When it was introduced by manufacturer Merck, Inc., in 2006, Gardasil was marketed as a preventative treatment for cervical cancer. A glitzy ad campaign urged parents to vaccinate their daughters, to ensure that “One Less” girl would die of cervical cancer.

But what followed were mounting reports to the CDC’s Vaccine Adverse Events Reporting System (VAERS). To date, there have been more than 20,000 reports of serious side effects that developed after patients received one or more of the three scheduled doses of the vaccine. These include blood clots, paralysis, seizures, Bells Palsy, Guillain-Barre Syndrome and pancreatitis.

Additionally, VAERS has collected information about 71 deaths among young people following HPV vaccinations, including three boys, as of September 15, 2011.

So far, physicians, health organizations like the CDC and the U.S. Food & Drug Administration (FDA), and of course the drug’s maker, Merck, insist that none of these reported side effects or deaths can be conclusively proven to be the result of the vaccine. A recent Merck-funded study insists clinical tests on patients who have received the vaccine demonstrate side effects no more serious than rashes, injection site swelling or fainting.

But at the heart of the matter is an even more important – and largely overlooked – question: does Gardasil do what it promises? Does it really prevent cancer?

According to Dr. Diane Harper, Professor and Vice-Chair of Research at the University of Missouri-Kansas City School of Medicine, specializing in Community and Family Medicine, Obstetrics and Gynecology, Bioinformatics and Personalized Medicine, who worked on the team that developed Gardasil, “duration of efficacy is the key to the entire question.”

She tells the Huffington Post that while Gardasil does offer some protection to sexually active women from four specific types of HPV, there is no evidence the drug’s protections last longer than five years. This means if a child as young as 9 receives the vaccine – as “recommended” – generally when that child reaches an age where he or she may be sexually active, the vaccine’s protection will have run out.

While she emphasizes that choosing whether or not to receive a vaccine or to allow your child to be vaccinated is a personal one, she urges those considering the HPV vaccine to weigh the pros and cons very carefully. She said she feels the “One Less” marketing campaign was designed to scare more people into choosing the vaccine.

“Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine,” she tells the Huffington Post. “If parents and girls were told the benefits and harms of Pap screening and HPV vaccines … an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.”

Fundamentally, Harper says, “Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection. Not the development of cervical cancer.”

So, yes, the HPV vaccine could prevent young men – within a five-year window of effectiveness – from developing HPV-related infections. But at what risk? And then what?

Sources:

Huffington Post
Bethlehem Patch
MSNBC

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The public forum was held in an Indianapolis community, sponsored by the Indiana Immunization Coalition. It featured among its panelists scientist Darron Brown, who is one of the creators of the HPV vaccine. He is a researcher at UI Health. He and other panelists were put on the spot when parents began peppering them with questions about the vaccine’s safety.

WISH TV8 reporter Deanna Dewberry, who attended the forum as part of her ongoing investigation about the HPV vaccine, said  the scene became more emotionally charged as some parents in the audience began to share stories about serious side effects suffered by their children, which they believed were directly related the Gardasil shots. Teenage girls cried as their parents shared information about the symptoms they reportedly suffer after receiving the vaccine.

Brown and other panelists, which included physicians and public health department representatives, argued such side effects have not been conclusively proven as resulting from the vaccine.

Since its approval by the FDA and introduction to the market in 2006, Gardasil has been linked to more than 20,000 reports of adverse side effects, including serious problems such as seizures, lupus, rheumatoid arthritis, multiple sclerosis and Guilliane Barre syndrome. There have been nearly 100 deaths reported among girls who received the Gardsail vaccine. At the end of 2011, the vaccine’s reach was expanded when it was approved for use in boys and young men.

Dr. Virginia Caine, director of the Marion County Public Health Department, assured parents that her office would follow up on reports of side effects linked to Gardasil.

Watch the News Report:

HPV vaccine forum turns emotional: wishtv.com

Source: WISH TV8

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The most effective treatment for cervical cancer is a regular gynecological exam, including a Pap smear. This simple test can check for dysplasia, or pre-cancerous cells, which can then be treated. A gynecologist also may administer an HPV test, to check for the human papillomavirus, which has been linked to the development of cervical cancer.

According to the NCCC, since its introduction more than 50 years ago, the Pap test has been the single greatest contributor to the decline in cervical cancer. Between the 1950s and early 1990s, cervical cancer deaths in the United States dropped by more than 70 percent, and continue to decline. A Pap test collects cells from the cervix, which can then be examined under a microscope to look for any abnormalities. Physicians recommend women begin having Pap tests within three years after their first sexual intercourse, or at age 21.

Today, there is much debate about including an HPV vaccine in the arsenal of treatments against cervical cancer. Gardasil, manufactured by Merck, Inc., is perhaps the best known of these vaccines. It has been recommended for girls as young as age 9, and is administered in a series of three shots. The vaccine protects against four of the hundreds of types of HPV, including two that are most often linked to the development of cervical cancer. HPV is a sexually transmitted virus.

However, since its introduction in 2006, the Vaccine Adverse Event Reporting System (VAERS) has received more than 20,000 reports of adverse side effects reportedly related to Gardasil. These reports include serious adverse side effects including Guilliane Barre, lupus, seizures, rheumatoid arthritis, and multiple sclerosis, among others. There also have been 92 reported deaths among girls who received the Gardasil vaccine.

Also, the Gardasil vaccine has a limited time frame for viability. Studies indicate the drug is not effective for more than about five years. However, according to statistics collected by the National Cancer Institute, cancer of the cervix tends to occur during midlife. Half the women diagnosed are between 35 and 55 years of age, and it rarely affects women younger than 20. So, for many of the young girls being vaccinated, the protection will wear off long before they are at risk for cervical cancer and, for many, long before they even become sexually active.

A Pap smear will usually detect cervical abnormalities and allow for early treatment. The NCCC points out that most women who develop cervical cancer have never had a Pap test, or have not had one in the three to five years prior to developing cervical cancer.

Because Gardasil and other HPV vaccines only protect against a very limited number of the many strains of HPV, it is imperative for women who choose to be vaccinated to still include a Pap smear in their regular line of defense against cervical cancer.

Sources:
National Cervical Cancer Coalition
National Cancer Institute

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Additionally, the U. S. Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) have thousands of reports filed by patients that indicate the drug could be linked to serious side effects. While the most commonly reported side effects are minor, such as swelling or redness at the injection site, fainting and nausea, some reports reflect a more dire outcome.

Patients have reported the development of severe adverse side effects after receiving the drug, including Guilliane Barre syndrome, Lupus, seizures, rheumatoid arthritis and multiple sclerosis. There also have been 92 reports of deaths among girls who received the Gardasil vaccine. While these serious adverse events have not been conclusively linked to Gardasil, many researchers say the drug calls for more testing and stronger warnings.

In fact, one of the researchers who led the development of two HPV vaccines, Dr. Diane Harper, told an audience of medical professionals in 2009 that she feels the vaccine is largely unnecessary, and that it has never been fully tested on females under the age of 15. She pointed out that the HPV virus is the most common sexually transmitted virus, and that most HPV infections are cleared naturally by the body’s immune system without any harmful effect.

Dr. Harper also pointed out that any abnormalities in the cervix that may be caused by HPV can be easily detected and treated with regular Pap tests.

If the results of the recent NIH study hold true, however, adolescent girls who feel protected will have less concern about contracting HPV and other sexually transmitted diseases, and may use less caution in protecting themselves or seeking regular preventative treatment.

Source: Reuters

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The study was published in May 2007, about one year after Gardasil was approved by the U.S. Food and Drug Administration. The drug was approved for girls and young women, as protection against the human papillomavirus, or HPV, a sexually-transmitted virus linked to the development of cervical cancer. The 98 percent figure was tied to the drug’s effectiveness in “preventing changes in the cervix uses as a marker for cervical cancer,” according to a recent article by Discover Magazine blog writer Jeanne Lenzer, a medical investigative journalist.

Based in part on these claims of astounding success, the drug’s use was eventually expanded, and last month approved for use in boys and young men. The theory most popularly given for this is to increase protection for women. Protect young men from developing HPV, and you build in protection for their future partners. Not mentioned nearly as often, the FDA also cites benefits for men including protection against oral and anal cancers.

But is Gardasil really that effective?

Lenzer digs deeper into the initial study to uncover the bottom line. She notes that Merck only obtained 98 percent efficacy when “all real-world problems that arose were excluded from analysis.” This included patients who never received the full series of three shots, or perhaps patients who were vaccinated when they didn’t meet certain required criteria.

