want is a quick and dirty answer about whether the cancer is widely disseminated or not, it's a relatively simple test to do."
Treatment
About 75 percent of lung cancer cases are categorized as non-small cell lung cancer, and the other 25 percent are small cell lung cancer. Lung cancer can multiply quickly and form large tumors, which sometimes spread to lymph nodes and other organs.
Once lung cancer is detected, a treatment plan is developed based on the patient's physical health, whether the lung cancer is small cell or non-small cell and how extensively the cancer has spread. (See "Stages of Lung Cancer.") Treatment may include surgery, chemotherapy, radiation, or a combination of two or more of these therapies.
FDA recently approved three therapies to treat non-small cell lung cancer: Photofrin (porfimer sodium), Taxol (paclitaxel) in combination with the commonly used cancer drug cisplatin, and Gemzar (gemcitabine hydrochloride) in combination with cisplatin.
Photofrin, a light-activated drug, was approved in January 1998 for patients with early stage, non-small cell lung cancer who cannot undergo surgery or radiotherapy due to other medical conditions. Administered intravenously, Photofrin accumulates in the tumor cells. A laser, directed toward the cancerous tissue, then activates the drug. A significant side effect is extreme photosensitivity, making it necessary for patients to stay out of the sun "almost completely for about a month," says Grant Williams, M.D., a medical team leader in the division of oncology drug products in FDA's Center for Drug Evaluation and Research.
Williams admits that the number of patients with early stage lung cancer who will be helped by Photofrin will be quite limited. "We're talking about a very small number of patients compared to the number of lung cancer patients who have extensive cancers that can't be operated on," he says.
Williams notes, however, that Photofrin may also be able to relieve symptoms in some patients with advanced non-small cell lung cancer. He explains that Photofrin has been demonstrated to be helpful in relieving breathing difficulties caused by tumors that are obstructing the flow of air through patients' bronchial tubes. Approval for this use was recommended by an FDA advisory committee in September 1998. Final FDA action is pending.
Taxol (paclitaxel), already approved to treat other cancers, was approved last year for use in combination with cisplatin for the first-line treatment of non-small cell lung cancer in patients who are not candidates for surgery or radiation therapy.
Gemzar (gemcitabine hydrochloride), another already approved cancer drug, received an additional approval in August for use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer.
Although results of some studies have shown that new treatments may only give patients an additional month or two to live, "there are not a lot of effective treatments for advanced stage non-small cell lung cancer," says Isagani Chico, M.D., a medical officer in FDA's division of oncology drug products.
Because small cell lung cancer has typically spread by the time it's detected, it generally cannot be cured by surgery. Treatment usually begins with a combination of two or more drugs to kill cancer cells throughout the body. Later, treatment with more drugs combined with radiation therapy or radiation alone, is often prescribed. Chemotherapy (drugs) and radiation therapy shrink tumors in most patients, and sometimes the disease goes into remission. But in many cases the cancer begins to grow again when it becomes resistant to treatment.
The Road Ahead
The future and course of lung cancer research seems to vary tremendously depending on who you talk to. Some experts believe prevention and early detection are the best bet. Others insist that improved treatments and gene therapy will be the answer. Paul Bunn Jr., M.D., believes that more research needs to be conducted to see if it's feasible to use x-rays to screen cigarette smokers and people exposed to asbestos, who are at highest risk of developing the disease. Bunn, the director of the University of Colorado Cancer Center and past chairman of FDA's Oncologic Drugs Advisory Committee, believes that the increased use of tobacco among teenagers and adults must be curtailed and that one of the best weapons against lung cancer is prevention.
As for lung cancer patient Ron Norgord, he's banking on a drug that's intended to cut off the blood supply to tumors using molecular technology. The 63-year-old resident of Pasadena, Calif., who has been on a variety of chemotherapy and radiotherapy treatments since he was diagnosed about a year and a half ago, was accepted in September into a clinical trial of a drug that inhibits the growth of tumor blood vessels at UCLA's Cancer Center. "I'm quite encouraged by the results so far," Norgord says. "It's too early to see yet, but I see some positive things coming out of the treatment." One positive sign came after his first treatment, when his chances for fighting infections improved because his white blood cell count finally came up into the normal range.
Researchers are currently studying a variety of drugs and drug combinations designed to extend patients' lives and improve their quality of life. They are also studying various aspects of the disease in the hope of someday developing more effective treatments. Here are just a few of the recent findings, studies and developments related to lung cancer:
Researchers at the Dana-Farber Cancer Institute and the Brigham and Women's Hospital in Boston have identified six factors that place patients with early-stage lung cancer at risk for recurrence. These factors include: large tumor size, a specific tumor subtype of adenocarcinoma (a type of lung cancer), evidence that the cancer has entered the channels of the lymph system, and the presence of certain proteins commonly associated with cancers. Patients with two or more of these risk factors have an increased chance of their cancers recurring. This knowledge may help doctors decide which patients would benefit most from chemotherapy after surgery.
The Radiation Therapy Oncology Group, a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide, recently began a randomized clinical trial that will evaluate whether amifostine, a radio-protective agent, can effectively reduce some side effects in certain lung cancer patients treated with combined radiation therapy and chemotherapy. The trial, which will study patients with inoperable non-small cell lung cancer, is important because lung cancer patients who are treated with radiation and chemotherapy sometimes develop inflammation of the esophagus, making it difficult for them to swallow.
At an American Association for Cancer research meeting in March, E. Premkumar Reddy, Ph.D., director of the Fels Institute for Cancer Research at Temple University School of Medicine in Philadelphia, reported that discovery of a new pathway for tumor growth may help researchers develop new types of diagnostic tests and anti-cancer agents. The new pathway, Src-Stat-3, is believed to play a critical role in the proliferation of cancer cells in the lung, breast, prostate, and ovary.
Meanwhile, lung cancer survivor Ken Giddes, who is also a voting patient representative on FDA's Oncology Drug Advisory Committee, continues to spread a message of hope to people throughout the country. "I want people to know that the diagnosis of cancer is not an automatic death sentence and to inform people of the many options available to them," he says. "I also want people to know that just because they have lung cancer they shouldn't be written off or forgotten. People try to make you feel bad, especially if you smoked, like it's your own fault. But I see plenty of people who have lung cancer and haven't smoked. And even if they did smoke, they didn't plan to get lung cancer."
Ellen Brown is a writer in Lakewood, Ohio.
Five years ago, when Ken Giddes was vacationing with his wife in Vancouver, British Columbia, the 61-year-old resident of Atlanta began feeling short of breath. But since he was "running around quite a bit," Giddes chalked up his problem to being an overachieving tourist. When he returned home, though, his shortness of breath persisted. The cause--uncovered by an x-ray--was a collapsed lung.
But it wasn't until he underwent surgery to repair his lung, that the cause of the collapse was clear: lung cancer had eaten a hole in the air sack of his lung. After surgeons removed his lung in an effort to contain the cancer, they checked Giddes for any traces of cancer every three months. Within a year there was more bad news: a CT scan revealed 13 spots on his remaining lung.
Surgery revealed the cancer had spread throughout his remaining lung. Giddes recalled that he was given less than a 30 percent chance of living another two years. But he decided to battle the cancer "with all the energy, hope and positive attitude I could muster." After 30 weeks of chemotherapy, he was told his cancer was in remission.
Today, he's glad he didn't give up because he's beaten the odds, surviving five years since his cancer was diagnosed. And as the head of the Caring Ambassador Program, sponsored by Republic Financial Corporation, he's helping other cancer survivors wage war on lung cancer, too.
Survival and Detection
Lung cancer is the leading cause of cancer deaths among both men and women, according to the American Cancer Society. Since 1987, more women have died each year of lung cancer than of breast cancer.
Detecting lung cancer in its early stages is difficult in some cases because the disease spreads very quickly and symptoms often don't appear until the disease is advanced. Only about 15 percent of lung cancers are found before the cells have spread to lymph nodes or distant organs.
Still, the survival rate for the disease has improved over the years. The one-year survival rate for patients is about 40 percent today compared with 32 percent in 1973. And five-year survival is up from 8 percent in the 1960s to 14 percent today. Improvement in survival rates can be attributed, at least partially, to diagnostics and new drugs that the Food and Drug Administration has approved.
Lung cancer can be diagnosed by:
a chest x-ray or CT scan to check for spots on the lungs
a microscopic analysis of phlegm cells
a bronchoscopy, which involves passing a lighted tube through the tubes that carry air to the lungs to see if tumors or blockages exist.
