Thursday, January 22, 2009
Will Mammograms Soon be Obsolete?
Mammograms are big business, generating a cash cow for many in the cancer industry. Consider the fact that annual mammograms are typically recommended for every women over 40, and you begin to get a feel for how much pull this industry has in the healthcare business and thus with the FDA. The sad truth is that mammograms are not very effective at finding and preventing tumors, but to make matters worse, undergoing the procedure exposes women to hazardous levels of radiation, and the process can also lead to spreading cancer cells if they are present due to intense squeezing of the breast.
It will be interesting to see if this saliva test goes anywhere or if it is quashed by those that will not turn away from the financial windfalls that mammograms provide, even though the health and welfare of women is the real issue here.
Breast Cancer Saliva Test to Make Dangerous Mammograms Obsolete
by David Gutierrez, staff writer
(NaturalNews) Researchers are working to develop a saliva test for breast cancer that could vastly reduce the use of dangerous and invasive breast cancer screening techniques such as mammograms."This will be a noninvasive, quick means of detection," said lead researcher Charles Streckfus, a professor of diagnostic sciences at the Dental Branch of the University of Texas (UT) at Houston. "With it, dentists will be able to catch cancers before a woman can feel a lump."
Researchers have discovered that the onset of breast cancer changes the density of different proteins excreted by the salivary glands. In the current study, published in the journal Cancer Investigation, Streckfus and other researchers from the UT-Houston Dental Branch and Medical School compared the protein levels found in the saliva of 10 women with breast cancer, 10 healthy women, and 10 women with a type of tumor called fibroadenoma.
Fibroadenoma is the most common kind of benign breast tumor.
"Saliva is a complex mixture of proteins," said researcher William Dubinsky. "We go through a process that compares different samples by chemically labeling them in such a way that we can not only identify the protein, but determine how much of it is in each sample. This allows us to compare the levels of 150-200 different proteins in cancerous versus non-cancerous specimens to identify possible markers for disease.
"The researchers identified 49 proteins that were present at different levels between the three groups. These proteins should hypothetically allow doctors to use such a saliva test to alert them when a woman has a tumor, and to determine whether it is cancerous or benign.
"This is a unique finding," Streckfus said, "as it targets both the benign and malignant tumor, which could potentially reduce the number of false positives and false negatives associated with current cancer diagnostics".
Previously, the same team of researchers was able to correctly detect whether a woman had breast cancer 85 percent of the time, using only one saliva protein as a marker. With 49 different markers, Streckfus says that the accuracy of the test should be closer to 95 percent.
In the current method, the saliva sample is placed onto a hand-held, gold-plated chip or lab dish, developed by UT-Austin biochemists. A laser analyzes the protein content of the sample.
"I see this as a future public health service by dentists" Streckfus said. "Most folks, especially women and children, visit the dental office way more often than they ever see the physician. Saliva is a non-invasive, quicker way for detection."
Many obstacles remain before this test could be available, however. The first step is more studies to confirm the effectiveness of the protein markers as diagnostic tools in a larger group of patients. Streckfus and colleagues hope to launch a large, multicenter clinical trial of the test within the next two years, and to apply for FDA approval within five.
The only saliva test currently approved by the FDA is one for HIV/AIDS.
A saliva test for breast cancer has many advantages over current diagnostic methods such as ultrasounds, mammograms, biopsies and blood tests. It would be far less invasive and expensive than most such tests, and have a much higher accuracy rate than blood tests, which are not currently favored for breast cancer diagnosis due to their poor accuracy.
The higher accuracy of a saliva test comes in part from the fact that saliva proteins are much easier to detect than the proteins in blood, Dubinsky said."In the case of breast cancer, saliva analysis has been used to monitor patient response to chemotherapy or surgical treatment of the disease," said Professor Damien Walmsley, scientific adviser for the British Dental Association. "The mouth itself is a good indicator of an individual's overall health, and dentists already play an important role in diagnosing and detecting oral cancers."