When results for all women in the study, not just the perfect cases, are analyzed, the efficacy rate is reported to be 44 percent. Still not bad. However, this number is then revealed to be tied only to those women who have one or both of the two strains of HPV that have been shown to be conclusively tied to cervical cancer, against which Gardasil protects.

Here’s where things really go off track. Lenzer reports that “when the researchers looked at negative cervical changes from any causes, they found that changes occurred in unvaccinated women at a rate of 1.5 events per 100 person-years, while vaccinated women had 1.3 events—dropping the benefit to 17 percent.”

Add into this the alarming number of serious adverse events reported by young women after receiving the vaccine – even deaths – and the risk to benefit ratio seems more than a little uneven. Even if adverse events have not been conclusively proven to be a result of the vaccine, there is a growing database of possible links.

The truth of the matter is that it is still too early to tell how well Gardail works in real-world conditions. It may be years yet before there is evidence of how well it works, or doesn’t work. And yet, already it is approved for an even broader distribution, now to boys and young men.

Shouldn’t we be more certain of the benefits – and the risks – before we line up our children for this vaccine?

Source:  Discover Magazine

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

While on the surface it would seem like a no-brainer to protect children against a virus that may cause cancer, some experts are cautioning the government to slow down where Gardasil is concerned. Since its launch in 2006, there have been more than 20,000 reports filed with the agency’s Vaccine Adverse Event Reporting System (VAERS), claiming serious side effects following the administration of the Gardasil vaccine. There also have been 92 reported deaths among girls who received the Gardasil vaccine.

Even one of the physicians who was a lead researcher in the development of Gardasil, Dr. Diane Harper, in 2009 expressed her concerns about the drug. She told an audience of medical professionals she feels the drug is “largely unnecessary,” as most HPV infections are cleared naturally by the body with no harmful effect. She pointed out that cervical abnormalities that may indicate a risk of cervical cancer are still easily detectable through the use of regular pap smears. And, unlike Gardasil, pap smears have no risk of adverse event and cost only a fraction of the cost of Gardasil.

Among its reasons for recommending the expanded use of the HPV vaccine to boys, the CDC advisory panel said it hopes that by vaccinating both genders there will be a reduction of transmission of the virus back and forth. The panel also pointed to recent studies possibly linking HPV to penile and rectal cancers, as well as head and neck cancer.

Gardasil has been in the national spotlight lately as a result of comments made by U.S. presidential candidate Michelle Bachmann, who after a GOP presidential debate said a woman in the audience told her the drug caused her daughter to become “mentally retarded.” Medical experts said there is no evidence that Gardasil causes “mental retardation,” and brush off side effects as relatively minor, including fever, swelling at the injection site, and headache.

But thousands of parents claim that after receiving the Gardasil vaccine, which never completed Phase 3 clinical testing, their daughters suffered serious adverse events including Guillain Barre syndrome, lupus, seizures, rheumatoid arthritis, multiple sclerosis, among others. They argue children who receive the HPV vaccine are little more than “human guinea pigs.”

Source: CNN

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

But in at least two news interviews after the debate, Bachmann told reporters Gardasil was linked to mental retardation as a possible side effect. She says she received this information from a parent she spoke with after the debate, whose child had received the Gardasil vaccine. This account left medical experts scratching their heads, as mental retardation is not listed among the adverse events currently reported in connection with Gardasil.

The controversy is leaving many wondering, did Bachmann simply misunderstand the adverse event described to her by a young girl’s distraught mother, or is she trying to sensationalize her story? Perhaps even more importantly, what are the risks associated with Gardasil?

Since Gardasil’s introduction in 2006, the Vaccine Adverse Event Reporting System (VAERS) has received more than 20,000 reports of adverse side effects related to Gardasil. These reports do include serious adverse side effects including Guillain Barre syndrome, lupus, seizures, rheumatoid arthritis, multiple sclerosis, among others. There also have been 92 reported deaths among girls who received the Gardasil vaccine.

In 2009, Dr. Diane Harper, one of the lead researchers in the development of two HPV vaccines, told an audience of medical professionals that in her opinion Gardasil is actually largely unnecessary. Almost all HPV infections are cleared naturally by the body’s immune system without harmful effect, she pointed out. In fact, Harper says, the rate of cervical cancer in the U.S. is so low, that vaccination is not expected to reduce the rate of cervical cancer in the U.S. at all.

Add to that, the vaccine has not been proven to last more than 5 years. In order for there to be true prevention, the vaccine would have to last a lifetime. For the target audience, 11-12-year-old girls, the vaccine is not likely to last long enough to protect them when they do become sexually active. However, cervical abnormalities that may indicate a risk of cervical cancer are still easily detectable through the use of regular pap smears. And, unlike Gardasil, pap smears have no risk of adverse event and cost only a fraction of the cost of Gardasil.

Despite the questions, by October 2009 the FDA had expanded the use of Gardasil in the U.S., approving it to treat boys and young men ages 9-26 for the prevention of genital warts, throat and anal cancers linked to HPV, as well as to curtail the spread of HPV. The Centers for Disease Control and Prevention (CDC) reports that approximately 32 million doses of the vaccine have been distributed in the United States since about September 2006.

Though Michele Bachmann’s attempt to point out the risks of Gardasil may not have been artful, she should be applauded for her attempt to spotlight the problems with Gardasil. Gardasil is a vaccination that is costly, potentially dangerous, and likely ineffective at preventing cancer. The cost and the risk of injury far outweigh any benefits. Rather than encouraging vaccination, the wiser course would be to proceed with great caution in the vaccination of young girls and boys.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

In its official news release, SANE Vax reports that 100 percent of the 13 samples of Gardasil they had tested were contaminated with recombinant HPV DNA. They report the vials of the vaccine were pulled from different lots being marketed in the United States, Australia, New Zealand, Spain, France and Poland. The tests were conducted on Merck’s HPV 4 Quadrivalent vaccine, Gardasil. The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology lab.

The reason for the tests, which SANE Vax said it instigated at the request of medical consumers, was because consumers “are concerned that the recombinant DNA, if present, may have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations,” according to the release.

In her letter to FDA Commissioner Hamburg, Norma Erickson, president of SANE Vax, writes, “There is no doubt that the HPV DNA found in the vaccine represents an adventitious agent left over from the DNA recombinant manufacturing process with potential adverse impacts on health safety of those vaccinated. The recombinant DNA found in Gardasil is very tightly bound to aluminum hydroxyphosphate. When injected intramuscularly, this combination may function as a DNA vaccine with uncertain consequences.”

SANE Vax is requesting that the FDA investigate the possible extent of any HPV DNA contamination of Gardasil HPV vaccine currently on the market to ensure public safety.

Source: MarketWatch

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Awad traveled to India to explore the practice of clinical research being conducted there, and to examine what role, if any, United States regulatory agencies play in oversees clinical trials. New America health editor Viji Sundaram recently interviewed Awad about her findings.

Awad says she found that both individuals and hospitals and other medical facilities are benefiting from participating in clinical trials oversees. Patients are often illiterate or unable to understand if their physician is prescribing an approved drug, or a drug that is in a testing trial, she says. Some knowingly participate in clinical trials in exchange for payment, because they can earn more than they might in day laborer type jobs typically available to them. Also, some health care facilities actively recruit patients for clinical trials, and are paid for these efforts by pharmaceutical companies, Awad reports.

In her report, “Outsourced: Clinical Trials Overseas,” Awad interviews a family who lost two daughters after they received the Merck vaccine, Gardasil. Gardasil is marketed as a preventive treatment against human papillomavirus (HPV), which is linked to the development of cervical cancer. Awad reports the girls were part of a study to determine whether Gardasil or another HPV vaccine, Cervarix, manufactured by GlaxoSmithKline, was more effective.

This vaccine study was actually administered through the girls’ school, whose headmaster gave permission for his students to participate. A few other girls also died after being vaccinated with Gardasil. However, health care professionals who investigated the deaths said they could find no conclusive evidence to link the deaths to Gardasil, and the government issued a report in which it said it believed none of the girls died as a result of the vaccine. However, there was no adequate follow-up with the girls’ families, so no record of what actually went wrong, Awad reports.

In 2010, the U.S. Department of Justice began an investigation into alleged industry-wide corruption in overseas clinical trials.

Watch “Outsourced: Clinical Trials Overseas.”

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

However, since its introduction, Gardasil, which is manufactured by Merck & Co., has come under scrutiny following thousands of reports of serious adverse side effects tied to the drug. There also have been more than 80 instances of deaths following the Gardasil vaccine. The drug company and doctors say there is currently no way to conclusively link the drug to these side effects and deaths, but parents are not so sure.

