Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

(NaturalNews) There is not enough evidence to confidently state that two popular vaccines against the human papillomavirus (HPV) will reliably prevent against the development of cervical cancer, according to two articles published in the New England Journal of Medicine.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” wrote Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, in the first article. “With so many essential questions still unanswered, there is good reason to be cautious.”

Haug noted that Merck’s Gardasil and GlaxoSmithKlein’s Cervarix have only been studied clinically for six and a half years at the most, and have only been on the market since 2006. This means that researchers still do not know if the vaccines are effective against HPV over the long term, or what cancer-related side effects they might have. For example, protecting the body from infection with certain HPV strains might have unforeseen immunological side effects, reducing the body’s resistance to other varieties.

Due to the newness of both vaccines, it is also not yet been possible to see whether they actually reduce cervical cancer rates. Normally, it takes years of HPV infection before cancer can develop – more time than either drug has been studied.

In the second article, a pair of Harvard researchers noted that HPV vaccination is not necessarily a cost-effective way to protect against cervical cancer. Current screening methods such as Pap smears have been very effective in reducing the death rate of cervical cancer already, but such tests must continue even after receiving an HPV vaccine. Even at their best, the vaccines do not protect against all cervical cancer strains that can cause cancer; a woman who has already been exposed to one of the strains in the vaccine will get no benefit from it.

“I believe the vaccine is a great advance,” said Philip Davies of the European Cervical Cancer Association, “but we have to implement it properly to get the benefits, and that hasn’t happened.”

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Well, Well, Well: Bad is bad

Well, Well, Well: Bad is bad

I’m honoured, and not at all surprised, to hear from Dr Mansi (“Merck Frosst responds,” Letters, Feb 5 – Feb 11, 2009). He obviously cares a lot about Gardasil and has put out some highly sensitive radar for commentary on it, which is good—this is a conversation we need to be having. 
Cervical cancer and other HPV-linked diseases are horrible, on that he and I agree—but that’s probably where our agreement ends. And despite his authoritative tone, I offered no misinformation. 
 
Mansi cites a US Centers for Disease Control (CDC) study that found no significant difference in adverse events between a Gardasil-vaccinated group and a non-Gardasil group. But a very recent study published in the Canadian Medical Association Journal found Gardasil to cause adverse reactions five to 26 times more often than other vaccines. That’s 500 per cent more, at the low end. The study was based on 114 000 young women who had received Gardasil compared to young women who had received other vaccines. 
 
But to bring in the perspective of someone with a little more credibility than I as a journalist might have, I spoke with neuroscientist and UBC professor Chris Shaw. Dr Shaw’s research has turned up some alarming links between aluminum hydroxide (used in vaccines) and neurological damage—something called neuro-inflammation, which is linked to autism, epilepsy, Alzheimer’s, Parkinson’s, ALS and autoimmune disease.
 
Gardasil contains aluminum, and although aluminum adjuvants—the non-viral component of vaccines, designed to stimulate immune response—have been used in vaccines for decades, Shaw says they either haven’t ever been properly tested for safety, or the evidence has been tossed aside. 
 
“Attenuated microbes alone don’t give a sustained immune response, but aluminum does,” he explains. “Without an adjuvant that stimulates a long-lasting immune response, vaccines just don’t work all that well.” 
 
But aluminum generates molecules called tau proteins, which form the clumps in the brain that we see with neurological disease. “What I’ve seen in the lab is the reason my daughter’s never had a vaccine,” he tells me. “The way the aluminum danger is usually dismissed is that we ingest aluminum all the time, but digestive systems have ways to excrete it. When it is injected, it’s an entirely different thing.”
 
Which brings me back to Gardasil and double-blind trials. When we’re comparing two groups, and the control group has been given other vaccines or an aluminum-containing placebo, reactions between the two groups will be similar. And that’s exactly the kind of comparison that has mostly been made in clinical trials. What we need for an accurate picture is to compare vaccinated with completely unvaccinated groups over a long period of time. 
 
As to approval given by Health Canada and other health agencies, we need only to have a look at history, to read accounts like that of former Health Canada employee and whistleblower Dr Shiv Chopra to be reminded of how things work. 
 
“Vaccines are a business, like any other,” the Cochrane Library Review reminds us. “The only difference is that governments are co-sponsors with industry … overestimation of the threat by the target diseases, suppression of data on adverse events and exaggeration of effectiveness are frequent. In the case of population vaccination programs, both governments and industry have conflicts of interest.” 
 
And financial interests, as we all know, tend to trump safety. “Merck lobbied every opinion leader, women’s group, medical society, politician, and went directly to the people—it created a sense of panic that says you have to have this vaccine now,” Dr Diane Harper—cervical cancer researcher, vaccine developer and professor of medicine at Dartmouth Medical School—told the New York Times last August.
 
Mansi insists that the full burden of disease prevented by Gardasil is being overlooked, but we may in fact not be decreasing the burden of disease at all. By continually over-stimulating the immune systems of our children we may be trading one tragedy for another, much greater one. 

As to the comment encouraging readers to consult physicians—absolutely, but it is fair to remind the public where physicians get their information on drugs and vaccines.

Vaccinating teens during menstrual phase may increase adverse reactions

Vaccinating teens during menstrual phase may increase adverse reactions

Why has there not been any mention of the potentially adverse effects of Merck’s cervical cancer vaccination, Gardasil® in relationship to the timing of the inoculation and where a young woman is in her menstrual cycle? This information is especially critical considering the vaccination is recommended for adolescent girls from the age of nine to young women up to 26-years.