Streckfus said that a saliva test would be particularly valuable in places where mammography centers are rare, such as in many Third World countries, or in breast cancer survivors who need to be regularly monitored for potential cancer recurrence.
Regular use of mammograms is not only expensive and emotionally distressing, but can also be dangerous. Because women are exposed to X-ray radiation as part of the mammogram procedure, regular mammogram use actually increases women's risk of developing various cancers. For this reason, mammograms are not normally performed for women under the age of 40, in whom the risk of breast cancer is relatively low unless symptoms are present.
But Streckfus warned that a saliva test cannot utterly replace mammograms, because the saliva test is unable to determine which breast contains the tumor.Nonetheless, cancer patient advocates have greeted the new research as promising. According to Leonard Lichtenfeld, deputy chief medical officer for the American Cancer Society, the saliva test will one day be "a terrific advance."
"I think advances like this test portend the day when we'll be able to diagnose disease that would be invisible using today's technologies," Lichtenfeld said. "[Patients will] be able to be diagnosed and treated before they would otherwise know they have the disease."
Streckfus and colleagues are also researching whether saliva tests can be used to diagnose other cancers, including of the cervix, uterus, head, neck and ovaries. Another group of researchers, at Johns Hopkins Kimmel Cancer Center, is also working on a saliva test for head-and-neck cancer. According to Lichtenfeld, the Johns Hopkins team is farther along than the UT-Houston team, because their test relies on genetic rather than protein markers.
http://www.naturalnews.com/z025348.html
Thursday, July 3, 2008
Potential Cancer Cure Linked to White Blood Cells
Such manipulation can happen in numerous ways. Often researchers and their work will be discredited and ridiculed in the academic community and the press, or a study can be bogged down with so many regulations and so much financial hanky-panky that it becomes impossible for the project to continue. Whatever the case, this story bears watching. Any possible remedy for cancer that can bypass the hazards of chemo and radiation therapies would seem to be welcomed by all, but unfortunately this is not always the case. This atmosphere that is so hostile to the truth is one of the reasons that nutritional and other natural approaches to fighting cancer, including a lifestyle of wellness that prevents the disease in the first place, have not been more widely accepted by the public and many in conventional medicine.
Cancer cure in mice to get human trials
Wake Forest University scientists studying genetic immunity in mice to start testing humans
Zoe Elizabeth Buck, Staff Writer
Clinical trials begin this week at Wake Forest University on a cancer therapy that has completely cured the disease in every mouse tested over the past few years.
The therapy involves the transfusion of white blood cells from cancer-resistant donors into cancer patients, letting loose a uniquely qualified army of disease fighters to attack the invading tumor.
Some scientists are skeptical about the move from mice to humans, but others are excited about the possibility of success.
Dr. Zheng Cui, the lead investigator, and his team at the Wake Forest University School of Medicine announced the move to human clinical trials Saturday at the Understanding Aging Conference in Los Angeles. The team recently won approval for human trials from the Food and Drug Administration.
"This is the first time that such aggressive cancer in mice has been eradicated like this," Cui said. "This is a very dramatic result."
The result is especially dramatic considering its discovery stemmed from a series of accidents, starting with one extraordinary mouse.
In the late 1990s, Cui and his team were using mice as experimental cancer patients for their research, injecting them with malignant cells. Within three to four weeks, as expected, all the injected mice developed tumors and died.
But in 1999, for some reason, one mouse didn't develop tumors and didn't die.
Dr. Lloyd Old of the Ludwig Institute for Cancer Research, who was collaborating in the research, later said that if Cui had been trained as an immunologist, he would have thrown out the mouse right then. But Cui was trained as a medical doctor, and his curiosity led him to continue testing the oddball mouse, injecting it with higher and higher lethal doses of carcinogens.
No matter how many times the researchers tried to give the mouse cancer, it didn't develop a tumor, and it didn't die.
The mouse was immune to cancer.
Making sure
As cautious scientists, Cui and his team decided to breed the mouse and test its offspring for cancer immunity.
"We knew that if we hadn't made a mistake, something very dramatic was happening, but we had to know we weren't making a mistake," he said.