If suspicious tissue or spots are detected, a needle biopsy is typically performed, so that a sample of the tumor can be obtained to confirm the diagnosis of lung cancer.
There also are two other diagnostic tools that may be used in place of a biopsy.
The Xillix LIFE-Lung Fluorescence Endoscopy System is a medical device FDA approved in 1996 for detecting bronchial tissue abnormalities in patients with previous, current or suspected lung cancer. A tube inserted through a patient's mouth into the bronchi (tubes leading from the trachea to the lungs) delivers a blue laser light to the bronchial tissue. The image the laser reveals is projected onto a video monitor. While normal tissue appears green, abnormal tissue will appear reddish brown. Suspicious areas can then be biopsied. The system was approved for use in conjunction with conventional white light bronchoscopy. While the illumination provided by the white light helps doctors identify tissue that looks abnormal, the new blue laser system detects more tissue changes than can be seen with the white light alone.
The approval of this device is significant, says Harry Sauberman, chief of the ear, nose and throat devices branch in FDA's Center for Devices and Radiological Health. It can spot moderate to severe dysplasia (irregular tissue), "some of which may turn out to be malignant and you'll have a case of lung cancer," he explains. Patients with dysplasia can then be closely monitored, and if cancer appears, it can be treated in its earliest stages.
The second diagnostic tool is an imaging agent called Nofetumomab (verluma). Approved by FDA in 1996, it can determine the extent of disease in patients already diagnosed with small cell lung cancer through a biopsy but who have not yet been treated. Nofetumomab is a fragment of a monoclonal (synthetic) antibody that, when tagged with a radioisotope, can detect a protein found on the surface of most small cell lung cancers. The antibody collects in tumor sites and other areas of the body where protein is detected and, using special cameras, doctors can see the areas as "hotspots." This information helps physicians see how far the cancer has spread without exploratory surgery or other diagnostic tests and allows them to develop a more effective treatment plan.
According to Patricia Keegan, M.D., deputy director for the division of clinical trials design and analysis in FDA's Center for Biologics Evaluation and Research, the major advantage of using the imaging agent is that it allows doctors to do a full body scan of a patient. "The disadvantage is that it isn't as sensitive in any one area as other scans," she says. "It's not as good as a CT scan for picking up every liver metastasis. And it isn't as good as an MRI or CT scan of the head to pick up brain metastasis. But if all you want is a quick and dirty answer about whether the cancer is widely disseminated or not, it's a relatively simple test to do."
Treatment
About 75 percent of lung cancer cases are categorized as non-small cell lung cancer, and the other 25 percent are small cell lung cancer. Lung cancer can multiply quickly and form large tumors, which sometimes spread to lymph nodes and other organs.
Once lung cancer is detected, a treatment plan is developed based on the patient's physical health, whether the lung cancer is small cell or non-small cell and how extensively the cancer has spread. (See "Stages of Lung Cancer.") Treatment may include surgery, chemotherapy, radiation, or a combination of two or more of these therapies.
FDA recently approved three therapies to treat non-small cell lung cancer: Photofrin (porfimer sodium), Taxol (paclitaxel) in combination with the commonly used cancer drug cisplatin, and Gemzar (gemcitabine hydrochloride) in combination with cisplatin.
Photofrin, a light-activated drug, was approved in January 1998 for patients with early stage, non-small cell lung cancer who cannot undergo surgery or radiotherapy due to other medical conditions. Administered intravenously, Photofrin accumulates in the tumor cells. A laser, directed toward the cancerous tissue, then activates the drug. A significant side effect is extreme photosensitivity, making it necessary for patients to stay out of the sun "almost completely for about a month," says Grant Williams, M.D., a medical team leader in the division of oncology drug products in FDA's Center for Drug Evaluation and Research.
Williams admits that the number of patients with early stage lung cancer who will be helped by Photofrin will be quite limited. "We're talking about a very small number of patients compared to the number of lung cancer patients who have extensive cancers that can't be operated on," he says.
Williams notes, however, that Photofrin may also be able to relieve symptoms in some patients with advanced non-small cell lung cancer. He explains that Photofrin has been demonstrated to be helpful in relieving breathing difficulties caused by tumors that are obstructing the flow of air through patients' bronchial tubes. Approval for this use was recommended by an FDA advisory committee in September 1998. Final FDA action is pending.
Taxol (paclitaxel), already approved to treat other cancers, was approved last year for use in combination with cisplatin for the first-line treatment of non-small cell lung cancer in patients who are not candidates for surgery or radiation therapy.
Gemzar (gemcitabine hydrochloride), another already approved cancer drug, received an additional approval in August for use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer.
Although results of some studies have shown that new treatments may only give patients an additional month or two to live, "there are not a lot of effective treatments for advanced stage non-small cell lung cancer," says Isagani Chico, M.D., a medical officer in FDA's division of oncology drug products.
Because small cell lung cancer has typically spread by the time it's detected, it generally cannot be cured by surgery. Treatment usually begins with a combination of two or more drugs to kill cancer cells throughout the body. Later, treatment with more drugs combined with radiation therapy or radiation alone, is often prescribed. Chemotherapy (drugs) and radiation therapy shrink tumors in most patients, and sometimes the disease goes into remission. But in many cases the cancer begins to grow again when it becomes resistant to treatment.
The Road Ahead
The future and course of lung cancer research seems to vary tremendously depending on who you talk to. Some experts believe prevention and early detection are the best bet. Others insist that improved treatments and gene therapy will be the answer. Paul Bunn Jr., M.D., believes that more research needs to be conducted to see if it's feasible to use x-rays to screen cigarette smokers and people exposed to asbestos, who are at highest risk of developing the disease. Bunn, the director of the University of Colorado Cancer Center and past chairman of FDA's Oncologic Drugs Advisory Committee, believes that the increased use of tobacco among teenagers and adults must be curtailed and that one of the best weapons against lung cancer is prevention.
As for lung cancer patient Ron Norgord, he's banking on a drug that's intended to cut off the blood supply to tumors using molecular technology. The 63-year-old resident of Pasadena, Calif., who has been on a variety of chemotherapy and radiotherapy treatments since he was diagnosed about a year and a half ago, was accepted in September into a clinical trial of a drug that inhibits the growth of tumor blood vessels at UCLA's Cancer Center. "I'm quite encouraged by the results so far," Norgord says. "It's too early to see yet, but I see some positive things coming out of the treatment." One positive sign came after his first treatment, when his chances for fighting infections improved because his white blood cell count finally came up into the normal range.
Researchers are currently studying a variety of drugs and drug combinations designed to extend patients' lives and improve their quality of life. They are also studying various aspects of the disease in the hope of someday developing more effective treatments. Here are just a few of the recent findings, studies and developments related to lung cancer:
Researchers at the Dana-Farber Cancer Institute and the Brigham and Women's Hospital in Boston have identified six factors that place patients with early-stage lung cancer at risk for recurrence. These factors include: large tumor size, a specific tumor subtype of adenocarcinoma (a type of lung cancer), evidence that the cancer has entered the channels of the lymph system, and the presence of certain proteins commonly associated with cancers. Patients with two or more of these risk factors have an increased chance of their cancers recurring. This knowledge may help doctors decide which patients would benefit most from chemotherapy after surgery.
The Radiation Therapy Oncology Group, a federally funded cancer clinical trials cooperative group, which carries out multi-disciplinary research nationwide, recently began a randomized clinical trial that will evaluate whether amifostine, a radio-protective agent, can effectively reduce some side effects in certain lung cancer patients treated with combined radiation therapy and chemotherapy. The trial, which will study patients with inoperable non-small cell lung cancer, is important because lung cancer patients who are treated with radiation and chemotherapy sometimes develop inflammation of the esophagus, making it difficult for them to swallow.
At an American Association for Cancer research meeting in March, E. Premkumar Reddy, Ph.D., director of the Fels Institute for Cancer Research at Temple University School of Medicine in Philadelphia, reported that discovery of a new pathway for tumor growth may help researchers develop new types of diagnostic tests and anti-cancer agents. The new pathway, Src-Stat-3, is believed to play a critical role in the proliferation of cancer cells in the lung, breast, prostate, and ovary.
Meanwhile, lung cancer survivor Ken Giddes, who is also a voting patient representative on FDA's Oncology Drug Advisory Committee, continues to spread a message of hope to people throughout the country. "I want people to know that the diagnosis of cancer is not an automatic death sentence and to inform people of the many options available to them," he says. "I also want people to know that just because they have lung cancer they shouldn't be written off or forgotten. People try to make you feel bad, especially if you smoked, like it's your own fault. But I see plenty of people who have lung cancer and haven't smoked. And even if they did smoke, they didn't plan to get lung cancer."