In 2009, Dr. Diane Harper, one of the lead researchers in the development of two HPV vaccines, told an audience of medical professionals that in her opinion Gardasil is actually largely unnecessary. Almost all HPV infections are cleared naturally by the body’s immune system without harmful effect, she pointed out. The Gardasil vaccine targets only four of hundreds of strains of HPV and, of those, only two that are most high-risk of causing cervical cancer. Also, in the case of young women, regular Pap tests can usually identify any changes in cervical cells, and treatment administered before they become cancerous.

The vaccine was rushed to market before phase 3 clinical trials were complete. But in the months following the vaccine’s introduction, the U.S. Vaccine Adverse Event Reporting System (VAERS) began tracking reports of minor adverse events, but also serious reactions including anaphylaxis, Guillain-Barre syndrome, transverse myelitis, pancreatitis and venous thromboembolic events (blood clots).

Because the VAERS is a voluntary reporting system, many physicians and researchers believe the actual incidence of events linked to this vaccine may be much higher.

The Centers for Disease Control and Prevention (CDC) reports that approximately 32 million doses of the vaccine have been distributed in the United States since about September 2010. Now that the market has been expanded to include children of both genders, it’s frightening to imagine the possible consequences.

Parents who are considering whether to include Gardasil when choosing vaccinations for their child should ask themselves, “Is the relatively limited benefit of this vaccine really worth the risk?”

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The campaign is aimed at two senior scientists in the U.S. government – Dr. Mark Schiffman, who SaneVax identifies as a senior investigator at the National Cancer Institute (NCI) and the official medical monitor of the HPV vaccine clinical trial; and Dr. Lauri Markowitz, a senior scientific officer of the Centers for Disease Control and Prevention (CDC), who is it says is responsible for instituting a post-licensure marketing program for HPV vaccines. Supporters of stronger regulations also are sending letters to their Congressional representatives.

According to the release, the letters demand the government “comply with the law and immediately implement a reliable post-licensure monitoring program to validate the benefits of the HPV vaccine, being marketed as a cancer vaccine, indeed outweigh its risks to consumers.”

Since Gardasil was approved for use in girls beginning as early as age 9, in 2006, there have been numerous reports of serious adverse events linked to the drug. Side effects reported following the vaccination include blood clots, immune deficiency disorders like Lupus, brain inflammation, seizures and even death. Because most side effects are reported through the voluntary Vaccine Adverse Event Reporting System (VAERS), some advocates believe the incidence of serious side effects is higher than officially reported, as some victims would not think to link the drug to later health problems, and so these problems go unreported.

Manufacturer Merck maintains the drug is safe, and says that there is no conclusive link between the drug and later adverse health events. In fact, the drug recently received expanded approval by the FDA for use in boys and young men, for the prevention of HPV, and the reduction of incidence of penile, anal and oral cancers.

For more information, and sample letters, visit the website “Gardasil and Unexplained Deaths.” This site is operated by Emily Tarsel, whose daughter, Chris, who died days after receiving the Gardasil vaccine.

Visit SANEVax online.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

An editorial published in the Journal of the American Medical Association (JAMA) in 2009 asks a number of important questions related to the Gardasil vaccine, and just why it was rushed to market.

The vaccine targets the human papillomavirus (HPV), which is linked to the development of cervical cancer. It was widely promoted and aggressively marketed to young women and their parents through the catchy “One Less” campaign, which urged them to receive the vaccine in order to be “one less” girl who developed cervical cancer in the future. What the ads didn’t emphasize is that HPV is the most common type of sexually transmitted infection. It also seems to be among the least harmful, because almost all HPV infections are cleared naturally by the body’s immune system without harmful effect.

What also was unknown when this marketing campaign cranked up to full steam was the nature of any harmful side effects from the vaccine.

However, in the months following the vaccine’s introduction, the U.S. Vaccine Adverse Event Reporting System (VAERS) began tracking reports of minor adverse events, but also serious reactions including anaphylaxis, Guillain-Barre syndrome, transverse myelitis, pancreatitis and venous thromboembolic events (blood clots). But because the VAERS is a voluntary reporting system, many physicians and researchers believe the actual incidence of events linked to this vaccine may be much higher. Conversely, the nature of the reporting system also makes it very difficult to tell when events are in fact not linked to the vaccine.

Generally, when determining whether to add a drug like a vaccine – which is given to an otherwise healthy person – a recommended procedure, there is a very careful weight of benefit and risk. Why then, was Gardasil so quickly added to the recommended regimen?

Studies in actual patients – the clinical trials – were not even complete when it was recommended. The risk of developing cervical cancer from HPV is relatively small, and a distant future for the target audience, 11-12 -year-old girls. Cervical abnormalities that may indicate a risk of cervical cancer are easily detectable and treatable through the use of regular pap smears. The Gardasil vaccine targets only four of hundreds of strains of HPV and, of those, only two that are most high-risk of causing cervical cancer.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Gardasil is a vaccine against four types of the human papillomavirus, a sexually transmitted virus linked to the development of cervical cancer. Recent studies are now saying that HPV also may be responsible for the development of throat cancers, which may be transmitted by oral sex, as well as penile and anal cancers.

However, the vaccine also is linked to thousands of reports of serious adverse side effects, including paralysis, blood clots, autoimmune deficiencies, and even death.

The Facebook page author says she is a 17-year-old girl who suffers from rheumatoid arthritis, stills disease, Crohns disease and fibromyalgia after receiving the vaccine.

Visit the Facebook page: Gardasil can be dangerous.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Austin says drug-maker Merck could not possibly be able to predict the long-term effects on the pre-pubescent girls that are its primary focus, because it was not tested on a large enough sample of children in that age group. The longest test trial, she says, was less than four years. This, despite the fact that the vaccine maker states the drug is only effective for a maximum of five years.

HPV, the virus linked to cervical cancer, is a sexually transmitted virus. This means that girls who receive the vaccine at age 11, or even younger, will most likely not even be sexually active during the vaccine’s peak effectiveness, based on Merck’s own information.

She writes, “This means my daughter will need at least four booster shots after the age of 11. What the drug makers do not mention is that this is the most expensive vaccine ever made, at $360 per three-shot series. They do not tell me about the vaccine’s known carcinogenic and estrogenic compounds that will be injected into the body of my pre-pubescent little girl, or the fact that the shot has not been tested to find out if it can potentially cause more cases of cancer than it is supposed to prevent.”

Additionally, Austin feels the drug maker is downplaying the risk of serious side effects. Statistics being reported to the Vaccine Adverse Effect Response System include children collapsing after receiving the shot, and reports of facial paralysis, Guillain-Barre Syndrome, and even death among girls who have received the shot.

While the drug maker argues there is not sufficient evidence to link these events to the Gardasil vaccine, Austin asks how many parents really want to take that chance with their child’s health.

She wonders, “Can I refuse this dangerous, experimental treatment if I do not want to have my child used in this way, so the pharmaceutical company (which will profit approximately 2 billion dollars a year on this vaccine) can find out exactly what it will do to little girls not even at puberty yet?”

Austin suggests a better solution: “Why not use the billions of dollars that will be going to Merck, and instead fund a campaign to make HPV screening and Pap smears (far cheaper and more effective tools for fighting cervical cancer) free and accessible to everyone?”

Since the time this article was published, the FDA also approved Gardasil for use in boys and young men, as well as girls.  HPV screening would also be effective in preventing the spread of this virus among boys.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

According to Kirsten’s video, featured on YouTube, Gabby was an active teenager, a cheerleader and gymnast with a 4.0 grade average. Until she received the Gardasil shots. Shortly after receiving the shots, which are given in a series of three, Gabby developed an inflammation of the central nervous system. This left her in constant pain, and she had to leave school. Her symptoms include seizures, headaches, swelling, dizziness, mini-strokes, vomiting and memory loss.

The drug’s manufacturer, Merck, says injuries like Gabby’s cannot be conclusively linked to the Gardasil vaccine, and that the thousands of serious illnesses and more than 80 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) are “anecdotal.”

Watch the video:

Click here to view the embedded video.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

In 2010, the Garasil vaccine was approved for use in boys and young men, to prevent the spread of HPV, which is a sexually transmitted virus. In this instance, the drug’s manufacturer, Merck, promotes the vaccine as an additional safeguard against oral, penile and anal cancers.

Watch the CNN video:

Click here to view the embedded video.