It wasn't a mistake. Three of the mouse's seven grandchildren didn't get cancer, either. Whatever was causing the cancer resistance was built into the mouse's family genes. News of the finding created a stir.
"Our lives were suddenly overtaken by an unexpected media frenzy," Cui wrote in 2003. Headlines proclaimed a cure for cancer -- albeit in mice.
"People got very excited for a reason," he said. "It was exciting. We had direct evidence for cancer immunity that we could reproduce at will. It was a very profound result, and it was not subtle. I don't think people could have overreacted."
The next step was to figure out how to transfer that cancer immunity from the special mice to mice that were dying of cancer. The solution is apparently hidden in the mice's white blood cells, which are like a tiny biological army. They are carried in the bloodstream to fight infection and disease throughout the body.
For some reason -- Cui and his team don't know why -- the white blood cells from the immune mice could defeat the cancer every time, while the other mice's white blood cells were unable to stave off the infection.
The majority of contemporary cancer research focuses on these cellular soldiers. But most research seeks to isolate certain parts of the cells and stimulate them in test tubes, a complex process.
Cui's procedure is simple.
"We don't have to do anything to manipulate the white blood cells," Cui said. All he and his team did was transfuse the immune mouse cells into the sick mice, and the tumors melted away.
"It's like we discovered aspirin, only instead of curing headaches it's curing cancer," Cui said. "We don't know how it works exactly, but it doesn't really matter."
A leap forward
Rather than spend years determining the mechanisms behind the miracle, Cui thought it was more important to press forward toward clinical trials in humans.
But Cui's eagerness to move forward could lead to problems.
"Anything that seems like a miracle always runs into roadblocks in the future," said Vivek Rangnekar, a cancer researcher at the University of Kentucky. "If you don't know the mechanism behind what is going on, you will not be equipped to deal with those roadblocks. For example, they could find that the cancer builds up a resistance, and if they don't know what's going on they will not be equipped to deal with that."
As Cui moves forward, he must first find a source for the cancer-fighting white blood cells -- the human equivalent of that miraculous mouse.
Next week, Cui's team will begin a search for cancer-resistant humans.
Next step: humans
Whether people are immune to cancer is probably rooted in their genetic background.
"Some families just don't have any cancer for generations, even among heavy smokers," he said. "Chances are it is probably not because they are lucky."
These cancer-resistant people are identified by examining how well their white blood cells fight off cancer cells in a test tube. Once a set of donors is selected, the clinical trial will move into the treatment stage, harvesting white blood cells from immune people and transfusing them into cancer patients. The process will be relatively painless by contrast with current cancer treatments such as chemotherapy or radiation therapy, which often have debilitating side effects.
"It's basically a blood transfusion -- a safe procedure that goes on all the time," Cui said.
Doubts and pessimism
Other researchers remain cautious. Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said it was important to note that we simply won't know anything about the viability of the therapy for humans until the clinical trial begins.
"We're always hopeful," he said, "but we have to temper our enthusiasm."
Some scientists expressed pessimism about the clinical trials. Lab mice have such close genetics that any two members of the same strain are essentially identical twins. This is not true in humans. Some experts worry that the cancer patients' bodies will reject the donated cells from the blood transfusion, or worse, that the white blood cells, designed to identify and attack anything foreign to them, will attack the body of the patient from the inside.
Cui said he is aware that the procedure comes with risks. But, he said, the white blood cell transfusions have been used in other fields of medicine for years.
"We've minimized all the risk, especially for these first few rounds of trials," he said. "We don't know what will happen, but we hope this will cure several types of cancer and help a few people in the next months. This could be another arrow in the cancer treatment quiver."
http://www.newsobserver.com/news/health_science/story/1124231.html
Tuesday, June 24, 2008
The Suppression of Alternative Cancer Treatments
If you are forced to deal with a cancer diagnosis or other degenerative diseases, I urge you to take time to research and educate yourself and then work with a health care provider who is open to and knowledgeable about alternative cancer protocols. Many forms of cancer have responded very successfully to alternative forms of treatment, little of which has been disclosed to the general public. Most cancer patients are not told, nor do they realize that there are many options for the cancer patient that exist, some of which include a combination of limited mainstream options in conjunction with a supportive regimen of natural and nutritional medicine which will actually support the body during the healing process.