Ellen Brown is a writer in Lakewood, Ohio.
New Health Initiative to Improve Cancer Treatments
Three Department of Health and Human Services agencies are working together for the first time to find biologic markers that could help improve cancer treatments.
In February 2006, the Food and Drug Administration; the National Cancer Institute (NCI), part of the National Institutes of Health (NIH); and the Centers for Medicare & Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI)--an agreement to collaborate on biomarker development and evaluation.
Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.
"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."
The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to
assess after one or two treatments whether a patient's tumor is responding to treatment
determine more definitively whether a tumor is dying, even if it is not shrinking
identify which cancer patients are at high risk of their tumor coming back after therapy
determine whether a patient's tumor is likely to respond at all to a specific treatment
efficiently evaluate whether an investigational therapy is effective for tumor treatment.
The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.
"Almost four years ago, NIH set out to create a ‘roadmap' for 21st century medical research," says NIH Director Elias A. Zerhouni, M.D. "Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration."
Under OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to use biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as with professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.
"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," says NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."
The first OBQI project will serve to validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma to determine whether FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.
"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," says CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."
Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and will address agency priorities identified through the FDA's Critical Path and the NIH's Roadmap Initiatives.
OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between the NCI and the FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments.
The FDA's Critical Path
Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments. New tools will lead to answers about how the safety and effectiveness of medical products can be demonstrated in faster timeframes with more certainty and at lower costs. Visit www.fda.gov/oc/initiatives/criticalpath/ for more information on the FDA's Critical Path.
The NIH Roadmap
The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address. The goals include making the biggest impact possible on the progress of medical research, and catalyzing changes that will transform new scientific knowledge into tangible benefits for public health. See www.nihroadmap.nih.gov for more on the NIH Roadmap.
In February 2006, the Food and Drug Administration; the National Cancer Institute (NCI), part of the National Institutes of Health (NIH); and the Centers for Medicare & Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI)--an agreement to collaborate on biomarker development and evaluation.
Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.
"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."
The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to
assess after one or two treatments whether a patient's tumor is responding to treatment
determine more definitively whether a tumor is dying, even if it is not shrinking
identify which cancer patients are at high risk of their tumor coming back after therapy
determine whether a patient's tumor is likely to respond at all to a specific treatment
efficiently evaluate whether an investigational therapy is effective for tumor treatment.
The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.
"Almost four years ago, NIH set out to create a ‘roadmap' for 21st century medical research," says NIH Director Elias A. Zerhouni, M.D. "Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration."
Under OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to use biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as with professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.
"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," says NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."
The first OBQI project will serve to validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma to determine whether FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.
"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," says CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."
Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and will address agency priorities identified through the FDA's Critical Path and the NIH's Roadmap Initiatives.
OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between the NCI and the FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments.
The FDA's Critical Path
Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments. New tools will lead to answers about how the safety and effectiveness of medical products can be demonstrated in faster timeframes with more certainty and at lower costs. Visit www.fda.gov/oc/initiatives/criticalpath/ for more information on the FDA's Critical Path.
The NIH Roadmap
The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address. The goals include making the biggest impact possible on the progress of medical research, and catalyzing changes that will transform new scientific knowledge into tangible benefits for public health. See www.nihroadmap.nih.gov for more on the NIH Roadmap.
Cervical Cancer Screening
By Linda Bren
A Pap smear has long been a part of a woman's routine health care. The Pap can detect cell changes that may lead to cancer of the cervix, the lower part of the uterus, or womb. Women age 30 and older can now opt to get an additional test along with their Pap smear to increase the odds of detecting abnormal, or precancerous, cells before they turn into cervical cancer. This test checks a sample of cervical cells for the presence of the genetic material (DNA) of human papillomaviruses (HPVs).
"One of the high risk factors for having cervical cancer is a persistent HPV infection," says Thomas Simms, a Food and Drug Administration biologist who evaluated the HPV DNA test. "Greater than 95 percent of cervical cancers have detectable HPV DNA in them."
In March 2003, the FDA approved the HPV DNA test to be used simultaneously with the Pap test to screen for cervical cancer in women age 30 and older. The Hybrid Capture 2 High-Risk HPV DNA, made by Digene Corp. of Gaithersburg, Md., was initially approved in 2000, but only as a follow-up test for women who had abnormal or inconclusive Pap tests.
The Tests and What They Mean
A woman who visits her doctor to have a Pap test may be offered the HPV DNA test as well. "A woman 30 years and older has an option to choose to have the HPV testing," says Noel Del Mundo, M.D., an FDA gynecologist. Women who have both the Pap and the HPV DNA tests performed will not notice any difference in the procedure. The doctor will collect cervical cells for both tests at the same time by gently rubbing the surface of the cervix with a special collection device. The cells will then be sent to a laboratory for analysis.
If both the Pap and the HPV DNA test results are negative, a woman's doctor may advise her to wait for three years before being retested, according to guidelines from the American College of Obstetricians and Gynecologists (ACOG). But more frequent testing is recommended if other high risk factors are present, such as a weakened immune system or a history of cervical cancer.
If only one of the tests is negative, the doctor may advise the woman to return for retesting in six to 12 months. But if the Pap smear shows a mild cellular abnormality (called atypical squamous cells of undetermined significance, or ASC-US), and the HPV DNA test is positive, the doctor may recommend further tests. "HPV DNA testing for women with mild cellular abnormality will help the physician determine whether the patient should have a colposcopy and biopsy," says Del Mundo.
In a colposcopy, the doctor looks for a lesion on the cervix with a special magnifying instrument called a colposcope. If a lesion is found, the doctor will take a biopsy, in which a sample of the lesion is removed to check it for precancerous cells.
The FDA cautions that, while a positive HPV test can provide useful information for a woman and her doctor, it does not necessarily mean that she will develop cervical cancer. And although negative Pap and HPV test results indicate a very low risk (0.2 percent) for developing cervical cancer, that doesn't mean that changes won't occur. Infections or changes in cells may arise in the future, so continued screening is important.
Although the HPV DNA test in conjunction with the Pap test is not advised for women under age 30, these women should still get annual Pap tests, according to ACOG guidelines. The first screening for cervical cancer should occur about three years after a woman has her first sexual intercourse, but no later than age 21.
All women, regardless of negative test results, should still visit their doctors yearly for a pelvic examination, which includes checking the reproductive and other organs for abnormality in shape or size.
HPVs are Common
There are more than 100 types of HPV, according to the American Cancer Society (ACS). Some of them cause the noncancerous warts that typically grow on the hands or the bottom of the feet.
Other types of HPVs are sexually transmitted. Some cause wart-like growths on or around the genitals and anus of both men and women, but these visible external warts have not been linked with cancer. Other HPVs cause visible warts in the cervix, but because they rarely develop into cancer, they are often referred to as "low-risk" HPVs. But still other types of HPVs have been linked with cancer. These "high-risk" HPVs aren't usually found as visible warts. Both high-risk and low-risk types can cause the growth of abnormal cells in the cervix. The HPV DNA test can detect the presence of 13 HPVs that are associated with a high risk of cervical cancer.
Sexually transmitted HPV infections are very common. Fortunately, it is very rare for an HPV infection to lead to cervical cancer. This is especially true for women under 30, who have a relatively high rate of HPV infection but rarely develop cervical cancer, says Simms. The HPV DNA test was approved for women age 30 and older because of the higher risk of cervical cancer in this age group. "Women over 30 have fewer HPV infections, but if they develop a persistent HPV infection, it can eventually lead to precancerous changes in the cervix," says Simms.
According to the ACS, most people will not know that they have HPV because it usually goes away on its own.
"Most HPV infections are detected only transiently--the body's immune system clears signs of the infection," says Laura Koutsky, Ph.D., professor of epidemiology at the University of Washington in Seattle. "Currently, it is not known if the virus clears in most women or only a few women," she says. "Regardless, if the virus is no longer detectable, a woman's risk for cancer appears to be very low."
Because HPVs can be sexually transmitted, a positive HPV DNA test result may be troubling to women and their partners. But testing positive for HPV does not necessarily mean that the virus was contracted recently, says Koutsky. "You or your husband or partner may have contracted the virus many, many years ago," she says. "Keep in mind that current estimates indicate that more than 50 percent of sexually active adults have been infected with HPV."
