Month: February 2011

by: Tony Isaacs

(NaturalNews) A new study, which is shaking the pillars of mainstream breast cancer care, has found that lymph node surgery for women, who had early breast cancer which had spread to the lymph nodes, did not improve their survival rate or prevent the further spread of cancer to other lymph nodes. The painful procedure of having cancerous lymph nodes removed has long been routine for breast cancer patients.

The discovery turns standard medical practice on its head. Surgeons have been removing lymph nodes from under the arms of breast cancer patients for 100 years, believing it would prolong women's lives by keeping the cancer from spreading or coming back.

The study, The American College of Surgeons Oncology Group Z0011 trial, which is being published this month in The Journal of the American Medical Association, was conducted at 115 medical centers and included 891 women. The median age was in the mid-50s, and the participants were followed for a median of 6.3 years.

After an initial node biopsy, women were randomly assigned to have 10 or more additional nodes removed or to leave the nodes alone. Over time, two groups had no difference in survival or recurrence.

Study authors Dr. Grant Walter Carlson and Dr. William C. Wood said that the study "definitively showed that axillary lymph node dissection is not beneficial,"

"Survival was independent of lymph node status" the study authors noted.

"Taken together, findings from these [and other] investigators provide strong evidence that patients undergoing partial mastectomy, whole-breast irradiation, and systemic therapy for early breast cancer with microscopic sentinel lymph node metastasis can be treated effectively and safely without axillary node dissection," they said.

"This is such a radical change in thought that it's been hard for many people to get their heads around it," said another study author, Dr. Monica Morrow, chief of the breast service at Sloan-Kettering.

The author of an editorial accompanying the study, Winship Cancer Institute at Emory University professor of surgery Dr. Grant W. Carlson, said: "I have a feeling we've been doing a lot of harm (by routinely taking out many nodes)."

Indeed, women in the study who had nodes taken out were far more likely to have complications (70 percent versus 25 percent). Such complications included infections, abnormal sensations and fluid collecting in the armpit, and lymphedema.

Dr. Armando E. Giuliano, the lead author of the study and the chief of surgical oncology at the John Wayne Cancer Institute at St. John's Health Center in Santa Monica, California, reported that the standard practice of lymph node removal has been so ingrained that "some prominent institutions wouldn't even take part in (the study)."

Coupled with recent findings about unnecessary mastectomies, and the proven dangers and ineffectiveness of chemo and radiation, the study is yet another indictment of the failed mainstream cancer treatments used in the failed "War on Cancer". Perhaps someday, mainstream medical science will come full circle and finally realize that clinging to ineffective and harmful treatments, which try to cut out, poison out or burn out the symptoms of cancer, will never cure cancer. A much better idea would be to look first to using nature to address cancer's root causes and build up immune systems, which are the natural first line of defense against cancer and other illness.

"It was a bad lot," said the girl's father to My FOX Houston, concerning the damage caused by the vaccine. "A week after (the shot), we noticed Kristen, at 18-months or two years old, her eyes started rolling in the back of her head."

In addition to losing her ability to speak, Kristen also began having up to 150 seizures a day, many of which are the serious "grand mal" or "tonic-clonic" type that affects the entire brain. According to Dr. Randall Wright, medical director of the Neurovascular Institute at Conroe Regional Medical Center near Houston, Tex., and neurologist at Sadler Clinic in the same area, because such seizures affect the whole brain rather than just portions, they can cause jerking responses throughout the entire body.

The Texas state legislature requires that all school-age children receive multiple doses of the DPT vaccine throughout their school years, unless their parents file proper exemptions. Three- and four-year-olds, for instance, are required to receive four doses of DPT before entering school, in addition to 14 other vaccines.

The DPT vaccine is known to cause neurological and brain damage, as well as sudden infant death syndrome and even death in older children. The U.S. Centers for Disease Control and Prevention (CDC) and other government agencies insist that the risk is small, but numerous children have died as a result of getting the shot, including the case of Lee Ann Manley, a young girl who died just hours after receiving her first DPT vaccine. Manley was one of the first cases to be acknowledged by the National Vaccine Injury Compensation Program as having died directly as a result of the DPT.

Over 7 million Americans have another disorder that leads to vision loss, called age-related macular degeneration (AMD). Cases of AMD, like retinopathy, are expected to skyrocket as the population ages. Just as retinopathy is caused by abnormal blood vessel growth, so is the most common form of AMD (known as "wet" AMD). And omega-3s appear to halt AMD, too.