It is also vital to remember that prevention is the best medicine when it comes to all forms of disease. If we choose to follow a lifestyle that pursues wellness, treating disease will most often be an issue that can be totally avoided. In addition, our bodies will then be better prepared to fight illness if it should occur.
CancerDecisions
Newsletter Archives
For June 22, 2008
A GREAT OPPORTUNITY LOST
Ralph Moss, Ph.D
Many readers have asked what happened to the National Institutes of Health-sponsored clinical trial of the Gonzalez regimen, the one that used orally administered enzymes for the treatment of pancreatic cancer?
In the 1980s, Nicholas Gonzalez, MD, was a disciple of Robert A. Good, MD, PhD, director of Sloan-Kettering Institute, New York. With Good's encouragement, he began a project (while still a Cornell medical student) to evaluate the enzyme treatment of cancer promoted by William Donald Kelley, DDS, of Grapevine, Texas.
Gonzalez felt this treatment was beneficial and eventually opened an office in Manhattan to treat patients using this protocol. He presented 25 of his best cases to the NCI's Division of Cancer Treatment (DCT) in July 1993. The pilot study was published in 1999 in the journal Nutrition and Cancer (Gonzalez 1999). Because of the positive findings of this pilot study, first the National Cancer Institute and then the National Center for Complementary and Alternative Medicine (NCCAM) proposed a formal clinical trial of the method.
A decade ago, hopes were high and this trial was promoted as a sterling example of how conventional and alternative medicine could work together for the good of patients, by seeking the truth about the relative merits of various contesting treatments. For example, John Chabot, MD, of the Herbert Irving Comprehensive Cancer Center of Columbia University, and Dr. Gonzalez spoke from the same podium at the 1999 Center for Mind-Body Medicine conference. It seemed like a transcendent moment.
The National Institutes of Health (NIH) awarded a grant of $1.4 million to Dr. Gonzalez. Alas, this clinical trial ran into trouble almost as soon as it was launched in March 1999. The trial was originally designed to randomize 90 pancreatic cancer patients to receive either gemcitabine (Gemzar) chemotherapy or a large daily dose of orally administered pancreatic enzymes. But the key word was 'randomize' -- patients were to be randomly assigned to one or the other group by the computer equivalent of a coin toss. However, most people who were attracted to this trial wanted the enzyme therapy, and not a 50-50 chance of getting chemotherapy. So in the end only three eligible patients agreed to be randomized in this fashion.
Sensing an approaching impasse, in 2000, NIH intervened to change the design. According to a government statement of the time:
"The design of the trial is now changing to a single-armed, non-randomized case-cohort study where patients will only be enrolled in what was the nutritional arm. Researchers plan to compare patients on the Gonzalez regimen to a concurrently accrued group of patients being treated with gemcitabine, although such comparisons are known to be difficult because patients selected for the newer or older treatments may not be entirely comparable."
In fact, the 'de-randomization' of the trial was a major blow to its credibility. I was on a panel of government advisors that was asked to endorse this decision. In a conference call a representative of the US Food and Drug Administration (FDA) stated clearly that his agency would not accept the results of any trial that was not fully randomized. Yet the NIH strongly recommended the change and the panel in question voted in favor of changing the protocol for pragmatic reasons.
I will not attempt to trace the deterioration of this trial in the next few years. Simply put, after the "honeymoon" phase of 1999-2000, there came a period of increasing tension between Dr. Gonzalez and the Columbia University investigators. Dr. Gonzalez claimed that after Columbia was chosen as the site of the trial, "the money went into their bank account, all of it, never to be seen again" (personal communication, June 19, 2008). He also claims that he wasn't adequately compensated for his treatment of the patients.
