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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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.

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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 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.

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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, 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.

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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.

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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.

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