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

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

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

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

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

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

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

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

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

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