Regular Screening Is Important
The ACS estimates that in 2003, more than 13,000 new cases of invasive cervical cancer will have occurred in the United States, resulting in 4,100 deaths from the disease. The rates of death from cervical cancer for several racial and ethnic groups, such as Hispanics and American Indians, are higher than the national average. And for blacks, the death rate is more than twice the national average.
The National Cancer Institute reports that regular Pap screening does reduce deaths from cervical cancer. Women who have not been screened face a significantly greater risk of developing the disease. With regular screening and follow-up care, cervical cancer is avoidable, and, if caught early, curable.
A Pap smear has long been a part of a woman's routine health care. The Pap can detect cell changes that may lead to cancer of the cervix, the lower part of the uterus, or womb. Women age 30 and older can now opt to get an additional test along with their Pap smear to increase the odds of detecting abnormal, or precancerous, cells before they turn into cervical cancer. This test checks a sample of cervical cells for the presence of the genetic material (DNA) of human papillomaviruses (HPVs).
"One of the high risk factors for having cervical cancer is a persistent HPV infection," says Thomas Simms, a Food and Drug Administration biologist who evaluated the HPV DNA test. "Greater than 95 percent of cervical cancers have detectable HPV DNA in them."
In March 2003, the FDA approved the HPV DNA test to be used simultaneously with the Pap test to screen for cervical cancer in women age 30 and older. The Hybrid Capture 2 High-Risk HPV DNA, made by Digene Corp. of Gaithersburg, Md., was initially approved in 2000, but only as a follow-up test for women who had abnormal or inconclusive Pap tests.
The Tests and What They Mean
A woman who visits her doctor to have a Pap test may be offered the HPV DNA test as well. "A woman 30 years and older has an option to choose to have the HPV testing," says Noel Del Mundo, M.D., an FDA gynecologist. Women who have both the Pap and the HPV DNA tests performed will not notice any difference in the procedure. The doctor will collect cervical cells for both tests at the same time by gently rubbing the surface of the cervix with a special collection device. The cells will then be sent to a laboratory for analysis.
If both the Pap and the HPV DNA test results are negative, a woman's doctor may advise her to wait for three years before being retested, according to guidelines from the American College of Obstetricians and Gynecologists (ACOG). But more frequent testing is recommended if other high risk factors are present, such as a weakened immune system or a history of cervical cancer.
If only one of the tests is negative, the doctor may advise the woman to return for retesting in six to 12 months. But if the Pap smear shows a mild cellular abnormality (called atypical squamous cells of undetermined significance, or ASC-US), and the HPV DNA test is positive, the doctor may recommend further tests. "HPV DNA testing for women with mild cellular abnormality will help the physician determine whether the patient should have a colposcopy and biopsy," says Del Mundo.
In a colposcopy, the doctor looks for a lesion on the cervix with a special magnifying instrument called a colposcope. If a lesion is found, the doctor will take a biopsy, in which a sample of the lesion is removed to check it for precancerous cells.
The FDA cautions that, while a positive HPV test can provide useful information for a woman and her doctor, it does not necessarily mean that she will develop cervical cancer. And although negative Pap and HPV test results indicate a very low risk (0.2 percent) for developing cervical cancer, that doesn't mean that changes won't occur. Infections or changes in cells may arise in the future, so continued screening is important.
Although the HPV DNA test in conjunction with the Pap test is not advised for women under age 30, these women should still get annual Pap tests, according to ACOG guidelines. The first screening for cervical cancer should occur about three years after a woman has her first sexual intercourse, but no later than age 21.
All women, regardless of negative test results, should still visit their doctors yearly for a pelvic examination, which includes checking the reproductive and other organs for abnormality in shape or size.
HPVs are Common
There are more than 100 types of HPV, according to the American Cancer Society (ACS). Some of them cause the noncancerous warts that typically grow on the hands or the bottom of the feet.
Other types of HPVs are sexually transmitted. Some cause wart-like growths on or around the genitals and anus of both men and women, but these visible external warts have not been linked with cancer. Other HPVs cause visible warts in the cervix, but because they rarely develop into cancer, they are often referred to as "low-risk" HPVs. But still other types of HPVs have been linked with cancer. These "high-risk" HPVs aren't usually found as visible warts. Both high-risk and low-risk types can cause the growth of abnormal cells in the cervix. The HPV DNA test can detect the presence of 13 HPVs that are associated with a high risk of cervical cancer.
Sexually transmitted HPV infections are very common. Fortunately, it is very rare for an HPV infection to lead to cervical cancer. This is especially true for women under 30, who have a relatively high rate of HPV infection but rarely develop cervical cancer, says Simms. The HPV DNA test was approved for women age 30 and older because of the higher risk of cervical cancer in this age group. "Women over 30 have fewer HPV infections, but if they develop a persistent HPV infection, it can eventually lead to precancerous changes in the cervix," says Simms.
According to the ACS, most people will not know that they have HPV because it usually goes away on its own.
"Most HPV infections are detected only transiently--the body's immune system clears signs of the infection," says Laura Koutsky, Ph.D., professor of epidemiology at the University of Washington in Seattle. "Currently, it is not known if the virus clears in most women or only a few women," she says. "Regardless, if the virus is no longer detectable, a woman's risk for cancer appears to be very low."
Because HPVs can be sexually transmitted, a positive HPV DNA test result may be troubling to women and their partners. But testing positive for HPV does not necessarily mean that the virus was contracted recently, says Koutsky. "You or your husband or partner may have contracted the virus many, many years ago," she says. "Keep in mind that current estimates indicate that more than 50 percent of sexually active adults have been infected with HPV."
Regular Screening Is Important
The ACS estimates that in 2003, more than 13,000 new cases of invasive cervical cancer will have occurred in the United States, resulting in 4,100 deaths from the disease. The rates of death from cervical cancer for several racial and ethnic groups, such as Hispanics and American Indians, are higher than the national average. And for blacks, the death rate is more than twice the national average.
The National Cancer Institute reports that regular Pap screening does reduce deaths from cervical cancer. Women who have not been screened face a significantly greater risk of developing the disease. With regular screening and follow-up care, cervical cancer is avoidable, and, if caught early, curable.
New Treatments for Colorectal Cancer
Colorectal cancer--cancer of the colon or rectum--is the second leading cause of cancer-related deaths, behind lung cancer, in the United States.
In February 2004, the Food and Drug Administration approved Avastin (bevacizumab) and Erbitux (cetuximab) to treat colorectal cancer that has spread to other parts of the body. Both drugs are genetically engineered versions of antibodies, which are proteins produced by the immune system to fight foreign substances. The antibodies can be produced in a laboratory to target a very specific portion of foreign substances. Because of its precision, treatment with the antibodies can be more effective with fewer side effects.
Avastin
Avastin is the first FDA-approved treatment for colorectal cancer that is thought to work by preventing the formation of new blood vessels needed by malignant tumors to grow. In a clinical trial of more than 800 people with colorectal cancer, roughly half of them received Avastin intravenously as a combination treatment with the "Salz regimen," also known as IFL, which is a standard chemotherapy for colon cancer. The other half received only IFL. IFL treatment includes irinotecan, 5-fluorouracil (5-FU), and leucovorin.
Overall, those given Avastin in combination with IFL survived about five months longer. Also, the average time before tumors started regrowing or new tumors appeared was four months longer than in those receiving IFL alone.
Serious but uncommon side effects of Avastin include a condition marked by the formation of holes in the colon called gastrointestinal perforation. The condition generally requires surgery and sometimes leads to abdominal infections.
Two distinct patterns of bleeding have been seen in people treated with Avastin. Minor hemorrhages, particularly nosebleeds, have been commonly seen. More serious bleeding from the lungs has also occurred in people with lung cancer who received the drug. Avastin is not approved as a treatment for lung cancer.
Other severe and life-threatening side effects that occurred in more people receiving Avastin alone, compared with those receiving chemotherapy alone, include abdominal pain, high blood pressure, tiredness, blood clots, fainting, diarrhea, constipation, and a decreased number of white blood cells. Headache, appetite loss, mouth sores, hemorrhoidal bleeding, and shortness of breath also occurred more commonly in people receiving Avastin plus chemotherapy when compared to those receiving chemotherapy alone.
Avastin is manufactured by Genentech Inc. of South San Francisco, Calif.
Erbitux
The FDA approved Erbitux as a combination treatment to be given intravenously with irinotecan, another drug approved to treat colorectal cancer. Erbitux can also be used alone for people who cannot tolerate irinotecan.
Erbitux was approved under the FDA's accelerated approval program, which allows the agency to approve products for cancer and other serious or life-threatening diseases based on early evidence of effectiveness. Though treatment with Erbitux has not been shown to extend people's lives, it was shown to shrink tumors in some people and delay tumor growth, especially when used as a combination treatment.
