Little do these women know that the vaccine they are about to put into their bodies is still in Phase 4 testing, contains known carcinogenic ingredients, and has many hidden dangers. Cervical Cancer Vaccine Wiki As the pharmaceutical industry brings in billions of dollars and tries to avoid the negative publicity surrounding Gardasil (the human papillomavirus vaccine), women are being put at risk. It is important for all women to know what the human papillomavirus (HPV) is, what the virus does, what the vaccine is known to do and what the side effects and dangers are of the vaccine in order to make informed and potentially life-saving choices.
The human papillomavirus can be found in over 100 strains and is a viral infection which can cause varied symptoms, ranging from warts to infections of the body's mucus membranes. The virus we will explore is the type that causes an infection of the body's mucus membranes. This virus often has no visible symptoms but creates small, painless lesions throughout the interior genital areas. These lesions create abnormal cells which are found to be the most common type of cell to place an individual at risk for cancer. However, as the U.S. National Cancer Institute reported about the link between the human papillomavirus and cancer, "direct causation has not been proven. In a controlled study of age-matched women, 67% of those with cervical cancer and 43% of those without were found to be HPV-positive" (1). So, although an individual may have HPV, there is no degree of certainty that cervical cancer will result. It is vital to understand that although one can be vaccinated for HPV, the need for a routine annual pap smear is just as strong as it is for those without the vaccine, and early detection of any abnormal cells will remain the key to staying cancer free.
The diagnosis of HPV is very easy, and HPV is treatable once detected. It's important that sexually active females have a pap smear annually to help identify HPV (and other viruses) in their systems as soon as possible so that treatment for HPV can be preformed with little or no adverse reactions. The Centers for Disease Control and Prevention produced a report to congress titled "Prevention of Genital Human Papillomavirus Infection" in which it was stated that "regular cervical cancer screening for all sexually active women and treatment for precancerous lesions remains the key strategy to prevent cervical cancer" (5). It is important to realize that although one can be vaccinated, routine testing for HPV should continue regardless as HPV is not the only cause of cervical cancer.
On June 8, 2006, a vaccination for HPV was licensed by the U.S. Food and Drug Administration. Since that date, 17 individuals have died from the vaccine; that equals approximately one individual per month that the vaccine has been on the market. One individual who died as a result of the HPV vaccine was a girl of 12 years of age who was encouraged by her school nurse to get vaccinated, another was a woman who was just 19 years old. Both seemingly healthy individuals died from heart complications caused by the HPV vaccination and had no prior history of medical complications. Although this data is readily available to the public online, few individuals make informed decisions about vaccines, and even fewer individuals take the time to read the U.S. Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS).
The VAERS is an online database which tracks all adverse reactions reported from vaccines which are currently on the market. To date, there are 3,461 adverse reaction reports on file with the FDA for Gardasil. This number makes up over 50% of all adverse reaction reports filed in 2006 and 2007 combined. The FDA is being flooded by reports of problems experienced from Gardasil and has allowed the product to stay on the market with close monitoring and tight restrictions. Some of those restrictions include: that the vaccine only be given to individuals between the ages of 9 to 26, individuals who already have contracted HPV should not be given the vaccine, and pregnant women should not be given the vaccine ("Merck's Gardasil Vaccine" 20). Although most drugs have some restrictions the concern rises with the number of restrictions associated with this vaccine and the vastness of the types of restrictions.
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Prior to the FDA's acceptance of this vaccine it had been tested on only 11,000 individuals (of which less than 1,000 were girls under the age of 20). This testing population raises the question of what a sample group should include. Is it safe to say that because 1,000 participants between 9 and 20 were tested that this vaccine is safe for all women between 9 and 20? Although a standard for testing population does not currently exist, it is safe to assume that Merck's sample population be too small to be of accurate proportion. Additionally, testing of this drug was conducted by a private corporation paid for by the drug's manufacturer, and the FDA did not do an audit of the findings to ensure their accuracy. In fact, the FDA never does audits on drug findings and always trusts the manufacturer. Is this a safe practice?
Individuals who participated in the experimentation of this drug were monitored for, on average, 18 months following vaccination (United States Food and Drug Administration Clinical Review of Biological License Application). This means that long term effects of the drug can not be determined since individuals were only watched for less than two years time. However, the long term effects are almost moot when you take into account that the short term effectiveness of the drug may not be known either. As Anastacia Austin, a reporter for Buzzle reported in review of the Gardasil trial reports:
Nobody in the study, control or placebo group, contracted the cancer. This is because its incubation period is 15-20 years; most women who have it (average age: 47) contracted the virus which caused it in their thirties. The longest test trial was less than four years. The vaccine's makers state that the effectiveness of this vaccine is five years, maximum (1).