That means increasing food sources of omega-3s in the diet (such as salmon and walnuts) and/or taking supplements of the essential fatty acid could dramatically reduce the loss of vision and related suffering in millions of people. It could also save an enormous amount of money in healthcare bills.

"The cost of omega-3 supplementation is about $10 a month, versus up to $4,000 a month for anti-VEGF therapy," ophthalmologist Lois Smith, MD, PhD, senior investigator on the study, said in a statement to the media. She was referring to drugs such as Macugen and Lucentis used in AMD and diabetic retinopathy. "Our new findings give us new information on how omega-3s work that makes them an even more promising option."

Omega-3 fatty acids are now known to be highly concentrated in the retina. Previous animal studies have shown omega-3s can prevent retinopathy. The new study reveals exactly how the essential fatty acids protect the eyes — and it also strongly suggests that omega-3s may be beneficial in diabetes.

The researchers have documented that omega-3s have a direct effect on blood vessel growth (angiogenesis). In fact, omega-3s selectively promote the growth of healthy blood vessels and halt abnormal vessels from growing.

Dr. Smith and her colleagues were able to isolate the specific compound in omega-3s that produces these beneficial effects — a metabolite of the omega-3 fatty acid DHA, known as 4-HDHA — and the enzyme that produces it (5-lipoxygenase, or 5-LOX). The study demonstrated that 5-LOX acts by activating the PPAR-gamma receptor, the same receptor targeted by Big Pharma drugs in the "glitazone" class such as Avandia, that are prescribed for people with type 2 diabetes to increase their sensitivity to insulin.

However, Avandia and related medications increase the risk for heart disease. So it appears that boosting omega-3 intake through diet or supplements might be a safer way to improve insulin sensitivity in patients with diabetes or pre-diabetes.

Dr. Smith is currently working with investigators at the National Eye Institute who are conducting an ongoing multi-center trial of omega-3 supplements in patients with AMD. The trial, dubbed AREDS2, will continue until 2013. An earlier retrospective study, (AREDS1) already found a higher intake of omega-3 containing fish was associated with a lower likelihood of AMD.

(NaturalNews) Corn sugar? It's high-fructose corn syrup by any other name, and it's dangerous. What sweeteners are safe? What's not? You may be surprised at the latest research.

Last September, manufacturers of high-fructose corn syrup (HFCS) asked the federal government for permission to sweeten its image with a new name: "corn sugar." Their TV ads say, "Your body can't tell the difference between corn sugar and cane sugar." A popular website, Sweet Scam (http://sweetscam.com/), purports to clear up the confusion, while condemning "activist groups like the Weston A. Price Foundation, Joseph Mercola, and the Naturopathy Movement, which have perpetuated unfounded myths about sweeteners [and] completely ignore the scientific and nutritional evidence to backup [sic] their outlandish claims."

The website was created by the Center for Consumer Freedom, a lobby begun with $600,000 from the Philip Morris tobacco company, and is sponsored by restaurant and food companies like Arby's, Tyson Foods, HMSHost Corp., and Wendy's. So much for impartiality.

High-fructose corn syrup is a corn syrup that has undergone enzymatic processing to convert some of its glucose into fructose to produce a desired level of sweetness. But because of its processing, some brands of HFCS may contain mercury, a known neurotoxin.

Moreover, many studies have indicated that it suppresses the sensation of being full, causing people to eat more of it. Rats fed HFCS developed fatty liver disease and type 2 diabetes, while those on a fructose-free diet did not. And when they were given a high-fat diet, they gained more weight than those who had been on a fructose-free diet. Other studies suggest that HFCS directly causes obesity. (Of course, the American Medical Association and the American Dietetic Association side with the Corn Refiners Association in thumbing their nose at the mountain of evidence.) HFCS also causes cardiovascular disease, even in children and adolescents as well.

Fructose is commonly thought of as "fruit sugar," but fruit also contains glucose and fiber, sometimes a great deal of it, not to mention other nutrients. But studies indicate that fructose, processed and stripped of its co-factors, causes metabolic syndrome in animals. The metabolic processes involved in the breakdown of fructose can lead to a buildup of uric acid, which is a risk factor for cardiovascular disease. Fructose can raise blood triglyceride levels, which can trigger atherosclerosis, increases fat deposits around the viscera, and decreases insulin sensitivity in overweight people.