Erbitux was studied in a controlled trial with 329 people and also in combination with irinotecan in 138 people. It was further evaluated as a single agent in a clinical trial with 57 people, and safety data from an additional 111 patients treated only with Erbitux were also evaluated.
The manufacturer of Erbitux, ImClone Systems Inc. of Branchburg, N.J., submitted its original request for approval in several sections between June and October 2001. The FDA determined at that time that the application could not be reviewed because about half of the patients studied had not failed treatment with irinotecan--a condition of the study. Also, important information about the safety and effectiveness of Erbitux in a portion of the remaining patients was missing.
In a new request for approval in August 2003, ImClone submitted results of a well-run trial that included 329 patients, as well as revisions to the original results from the earlier studies.
Two studies involving about 2,000 people are currently underway to assess the ability of Erbitux to stop the progression of colorectal cancer and to extend the amount of time patients survive with the disease.
Erbitux can cause serious side effects, usually during the administration of the first treatment. Side effects may include difficulty breathing and low blood pressure. Other more common side effects of Erbitux include acne-like rash, dry skin, tiredness or weakness, fever, constipation, and abdominal pain.
Erbitux is distributed and marketed by Bristol-Myers Squibb Co. of Princeton, N.J.
In February 2004, the Food and Drug Administration approved Avastin (bevacizumab) and Erbitux (cetuximab) to treat colorectal cancer that has spread to other parts of the body. Both drugs are genetically engineered versions of antibodies, which are proteins produced by the immune system to fight foreign substances. The antibodies can be produced in a laboratory to target a very specific portion of foreign substances. Because of its precision, treatment with the antibodies can be more effective with fewer side effects.
Avastin
Avastin is the first FDA-approved treatment for colorectal cancer that is thought to work by preventing the formation of new blood vessels needed by malignant tumors to grow. In a clinical trial of more than 800 people with colorectal cancer, roughly half of them received Avastin intravenously as a combination treatment with the "Salz regimen," also known as IFL, which is a standard chemotherapy for colon cancer. The other half received only IFL. IFL treatment includes irinotecan, 5-fluorouracil (5-FU), and leucovorin.
Overall, those given Avastin in combination with IFL survived about five months longer. Also, the average time before tumors started regrowing or new tumors appeared was four months longer than in those receiving IFL alone.
Serious but uncommon side effects of Avastin include a condition marked by the formation of holes in the colon called gastrointestinal perforation. The condition generally requires surgery and sometimes leads to abdominal infections.
Two distinct patterns of bleeding have been seen in people treated with Avastin. Minor hemorrhages, particularly nosebleeds, have been commonly seen. More serious bleeding from the lungs has also occurred in people with lung cancer who received the drug. Avastin is not approved as a treatment for lung cancer.
Other severe and life-threatening side effects that occurred in more people receiving Avastin alone, compared with those receiving chemotherapy alone, include abdominal pain, high blood pressure, tiredness, blood clots, fainting, diarrhea, constipation, and a decreased number of white blood cells. Headache, appetite loss, mouth sores, hemorrhoidal bleeding, and shortness of breath also occurred more commonly in people receiving Avastin plus chemotherapy when compared to those receiving chemotherapy alone.
Avastin is manufactured by Genentech Inc. of South San Francisco, Calif.
Erbitux
The FDA approved Erbitux as a combination treatment to be given intravenously with irinotecan, another drug approved to treat colorectal cancer. Erbitux can also be used alone for people who cannot tolerate irinotecan.
Erbitux was approved under the FDA's accelerated approval program, which allows the agency to approve products for cancer and other serious or life-threatening diseases based on early evidence of effectiveness. Though treatment with Erbitux has not been shown to extend people's lives, it was shown to shrink tumors in some people and delay tumor growth, especially when used as a combination treatment.
Erbitux was studied in a controlled trial with 329 people and also in combination with irinotecan in 138 people. It was further evaluated as a single agent in a clinical trial with 57 people, and safety data from an additional 111 patients treated only with Erbitux were also evaluated.
The manufacturer of Erbitux, ImClone Systems Inc. of Branchburg, N.J., submitted its original request for approval in several sections between June and October 2001. The FDA determined at that time that the application could not be reviewed because about half of the patients studied had not failed treatment with irinotecan--a condition of the study. Also, important information about the safety and effectiveness of Erbitux in a portion of the remaining patients was missing.
In a new request for approval in August 2003, ImClone submitted results of a well-run trial that included 329 patients, as well as revisions to the original results from the earlier studies.
Two studies involving about 2,000 people are currently underway to assess the ability of Erbitux to stop the progression of colorectal cancer and to extend the amount of time patients survive with the disease.
Erbitux can cause serious side effects, usually during the administration of the first treatment. Side effects may include difficulty breathing and low blood pressure. Other more common side effects of Erbitux include acne-like rash, dry skin, tiredness or weakness, fever, constipation, and abdominal pain.
Erbitux is distributed and marketed by Bristol-Myers Squibb Co. of Princeton, N.J.
Cancer Vaccines: Training the Immune System to Fight Cancer
By Michelle Meadows
Vaccines traditionally have been used to prevent infectious diseases such as measles and the flu. But with cancer vaccines, the emphasis is on treatment, at least for now. The idea is to inject a preparation of inactivated cancer cells or proteins that are unique to cancer cells into a person who has cancer. The goal: to train the person's immune system to recognize the living cancer cells and attack them. (See "The Immune System and How It Works.")
"The best settings are for treating people who have minimal disease or a high risk of recurrence," says Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI). "But at this time, most therapeutic cancer vaccines are being studied in people who have failed other therapies."
Cancer vaccines are experimental; none have been licensed by the Food and Drug Administration. But there are about a dozen cancer vaccines in advanced clinical trials, says Steven Hirschfeld, M.D., a medical officer in the FDA's Center for Biologics Evaluation and Research. "Research has shown us that the fundamental approach to cancer vaccines is right; we are moving in the right direction," he says.
The three standard cancer therapies are surgery to remove tumors; chemotherapy, which modifies or destroys cancer cells with drugs; and radiation, which destroys cancer cells with high-energy X-rays. Immunotherapy, which includes cancer vaccines, is considered a fourth, and still investigational, type of therapy. Cancer vaccines are sometimes used alone, but are often combined with a standard therapy.
While standard treatments alone have proven effective, they also have limitations. Radiation and chemotherapy can wipe out a person's cancer cells, but they also damage normal cells. "We want to find treatment that is more targeted and less toxic," says Hirschfeld. "Cancer vaccines are designed to be specific, targeting only the cancer cells without harming the healthy ones."
The approach has made cancer vaccines generally well tolerated, allowing them to be used in outpatient settings. And they can be added to standard therapy with a low likelihood of causing further serious side effects.
How Cancer Vaccines Work
Cancer is a term for more than 100 diseases characterized by the uncontrolled, abnormal growth of cells. To the immune system--the body's natural defense system against disease--cancer cells and normal cells look the same. The immune system tends to tolerate the cancer cells, just as it tolerates the normal cells. That's because the immune system doesn't recognize cancer cells as something foreign, Hirschfeld says. Rather, cancer cells are once-normal cells that have gone awry. Cancer vaccines try to get the immune system to overcome its tolerance of cancer cells so that it can recognize them and attack them.
All cells have unique proteins or bits of proteins on their surface called antigens. Many cancer cells make cancer-specific antigens. The goal of using cancer antigens as a vaccine is to teach the immune system to recognize the cancer-specific antigens and to reject any cells with those antigens. The antigens activate white blood cells called B lymphocytes (B cells) and T lymphocytes (T cells). B cells produce antibodies that recognize a particular antigen and bind to it to help destroy the cancer cells. T cells that recognize a particular antigen can attack and kill cancer cells. In 1991, the first human cancer antigen was found in cells of a person with melanoma, a discovery that encouraged researchers to search for antigens on other types of cancer, according to the NCI.
The two main approaches for cancer vaccines are whole-cell vaccines and antigen vaccines. Whole-cell vaccines may take whole cancer cells from a patient or sometimes several patients, or use human tumor cell lines derived in a laboratory. "Some cell-based vaccines use tumor cells from the patient, some contain something that looks like a tumor cell but was created in a lab, and others are personalized vaccines that use some cells from the patient and some from the lab," Hirschfeld says. Cells that are taken from people with cancer are altered in a lab to inactivate them so that they are safe to re-inject.