Source:
www.VaccinationEducation.com

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The vaccine, which is touted as a prevention for four types of human papillomavirus (HPV) that could cause cervical cancer, has been linked to thousands of serious adverse event reports and more than 80 deaths. Leigh O’Dell, a lawyer in our Mass Torts Section, is working on a number of cases on behalf of clients who were harmed by Gardasil.

“We believe that efforts such as this film, ‘One More Girl,’ are vital to getting the word out about the dangers of Gardasil,” she says. “We are pleased to be able to support this worthwhile project and trust that many will learn about the unreasonable risks associated with Gardasil prior to having their daughters vaccinated.”

The film’s title is a play on the effective Gardasil advertising campaign, “One Less,” which encouraged girls to be vaccinated so they could be “one less girl with cervical cancer.” The drug is manufactured and marketed by Merck & Co. Filmmakers Ryan and David Richardson decided to make the film after their sister, Donielle Richardson, suffered an adverse reaction after receiving the vaccine. They found thousands of other cases of girls suffering serious illnesses, or who had died, after receiving the vaccine.

Their production company is named ThinkExist Productions. They have partnered with two Gardasil advocacy groups, TruthAboutGardasil.org and SANE VAX Inc., to develop the film, which will share personal stories of adverse reactions and deaths linked to the drug, and also will cover the social and political trail of deception over the global mass marketing of HPV vaccines. The film is expected to begin production this summer, with release tentatively scheduled in 2012.

For more information, visit the official film website at www.onemoregirlfilm.com.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Julie Smith was alarmed when her daughter brought home a flyer from her school, notifying parents that all girls in grade 8 would be addressed by the public health nurse about the vaccine. Smith was concerned that important information about the sexually transmitted HPV was being presented to 12-year-old girls, instead of their parents.

“It is a decision that should be made by adults,” she told The Timaru Herald. “At the very least, parents should have been invited to attend the meeting to hear what information is being given to their children.”

She says parents were asked to sign a permission slip only to notify the school if their daughter could NOT attend the presentation. It should have been the other way around, she says, with permission slips required in order to attend the meeting. She worried that some girls might forget to talk to their parents about the meeting to have the letter signed, and might then attend the meeting without their parents’ knowledge or consent.

The website founded by Ms. Smith is called “Off The Radar.” She lists the reason for founding the site as follows:

This site was born out of the frustration of a parent who wished to make an “informed” decision about Gardasil for their daughter, and the difficulty they incurred at not being told the complete story about the vaccine by “The Ministry of Health and medical establishment”. To have a “one stop shop” of information for parents concerning what is being put into their children, whether by vaccine or food, this site endeavours to tell “what they didn’t want you to hear.”

Visit this site at http://offtheradar.co.nz/.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Gardasil, manufactured by Merck, is promoted as a preventive treatment against cervical cancer, which is caused by certain types of HPV, which is transmitted through sexual contact. Gardasil protects against four types of HPV, including two that indicate the highest risk of causing cervical cancer. However, the vaccine also has been linked to serious side effects including lupus, autoimmune disorders, seizures and even death following injections.

The news story notes that vaccination rates in Canterbury are less than half that in some other cities, such as Auckland and Wellington, where immunization rates are nearly 40 percent. However, vaccination rates are higher in Canterbury for older girls. Statistics indicate parents are concerned about vaccinating their daughters before the girls are sexually active, but not when they are as young as 12.

Source: The Press

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Gardasil was recommended for girls beginning as young as age 9, and presented as an “anti-cancer vaccine.” The drug actually protects against four of hundreds of strains of human papillomavirus (HPV), two of which are high risk, responsible for about 70 percent of cervical cancers, and two lower-risk types of HPV. However, what the advertising campaign failed to point out is that not every woman is at the same risk for cervical cancer, and that routine gynecological examinations and Pap smears are equally if not more important in the early detection and prevention of cervical cancer.

According the the SMU Daily Campus news website, the lecture explored the idea that the advertising campaign used to promote the new vaccine was designed to play on the public’s fear of cancer. The lecture was presented by Sheila M. Rothman, Ph.D., a professor of public health in the division of sociomedical sciences at Columbia University’s Joseph L. Mailman School of Public Health, as well as Deputy Director of the Center for the Study of Society and Medicine at the Columbia College of Physicians and Surgeons.

During the lecture, Dr. Rothman pointed out that as a result of a general marketing campaign aimed at both young women and the parents of young girls, large portions of the population were vaccinated without regard to or knowledge of their actual risk factor for cervical cancer. Those at high risk, she says, are those who do not have access to adequate health care, and are therefore unable to get annual Pap smears.

Others at higher risk for cervical cancer include women who smoke, who have a diet low in fruits and vegetables, take birth control pills for more than five years, have had more than three full-term pregnancies or have HIV or a Chlamydia infection, according Dr. Richard Gajdowski, medical director for United Healthcare of Michigan.

In its advertising, Merck also failed to point out rates of cervical cancer versus other types of cancer, or to mention that yearly Pap tests also would reduce risk, Dr. Rothman said. The American Cancer Society recommends women begin receiving regular Pap smears at least three years after the onset of vaginal intercourse and no later than age 21.

It is the goal of the Maguire Center to promote student awareness of pertinent ethical issues, and to promote ethics not just as an awareness of what is “right and wrong” but as a social responsibility,” according to center director Rita Kirk, Ph.D.

Source: SMU Daily Campus

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The Centers for Disease Control and Prevention (CDC) reports that approximately 32 million doses of the vaccine have been distributed in the United States since about September 2010. They argue that the more than 17,000 reports of serious adverse events – including things like immune deficiencies, Lupus, seizures, and blood clots in addition to the reports of deaths following administration of the vaccine – make up a relatively small percentage of the total number of doses given.

But do parents really want to take a gamble on that kind of risk?

Until recently the vaccine has been given exclusively to girls, with no recommendations for its use in boys. Now that the market has been expanded to include children of both genders, it’s frightening to imagine the possible consequences.

According to information about HPV found at WebMD, the infection is very common, affecting about 20 million people in the U.S. HPV could cause genital warts or abnormal changes in the cervix and other genital areas that can lead to cancer. However, for most people, the body will clear HPV infection on its own. Women are encouraged to get a gynecological examination and Pap smear annually as the best way to detect and treat pre-cancerous cells, whether or not they have ever received the Gardasil vaccine.

Because the vaccine only prevents against a fraction of the types of HPV, and because the vaccine’s efficacy is only 5 years from the point of vaccination, receiving the shots does not guarantee a person will never develop HPV.

Parents who are considering whether to include Gardasil when choosing vaccinations for their child should ask themselves, “Is the relatively limited benefit of this vaccine really worth the risk?”

Source: Yahoo! News

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The report is based on the findings of the Australian Medical Association, published in Women’s Health Issues, part of the Australia’s Health 201 report. The Advertiser notes that according to the report, the number of women between the ages of 20-24 who get cervical cancer screenings has declined steadily since 2006, the year Gardasil was introduced and recommended for young women.

The paper quotes Dr. Andrew Pesce, president of the Australian Medical Association, as saying “Even though vaccination protects women against the type of HPV that causes about 70 percent of all cervical cancers, it is vital for women who have been vaccinated to continue regular screening. It ensures any cervical abnormalities which might develop into cancer are detected early whilst still easily treatable.”

While Pap smears are the most effective tool for identifying and treating pre-cancerous lesions before they develop into cancer, the introduction of a cervical cancer vaccine has made many women complacent about receiving the annual test, the news agency reports.

Source: The Advertiser

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However, researchers say the girls and their parents are choosing instead the more traditional route of annual physical check-ups and Pap smears as a method for detecting and treating any signs of HPV or pre-cancerous cells. Some parents have said they consider the vaccine to be unsafe, while others simply feel it is unnecessary, as most cases of HPV clear themselves without causing any adverse events.

Conversely, the HPV vaccine Gardasil, and similar vaccine Cervarix, have been linked to thousands of adverse event reports, including serious reactions. According to the Public Health Agency of Canada, 38 people have been hospitalized following a Gardasil vaccine since 2007, and one person has died. While the agency said there is not sufficient evidence to link the death to the vaccine, it is enough for some patients and parents to stop and think twice.

The Middlesex-London Health Unit started administering the Gardasil vaccine through a school-based program in 2007.

Source: London Free Press

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Although not reported in most mainstream media, SANE VAX discovered the French government had banned Gardasil ads in August 2010. The drug, which targets and prevents four types of human papillomavirus (HPV) linked to cervical cancer, is produced by Merck & Co. and marketed in France by its partner Sanofli-Pasteur. On Jan. 4, 2011, SANE VAX issued a news release about the ban, which was handed down by the Director General of the French Agency for Safety of Health Products (AFSSAPS).

