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

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

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

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

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

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

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?

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