Regardless of the exact source of the cells, whole cell vaccines potentially use all the antigens found on the tumor cells. Antigen vaccines try to trigger an immune response by using only certain antigens from cancer cells. Hirschfeld says antigens may be particular to an individual, to a certain type of cancer, or to several types of cancers.
Boosting the Immune Response
In the early 1990s, Steven Rosenberg, M.D., one of the pioneers of immunotherapy and chief of surgery at the NCI, wrote that trying to use the immune system to fight cancer is so difficult that it made him feel "like a dog trying to bite a basketball." Among Rosenberg's contributions was identifying the antigens that trigger an immune response, and cloning genes that look for, or "code for," those antigens.
Researchers have been working to develop cancer vaccines for more than 100 years in one form or another, and the main mission has always been to make the immune system's response to the cancer antigens as strong as possible.
One major strategy involves combining vaccines with additional substances called adjuvants, which act as chemical messengers that help T cells work better. An example of one type of adjuvant, called a cytokine, is interleukin-2. This protein is made by the body's immune system and can also be made in a lab.
There have also been improvements in vaccine delivery. For example, Schlom developed a vaccine in which genes for tumor antigens are put into a weakened virus called a "vector" that delivers genetic materials to cells. This makes the tumor antigen more visible to the immune system. The CEA-TRICOM vaccine was developed at the NCI through a cooperative research and development agreement with Therion Biologics in Cambridge, Mass. Researchers use the vaccinia virus, the same virus in the smallpox vaccine, as the vector. The carcinoembryonic antigen (CEA), which is found on most breast, lung, colon, and pancreatic tumors, is added to the virus. Researchers also add three molecules, called "costimulatory molecules," which serve as signals that make the vaccine more potent than it would be if the antigen were used alone. A similar vaccine developed under the NCI agreement with Therion is the PANVAC vaccine, which has now entered advanced study as a treatment for pancreatic cancer.
In addition to studying this type of virus-based technique, researchers at Duke University's Cancer Center in Durham, N.C., have been studying vaccines that mix white blood cells called dendritic cells with genetic material from a person's tumor.
Dendritic cells, which can activate T cells, work by looking around, finding antigens, and showing them to the fighter T cells. Researchers have found ways to increase the number of dendritic cells in a vaccine. "Employing millions of 'pumped up' dendritic cells can help elicit a strong immune response," says H. Kim Lyerly, M.D., director of the Duke cancer center.
Recent work by Lyerly and Duke investigators Michael Morse, M.D., and Timothy Clay, Ph.D., has focused on modifying dendritic cells with viruses so that they activate even stronger T cell responses against cancer antigens.
"This is an evolving area, and it's exciting to be able to make progress," says Lyerly. "For decades, people thought it wasn't even fundamentally possible to develop cancer vaccines, and here we are. The science behind cancer vaccines is leading us to believe that we will find the answers."
Promising, But Still Early
As with any new treatment, cancer vaccines must be first studied in lab animals and then tested for safety and effectiveness in three phases of human studies, called "clinical trials," before they can be approved by the FDA. In Phase 1 clinical trials, cancer vaccines are used alone and studied for safety and to determine the proper dose. In Phase 2 trials, they are tested for effectiveness and may be used alone or in combination with another therapy. Phase 3 trials are large-scale studies testing effectiveness and usually comparing a vaccine with some standard therapy. Researchers are testing vaccines using various adjuvants, delivery methods, and types of antigens.
Cancer vaccines have shown promise in clinical trials with many types of cancer. According to Howard Streicher, M.D., a senior investigator with the NCI's Cancer Therapy Evaluation Program, it's too soon to say which cancers will be treated with vaccine therapy. The types of tumors that have proven most susceptible to vaccines so far, he says, are: skin cancer (melanoma); kidney cancer (renal cell); a group of cancers that affect the lymphatic system (lymphoma); a malignant tumor of the bone marrow (myeloma); and solid tumors, such as lung cancer. The most work has been done in the area of melanoma, a type of skin cancer in which treatment options are limited when the disease is in advanced stages.
"After having a tumor removed, about half of patients with stage III melanoma may have a recurrence, and we want to prevent that," Streicher says. "Chemotherapy doesn't work in this area, so our hope is that this could be just the right place for a vaccine."
James Mulé, M.D., Ph.D., associate director of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., says, though some early studies have shown that some people's tumors shrank or even disappeared in response to a cancer vaccine, it's still early. Mulé was an investigator on the first study that tested dendritic cells in children. In the Phase 1 study, one 16-year-old with cancer that had spread to her lungs and spine showed significant shrinkage of tumors.
"There is promise in the sense that some of these vaccines can illicit a powerful immune response in some patients, but I think we have to be careful about getting too excited over early studies that can't be reproduced," Mulé says.
Jeffrey Weber, M.D., Ph.D., director of the Norris Melanoma Center at the University of Southern California, says there is also still a lot of work to be done in discovering new antigens and adjuvants and more sophisticated strategies to overcome the immune system's tolerance of cancer cells. "We are still discovering molecules that regulate the immune system such as CTLA-4, so we're still in the dark in some areas," Weber says. Recent research has found that inhibiting CTLA-4 can help the immune system attack some tumors.
Experts say that no therapeutic cancer vaccine has been licensed yet because few Phase 3 studies have been completed, and those that have been completed did not meet their goals of demonstrating safety and effectiveness of the vaccine. "We are still working with industry to define the characteristics, including potency," says the FDA's Hirschfeld. "So a trial may look promising early on, but our job is to make sure it can be reproduced. We have to ask: 'Will this treatment work in the larger population?'"
One of the challenges is that cancer vaccines may produce different effects than those caused by cancer drugs. With cancer drugs, experts ask whether there is an objective, measurable response, such as tumor shrinkage. A cancer drug may cause tumors to shrink, but a person still may not live longer. With a cancer vaccine, there may be fewer signs of tumor shrinkage, but a person might live longer.
There aren't the same landmarks that you would see with traditional therapies, says Natalie Sacks, M.D., medical director in the clinical research division at San Francisco-based Cell Genesys, which is studying its vaccines, called GVAX, in people with prostate cancer, pancreatic cancer, leukemia, and myeloma. These whole-cell vaccines all use a hormone that stimulates immune response, called granulocyte macrophage colony stimulating factor (GM-CSF).
"As sponsors, we want to develop treatments and get them out to the market and help patients," Sacks says. "In the case of cytotoxic chemotherapies, the traditional endpoints used in drug development are shorter-term outcomes, such as tumor response and progression-free survival. Where I expect immunotherapy to be successful is in longer-term outcomes and increased survival. Because of the mechanism of action, the patient may not show an immediate response as is generally observed with standard chemotherapies, and the trial may take longer."
Finding a Clinical Trial
Cancer researchers say their work won't mean much if more people don't enroll in clinical trials. According to the NCI, less than 3 percent of U.S. adults with cancer participate in clinical trials.
If there is a standard treatment available for a type of cancer, the NCI recommends choosing it over an experimental therapy. Cancer vaccines show the most promise at preventing a recurrence of cancer after surgery, radiation, or chemotherapy because the immune system will need to recognize and attack a smaller number of cancer cells. Cancer vaccines are also being tested as a treatment for advanced cancer.
Gary Montgomery, 66, of Redmond, Wash., enrolled in a cancer vaccine trial in 2002 to treat a rare form of abdominal cancer called pseudomyxoma peritonei. According to the National Organization for Rare Disorders, the disease is characterized by the accumulation of mucus-secreting tumor cells in the abdomen and pelvis. As the mass of tumor cells grows, the abdomen swells and digestive function becomes impaired.
Montgomery first had the standard therapy of surgery to remove the tumors in 2000. "They opened me up like a sardine can--from the sternum to the abdomen--and took out as many tumors as possible," Montgomery says. Then they inserted a tube into the abdomen, which delivered chemotherapy for six months. He experienced no tumor growth for about a year, but then the tumors came back. "It's known as a relentless form of cancer that wears you down," he says. "The doctor said that with the exception of another surgery, there was really nothing else they could do."
So Montgomery started with the Internet and found one NCI study that involved surgery and chemotherapy with an agent different from the one he had before. But the trial was closed. Taking advice from a friend, he checked at the Lombardi Cancer Center at Georgetown University in Washington, D.C. "I was feeling pretty low at this point," he says. He found out the one vaccine study he was interested in had just ended. But a nurse told him that another trial with newer versions of cancer vaccines developed at the NCI was about to start. "There were two slots left," he says. "Luckily, I met the criteria."