As Dr. David G. Williams writes in his Alternatives newsletter,

"Cancer cells thrive on sugars, particularly fructose. It has been demonstrated that cancer cells actually metabolize glucose and fructose differently from other cells. While cancer thrives on both, it uses fructose specifically to proliferate. It's no wonder that cancer has moved quickly up the list of killers in our society since we started adding high-fructose corn syrup to everything from sodas to bread. With such damning and irrefutable research, I still don't understand why it hasn't become standard practice to immediately put cancer patients on fructose-free diets to help disrupt cancer growth."

Agave, which is derived from the agave cactus (which also produces tequila), sounds like an ideal alternative, but some health advocates like Dr. Joseph Mercola have some serious concerns about it , and say its acceptance is the result of deceptive marketing . They say that most of the agave sweeteners you find on supermarket shelves are not natural products and are not organic. What is clear is that it is not low-calorie and does not have a low glycemic index. It is 50% to 90% fructose.

All this has led many people to go back to "good old sugar." But is that wise?

Sugar is an ingredient in 70% of manufactured food , according to The Economist. But sugar and simple carbs (refined grains, high-fructose corn syrup, etc.) may adversely affect blood lipids , according to the Journal of the American Medical Association, increasing your risk for heart disease and stroke through fat accumulation, metabolic syndrome, obesity, premature aging, and type 2 diabetes. Sugar molecules bond with proteins to create AGEs (advanced glycation end-products) — which can wreak havoc on blood vessels, including those of the heart and kidneys. AGEs appear to be responsible for many of the long-term complications of diabetes.

Dr. David Williams again: "There is no 'maybe' about the connection between sugar and heart disease. I can't put it more plainly: sugar kills." (Alternatives, June 2010)

George Mason University professor of economics Walter E. Williams points to powerful sugar companies whose massive political donations — millions of dollars to both parties — ensure that Congress keeps tariffs high on foreign sugar so the US sugar industry can charge higher prices. According to one study, one politically connected sugar-manufacturing family alone earns about $65 million a year from congressional protectionism. The Archer Daniels Midland company makes similarly huge donations, because higher sugar prices benefit ADM, who produces corn syrup (fructose), which is a sugar substitute. When sugar prices are high, sugar users (soda, candy, and food processors) turn to corn syrup as a cheaper substitute sweetener.

What about artificial sweeteners, then? Surely they're better for you than sugar!

Aspartame (Equal and NutraSweet), which is used in more than 6,000 diet products, beverages, and pharmaceuticals, has remained a battleground. Despite FDA officials describing aspartame as "one of the most thoroughly tested and studied food additives the agency has ever approved" and its safety as "clear cut," in March 2006, Environmental Health Perspectives (from the National Institutes of Health) published the first compelling experimental evidence for the carcinogenic effects of aspartame at a dose level within range of human daily intake. A second animal study by the same research team now indicates that the carcinogenic effects of aspartame are magnified when exposure begins during fetal life . One packet of Equal contains 33 mg. of aspartame; one can of Diet Coke (355 ml.) contains 131 mg. of aspartame; and one-half cup of Jello Light contains 40 mg. of aspartame, according to the Canadian Diabetes Association . A 44-pound (20-kg.) child would only have to consume 400 mg., about the equivalent of three Diet Cokes per day, to reach the carcinogenic 20 mg./kg. bodyweight dose.

Jonathan V. Wright, MD (who contributed last week's article on antioxidants ), notes that 10% of aspartame is methanol, which is converted to formaldehyde which, in turn, is converted to formic acid — which is used to strip epoxy! The other 90% is composed of phenylalanine and aspartic acid. These amino acids are normally harmless, but in isolation they are neurotoxic. He also revealed in the August 2009 issue of his Nutrition and Healing newsletter that aspartame decreases the availability of tryptophan and reduces the brain's level of serotonin. However, it should be noted that Dr. Wright himself uses aspartame — to get rid of carpenter ants!

Diet Coke contains aspartame. Yet in 1985, as a member of the National Soft Drink Association, Coca-Cola opposed the FDA approval of aspartame for beverages. The company's own objections — running to several pages in the Congressional Record — included the assertion that aspartame is uniquely and inherently unstable and breaks down in the can. It decomposes into formaldehyde, methyl alcohol, formic acid, diketopiperazine, and other toxins. In a study on seven monkeys, five had grand mal seizures and one died, a casualty rate of 86%.

