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

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The study was published in May 2007, about one year after Gardasil was approved by the U.S. Food and Drug Administration. The drug was approved for girls and young women, as protection against the human papillomavirus, or HPV, a sexually-transmitted virus linked to the development of cervical cancer. The 98 percent figure was tied to the drug’s effectiveness in “preventing changes in the cervix uses as a marker for cervical cancer,” according to a recent article by Discover Magazine blog writer Jeanne Lenzer, a medical investigative journalist.

Based in part on these claims of astounding success, the drug’s use was eventually expanded, and last month approved for use in boys and young men. The theory most popularly given for this is to increase protection for women. Protect young men from developing HPV, and you build in protection for their future partners. Not mentioned nearly as often, the FDA also cites benefits for men including protection against oral and anal cancers.

But is Gardasil really that effective?

Lenzer digs deeper into the initial study to uncover the bottom line. She notes that Merck only obtained 98 percent efficacy when “all real-world problems that arose were excluded from analysis.” This included patients who never received the full series of three shots, or perhaps patients who were vaccinated when they didn’t meet certain required criteria.

When results for all women in the study, not just the perfect cases, are analyzed, the efficacy rate is reported to be 44 percent. Still not bad. However, this number is then revealed to be tied only to those women who have one or both of the two strains of HPV that have been shown to be conclusively tied to cervical cancer, against which Gardasil protects.

Here’s where things really go off track. Lenzer reports that “when the researchers looked at negative cervical changes from any causes, they found that changes occurred in unvaccinated women at a rate of 1.5 events per 100 person-years, while vaccinated women had 1.3 events—dropping the benefit to 17 percent.”

Add into this the alarming number of serious adverse events reported by young women after receiving the vaccine – even deaths – and the risk to benefit ratio seems more than a little uneven. Even if adverse events have not been conclusively proven to be a result of the vaccine, there is a growing database of possible links.

The truth of the matter is that it is still too early to tell how well Gardail works in real-world conditions. It may be years yet before there is evidence of how well it works, or doesn’t work. And yet, already it is approved for an even broader distribution, now to boys and young men.

Shouldn’t we be more certain of the benefits – and the risks – before we line up our children for this vaccine?

Source:  Discover Magazine

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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

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In its official news release, SANE Vax reports that 100 percent of the 13 samples of Gardasil they had tested were contaminated with recombinant HPV DNA. They report the vials of the vaccine were pulled from different lots being marketed in the United States, Australia, New Zealand, Spain, France and Poland. The tests were conducted on Merck’s HPV 4 Quadrivalent vaccine, Gardasil. The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology lab.

The reason for the tests, which SANE Vax said it instigated at the request of medical consumers, was because consumers “are concerned that the recombinant DNA, if present, may have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations,” according to the release.

In her letter to FDA Commissioner Hamburg, Norma Erickson, president of SANE Vax, writes, “There is no doubt that the HPV DNA found in the vaccine represents an adventitious agent left over from the DNA recombinant manufacturing process with potential adverse impacts on health safety of those vaccinated. The recombinant DNA found in Gardasil is very tightly bound to aluminum hydroxyphosphate. When injected intramuscularly, this combination may function as a DNA vaccine with uncertain consequences.”

SANE Vax is requesting that the FDA investigate the possible extent of any HPV DNA contamination of Gardasil HPV vaccine currently on the market to ensure public safety.

Source: MarketWatch

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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.

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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 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

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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

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The approval expands the audience for the Merck & Col. manufactured drug to include all people – boys and girls – ages 9 through 26. Gardasil protects against four kinds of HPV – 6, 11, 16 and 18 – that cause up to 90 percent of anal cancer cases. Recently, Gardasil’s use was expanded to include prevention of vulvar and vaginal cancer in girls and young women, and for the prevention of genital warts in both males and females.

While the Gardasil vaccine is “recommended” by the FDA for the prevention of cervical cancer, it does not yet have that same approval for universal vaccination for males. The risk of anal cancer is higher for homosexual men who engage in sex with other men.