Being that no one in the study contracted cervical cancer and the drug's effectiveness is limited to five years (although the study was only completed for 18 months), how is it that we can say with any degree of certainty that this vaccine works? We can't. It appears that Merck is marketing a drug to a population that doesn't need it, and the testing of the drug cannot be found to hold any degree of effectiveness since individuals within the entire sample population (those who received the vaccine and those that didn't) never contracted cervical cancer.
Since the sample population of 11,000 women included individuals who never contracted cervical cancer, is it safe to say that only a small portion of women will contract this form of cancer? The CDC reports that "less than 1% of all female cancer cases and deaths in the US" are from cervical cancer (Lobato 4). This number raises the immediate question of why there seems to be a need for the vaccine if so few individuals contract this form of cancer. In "The epidemiology of the human papillomavirus infections" published in a recent scientific journal, genital HPV infections are reported as "very common, with estimates suggesting that more than 50% of women will become infected with one or more of the sexually transmitted HPV types at some time in adulthood" (16). So, although the vast majority of women contract HPV, there seems to be a very slim margin that actually results in cervical cancer.
Helen Lobato, a renown medical reporter focused on the advocacy of patient rights, reported that "only one percent of women develop cervical cancer...mortality rates [from cervical cancer] generally increase with age with the highest number of deaths occurring in the 75-79 age group" (1). Being that cervical cancer is more prominent in women of this age group, it would require that Gardasil stay effective and efficient in the body for 53 years. However, Gardasil's trials were only tested on the product's effectiveness for 18 months, there is no way of telling if the drug will be effective at the time in a woman's life when it will be most needed, again defeating the purpose of the vaccine.
Another major concern associated with the testing and trials of Gardasil is the methodology used in the placebo practice. The National Vaccine Information Center noted in reviewing the Merck trials that "the FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for...trial participants, rather than a non-reactive saline solution placebo" (1). This is a key factor in the findings associated with the testing of Gardasil. The use of an aluminum containing placebo has been known to artificially inflate the number of adverse reactions in the placebo group (Merck's Gardasil Vaccine Not Proven Safe for Little Girls). If the number of adverse reactions in the placebo group is abnormally high, it makes the trial group reactions appear lower and allows for a misrepresentation of the vaccines safety.
Gardasil itself "contains 225mcg of aluminum " (Gardasil Product Label 1). Reported in "Effects of Aluminum on the Neurotoxicty of Primary Cultured Neurons and on the Aggregation of Betamyloid Protein," a study on the effects of aluminum, "animal and human studies have shown that aluminum can cause nerve cell death" (1). This information is only vital if it pertains to Gardasil. Does it? Guillain-Barre Syndrome (GBS) has been found to make up approximately 5% of the reported adverse reactions to Gardasil. GBS is "a neurological illness resulting in muscle weakness and sometimes in paralysis" (HPV Vaccine 2). GBS can be linked to an excess of metal in the blood supply and therefore can be found to be in correlations with Merck's use of aluminum in Gardasil (Kawahara 211-217). "Shannon Nelson, an 18 year old athlete...got the HPV shot...within a week, she developed Guillian-Barre Syndrome (GBS)...in Nelson's case, she developed paralysis that lasted for over two months" (Worries Remain 1). Other illnesses associated with metal toxicity in the body include Bell's Palsy and seizures.
The question arises, why would the FDA authorize this vaccine with all these known flaws? The fact is that they haven't provided this vaccine with full authorization. In fact, the licensure provided for Gardasil is a trial license which includes the FDA note to the manufacturer which requires Merck to "conduct several additional studies...including studies to further evaluate general safety and long-term effects" of the drug (2). The FDA is well aware that Merck's trials so far have not proven effectiveness and the general safety is still in question; however, the FDA would like to see a larger population tested, so the general public is used for experimentation.
The FDA has another grave concern to consider with this drug and asked that "the manufacturer...monitor pregnancy outcomes of women who received Gardasil while unknowingly pregnant" (Food and Drug Administration 2). While available to the public, 77 women who were unknowingly pregnant received Gardasil. Judicial Watch, a Washington D.C. based consumer advocacy group, reported that "Of the 77 women who received the vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortions to fetal abnormalities" (1). That means that 43% of women who received Gardasil while pregnant had major complications. This percentage is extremely high and because of this correlation, it should be recommended that all sexually active individuals looking to get Gardasil be first tested for pregnancy (but it's not). This raises the question of what happens in ten years when the women who are receiving Gardasil now decide to have children. There is only speculation available at this time as to whether babies from Gardasil recipients will be healthy or have abnormalities, since Gardasil's long term effects have not been reviewed to date.
Having the knowledge to make an informed decision about the products put into your body is the key to remaining safe in an environment that doesn't always have the consumer's best interest at hand. Before rushing to the doctor to receive the latest and greatest in drug technology, take the time to research the product, read the label and review the findings. Just because the product is being offered to you, doesn't mean that testing is complete. Being an informed consumer is the only way to avoid being a guinea pig.
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