Aspartame is another glaring example of crony capitalism at work. The sweetener was discovered in 1965 by the G.D. Searle chemical company. In 1980 an FDA Board of Inquiry comprised of three independent scientists confirmed that aspartame "might induce brain tumors" and banned it. On January 21, 1981, the day after Ronald Reagan's inauguration, Searle re-applied to the FDA for approval to use aspartame in food sweetener, and Reagan's new FDA commissioner, Arthur Hayes Hull, Jr., appointed a five-person Scientific Commission to review the Board of Inquiry's decision.

It soon became clear that the panel would uphold the ban by a 3-to-2 decision, but Hull installed a sixth member on the commission, and the vote became deadlocked. He then personally broke the tie in aspartame's favor. Hull later left the FDA under allegations of impropriety, served briefly as Provost at New York Medical College, then took a position with Burston-Marsteller, the chief public relations firm for both Monsanto and G.D. Searle. Searle was purchased by Monsanto in 1985.

Neotame is a version of aspartame made by NutraSweet which is between 7,000 and 13,000 times sweeter than table sugar and 30 to 60 times sweeter than aspartame. It was approved by the FDA in 2002. According to Dr. Mercola , "Judging by the chemicals used in its manufacturing, it appears even more toxic than aspartame, although the proponents of neotame claim that increased toxicity is not a concern, because less of it is needed to achieve the desired effect." It is chemically very similar to aspartame but with the addition of 3-dimethylbutyl, which is listed on the EPA's most hazardous chemical list. While it is not currently in wide use, it is attractive to food manufacturers for two reasons: it would greatly lower the cost of production compared to using sugar or high fructose corn syrup due to the lower quantities needed to achieve the same sweetening; and it is approved for use in a wider array of food products, including baked goods, because it is more stable at higher temperatures.

Saccharin (marketed as Sweet'N Lo), which is much sweeter than sucrose but has a bitter or metallic aftertaste in high concentrations, became mired in controversy in 1977, when a study indicated that the substance might contribute to bladder cancer in rats. But in 2000, the chemical was officially removed from the federal government's list of suspected carcinogens once scientists learned that rodents have high pH, high calcium, and high protein levels in their urine, and this combines with saccharine to cause tumors. As this does not happen in humans, there is no elevated bladder cancer risk, so it appears to be one of the safer artificial sweeteners.

However, it still contributes to obesity and even the development of type 2 diabetes, despite its lack of calories.

The reason, as Science News points out, is that there are taste cells in the stomach, intestine and, evidence suggests, the pancreas, colon and esophagus. When the taste sensors in the gut encounter something sweet, they send a "prepare for fuel" message that results in cranked-up insulin levels in the blood . This, in turn, causes sugar cravings, and the cycle keeps repeating.

This means that even no-calorie sweeteners like saccharine can trigger the release of insulin and cause weight gain — all because of their sweet taste.

Sucralose (Splenda) alters the microflora in the intestine and "exerts numerous adverse effects," according to Duke University study , including an increase in body weight (not quite what a "diet aid" is supposed to do!), and an elevation of liver enzymes, which negatively affects the bioavailability of nutrients. And as our colleagues at ANH-Europe note , sucralose is an organochloride compound. Most of the derivatives of this type of compound are insecticides, herbicides, and pesticides — not something you'd put in children's lunch boxes. In an article entitled "The Lethal Science of Splenda, a Poisonous Chlorocarbon," Dr. James Bowen warns that "any chlorocarbons not directly excreted from the body intact can cause immense damage to the processes of human metabolism and, eventually, our internal organs. The liver is a detoxification organ which deals with ingested poisons. Chlorocarbons damage the hepatocytes, the liver's metabolic cells, and destroy them."

Is nothing safe?

Bearing in mind what we noted above, that all sweet tastes raise insulin, which causes overeating and sets the stage for type 2 diabetes, there are some alternatives you might consider.

Low-calorie alternatives:

Stevia is a South American herb that is estimated to be some 150 to 400 times sweeter than sugar. Since the mid-1980s, the FDA has labeled stevia as an "unsafe food additive" and has gone to extensive lengths to keep it off the US market — including initiating a search-and-seizure campaign and full-fledged "import alert" — despite the fact it has been used by millions of people around the world, in some locales for hundreds of years, with no ill effects.

