Gardasil

FDA Expands Gardasil to Include Adults Up to Age 45

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The US Food and Drug Administration (FDA) has approved a supplemental application for Merck’s 9-valent human papillomavirus vaccine (Gardasil 9) to include women and men aged 27 through 45 years.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release.

“The Centers for Disease Control and Prevention [CDC] has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing,” Marks noted.

The CDC estimates that every year about 14 million Americans become infected with HPV. About 12,000 women are diagnosed with cervical cancer and about 4000 women die from cervical cancer caused by certain HPV viruses. HPV is also associated with several other forms of cancer affecting men and women.

Gardasil, which was first approved by the FDA in 2006 to prevent certain cancers and diseases caused by HPV types 6, 11, 16, and 18, is no longer distributed in the United States.

In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil as well as five additional types (31, 33, 45, 52, and 58). Gardasil 9 was first approved for use in males and females aged 9 through 26 years.

According to the FDA, in a study in roughly 3200 women aged between 27 and 45 years followed for an average of 3.5 years, Gardasil was 88% effective in preventing the combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

“The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study,” the FDA said.

“Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months,” the agency said.

The safety of Gardasil 9 was evaluated in a total of about 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.

The FDA granted the Gardasil 9 application priority review status, a program that facilitates and expedites the review of medical products that address a serious or life-threatening condition.

Cancer doctors leading campaign to boost use of HPV vaccine

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Certified medical assistant Karla Huerta holds vials of the HPV vaccination drug Gardasil at Amistad Community Health Center in Corpus Christi, Texas.

The nation’s leading cancer doctors are pushing pediatricians and other providers to help increase use of the HPV vaccine, which studies show could help avert tens of thousands of cancer cases during young Americans’ lives. Yet a decade after its controversial introduction, the vaccine remains stubbornly underused even as some of those diseases surge.

The vaccine’s low uptake among preteens and adolescents belies its universally acknowledged effectiveness in preventing the most common sexually transmitted infections linked to the human papillomavirus. Those infections can cause a half-dozen cancers, including more than 90 percent of anal and cervical cancers; 70 percent of vaginal, vulvar and oropharyngeal, or middle throat, cancers; and 60 percent of penile cancers.

The oncologists’ goal is to rebrand the vaccine to focus on cancer prevention. They are determined to dismantle what researchers say is the No. 1 obstacle to wider inoculation: pediatricians and family doctors who aren’t strongly recommending the vaccine.

We have a vaccine for certain cancers. Why don’t more people get it?

Studies show that a forceful endorsement from a physician is the most important factor in whether children get the vaccine, which is recommended for ages 11 and 12. Yet a frustrating level of “provider hesitancy” persists.

“The failure belongs to us,” acknowledged Jason Terk, a pediatrician in Keller, Tex. “It’s an epic fail.”

Terk has been working with experts at MD Anderson Cancer Center in Houston to spread the word. Lois Ramondetta, one of the hospital’s gynecologic oncologists, has taken to the road to meet with practitioners across the state.

Last month, she delivered a blunt message to the staff of Su Clinica in Harlingen, deep in the state’s south valley: If they didn’t increase HPV vaccination of their young patients, those youths would face a greater risk of developing deadly cancers as adults. Boys would be especially vulnerable to throat cancers, a growing scourge of middle-aged men.

“If you are not recommending the vaccine, you are not doing your job,” Ramondetta said. “It’s the equivalent of having patients in their 50s and not recommending a colonoscopy — and then having them come back with cancer.”

 

For Su Clinica’s doctors, the candid discussion hit home and quickly prompted changes in some procedures. Gynecologist Rose Gowen said many of the staff were especially surprised by the urgent need to vaccinate boys.

Ramondetta understands why the challenges are so pervasive. “Pediatricians never see the cancers caused by HPV, so some of them don’t recognize the vaccine’s importance in preventing cancer,” she said. “They don’t know how to talk about it with patients, or they wait too long. And their knowledge level is not where it should be.”

While the HPV vaccination rate varies widely from state to state, it has ticked up nationally over the past few years. Yet the latest statistics from the Centers for Disease Control and Prevention show that in 2014, 40 percent of teenage girls and 22 percent of boys had gotten all three doses. That’s far below the 80 percent to 90 percent rate for the vaccine booster for tetanus, diphtheria and pertussis — as well as for the shot to prevent meningitis — that most states require for middle-schoolers.

The 64,000-member American Academy of Pediatrics has urged members to use the vaccine. But Cleveland pediatrician Margaret Stager, who works on adolescent health issues for the organization, said it remains “brand-new territory” for many doctors, especially older physicians.

“They have seen whooping cough, meningitis, measles and mumps and have real-life evidence of the power of vaccines to save lives,” she said. “Now we have a whole new fundamental concept, because this vaccine is trying to prevent cancer several decades from now.”

A 2014 U.S. study, for example, projected that nearly 29,000 additional cases of cervical cancer would be averted over young girls’ lifetimes with a vaccination rate of 80 percent compared with 50 percent. Cancer doctors hope that pressing the case with such statistics can provide reinforcement for public health officials at the CDC and in state and local governments, as well as for the other medical groups encouraging doctors and parents.


Medical assistant Karla Huerta prepares to give HPV vaccinations to children at the Community Health Center in Corpus Christi, Tex.

Much of their current activity dates to 2013 when the President’s Cancer Panel, alarmed by how the HPV vaccination rate was leveling out, called for a drastic acceleration. The National Cancer Institute funded several efforts to identify barriers to vaccination, and earlier this year, all 69 NCI-designated cancer centers issued a first-of-its kind consensus statement saying the HPV vaccine was “tragically underused” and calling on doctors to strongly recommend it. The American Society of Clinical Oncology followed with a similar statement.

Cancer doctors have been reaching out to primary-care physicians and consumers throughout the country. Jennifer Young Pierce, a gynecologic oncologist at the Medical University of South Carolina, has held town halls around her state to talk up the vaccine. In Upstate New York, doctors at the Roswell Park Cancer Institute are taking part in a regional vaccine coalition and have met with local dentists and legislators interested in promoting HPV vaccination.

Meanwhile, the NCI is planning a large clinical trial to determine whether a single dose would be as effective as the current regimen. That could sharply accelerate utilization, especially in developing countries, where cervical cancer is among the deadliest cancers.

“We’re doing this to help the women of the world,” said NCI acting director Douglas Lowy, who was instrumental in discoveries that paved the way for the vaccine.