According to the news release, the AFSSAPS found Gardasil ads to be in “direct violation of the French public health code.” At issue are claims of longer efficacy for the drug than has been actually proving, and making false claims that the drug is a “cure” for cervical cancer.

In actuality, the French Committee on Immunization Practices (CTV) and the High Council of Public Health (HCSP) say “the vaccine’s impact on the incidence and mortality of cervical cancer will only become apparent in the long term, in 15 to 20 years.”

The American Chronicle reports that as a result of the French decision and ban of Gardasil ads, similar advertising for Gardasil and the GlaxoSmithKline (GSK) manufactured HPV vaccination, Cervarix, have been removed in the UK. In particular, the UK’s Advertising Standards Authority cited GlaxoSmithKline for making claims that the Cervarix vaccine would protect young women indefinitely against cervical cancer, using the slogan “Armed for Life.” The agency instructed the manufacturer to change the ad to clarify the language. Eventually, the local Primary Care Trust decided to remove the advertisements altogether.

Additionally, the publication reports India has had similar problems with HPV advertisements, and in December 2009 the Drugs Controller General of India (DCGI), which is the drug regulatory agency, took issue with the way GlaxoSmithKline was promoting Cervarix in India. The DCGI says the manufacturer was misleading the public and accused the drugmaker of “unlawful propagation of its cervical cancer vaccine, Cervarix, through mass media.”

American Chronicle reporter Christina England reports that other countries also have reported seeing false advertising for Cervarix and Gardasil, usually linked to claims that the drugs will prevent cervical cancer.

For more information:

American Chronicle article
SANE VAX website

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Since its introduction in 2006, the Gardasil vaccine has been linked to a number of side effects, some serious, like lupus, seizures, paralysis, blood clots and others. There also have been more than 70 deaths reported following administration of the Gardasil vaccine, which is given in a series of three injections over a six month period.

However, the coroner in this recent case, Michel Ferland, is concerned because it appears the victim died as a result of drowning. She was found in the bathtub of her family home. According to a report in the Toronto Sun, the girl’s mother said she had a number of adverse reactions following her first dose of the Gardasil vaccine, including dizziness and memory loss. She was treated for those symptoms at a Montreal hospital. Two months later, she received the second in the series of vaccinations. Days later, she was dead.

Is it possible that a recurrence of side effects like dizziness struck the young teen, making her incapable of leaving the bath or calling for help, resulting in her drowning? Or might her death be more directly related to another serious side effect of the drug?

Ferland is concerned enough about a possible link between the Gardasil vaccine and the young girl’s death that he is calling for further studies of the drug to be conducted in Canada, and he is asking the Canadian health agency to provide better information to patients about possible side effects of the drug. Health Canada approved the drug in 2006.

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If the advisory panel finds there is sufficient clinical data to show that the vaccine would prevent anal lesions and anal cancer in men, it could advise that the FDA change the drug’s status to “recommended” for boys and young men as well.

According to a recent report on MSNBC.com, the recommendation could be controversial.  The use of this vaccine already has sparked a debate about whether or not its use suggests a “free pass” to young people to have sexual intercourse because they feel it protects them from disease. Adding to the controversy about the vaccine for boys, is whether or not to advocate the vaccine for all boys, or only those who have determined they are gay or bisexual.

Studies show the group most likely to benefit from the Gardasil vaccine among young men are those who have sex with other men. In this group, the vaccine has shown to be 78 percent effective at preventing anal lesions and anal cancer, MSNBC.com reports.  However, researchers wonder if a targeted vaccine would miss much of its intended audience because it is given at such a young age that a boy making the decision to be vaccinated – or his parents – would be unaware that he is gay. Also, experts think a targeted vaccine might not be effective because young men who do feel they are gay may avoid getting the vaccine because they think it may stigmatize them, exposing them to harassment or judgment.

On the other hand, physicians are hesitant to recommend the vaccine for all boys, when studies show it would be largely ineffective or unnecessary for the majority of boys who might receive it, who are at very small risk. According to U.S. News.com’s Health report, complications from HPV for young men are quite rare. “For the average guy,” the report states, “the virus lies silent, doesn’t cause problems, and clears in a year or two.”

The FDA is expected to make its decision whether or not to expand the marketing of Gardasil as “recommended” for boys by the end of the year. After that, the federal Advisory Committee on Immunization Practices (ACIP) will determine whether to issue its own public recommendation. That decision should occur around February 2011.

Sources: MSNBC.com; US News.com

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Gardasil, which was released by manufacturer Merck in 2006, has recently been approved for use by boys and young men, for the prevention of HPV linked to the development of genital warts and penile and anal cancers. To date, both Merck and the FDA have said the drug is safe and effective, and that its benefits outweigh the risks.

In the following video, Dr. Wheldon Chafe, a cervical cancer expert with the VCU Massey Cancer Center, discusses the FDA report with CBS 6 anchor Stephanie Rochon. He advises parents to talk with their pediatrician and carefully weigh the risks of the Gardasil vaccine prior to approving its use for their children. He says the increased numbers of adverse events reported linked to the drug are “alarming.”

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Last week, Judicial Watch, a government watchdog group, obtained reports from the U.S. Food & Drug Administration (FDA) that contain extensive new documentation of deaths and adverse events linked to the Gardasil vaccine. The FDA report documents incidents that occurred between May 2009 and September 2010. According to its website, Judicial Watch, Inc., is a “conservative, non-partisan educational foundation that promotes transparency, accountability and integrity in government, politics and the law.”

WTVR CBS-6 news in Richmond, Virginia, reported the new findings. According to the news story, among the adverse events reported, 789 were listed as “serious” and 213 cases involve permanent disability following the vaccine. Additionally, four of the 16 deaths reported were suicides.

Judicial Watch obtained the FDA documents through a Freedom of Information Act request. In a news release, Judicial Watch President Tom Fitton says “the FDA and other public health authorities may be asleep at the switch” when it comes to Gardasil. “To say Gardasil has a suspect safety record is a big understatement,” he says.

Since the release of Gardasil in 2006, both drug maker Merck and the FDA have insisted the drug is safe and effective, and that its benefits outweigh its risks. The drug recently has been approved for use in boys and young men, for the prevention of HPV and genital warts.

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Watch the video here:

Click here to view the embedded video.

Thompson has served as Director of the HSI for 11 years, after a brief career in the health care industry. In that job, she says, she realized that hospitals worked to turnover patients as quickly as possible, “without killing them.” She says she saw that the health care industry all too often cares more for its bottom line than for health. The HSI is a membership-based organization that provides information about alternative medicines, and works to provide warnings about dangerous drugs and medical practices to its members.

For more information, visit hsionline.com.

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Gardasil, manufactured by Merck & Co., and Cervarix, manufactured by GlaxoSmithKline, are promoted for the prevention of the human papillomavirus (HPV), a sexually transmitted virus linked to the development of cervical cancer. However, the vaccines only treat four of the more than 40 types of HPV, and experts say studies show that the human body naturally eliminates more than 90 percent of HPV infections, making the vaccine irrelevant and redundant. Medical professionals also point out that pre-cancerous lesions can be safely detected with regular annual Pap smears, eliminating the need for the vaccine.

The columnist also points out that the HPV vaccine is controversial because of its spotty safety record. In the United States, the Vaccine Adverse Event Reporting System (VAERS) has logged consumer complaints about serious adverse events following the Gardasil vaccine, including pulmonary emabolism and Guillain-Barre syndrome, as well as more than 50 reports of death among girls who received the vaccine. It is estimated that the number of adverse events linked to these vaccines may be even higher, as not everyone who experiences a serious side effect reports it.

Gardasil was approved by the U.S. Food and Drug Administration (FDA) for use in 2006, and Cervarix by the FDA in 2009.

In addition to its concerns about the efficacy and safety of HPV vaccines, the Consumers Association of Penang is concerned about the plan for the MOH to work in conjunction with the Ministry of Education to administer the vaccine to the school-age girls without providing additional information about the vaccine to their parents. At the very least, Idris says, the MOH must provide parents with the opportunity to exercise their right to informed consent by supplying them with comprehensive information about the vaccination process and the risks involved.

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Manufactured by Merck & Co., Gardasil is promoted as a vaccination to protect young women against cervical cancer. What the drug actually does is guard against four out of about 40 types of human papillomavirus, or HPV. HPV is a sexually transmitted virus linked to the development of cervical cancer. Recently, recommended use of Gardasil has been expanded to include vaccinations for boys and young men, also for the prevention and spread of HPV.