So adamant has the FDA remained on the subject that even though stevia can now be legally marketed as a dietary supplement under legislation enacted in 1994, any mention of its possible use as a sweetener or tea was strictly prohibited — that is, until 2007, when Coca-Cola announced plans to obtain approval for their stevia-derived sweetener, Rebiana, for use as a food additive. FDA approved it in 2008. Coca-Cola announced intentions to release stevia-sweetened beverages shortly thereafter.

Sugar alcohols like xylitol and erythritol seem to be safe, though some people find that xylitol has a laxative effect. Xylitol was originally isolated from birch sap. Erythritol occurs naturally in fruits and fermented foods. And Xylitol, used as mouth rinse, prevents cavities very effectively. It is especially good for children, particularly those who have not had their teeth treated with a tooth sealant that contains BPA.

Inulin, which is isolated from Jerusalem artichoke, is available as a powder or as Jerusalem artichoke syrup. Inulin is a long-chain polysaccharide that is mostly too long a sugar to absorb into the blood stream, though too much inulin intake can cause digestive distress in some people.

Higher-calorie alternatives:

Honey (raw, organic) is always the natural sweetener of choice. Look for wild honey because it is lower in free fructose and higher in trace mineral content, especially the richer dark varieties.

Maple syrup is the only sustainably-harvested, large-scale, forest sweetener in the world. Maple is one of the richest source of minerals found in any sweetener. Look for organic maple syrup and maple crystals as an ingredient.

Unsulfured, organic sugarcane molasses is fairly rich in vitamins and minerals and has been purported (like fresh sugar cane) to have "anti-stiffness factors" that break down detrimental calcification.

Coconut palm sugar is now available as a sweetener. It is usually heat-processed, so try to find raw coconut palm sugar

Lo Han Guo is a non-glycemic sweetener made from a type of wild cucumber. It is used in Traditional Chinese Medicine to treat cough and laryngitis.

DHEA (dehydroepiandrosterone) is one of the critical hormones that scientists are calling the `fountain of youth.` This hormone is made from cholesterol by the adrenal glands and is a precursor to 18 steroid hormones including the commonly known sex hormones estrogen and testosterone. Healthy DHEA production is critical for lean muscle development, fat burning, bone growth, skin health, and immunity.

Cholesterol (statin) lowering medications reduce DHEA content and therefore accelerate the aging process. This is one of the reasons why cholesterol lowering medications have been linked to all-cause early mortality. A DHEA deficiency significantly increases the risk of getting certain cancers (including breast, ovarian, prostate, and bladder), atherosclerosis, high blood pressure, Parkinson's disease, diabetes, nervous system degeneration, and other age-related conditions.

Our DHEA production naturally peaks between 20-25 years of age and then steadily declines. Many in our society see a sharp decline due to overburdened adrenals that are unable to synthesize adequate DHEA. This adrenal insufficiency syndrome is becoming more and more common due to an overstressed and malnourished American lifestyle.

High sugar and carbohydrate consumption increases blood sugar and insulin levels. Elevated insulin causes a decreased production of DHEA in the adrenals. Blood sugar imbalances also create critical vitamin and mineral imbalances that stress the adrenals and reduce DHEA production. Alcohol and caffeine consumption also decrease DHEA levels.

High stress and poor sleeping habits also cause increased cortisol (stress hormone) levels. When these issues become chronic they cause a phenomenon called `pregnenolone steal.` Pregnenolone is a byproduct of cholesterol metabolism that is necessary to produce both cortisol and DHEA. High stress causes this process to shift towards cortisol production. This shift essentially `steals` the necessary pregnenolone from the DHEA production pathway to produce more cortisol. This process depletes DHEA levels.

Many people rush out and look for DHEA boosting supplements; however, lifestyle factors that deplete DHEA levels should be addressed first. The most important factor includes reducing/eliminating adrenal stressors such as medications, stress, leaky gut syndrome, parasites and other infectious agents, chronic inflammation, physical nerve stress, nutrient deficiencies, poor sleep, & blood sugar imbalances.

An anti-inflammatory diet is a critical part to de-stressing the body and boosting DHEA levels. This diet should be very low in sugar and carbohydrates and very rich in phytonutrients and trace minerals from fresh, raw or lightly steamed vegetables. Powerful anti-inflammatory herbs such as turmeric, ginger, rosemary, thyme, oregano, & cinnamon should be generously consumed on a regular basis.