The newly non-randomized trail was supposed to accrue between 72 and 90 participants within the first three years. But it dragged on and on, with insufficient recruitment and a growing atmosphere of disagreement. Finally, in 2007 the trial was suspended. Its entry at www.clinicaltrials.gov states: "This study is ongoing, but not recruiting patients." In fact, the trial in its current incarnation is unlikely ever to start up again.
According to Columbia's own Web site, the Irving Center diagnoses and treats 3,500 cancer cases per year. I find it amazing that Columbia University could not recruit 72 to 90 suitable participants over 8 years. But that was not the limit of potential patients. There could also be referrals from other centers.
Each year, more than 37,000 Americans are diagnosed with pancreatic cancer and 34,000 die of this disease. Many people are eventually told that they have the kind of incurable, inoperable disease that was targeted in this trial. Yet NCI and Columbia University between them apparently could not find 70 people to fill the trial, even though about a quarter of a million such patients were diagnosed with this cancer in the US during the period in question.
Imagine if the NCI and NIH, sponsors of the trial, had released a series of press releases, or launched a vigorous advertising campaign, whose purpose was to inform the American public about the availability of this non-toxic dietary treatment for cancer. They could probably have populated a dozen such trials! It seems to me that the basic difficulty was a lack of genuine interest or enthusiasm on the part of the academic participants.
At the same time, the trial came under tremendous pressure from doctors and compliant journalists who opposed the testing of alternative treatments. Sometimes this opposition was little more than a hatchet job.
It was unfortunate that, as time progressed, most of the medico-political support for the trial drained away. At the time of its initiation, some of its prominent supporters included not just members of Congress, but Drs. Ernst Wynder, head of the American Health Foundation, New York; William Fair, MD, chairman of urology at Memorial Sloan-Kettering Cancer Center, New York; Karen Antman, MD, professor of medicine and pharmacology at Columbia's medical school, and director of Columbia's Irving Comprehensive Cancer Center; Michael A. Friedman, deputy director of the National Cancer Institute; Wayne Jonas, MD, director of the Office of Alternative Medicine (now the National Center for Complementary and Alternative Medicine); and John Paul Jones III, research vice president of the giant Proctor & Gamble company.
What a difference a decade makes! Wynder and Fair died soon afterwards; Antman and Friedman moved to even more prestigious jobs; Jonas was replaced by a new NCCAM director, who was indifferent (if not downright hostile) to the project; and Jones retired from P&G. By 2007, Gonzalez himself had become "One Man Alone" -- ironically, the title of his 1990 monograph on the program's developer, William Donald Kelley, DDS. One hundred years after John Beard, DSc, of the University of Edinburgh, first proposed the treatment of cancer with pancreatic enzymes, this plausible approach still lacks a rigorous clinical trial in humans.
Because of the radically different interpretations being put forward about the trial, Dr. Gonzalez submitted the dispute for adjudication to the Office for Human Research Protection (OHRP), a branch of the Department of Health and Human Services. On February 25, 2008 OHRP sent a letter to Steven Shea, MD, Vice President and Dean of the Columbia Center, which is now available online.
This letter from the OHRP confirms some of Dr. Gonzalez's accusations concerning the conduct of this failed trial. The most surprising government finding was as follows: "We note that Columbia University Medical Center (CUMC) found that for 40 of 62 subjects it appeared that informed consent was not documented with a signed written consent form prior to the initiation of research activities involving human subjects." Read that over-nearly two-thirds of the participants were not even properly informed of the risks and benefits of participation in the trial!
There were other irregularities as well. The OHRP requested of Columbia's dean: "Please provide us with a corrective action plan that addresses the above determinations by March 21, 2008." The letter does not state whether or not any corrective plan has been proposed.