About 79 million Americans are infected with HPV, and 14 million become newly infected each year. While the body’s immune system clears most of the infections, high-risk strains are directly linked to 27,000 new cancers a year.

The vaccine is recommended for preteens because their bodies have the most robust responses, and it works best before sexual activity begins. (Intercourse isn’t necessary to contract HPV.) In 2006, the vaccine was first approved as Gardasil for girls, followed a few years later for boys, amid controversy that has never completely dissipated. Critics questioned the safety of the vaccine, made by Merck, and said it would encourage teenagers to be promiscuous — concerns that research has shown to be unfounded.

Ruth Marroquin, 13, looks away as she is vaccinated against HPV. (Matthew Busch for The Washington Post)

Unlike other childhood shots, the one for HPV isn’t required by most states; only Virginia, Rhode Island and the District have mandates. The vaccination rate varies sharply across the country, with relatively high rates in the Northeast and California and lower rates in the South.

Yet the vaccine is having an impact overall. A CDC study published earlier this year showed that the prevalence of the virus was reduced by almost two-thirds among teenage girls, compared with the years before the vaccine became available.

And this month, Merck announced that a review of 58 studies published in the last decade in North America, Europe, Australia and New Zealand found that vaccination sharply reduced cervical pre-
cancers and genital warts.

As for side effects, the most common are swelling and pain at the injection site, with occasional fainting. Several large studies over the past decade have more than proved the vaccine’s safety, the CDC says

 

But the concerns of some parents still aren’t assuaged. Aimee Gardiner, who is leading a group to repeal the Rhode Island mandate, said she won’t have her children inoculated. “I don’t think the risks of HPV are high enough to warrant getting the vaccine,” she said.

Similarly, the National Vaccine Information Center, an advocacy group founded by parents who opposed routine childhood inoculations, continues to raise questions about the research behind the HPV vaccine and its safety.

But in many cases, the chief obstacle is physician ambivalence more than parental opposition. Researchers at Harvard Medical School and the University of North Carolina reported last fall that an online survey of 776 doctors showed that many talked about HPV vaccination in a way likely to discourage parents. More than a quarter of the doctors said they didn’t strongly endorse the vaccine and a similar proportion didn’t recommend it for preteens.


Abraham Vidaurre, 12, checks his arm after receiving the HPV vaccine.

In Texas, Terk says he advises fellow pediatricians to recommend the shots in a matter-of-fact manner, to “bundle it” with other inoculations and to avoid talking about sex unless asked. “If you approach it in a confident, presumptive way, many parents will say, ‘Let’s do it,’ ” he said.

The HPV vaccine has a fraught history in Texas. In 2007, Republican Rick Perry became the nation’s first governor to require girls to get the vaccine, which caused a firestorm in part because of his close relationship with a former chief of staff who was a lobbyist for Merck. The Legislature overturned the mandate.

MD Anderson has been leading a major HPV initiative since 2014 that involves other cancer centers, pediatricians, nurses and school officials. During a meeting last summer, 69-year-old Michael Terry described his struggle with HPV-related throat cancer, saying, “You need to know how miserable it is to suffer from this disease.”

Terry, whose father was Luther Terry, the 1960s-era U.S. surgeon general who issued a landmark report about the dangers of tobacco, talked about undergoing surgery, chemotherapy and radiation and about living with splitting headaches, neck aches and difficulties swallowing. His concluding plea: “Vaccinate, vaccinate, vaccinate, boys and girls.”

 

In the fall, pediatrician Lori Anderson took a couple of pediatric residents from her community health clinic in Corpus Christi to hear Ramondetta speak at a Texas Pediatric Society meeting. The oncologist showed an emotionally wrenching documentary about cervical cancer called “Someone You Love.” When the lights went up, some of the doctors were in tears.

“I think it was an ‘aha moment’ for the residents,” Anderson said. With her help, they organized a recent school health fair in the beach community of Port Aransas.

Two dozen children got vaccinated against HPV.


Pediatrician Lori Anderson speaks with Angel Garcia, 11, left, April Garcia, 13, Guadalupe Salgado, 13, and Favian Garcia, 7, after Angel and Guadalupe got HPV vaccinations at Amistad Community Health Center in Corpus Christi, Tex. Anderson has been spearheading an effort to have more local children inoculated against the virus.

Young woman’s ovaries destroyed by Gardasil: Merck ‘forgot to research’ effects of vaccine on female reproduction.

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A newly-published study has revealed that Merck & Co., the corporate mastermind behind the infamous Gardasil vaccine for human papillomavirus (HPV), conveniently forgot to research the effects of this deadly vaccine on women’s reproductive systems. And at least one young woman, in this case from Australia, bore the brunt of this inexcusable failure after discovering that her own ovaries had been completely destroyed as a result of getting the vaccine.

Published in the peer-reviewed British Medical Journal (BMJ), the harrowing recount of this young 16-year-old girl’s experience should give pause to all parents currently being pressured by their doctors into having their young daughters jabbed with Gardasil. Robbed of her natural ability to experience full womanhood, this young woman experienced early menopause, in which her ovaries completely shut down before they were even able to fully develop.

Entitled Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination, this latest case study provides solid evidence that Gardasil is, at the very least, a serious threat to normal ovarian function. Not only was the damaged girl examined and verified to have had healthy ovaries prior to the shots, but there were no other identified factors besides Gardasil that could have possibly been involved in her sudden ill-fate.

Worse is the fact that information later obtained from the Australian Therapeutic Goods Administration (TGA) for the case — TGA is Australia’s equivalent of the Food and Drug Administration (FDA) in the U.S. — revealed that Merck had never even conducted safety testing on Gardasil in relation to its effects on women’s ovaries. According to the report, Merck had only tested Gardasil’s effects on male testes.

“Although the TGA’s Australian Public Assessment Report for Human Papillomavirus Quadrivalent Vaccine, February 2011, does report on the histology of vaccinated rat testes and epididymides, no histological report has been available for vaccinated rat ovaries,” explains the report. “[A] histological report of the ovaries of vaccinated rats remained unavailable beyond a numbering of the corpora lutea present at postweaning euthanasia following the first litter.”

In other words, Merck either intentionally or accidentally — either option is completely unacceptable, by the way — failed to check whether or not Gardasil has the potential to damage young women’s reproductive systems, even though young women have always been the primary target market for the vaccine. Only recently have young boys been pulled into the Gardasil fray, despite the fact that the long-term side effects of the vaccine in males is still largely unknown.