Healthy fat consumption is an essential part of creating cholesterol which is needed to produce DHEA. Healthy fat sources include coconut products, avocados, olive oil, nuts, seeds, & purified omega-3 fish oil supplements. Healthy protein sources to boost DHEA production include wild-caught fish, grass-fed red meat and free range chicken, turkey, and organic eggs.

Other lifestyle factors that are critical for healthy DHEA levels include regular sun exposure and/or supplementation to maintain vitamin D (25-OH) levels between 70-100 ng/ml. Regular high intensity exercise is also very important for improving intracellular anti-oxidant capabilities while boosting anti-aging hormone secretions. Getting 7-9 hours of sleep regularly by going to bed early (10-11pm ) will allow for the adrenals to effectively heal and repair from lifestyle stress.

This most recent American study, published in the Proceedings of the National Academy of Sciences, confirms and expands upon the findings of a previous, more extensive study done in Italy and published in 2008 in the journal Neurology.

The Italian study followed a group of subjects aged 65 years and older for four years, using cognitive assessment tests to gauge the health of participants, and correlating the findings to information about participants' exercise habits. The study was significant not only because it found dramatic reductions in development of dementia for those who exercised regularly (a 73% decrease), it also showed that the intensity of exercise had almost no bearing on results: exercises like walking, climbing stairs and gardening were just as effective at staving off dementia as more strenuous activities.

The American study used magnetic resonance imaging (MRI) to assess changes in hippocampal volume in a group of participants over age 65, who performed regular aerobic exercise, and in a control group, who did not. Despite the fact that adults of this age lose 1% to 2% of their hippocampal volume per year, this study found an average gain of 2% in hippocampal volume among participants who engaged in regular aerobic walking, and the expected average loss of 1.4% in the control group. The study additionally found that increases in hippocampal volume accompanied increases in memory function.

Studies that look at exercise's effect on the brain during aging are ongoing and very popular, with all signs pointing to the same conclusion: regular moderate exercise, especially aerobic walking, is an excellent way to fight cognitive decline. It is similarly associated with a significant decrease in the development of Alzheimer's, and it has even been shown to slow the progression of the disease in individuals already affected.

So with all this evidence pointing to the inescapable conclusion that aerobic exercise is essential for aging well, there's more reason than ever to do your body this favor. Go take that 30-minute walk today, and then tomorrow, get up and do it again. Your brain will inevitably thank you.

by: Rosemary Mathis, Director of SANE VAX, INC.

1) The efficacy of Gardasil in preventing cervical cancer has not been demonstrated and the marketing campaign has been misleading. The efficacy of Gardasil remains unsubstantiated since the vaccine hasn't been adequately tested on the primary age group to which it is currently given.

Merck promoted Gardasil primarily as a vaccine against cervical cancer, rather than promoting it as a vaccine against HPV infection or sexually transmitted diseases.

According to recent reports published in two highly respected scientific journals, Nature Biotechnology and Journal of American Medical Association (JAMA):

"Most genital infections are asymptomatic and resolve spontaneously, but the virus can persist and cause precancerous lesions that can become malignant over the subsequent 20-30 years." (Nature Biotechnology, 2007 2)

"So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls a vaccine that partly prevents infection caused by a sexually transmitted disease (HPV infection), an infection that in a few cases will cause cancer 20 to 40 years from now? (JAMA, 2009 3).

The fact is that malignant cervical cancer takes decades to develop and yet the longest clinical trial on Gardasil was only four years in duration. In other words, Gardasil was never shown to prevent cervical cancer [emphasis added]. Furthermore, in all clinical trials conducted by Merck the cervical intraepithelial neoplasia (CIN) 2/3 precancerous lesion was used as the efficacy endpoint for evaluating the Gardasil. What is the problem with using the CIN 2/3 lesion as the standard for efficacy? First, if the marketing claim for Gardasil is that the vaccine "protects against cervical cancer" then cervical cancer should have been used as the endpoint for efficacy, not a surrogate marker such as a CIN 2/3 precancerous lesion [emphasis added]. Second, in the natural course of cervical cancer, only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions and only a small fraction of CIN 3 lesions will eventually progress to cervical cancer. Furthermore, even CIN 3 lesions are heterogeneous (there are early small lesions and old advanced lesions and we do not know what proportion of the small lesions, which serve as clinical endpoints in current studies, would persist to become large, advanced CIN3 lesions). Therefore, in any female population (and that includes those who have undergone Gardasil clinical trials) there are many more CIN 2 lesions than a combination of CIN 3 lesions and cervical cancers. As a result, the vast majority of the "CIN 2/3 or worse" cases used for evaluation of efficacy, and listed in Merck's report to FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8), must have been CIN 2 lesions.

