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

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

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

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

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

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.

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