However, since its introduction in 2006, Gardasil has been linked to a number of serious adverse events, including seizures and auto-immune disorders. More than 50 young women have died shortly after receiving the Gardasil vaccine.

In addition to these reports, SaneVax, Inc., is concerned about potential HPV vaccine-induced increased risks of cancer.There have been 283 cases of post-vaccination abnormal PAP smears reported to the Vaccine Adverse Event Reporting System (VAERS), with more reports of high-risk HPV, cervical lesions and cervical cancer also beginning to be recorded following vaccinations with Gardasil. Also, data collected by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) indicate exposure to HPV prior to vaccination with Gardasil raises a woman’s risk of cervical cancer by 44.6 percent.

SaneVax will operate a comprehensive website with news, research, videos, profiles of victims, a forum and more. It also plans to offer affordable, highly sensitive HPV testing using specific genotyping by DNA sequencing for pre- and post-vaccination.

“Pre- and post-HPV testing is crucial to identify whether a young woman has already been exposed to HPV, and to try and understand the mechanisms of action causing the injury and death of innocent girls after innoculation,” says SaneVax, Inc., board member Leslie Carol Botha, a Women’s Health educator and broadcast journalist.

Other board members include Norma Erickson (Chairman of the Board); Rosemary Mathis, who believes her daughter was injured by the Gardasil vaccine; Freda Birrell, political lobbyist int he UK and Scotland; and Janny Stokvis, vaccine researcher. They hope to expand the mission of SaneVax, Inc., to eventually include research, studies and data on all vaccines marketed in the United States.

For more information, visit sanevax.org or email info@sanevax.org.

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Some have already suggested boys ought to be included in Gardasil vaccinations, in order to limit the possibility of their spreading the virus to their partners when they become sexually active. The FDA has recently approved the use of Gardasil in boys, but only to prevent genital warts. HPV also has now been linked to the development of penile and anal cancer.

According to a recent story on Forbes. com, the link between HPV and throat cancer has only come about in the last few years, with researchers believing it may be linked to oral sex. According to the report, there are approximately 11,300 HPV-related throat cancers diagnosed in the U.S. each year. Throat cancer has traditionally been linked to smoking and drinking alcohol.

However, since Gardasil’s introduction in 2006 for the treatment of cervical cancer, there have been a number of troubling developments. The drug has been linked to a number of serious adverse events reported by young women shortly after receiving the vaccine, which is usually given in a series of three shots. Adverse events have been reported after receiving one or more of the shots. These side effects have included such serious problems as blood clots, seizures and auto-immune disorders. There also have been more than 50 reports of young women who have died shortly after receiving the Gardasil vaccine.

Even if there are no side effects, some physicians are questioning the benefit of the vaccine. About 90 percent of HPV infections are cleared naturally by the body, never developing into pre-cancerous lesions or cancer. For girls, regular Pap tests can usually detect any pre-cancerous lesions and treat them before they develop into cancer. And, generally all papilloma viruses are slow-moving, with any pre-cancerous lesions they cause developing over time, more easy to find and diagnose before they cause a problem.

Unfortunately, it is not as easy to detect such lesions in the throat, which some researchers argue is a positive in favor of the HPV vaccination. However, it also makes studies that would determine the effectiveness of a vaccine like Gardasil for the treatment of throat cancer much more difficult to determine. Without effective clinical trials with easy to measure results, it is unlikely the FDA would grant approval to the vaccine for this type of use.

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Dr. Barta acknowledges that the Gardasil vaccine is effective against four types of Human Papillomavirus (HPV), two of which are linked to 70 percent of cervical cancers. HPV is transmitted sexually. However, he points out, data supports the fact that about 90 percent of HPV cases are cured by the body’s own defenses, never developing into cancer. Additionally, medical evidence bears out that cervical cancer is an extremely slowly developing cancer, and that women who receive regular PAP tests can be easily diagnosed, treated and cured when early pre-cancerous indicators are detected.

“When the National Breast and Cervical Cancer Early Detection Program, geared to low-income women, was implemented, a dramatic drop in cervical cancer resulted,” he writes. “Most cervical cancer deaths occur in women who have never been screened or had a Pap smear within the last five years. The cure for cervical cancer is largely early detection of cell changes years before a cancer develops,” he says.

On the other hand, any vaccine carries with it inherent risks for adverse events. And, even if young women are not injured by the vaccine, Dr. Barta points out that mandatory vaccinations at the very least will incur huge economic costs.

“Even if Gardasil proves to be completely safe, is there evidence of benefits above regular screening to justify the huge cost of widespread vaccinations?” he asks.

Because the effectiveness of Gardasil is estimated to last only about five years, girls would not only need to receive the initial series of vaccines, but also theoretically some type of booster shot after its efficacy period. Also, he points out, the marketing of Gardasil is now being expanded to include young boys and men. This increases the likelihood of additional reports of adverse side effects, as well as additional expense for states mandating the vaccine.

Ultimately, Dr. Barta says, the vaccine doesn’t make sense as a mandatory treatment for young people, as HPV is not communicable in the same way that other childhood illnesses are, or even the flu.

“This is not a communicable disease in the sense that the flu, measles, etc. are,” he writes. “You don’t walk into a crowded room and catch it. A non-sexually active 17-year-old girl can’t catch it.”

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According to a report on U.S. News & World Report’s Health Day, the study involved a randomized control trial of nearly 18,000 women ages 16-26, and was conducted by the department of medical microbiology at Lund University, Malmo University in Sweden. Researchers report “significant protection” against the warts and other growths in “susceptible women.”

Gardasil entered the scene in2006 as a drug intended to protect young women against the development of cervical cancer by vaccinating against four strains of Human Papillomavirus (HPV). The vaccine is given as a series of three shots. It has an efficacy period of about five years.

However, since its introduction, Gardasil has come under fire as it has been linked to serious adverse events. Parents of young girls who receive the vaccine, or young women who received the vaccine, have reported experiencing side effects after receiving the vaccine, which they blame on the drug. Complaints range from fainting and muscle weakness to serious auto-immune deficiencies, chronic pain, Lupus, blood clots, seizures and even more than 50 reports of deaths. The makers of Gardasil deny any connection to the vaccine.

As of May 31, 2010, the Centers for Disease Control and Prevention (CDC) has received more than 16,000 reports of adverse side effects, reported by consumers through the FDA’s Vaccine Adverse Event Reporting System (VAERS). The CDC has record of 53 U.S. reports of death among females who have received Gardasil. Twenty-nine of these reports have been confirmed.

Now, it appears the push is on to add boys to this list. Merck generated more than $1 billion in sales during the first year Gardasil was available. Is it any wonder the drug maker is eager to expand its customer base?

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The question was medically reviewed by Marie Savard, MD. She said that while many professional organizations, such as the American College of Obstetricians and Gynecologists and the American Cancer Society recommend that women who are older than 30 receive an HPV test, the recommendation says the test should be done in conjunction with a regular Pap test.

“Studies find that the combination of a Pap test and HPV test is the most effective way to find cervical disease and cancer, better than using a Pap alone,” the answer reads. But, they quickly point out, just because a woman receives a positive HPV test, indicating the presence of an HPV, doesn’t mean she will get cancer. “Almost all women clear the virus with the help of their immune systems,” the article says. The presence of HPV only means that a woman’s doctor may want to monitor her more closely for any cell changes that may result from the HPV infection. Regular Pap tests will identify these cells, which can then be safely treated.

This answer may come as a surprise to many women who have been inundated with television ads and other marketing materials touting the benefits of an HPV preventive vaccine, Gardasil, manufactured by Merck & Co. The ads urge women to have the vaccine, or parents to vaccinate their daughters, ensuring they will be “one less” case of cervical cancer. However, the Gardasil vaccine actually only protects against four of nearly 40 types of HPV. While one of these types may lead to the development of cervical cancer, generally, as Dr. Savard pointed out, the body’s own immune system will clear most types of HPV before they cause a problem, and regular Pap tests can detect irregular cells for effective treatment before any cervical cancer develops.

Additionally, since its introduction in 2006, Gardasil has been associated with a number of adverse event reports, including incidents of paralysis and the development of lupus. There also have been more than 50 reports of deaths linked to young women who received Gardasil.

The medical advice on the Healthy Women website goes on to say that women younger than 30 don’t need HPV tests at all, unless their Pap test indicates a reason why it might be necessary, or is inconclusive, in which case the HPV test can be given as an extra measure of precaution. “Most young women will have an active infection at some point,” the article says, “but the infection will clear up on its own without problems.”

How about “one less” useless and potentially dangerous drug?