Dr. Gonzalez alleges much more widespread malfeasance on the part of his erstwhile academic collaborators. It certainly seems that the OHRP charges, although mildly phrased, confirm that all was not as it should have been at Columbia. Given the fact that two-thirds of the subjects did not give proper informed consent - responsibility for which rested entirely with Dr. Chabot and Columbia - one wonders exactly what prospective patients were told about the relative merits of the two arms of the trial. I understand that at least one Congressman, Dan Burton (R-IN), has taken an interest in the failure of this once-promising trial. It is certainly time for a full-scale Congressional investigation of this failure - of what exactly went wrong and, in the broader sense, whether the public is getting the truth about the potential benefits of alternative treatments for cancer.
NOTE: The formal title of the trial was "A Phase III Study of Gemcitabine Compared With Pancreatic Enzyme Therapy Plus Specialized Diet (Gonzalez Regimen) in Treating Patients Who Have Stage II, Stage III or Stage IV Pancreatic Cancer." The principal investigator was the aforementioned Dr. Chabot. The project number was P30-CA13696.
http://www.cancerdecisions.com/062208_page.html
Sunday, December 9, 2007
Ixempra - Newest Drug for Advanced Breast Cancer
Notice the side effects of Ixempra and how many of them have to do with the digestive tract. Once the digestive tract, which is where 70-80% of the immune system is located, is compromised it becomes very difficult to bring it back into uncompromised health. Not impossible, but very difficult. And even then there will almost always be future digestive tract issues that are a result of chemotherapy.
Almost all chemotherapy is experimental medicine, meaning that the patient is being used as a guinea pig in the name of cancer research. Through these experiments patients are used to determine the type of drugs that seemingly get a response when mixed (chemo cocktails), dosage amounts (some trials have been stopped because patients died from what was discovered to be over-dosage), severity of side effects along with survival rates using different ratios of the above.
It is time that America insist that the cancer-game that we have been playing, in the name of cancer research, for the last 30 plus years be stopped. We need to take our focus off of toxic drugs that harm the entire body and instead focus on giving the body (immune system) what it needs to get well. As long as we believe the mass media marketing by the NCI and cancer treatment hospitals that poisoning the body with chemicals and then hoping for wellness is actually obtainable, this barbaric treatment will continue. It hasn't worked in the past and it will not work in the future. Remember, the definition of insanity is doing the same thing over and over and expecting different results. Right now, cancer treatment in the U.S. is in the realm of insanity.
IXEMPRA - A NEW DRUG FOR ADVANCED BREAST CANCER
In October 2007, the FDA approved Ixempra (ixabepilone) for the treatment of advanced breast cancer. Specifically, the drug was approved for the treatment of patients whose metastatic or locally advanced breast cancer has become resistant to standard drugs such as anthracyclines, taxanes, and capecitabine (Xeloda). Ixempra is classified as a "microtubule inhibitor." It is thus similar to the taxanes but is said by the manufacturer, Bristol-Myers, to be somewhat less toxic.
"Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options," said Linda Vahdat, M.D., of New York Presbyterian Hospital Weill Cornell Medical Center, in a statement released by the company. "The approval of Ixempra means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies."
Let us therefore examine just how "important" this new option is likely to be to patients with metastatic breast cancer.
First of Two Trials
The FDA approval of Ixempra was based on two clinical trials that included a total of 878 patients. The first of these studies was a phase II (non-randomized) trial of Ixempra as a stand-alone treatment. That study enrolled 126 patients with either metastatic or locally advanced breast cancer that had proven resistant to three prior therapies. There was an "objective partial response" in 12.4 percent of 113 evaluable patients. In other words, fewer than one out of eight patients who got the drug saw their tumors shrink. (And, by the way, whatever happened to the other 13 "unevaluable" patients in the study? Under the commonly observed intent-to-treat rule of medical statistics, they should have been included in this analysis.)A partial response is generally defined as an incomplete shrinkage of the tumor by more than 50 percent for one month or more. As long-time readers of this newsletter will know, a partial response generally does not correlate with increased survival.