Approved in 2006 for the prevention of cervical cancer only, the Gardasil vaccine has since been linked to serious adverse events, including blood clots, autoimmune disorders and more than 30 reports of death following the injections. The vaccine is given in a series of three injections over a six-month period.

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

If the advisory panel finds there is sufficient clinical data to show that the vaccine would prevent anal lesions and anal cancer in men, it could advise that the FDA change the drug’s status to “recommended” for boys and young men as well.

According to a recent report on MSNBC.com, the recommendation could be controversial.  The use of this vaccine already has sparked a debate about whether or not its use suggests a “free pass” to young people to have sexual intercourse because they feel it protects them from disease. Adding to the controversy about the vaccine for boys, is whether or not to advocate the vaccine for all boys, or only those who have determined they are gay or bisexual.

Studies show the group most likely to benefit from the Gardasil vaccine among young men are those who have sex with other men. In this group, the vaccine has shown to be 78 percent effective at preventing anal lesions and anal cancer, MSNBC.com reports.  However, researchers wonder if a targeted vaccine would miss much of its intended audience because it is given at such a young age that a boy making the decision to be vaccinated – or his parents – would be unaware that he is gay. Also, experts think a targeted vaccine might not be effective because young men who do feel they are gay may avoid getting the vaccine because they think it may stigmatize them, exposing them to harassment or judgment.

On the other hand, physicians are hesitant to recommend the vaccine for all boys, when studies show it would be largely ineffective or unnecessary for the majority of boys who might receive it, who are at very small risk. According to U.S. News.com’s Health report, complications from HPV for young men are quite rare. “For the average guy,” the report states, “the virus lies silent, doesn’t cause problems, and clears in a year or two.”

The FDA is expected to make its decision whether or not to expand the marketing of Gardasil as “recommended” for boys by the end of the year. After that, the federal Advisory Committee on Immunization Practices (ACIP) will determine whether to issue its own public recommendation. That decision should occur around February 2011.

Sources: MSNBC.com; US News.com

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Gardasil, which was released by manufacturer Merck in 2006, has recently been approved for use by boys and young men, for the prevention of HPV linked to the development of genital warts and penile and anal cancers. To date, both Merck and the FDA have said the drug is safe and effective, and that its benefits outweigh the risks.

In the following video, Dr. Wheldon Chafe, a cervical cancer expert with the VCU Massey Cancer Center, discusses the FDA report with CBS 6 anchor Stephanie Rochon. He advises parents to talk with their pediatrician and carefully weigh the risks of the Gardasil vaccine prior to approving its use for their children. He says the increased numbers of adverse events reported linked to the drug are “alarming.”

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Last week, Judicial Watch, a government watchdog group, obtained reports from the U.S. Food & Drug Administration (FDA) that contain extensive new documentation of deaths and adverse events linked to the Gardasil vaccine. The FDA report documents incidents that occurred between May 2009 and September 2010. According to its website, Judicial Watch, Inc., is a “conservative, non-partisan educational foundation that promotes transparency, accountability and integrity in government, politics and the law.”

WTVR CBS-6 news in Richmond, Virginia, reported the new findings. According to the news story, among the adverse events reported, 789 were listed as “serious” and 213 cases involve permanent disability following the vaccine. Additionally, four of the 16 deaths reported were suicides.

Judicial Watch obtained the FDA documents through a Freedom of Information Act request. In a news release, Judicial Watch President Tom Fitton says “the FDA and other public health authorities may be asleep at the switch” when it comes to Gardasil. “To say Gardasil has a suspect safety record is a big understatement,” he says.

Since the release of Gardasil in 2006, both drug maker Merck and the FDA have insisted the drug is safe and effective, and that its benefits outweigh its risks. The drug recently has been approved for use in boys and young men, for the prevention of HPV and genital warts.

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

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.

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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?

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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