In a review of the literature from 1950-1992, it was noted that 60 percent of CIN 1 lesions regressed, 30% persisted, 10 percent progressed to CIN 3, and only 1 percent progressed to invasive cancer. The corresponding approximations for CIN 2 were 40 percent, 40 percent, 20 percent, and 5 percent, respectively. The likelihood of CIN 3 regressing was 33 percent and that of progressing to invasive cancer was greater than 12 percent.

The author of the study, Andrew G Ostor, MD, from the Departments of Obstetrics and Gynaecology and Pathology, University of Melbourne noted:

"It is obvious from the above figures that the probability of an atypical epithelium becoming invasive increases with the severity of the atypia, but does not occur in every case. Even the higher degrees of atypia may regress in a significant proportion of cases. As morphology by itself does not predict which lesion will progress or regress, future efforts should seek factors other than morphological to determine the prognosis in individual patients."

The above remark leads us to a third reason why a surrogate morphological marker is not an adequate endpoint for assessing the efficacy of cervical cancer vaccines:

"CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less than-perfect representation of the underlying disease state."

Furthermore, the same report by the National Cancer Institute (NCI 9) states that:

"That CIN2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error."

Finally, according to second report by the NCI 10:

"Approximately 40 percent of undiagnosed CIN 2 will regress over two years." (this also precisely corroborates the findings of the study by Ostor)

Gardasil is marketed as the vaccine that prevents cervical cancer. This statement is incorrect. Based on the above NCI findings, we can conclude that the data presented in the VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine 8 only supports the claim that Gardasil can prevent "an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer" – about half of which are self-reversing to normal cases and not reflect actual cervical cancer.

There was yet another important oversight in assessing the efficacy of Gardasil. Most cervical cancers are believed to be linked to infection with genital HPV types 6, 11, 16, and 18 2 3 11. According to NCI, the only reliable HPV genotyping method is a "PCR system with short target sequences" or alternatively, "'sentinel-base' genotyping by PCR." Ironically, these HPV genotyping methods were never used to determine the HPV type associated with precancerous lesions in the clinical trials for evaluation of the efficacy of Gardasil to prevent type-specific HPV infections.

2) Cervical cancer is a rare disease in developed countries which invalidates the recommendations for universal immunization with any HPV vaccine. The incidence of cervical cancer has dropped substantially since implementation of regular Pap screening procedures. Currently, in the US, the death rate from cervical cancer (2.4/100,000 women) is lower than the rate of reported serious adverse events, including death, from Gardasil (3.34/100,000 doses distributed)

The severity of cervical cancer should not be undermined. Advanced cervical cancer is a deadly disease, especially in areas where the resources and infrastructure to fully implement

Papanicolaou (Pap) smear tests are limited such as Latin America, Africa, India and South Asia. In the past four decades, industrialized countries such as the US, have cut cervical cancer mortality and incidence rates by 74 percent largely through the use of the Pap smear 2.

Thus, as noted by Diane Harper, MD, Professor and Vice Chair, Obstetrics and Gynecology, Community and Family Medicine and Informatics and Personalized Medicine, who conducted the phase 2 and phase 3 trials for Gardasil, authoring their publications, in developed countries such as the US, which have regular Pap screening programs in place, the HPV vaccine will do little to decrease the already very small cancer rate. In fact, Harper noted that if women who are vaccinated stop going for Pap smears, the incidence rate for cervical cancer would increase.

Based on L1-encoded virus-like particles, Gardasil should protect against the HPV genotypes 16 and 18, which are thought to account for 70 percent of cervical cancers. Since Gardasil does not even claim to protect against all cases of cervical cancer but only those "caused by HPV strains 16 & 18", it does not replace the need for a regular pap smear.