Montgomery received a "prime-boost regimen" of Therion Biologics' TRICOM vaccine. He first received an injection in the upper leg of a modified version of the smallpox vaccine to prime the immune system. Then he received monthly boosters of a vaccine called fowlpox CEA (carcinoembryonic antigen), an antigen found on most colorectal and pancreatic cancers. He also received a shot of the hormone GM-CSF, which helps stimulate the cells of the immune system. He had to give some of the injections to himself when he arrived back home in Washington state.
He says he experienced minimal side effects, such as soreness at the site of injection and mild flu-like symptoms. Though most cancer vaccines have been well-tolerated, in other trials some people have experienced autoimmune problems such as inflammation of the thyroid gland, skin disorders, and colitis. Autoimmune conditions are those in which the immune system mistakenly attacks the body's tissues and organs. Before he began the trial, Montgomery signed an informed consent form acknowledging that he was aware of all the risks.
Montgomery continues to participate in the trial and flies to the nation's capital every month to receive treatment because it's been working. "It hasn't cured the cancer," Montgomery says, "but it seems to be keeping it in check. And that's good enough for me."
Those interested in finding out about clinical trials to treat cancer should talk with their doctors and contact the NCI at (800) 4-CANCER (422-6237) or on the Web at www.clinicaltrials.gov.
The Immune System and How It Works
Your immune system includes your spleen, lymph nodes, tonsils, bone marrow, and white blood cells. These all help protect you from getting infections and diseases. When your immune system works the way it should, it can tell the difference between "good" cells that keep you healthy and "bad" cells that make you sick. But sometimes this doesn't happen. Doctors are doing research to learn why some immune systems don't fight off diseases like cancer.
White blood cells are an important part of your immune system. When your doctor or nurse talks about your white blood cells, he or she may use words like:
Monocytes (MON-o-cites) are types of white blood cells.
Lymphocytes (LYM-fo-cites) are types of white blood cells.
B cells, T cells, and "natural killer cells" are kinds of lymphocytes.
Cancer Vaccine Facts
Cancer vaccines are intended either to treat existing cancers (therapeutic vaccines) or to prevent the development of cancer (prophylactic vaccines).
Therapeutic vaccines, which are administered to cancer patients, are designed to treat cancer by stimulating the immune system to recognize and attack human cancer cells without harming normal cells. Prophylactic vaccines, on the other hand, are given to healthy individuals to stimulate the immune system to attack cancer-causing viruses and prevent viral infection.
There is a prophylactic vaccine against hepatitis B virus, an infectious agent associated with liver cancer.
Scientists are currently evaluating several different vaccines in large human trials to determine which approaches are most effective for particular kinds of cancers.
Vaccines traditionally have been used to prevent infectious diseases such as measles and the flu. But with cancer vaccines, the emphasis is on treatment, at least for now. The idea is to inject a preparation of inactivated cancer cells or proteins that are unique to cancer cells into a person who has cancer. The goal: to train the person's immune system to recognize the living cancer cells and attack them. (See "The Immune System and How It Works.")
"The best settings are for treating people who have minimal disease or a high risk of recurrence," says Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI). "But at this time, most therapeutic cancer vaccines are being studied in people who have failed other therapies."
Cancer vaccines are experimental; none have been licensed by the Food and Drug Administration. But there are about a dozen cancer vaccines in advanced clinical trials, says Steven Hirschfeld, M.D., a medical officer in the FDA's Center for Biologics Evaluation and Research. "Research has shown us that the fundamental approach to cancer vaccines is right; we are moving in the right direction," he says.
The three standard cancer therapies are surgery to remove tumors; chemotherapy, which modifies or destroys cancer cells with drugs; and radiation, which destroys cancer cells with high-energy X-rays. Immunotherapy, which includes cancer vaccines, is considered a fourth, and still investigational, type of therapy. Cancer vaccines are sometimes used alone, but are often combined with a standard therapy.
While standard treatments alone have proven effective, they also have limitations. Radiation and chemotherapy can wipe out a person's cancer cells, but they also damage normal cells. "We want to find treatment that is more targeted and less toxic," says Hirschfeld. "Cancer vaccines are designed to be specific, targeting only the cancer cells without harming the healthy ones."
The approach has made cancer vaccines generally well tolerated, allowing them to be used in outpatient settings. And they can be added to standard therapy with a low likelihood of causing further serious side effects.
How Cancer Vaccines Work
Cancer is a term for more than 100 diseases characterized by the uncontrolled, abnormal growth of cells. To the immune system--the body's natural defense system against disease--cancer cells and normal cells look the same. The immune system tends to tolerate the cancer cells, just as it tolerates the normal cells. That's because the immune system doesn't recognize cancer cells as something foreign, Hirschfeld says. Rather, cancer cells are once-normal cells that have gone awry. Cancer vaccines try to get the immune system to overcome its tolerance of cancer cells so that it can recognize them and attack them.
All cells have unique proteins or bits of proteins on their surface called antigens. Many cancer cells make cancer-specific antigens. The goal of using cancer antigens as a vaccine is to teach the immune system to recognize the cancer-specific antigens and to reject any cells with those antigens. The antigens activate white blood cells called B lymphocytes (B cells) and T lymphocytes (T cells). B cells produce antibodies that recognize a particular antigen and bind to it to help destroy the cancer cells. T cells that recognize a particular antigen can attack and kill cancer cells. In 1991, the first human cancer antigen was found in cells of a person with melanoma, a discovery that encouraged researchers to search for antigens on other types of cancer, according to the NCI.
The two main approaches for cancer vaccines are whole-cell vaccines and antigen vaccines. Whole-cell vaccines may take whole cancer cells from a patient or sometimes several patients, or use human tumor cell lines derived in a laboratory. "Some cell-based vaccines use tumor cells from the patient, some contain something that looks like a tumor cell but was created in a lab, and others are personalized vaccines that use some cells from the patient and some from the lab," Hirschfeld says. Cells that are taken from people with cancer are altered in a lab to inactivate them so that they are safe to re-inject.
Regardless of the exact source of the cells, whole cell vaccines potentially use all the antigens found on the tumor cells. Antigen vaccines try to trigger an immune response by using only certain antigens from cancer cells. Hirschfeld says antigens may be particular to an individual, to a certain type of cancer, or to several types of cancers.
Boosting the Immune Response
In the early 1990s, Steven Rosenberg, M.D., one of the pioneers of immunotherapy and chief of surgery at the NCI, wrote that trying to use the immune system to fight cancer is so difficult that it made him feel "like a dog trying to bite a basketball." Among Rosenberg's contributions was identifying the antigens that trigger an immune response, and cloning genes that look for, or "code for," those antigens.
Researchers have been working to develop cancer vaccines for more than 100 years in one form or another, and the main mission has always been to make the immune system's response to the cancer antigens as strong as possible.
One major strategy involves combining vaccines with additional substances called adjuvants, which act as chemical messengers that help T cells work better. An example of one type of adjuvant, called a cytokine, is interleukin-2. This protein is made by the body's immune system and can also be made in a lab.
There have also been improvements in vaccine delivery. For example, Schlom developed a vaccine in which genes for tumor antigens are put into a weakened virus called a "vector" that delivers genetic materials to cells. This makes the tumor antigen more visible to the immune system. The CEA-TRICOM vaccine was developed at the NCI through a cooperative research and development agreement with Therion Biologics in Cambridge, Mass. Researchers use the vaccinia virus, the same virus in the smallpox vaccine, as the vector. The carcinoembryonic antigen (CEA), which is found on most breast, lung, colon, and pancreatic tumors, is added to the virus. Researchers also add three molecules, called "costimulatory molecules," which serve as signals that make the vaccine more potent than it would be if the antigen were used alone. A similar vaccine developed under the NCI agreement with Therion is the PANVAC vaccine, which has now entered advanced study as a treatment for pancreatic cancer.
In addition to studying this type of virus-based technique, researchers at Duke University's Cancer Center in Durham, N.C., have been studying vaccines that mix white blood cells called dendritic cells with genetic material from a person's tumor.
Dendritic cells, which can activate T cells, work by looking around, finding antigens, and showing them to the fighter T cells. Researchers have found ways to increase the number of dendritic cells in a vaccine. "Employing millions of 'pumped up' dendritic cells can help elicit a strong immune response," says H. Kim Lyerly, M.D., director of the Duke cancer center.
Recent work by Lyerly and Duke investigators Michael Morse, M.D., and Timothy Clay, Ph.D., has focused on modifying dendritic cells with viruses so that they activate even stronger T cell responses against cancer antigens.