Side effects of Ixempra in this trial included the following:
- Peripheral sensory neuropathy in 62 percent of patients, with serious to severe effects (Grades 3 and 4) in 14 percent;
- Fatigue, asthenia 56 percent (Grade 3/4: 13 percent);
- Myalgia, arthralgia 49 percent (Grade 3/4: 8 percent);
- Alopecia 48 percent (Grade 3/4: 0 percent);
- Nausea 42 percent (Grade 3/4: 2 percent);
- Stomatitis,mucositis 29 percent (Grade 3/4: 6 percent);
- Vomiting 29 percent (Grade 3/4: 1 percent);
- Diarrhea 22 percent (Grade 3/4: 1 percent);
- Musculoskeletal pain 20 percent (Grade 3/4: 3 percent).
Major hematologic [blood-related] adverse events included neutropenia [Grade 3-4 in 54 percent] and leukopenia [Grade 3-4 in 49 percent].
Combination Trial
FDA also took into consideration a larger phase III randomized trial which evaluated the efficacy and safety of Ixempra combined with Xeloda (capecitabine) in comparison to Xeloda used as a stand alone treatment. This trial included 752 patients who were previously treated with anthracyclines (such as Adriamycin) and taxanes (such as Taxol), and whose tumors had already shown resistance to these therapies. In this trial, Ixempra in combination with Xeloda resulted in a slight improvement in progression-free survival (PFS) compared to Xeloda given alone.
The median survival with the combination of Ixempra and Xeloda was 5.7 months vs. 4.1 months for Xeloda alone - a gain of 1.6 months. But the side effects included peripheral sensory neuropathy in 65 percent, hand-foot syndrome in 64 percent, nausea in 53 percent, diarrhea in 44 percent, etc.
Again, readers will note that the above statistics do not yield any information on overall survival, i.e., how long on average Ixempra patients can be expected to live compared to those who got either Xeloda alone or no further treatment. The increase of 1.6 months (which you can be sure will be widely bandied about as indicative of the "value" of Ixempra) refers solely to an improvement in progression-free survival. But progression-free survival is not at all the same thing as improved overall survival. Progression-free survival is the time during which the disease appears stable before once again beginning to advance. It is entirely possible that two groups of patients could have a significant difference in this parameter, but the disease could still claim their lives at roughly the same time.
A Bristol-Myers spokesperson has been quoted as saying that the cost of a full course of Ixempra would be between $18,440 to $23,050.
There was a time when FDA required proof of increased survival before it would approve a new drug. Now Bristol-Myers has gotten Ixempra onto the market, having only shown a slight increase in a surrogate marker of doubtful benefit.
--Ralph W. Moss, Ph.D.
http://www.cancerdecisions.com/
References:
Ixempra company web site: http://www.ixempra.com/
Cost of Ixempra: http://www.topnews.in/bristol-myers-breast-cancer-drug-won-us-fda-approval-23921
Tuesday, December 4, 2007
A Safer Option to Mammography
Finding cancer at the very earliest stage is not necessarily the end-all that conventional medicine promotes. The body develops cancer cells every day and it is supposed that everyone develops very small tumors. In a healthy body (healthy immune system) the body will recognize these cells and small tumors and dispose of them in a natural way. The key is to keep the immune system functioning at healthy levels. However, if we automatically begin drugging and radiating the smallest of these growths, in the long run, we may be doing ourselves more harm than good when, if left alone, the body would take care of the concern on its own.
This piece also presents a diagnostic tool for breast cancer that can serve as an alternative to mammography. It is not usually offered by most practitioners, but as a savvy consumer, you should be aware of it and request it in lieu of exposing yourself to the hazards of mammography. As women become more knowledgeable and proactive regarding health care issues, safer, more effective, and less invasive procedures such as this will become more widely available.
Thermography: A Safer Option for Breast Cancer Detection
by Mary Laredo http://www.NewsTarget.com/022227.html
(NewsTarget) The occurrence of breast cancer has dramatically increased in the past 50 years and the medical establishment encourages the use of annual mammogram screenings as a womans best option for early detection. In fact, for more than 30 years it has been the unquestioned, standard screening device used by the medical community. While mammography may be useful in certain situations, it has many disturbing drawbacks.
