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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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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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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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.

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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.

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

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.

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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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