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

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.

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

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.

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

Washington Examiner

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

Merck

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