Gardasil loaded with additives known to damage female reproduction

As reported by investigative journalist Heidi Stevenson, there are at least two additive ingredients in Gardasil that may be responsible for damaging women’s ovaries. These ingredients are polysorbate 80, an emulsifying preservative, and L-histidine, a natural amino acid. Both of these ingredients are, of course, used in processed foods, which millions of people consume every day. But injecting them into the body has a much different biological effect than simply consuming them.

As it turns out, polysorbate 80, which also goes by the names Tween 80, Alkest, and Canarcel, has been shown in studies to damage female reproduction. Not only does this chemical additive greatly accelerate sexual maturation in women, but it also tends to reduce the weight and function of both the ovaries and the uterus. Similarly, L-histidine, when injected into muscle tissue, can cause the body to develop an autoimmune response to the natural substance, which can lead to many of the serious side effects being observed in many young girls who have been jabbed with Gardasil.

Be sure to read the following two reports by Heidi Stevenson to learn more about how Gardasil appears to damage female reproduction:
http://www.thelibertybeacon.com
http://gaia-health.com
Gardasil

Gardasil Researcher Speaks Out

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Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing.
Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved.Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years.

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. “The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program.”

“The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade’s article, as they are based on a denominator of doses distributed from Merck’s warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade’s work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information,” said Harper.

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks – “small but real” – could occur more often than the cervical cancer itself would.

“Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade’s work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil.”

She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. “The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers – something never stated, but often inferred by many in the population– a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably.”

CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.

Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”

Gardasil for Boys? The American Cancer Society Doubles Down, for No good reason.

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the ACS Board of Directors recently voted to make prevention of HPV-associated cancers through increased vaccination a nationwide priority for the organization. The ACS convened and leads the National HPV Vaccination Roundtable, a national coalition of over 70 organizations working together to prevent HPV-associated cancers and precancers by increasing and sustaining US HPV vaccination.”

shamrock

— Human Papillomavirus Vaccination Guideline Update: American Cancer Society Guideline Endorsement 

The American Cancer Society (ACS) has recently doubled down on its endorsement of the HPV vaccine (Gardasil 9) for boys and girls aged 9 through 26, according to a recent press release. This amendment to their policy is in response to the December 2015  Advisory Committee on Immunization Practices’ (ACIP) recommendation for Gardasil 9. The ACS press release appears to promote the vaccine without stating the risks, the side effects, the contraindications, or the risk that getting the vaccine can potentially progress an existing HPV infection and and cause cancer if left untreated.

CDC poster boys

I contacted the ACS for comment, and I was directed to a footnote citation aimed at clinicians which details the reasons behind their policy update. However, contraindications were not discussed anywhere in this document, and they punted safety issues to the ACIP and CDC (page 6). Also, nowhere does the press release state that pap tests, the only measure proven thus far to reduce the incidence of cervical cancer, will continue to be necessary. When I asked why that was, I was told that that information is contained elsewhere on their website. When I asked why Gardasil 9 was being recommended for boys when no new data was available, I was referred to the above-mentioned clinicians’ report, which incredibly concludes (page 21) that “At this time, there is a lack of direct evidence of efficacy for cancer or pre-cancer prevention in average-risk men . . . .” Confused? More on that later on.

Ultimately, the ACS recommendation fails to advise the public adequately with the unbiased, independent information on cervical, throat, penile, and anal cancers contained on its own website. I’m not saying there is a conflict of interest when a nonprofit supposedly dedicated to health endorses a product made by their very generous corporate donor (Merck), but I might be implying it.

One could be forgiven for not knowing which way to turn when it comes to advice on whether or not to vaccinate your 11-year-old boys and girls with Gardasil. Previously, the vaccine had been heavily marketed to girls for prevention of cervical cancer. However, the narrative has been changing over the years, with a seeming exponential explosion in the number of cancers that HPV is associated with — cancers of the vagina, vulva, penis, anus, rectum, and throat, and now the more general “head and neck” cancers, which doesn’t have the obvious connection with the sexually transmitted nature of HPV infection. As in the ACS press release, we are now hearing the vaccine referred to simply as the “HPV vaccine.” It seems to have been completely rebranded, topped off with the most offensive, egregious TV ad I have ever seen, to ensure that the kids get the message. The fear mongering is at an all-time high for a condition which clears spontaneously, without symptoms, in most people. It’s as if we have all forgotten that HPV is a sexually transmitted infection with no symptoms in over 90% of cases and rarely leads to cancer.

CDC poster boys

CDC poster boys

So why vaccinate the boys? The reasons given for vaccinating boys vary depending on the source and the marketing tactics used. To ease us into it in 2010 — because, remember, boys don’t have a cervix — we were told it was because of the risk of genital warts (apparently there is a new case every minute!). During the Gardasil trials, the vaccine was never shown to prevent genital warts in men or boys; it was an endpoint in an uncontrolled clinical trial in women aged 27-45 (page 14). Based on this, an assumption was made about efficacy in boys, which I guess could be valid, but it is an assumption.

Merck then sponsored a study, Protocol 020, which was presented to the FDA in 2011 to argue that the vaccine be licensed for men who have sex with men, where genital wartswas an endpoint. Merck planned a “long-term extension study” to follow the men for 10 years, but it was without a placebo control, which experts deemed was necessary to conclude effectiveness, safety, and immunogenicity of the vaccine. What is interesting about this study is, it also attempted (but failed) to show efficacy against pre-cancerous anal lesions. More on that in a moment.

We were then told that Gardasil could be used to prevent many penile, anal, and throat cancers. I think Merck’s marketing people were getting brave and decided we could handle casually mentioning “penile” and “anal” cancer as if we’ve always been worried about them — just so long as no one mentions the uncomfortable fact that the most at-risk population for these cancers is the gay and bisexual population. However, just like genital warts, Gardasil has not been demonstrated to prevent penile, anal, or throat cancer. In fact, a quick control-F on Gardasil 9’s package insert does not even come up with the word “throat.” I’m not sure why ENT doctors all over the country are collectively losing their minds over this vaccine and pushing to mandate it, hoping it will reduce incidence of throat cancer. Is smoking all of a sudden off the hook? There are many recent studies citing HPV 16 as a possible suspect in throat cancer, but it’s not the overriding culprit in 80% of cases per this large international study. However, in this study, conducted by a Sanofi-Pasteur MSD (European distributor of Gardasil) consultant, the results were quite different and showed a large number of head and neck cancers relating to HPV. It should be noted that neither study has said that a vaccine can prevent throat cancer, and only the latter mentioned that it was theoretically possible.