More crucially, however, for deciding whether a risk of adverse effects from the HPV vaccine is worth taking, much depends on the perceived benefit from the vaccine relative to that risk. If benefits are indeed substantial, then many individuals would be willing to accept the risk. However, if the benefit of the vaccine has not been demonstrated and is in fact only speculative, and if a majority of those women who are persistently infected with HPV are not likely to develop cancer providing they are adequately screened, then most reasonably they will only be willing to accept very small risk of harm from the vaccine. Data from clinical safety trials argue against small risks from Gardasil vaccination. In a paper published in JAMA, Slade et al. (2009) 11 report that from June 1, 2006, through December 31, 2008, the US Vaccine Adverse Event Reporting System (VAERS) received 424 reports of adverse reaction following receipt of Gardasil amongst which, 772 (6.2 percent) were serious, including 32 deaths. Given the overall reporting rate of 53.9 reports per 100, vaccine doses distributed, the estimated rate of reported serious adverse events from Gardasil is 3.34/100 doses distributed. This rate is higher than the death rate from cervical cancer in the US which stands at 2.4/100 women (according to CDC statistics, 15).

Harper poses an important question 14:

"Would a parent accept such a rate of serious adverse events if the same cancer prevention can occur with continued Pap screening? Is there any acceptable level of risk of serious adverse events, including death, to prevent genital warts?" [emphasis added]

The later claim was in reference to one of the vaccine's other claimed benefits.

3) Most HPV infections are benign and resolve spontaneously without causing cervical cancer

According to Harper 16:

"70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer."
These numbers are consistent with those above quoted from Nature Biotechnology:

"Most genital infections are asymptomatic and resolve spontaneously, but the virus can persist and cause precancerous lesions that can become malignant over the subsequent 20-30 years."

In addition, in a recent JAMA editorial, Charlotte Haug, MD, PhD, emphasized:

"The virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system. In a few women, the HPV infection persists, and some women may develop precancerous cervical lesions and eventually cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now."

Thus, again, there appears to be little rationale in support of universal immunization with any HPV vaccine.

(Note from SaneVax: Are the benefits of Gardasil vaccination worth the risks?)

About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.

Articles on this site are written by Norma Erickson, President and Leslie Carol Botha, women's health educator, broadcast journalist and Vice-President Public Relations for SANE Vax, Inc. Other members include Rosemary Mathis, mother of a Gardasil-injured daughter and Vice President Victim Support; Janny Stokvis, Vice-President Research, Freda Birrell, Secretary and HPV vaccine lobbyist United Kingdom /Scotland, and Linda Thompson, Treasurer.

We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.

On average, a body temperature of 37C/98.6F is considered 'normal.' This doesn't take into account the fact that children are generally warmer than adults. Recent exercise, dressing too warmly, consuming hot foods, and even the menstrual cycle in teenage girls can cause the body temperature to rise by a degree or two.

Fevers tend to hit their highest point at late afternoon, so if your child's body temperature is slightly higher than normal at that time, it is generally no cause for panic. But if your child awakens and has a low-grade fever, you may want to encourage him/her to stay at home and get some rest, so that the fever can do its job of fighting any infections which may be present.

Causes of fever most commonly include infections, dehydration, vaccinations, medications, tumours, juvenile rheumatoid arthritis, inflammation and teething in infants.

The only time a fever can do harm is when it rises above 106F/41C. It can them do harm to the brain and heart. Although, during most infections, the brain will do its job of keeping the body temperature at around the 104C/40F mark.

There are however times when medical attention should be sought for high fevers. These include fevers in children younger than 3 months, who have a fever of more than 100.4F. (While waiting for medical attention, try to breastfeed the infant, as mothers' milk contains natural antibodies made at the breast as it comes into contact with the pathogens in the baby's mouth.) Medical attention should also be sought for children between 3 months and 3 years old, who have a fever higher than 102.2F, and for anyone who has a fever higher than 104.5F.

The best course of action regarding fever treatment may be to seek out natural or homeopathic remedies, as these are far safer and pose little to no risk with regards to dangerous side-effects. Over-the-counter medications have been known to cause more harm than good in children.

What can be done to make children feel better during these times is to ensure they get plenty of rest and liquids. Avoid sugary liquids and foods as these can significantly suppress the immune systems' ability to fight the infection. Try not to force them to eat, as they will eat when they are ready. A good home-made chicken broth will normally suffice, as it is easily digestible.

Herbal remedies such as catnip and Echinacea (made into a tea or tincture) help to promote sweating and reduce fevers naturally, while hyssop combined with liquorice root and thyme has also been known to reduce fevers naturally.