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According to the language in the final version of the legislation, the state’s Department of Health and Senior Services will be responsible for developing “an informational brochure relating to the connection between human papillomavirus and cervical cancer, and that an immunization against the human papillomavirus infection is available.” The legislation says the brochure will be made available on the health department’s website and that the department will notify each public school district in the state of the availability of the materials.

It is unclear whether the new literature will specifically name or endorse the Gardasil vaccine, but the language of the bill suggests that educational materials will imply the vaccine is a true preventive measure against cervical cancer, when in fact the drug only protects against four out of about 40 different types of HPV.

It is also is unclear whether the new literature will clarify that medical professionals say about 90 percent of HPV infections are cleared by the body on its own, making the vaccination largely unnecessary, or whether the literature will outline the many serious adverse events associated with Gardasil. Since its introduction in 2006, Gardasil has been linked to reports of such serious side effects as seizures and lupus. There also have been more than 50 deaths reported following Gardasil vaccinations.

The brochure will include language about the importance of Pap tests in detecting precancerous changes that can develop into cervical cancer.

The bill, which was sponsored by Rep. Robert Cooper (R) and handled in the Senate by Sen. Jolie Justus (D), also allows physicians to prescribe medication for the sexual partners of their patients to treat sexually transmitted diseases chlamydia and gonorrhea, a practice known as “expedited therapy.”

Read the Missouri HB1375T.

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In addition to Gardasil, which is marketed to prevent cervical cancer by targeting four types of human papillomavirus (HPV), Sinopharm will help distribute other Merck products including Januvia, for the treatment of diabetes, Cozaar and Hyzaar (heart drugs), Remicade (rheumatoid arthritis) and Singulair and Nasonex (allergy treatments).

According to a Merck news release dated July 27, 2010, the two companies have signed a statement of mutual intent. “Under the statement, Sinopharm and Merck will cooperate on HPV vaccine and other mutually selected vaccine products in China, and will also discuss the potential for promoting and marketing Merck’s pharmaceutical products in China,” the release reads.

The release describes Sinopharm as China’s largest pharmaceutical and health industrial group under State-Owned Assets Supervision and Administration Commission of the State Council. It has China’s largest bio-pharmaceutical manufacturing company and China’s largest (the world’s third largest) pharmaceutical distribution company.

Nearly 30 million doses of the Gardasil vaccine have been distributed in the U.S. since 2006, and Merck generates about $1 billion in revenues from the drug annually. It is marketed as a preventive treatment for cervical cancer, protecting against four of 40 strains of HPV. Recently, the drug also was approved for use in boys, to protect against the transmission of HPV and genital warts, which the company says could lead to penile and anal cancers.

However, the drug has come under fire from critics following a series of adverse events in girls who received the vaccine. These include serious side effects like blood clots and muscle weakness. There also have been reports of 53 deaths in girls and women who received Gardasil.

Perhaps most startling, recently one of Gardasil’s own primary researchers, Dr. Diane Harper, said she believes the drug is unnecessary at best, and dangerous at worst. She points out that 90 percent of HPV infections resolve themselves, and that annual Pap tests beginning at age 21 for women are effective at catching and treating precancerous lesions before cervical cancer develops.

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The only exception, according to the ACOG, is for adolescents with compromised immune systems, due to conditions such as HIV infection, organ transplant or long-term steriod use. This group makes up less than 1 percent of adolescents, but they are more at risk that HPV could develop into cancer.

However, the ACOG is quick to say that Pap tests are still the best defense for early detection and treatment of precancerous cells that could eventually lead to cervical cancer. They still recommend women 21 and older undergo regular Pap tests. According to the MSNBC report, cervical cancer rates in the United States have dropped by more than half in the past 30 years, which is largely attributed to cervical cancer screening – the Pap test.

Recently, there has been some debate about a relatively new vaccine offered by Merck pharmaceuticals, Gardasil. The vaccine is promoted as a preventive treatment for cervical cancer, and is being marketed for girls beginning at around age 9-11. The vaccine is given in a series of three shots.

However, Gardasil also has been associated with serious adverse events, including more than 50 reports of deaths that may be linked to the vaccine. Additionally, the vaccine doesn’t last for more than five years, meaning that any potential benefit it might provide is likely to be inactive by the time the girl is old enough to be sexually active. HPV is a virus transmitted through sexual activity.

In fact, at the International Public Conference on Vaccination in 2008, the lead researcher in the development of the Gardasil vaccine, Dr. Diane Harper, stunned the assembled audience when she said the vaccine is unnecessary at best, and dangerous, at worst. She cited the risk of serious side effects as an argument against the drug, and instead recommended the proven protection against cervical cancer – regular Pap tests. She even called Gardasil “a great big public health experiment.”

Pap tests – often also called Pap smears – are effective because HPV is a slow-moving virus, which generally causes pre-cancerous lesions that may develop into cancer over time. A Pap test will detect these pre-cancerous cells, which can be treated.

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It’s a rhetorical question, but it makes you wonder if it’s somehow more permissible to be killed or injured by a drug than it is by a defective automobile.

Merck has lobbied federal regulators hard to make Gardasil mandatory for all American schoolgirls. Fortunately, the drug giant’s vision of requiring every girl in the nation to receive its three-tiered shot fell short of becoming law. Although many states require sixth-grade girls to receive the shot, parents have the legal right to refuse it. But very few of them know about the drug’s risks and how it has harmed and occasionally killed perfectly healthy girls.

According to the Washington Examiner, 20-year-old Mary Katherine Davison of Frederick, Maryland, became dizzy and nauseated after receiving her second Gardasil shot in January 2008. Although her two younger sisters had no reactions, Mary Katherine suffered a massive stroke and spent 2 months in rehab re-learning how to walk. Her mother, Mary Davison, said that she made no connection between her daughter’s stroke and Gardasil until Mary Katherine’s doctor refused to schedule her for the final Gardasil shot.

Days later, 17-year-old Jessica Ericzon of Alexandria Bay, New York, collapsed and died on the bathroom floor just 40 hours after receiving her third Gardasil shot. Jessica had complained of pain and dizziness after her second shot, but sadly nobody connected her symptoms to Garsdasil.

21-year-old Christina Tarsell of Sparks, Maryland, received her third Gardasil shot and spent more then 2 weeks feeling dizzy, nauseated and fatigued before she died.

“We had no clue that these were all symptoms of something,” her mother told the Washington Examiner. In all these cases, autopsies and toxicology screenings failed to determine the cause of death.

Naturally, Merck defends its Gardasil vaccine. The pharmaceutical giant also has a powerful ally in the CDC, which officially reported in 2008 that Gardasil recipients didn’t experience negative reactions any more than non-recipients.

That claim, however, was countered by the National Vaccine Information Center, which used the same CDC data to show that Gardasil was linked to “at least four times as many death and cardiac arrest reports” as Cervarix and “seemed to be associated with an unusually high number of reports of atypical collapse.”

“CDC is still saying this is a safe vaccine. With Pap smears, there was no medical reason for fast-tracking FDA approval. They made it (cervical cancer) sound like it was some kind of pandemic,” Christina Tarsell’s mother, Emily, told the Washington Examiner, adding that nobody from the CDC will respond to her calls.

Source: http://www.washingtonexaminer.com/opinion/columns/Time-for-the-truth-about-Gardasil-89466882.html

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

First, the vaccines are known to have serious risks. The threat of blood clots, seizure, paralysis, outbreak of warts, and sudden death has been documented in thousands of adverse event reports obtained by Judicial Watch under Freedom of Information law. The risks may be small for most of the women and girls who receive the vaccines (administered in a series of three shots), but they are nonetheless real.

Girls and women who are not sexually active are not at risk of contracting HPV. Merck lobbyists pushed to make the shots mandatory for all school girls as young as 9 years old. However, unless those 9-year-olds are sexually active, their chances of becoming infected with HPV and developing cervical cancer are zero.

Women who receive regular pap screenings are at minimal risk of developing cervical cancer because testing will detect precancers if they are present. Precancerous cells can be treated safely and effectively with traditional therapies to prevent the development of cancer.

The incidence of cervical cancer among women who do not receive screening or vaccination is about 90 per 100,000. According to Dr. Diane Harper, who is widely regarded as the top expert on HPV and the Gardasil vaccine, “the combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level.” That assertion contradicts the claims of some HPV vaccine advocates.

So who might HPV vaccines benefit? Sexually active women who don’t receive regular pap tests would benefit the most, but only if they are willing to assume the risk of being either injured by the vaccine or, in the rare event, killed. For the vast majority of women, the risks of receiving Gardasil or Cervarix vaccinations simply outweigh any benefits.