Next we see that any claim about prevention of penile cancer was eliminated following the original trials for Gardasil when Merck admitted in the original package insert (Page 16) that the results were statistically insignificant:

Efficacy against penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3 or penile/perineal/perianal cancer was not demonstrated as the number of cases was too limited to reach statistical significance.

Just like “throat,” the word “penile” is not even mentioned in Gardasil 9’s package insert. Why is penile cancer even mentioned by doctors with regard to this vaccine, especially given the average age of penile cancer diagnosis is 65? There are only 2,000 cases a year in the U.S., only about half of which are associated with HPV infection, with an 85% survival rate. This is hardly something 11-year-old boys and their parents should be worried about.

Finally, let’s look at anal cancer, for which the average age of diagnosis is mid-60s. The (composite) endpoint used in the trials for anal cancer was stage 1, 2, or 3 of Anal Intraepithelial Neoplasia in a cohort of 200 16-26 year old boys and men in an uncontrolled clinical trial (Protocol 020), i.e. the placebo was not saline or an inert substance, it was the adjuvant and vaccine excipients (page 13). The efficacy came out at around 75% for the quadrivalent vaccine. According to Medscape, Dr. Diane Harper noted that of the five cases of AIN lesions reported in Protocol 020, only two were possibly carcinogenic and three were not. However, combining the results is how investigators arrived at statistical significance and were able to report a positive finding.

Furthermore, buried in the Gardasil 9 package insert, we see that Merck could find no association with incidence in the other five HPV types in the vaccine, rendering the “upgrade” to Gardasil 9 unnecessary: “Efficacy of GARDASIL 9 against anal lesions caused by HPV Types 31, 33, 45, 52, and 58 was not assessed due to low incidence.”

American Cancer Society Logo (PRNewsFoto/Live Nation Entertainment)

In this press-release-disguised-Gardasil-commercial, the ACS also claims that “Studies now show that vaccination in males is effective in preventing HPV infection. New evidence has also allowed the ACS to make recommendations for vaccination through age 26.” There are two problems with this statement, for which there was no footnote citation:

One, I know of no such “new evidence” of safety or efficacy for males beyond the paltry uncontrolled clinical trials I have described above, none of which focused on safety beyond the 14-day follow-up period. The ACS did cite 10 studies in its addendum for clinicians at the bottom of the press release but it’s a few clicks in and you really need to know what you’re looking for. The studies they rely on to base their recommendations can be found on page 13 here, which are all Merck-funded and show no new data.

Second, if the ACS is now recommending that the vaccine be given to an age group which is sexually active, then people in that age group should know that Gardasil vaccination might increase their risk of developing cancer should they already have an HPV infection of the type they were vaccinated for. Merck showed this “negative efficacy” (a 44.6% increase in pre-canercous lesions in women who received the vaccine; men were not studied, but if we can assume prevention of genital warts based on the women’s result then why not assume increase in cancer risk based on the women’s result?), in Protocol 013 in the original trials (table 17, page 13).

When I asked the ACS why they did not raise the alarm on the outcome of study Protocol 013 when universally recommending the vaccine for everyone up to the age of 26, they merely quoted the Center for Biologics Evaluation and Research’s (CBER) assessment (which I provided to them) on page 14 that stated

This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case it appeared that subjects in this subgroup of study 013 who received GardasilTM might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. (emphases mine)

The key word here is “might.” What does that mean? It “might” mean that they are presuming that some risk factors present contributed to the progression of the infection. And what exactly are those risk factors? Arguably, the very ones that exist in the real world: smoking, a history of STDs, and an irregular pap smear test, which makes complete sense and should not be disregarded! When a package insert lists ingredients as “approximate” and words like “might” are used to explain away a highly significant safety signal, I have a hard time believing that the proper testing and controls that should be in place for such a complex medical product as this one, actually are.

The ACS should also be asking, since Gardasil only has four HPV types, how is Merck allowed to say that Gardasil 9 can protect against the additional five strains they claim lead to more cancer in males? In fact, they can’t say this at all. In the package insert, buried on page 14, Merck admits that during the uncontrolled studies they conducted

The effectiveness of GARDASIL 9 in girls and boys 9 through 15 years old and in boys and men 16 through 26 years old was inferred based on a comparison of type-specific antibody GMTs to those of 16 through 26-year-old girls and women following vaccination with GARDASIL 9.

For all endpoints, the efficacy against the HPV Types 31, 33, 45, 52 and 58 in GARDASIL 9 was evaluated compared with GARDASIL. Efficacy of GARDASIL 9 against anal lesions caused by HPV Types 31, 33, 45, 52, and 58 was not assessed due to low incidence. Effectiveness of GARDASIL 9 against anal lesions was inferred from the efficacy of GARDASIL against anal lesions caused by HPV types 6, 11, 16 and 18 in men and antibody responses elicited by GARDASIL 9 against the HPV types covered by the vaccine. (emphases mine)

However, the ACS did provide some additional information based on a review of Pubmed research they performed to find support for endorsing this vaccine for boys. Incredibly they admit that they found no evidence it would be effective in preventing cancer in boys at all, which leaves us scratching our heads. In the supporting citation, under “Discussion,”paragraph 9, linked (buried) in its press release it states:

For average-risk men (excluding men who have sex with men and immunocompromised/HIV-positive men), there is no direct evidence of efficacy for cancer or precancer prevention because of the small number of disease outcomes. There is also no evidence for prevention of oropharyngeal cancers in males or females; however, there is limited evidence of prevention of oral HPV infection. (emphases mine)

In fact, in addition to the assumed but not demonstrated prevention of rare cancers in males, the only reason the ACS can come up with to vaccinate the boys is to support “herd immunity” which “may” provide protection for girls:

“Modeling results suggest that vaccination of males, through herd immunity, may provide additional protection to females in addition to providing protection against HPV-associated cancers in males.” (emphases mine)

And is vaccinating their boys to possibly protect girls the reason why parents are agreeing to give this vaccine to their children? Shouldn’t the ACS and doctors be telling parents that they are putting their 11-year-old boys at risk of vaccine injury in order to protect a girl they have not yet met or had sex with at some point possibly in the future? But given the tone of the new TV ad, that’s not what they’re saying, is it?

“Did you know, Mom? Dad?”

“Did you know, Mom? Dad?”

If “herd immunity” existed in the female population then there would be no need to vaccinate heterosexual boys to protect them. The problem arises when there is only 30% uptake in girls and 18% in boys, as we currently have in the US. However, this type of narrative provides a dangerous argument for mandating this vaccine for 11 and 12-year-olds, something that will be a disaster for every state that implements such a law. It would put thousands of children in harm’s way for a perceived, unproven benefit, decades into the future, based on incomplete studies which are without proper inert placebo controls.