With toxic radiation, mammogram testing compresses sensitive breast tissue causing pain and possible tissue damage. To make matters worse, the false negative and false positive rates of mammography are a troubling 30% and 89% respectively.(1) Another concern is that many breast cancers occur below the armpits; however, mammography completely misses this auxiliary region, viewing only the breast tissue compressed between two plates of glass. Considering these drawbacks, breast thermography should be given closer consideration.
Thermography (also called thermology) is a little-known technique for breast cancer detection that has been available since the 1960s. It is non-invasive and non-toxic, using an infrared camera to measure thermal emissions from the entire chest and auxiliary regions. Cancerous tissue develops a blood supply to feed a growing tumor, and the abnormal blood vessel formations generate significantly more heat than the surrounding healthy tissue. The infrared camera detects the differences in heat emitted from abnormal tissue (including malignancies, benign tumors and fibrocystic disease), as compared to normal tissue. There is no physical contact with the patient, who stands several feet away from the camera while a technician takes a series of images.
A second set of images is taken following a cold challenge. The patient places her hands in ice cold water for one minute causing healthy tissue to constrict while the abnormal tumor tissue remains hot. The infrared scanner easily distinguishes the difference, and these images are compared with the first set for confirmation.
Thermography can detect abnormalities before the onset of a malignancy, and as early as ten years before being recognized by other procedures such as manual breast exam, mammography, ultrasound or MRI.(2) This makes it potentially life-saving for women who are unknowingly developing abnormalities, as it can take several years for a cancerous tumor to develop and be detected by mammogram. Its accuracy is also impressive, with false negative and false positive rates at 9% for each.(3) Thermography is also an effective way to establish a baseline for comparison with future scans; therefore, women should begin screening by the age of 25.
Although widely embraced by alternative health care practitioners, thermographys obscurity in the mainstream means that too many women rely on mammograms as their only option. There are several reasons for thermographys lack of support by the conventional medical community. Early thermal scanners were not very sensitive, nor were they well-tested before being used in clinical practice. This resulted in many misdiagnosed cases and its utter dismissal by the medical community. Since then the technology has advanced dramatically and thermography now uses highly sensitive state-of-the-art infrared cameras and sophisticated computers. A wealth of clinical research attests to its high degree of sensitivity and accuracy. In 1982, the FDA approved thermography for breast cancer screening, yet most of the medical establishment is either unaware of it or still associates it with its early false start. Since most women are also uninformed of the technology there is no pressure on the medical community to support it.
This author - who knows from first-hand experience the physical and emotional trauma of mammography as well as the passive and comforting accuracy of thermal scanning - would have been spared from years of radiation exposure with an earlier knowledge of thermography. The importance of education and awareness of this technology cannot be overstated.
When a thermographic report is negative, annual monitoring is essential to note any changes as early as possible. A positive report should be discussed with a health care practitioner as it may be necessary to follow up with another detection method such as mammography or ultrasound to identify the exact location of the abnormality and to determine whether tissue biopsy is needed. If mammography is used to complement the thermal scan, it is important to offset the affects of radiation prior to and following the procedure. Wheat grass juice, green super foods, or brown seaweed such as Modifilan are powerful detoxifiers.
Breast abnormalities and tumors are merely symptoms of imbalances within the bodys internal terrain that need to be identified and corrected. A thoughtful and careful look at diet, exposure to toxins, and lifestyle should be the first line of defense against any disease. This, and regular thermal screenings provide an effective arsenal against breast cancer. An internet search of thermography will locate qualified technicians in your area.
1. Saputo, MD. Len. Overview: Beyond Mammography. From his account of the Breast Cancer Detection Demonstration Project: Five Year summary Report CA: A Cancer Journal for Clinicians, Vol 32, 194-225, Copyright 1982 by American Cancer Society.
2. International Academy of Clinical Thermology, www.iact-org.org
3. http://healthybreasts.info/ Summary from Value and Interest of Dynamic Telethermography in Detection of Breast Cancer, ACTA Thermographica, Vol. 1, Num. 2, 89-96, 1976.