"This is an evolving area, and it's exciting to be able to make progress," says Lyerly. "For decades, people thought it wasn't even fundamentally possible to develop cancer vaccines, and here we are. The science behind cancer vaccines is leading us to believe that we will find the answers."
Promising, But Still Early
As with any new treatment, cancer vaccines must be first studied in lab animals and then tested for safety and effectiveness in three phases of human studies, called "clinical trials," before they can be approved by the FDA. In Phase 1 clinical trials, cancer vaccines are used alone and studied for safety and to determine the proper dose. In Phase 2 trials, they are tested for effectiveness and may be used alone or in combination with another therapy. Phase 3 trials are large-scale studies testing effectiveness and usually comparing a vaccine with some standard therapy. Researchers are testing vaccines using various adjuvants, delivery methods, and types of antigens.
Cancer vaccines have shown promise in clinical trials with many types of cancer. According to Howard Streicher, M.D., a senior investigator with the NCI's Cancer Therapy Evaluation Program, it's too soon to say which cancers will be treated with vaccine therapy. The types of tumors that have proven most susceptible to vaccines so far, he says, are: skin cancer (melanoma); kidney cancer (renal cell); a group of cancers that affect the lymphatic system (lymphoma); a malignant tumor of the bone marrow (myeloma); and solid tumors, such as lung cancer. The most work has been done in the area of melanoma, a type of skin cancer in which treatment options are limited when the disease is in advanced stages.
"After having a tumor removed, about half of patients with stage III melanoma may have a recurrence, and we want to prevent that," Streicher says. "Chemotherapy doesn't work in this area, so our hope is that this could be just the right place for a vaccine."
James Mulé, M.D., Ph.D., associate director of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., says, though some early studies have shown that some people's tumors shrank or even disappeared in response to a cancer vaccine, it's still early. Mulé was an investigator on the first study that tested dendritic cells in children. In the Phase 1 study, one 16-year-old with cancer that had spread to her lungs and spine showed significant shrinkage of tumors.
"There is promise in the sense that some of these vaccines can illicit a powerful immune response in some patients, but I think we have to be careful about getting too excited over early studies that can't be reproduced," Mulé says.
Jeffrey Weber, M.D., Ph.D., director of the Norris Melanoma Center at the University of Southern California, says there is also still a lot of work to be done in discovering new antigens and adjuvants and more sophisticated strategies to overcome the immune system's tolerance of cancer cells. "We are still discovering molecules that regulate the immune system such as CTLA-4, so we're still in the dark in some areas," Weber says. Recent research has found that inhibiting CTLA-4 can help the immune system attack some tumors.
Experts say that no therapeutic cancer vaccine has been licensed yet because few Phase 3 studies have been completed, and those that have been completed did not meet their goals of demonstrating safety and effectiveness of the vaccine. "We are still working with industry to define the characteristics, including potency," says the FDA's Hirschfeld. "So a trial may look promising early on, but our job is to make sure it can be reproduced. We have to ask: 'Will this treatment work in the larger population?'"
One of the challenges is that cancer vaccines may produce different effects than those caused by cancer drugs. With cancer drugs, experts ask whether there is an objective, measurable response, such as tumor shrinkage. A cancer drug may cause tumors to shrink, but a person still may not live longer. With a cancer vaccine, there may be fewer signs of tumor shrinkage, but a person might live longer.
There aren't the same landmarks that you would see with traditional therapies, says Natalie Sacks, M.D., medical director in the clinical research division at San Francisco-based Cell Genesys, which is studying its vaccines, called GVAX, in people with prostate cancer, pancreatic cancer, leukemia, and myeloma. These whole-cell vaccines all use a hormone that stimulates immune response, called granulocyte macrophage colony stimulating factor (GM-CSF).
"As sponsors, we want to develop treatments and get them out to the market and help patients," Sacks says. "In the case of cytotoxic chemotherapies, the traditional endpoints used in drug development are shorter-term outcomes, such as tumor response and progression-free survival. Where I expect immunotherapy to be successful is in longer-term outcomes and increased survival. Because of the mechanism of action, the patient may not show an immediate response as is generally observed with standard chemotherapies, and the trial may take longer."
Finding a Clinical Trial
Cancer researchers say their work won't mean much if more people don't enroll in clinical trials. According to the NCI, less than 3 percent of U.S. adults with cancer participate in clinical trials.
If there is a standard treatment available for a type of cancer, the NCI recommends choosing it over an experimental therapy. Cancer vaccines show the most promise at preventing a recurrence of cancer after surgery, radiation, or chemotherapy because the immune system will need to recognize and attack a smaller number of cancer cells. Cancer vaccines are also being tested as a treatment for advanced cancer.
Gary Montgomery, 66, of Redmond, Wash., enrolled in a cancer vaccine trial in 2002 to treat a rare form of abdominal cancer called pseudomyxoma peritonei. According to the National Organization for Rare Disorders, the disease is characterized by the accumulation of mucus-secreting tumor cells in the abdomen and pelvis. As the mass of tumor cells grows, the abdomen swells and digestive function becomes impaired.
Montgomery first had the standard therapy of surgery to remove the tumors in 2000. "They opened me up like a sardine can--from the sternum to the abdomen--and took out as many tumors as possible," Montgomery says. Then they inserted a tube into the abdomen, which delivered chemotherapy for six months. He experienced no tumor growth for about a year, but then the tumors came back. "It's known as a relentless form of cancer that wears you down," he says. "The doctor said that with the exception of another surgery, there was really nothing else they could do."
So Montgomery started with the Internet and found one NCI study that involved surgery and chemotherapy with an agent different from the one he had before. But the trial was closed. Taking advice from a friend, he checked at the Lombardi Cancer Center at Georgetown University in Washington, D.C. "I was feeling pretty low at this point," he says. He found out the one vaccine study he was interested in had just ended. But a nurse told him that another trial with newer versions of cancer vaccines developed at the NCI was about to start. "There were two slots left," he says. "Luckily, I met the criteria."
Montgomery received a "prime-boost regimen" of Therion Biologics' TRICOM vaccine. He first received an injection in the upper leg of a modified version of the smallpox vaccine to prime the immune system. Then he received monthly boosters of a vaccine called fowlpox CEA (carcinoembryonic antigen), an antigen found on most colorectal and pancreatic cancers. He also received a shot of the hormone GM-CSF, which helps stimulate the cells of the immune system. He had to give some of the injections to himself when he arrived back home in Washington state.
He says he experienced minimal side effects, such as soreness at the site of injection and mild flu-like symptoms. Though most cancer vaccines have been well-tolerated, in other trials some people have experienced autoimmune problems such as inflammation of the thyroid gland, skin disorders, and colitis. Autoimmune conditions are those in which the immune system mistakenly attacks the body's tissues and organs. Before he began the trial, Montgomery signed an informed consent form acknowledging that he was aware of all the risks.
Montgomery continues to participate in the trial and flies to the nation's capital every month to receive treatment because it's been working. "It hasn't cured the cancer," Montgomery says, "but it seems to be keeping it in check. And that's good enough for me."
Those interested in finding out about clinical trials to treat cancer should talk with their doctors and contact the NCI at (800) 4-CANCER (422-6237) or on the Web at www.clinicaltrials.gov.
The Immune System and How It Works
Your immune system includes your spleen, lymph nodes, tonsils, bone marrow, and white blood cells. These all help protect you from getting infections and diseases. When your immune system works the way it should, it can tell the difference between "good" cells that keep you healthy and "bad" cells that make you sick. But sometimes this doesn't happen. Doctors are doing research to learn why some immune systems don't fight off diseases like cancer.
White blood cells are an important part of your immune system. When your doctor or nurse talks about your white blood cells, he or she may use words like:
Monocytes (MON-o-cites) are types of white blood cells.
Lymphocytes (LYM-fo-cites) are types of white blood cells.
B cells, T cells, and "natural killer cells" are kinds of lymphocytes.
Cancer Vaccine Facts
Cancer vaccines are intended either to treat existing cancers (therapeutic vaccines) or to prevent the development of cancer (prophylactic vaccines).
Therapeutic vaccines, which are administered to cancer patients, are designed to treat cancer by stimulating the immune system to recognize and attack human cancer cells without harming normal cells. Prophylactic vaccines, on the other hand, are given to healthy individuals to stimulate the immune system to attack cancer-causing viruses and prevent viral infection.
There is a prophylactic vaccine against hepatitis B virus, an infectious agent associated with liver cancer.
Scientists are currently evaluating several different vaccines in large human trials to determine which approaches are most effective for particular kinds of cancers.
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