Incredibly, the American Cancer Society has chosen to promote a vaccine for boys, without demonstrating a benefit for any but a very small minority of the population. It’s hard to imagine why universal vaccination is the preferred path over pap tests (for women) and better sexual health education (for all), considering the magnitude of the possible risks and the groundswell of resistance that exists in the public mindset as regards this vaccine. And we haven’t even discussed the cost. Why are doctors not listening? Well, to answer that I would have to go all conspiracy-nut on you, so I won’t.

Welcome to a world where parents are losing their right to make these important medical decisions for their children. Welcome to the era of vaccine mandates and pharmaceutical dominance over our government, where conflicts of interest are now the norm. Welcome to an incredible new vaccine paradigm where doctors and the trusted American Cancer Society will tell you a vaccine prevents cancer, even when the manufacturer has never shown that it does.

Lead Gardasil developer clears conscience, admits vaccine is useless and deadly

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The original reporter who covered Dr. Harper’s presentations both in 2007 and 2009 claims Dr. Harper’s statements about being able to “sleep at night” have been taken out of context. According to this reporter, Dr. Harper expressed serious concerns about Gardasil and Cervarix being mandated because of their many potential side effects, but did not actually “come clean” about the dangers and uselessness of the vaccines at these two particular events. Dr. Harper did, however, admit that it would take 60 years of vaccinating every single young girl in the U.S. to even make “an iota of difference” with regards to the cervical cancer rate, which suggests that the vaccine is, indeed, useless, just as we reported here.

Additionally, Dr. Harper’s statements as quoted by Sharyl Attkisson over at CBS News, which we also referenced in this article, substantiate Dr. Harper’s position, at least at one time, that HPV vaccines are both dangerous and useless, just as we reported here. Based on these statements made by Dr. Harper, she did, indeed, come clean about the fraud that is HPV vaccines. You can review Dr. Harper’s statements, as quoted by Sharyl Attkisson, here:
http://www.cbsnews.com/2100-500690_162-52534…

never “cleared her conscience” about the dangers of Gardasil and Cervarix, nor did she admit that either vaccine was more dangerous than the conditions they are claimed to prevent. This same reporter admits that Dr. Harper did, however, make some powerful admissions that suggest both Gardasil and Cervarix are, indeed, dangerous and not worth getting. Corrections made throughout this piece are italicized and preceded by an asterisk.

Health news

Did you know that one of the lead researchers involved with developing the two available vaccines for human papillomavirus (HPV), Gardasil (Merck & Co.) and Cervarix (GlaxoSmithKline), admitted back in 2009 that the jabs are essentially useless and more dangerous than the very conditions they are hailed as preventing and treating?

Before the vaccine industry apparently convinced her to change her story — you can read more about the saga here — Dr. Diane Harper, a key developer of Gardasil, is on the record as having cleared her conscience about this fraudulent vaccine, which has been shown to be both ineffective and dangerous.

One particular quote, which was pulled up using the Way Back Machine, reveals both Gardasil and Cervarix do nothing to prevent cervical cancer, which is their primary claim to fame. A 2009 article published by CBS News, in fact, which is still available online, reveals the truth about these snake oil vaccines.

“The rate of serious adverse events (from Gardasil) is on par with the death rate of cervical cancer,” admitted Dr. Harper at that time, refuting a pro-Gardasil piece published by Slate. “Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year.”

Dr. Harper went on to admit that deaths from Gardasil have been underreported by the U.S. Centers for Disease Control and Prevention (CDC), which has given the illusion that the vaccine is somehow safe. Beyond this, Dr. Harper dropped a bomb when she told reporters that the public health benefit of getting vaccinated with Gardasil “is nothing,” adding that the vaccine has led to “no reduction in cervical cancers.”

This admission by Dr. Harper rocked the conventional medical system, which has repeatedly lied to the public with claims that getting vaccinated for HPV will prevent the most common forms of cervical cancer. Because of these lies, literally millions of young girls and now boys, some as young as nine years old, have received the deadly jab since it was first introduced back in 2006.

Beyond this, Dr. Harper is on the record as having told attendees of the 4th International Public Conference on Vaccination back in 2009 that the vast majority of HPV infections resolve themselves on their own within a year, and nearly all of them within two years. She also admitted that an extremely small number of people experience symptoms from infection.

Dr. Harper suddenly retracts statements, claims they were made up

But not long after clearing her conscience on this important issue so that she could sleep at night, Dr. Harper basically retracted all of her statements, claiming that media reports citing them were made up. What? The vaccine industry or some other power apparently got to Dr. Harper and convinced her to change her story — either that or she is schizophrenic.

In any case, the truth about Gardasil and its counterpart Cervarix has been revealed, and still nothing has been done to pull the vaccine from the market. States like California and Michigan are actually administering these two vaccines to some children without parental consent, and many other states are “mandating” it for students who enroll in public school.

Meanwhile, there are many natural, homeopathic-based remedies that actually work to prevent diseases like HPV that are being ignored by the medical system.

Learn more: http://www.naturalnews.com/041644_Gardasil_vaccination_scam_HPV_vaccine.html#ixzz3w6W5GWx8

Merck’s Former Doctor Predicts Gardasil To Become The Greatest Medical Scandal Of All Time

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dr-bernard-dalbergue
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine” –(source) Marica Angell. She is a physician and author, along with being the first woman to serve as editor-in-chief of The New England Journal of Medicine – regarded as one of the most prestigious peer-reviewed medical journals in the world.

Since the Food and Drug Administration (FDA) approved Merck & Co.’s Gardasil vaccine in 2006, it has been surrounded by tremendous amounts of information, controversy and misinformation. This controversy has garnered much attention as people become more aware of the importance of paying attention to what goes into their bodies. It’s imperative that one examines a large body of evidence before believing what is seen on TV or stated on a radio advertisement, and people are slowly starting to wake up to this fact.

“It is a vaccine that’s been highly marketed, the benefits are over-hyped, and the dangers are underestimated.” –  (Taken from the ONE MORE GIRL DOCUMENTARY) – Dr. Chris Shaw, Professor at the University of British Columbia, in the department of Neuroscience, Ophthalmology, and Visual Sciences.

Gardasil, also known as the Human papilloma virus (HPV) vaccine, is given as a series of three shots over 6 months to protect against HPV infection and its associated health problems. Two vaccines (Cervarix and Gardasil) are said to protect against cervical cancers in women. Gardasil is also said to protect against genital warts and cancers of the anus, vagina and vulva. Both vaccines are available for females, while only Gardasil is available for males.

