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 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 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

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

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.

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

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.

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

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.

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

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