Sources:

http://www.infonews.co.nz/news.cfm?l=1&t=0&id=23815

http://www.stuff.co.nz/timaru-herald/news/3228514/Concerned-mum-sets-up-vaccine-site

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Pap smears are screening tests used by gynecologists to detect cervical cancer cells. Changes in the cell processes signal the development of cervical cancer and prompt the physician to start treatment.

According to Dr. Harper, “Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.”

“Gardasil is associated with serious adverse events, including death,” Dr. Harper explained. “If Gardasil is given to 11-year-olds, and the vaccine does not last at least 15 years, then there is no benefit – and only risk – for the young girl.”

Without boosters, Gardasil vaccines remain effective for five years.

“Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life,” Dr. Harper added.

Dr. Harper told Yerman in a written communication that she disagreed with Merck’s campaign to make the vaccine mandatory for school-age girls.

“The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value.”

The choice to receive the Gardasil vaccine “is entirely a personal value judgment,” Dr. Harper said.

When asked about Merck’s “one less” marketing campaign, Dr. Harper told Yerman that it “was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine.”

“If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being “one” and would not be “one less,” Dr. Harper told Yerman.

“She would not have been ‘one’ to begin with!”

To read the entire interview with Dr. Harper, please click here.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

As head of Merck’s $5 billion global vaccine arm, Dr. Gerberding will likely be responsible for revitalizing Gardasil’s waning sales. Merck won FDA approval for the vaccine in 2007 and immediately launched an aggressive campaign to make Gardasil shots mandatory for school girls as young as 11. However, the ambitious plan ultimately failed, thanks to the outcry of consumer and health advocates who challenged the vaccine’s safety profile.

Other critics say that the Gardasil vaccine is useless and that its risks exceed its benefits.

Dr. Charlotte Haug, the editor-in-chief of the Journal of the Norwegian Medical Association criticized Gardasil in an editorial published last month in the Journal of the American Medical Association (JAMA).

“Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened…”

Dr. Diane Harper, the lead researcher in HPV vaccine development, announced at a conference in October that she considered Gardasil a useless vaccine, and that Merck’s efforts in pushing the Gardasil vaccine amount to what she called “a great big public health experiment.”

Gardasil’s side effects include fainting, redness and inflammation at the vaccination site, dizziness, and fever. However, the most dangerous side effect reported so far has been an increase in the risk and rate of blood clots. According to JAMA, blood clots resulting from Gardasil may have caused 32 unconfirmed deaths so far.

Gardasil sales have been floundering recently, down 22 percent in the third quarter at $311 million.

Dr. Gerberding’s controversial tenure at the CDC was rife with allegations that she put party politics before science and public health, and that her strategic decisions crippled the agency’s ability to respond effectively to public health crises. In December 2005, five former CDC directors jointly wrote a letter to Dr. Gerberding, expressing alarm over the departure of key staff members and warning that her leadership jeopardized the agency’s ability to perform effectively.

If the concerns of the CDC’s former directors and leading scientists are valid, then Dr. Gerberding may be the right person to shore up Gardasil’s place in the drug market.

“As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck’s engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives,” Merck Chief Executive Officer Richard Clark said in a statement.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The directive went into effect in July of last year, mandating Gardasil shots for immigrant females despite mounting evidence that the shots could cause serious injury and death. The shots were also required of females who posed no risk of contracting or spreading HPV to the wider population.

In determining which vaccines immigrants are required to have, the CDC’s rule of thumb is that the vaccine must target viruses that could potentially cause an outbreak and viruses that either have been eliminated from the United States or are in the process of elimination. HPV does not fit any of the criteria.

Immigrants are still required to undergo a series of 15 other vaccinations before gaining U.S. resident status and citizenship. Neither federal health officials nor the pharmaceutical companies have tested the safety of vaccinations in combination. No research has been conducted on the interaction of Gardasil vaccines with other vaccines and what adverse effects such cocktails could have on the recipient.

Soon after the CDC added Gardasil to the list of required vaccines for immigrants, more than 100 advocacy groups representing women, immigrants, and consumer health challenged the requirement, protesting that it was unfair to require HPV vaccines for immigrants but not all U.S. citizens.

Merck had been lobbying hard to make the vaccines mandatory for all school-age American girls, but their plans were strongly opposed by an unlikely band of abstinence-only conservatives, Big Pharma critics, individual parents and parent groups, a growing anti-vaccine movement, and a number of consumer advocacy and women’s rights groups.

The 3-shot series costs between $300 and $1,000, putting a financial strain on immigrants already burdened by thousands of dollars in application fees and mandatory medical exams. Mandatory Gardasil vaccinations would have provided Merck with a revenue stream of at least $4 billion annually.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Although the committee did not press for the use of Gardasil in men, it did advise U.S. doctors to use the vaccine at their discretion. It also recommended that the shot be included in the federally funded Vaccines for Children program for boys 9 to 18 years old.

The FDA approved Gardasil on October 16 for use in preventing genital warts in males age 9 to 26. Men may carry HPV and never know about it unless it develops into warts, and even then there are no long-term effects. On the other hand, women infected with genital warts are at risk of developing cervical cancers.

Gardasil only protects against 4 strains of HPV that cause cancer and 2 strains that cause warts.

Vaccinating boys and men with Gardasil would primarily be done to reduce the number of females exposed to HPV. However, the serious risks that the Gardasil shots carry, combined with their steep cost – about $500 for a complete regimen – leave many health professionals and patients questioning whether the vaccines are worth it.

Since 2006, when the FDA approved Gardasil for use in females, more than 15,000 girls have reported adverse side effects to the FDA’s Vaccine Adverse Event Reporting System (VAERS). Reactions that have been officially reported include brain inflammation, seizures, blood clots, paralysis, lupus, Guilliane Barre Syndrome, and several others. 44 deaths attributed to the vaccine have been reported to the Centers for Disease Control and Prevention (CDC).

Merck, which stands to earn billions from the shots, maintains that the vaccine is safe and that the benefits outweigh the risks. But for thousands of girls and women injured by Gardasil, the vaccines were anything but harmless – a fact made more frustratingly tragic by the lead developer’s own admission that Gardasil is ineffective and unnecessary.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Preventative measures and current treatments are already lowering the occurrence of HPV and cervical cancer faster than the vaccination could, Dr. Harper said, explaining that the cervical cancer rate will be reduced more than 91 percent in 60 years time without the vaccination.

But Dr. Harper’s explanation of Gardasil’s uselessness wasn’t as eye-opening or alarming as some of her other allegations. In light of Merck’s aggressive lobbying efforts to make Gardasil mandatory for school-age girls, it’s especially upsetting that Dr. Harper told her audience that the manufacturer never conducted any safety or efficacy trials in girls under 15 years old and that vaccinating young girls en masse amounted to “a great big public health experiment.”

That Merck would develop an unnecessary vaccine, force it on the public, and then take a “wait and see” approach to gauge its safety is unconscionable. One can only imagine the dollar signs Merck’s leadership saw as they looked upon a whole nation of girls unvaccinated against HPV.

Any corporation like Merck that holds the health of millions in its grasp wields a staggering amount of power. It should upset the millions of American moms and dads that Merck regards their young daughters as guinea pigs – the unwitting subjects of a vaccination experiment destined to add billions more dollars to its corporate coffers. How many health professionals and medical organizations have been swayed by Merck’s political lobbying, financial rewards, misinformation and other abuses of that power?

A lot, I suspect. My younger sister has four daughters who range in age from 16 years to 2. When she takes her two oldest daughters for check ups, the pediatrician typically tells her she should have them vaccinated against HPV with injections of Gardasil. Most recently, the doctor pressured my sister to have her 11-year-old vaccinated.

Fortunately, my sister decided to research the vaccine before agreeing to the shots and has said no.

“It’s such a shame that companies are allowed to prey on kids like that,” my sister told me, adding that she is glad she has repeatedly told the doctors “no” to the shots in light of the news that they are dangerous and potentially deadly to some girls.

Since Gardasil first appeared in 2006, 15,037 inoculated girls have reported adverse side effects to the Vaccine Adverse Event Reporting System (VAERS). Reactions that have been officially reported include brain inflammation, seizures, blood clots, paralysis, lupus, Guilliane Barre Syndrome, and several others. 44 deaths attributed to the vaccine have been reported to the Centers for Disease Control and Prevention (CDC).

If what Dr. Harper says is true, then all 44 of those deaths were completely unnecessary. That even more women and girls will be sacrificed for Merck’s bottom line as Gardasil shots are unnecessarily doled out is nothing less than criminal.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site