The Centers For Disease Control (CDC) claims that the HPV vaccine offers the best protection to girls and boys who receive all three vaccine doses and have time to develop an immune response before being sexually active.  This is why it is recommended for children who have reached the age of 11 or 12.

There is a long list of educated people speaking out about this vaccine. This time around, it’s Dr. Bernard Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck who has started to raise his voice against the HPV vaccine, along with the pharmaceutical industry as a whole. He joins a long list of experts from within the industry who have slammed the rampant manipulation and control of clinical research done by the pharmaceutical industry.

This quote is taken from an interview that happened in April of 2014, from an issue of the French magazine Principes de Santé (Health Principles):

“The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless.  Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.I predict that Gardasil will become the greatest medical scandal of all time because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers. Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it! Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine.” (source) – Dr. Bernard Dalbergue

Dr. Dalbergue has also recently released a book titled “Omerta dans les labos pharmaceutiques: Confessions d’un medicine,” which goes into more detail about corruption in the medical/pharmaceutical industry. He also recently made an appearance on a popular radio show in France, you can watch here. Althought it’s in French, it’s nice to put a face to the name so that you can see he is real.

Scandal, misinformation, and data manipulation have become part and parcel of clinical research and pharmaceutical drug development. It is important that we realize this as fact and not hearsay; apart from whistle-blowers, there are numerous documents that illustrate this reality. One of the best examples (out of many) comes from Lucija Tomljenovic, PhD, from the Neural Dynamics Research Group in the Department of Ophthalmology and Visual Sciences at the University of British Columbia. In 2011 she obtained documents which reveal that vaccine manufacturers, pharmaceutical companies, and health authorities have known about the multiple dangers associated with vaccines but have chosen to withhold them from the public. The documents were obtained from the UK Department of Health (DH) and the Joint Committee on Vaccination and Immunization (JCVI), who advise the Secretaries of State for Health in the UK about diseases preventable through immunizations.

Another doctor making noise regarding the HPV vaccine is Dr. Diane Harper. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published papers about it. She has been a paid speaker and consultant to Merck. It’s very unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved, it is a credit to her character for doing so. It also says a lot that she agreed to participate in the ONE MORE GIRL documentary, which implies (I believe) there is a chance she resonates with the other information that’s stated in the documentary that she has not said publicly.

ONE MORE GIRL is an answer to Merck & Co’s One Less Girl marketing campaign for the HPV vaccine Gardasil. The parents who encouraged their daughters to get the HPV vaccine did so on the advice of their doctors, their government, and their belief in pharmaceutical industry. They were not “anti-vaccine,” they played by the rules, and now they are paying the price. It’s a documentary that has several experts from the industry, various doctors, and university researchers speaking out about the vaccine.

“They created a huge amount of fear in mothers, and appealed to mothers’ sense of duty to get them to get their daughters vaccinated” – Dr Diane Harper (source)

The above quote was taken from the film, and here is an excerpt of her raising some important things to consider regarding the vaccine.

Some Research

If we are talking about recent research regarding the HPV vaccine, a new review was just published  in the journal Autoimmunity Reviews titled, “On the relationship between human papilloma virus vaccine and autoimmune disease.” 

The authors of this study came to the same conclusion as Dr. Harper, a doctor that was directly involved with the clinical trials for the approval of the vaccine (mentioned earlier in the article). They concluded that:

“The decision to vaccinate with HPV vaccine is a personal decision, not one that must be made for public health. HPV is not a lethal disease in 95% of the infections; and the other 5% are detectable and treatable in the precancerous stage.” (If you are interested you can access the paper here)

They also listed several conditions in which HPV vaccination is most likely the culprit, having been linked to a variety of autoimmune diseases which include: Multiple sclerosis, Guillain-Barre syndrome, primary ovarian failure, and more.

The 2008 FDA Closing Statement on Gardasil reports that 73.3% of the ‘healthy’ girls who participated in the clinical trials developed ‘New Medical Conditions. The list below highlights some of the ‘New Medical Conditions’ reported in the 2008 FDA Closing Statement on Gardasil. (source)

    • Blood & Lymphatic System Disorders 2.9% = 1 in 34
    • Gastrointestinal Disorders 13.4% = 1 in 7
    • General & Administration Site Conditions 3.8% = 1 in 33
    • Immune System Disorders 2.4% =1 in 50
    • Infections & Infestations 52.9% = 1 in 2
    • Injury, Poisoning, & Procedural Complications 8.0% =1 in 12
    • Investigations 11.8% =1 in 9
    • Musculoskeletal & Connective Tissue Disorders 6.8% =1 in 14
    • Nervous System Disorders 9.4% = 1 in 10
    • Pregnancy, Puerperium & Perinatal Conditions 2.0% = 1 in 50
    • Psychiatric Disorders 4.4% =1 in 22
    • Renal Disorders 2.7% =1 in 37
    • Reproductive & Brest Disorders 24.8 % = 1 in 14
    • Respiratory, Thoracic & Mediastinal Disorders 5.5% = 1 in 18
    • Skin & Subcutaneous Tissue Disorders 7.4% = 1 in 13
    • Surgical Procedures = Appendectomy 10.2% = 1 in 10

A year ago the vaccine was taken off the recommended vaccine schedule in Japan due to it’s adverse effects. What’s even more concerning is the fact that today’s vaccine has twice the amount of aluminum in it.

Related CE Article:

This is what can happen to children who receive aluminum containing vaccines.

Another groundbreaking article titled “Quantifying the possible cross-reactivity  risk of an HPV16 vaccine, published in the Journal of Experimental Therapeutics and Oncology concluded that:

“The number of viral matches and their locations make the occurrence of side autoimmune cross-reactions in the human host following HPV16-based vaccination almost unavoidable.” (source)

The list is literally endless, and for the sake of not turning this article into an essay, I’ll stop here. Hopefully I’ve provided you with enough information to further your research if interested. If you want to look at more scientific data, you can check out:

Giant Database of Studies Regarding The Gardasil Vaccine.

Sources:

All other sources are linked throughout the article.

 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964337/

http://www.greenmedinfo.com/anti-therapeutic-action/vaccination-hpv-gardisil

http://www.sciencedirect.com/science/article/pii/S1568997214000664

http://onemoregirlmovie.com/

http://www.cbsnews.com/news/gardasil-researcher-speaks-out/

 http://nsnbc.me/wp-content/uploads/2013/05/BSEM-2011.pdf

Giant Database of Studies Regarding The Gardasil Vaccine.