SHAME, SHAME, SHAME ON BOTH INDSUTRIES

Gardasil®, as well as other immunizations administered to adolescent women, are dispensed without regard to where a woman is within her menstrual cycle. During Gardasil®’s, clinical trial period, FDA approval, and during the two years it has been on the market, not one article has been written about how a young woman might tolerate the injection during premenstruum; nor is there any information in the Patient Product Information or the Prescribing Information on the Gardasil® web site, that cites any corollary to adverse reactions to the injection in relationship to the menstrual cycle.

Withholding this information is nothing less than a crime against women

Earlier this month the Center for Disease Control (CDC) released report on the number of adverse reactions to Merck Pharmaceutical’s Gardasil® vaccine for cervical cancer. According to the report over 14,796 adverse events have been reported to the Vaccine Adverse Events Reporting System (VAERS) since 2006 when the controversial vaccine for cervical cancer was approved by the Food and Drug Administration (FDA) and introduced to the mass market. Since the 2006 approval, nearly 8-million adolescent girls and young women have currently received the Gardasil® vaccination.

While Wall Street reported Merck’s 1.5-billion dollar revenue3 windfall from the sale of the Gardasil®, fifteen deaths and two lawsuits are amongst the nearly 8,000 reports, according to the CDC. On August 14, 2008 the National Vaccine Information Center (NVIC) sent out an email blast with more shocking statistics; there are now 35 confirmed deaths. On July 22, 2008, The Board of Directors of Merck & Co., declared a quarterly dividend of $0.38 per share on the Company’s common stock for the fourth quarter of 2008.

If one does the quick math, it becomes obvious that nearly 10% of the women who received the Gardasil® vaccination experienced an adverse reaction. In our humble opinion, that is an incredibly high percentage. Add that to the number of unknown and unreported incidents of an adverse reaction to Gardasil®, and the percentage could actually be far greater. David Kessler, former Commissioner of the FDA reported in an article in JAMA — June 2,1993, Vol. 269, No.21; “…it is estimated that only between 1-10% of immunization events are reported to the Vaccine Adverse Events Reporting System;” a figure supported by two NVIC investigations.

NVIC also reported that “In New York, only one out of 40 doctor’s offices or 2.5% confirmed that they report a death or injury following vaccination” leaving 97.5% of vaccine related deaths and disabilities unreported.

The percentage of adverse reactions to Gardasil® could indeed, be significantly higher than researchers have estimated.

ADVERSE REACTIONS

It is possible and probable that some of the adverse reactions to the Gardasil® vaccine are due to the shot being administered during the paramenstrum. It is also possible and probable that some of the adverse reactions to the vaccination may be hormonally related to the premenstrual phase — and not due to the vaccination.

Based on the current research and the unacceptable number of adverse reactions and unexplained fatalities “coincidentally” related to the Gardasil® inoculations, it would behoove Merck Pharmaceuticals to include menstrual cycle evaluation with the overall guidelines in the Gardasil® Patient Product Information and the Prescribing Information. For that matter, every pharmaceutical company producing and marketing drugs to women should also have this information in their product and patient information.

Full Article

Gardasil trials update–“New Medical Conditions”

Gardasil trials update–“New Medical Conditions”

By Cynthia A. Janak

…I found an interesting document on the FDA website about my favorite topic, Gardasil.

Subject: Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18.

Dated September 11, 2008

http://www.fda.gov/cber/products/gardasil/gardasil091108.pdf

This document is 187 pages long and I was scanning this document for adverse events. I did find something interesting starting on their page 132; it was Table 73, titled “New Medical Conditions” Days 1–15…

The total study participants were 5088 for Gardasil and 3790 for the Placebo. (Now let us remember that this group includes the Alum and carrier solution placebos.) The participants that they were able to follow-up with were 5012 for Gardasil and 3725 for the Placebo group.

What caught my eye with this table was the fact that these participants did not have these conditions prior to the study. I surmise this because of the title “New Medical Conditions”. So in essence these individuals were probably healthy average people with active lives and families.

Here is what I found.

Continued

Gardasil Mandated For New U.S. Citizens

Gardasil Mandated For New U.S. Citizens

If at first you don’t succeed, try, try, again. That’s exactly what the giant drug company Merck has done; it changed its lobbying target and now has the federal government mandating injections of its vaccine for legal immigrants, ensuring a continuous return on its product development investment.

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National Vaccine Information Center Says Government Denies Gardasil Risks

National Vaccine Information Center Says Government Denies Gardasil Risks

The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

– In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

– In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

– During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

– Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

Source
Barbara Loe Fisher
National Vaccine Information Center

HPV mandatory for Immigrants-Oh MY!

Genetically engineered Merck Cancer Vaccine Made Mandatory For Immigrants

Immigrants seeking permanent legal residency in the U.S. are now mandated to take an expensive and controversial vaccine that has been linked with thousands of serious complaints and several deaths.

The Human Papillomavirus (HPV) vaccine — known as Gardasil — is one of five the U.S. Citizenship and Immigration Services recently added to the required list, reports Fox 8 News.

A press release from the U.S. Citizenship and Immigration Services Agency confirms that the requirements for the vaccine went into effect on July 1, 2008.

More on this story..