Gardasil: An International Scandal.

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Michèle Rivasi, MEP Vice-Chair of the Greens/EFA in the European Parliament, organized a press conference in Paris on April 2, the topic was Gardasil, a vaccine from Sanofi-Pasteur MSD against certain human papillomavirus responsible for cancer.
In the space of seven years, nearly 2 million young women aged 13-26 years received at least one dose of this vaccine in France, reimbursed at 65% by the Social Security … even though the evidence of its effectiveness has not yet been proven.`
For Michèle Rivasi, it is likely that clinical trials of Gardasil were not conducted following the rules of science. Normally, to evaluate safety, the treatment must be compared with placebo. However, in the case of this vaccine, the “placebo” that was used was the vaccine adjuvant itself.
The French Agency for Sanitary Safety of Health Products (AFSSAPS) registered Gardasil on its list of drugs under surveillance after the crisis of the Mediator.
Today in Europe, many young women, aged 18-24 years without medical history are affected with very debilitating diseases that could be attributed directly to vaccination. Océane Bourguignon was 15 when she received two injections of Gardasil. Within months she was hospitalized for multiple sclerosis. She temporarily lost her sight and the use of her legs. Her father, Jean-Jacques, was present at the conference with their lawyer, Jean-Christophe Coubris, together with the mother of Orianne Lochu, another young victim.
Today, many whistleblowers, researchers, physicians and health professionals are against the objective set in the Cancer Plan announced by François Hollande on February 4, which is to double the “coverage “of vaccination of young girls with Gardasil until 2021 because:
– Cervical cancer in France is no longer a public health problem (1.7 % of all cancers)
– The vaccine is only effective against infections caused by some strains of the virus: Gardasil contains antigens only for strains of type 6, 11, 16 and 18 and the other vaccine, Cervarix, for 2 strains. However, infections with strains 16 and 18, established as scarecrows by manufacturers, seem rarer in Europe. Note that there are more than 100 strains, including 18 considered high-risk oncogenic
– There is no evidence to date demonstrating efficacy of the vaccine against the occurrence of cervical cancer! 20 years back would still be necessary to obtain such evidence, however, the duration of vaccine protection is limited in time.
– The presence of aluminum adjuvant is very problematic, as shown by scientists Chris Shaw and Lucija Tomljenovic, from the University of British Columbia, and Professor Authier and Gherardi, from Hospital Henri-Mondor (Créteil), all present at the conference. The aluminum migrates into the body and reaches the brain, where it accumulates. There are many adverse effects noted: death, convulsions, syncope, Guillain-Barré syndrome, transverse myelitis, facial paralysis, chronic fatigue syndrome, autoimmune diseases, pulmonary embolisms, myofasciitis macrophages, pancreatitis…
– The effectiveness of conventional smears to detect cervical cancer has been proven.
– Deal with these risks. Austria refused to include these vaccines in the vaccination schedule and Japan no longer recommends this vaccination; many challenges exist in other countries.
– A dose of Gardasil costs 123.44 euros in France, or 370.32 euros for 3 injections required, this is far too expensive. This cost could increase if boosters were necessary, because the duration of protection of initial vaccination is still not known. The period of “catch-up” could generate a cost to social security of 926 M° euros. In subsequent years the annual cost would be € 148 M °.
-An indecent campaign of communication was engaged years ago to promote this vaccine: lobbying campaigns and aggressive advertising are conducted by laboratories that play on the fears and guilt, especially of mothers: “Protect your daughter, this is what is more natural for a mother.” One of these commercials has also been banned by the Medicines Agency in August 2010 for “lack of objectivity “.

For all of these reasons, MEP Michèle Rivasi calls for a moratorium: member states must stop recommending this vaccine until more studies are conducted on Gardasil, its effectiveness and dangers.

Merck’s Former Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time | Health Impact News

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Dr Bernard Dalbergue Mercks Former Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time

Health Impact News Editor

Dr. Dalbergue (pictured above), a former pharmaceutical industry physician with Gardasil manufacturer Merck, was interviewed in the April 2014 issue of the French magazine Principes de Santé (Health Principles).

Excerpts:

The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless!  Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.

Gardasil is useless and costs a fortune!  In addition, decision-makers at all levels are aware of it!

Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine.

I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.

There is far too much financial interest for these medicines to be withdrawn.

As we have reported in many previous articles here at Health Impact News, the HPV vaccine has become a huge international controversy, while enjoying widespread mainstream media and medical acceptance here in the United States. Any mainstream media reporter who dares to report on the controversy surrounding Gardasil faces ridicule and a potential loss of their career. (Just ask Katie Couric.)

U.S. law prevents anyone from suing Merck or any other vaccine manufacturer as the U.S. Congress gave them total immunity from civil lawsuits in 1986, and that legal protection which gives them a free pass to put as many vaccines into the market as they want to, was upheld by the U.S. Supreme Court in 2011. In addition, the National Institute of Health receives royalties from the sales of Gardasil. So don’t expect objective, true information from the U.S. mainstream media, or your U.S. doctor.

But Merck does not have the same legal protection outside the U.S., and it is here we must find information regarding lawsuits over injuries and deaths related to Gardasil.

Gardasil: An International Scandal

SaneVax, Inc.

Press Release from Michèle Rivasi, MEP France

Michèle Rivasi, MEP Vice-Chair of the Greens/EFA in the European Parliament, organized a press conference in Paris on April 2, the topic was Gardasil, a vaccine from Sanofi-Pasteur MSD against certain human papillomavirus responsible for cancer.

In the space of seven years, nearly 2 million young women aged 13-26 years received at least one dose of this vaccine in France, reimbursed at 65% by the Social Security … even though the evidence of its effectiveness has not yet been proven.`

For Michèle Rivasi, it is likely that clinical trials of Gardasil were not conducted following the rules of science. Normally, to evaluate safety, the treatment must be compared with placebo. However, in the case of this vaccine, the “placebo” that was used was the vaccine adjuvant itself.

The French Agency for Sanitary Safety of Health Products (AFSSAPS) registered Gardasil on its list of drugs under surveillance after the crisis of the Mediator.

Today in Europe, many young women, aged 18-24 years without medical history are affected with very debilitating diseases that could be attributed directly to vaccination. Océane Bourguignon was 15 when she received two injections of Gardasil. Within months she was hospitalized for multiple sclerosis. She temporarily lost her sight and the use of her legs. Her father, Jean-Jacques, was present at the conference with their lawyer, Jean-Christophe Coubris, together with the mother of Orianne Lochu, another young victim.

Today, many whistleblowers, researchers, physicians and health professionals are against the objective set in the Cancer Plan announced by François Hollande on February 4, which is to double the “coverage “of vaccination of young girls with Gardasil until 2021 because:

– Cervical cancer in France is no longer a public health problem (1.7 % of all cancers)

– The vaccine is only effective against infections caused by some strains of the virus: Gardasil contains antigens only for strains of type 6, 11, 16 and 18 and the other vaccine, Cervarix, for 2 strains. However, infections with strains 16 and 18, established as scarecrows by manufacturers, seem rarer in Europe. Note that there are more than 100 strains, including 18 considered high-risk oncogenic

– There is no evidence to date demonstrating efficacy of the vaccine against the occurrence of cervical cancer! 20 years back would still be necessary to obtain such evidence, however, the duration of vaccine protection is limited in time.

– The presence of aluminum adjuvant is very problematic, as shown by scientists Chris Shaw and Lucija Tomljenovic, from the University of British Columbia, and Professor Authier and Gherardi, from Hospital Henri-Mondor (Créteil), all present at the conference. The aluminum migrates into the body and reaches the brain, where it accumulates. There are many adverse effects noted: death, convulsions, syncope, Guillain-Barré syndrome, transverse myelitis, facial paralysis, chronic fatigue syndrome, autoimmune diseases, pulmonary embolisms, myofasciitis macrophages, pancreatitis…

– The effectiveness of conventional smears to detect cervical cancer has been proven.

– Deal with these risks. Austria refused to include these vaccines in the vaccination schedule and Japan no longer recommends this vaccination; many challenges exist in other countries.

– A dose of Gardasil costs 123.44 euros in France, or 370.32 euros for 3 injections required, this is far too expensive. This cost could increase if boosters were necessary, because the duration of protection of initial vaccination is still not known. The period of “catch-up” could generate a cost to social security of 926 M°  euros. In subsequent years the annual cost would be € 148 M °.

-An indecent campaign of communication was engaged years ago to promote this vaccine: lobbying campaigns and aggressive advertising are conducted by laboratories that play on the fears and guilt, especially of mothers: “Protect your daughter, this is what is more natural for a mother.” One of these commercials has also been banned by the Medicines Agency in August 2010 for “lack of objectivity “.

For all of these reasons, MEP Michèle Rivasi calls for a moratorium: member states must stop recommending this vaccine until more studies are conducted on Gardasil, its effectiveness and dangers.

Vaccines Do Not Cover Most Common HPV Types in Black Women.

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The HPV subtypes that are most common in black women in the United States are not targeted by the currently available vaccinesGardasil and Cervarix, according to new research.

The findings suggest that current HPV vaccination will be less beneficial for black women in the US than for their white counterparts, said study coauthor Catherine Hoyo, PhD, MPH, of Duke University, in Durham, North Carolina.

She spoke at a press briefing today at the annual International Conference on Frontiers in Cancer Prevention Research, in National Harbor, Maryland. The meeting is sponsored by the American Association for Cancer Research.

“The approved cervical cancer vaccines are effective but may not be effective for everyone,” said Paul Limburg, MD, from the Mayo Clinic, in Rochester, Minnesota, who moderated the press briefing. He was not involved with the study.

Persistent infection with HPV 16 and/or HPV 18 accounts for about 70% of all cervical cancers, said Dr. Hoyo. These are the subtypes targeted by Gardasil and Cervarix. Gardasil also targets HPV 6 and HPV 11.

Some black women in the new study did, in fact, have infections with HPV 16 and/or HPV 18. But much less often — their rate was about half of that of white women.

“Since African-American women don’t seem to be getting the same subtypes of HPV with the same frequency, the vaccines aren’t helping all women equally,” said study coauthor Adriana Vidal, PhD, in a press statement. She is also from Duke University.

The investigators prospectively looked at 572 women at 10 Duke-affiliated clinics with abnormal Pap tests who then underwent colposcopy; the group was about evenly divided among blacks (n = 280) and whites (n = 292). And just about even numbers of the respective racial groups subsequently had evidence of cervical intraepithelial neoplasia 1 (CIN1; 112 vs 118).

For whites with CIN1, the most frequent HPV subtypes were 16, 18, 56, 39, and 66.

But for blacks with CIN1, the most frequent HPV subtypes were 33, 35, 58, and 68.

Thus, in blacks, the most common genotypes were not HPV 16 and 18, which defies conventional wisdom about HPV infection.

There were no data on Hispanics in the new presentation because their numbers were too small at this point to be included, said Dr. Hoyo.

Without HPV 16/18, Are Some Black Women “Getting Dropped”?

The study findings may help explain why black women in the US are harder hit by cervical cancer than white women, said Dr. Hoyo.

She pointed out that both the incidence of invasive cervical cancer and related mortality rates are higher in blacks than in whites.

“We don’t know what is causing the disparity,” Dr. Hoyo told Medscape Medical News in a phone interview after the press conference.

“The problem is not likely detection,” she said, explaining that screening rates for precancerous lesions are comparable for black and white women.

The new data, however, suggest that, if clinicians are strongly focusing on HPV 16 and 18 for more careful follow-up in their black patients, then they may be missing some eventual cervical cancers, Dr. Hoyo said.

“Somewhere along the line, some black women may be getting dropped because they don’t have the HPV subtypes that are considered to be most aggressive,” she summarized.

Her advice to clinicians with black females who HPV infection and CIN is: “Broaden the subtypes that you look at.”

Currently, there is a vaccine in phase 3 clinical trials that targets 9 HPV subtypes (6, 11, 16, 18, 31, 45, 52, and 58). That means that 2 of the 4 most common subtypes in blacks are targeted by the experimental vaccine. “We need more African American women to enroll in trials like this to see how beneficial this new vaccine will be for them,” Dr. Hoyo said.

The new study is not the first to indicate that black women have lower rates of HPV 16 and 18.

A recent report found that black race was a predictor of lower HPV 16 and 18 positivity among women with high-grade cervical lesions (Cancer. 2013;119(16):3052-3058).

However, the new study from the Duke team is the first to indicate that this race-influenced distribution of HPV subtypes also occurs in lower-grade cervical lesions.

The Duke investigators also looked at high-grade lesions (CIN2/3).

In CIN2/3, HPV 16, 18, 33, 39, and 59 were the most common genotypes detected in white women, whereas HPV 31, 35, 45, 56, 58, 66, and 68 were the most prevalent in African American women.